It’s difficult to get a man to understand something when his salary depends on his not understanding it. –Upton Sinclair.
In 1940, after conquering most of Western Europe, Hitler mercilessly bombed British cities and tried to bring England to its knees. 18,000 tons of explosives over 8 months killed close to 40,000 people.16 3 ½ million people were moved to the countryside and the Ministry of Health “built or expanded hundreds of hospitals”, updated laboratories, X-ray facilities. He began paying for ambulances and the care of civilians and combatants who suffered fractures, burns, and head injuries. The ill and injured were transferred to private suburban hospitals and “doctors received government salaries.” Unexpectedly amidst the death and destruction most Brits got healthier, and when the war ended the Brits didn’t want government care to end. In 1948 parliament formally passed the National Health Service act and health care became a right. 4
Postwar France was devastated. “Seventy-five per cent of the population paid cash for private medical care. Many people had become too destitute to afford heat, let alone medications or hospital visits.” However, pre war, some manufacturers and unions had instituted a self imposed payroll tax. They now used the money for medical care. As an outgrowth, France currently has a number of non profit insurance funds.
In the U.S. president Franklin Roosevelt didn’t mention health care or use the word “rights” in his famous 1941 speech to congress. The four freedoms he championed were speech and expression, “the freedom to worship God in a person’s own way, freedom from want and freedom from fear.” He had wanted federally sponsored health insurance to be part of the 1935 Social Security act, but “he allowed it to be thrown out in order to hurry the bill through Congress.2”
Before health insurance was more than a concept, the military and VA were caring for the wounded. During the Second World War employers attracted workers by offering health insurance. At the time the wages industry could offer were restricted as part of the 1942 Emergency Stabilization Act. Our nation’s work related system created inequities and it helped foster the rugged individualistic belief that people don’t deserve health care. They have to earn it.
In 1947 health care costs were rising and it was too expensive for many. That January in his State of the Union address, President Truman said: “Of all our basic resources none is more valuable than the health of our people.” He proposed a plan that provided medical care to all who need it. “A government funded health care program that everyone pays into and from which they can withdraw when they need it. Not a charity, but (care) on the basis of payments made by the beneficiaries of the program.”
Truman’s idea initially had widespread support. Then the powerful white male American Medical Association (AMA) launched a massive campaign: Radio and newspaper ads. Pamphlets and mailers. “Keep politics out of medicine.” Truman was a Communist. (At the time Communism was a real scare.) “His plan was socialized medicine. Government officials will intervene in medical decisions and destroy the “sacred doctor patient relationship.”
Popular support plummeted and the bill failed to get through congress.6” Efforts by subsequent politicians to provide government sponsored health insurance was repeatedly opposed by the “influential” American Medical Association.
In the post war years Blue Cross and Blue Shield were started in one state, then another as public, tax-exempt corporations. By 1945 the “blues” were responsible for 2/3 of the nations’ hospital insurance, and by 1955, 60 percent of Americans had an insurance policy.1
Aetna and Cigna began marketing medical policies in 1951. They tended to target people who were healthy and unlikely to need expensive care. The IRS did not treat employer provided health care as part of a person’s taxable income and the Revenue Act of 1954 made it official.6
In 1960 John Kennedy, the son of a wealthy Irish immigrant became the nation’s youngest ever president. In 1959, the year before Kennedy was elected, Cuban revolutionaries ousted their ruler, a dictator named Batista, and Fidel Castro became the country’s leader. He was a communist and “Under communism, virtually everything belongs to the state.” Large single owner farms were taken over by the government and “either redistributed to peasants or run as communes.” The U.S. and Russia were in the midst of a “cold war”, and the thought of a Soviet ally a mere 110 miles south of Florida troubled some of the nation’s leaders. In 1961 a group of Cubans, sponsored by the CIA invaded the island. The U.S military didn’t get involved and the intruders were quickly defeated and captured. After that the popularity of the U.S. president waned.9
At the time Kennedy was trying to change the system that prevented blacks in the South from voting. His efforts went nowhere. Nor was he able to convince Congress to pass legislation that provided medical care to our older citizens.
Then in the fall of 1963 Kennedy was assassinated. The nation mourned, and Lyndon Johnson, former leader of the senate, became the nation’s president. Under his direction Congress paid tribute to their slain leader. The voting rights act and Medicare and Medicaid became the law of the land. (see prior chapter.)
During the subsequent decade medical care became more effective, technical, and hospital based. Costs escalated. In the early 1970s the political elite felt there was a “crisis”. In 1973, during the Nixon presidency, the HMO: health maintenance organization–act was passed. The idea was to get groups of doctors working together. In addition to treating illnesses physicians were now being asked to keep people healthy. Companies with more than 25 employees were required to offer this new entity as an option.
Groups popped up all over the country, and they took customers away from the ‘indemnity” insurance companies. In response traditional insurers started buying HMO’s and the new bosses put pressure doctors and hospitals. They tried to modify the way medicine was practiced by enforcing “guidelines”, recommendations by authoritative medical committees that told doctors what tests to perform in certain situations. Physicians were paid less. Knowing they would only be compensated for a portion of their charges, doctors and hospitals raised the “list price” of their surgeries, visits, and procedures.
At one time HMOs tried to kick women out of the hospital the day after they delivered a child or had a breast surgically removed. Some of the patients were ready to go home, but others had medical or physical problems that created risks. An outcry led to publicity and lobbying. Laws were passed, and the practice ended.
The law restricted the amount a sick person in an HMO had to pay in the form of co-pays and deductibles. And it required HMOs to hold an annual open enrollment period. During that time people with pre-existing conditions could become members. HMOs were required to provide insurance “without regard to health status.”
For-profit companies could exclude high risk individuals. A law passed in 1945, the McCarran-Ferguson Act, had “exempted the business of insurance from most federal regulation.” For profit companies were able to cherry pick—to offer the young, healthy, and employed, low cost policies, and they were able to reject individuals with medical problems, people who needed health care. An expectation—a de-facto right—was created for young, healthy, and employed and it was taken away from others. HMO’s could not offer companies high deductible or low benefit policies, but for-profit insurers could and did. Employers and healthy individuals increasingly bought policies from for profit companies.
Over the years the high risk populations of HMOs like Kaiser of Northern California and the Blues grew. For the young and healthy the plans they offered were costlier than those offered by for- profit companies, and the young and healthy increasingly chose private insurers.
In time “the Blues were hemorrhaging money”. The HMO I worked for was in grave risk of failing.
In 1993 Bill Clinton became president and he asked his wife, Hillary, to form a committee and come up with a bill that would do something about the rising cost of health insurance. The premiums people paid were going up 8.5% a year; many Americans were dropping their coverage, and polls indicated the public would welcome controls.
At the time the government, under Medicare and Medicaid (and to a lesser extent the Public Health Service, the National Institutes of Health (NIH), Indian Health etc.) was on the hook for more than half of the nation’s health care costs.
Blue Cross controlled a large part of the private insurance market. The Blues weren’t a single large company. They were a conglomeration of state by state plans that were non-profit and tax exempt. Their boards and CEOs were very well (and sometimes quite richly) compensated, but they had no shareholders. They didn’t need to earn money or pay dividends.
In 1990, while Hillary Clinton’s group was working on their bill, the CEOs of insurance companies pow-wowed with the people in charge of hospitals, and with drug and medical device manufacturers. They formed a group called the HLC., the Health Care Leadership Council.
I suspect the Clintons thought their proposals would be popular. I doubt they were prepared for the HLC attack and spin that followed.
For the record the plan Hillary and her medical advisors (Atul Gawande was one of them) came up with sounds a lot like Bernie’s Medicare for all. It didn’t pass so it’s not really part of the “real history of medicine.” Many of the details are in the foot notes.11
The proposed legislation would have required health plans to provide an all inclusive benefit package. It would have been regulated by a regional non-profit organization or an agency of the state. When people got their insurance from their jobs the employer had to pay 80 percent of the cost of the premiums.
AND, it WAS comprehensive. Hospital, outpatient, drug, and dental care were part of the scheme.
To keep costs from going through the roof there was a regional money target. If it was exceeded the payments to hospitals and doctors would drop. Out of network emergency charges couldn’t be inflated. Balanced billing–making the patient kick in when the insurance company refused, was prohibited. There were caps on premiums and drug prices would have been “reviewed.” A tax increase was not recommended. (details in the foot notes.)
The HLC claimed that if the proposals became law: Health care would be rationed. Patient’s rights would be compromised. The Clinton plan “was formed by academic elites behind closed doors.”
T.V. ads featured Harry and Louise, two fictional Americans who thought the suggestions would let “Washington bureaucrats decide how much care you and your family receive.”
Congressmen and women were lobbied. There were letter writing campaigns. The Medicare program was pronounced “dysfunctional”.
The effort to prevent health care reform cost $300 million. Insurance companies argued that the “free market could work if government got out of the way. “
In the end the Clinton proposals were not accepted by Congress, and Clinton went on to fight other battles.
As I read about the political clout of the AMA, American Medical Association, I began wondering how doctors decades later allowed the for profit insurance companies to totally take over the entirety of health insurance. Where were we? Why didn’t we do or say something?
My answer: Doctors in the 50s and 60s had feared and fought government involvement, but they found Medicare led to better care and higher salaries. I think the experience lulled the profession and made us more trusting and complacent. Big organizations, it turned out, weren’t bad after all.
Insurance company representatives were smooth and seemed to be good guys. A prominent Georgia doctor named Leaderman was convinced the companies would “respect physicians” and allow them to provide high quality, cost effective care.”
At the time that Clintons released their plan, Blue Cross and Blue Shield created obstacles to the for-profit companies. They controlled a large part of the health care market. The money they took in was actually used to pay for medical care. Driven by “need” not “greed”, these companies only charged what they needed to cover their costs. By so doing they established a de-facto price boundary, and it limited the amount the for-profits could charge for policies.
But over many decades the Blues had gradually lost market share, and they were about to crack3.
Then, one day in 1994 I heard a group at the nurses’ station discussing an article in the local paper. The board of directors of Blue Cross had resigned. They formed a for-profit health care organization and took all the low risk policies with them.
We now know7 that in 1994 the national Blue Cross and Blue Shields board of directors met in Washington D.C. and voted to allow its members to “operate as for profit companies.” Blue Cross of California changed its name to WellPoint, took a bulk of the policies that insured low risk individuals, and they became a new, for-profit company. They then bought the non- profit Blues plans in Missouri and Wisconsin. Blue Cross of Indiana became Anthem, and merged with WellPoint. By 1996 California, Colorado, Ohio, Virginia, Kansas, Maine, Missouri and Georgia had changed over. There were few remaining not-for-profit insurance plans. But the private companies were in charge and could now call the shots.
The for-profits were not required to “provide affordable, accessible health care” to all the people of their state. They could, instead, provide and/or charge for health care according to risk, and they could concentrate on making money for their stockholders. Kaiser, the group I worked for, modified its business model.
In 1987, the for-profit companies contended they were providing a service to the community and convinced the IRS to give them “special tax benefits.”
In 2008 a former insurance executive named Wendell Potter had enough, quit, and wrote an “expose”, a book titled Deadly Spin. His revelations didn’t make headlines or shake events much. But his story is similar in some ways to that of the man who exposed big tobacco. Formerly one of the nation’s better PR people, he was a “spin” expert. When the press came after his company for misdeeds, questions were not answered. He taught his people to respond with talking points. CEOs were trained. Potter attended interviews, and he limited the scope and duration of the sessions.
In his book he explained the “right way” to reply to questions about the 45 million Americans who didn’t have health insurance. Spokesmen and women were taught to blame the victim: 40% of the uninsured were young adults, and company representatives explained that many of the uninsured believed the risk of injury or illness was too low to justify the cost of the premium. 35% earned $50,000 a year and should be able to afford insurance, so it was a question of choice. 20% were not citizens.
Potter, a poor boy from the back country of Tennessee, was the first in his family to go to college. His father served in Europe and North Africa during the Second World War, then came home, married, and opened a grocery store. When the business lost money his dad got a job in a “brutally hot factory”, and toiled there until he retired.
In and after college Potter was briefly a journalist. Later he became a press secretary for a man who ran for governor and lost, and he next became a “spokesman for a failing banking empire.” In time the health insurer Cigna hired him “to help boost awareness” of the company’s health care business. He became a PR man extraordinaire and helped devise the messages of some of the nation’s leading insurance companies. He participated in the demolition of Bill Clinton’s health bill. Well paid, important, and at the top of his game, he paid a visit to his parents in July 2007. While there he learned that John Edwards, the presidential candidate, was scheduled to talk about health care reform at a fair in nearby Wise County Virginia. Wendell decided to attend and listen. He was devising talking points for his company and was looking for inspiration.
The health fair was produced by an adventurer and T.V. personality named Stan Brock. In 1985 Brock had founded a nonprofit organization called Remote Area Medical. “Volunteer doctors, nurses, technicians, and veterinarians, at their own expense, were taken on expeditions where they treated hundreds of patients a day under some of the worst conditions.” Crews worked in Katrina after the hurricane, Haiti after the earthquake, and held day long clinics in underserved areas in the U.S. Wise County Virginia was one of those locations.
Potter arrived early and parked in a jammed lot. Some of the people who formed long lines had slept in their vehicles. It had rained the night before and it was damp. Inside the treatment area large numbers of people waited in lines that led to clinics. Some people got their care in tents or animal stalls. Dentists pulled teeth. Nurses performed pap smears. Potter recalled mammograms, sigmoidoscopies, and doctors cutting out skin tumors.
He was troubled by what he saw. This wasn’t happening in a third world country. This was America, the land with the best health care in the world. Two thirds of the people at the health fair had no insurance, but a third did. Problem was many of their policies didn’t kick in until thousands of medical dollars were paid by the policy holder. In some cases we’re talking about $15,000 each year. In other cases the amount was $30,000. The average income in the nearby counties was $23,000 to $26,000. A “family health insurance” policy went for $13,375.
62% of bankruptcy filings in 2007 were the result of healthcare costs.5
What Potter witnessed could have been spun. The young uninsured were risk takers. People who earned $50,000 a year were shirking their responsibilities. Non citizens would be lumped and denounced as illegal aliens, though many were students. Other non citizens were in the country legally, and were performing jobs Americans couldn’t or wouldn’t do. They didn’t have health care because they couldn’t afford it.
Potter knew how to tell the story, but when he looked into the faces of the people standing in the line in the rain for hours to get care in animal stalls, Wendell saw folks who could have been his relatives or neighbors. He didn’t know them, but they seemed so familiar. They were like his dad and mother. The army had sent Potter’s father to Europe and North Africa during World War Two. When his dad returned, both parents dropped out of high school and worked. “They sacrificed years to send Wendell to college.” The people Potter was being paid to vilify were no longer anonymous or faceless.
A few days later Wendell was aboard a company jet. When his food arrived on a gold trimmed plate, he thought about the people who days earlier were receiving medical care in animal stalls. That’s when he decided to quit the spin game. The contrast between the compensation executives exacted and the care they denied was something that Potter pointed out in his book.
When Edward Hanaway left Cigna in 2009 he wrote a book blaming the health care consumer for the rising cost of health care. His retirement package was valued at $111 million. In 2007 a top average Health Insurance CEO had a salary of over $11 million. William McGuire of UnitedHealth backdated his stock options, was caught, and paid back $620 million dollars. He then managed to survive on $530 million in non stock compensation plus an additional $800 million in stock options.
In his book Potter documented, but avoided direct comments about the pay executives received, dollars that could have gone into providing better or more care (or even used as dividends for investors).4
Corporations in this country are strange inventions. They are endowed with the same freedoms of speech the constitution gives to humans. Some tend to only have the conscience and ethics needed to mollify the public and the government. They make no bones about their purpose for being. Their job is to make money, nothing more.
1. An American Sickness by Elizabeth Rosenthal. Penguin Press. 2017.
7. https://www.managedcaremag.com/archives/1996/6/what-profit-trend-health-care-really-means ——Managed Care Magazine June 1996: “In June 1994, a little-known event occurred behind closed doors in Washington, D.C., that opened the path for any of the 63 Blues plans to switch. The Blue Cross and Blue Shield Association’s board of directors gathered to discuss, among other things, changing the association’s bylaws to allow its affiliates to operate as for-profit companies. It wasn’t the first time the board discussed the hotly-debated issue, but this time the measure had enough supporters to enact the proposed reform by a narrow margin. Until then, the board only allowed its plans to operate for-profit subsidiaries, while the parent company using the Blue Cross and Blue Shield name had to remain nonprofit.”…”Whatever its implications for that “social value,” the market — employers, government and patients themselves — is clearly calling the shots in health care today. In most places, it seems to be saying that for-profit plans are the wave of the future.”
11. The Hillary Clinton Health care proposal (abridged.) The health plans they proposed had to cover: hospital services; health professionals; emergency and ambulatory medical and surgical services; clinical preventive services; mental illness and substance abuse services; family planning and services for pregnant women; hospice and home health care. extended care and ambulance services outpatient laboratory, radiology, and diagnostic services; outpatient prescription drugs and biological; outpatient rehabilitation services durable medical equipment; prosthetic and orthotic devices; vision care; dental care; health education classes; investigational treatments;
The items and services provided could not be subject to any duration, scope limitation, deductible, copayment, or coinsurance.
The legislative proposal included a “low” cost sharing schedule: no deductibles; An annual individual out-of-pocket limit on cost sharing of $1500; and (B) an annual family out-of-pocket limit on cost sharing of $3000;
High cost packages which (with a few exceptions) had an annual individual general deductible of $200 and an annual family general deductible of $400.
Individuals had to pay for the first day of care for each episode of inpatient and residential mental illness and substance abuse, and for each episode of intensive nonresidential mental illness and substance abuse treatment. And patients were responsible for the first $250 for outpatient prescription drugs and biological. Then the plan provided benefits.
To keep costs from going through the roof there was a regional target. If the projected cost of care was exceeded there were: automatic, mandatory, nondiscretionary reductions in payments to health care providers.
For out of network emergency and urgent care, individuals had to pay “a percentage of fee set by the alliance.
The items and services provided could not be subject to any duration, scope limitation, deductible, copayment, or coinsurance.
The legislative proposal included a “low” cost sharing schedule: no deductibles; An annual individual out-of-pocket limit on cost sharing of $1500; and (B) an annual family out-of-pocket limit on cost sharing of $3000;
Balanced billing was prohibited: A provider was not allowed to charge or collect money in excess of the fee schedule. And they couldn’t directly bill the patient.
They also recommended caps on health insurance premiums. Companies who wanted to charge more would now have to come before a commission and explain where the money was going and why it was needed.
“It always seems impossible until it’s done.” – Nelson Mandela
Over the course of many decades one American group, then another, was given the RIGHT to receive state of the art, health care.
The right to health care
Medical care was not one of the rights mentioned in the Declaration of Independence, and the ones that were said to be “God given and self evident” were little more than a philosophic utterances or commandments carved on a stone tablet. They wouldn’t become “real” until they were granted and funded by government. The right to liberty didn’t exist for black people who were held as slaves before 1865 when the 13th amendment became law. Women didn’t have the “right” to vote until 1920, when enough states ratified the 19th amendment. The right to bear arms was established in 1791, but was never funded. Guns aren’t free. They aren’t supplied by the government. We have to buy them.
In the late 1700s few thought health care should be a right, in part because most of the treatments used by the doctors of the day were pretty awful. Like—the December morning in 1799 when 67 year old George Washington awoke desperately ill. He was retired, living at Mt. Vernon. (As related by his secretary Tobias Lear1) The previous day Washington felt well and went out in the snow to “mark trees that were to be cut down.” Upon awakening the day in question he couldn’t talk and had trouble breathing. His wife sent for one doctor, then another. George and his wife Martha were two of the country’s richest people; they didn’t need subsidized care.
During the day three prominent physicians came to the home and plied their trade. The doctors were among the country’s best and they worked hard. On 4 occasions they bled the sick man and removed a lot of blood. His throat was swabbed, he gargled, his feet were covered with wheat bran, and he was given an emetic to induce vomiting. Nothing worked and Washington’s breathing got worse, so he dressed, thanked his 3 doctors, and made arrangements for his burial. That night he died.
In 1781 we didn’t know bacteria and viruses caused infections. Doctors (and barbers) were skilled at cutting off wounded or infected limbs. Surgery was risky. Antibiotics didn’t exist. There were no blood banks. And most doctors hadn’t developed the skills or knowledge needed to remove damaged organs safely.
In 1914, when the First World War started, physicians had a better understanding of illnesses and their cause, but they still were unable to do anything to prevent or treat them. My dad was six at the time. The family lived in a small, wooden, dirt floor, cottage in a Shtetl that straddled one of the main Ukrainian east- west highways. That year acting on orders from the Czar, the Russian army attacked Germany, entered their enemy’s territory, and fell into a trap. The second army was virtually` destroyed at the Battle off Tannenberg. Thousands of the surviving soldiers retreated. When they came through my father’s town the fleeing Cossacks burned the family home to the ground. During the subsequent years the family crowded into one of the remaining cabins on the edge of the village. It was owned by an elderly Ukrainian who hadn’t left for mother Russia with his family.
During the war years no one bathed; everyone’s garments and bedding contained body lice. One winter there was a typhus outbreak. The infectious disease is caused by a tiny bacterium (ricketsia) that lives in the lice. When people scratch and tear their skin the bacteria enters their bodies causing a severe illness: chills, high fevers, lethargy, rash, and a cough. Some people become delirious or lapse into a stupor. “During the eight-year period from 1917 to 1925, over 25 million people living in Russia developed epidemic typhus; three million died. Some claim epidemic typhus has caused more deaths than all the wars in history.3”
Antibiotics had not yet been discovered, so doctors could diagnose the disease but they had no treatment. When the town’s typhus outbreak became rampant a horse drawn wagon came around. People with high fevers and confusion were loaded onto these carts and taken to a large hall full of beds where most of them died. (In the 21st century Typhus is easily cured and prevented with the antibiotic Doxycycline.)
My father always remembered his boyhood, and when I chose to go to medical school he shrugged. Based on what he witnessed, he had concluded that doctors knew how to recognize and diagnose illness, but that’s all they could do.
Back then, as now, most people who get sick recover. Smallpox once killed 30 % of those infected, but 70 percent mounted a defense and lived. After a person donates a kidney or half a liver (to be transplanted in another body), the donor usually recovers completely and lives a normal life. When a wounded or infected body is given the right boost, it will usually do the majority of the heavy lifting.
During the last century and a half the right to receive state of the art care was periodically granted to one group, then another, and black men and women were gradually and reluctantly allowed to participate.
After the American Civil War ended the government faced a humanitarian crisis. Four million former slaves were abruptly told you’re free to leave, but they had no resources and nowhere to go to– no basic shelter. Often cramped together in abandoned buildings, they couldn’t maintain basic hygiene, and many got sick. Privately run institutions for the very poor existed, but there were no hospitals, and the private shelters wouldn’t accept the newly emancipated. Former slaves died in large numbers. In some places “their bodies were littering the streets.” About that time there were 54,000 male and 300 female medical doctors in the U.S. and only a few were people of color.41,42
Congress established the Freedman’s Bureau in the South.” It “fed millions of former slaves and poor whites, built hospitals, and provided medical aid. But its hospitals didn’t have enough beds, linens, quarantine facilities. There were merely 120 doctors for the entire population. And there was a smallpox outbreak. In July of 1872, “responding to the continued hostility of white Southerners, Congress terminated the Freedman’s bureau.”
In the early post Civil war years the government founded a number of black schools and colleges. In 1868, one of them, Howard University in Washington D.C., “became the first school to have a medical program for blacks.”2.
The country’s first black surgeon, James McCune Smith, had to go to England to get his medical degree. He grew up in New York and had a black mother who had been a slave and a white father. Educated in the city’s African Free School, he was denied entrance to an American University and went to college in Glasgow. In 1937 he graduated from a London medical school, returned to the U.S. and became a vocal abolitionist. He wrote the introduction to the Frederick Douglass book “My bondage and my freedom,” and was practicing medicine in Brooklyn when the Civil War ended.40
Rebecca Lee Crumpler became the country’s first black “doctress” of medicine in 1864. Born a “free” black in Delaware in 1831, she later wrote about her journey in the Book ofMedical Discourses. It was published in 1883. “Having been reared by a kind aunt in Pennsylvania, whose usefulness with the sick was continually sought, I early conceived a liking for, and sought every opportunity to relieve the sufferings of others.” Between 1852 and 1860 Crumpler “served as a nurse under several doctors. In 1860 she “was admitted to the New England Female Medical College, the first institution in the U.S. to train women in medicine.” It merged with Boston University in 1873.40 Students were “taught by rote–four lectures each day, often clocking in at eight hours total. A systematic course of study with nominal variation from college to college didn’t exist, and there were no “medical licenses” or exiting exams.” 41
Educated in the days before Pasteur and Koch discovered that bacteria—germs– cause infections, Crumpler explained that infectious diarrhea—she called it cholera infantum– was caused by “poor milk, bad air arising from old water-soaked cellars, or some atmospheric phenomena.”
When I entered Washington U medical school in 1958, my class consisted of 75 white men, 8 women and the school’s first black student. His name was James Sweatt and for decades he “had the impression that it was routine for all the professors of the departments in the medical school to sit around and quiz applicants for admission. At the 25th or 50th class reunion he found out that everyone else who was interviewed for medical school had been seen by one person and that was that.” I was introduced to Jim’s world one evening when, after an evening of study at the library, he was one of the group of med students who went to a local diner for a late night snack. After a series of waitresses bypassed our table we asked the guy in charge why no one had taken our order. “You look like smart guys” he said. “What do you think?” Dr. Sweatt grew up in Dallas, a town where, in the 1950s“Whites Only” signs peppered the landscape. Blacks were allowed to buy clothes in the town’s department stores, but they weren’t allowed to try them on.” His mother was an 8th grade teacher, his father a high school principle and he was educated in white schools and at a university where he was one of each institution’s 2- 3 black students. After Jim graduated from Medical School in 1962 he became a thoracic surgeon and practiced in Dallas. In 1995, he became the first African-American president of the Dallas County Medical Society. After he graduated our school, Washington U., didn’t admit another black medical student for 10 years. 39
St. Louis City hospital was integrated by the mayor in 1955, the year after the Brown v. Board of Education decision. At the time black physicians, by and large, couldn’t get privileges to practice at hospitals dominated by whites. Ninety six percent of the patient’s in New York’s for-profit hospitals were white and 97% of the people in the city’s private and semi-private not-for-profit hospitals were caucasian.26” Throughout the American South and in many of the border states black physicians were denied membership in the local medical association, and non members could not get hospital admitting privileges.37
As late as 1968, the AMA condemned racial discrimination but allowed its member medical societies to discriminate. The AMA didn’t adopt a policy that banned racial discrimination in membership of national and state medical societies until 1968.”
Seemingly politically influential, the AMA is a national conglomeration of physician groups. It opposed national health insurance, currently disapproves of the single payer option, and for years ran cigarette advertisements that touted the health benefits of filtered cigarettes in the JAMA, their journal. They didn’t consider smoking a health risk until 1963, the year before the U.S. surgeon general, on the basis of more than 7,000 medical articles that were available and doctors should have read“ concluded”: Cigarettes cause lung cancer, laryngeal cancer, and chronic bronchitis30.
Physicians who were not members of the AMA could not get admitting privileges to most U.S. hospitals. Many primary care doctors had separate waiting rooms. Black patients were seen after the white patients were seen. Some of the ill went to county hospitals—where they often sat for hours on wooden benches waiting to be called. Black people were bedded in the basement wards of white hospitals or cared for in black hospitals, which were few and far between. St. Louis uniquely had a large hospital that served the black community. Founded in 1937 after a political struggle, Homer G Phillips hospital had 600 patient beds, was the primary source of health care for the area’s indigent blacks, and was a major training center for African American doctors. It closed in 197927.
That all started to change in 1965. That year Congress passed and President Johnson signed a law that established a new “right” –and created two new programs: Medicare and Medicaid. The entities were funded by a payroll tax; an additional 2.9% of a person’s earnings were taken from each paycheck.
Medicare– paid for the hospital care and some home services for citizens over 65.
Medicaid covered the care of citizens who were “poor enough”–whose “resources were insufficient to pay for health care.29”
Medicaid also covers nursing home costs for people who meet the eligibility requirements.
50 to 75% of Medicaid’s costs were paid by the feds and each state paid the rest. States with higher per capita income paid more.
Every state got to limit the amount a family could earn before they no longer qualified, and criteria for inclusion in the “program” have changed over time, so there are variations in Medicaid coverage across the country.1
Additionally—Medicare later established a hospice benefit. Dying people now had help and many could and preferred to manage their pain and problems in their own homes.
As part of The Emergency Medical Treatment and Labor law, hospitals had to provide pregnant women “appropriate medical screenings and stabilizing treatments.
Medicaid coverage for pregnant women and infants (up to 1 year of age) was established as a state option for people who earned up to 100% of the Federal Poverty Level (FPL).
“In 1964, a year before it enacted Medicare, Congress passed the Civil Rights Act. One of its provisions, Title VI, prohibited discrimination on the bases of race, color, or national origin in programs that received federal funding.
The following year when Medicare was being debated there was no mention of Title VI. It didn’t come up and nobody wanted to raise it. “The assumption was that some accommodation would be made that would allow segregation to continue on a separate but equal basis.” The nation’s response to the 1954 Brown v. Board of Education Supreme Court decision had shown that when it comes to race, changes don’t happen very much or very fast. The ruling ordered states to put a stop to segregation in schools with “all deliberate speed.” But “The vagueness about how to enforce the ruling gave segregationists an opportunity to organize resistance.”
In 1956, two years after the Supreme Court decision, the University of Alabama enrolled the first black student, Autherine Lucy. Then “riots engulfed the campus and she was expelled for “her own safety”. In 1962 demonstrations greeted James Meredith, the first black student to attend the University of Mississippi. My medical school, Washington U. in St. Louis, didn’t graduate its first black physician until 1962. Berkeley California became the first sizable city with a “substantial portion of black students” to voluntarily begin two way bussing. Some white children were transported to schools in black neighborhoods and some black students were bused to schools that were largely white. The program started 12 years after the Supreme Court ruling.
“The Medicare law might carry the threat that federal funding could be withheld from any hospital that practiced racial discrimination. That’s what Title VI of the Civil Rights Act “required.” But the Office of Equal Health Opportunity was in charge of federal funding based on the presence or absence of discrimination and it only had five employees. Swift action seemed unlikely. “Hospitals might have to come up with a plan, but they could presumably proceed gradually and cautiously. Ultimately racial changes wouldn’t get done; hospitals would operate on a business as usual basis.”
Then HEW Secretary John Gardner, put out a quiet call for volunteers. More than 1,000 people from federal agencies offered to help, along with tens of thousands of Civil Rights organizers. Field inspectors fanned out to hospitals to make sure they were in compliance with the law and eligible for federal funds. As David Barton Smith explained in his book, “They wouldn’t let anybody off the hook,” “The reason they were so successful is that they had this secret army of local civil rights workers and local health workers making sure [the hospitals] complied. Hospitals quickly figured out that they couldn’t fake it.”2
As previously noted, the hospital I worked and trained in was integrated. But after the Medicare/Medicaid law was passed a lot of our clientele chose to go to more upscale hospitals in the community. The following summer the wards were sparsely occupied. St. Louis City Hospital continued to exist until 1985; then it closed. Large and important City and county hospitals elsewhere in the country remain very much alive and well.
Medicare initially reimbursed hospitals based on the number of days a person spent in the hospital. After 1983 they linked the amount they paid to the patient’s diagnosis. The new approach made sense because doctors, at times, appeared to be keeping people recovering from surgery or an illness an extra day or two when it wasn’t clearly “medically necessary”. Some of the delays were a matter of caution: a physician wanted “to be sure the person was OK” before they sent them home. Others seemed to be for the convenience of the physician. It takes a long time to discharge a person and arrange for their post hospital care. At times the hold-up was caused by the patient. People work. It’s hard to get a ride home at an inconvenient hour. An extra day in a hospital commonly costs a few thousand dollars. Hospital acquired infections are not unusual, people lying in bed for a time can develop pressure sores, and the weakened or neurologically impaired risk a fall when they get out of bed without assistance. The practice of “reimbursement based on a predetermined, fixed amount” is also probably responsible for some unstable sick people being discharged “quicker and sicker.4”
On October 30, 1972 The U.S. government chose a very expensive pre-existing condition (advanced renal –kidney failure) and made its care a “right.”
Kidney failure wasn’t part of the bill the Senate debated during a rare Saturday morning session on September 30, 1972. Nor was it part of the legislation passed earlier by the House of Representatives. The amendment that added dialysis to the Medicare bill was introduced late that Saturday morning. There was 30 minutes of debate before it was accepted by a 52 to 3 vote. Weeks later a House, Senate Committee discussed the kidney amendment for 10 minutes, and left it in the bill. Nixon, who was a pro health care president, signed the legislation with a flourish a week before he was re elected.
Bodies have two kidneys. They are located near the back of the upper abdomen on both sides of the spine. They strain the blood and produce urine, fluid that is unneeded and unwanted. The urine, in turn, is “flavored” by a number of soluble additives: debris, break down wastes, and proteins that in high concentrations are toxic. After the blood is filtered the liquid pulp is returned to the body. A number of conditions and diseases can cause the kidneys to malfunction or fail.
When I started medical school people with chronic renal failure died.
“In 1960, a group led by Dr. Belding Scribner, a man who called himself Scrib, connected the artery and vein in a person’s forearm with a Teflon catheter. It allowed doctors to repeatedly draw blood from a body, cleanse it, and return it. Located on the skin surface, and subject to infection, and displacement, the device needed a lot of care. But it allowed physicians to start and keep people on intermittent hemodialysis.” The man who created the pivotal gadget was able to see thanks to transplants of his cornea, the outer lens of his eye. Over time they “became very scarred,” but he didn’t need to drive to work. He lived on a houseboat on a lake near the Seattle hospital where he practiced, and he rowed a canoe to work each day.38
In 1963 “the Veterans Administration (VA) decided to “establish approximately 30 dialysis treatment units in VA hospitals across the country.” In 1964 learning that “immunosuppressive drugs prevented the rejection of transplanted kidneys, the NIH established a program in transplant immunology.”
Over the subsequent 8 years “Programs sprang up across the country,” By 1972 10,000 Americans with renal failure were being dialyzed. Funding was a problem and some people were left out.3
Dialysis became a big business and a significant part of the Medicare budget. 4000+ free-standing centers were established in hundreds of cities by corporations, not hospitals. Their number in the U.S. has increased 4% a year. More than half are owned by Denver-based DaVita, a Fortune 500 company. The other big player, Fresenius is a subsidiary of a German company that operates centers in 28 countries and also sells the machines and other supplies.
Dialysis accounts for 6% of Medicare money. In the first quarter of 2008 DaVita’s revenues were $1.45 billion, up more than 8% from the first quarter of 2008. Fresenius’ revenues from dialysis in North America were $1.57 billion.
The external shunt is no longer used. Before hemodialysis is initiated an artery and a vein are sewed together to create a large blood vessel –a shunt–under the skin. Then three times a week patients with end stage renal disease come to a center and sit in a lounge chair for a few hours. A needle is inserted into the artery-vein, and blood is drawn into a machine. It flows past the “cleansing” membrane. The toxin level in the blood is lowered, the excess fluid is removed, and the blood is returned to the body via the same shunt.
Some people opt for peritoneal dialysis, using the lining wall of the abdomen, the peritoneum, as the filter. Initially a physician places a permanent catheter deep in the cavity. Then, usually nightly in the person’s home, a patient pours a sterile solution (dialysate) into the peritoneal cavity. The membrane’s pores allow waste products like urea and creatinine to seep into the fluid. The liquid is left alone for a few hours, then it is drained. Some studies suggest that people who use this approach do better the first year, and they are more independent. A year of hemodialysis can cost up to $88,000, while a year of peritoneal dialysis costs about $53,000, according to information from the U.S. Renal Data System.
People with very diseased kidneys are usually anemic. To stimulate the production of red cells people on dialysis are also commonly given injections of erythropoietin, a costly hormone, normally produced by healthy kidneys.
A fourth of the people who were being dialyzed died annually, and 80% who started live for less than 5 years. That’s largely because more people starting dialysis were over 50. The mortality rate in the older and sicker people was higher than it was in younger patients or individuals who had hereditary polycystic kidneys. In 1972 high blood pressure was the leading cause of end stage renal disease. Today obesity and diabetes are keeping the dialysis machines whirring. The annual death rate of Americans on dialysis (20.1 % in the U.S. in 2006) is higher than it is in France, 8%, or Japan, 7%. Americans who started dialysis after they were confined to a nursing home did poorly. The first year 58% died and 29% were less functional.6 Nearly 20 percent of dialysis patients stop dialysis prior to death.9
That’s what happened to the famous humorist Art Buchwald. In his later years he had diabetes and high blood pressure; when he was 74 he had a significant stroke. 6 years later a leg was amputated. I don’t know when or if he started dialyzing his blood, but in 2006, when he was 80 he decided to stop and apparently described his decision as his last hurrah. Contemplating death he wrote “the question isn’t where you are going, it’s what you are doing here in the first place.” Known in the hospice as the man who wouldn’t die, he once quipped: “to land a big obituary in the New York Times you have to “make sure no head of state or Nobel Prize winner dies on the same day” and “Whether it’s the best of times or the worst of time it’s the only time we’ve got. The best things in life aren’t things.” A year after he stopped dialysis his heart stopped beating. The cause of death was kidney failure.
Medicare also pays for kidney transplantation. The procedure wasn’t very good until we had adequate immunosuppressive drugs, but by 1974 over 3000 kidneys were being transplanted annually in the U.S. The number tripled by 1986 and in 2016 reached 13,431.
5600 of the kidneys came from live donors. We were visiting an acquaintance who was in the hospital recovering from a transplant. “So” she said, “things kept going wrong with my shunt and my dialysis and it seemed like I was always in the hospital on the phone complaining. One day I was in the midst of a tirade and the friend I was talking to stopped me cold. “Ok, ok” she said. I’ll give you a kidney, and here I am.
Nine of ten transplanted kidneys were alive and working a year after they were implanted, and half lasted at least 10 years. 93,000 people in our country are currently on waiting lists. The wait is longer, and the people are sicker in New York and California than they are in many other parts of the country. For transplant reasons, the nation was divided into 11 geographic regions; some cover large areas. Committees establish recipient transplant criteria—how sick, how old, body mass index, drug addiction, alcoholism, HIV. And “federal mandate prohibits the allocation of solid organs for transplantation based on “accidents of geography.”
The feds pay for most of the charges associated with a kidney transplantation and pay for the drugs that prevent the body from rejecting a kidney for the first three years post transplant. After 36 months patients are expected to pay for their own medications.
Liver, lung, and heart transplantation is also a “right” for those who “already have Medicare due to age or disability.”28
41 years after the Medicare dialysis benefit was initiated the NIH reported that 63.7 percent of people with advanced renal disease were receiving hemodialysis, 6.8 percent were being treated with peritoneal dialysis, and 29.2 percent had a functioning kidney transplant.7
6000 undocumented Americans have end stage renal disease. A few came to this country when they were young and never lived anywhere else. They went to school, paid taxes, and worked until they got sick. Unfortunately decades back, sometimes when they were children, they crossed the border illegally.
For context there are 11 million undocumented people in this country of which one in 1833 needs dialysis. More than 400,000 documented Americans are dialyzed on a regular basis.
Federal funds can’t be used to dialyze undocumented individuals. California and Massachusetts pay for the procedure with county taxes or state-allocated Medicaid funds. Texas and most other states only detoxify the blood of people whose serum potassium is so high or whose build up of toxins is so extreme that death is imminent. People have to wait until dialysis has literally become a matter of life and death.
180 of the 6000 undocumented people with end stage kidney disease live semi-near the Texas Baylor Emergency room. Each day many come to the E.R. and wait. Their blood is drawn; EKG’s are obtained, and they are assessed. The hospital has 12 dialysis chairs, and the people who occupy hospital beds are dialyzed first. Then the sickest of the undocumented are served.8
In 1997 congress granted the “right” to health and preventative care to kids from very poor families who didn’t qualify for Medicaid. The program goes by the initials CHIP, is individually run by each state, and is funded by the Medicaid – state/federal formula. It took years before most of the kids who are eligible signed up. But the program was popular, and granted coverage in 2009.
The program was partially paid for by raising the federal cigarette tax from 24-cents-a-pack to 67 cents. That rangled some Republicans. Their election campaigns were aided by the cigarette industry. Their policy committee argued “the lost cigarette revenue would cost too much. States and localities would lose $6.5 billion over five years.” Orin Hatch, a Republican who supported the program found their argument “absolutely preposterous. Does that mean that 419,000 Americans must die every year in order to preserve the state tobacco revenues? That’s like saying we should withhold life-saving treatment from senior citizens in order to save Medicare money.”36
In 1976 the U.S. Supreme Court created a right for medical care to people who are incarcerated. Eight of nine justices “acknowledged that the eight and fourteenth amendments required the Texas government to provide medical care for prisoners.10” The eighth amendment of the U.S. Constitution prohibits governments from imposing cruel and unusual punishments. When the Supreme Court rules that a practice is unconstitutional in one state it’s automatically unconstitutional in all states.
To be meaningful, of course, rights need to lead to action. Each state deals with its inmates a little differently. California, for example, has more than 150,000 prisoners. In 2006, in response to a law suit, a federal judge learned that prison conditions were “disgraceful”, declared the health care the institutions provided was unconstitutional,” and put the California State facilities into receivership.11
San Quentin Prison sits on San Francisco Bay and houses over 5000 inmates. Many have mental health problems. In 2009, as a result of a judge’s order, the facility opened a $136 million, 5 story hospital. The prison employs 10 full time psychiatrists. Pay, according to one internet ad, starts at $19,000 a month plus benefits. According to Eric Monthei the chief psychologist, clinicians try to give care similar to that of their colleagues in the community. But they must deal with the prison environment, something we can’t begin to understand on a gut level. The population contains a disproportionate number of people with personality disorders, depression, and substance abuse issues. Psychiatrists see people for medication management if they have serious symptoms or if they wish to be seen. If there is a psychiatric emergency, if someone who is incarcerated becomes suicidal or homicidal, there is a 7 bed psychiatric ward. In the private world psychiatrists are responsible for hospitalized people and drugs. In prison a psychologist works in the hospital. Some of the prisoners are “Axis one”. They have major mental health disorders like Schizophrenia, bipolar or schizo- affective disease. Some committed crimes under the influence of methamphetamine, alcohol or other drugs. There are non violent offenders who have committed their third felony and are thus in prison for life because of the California three strike law.12
According to the psychiatrist I interviewed, when prisoners arrive they are screened by a psychologist and interviewed by a social worker. They are assigned a case worker who is responsible for their medical care (with the exception of medication.) Some people are already on drugs, so called “bus meds”, pharmaceuticals like the anti depressant Prozac, and they will need to see a Psychiatrist for refills. Prisoners who are “triple CMS”, those taking psychiatric drugs who have medical problems, are placed in single cells.
When the MD psychiatrist arrives in the morning he or she is given a “docket”, a list of people he/she must see that day. There can be as few as 4 to 5 and as many as 14; visits commonly run 30 to 45 minutes. Inmates who are not administratively segregated or in protective custody come as a group and wait in a holding area. Others arrive one by one heavily guarded and shackled. The “non dangerous” people are seen in an office. The “dangerous” prisoners are seen while they sit in corrugated metal “cages.” The interface between physician and inmate is like a heavy metal chain link fence. There is a spit mask and the prisoners are tied. The psychiatrist carries a fire arm and a whistle. When the doctor speaks to the patient, the guard is usually outside the door, just out of ear shot.
The psychiatrist I interviewed worked at San Quentin, California’s oldest. Located on 400 acres of prime real estate, it borders San Francisco Bay, and is largely sheltered from the fog and ocean breezes that batter some of the areas multimillion dollar houses. The home of some of the nation’s more significant criminals, it has a death row that houses 737 individuals. In the U.S., a nation of 76 million people, 2.3 million people were confined in March 2020; 450,000 people are locked up for a non violent drug offense each day. Most of the crimes that lead to jail or prison time are non violent. Many who are jailed will soon make bail or can’t afford it and plan to stand trial.
The nation has 1,833 state prisons, 110 federal prisons, 1,772 juvenile correctional facilities, 3,134 local jails, 218 immigration detention facilities, 80 Indian Country jails, and many more. 9% of the prisons are run by private for profit organizations.34
“Incarcerated persons have high rates of communicable and chronic diseases, and though health care is a “right”, “the type and quality of the care depends to some extent on variations in policies, budgets, and staffing across federal, state, and local jurisdictions.”32
In 1986 by passing the Emergency Medical treatment and Active Labor Act, (EMTALA) congress created an important right for everyone.
That includes –the insured and uninsured.
Citizens, foreigners, and “illegals”.
Anyone who suffers an acute illness or injury;
people who show up in the emergency room and
those who call an ambulance. They all have to be treated.
Hospitals that take Medicare funds, in other word almost every hospital in the country, is required to provide emergency and necessary hospital care for: serious illnesses, injuries-for women in labor—the ill and injured. The care must continue until they are “stable.13”
Before the law was passed some hospitals wouldn’t care for you if you couldn’t pay. Sick unstable uninsured people were “dumped”. People were “transferred for financial reasons, from private to public hospitals without consideration of their medical condition or stability.” Some of them died.
After Congress passed the law one of the government agencies, the HCFA, (Health Care Finance Administration) held hearings and created a number of rules and regulations. Their guidelines “have the force of law” and they apply to all of the 98% of U.S hospitals who participate in Medicare. Hospitals are required to medically screen any person who comes to the hospital emergency room and asks to be checked out. If the person has an “emergency” problem the hospital must stabilize the situation if they can. For example: a person with a ruptured appendix must be treated medically and/or surgically before he or she is discharged.
A person with an acute myocardial infarction (if medically appropriate) must be catheterized, stented, and observed before he or she is released.
If the hospital doesn’t have the expertise or equipment to care for a person, they must transfer the patient to an appropriate hospital.
They are in violation of the law if they delay services “in order to inquire about the individual’s method of payment or insurance status”
The sick person doesn’t have to be in the emergency room. They can be in almost “any area of the hospital “campus” including structures and all areas that are not strictly contiguous with the main building but are located within 250 yards of it –or of hospital owned and operated ambulances.
Doctors who are on call are also, often, on the hook. In some states they must show up within 30 minutes of being notified. There are rules, and physicians face fines if they violate them. We’re talking up to $50,000, money that is not covered by malpractice insurance. Transfers are possible with a patient’s consent, if they are “stable.14 “
A friend of mine awoke one night with chest pain. He was sweating and dizzy, and his daughter called 911. The ambulance arrived quickly. The paramedic determined he was having an acute myocardial infarction. He was rushed to the county hospital where a skilled cardiologist was ready to act. Within minutes a tube was inserted into an artery in his leg and threaded up the aorta. When it reached the heart it entered a coronary artery. Injected dye revealed an important artery was obstructed. The tube was removed and was replaced by a catheter and stent. A balloon on the catheter opened the artery and the stent kept it open. Blood flowed to the oxygen starved portion of the heart muscle, and it looked like the heart had escaped serious injury. My friend lived from paycheck to paycheck, didn’t own a home, and had allowed his insurance to lapse. He was observed for a day, went home, and was sent a bill. .
The Emergency Care Law (EMTALA) gave people having an acute medical problem the right to receive one of the benefits of modern life— but it was not funded. The care is not free.
U.S. hospitals and doctors accept the amount paid by Medicare and Medicaid as payment in full. (That’s the law.)
There’s a website that tells how much insurance companies really pay. Called Healthcare Bluebook, it allows people to punch in their disease and zip code. The program provides a dollar amount. If the website is correct the bill my friend with a heart attack received was outrageous.
The “fair price” for a coronary angioplasty and three days in a hospital in his zip code (per the Bluebook) was $24, 853. (That covers the cost of the catheterization room, the equipment, and the hospital bed.)
The “fair” physician remuneration for stenting a single vessel was $1105. (Add 25% for additional arteries.) And the “fair” anesthesiologist fee for close to three hours of work was $1325.18
My friend’s bill for his heart stent and two days in the hospital was in excess of $100,000.
What will it cost if you’re appendix bursts or you have a severe asthma attack when you’re in Paris? Not much. Health Care is good in France; an emergency room visit costs about $120, and a doctor’s visit goes for less than $30.
When someone is in the U.S. doesn’t have insurance and has an emergency, they get a bill. When the hospital or physician that provided the care didn’t have a contract with the person’s insurance company, and the policy only covers in-network emergencies the bills for the service can be enormous.
In San Francisco, as the Chronicle put it, injured parties “can (now) rest easy,’ “If you’re hit by a car, shot, fall off a roof or suffer any other major injury, you can now receive top-notch medical care at the city’s only trauma center without risking bankruptcy.”35
In early 2019, San Francisco General Hospital, the city’s trauma center, was under pressure for its unfair billing system. The hospital had no contracts with insurance companies. All the care it provided was out-of-network. As a result the city could bill as much as their self-determined rates allowed. Health Insurance companies could kick in as little as their self-determined policies permit. The difference, thousands of charged and unpaid dollars, became the burden of the ill and injured people who showed up in the facility’s emergency room. “Three simple appendectomies left stunned patients on the hook for bills ranging from “$54,000 to $92,000”. Well meaning doctors, nurses, clerks, and ambulance drivers were treating people’s physical maladies and destroying their economic well being. The city owned the hospital, and taxes paid for some of the care. Then– in place of being fiscally “prudent”, the hospital did something that, best I can tell, was unprecedented. They adopted a humane approach. They stopped billing poor people. And they charged a maximum of $4800 to people who earned $121,000 (single person) or $250,000 (family). The affect on the hospital’s income was a fifth of a percent.
Insurance companies have long argued that “networks” allow them to control the cost of care. They meet with hospitals, agree on fees, and sign in-network agreements. New York and a number of other states have laws “that cap or limit charges for services that are delivered out-of-network, especially for emergency care.”23
“Between 2010 and 2016 the number of out of network bills rose from 32.3% to 42.8%; the number of inpatients who got an out of network bill for some of their care rose from 26.3% to 42%. The cost of an ER visit, in that six year period increased, on average from $220 to $628 and hospitalization charges rose from $804 to $2,040.” Fifteen percent of hospitals have out-of-network billing rates that are 80 percent above the standard rate. Some of the physicians in one study charged over 600% of the Medicare rate.23
California AB 1611 would have limited the fees charged for people who have insurance, but, due to a medical emergency, are seen at a hospital that’s “out of network.” As it was about to be proposed to the state Senate health committee the sponsoring legislator “pulled” it as a result of “insurmountable” opposition from lobbyists and CEOS for California hospitals”15
10 percent of anesthesiologists, pathologists, and surgical assistants sent patients who have insurance a bill because their insurer refuses to pay or only pays a portion of the bill.
They call the process “balanced billing” and it’s no longer legal in California. In 2009 the California Supreme court ruled that the 1975 Knox-Keene act implicitly forbids “balanced billing” for certain but not all types of insurance.
At present, there are more than 4,500 emergency departments in the country, and they are staffed by about 40,000 physicians. One investigator found that “65 percent of hospitals contract out their emergency providers.24” Another that two large companies EmCare and TeamHealth control 30 percent of the physician market, establish fees, and send bills. In Texas the three largest insurance companies “had no in-network emergency room doctors24.”
California bill AB72 limited the amount people pay when they get elective care at an “in network” facility but part of the care is provided by a physician who is “not in network.” Physicians can’t charge “more than the in-network cost-sharing amount.”
I’m a physician. 2 decades back an out-of-network physician operated on a disc in my neck. I asked him how much he would charge and he said he didn’t know. Someone would send me a bill. Our visit lasted half an hour in the office and Surgery may have taken two hours. He was great and the operation went well. I spent the night in the hospital and didn’t need any post op pain medicine. Just coffee. My bill for “his role” arrived in the mail. $8000. I saw him a few weeks later for my only post op visit and I handed him a check for $4000. Is that O.K.? He looked stunned. I have no idea what he was thinking, but he took the money and when I left he shook my hand.
Affordable quality health care became a “right” for federal employees in 1960 when “The government began to contribute 72% to 75% of the cost of the health care insurance premiums.” That brought the price of the policies way down. “At least 10 fee-for-service plans” compete in a special marketplace congress created. Applicants don’t have to worry about their age or any pre existing conditions. More than 8 million people who work or have worked for the federal government—and their spouses, dependents, and retirees—and legislators and their families– were allowed to buy the insurance. About 90 percent of the employees of the federal government participate. The FEHB, federal employees’ health benefit program, is administered by an agency of the government whose director is appointed by the president. The privilege/right is technically called a managed care scheme. (A right may or may not be self evident ; it may or may not be endowed by our creator; but when it is granted and funded by the government it exists.17)
As part of the Affordable Care Act, members of congress and their staff members lost the ability to purchase insurance through the FEHB. To maintain their “right” to affordable, quality medical care they established a new way to buy highly subsidized care. They are using the DC health care exchange, and the government still kicks in 72% of the cost of the premium—for those who chose a gold plan. When and if one of them retires with five years of government service under their belt they can again be insured through the FEHB.19
In 1993 children whose insurance didn’t cover the cost of 16 important vaccines were given the right to receive them free. Congress created the Vaccines for Children Program, the CDC (center for disease control) managed it, and 40,000 doctors throughout the country administer the vaccines.
In 1811 federal legislators established and funded a home and medical clinic for military veterans. Fifty years later, after half a million fighting men died of wounds and illness in our destructive civil war (1860-64),the government created a number of veterans homes – that “incidentally” provided medical and hospital treatment.
50 years thereafter our nation entered the First World War (1917-18). 116,000 men lost their lives. Many more were wounded and disabled–and a number of facilities were built. After they were officially launched in 1921, the Veterans Administration started building hospitals. By 1948 there were 125, and the VA currently says they operate 1600 health care facilities.5 They once cared for all service men and women who had been on active duty, even briefly. After September 1980 the government began limiting the pool by requiring a “minimum length of service.”
Indian Health, while being a right, is also a small underfunded and significant part of the care supplied by the federal government. In the centuries that followed Columbus first voyage, 95% of the continent’s indigenous people died. The Europeans brought infectious illnesses with them that were unknown and had never been confronted by the immune systems of the people of the continent.33 “Smallpox undoubtedly played a huge part in the fall of the Aztec Empire.” Early settlers alternatively courted and hunted the people of the land. Some of our elders tried to integrate natives into our society; others gave them terrain which was “eternally theirs”, and still others reneged on one promise or another. In 1830 President Andrew Jackson signed the law that officially required tribes living east of the Mississippi River to relocate on lands west of the waterway. They moved only to later discover that many Americans believed the United States was “destined to expand across the North American continent, from the Atlantic seaboard to the Pacific Ocean.” Over the centuries some natives came to our cities and many blended in. (There are clinics for Native Americans in Oakland California and many other large towns.) For others there were reservations, (areas of self government that are “managed” by the U.S. Bureau of Indian Affairs).
The war department got involved in the health of the Native populations in the 1800s after they decided to vaccinate the indigenous people against Small pox to protect soldiers in remote forts. In the 1880s the Department of the Interior constructed infirmaries and hospitals.
The government’s involvement in any kind of health care was pretty limited until Congress passed the massive Public Health Service Act of 1944 and established the NIH (National Institute of Health) the CDC (Center for Disease Control), and the now defunct Public Health Service hospitals. The Indian Health Service was created and added to the mix in 1955. Serving half of the known Native Americans of the day, the VA like system covers the people who lived on the remote rural reservations, and they run urban clinics that do what they can for the indigent Native Americans in our cities. Half the identified Indians try to maintain their distinctiveness. The service is “culturally sensitive.” Local beliefs and traditional practices are blended with the modern medical model. The emphasis is on public health and community outreach activities. In her book The Scalpel and the Silver Bear, Lori Alvord M.D. a Stanford educated, half Navajo, physician who practiced medicine at an Indian Hospital recalled how the chant of a medicine man gave emotional strength to a male with advanced cancer. She had removed his tumor and he was receiving chemotherapy, but he was despondent and had lost hope before the “singer” arrived and performed a ceremony known as a Chantaway. As she explained, different songs and ceremonies help different illnesses: If an accident caused the disability, the Lifeaway ceremony was performed. The Shooting way was chanted if an arrow or lightning was the source of the problem.20
The federal government spends $3.5 billion a year for a service that delivers health care to 1.9 million of the nation’s 3.3 million American and Alaska Natives. The “system” is large and spread out. By their count there are 31 hospitals, 63 health centers, and 30 health stations plus 34 urban Indian health projects. They are staffed by 2,400 nurses, 800 physicians, 400 engineers, 500 pharmacists, 300 dentists, and 300 sanitarians. The patient pays nothing, not even a co pay, for testing, drugs, or hospitalization. Part of the funding for the Indian health service comes from other government programs. If a patient was covered by Medicare, Medicaid, or had insurance through their work, the insurer could be billed, and the money could be used to help cover the costs of care.
The facilities are up to snuff. All 31 IHS-operated and all 14 of the tribally operated hospitals have been inspected and accredited.
Despite this the Indian life expectancy (72.3 years) is still about 4.6 years less than that for the U.S. general population (76.9 years). Death rates for some conditions are significantly higher. Tuberculosis is 750% more common, and there are elevated rates of alcoholism (550% higher), diabetes (190% higher), unintentional injuries (150% higher), homicide (100% higher), and suicide (70% higher).
Juliet told Romeo that a rose by any other name would smell as sweet. In this country most have the right to affordable health care. Many are left out. We don’t call a spade a spade. And many have lost their ability to smell.
Over the last 80 years one group of Americans then another has acquired the right or expectation that they will receive the health care they want or need. At times their access is funded by the government through taxes. On other occasions employees receive benefits in place of a good wage or the care is provided by employers who get tax breaks. At the same time many people living in our country are excluded.
The medical care most of us currently access is a combination of high tech studies, procedures performed by skilled specialists and primary care:
Preventive interventions— an array of vaccines that prevent many acute and chronic diseases and a few cancers: Immunizing newborns whose mothers have hepatitis B can prevent a future case of liver cancer. When teen age girls receive the vaccine that prevents infections with human papilloma virus they are much less likely to someday develop cancer of the cervix.
Screening: People are checked for, among other problems, hypertension, diabetes, elevated cholesterol, HIV, hepatitis C, and glaucoma.
Diagnosis and treatment: By the 21st century, 4000 medical and surgical interventions had been classified; more than 1400 medications were available–or unavailable. The “craft” has become so complex that doctors and nurses increasingly have to specialize. In 2003 the 3 billion base pairs of human genome had been sequenced. Much as the musical score is a sequence of notes or a novel is a sequence of letters of the alphabet, the code that tells every cell in our body what to do is a sequence of the 4 letter DNA alphabet. After they were able to access the DNA scientists started assailing the genetic diseases of man.1
When asked if they thought health care was a right, people interviewed in Athens Ohio pointed to neighbors who were unwilling to work yet qualified for “Medicaid”, the taxpayer funded program for the very poor. One of the people interviewed thought “People should contribute to the cost”. Health care shouldn’t be free unless you’re really hard up. At the same time, as one citizen explained, “You shouldn’t have to worry about medical care anymore than you worry about “the fire department, or the police…or the roads we travel on.”43
11. Nearly 20 percent of dialysis patients stop dialysis prior to death.9 and, increasingly, older patients are choosing not to begin dialysis, in part due to poor outcomes and decreasing functional status with dialysis. Now and then people whose lives could be prolonged by dialysis choose to die of uremia. I’m thinking of the famous humorist Art Buchwald. In his later years he had diabetes and high blood pressure; when he was 74 he had a significant stroke. 6 years later a leg was amputated. I don’t know when he started dialyzing his blood, but in 2006, when he was 80 he decided to stop. He made an announcement and apparently described his decision as his last hurrah. Contemplating death he wrote “the question isn’t where you are going, it’s what you are doing here in the first place.” By one account when he stopped dialysis he entered hospice and friends wrote Eulogies. But he didn’t die. So he wrote a book called Too Soon to Say Goodbye; in it he included some eulogies friends had written months earlier. A year after he stopped dialysis his heart stopped beating. The cause of death was kidney failure.
A friend awoke with chest pain and a cold sweat, and his daughter called 911. The EKG in the ambulance showed evidence of an acute myocardial infarction. Part of the heart muscle was dying.
Developed in the early part of the 20th century, the device the paramedics attached,the EKG, detects and records the flow of current as it travels along the heart’s “electrical” conduction fibers. The up and down squiggles, the “wave”, has a distinctive pattern when a person is having a heart attack. Like hieroglyphics on an ancient tomb, their meaning was baffling before Willem Einthoven learned how to interpret them. A descendant of Spanish Jews who fled to Holland at the time of Spanish Inquisition, Willem was born in Java. His father, a physician, died when Willem was 6 and a few years later his mother returned to the Netherlands. After college Willem went to medical school and he later became a professor of physiology at the University of Leiden, Holland’s oldest, a center of learning that was (according to local lore) created in 1575 by William of Orange for the town’s inhabitants after they were besieged by invading Spaniards and refused to surrender. Married to a cousin and the father of 4 Willem was a gymnast and fencer. He rode his bike to and from the university and often worked “until he was reminded to go home by his assistants upon request from his wife.”
After the computer in the ambulance interpreted the EKG, the paramedic radioed ahead, and the vehicle sped to a nearby hospital where a catheterization team was available 24 hours a day. When they arrived the doctor and squad were ready to go. Within half an hour a mild sedative calmed the man’s brain and a cardiologist was advancing device one, a narrow rigid yet flexible tube he had been inserted through a groin artery. Under fluoroscopy the physician pushed and maneuvered the tip through the aorta– the body’s central blood vessel. It quickly reached the coronary arteries– the vessels that drape over the surface of the heart and deliver oxygen to its muscles. The entrance to the coronary arteries is located in the aorta just beyond the point where it attaches to the heart.
As we age, smoke and eat rich food, plaques develop on the inner wall of many of the arteries that supply oxygen and nutrition to our bodies. These “barnacles” are full of inflammatory cells and fat. When their fibrous cap ruptures the body tries keep the contents from escaping. Platelets and clotting proteins pile onto the exposed gap. If the reaction is large enough, like a jack knifed 18 wheeler, it can close down the highway– in this case obstruct the flow of blood.
Dye was injected into the coronary arteries and the occluded vessel was identified. Device one was removed and a second catheter, device two, was inserted and passed to and through the coronary artery occlusion. This catheter had a strong balloon near its tip. It was inflated, the narrowed area was forced open, and blood flowed and oxygenated the heart. A third device, a “stent”, a thin mesh hollow tube made of stainless steel and cobalt-chrome, was advanced to and through the vessel. Its outer surface was coated with a polymer that “carried” a drug that was slowly released. The chemical helps preserve the stent’s patency. Blood now flowed through the tubing and the heart muscle was able to breathe again.
A cousin dodged death. Her surgeon had successfully clipped the bleeding brain aneurysm, the thin walled balloon like bulge in the wall of one of her arteries, but a few days later the cerebral spinal fluid that normally coats the outside of the brain wasn’t flowing. Pressure was building in her head. Her physician drilled a hole in her skull and inserted a thin tube into a liquid filled chamber in the center of the brain, the ventricle. He tunneled the other end of the tube under her skin and inserted it into her abdomen. Spinal fluid poured out of the brain, and the force that was squeezing the brain decreased.
The shunt, the small hose that relieved the pressure was created by an engineer in 1955. He was the father of Casey, an infant who had hydrocephalus, too much fluid and pressure on the brain. His doctors initially avoided the kid’s dad. They didn’t want to deal with his reaction when they told him that his son was going to die. John, the father, was 35, had been in Europe during the Second World War and was working in a hydraulics research laboratory. When his only child was born with multiple congenital defects he watched as the infant underwent a number of operations. Then his head started enlarging. Liquid accumulated in the brain chamber, the pressure in the skull increased, and the doctors didn’t have a good way to treat it. To decompress the situation, according to his troubled father, Casey was taken to “the torture chamber.” A doctor would insert a needle through his fontanel, the area on the top of his head where the skull bones had not yet fused. Using a syringe the M.D. withdrew fluid. Doctors eventually talked to dad and explained that if they tried to fix the problem by inserting one end of a tube into the cerebral cavity, they would need to attach the other end to a vein. Every time the child coughed or sneezed blood would flow up the tube, its hollow inside would fill with blood, and a clot would form.
Holter pondered the problem. He knew autos had pressure release valves. They used a ball that was displaced when the tension was high. In people a similar approach would fail when the head was in certain positions.
Then Holter thought about the nipple on a baby bottle. It only opened when the tension was high. Then it closed. Using it as a model he designed a pressure sensitive valve. In place of a tip it had a “slit similar to the one on the nipple. He hooked the valve to a rubber, later a plastic tube, and his device worked. Unfortunately it lost its shape when the tubing was heat sterilized. Then he learned that Dow made temperature resistant silicone tubing. It didn’t take him long to sort out the details, and he created a pressure sensitive tube.
In three weeks Holter solved a dilemma that had plagued doctors for more than a century and his invention “is still widely used.18” Before the doctors were able to put a device in Casey’s head the infant had a cardiac arrest that lasted 30 minutes and his brain was damaged. With the shunt in place his very limited body survived five years.
At 96 a friend’s mother was clear minded and living alone when she fell and couldn’t get up. Four hours later help arrived. In the hospital physicians diagnosed and successfully treated sepsis caused by a urinary tract infection. But when they examined her heart they heard a loud woosh of blood, a heart murmur. A heart ultrasound revealed severe aortic stenosis. The valve that swings open and closed when the heart contracts, the gate that allows blood to flow out of the heart and into the vessels of the body, had grown quite stiff. Her days were numbered. The valve could be surgically replaced, but she was old and frail. Open heart surgery would be quite risky, but there now was another option. A recently approved device, a replacement aortic valve could be inserted into a groin artery, slid up the aorta and through the old stiffened valve. Once in place it would, umbrella like, open and close each time the heart contracted. People in Europe had been using the device for 5 years. At the end of that period of time the new valves were as successful as the surgically planted valves. She opted for the new gadget and did well.
My wife’s cousin was in her 80s and lived on the second floor. Her knees were arthritic and the pain of going up and down the stairs had become so intense that she seldom left home. She had heard “horror stories” about knee joint replacement but dreading the thought of a nursing home, she bit the bullet. Over the next year and a half each of her knee joints was replaced. The arthritic surface, the eroded area on the end of the bone, was sliced off and the raw area was “re-soled”. The day after each operation she was able to walk. Within months of the second procedure she felt normal, mobile, like she was ten years younger.
The first really successful joint replacements were performed by a talented surgeon named Charnley. A Brit with “febrile inventiveness and a powerful command of the English language” he helped care for the soldiers who were evacuated from Dunkirk, and spent most of the Second World War as a medical officer in Egypt. When he was 46 and skiing in Austria, he met and married Jill the woman who became Lady Jill after Charnley was knighted.20
In 1960, having established himself as an orthopedic innovator he turned an old T.B. hospital into a hip center. A local medical equipment manufacturer, Thackeray’s, fashioned the “metal femoral stem and polyethylene cup (acetabular) component.” Charnley used acrylic bone cement as grout, not glue, and successfully produced a low friction prosthesis that when implanted allowed people with bad arthritis to walk without pain. His achievement inspired a new approach to worn out joints. According to Arthritis UK we’ve now gotten to a point where 80% of “cemented hips should last for 20 years” When or if they fail and a person is healthy enough to undergo repeat surgery, it’s usually successful. “The results are less good after each revision,but 80% of re-dos are good for 10 years.”
While Charnley was developing his low friction hip, surgeons in various parts of the world tried to design workable knee replacements, and people with disabling pain were willing guinea pigs. In 1969, feeling that he didn’t have a “reliable knee implant” New York orthopedist John Insall, “designed and developed 4 of the devices that are currently used. A Brit, Insall was born in Bornemouth, a town on the U.K.’s south coast that boasts “seven miles of sandy beach and an exceptionally warm microclimate.” He decided to go to medical school because too many members of his family were already in the military and police. Turned down the first three times he applied, he graduated at the top of his medical school class, and worked for 2 years as a casualty medical officer. Then he traveled to India to learn and work. While there he wrote the hip transplant pioneer Charnley and asked for “an appointment as a House officer.” ”Charnley wrote back “India needs doctors to treat fractures and tumors, not hip replacements.” In 1963 war broke out between India and China and Insall left the country with eight dollars in his pocket. He eventually became a hand surgeon at New York’s Hospital for Special Surgery (HSS). Years later he met and played tennis with the engineer who helped him design the early knee prostheses.17
Currently over 700,000 American knees are restored annually. Some think that by 2030, over three million Americans per year will get a new knee. Four manufacturers make a majority of the implants. Many of us have been saved from death, poor mobility, or disability at least once in our lives as a result of an amazing array of “devices”.24
In 1895 a German researcher named Wilhelm Röntgen “noticed that when electric current was flowing through his Crook’s tube, a board on the wall that was covered with Phosphorus started to glow.” He asked his wife, Anna Bertha, to place her hand in front of a photographic plate, activated the tube and visualized bones and a wedding ring.”21 An invisible wave had somehow passed through the walls of the sealed tube and through a human body. He rechecked his findings a few times. When he was convinced what he witnessed was real he announced his discovery to colleagues and the newspapers and it became a phenomenon.26
He didn’t invent the sealed tube with the air sucked out of it. Named for its creator it had been around for a few decades and was called the Crookes tube. The wealthy British researcher who developed the device also happened to believe in the paranormal. In his later life William Crookes tried to communicate with his dead wife through a medium and, along with Charles Dickens and Arthur Conan Doyle, Crookes was a member of the Ghost club.27
In the years following the tube’s creation a few researchers had allegedly passed electricity through the airless device and had seen a weird glow, but they hadn’t discovered its significance. Rontgen did and he became famous. Not one of the creative geniuses of his day, Rontgen came from money so when he was expelled from a school in Holland for a boyhood prank he was able to go to get an education in Switzerland. His wife was a waitress three years his senior who he met and fell for. He was a good but not an amazing German researcher. But he was the person who saw what other had seen, and wondered what was going on; and he made an important discovery.1,25
Thanks to his invisible wave interventional radiologists are able to use a fluoroscope as a guide. Slipping a needle through the outer wall of the abdomen or chest, they can jab it into the deep worrisome shadow that’s being biopsied. The beam, as we’ve learned has to be used sparingly. Pulsing the x-ray lowers the radiation dose, and people who are exposed to the rays wear heavy lead aprons to protect themselves. There is no absolutely safe dose of radiation. When I was a medical student the head of radiology at Washington U was missing a few fingers. They were damaged when he held people erect while taking x-ray pictures.
By the time I finished medical school x-ray films were taken from many angles. Air (lung) was black. Bone was white and tissue grey. By altering the focus of our tube we could get a sharp view of various depths of a body. As computing became faster and programs became increasingly sophisticated, algorithms were added. Now, using advanced devices physicians can get deep detailed views of sections of the body, head and limbs. We can use x-ray beams (CAT scans) or strong magnets (MRI). And we can visualize much with medical Radar, ultrasound machines.
In the last 70 or so years devices that allow interventional physicians to thread a catheter into a leg artery and advance its tip to the vessels of the brain, heart and abdomen have been created and modified. If the main abdominal artery, the aorta, is significantly bulging or enlarging, it can be replaced surgically, or it can be splinted by a device, a synthetic expandable stent graft that is inserted through a leg artery and becomes the aorta’s inner wall.“In 2003, the interventional approach passed open aortic surgery as the most common technique for repair of abdominal aortic aneurysm, and in 2010, the procedure accounted for 78% of the repairs of all U.S. aneurysms that had not already ruptured.13
The arteries of the brain are currently accessible. Experts have learned how to thread hollow catheters through one of the four large arteries that supply blood to the region. Two carotid arteries run on each side of the front of the neck. Two “vertebral” arteries course through openings in the vertebrae of the spine. The vessels communicate and deliver blood to a ring of arteries on the underside of the brain. An aneurysm, a weakness in the wall of an artery that becomes a bulge, isn’t that uncommon. One in 50 of us will develop one. Some say 1% others up to 3% will eventually rupture. Half of the people whose aneurysms start bleeding die before they get to a hospital. The other half stop leaking blood but the flow of can start again within a few days. Surgically clipping a “ruptured” aneurysm is risky but it’s often necessary. And a rupture can be prevented by filling the ballooned area with clotted blood. Interventional radiologists have become proficient at inserting devices–small platinum coils, into aneurysmal defects. They detach, remain in the ballooned area, and a thrombus forms and fills the bulge. The device that made it possible to disengage the wire was developed by an Italian neurosurgeon named Guido Gugliemi. Born and trained in Rome, Guido was the son of a physician and originally planned to be an electronic engineer. In medical school he was drawn to the brain’s wiring. He saw an area that “constituted of millions of relays and millions of wires that transmit electricity and are connected to one another.” As a neurosurgeon he witnessed and treated ruptured aneurysms. Brain surgery was difficult and bloody. The engineer in him thought there must a way to use the interventional approach and induce a clot to form. He wanted to insert magnets and use electricity, and a friend thought his idea might work. Guido got financing and moved to Los Angeles with his wife and children. He checked out his approach and it didn’t pan out. Deciding to stay in L.A., he used his knowledge of soldering and electricity to develop a detachable wire. Turning the concept into a useable product required countless nights in the lab tweeking and testing his gadget. He eventually was able to predictably insert and detach the coil. His invention is currently used in 90 percent of the brain aneurysms that doctors treat. Most of the aneurysms wouldn’t have ruptured and in some hospitals the device is probably over used. After ten years in southern California Guido and family moved back to Rome.
In 1958 Earl Bakken Bakken created the first wearable battery-powered cardiac pacemaker. He did it by modifying a circuit for a transistorized metronome, a gadget used by musicians to keep the beat. He got the plans from a magazine called Popular Electronics. The device was developed after a local heart surgeon named C. Walton Lillehei spoke with Bakken and asked him if it was possible.
The heart is a muscular cavity whose contraction is controlled by the special cells in the sino-atrial node. One or more times a second they emit a quantum of energy. The current flows down the main conduction fibers of the heart, reaches all the muscular filaments, and they shorten in unison. After the cells have released their energy, sodium, potassium and calcium seep in and out and recharge the node. The power can’t be stored, so when the heart’s pacemaker is fully energized it discharges. When our hearts don’t beat like they are supposed to, there are currently wide arrays of battery powered devices that take over and emit periodic mini jolts. They are implanted on the heart’s outer surface or slipped into one of the upper heart chambers then attached onto the inner lining.
As a teenager Bakken was the “nerd who took care of the high school public address system, the movie projector, and other electrical equipment.” After serving in the army signal corps during the Second World War, he married a medical technologist. While courting her he hung out at the hospital and met doctors and others. He repaired their broken devices and realized that hospitals need people to keep their medical equipment working. He set up a shop in his garage and that’s where he made a wearable pacemaker that was the size of a few decks of cards.
When he turned the first pacemaker over to the doctors they inserted it into the heart of an animal with heart block. Dr Lillihei saw the gadget was working, removed it from the animal and planted it in a child whose ventricular septal defect had just been sewn shut.
The congenital opening between the two largest chambers of the heart, the ventriculo septal defect, is the heart’s most common congenital abnormality. Doctor Lillihei, working at the Mayo Clinic started learning how to patch the gap in 1954 and by 1958 he had performed the operation a number of times. While sewing in a patch, a suture can easily capture the electrical fiber that runs along the border of the heart defect. When a surgeon ties the knot, the main fiber is constricted and the electrical energy can’t flow. Hearts stop beating or contract very slowly and children die. .
It would be an understatement to say pacemakers have, over the last 60 years, become a big business. There are multiple manufacturers in the U.S. Europe and Asia. Over 200,000 devices are planted annually. In the U.S. Cardiologists spend a lot of time, inserting them, checking battery life, replacing batteries if indicated, and remotely “interrogating” the devices and seeing how often and how well they worked.
There’s also a pacemaker that’s inserted into the body of the occasional person who has recurrent ventricular fibrillation and survives. The rhythmic catastrophe is usually seen when someone has an acute myocardial infarction or has a disease of the heart muscle, a cardiomyopathy. Fibrils of the heart quiver and fail to beat in unison, the heart muscle doesn’t contract, blood stops flowing and a person drops dead. .
The arrhythmia can be treated with a sudden jolt of electricity. The current brings all muscular activity to a screeching halt. Fibrils of muscle rest for a second or two. When they next shorten they tend to do so in unison and the heart starts pumping blood. If a heart is shocked within the four minutes after it started fibrillating the brain isn’t usually damaged, and people have an excellent chance of surviving and continuing to be fully functioning individuals.
There are defibrillators in airports and many shopping centers. They’re not pricey, and they are easy to operate. But many are afraid to use them. U.C. Berkeley put one near a volley ball court. It’s in a locked case where no one can get to it if someone drops. Hard to figure what they were thinking.
In the absence of a defibrillator we commonly resort to plan B and give CPR. Our efforts push some blood through the system, but not nearly enough.
My hospital required I retake a class in CPR every 2 years. The last time I took the course the teacher said people who develop a lethal rhythm need to be shocked early. If the jolt is delivered within a minute, 90% of people survive (presumably without noticeable brain damage). After 2 minutes 75% survive and at 4 minutes only 55%.
There are defibrillators up and down the halls of Chicago’s O’Hare Airport. A survey performed shortly after they were installed found the gadgets had already been used 14 times, and 9 of those shocked came back to life.
When someone witnesses a sudden death, confirms the heart isn’t beating, and has access to an AED –automated external defibrillator, they merely need to open the case and listen.
An automated recorded voice tells them what to do next:
“Attach the electrode pads.
Don’t touch the patient.
Analyzing. Shock advised.
Charging. Stand clear.
Push the flashing button to deliver shock. Stand clear.”
Most people who check out one of the brief You Tube videos on AED’s, automated external defibrillators, realize how simple their operation has become. If they’ve seen episodes of the T.V shows like “ER” they’ve witnessed the drill a few times. Which doesn’t mean it’s not frightening to perform the task on a live person.
The devices that shock hearts have become more common but they aren’t ubiquitous and are only noticed by people who are tuned in. A survey in a Netherlands train station (per a project manager from Kings County Washington) found that half the people questioned “couldn’t identify an AED”, and less than half of them wouldn’t consider using one of the devices.
After 40 years 300,000 people are still dropping and dying each year and the survival rate to hospital discharge is 8.4%.
Some people with damaged hearts have repeated episodes of Ventricular fibrillation. Muscle cells periodically stop working as a group and their heart stops beating. A few wear pacemakers that shock the heart when it starts fibrillating. Richard Cheney the former Vice President of the U.S. was one of those people. He had the first of his five myocardial infarctions when he was 37 years old. Unpopular in many circles, Cheney feared terrorists might try to assassinate him by remotely instructing his defibrillator to shock him, so he asked his doctor to replace his defibrillator with one that wasn’t remotely accessible.22 When he was in his 60s his heart started failing, it didn’t propel enough blood with each contraction. Doctors inserted one end of a tube into his left ventricle and the other end of the aorta. Blood was pumped through it by a small electrical motor. It helped for a while. At age 71 Cheney received a heart transplant and did well.
When I was in medical school we were taught that most colon cancers originated near the lower end of the bowel and could be detected by a probing finger or by passing a well lit, metal, foot long, hollow sigmoidoscope through the anus. Decades later doctors used snake like scopes with lenses connected to fiber optic bundles. (The eyes of a fly are made up of thousands of individual visual receptors. They work together to create an image.) Doctors learned how to guide the instruments around corners, view the entire large intestine, and biopsy or remove growths or tissue as needed. By the year 2000 our endoscopes had an optic chip near the tip and doctors monitored their progress on a T.V. screen. The devices could be totally immersed in chemicals that killed any virus or bacteria that hadn’t been removed with vigorous washing. Sedating drugs controlled the discomfort of the exam.
In 1998 the 42 year old husband of a famous T.V. personality Katy Couric died of colon cancer. She became a spokesperson for early detection of cancer by periodically screening the colons of people without symptoms, and colonoscopy became big business. Gastroenterologists became skilled, could usually pass the scope to the far end of a colon in 5 to 10 minutes. I typically performed five or more procedures in a half day. A similar chip based scope allowed us to see the stomach and duodenum, treat bleeding vessels, and biopsy worrisome abnormalities.
The small intestine, the 9 to 30 foot long stretch of bowel between the stomach and the colon absorbs food and fluids and is essential to life. It can be partially visualized with a scope, but passing the instrument is difficult and tedious. There’s a “capsule” that allows us to view the bowel another way. It’s produced by a high tech company headquartered in a once sleepy Israeli town in the Jezreel valley, a village where, in the 1970s, immigrants from Yemen sold pita filled with falafel in the sun filled town square. The small bowel device and its function are best understood by comparing it to an I-phone. The phone can snap a picture and send it by text or Email to another I-phone half way around the world. The Israeli company uses a camera and similar technology, packaged in a capsule. The “pill” also contains a flash so it can take photos in the dark. There’s a “transmitter and batteries that last 8 hours. “
A person with a potential small bowel problem swallows the gadget. As it passes through the stomach and lengthy small intestine it snaps two photos a second. It can’t store the images, so it instantly transmits them wirelessly –like a text photo—to a receiver, worn on a belt by the patient who swallowed the pill. At the end of the exam the capsule is passed in the stool. The storage disc is then plugged into a computer and a program turns the thousands of snapshots into a video that can be viewed and interpreted by a knowledgeable physician or technician.14
A medical “device”, according to the FDA, is something used to help “diagnose, treat, mitigate, or cure a human or animal disease or condition. The category includes everything from instruments and apparatuses– to machines or implants. Chemicals that don’t have to be metabolized to work are devices. Before they are sold in the U.S. “devices” must be registered, listed, and correctly labeled. Production has to be performed “in accordance with good manufacturing practices.” If something goes wrong, if there is an adverse event, the FDA must be notified.3
Each year “over 4000 new, low-risk (class I) devices are marketed”. They don’t need to be approved, but recalls and problems need to be reported to the agency.
At the same time High riskdevices go through an extensive authorization process. Annually 50 to 80 of them are approved by the FDA.
Most of the other 3500 devices that are “permitted” each year are minor modifications of an existing product. In terms of safety and effectiveness they are “substantially equivalent” to the currently used item. The verification process they go through, called 501k, is not particularly stringent. Only 8 percent need “special controls and clinical data.” “Bench testing “is sometimes adequate, and some gadget-tool-appliances have to be checked out “under conditions of clinical usage. “ When lasers for “cutting or ablation” of tissue replaced heated wire cautery, they were approved by the 501k process.
The substantially equivalent requirement has periodically been misapplied. On occasion a manufacturer obtained FDA clearance without revealing the actual use of the device. At other times the FDA and manufacturer misjudged. The new product didn’t seem that different–but it was, and it should have been extensively tested before it was widely used. In hindsight that probably was the scenario when the metal on metal hip prosthesis was approved.
For years surgeons had replaced painful arthritic hips by inserting a metal stem into the femur. The socket in the pelvis was covered by a “plastic (polyethylene.)” insert. It made sense to many that if both articulating surfaces were metal the joint would last longer and work better. The manufacturer and FDA apparently decided that making the socket metal, not polyethylene, was a minor change—that the modified prosthesis was actually “substantially equivalent.16” It was not necessary to test people. Cobalt and chromium alloy prostheses received FDA clearance in July 2008 without a clinical study. They were then implanted in 100,000 patients. Over time the metal on the articular connecting surface of the bone tended to erode. Sometimes particles “migrated into the surrounding tissues and the bloodstream. 21% of the alloy prostheses had to be replaced or revised within 4 years and 49% within 6 years.”4
Also approved by the 501k process, transvaginal mesh was used when surgeons operated on pelvic organs that prolapsed, slipped down and were protruding into the vagina. No clinical trials were conducted at the time, and sixty-one products were marketed between 1985 and 1996. Made of a type of plastic called polypropylene, their lattice corralled parts of the intestine or a bladder. Over the years the mesh caused a number of complications “including pain, adhesions, bowel obstructions, and infections.” In January of 2016 the FDA issued a high risk warning, and in April 2019 the agency told manufacturers to stop selling the material.5
Manufacturers and clinical facilities have to report device-related deaths and serious injuries to the FDA. In 2002 the agency received 2500 reports from clinical facilities and 3500 from consumers.
“Over 1000 devices are recalled each year.” Half have low risk drawbacks. Most of the rest are intermediate risk. And 10 to 20 of the problems are serious. Recalls require manufacturers halt production and dissemination of the devices, and they must alert clinicians. Post recall doctors and nurses are supposed to keep an eye and ear out for difficulties with “Heart valves, joint prostheses, implants, cardioverters, defibrillators, respirators, infusion pumps, hemodialysis equipment, cutting and coagulation equipment, endoscopes, etc.”6
The FDA, via a new precertification program is working with industry to try to find a way to evaluate the effectiveness and safety of software as a device.”9 “81% of North American adults own a smart phone, and many companies are trying to use technology to monitor health and help manage certain chronic diseases.” Some devices can detect the heart rate; others the number of steps a person takes during a day.
In 2020 a corona virus that modern man’s immune system had never previously encountered jumped from a bat to a man. It often made people very ill and was extremely contagious. At times it caused an infectious process that filled the lungs with fluid and made oxygenation impossible. Many were saved by respirators that mechanically ventilated lungs for days to weeks. But in hard hit areas like Italy and New York there weren’t enough ventilators for everyone who needed them. The president, the press, and politicians of the time regularly attacked and blamed one another every time there was a mishap or an unheeded warning.
The nation was caught shorthanded even though government officials had anticipated a potential need for the devices and had ordered many a few years earlier. By April 20th few had arrived. The dearth of respirators was big news and people wanted to know who screwed up.
The blood that flows into the heart from the body enters through the right upper chamber, the atrium and progresses to the pumping chamber, the right ventricle. The ventricle pumps the blood into the lung. The human lung is a collection of about 500 million tiny air chambers called alveoli. A cubic millimeter of lung tissue contains about 170 of them. They are surrounded by thread like vessels, capillaries. Erythrocytes, red blood cells stream through them. The cells deliver their carbon dioxide to the alveoli and collect oxygen.
Air is sucked into the lungs when a vacuum is created by breathing– expanding our chest and lowering our diaphragms. Earlier in the 20th century when the muscles of a child with polio were so weak that the person couldn’t inhale, he or she was placed in a long sealed tube. Their head hung out of the top. Multiple times a minute the machine created a vacuum and air was sucked into a person’s lungs.
During the Second World War the military needed a device that forced air into the lungs. Driving oxygen into the circulation allowed pilots to fly at high altitudes. The devices were developed by Dr. V. Ray Bennett and Dr. Forrest Bird. After the war each went on to develop forced air ventilators. One of the inventors, Forrest Bird, had a father who flew combat planes during the First World War and had taught his young son how to fly a plane.
Positive pressure ventilators were commonly used in the 1950s for people with severe pneumonia who couldn’t move air into their lungs. Over the subsequent 60 plus years Bird, Bennet, and others modified and improved the devices.
Shortly after the 2003 SARS respiratory epidemic the department of Homeland Security decided to stockpile an additional 70,000 respirators. They might be required in a moderate influenza pandemic. Before the government ordered the machines a panel of experts decided which bells, whistles and capabilities the respirators would need. The machines on the market were costing $10,000 a unit and the group, presumably, thought they were overpriced. They decided new respirators should not cost more than $3,000 each. In 2008, the government asked companies to bid on the project. As developer and supplier they chose Newport Medical Instruments, a small outfit in Costa Mesa, California, a company that was “small and nimble.” After the deal was inked the government gave Newport $6 million to develop the machines and said they would pay the rest when the devices were delivered. Reading between the lines it sounds like the people at Newport knew they would lose money on the deal. “but would be able to make up for any losses by selling the ventilators around the world.”
Research started and every three months, government officials visited Newport’s headquarters. “There were monthly scheduled requirements and deliverables.”
In 2011, 3 prototypes were sent to Washington and the company planned to “file for market approval and start producing the machines in the fall of 2013. Then the company was sold. Established 45 years earlier by physicians, Newport Medical was Japanese owned. Covidien, a company that was formed when Tyco “spun off” its health care division, purchased Newport for a little over $100 million. Then Covidien wanted the government to provide additional funding and a higher sales price. The government said OK. The U.S. gave Covidien an additional $1.4 million. The next year Covidien decided they wanted out the contract. The deal “was not sufficiently profitable” The government agreed and awarded a new contract for $13.8 million to the giant Dutch company Phillips. In July 2019 the F.D.A. signed off on the new Philips ventilator, the Trilogy Evo. The government ordered 10,000 units in December, setting a delivery date in mid-2020. In January 2020 a major coronavirus epidemic started spreading out of China.
On March 31, 2020 a Pennsylvania subsidiary of Phillips was producing the cheap portable ventilators but they didn’t deliver them to the U.S. They sold them to other countries. Called Trilogy Evo the ventilators were priced at $3,280 each. the company is currently negotiating with a White House team for43,000 additional ventilators. In March 2020, invoking the defense production act, President Trump told General Motors to make the ventilators.
In 2017 the top 10 device makers had over $170 billion dollars in revenue and the top 30 took in more than $270 billion. Devices are responsible for roughly 6% of U.S. health care spending or about $200 million a year.10
Like pharmaceuticals –MRI machines, vascular catheters, endoscopes etc. are very expensive. Little is known about how companies and hospitals negotiate. A friend who purchased equipment for a chain talked about the days after the hospitals he worked for merged with another hospital group. He visited one newly acquired facility at a time and met with the local doctors. They had attitudes and beliefs about which scopes, artificial joints, heart valves, etc. were easier to use, more effective, and more durable. Some cared about the brand of material used to sew wounds shut. Since many surgeons could choose where they admitted their patients, where they performed their procedures, the hospitals needed their business. At times my friend had to buy a brand of equipment that wasn’t perceivably better and was more expensive.
Given our current system I think an attempt to regulate the cost of medical devices doesn’t make sense. In Europe, on the other hand, medicine is commonly state run. Administrators have a greater say and can more effectively use price as a bargaining factor. Not surprisingly European nations pay less for medical devices than we do in the U.S.
To even out the costs and to help make health care affordable to all, Congress, as part of the Affordable Care Act (Obamacare), enacted a 2.3 percent medical devise tax. It was briefly collected then put on hold, and recently was repealed. .
The world’s largest device maker, Medtronic, the Minnesota Company with revenues of about $30 billion a year, spent a decade acquiring and integrating 20 smaller companies. Then, in 2015, the American corporation purchased a company headquartered in Ireland called Covidien. As discussed earlier it was a 2007 spin off of Tyco.
After the merger was consummated Medtronic moved its official headquarters to Ireland. According to The Street: Medtronic’s 49.9 billion acquisition of Dublin-based Covidien, the largest tax inversion deal ever — was going to leave shareholders with a big tax bill, while allowing the Minnesota-based company to pay little or no U.S. corporate taxes.
“It is not inconceivable that [Medtronic] may not be taxed at all.” on its U.S. operations, said Robert Willens, tax consultant and professor at Columbia University.11
In 2018 Medtronic, now an Irish company, had net earnings of 3.104 billion, Half the money came from sales to physicians and hospitals in the U.S. “Medtronic’s total revenues grew from $28.8 billion in fiscal 2016 to $30.6 billion in fiscal 2019.15 “
Of the 5 medical device companies having the greatest annual revenue:
Johnson and Johnson with $26 billion in revenue is headquartered in New Brunswick, New Jersey;—————-
$19 billion GE Healthcare is based in Chicago; ———-
$16 billion Royal Phillips calls Amsterdam home. —————
13. Dua, A (2014). “Epidemiology of aortic aneurysm repair in the United States from 2000 to 2010”. J Vasc Surg. 59 (6): 1512–7. doi:10.1016/j.jvs.2014.01.007. PMID24560865.
Reality is a crutch for people who can’t cope with drugs. Lily Tomlin
A New York Times article tells of employees at the large Wockhardt facility in India who were “knowingly throwing away vials of insulin that contained metal fragments” and were caught. They were seen by Peter Baker, a man who spent six years inspecting generic factories in India. He discovered some if the company’s employees were fabricating, backdating and falsifying. Some of the data in 29 of the 38 plants he inspected was allegedly fraudulent or deceptive.2
Wockhardt is India’s 5th largest pharmaceutical manufacture and has 8600 employees worldwide. And it’s not the only company where short cuts and violations were detected. In 2014 the FDA sent cautionary letters … to companies operating plants in Australia, Austria, Canada, China, Germany, Japan, Ireland, and Spain.” They discussed manufacturing and packaging violations, testing, quality checks,..data collection, and contaminated products.”
I’m not saying that brand name medications are safer than generics. According to Consumer reports “Many brand-name drugs are produced overseas, often in the same plants as the generic equivalents.”3
In her excellent book, Bottle of Lies, Katherine Eban tells the story of how one of the large producers of drugs in India entered the American market. Then they cheated, deceived, and ultimately went under.4
The company in question, Ranbaxy, was incorporated in 1961 by Bhai Singh, a member of a wealthy Sikh family. It initially distributed cheap Japanese pharmaceuticals and had one factory that “reformulated bulk drugs into tablets and capsules.” In 1968 the company created and marketed a generic version of Valium. The drug became a best seller and Ranbaxy had value. The sons of the founder were studying in the U.S. and they came home. Over the next twenty years they were welcomed into the family businesses, and they eventually started fighting over who was in charge. In 1995 Ranbaxy entered the U.S. market and seemed to be playing by rules set down by the FDA.
The U.S agency inspects and checks manufacturers, but they also expect companies to police themselves, keep records, and submit them to the agency. The rules for good manufacturing practices were created in the early 1960s. Each critical step has to be performed and documented competently. Each batch of drugs needs a record. The policy calls for “preventative and corrective action,” and Ranbaxy seemed to be compliant. Not that the company had the same ethos as their competitor Cipla. A Gandhi inspired pharmaceutical company, Cipla was clean, well run, and was devoted to supplying medicines to the underserved. Ranbaxy was in business to make a profit. But they were competent and efficient; and the company grew in size and importance. Then they hired an expert to computerize their data and he took his job seriously and the company started to unravel.
In November 1984 Congress unanimously passed the law that turned the drug market on its head. It allowed generic drugs to enter the market without undergoing redundant testing. It had its flaws and created new dilemmas. (See Hatch Waxman in the FDA chapter.). Some contend that the recent creation of a number of high priced medications is in part a reaction to the revenue big Pharma lost to generic competitors.13
Before the 1984 law most U.S. medications whose patents had expired—drugs that were in the public domain –were still made and sold by one and only one pharmaceutical company. They distributed the medication and determined its price. Other companies could not market an exact replica of a drug U.S. unless or until their product survived a double blind control study. Half the subjects had to be given a real drug and half a placebo—a dud. These kinds of investigations were expensive, time consuming, and, since half the people were being deprived of a known medication, the studies were potentially unethical. Only 13 percent of U.S. prescriptions were written for generic medications.
The new law changed everything, and by 1994 copy cats accounted for half the drugs that were prescribed. During the early months and years that followed the changes, the FDA was flooded with fraudulent drug applications, and the agency got tough and created and enforced a number of new policies.
Each drug producing establishment was supposed to be checked every 2 years. That wasn’t possible, so the FDA employed a model that relied in part on the risk. The company’s inspection history helped tell them which facilities to scrutinize. Foreign offices did some of the inspections. Between the years 2000 and 2008 the FDA conducted over a 1000 domestic inspections a year and fewer than 400 check ups in foreign countries. 14
By 2012, 84 percent of the pharmaceuticals used by Americans moved along the assembly lines of generic manufacturers.
It’s not easy to create a drug that is truly generic. Not because manufacturers have a problem acquiring the needed chemicals. They don’t. A medication’s active ingredient, the substance that lowers a person’s blood pressure, slows clotting, or sinks the level of sugar in the blood can usually be purchased. It’s often produced in large quantities in factories (commonly in China.). Once the patent for the original medication has expired sophisticated chemists seem to know what to do.
Most medications are part API’s—active pharmaceutical ingredients. And part “excipients”–inactive substances. Drugs become truly generic when their active and inactive substances are absorbed like the brand named drug, when they circulate, reach the right blood level at the right time, and when they work as long as the original drug. Nowadays the original fabricator usually patents the various manufacturing steps, so generic manufacturers have to use a different path to produce the product.
“The U.S.’s top 5 sources of pharmaceutical imports by “value”–not quantity– (in 2015) were Ireland, Germany, the U.K., Switzerland and India.” Indian companies produce large volumes of cheap generics that are no longer patent protected. The medications “account for 22 percent of spending,” China doesn’t sell many “finished drugs” but they produce 40% of the global chemical components used for our medications.1
Companies that produce a drug and sell a medication in the U.S. need to tell the FDA the name and business address of the manufacturer. In 2009 over a thousand generic plants applied to the FDA for permission to sell their drugs here. 43% of the plants were in China; 39% in India.
One of the problems that doomed Ranbaxy, the company that motivated Eban to question generic drugs, was the way the company handled their version of the acne medicine Accutane. Their product was called Storet. Ranbaxy was ready to market their drug when further testing showed the generic formulation wasn’t absorbed appropriately. Small quantities of the drug had worked in the lab, but when the company started producing it in quantity it “was failing”. Ranbaxy should have delayed its launch, kept it off the market until they figured out how to correct the problem. But they decided to sell the defective medication to the public while the company’s scientists tried to figure out what they were doing wrong. They “concealed the problem from regulators”, and they memorialized their findings and decisions in a dossier that was labeled “DON’T SHOW TO THE FDA.” That decision would come back to haunt them.
As Eban explained in her book, drug companies were expected to emphasize quality over cost. “Manufacturing processes had to be transparent, repeatable, and investigate-able.” There’s, apparently, always some variation between batches of medicine, so companies are expected to test each group and keep real time records of each drug making step.
At one point Ranbaxy was getting big, and it was hard to keep track of what was happening in their factories. So they hired a data expert who was born in India and learned his trade while working for the American drug manufacturer Bristol Myers Squibb. His name was Dinesh Thakur and he took his job seriously. Before he could computerize figures from the company’s many factories he had to collect the information. He sent his assistants to the facilities, and one by one they came back empty handed. Ranbaxy, it turned out, had been faking the data that “showed” each batch was tested. They were telling the FDA they were regularly checking the drugs that came off their assembly lines, and they were claiming they had proved that each batch was “properly formulated, stable, and effective.” But half the information submitted to American and European regulators was bogus. Drugs sold to people in India were not tested for stability and bioequivalence. Adverse events were not reported to the FDA. The drugs may or may not have performed appropriately. The data that said they were up to snuff looked impressive, but it was phony. Drugs made for third world countries were formulated using relatively impure, cheaper ingredients. Sometimes, instead of testing products they made, people at their factories would crush and test brand named drugs. Documents were back dated.
In 2004 after his team gathered proof, Thakur reported to his boss, Raj Kumar. It took a little convincing but eventually Raj was persuaded. The company was systematically faking data. The board of directors had to be notified. Raj created a power point explanation of what was happening. He believed the drugs that had been misrepresented had to be pulled from the market and the company had to reapply to the FDA.
He made his presentation to the people in charge. It was called a self assessment report (SAR). When Raj finished, his statement to the board was met with silence. The company leaders didn’t seem surprised, and they weren’t willing to admit they were wrong. They would not reapply to the FDA. Kumar was told to destroy his slides and presentation—the SAR. As a result of the leadership’s refusal Kumar resigned. That was in October 2004.
Thakur stayed but was troubled by many of the company’s products. He worried about the HIV fighting drugs that were being shipped to Africa. “He knew they were bad, degraded easily, and would be useless in the heat of Sub Saharan Africa.” Two years after he joined the company Thakur resigned. But he remained troubled. Four months later Thakur assumed a pseudonym and started writing, initially to the World Health Organization, then to several FDA officials, and ultimately an FDA commissioner. He told them Ranbaxy was faking data. –that they were fabricating information to support stability.” At the time whistle blowers in India had sometimes been killed, and Thakur felt he had to hide his identity. But he also felt compelled to act because he believed “executives at India’s biggest pharmaceutical company had committed intentional global fraud.” The people at the FDA who received the emails Thakur sent didn’t know what to do. Ranbaxy was a huge company with multiple factories and paper work that seemed impeccable.
In India companies were always notified when the FDA was sending an inspector. Visits were scheduled and manufacturers had days to make their facility spotless. And that was a potential problem. Sometime during the subsequent year the company was checked out by an FDA examiner who, apparently, didn’t know about the allegations. He believed the company was honest and honorable. He spent his days identifying and pointing out deficiencies, and he gave the factory a passing grade. The people at Ranbaxy thanked him and promised to fix the problems. By February 2006, having received multiple surreptitious emails from Thakur, a few people in the FDA had grown suspicious. The Ranbaxy factory was re-inspected. This time two hardnosed investigators surveyed the plant. They found deficiencies, and the FDA stalled one of the company’s new drug applications. Eventually, on Feb 14, 2007 officers carrying guns and wearing bullet proof vests raided Ranbaxy’s New Jersey facility. They carried away hard drives and a copy of the company’s internal report on their Accutane drug. It was labeled DO NOT GIVE TO FDA, and it proved someone in the company had lied. But it didn’t provide evidence of systemic fraud. FDA investigators tried to contact Raj Kumar, the man who gave the power point presentation, and he evaded them. A company lawyer warned Raj to “be careful about what he tells the FDA because he had exposure.” Some leaders at the FDA found it hard to believe that a company with manufacturing plants in eleven countries and sales in 125 nations was systematically providing fraudulent data.
About that time Tsutomo Une, a leader of a Japanese pharmaceutical house Daiichi Sankyo, contacted the head of Ranbaxy and spoke of a joint venture. His company wanted to grow. Japanese drug manufactures were at the time (and still are) known to be leaders in the field of quality control. The leaders of the two firms met a number of times. Within 4 months a merger of sorts seemed likely, but Une was hesitant. It was public knowledge that the Indian company had been raided and had received warning letters from the FDA. Malvinder, head of Ranbaxy told Une that the raid was really incited by Pfizer. They were trying to get back at Ranbaxy because the Indian company had “prevailed in the Lipitor patent litigation.” And Une believed him.
But Malvinder was worried. His lawyers learned that when the FDA raided the New Jersey Ranbaxy headquarters, among the data they had hauled away was the 2004 SAR. It was a smoking gun and showed that Ranbaxy had been faking the data they presented to the FDA. Malvinder fretted but didn’t tell his Japanese counterpart.
In 2008 Daiichi Sankyo became Ranbaxy’s principle share holder. In September 2008 the FDA barred the import of 30 drugs from two Ranbaxy plants, and in early 2009 the FDA formally issued an “AIP.” The letter notified the company that the agency believed it had evidence that the company’s applications had been “fraudulent or unreliable.” Malvinder was forced to resign as head of Ranbaxy. He paid a large fine to the FDA but avoided criminal prosecution. He was later sued by the Japanese and was forced to pay them $550 million for overstating the value of his company. Ranbaxy agreed to plead guilty to three felony counts of violating the federal drug safety law and four counts of making false statements to the F.D.A. The company also admitted that they failed to complete the proper safety and quality control tests on several of the drugs that were manufactured in the Indian factories. We probably would not have learned that Ranbaxy was faking their data had it not been for a troubled whistle blower.
In subsequent years the FDA’s presence in India has gradually expanded. They claim to have more than a dozen full-time staff. Inspections are (officially) frequent and increasingly unannounced. If the agency finds problems, it issues a Form 483, a notice outlining the violations, which if not resolved can lead to a warning letter and in worst case, a ban. Violations range from hygiene, such as rat traps and dirty laboratories, to inadequate controls on systems that store data, leaving it open to tampering.5.
Eban’s book goes on to tell of a few other companies that cheated. .
In the early 1990s an FDA inspector observed Sherman Pharmaceuticals of Louisiana burning medication that was returned due to contamination. Penalized in 1995, the company went out of business.
In 2007, the anticoagulant heparin was manufactured by the American company, Baxter, and it made kids who were receiving kidney dialysis sick. The substance that caused the harm turned out to be a contaminant in the Chinese chemicals that were used to make the heparin. And there were others.
In 2012, Congress passed the FDA Safety and Innovation Act. It directed the FDA to inspect foreign facilities as frequently as domestic plants.
In 2013 “the Indian government approved the addition of seven new FDA drug investigators, and brought the total number of Americans checking their facilities to 19.
That year the number of inspectors in China went from 8 to 27.”
By 2014 the FDA was complying with the law. They conducted over 800 inspections in the U.S. that year and they checked an equal number of facilities abroad.
By July 2016 965 foreign production facilities had never been inspected. And before 2020 the agency had, at least once, assessed 495 or 51% of them.14
Based on the Ranbaxy story and numerous interviews Eban asks a very important question: Should brand name and/or generic pharmaceuticals be trusted? It’s an especially important question because more than 40 percent of finished drugs used in the U.S., and 80 percent of active pharmaceutical ingredients are produced overseas. Pharmaceutical factories are scattered around the globe. There’s a lot of money involved, and people sometimes cheat.
Deception by major players, sadly, is not confined to the generic pharmaceutical industry.
In 2015 the environmental protection agency discovered that 11 million diesel autos made by Volkswagen contained a special device that allowed the company to intentionally lie about their emissions. The company admitted guilt and paid a $25 billion fine.
In 2008 the former head of Nasdaq, Bernie Madoff, admitted he had, over many decades, “conned his investors out of $65 billion.” He went to jail.
More recently airplane manufacturer Boeing, fitted some of its newer planes with large engines and special software but failed to train some of the pilots. Their actions led to the crash of two air craft and the loss of hundreds of lives.
Early in this century huge trusted banks sold collections of mortgages whose quality was falsely inflated. When housing prices started dropping in 2007, the values of these mortgages plummeted and the banks didn’t have enough cash to avoid a run. The economy was saved by a $16.8 trillion dollar government bailout. .
In the EU, national competent authorities are responsible for inspecting manufacturing sites located within their own territories. Sites outside the EU are inspected by the State where the EU importer is located or by the manufacturing country’s examiners.
If products are imported directly into more than one member state from a manufacturing site outside the EU, there may be more than one responsible authority. Routine inspections are performed using a risk-based approach and when there is suspicion of non-compliance.7
Facilities in Europe are apparently rarely inspected by our FDA. Thanks to the 2012 Food and Drug Administration Safety and Innovation Act, the FDA turned over the inspection of meds made in Europe to the inspectors of each country.8
Pharmaceutical manufacturing is a large global industry.
In 2003, worldwide pharmaceutical industry sales totaled $491.8 billion.
The U.S. accounted for 44 percent of global industry sales for a total of $216.4 billion.
The ten largest pharmaceutical corporations made almost 60 percent of total U.S. sales in 2004.
There are a few pharmaceutical companies that participate in both the branded and generic parts of the industry.
All manufacturers use electronic bar-coding technology on drug packaging. Hospitals claim bar coding each pill makes it less likely a sick in-patient will be given the wrong medication. In Europe (starting in 2019), all marketed medicines need a 2D Barcode. Central verification systems are supposed to be able to trace each and every medication.
Hospitals in Holland have shown that when all Single Unit of Use Packages contain the correct barcode – record, doctors and nurses make fewer mistakes.10 .
In the U.S. the person who fills a prescription and puts the medication in his or her body is not informed of its country or manufacturer of origin. The side of the refill bottle of a prescription medicine I take has a bar code. It is 8 numbers long and I don’t know how to access the information it encodes. If the pill doesn’t work or causes a reaction I currently am unable type the numbers into a web site and get that information. What if everyone could post medication problems with details about where the drug was manufactured on a web site that others or the FDA could check?
Pharmacy benefit managers choose which drugs we take on the basis of price, kickbacks, quality, and reliability. How do financial incentives affect quality of our drugs?
ARE GENERIC DRUGS SAFE AND EFFECIVE? The world has bad actors and cheaters, but most companies and inspectors take pride in their work. They don’t want to let their friends and neighbors down, and they strive to avoid creating or choosing an inferior, worthless or harmful product.
A Medicare buy-in plan for parts of the country was proposed by Senators Michael Bennet and Tim Caine. Pointing out that health care that’s not affordable or contains extravagant co-pays isn’t usable–they want to give people who live in certain areas the ability to enroll in the government program. Policies would provide maternity, pediatric and newborn care, and hospitals and doctors would be reimbursed at 125% of the standard Medicare rate. They would start in areas where the insurance exchange offers “one or no options” and in counties where: the price is high, there aren’t enough doctors or there’s a lack of competition. After 4 years they would make Medicare insurance “available to small businesses and to individuals.” Each state’s department of health care services and state health commissioners would create the rates. There would still be three tiers of service, and federal goodies like tax credits would remain. The plan would allow each state to negotiate the price of drugs covered by MedicareD. Administrative costs would be paid for by medical premiums.1
A community where more doctors and competition did NOT help keep costs down, McAllen Texas is a poor border town and is “one of the most expensive health-care markets in the country.” It had more than its share advanced technology and highly trained doctors, but based on outcomes, the results here were average. In the opinion of one of the towns displeased surgeons, medical care was over utilized. Tests and surgeries were performed for marginal indications. And medicine had become too much of a business. The town’s newest hospital was physician owned. It’s owners denied claims that they recruit high volume physicians and that physicians “receive not only their fee for whatever service they provide but also a percentage of the hospital’s profits from the tests, surgery, or other care patients are given.5 ”
Four steps that were needed if the affordable care act was going to be used to provide universal coverage, per Matthew Fiedler and 4 health policy experts:
For starters they would use a “carrot and a stick”–financial incentives and penalties to convince “wayward” states to offer Medicaid coverage to people whose incomes were below 138 percent of poverty. Second: they would offer tax credits and subsidies to the uninsured whose incomes were below 400% of poverty and to people whose workplace policies came with excessively high co-pays. (They pegged the number of U.S. residents who didn’t have “coverage” in 2019 at 9%.) Third: They would “streamline enrollment procedures” for people eligible for Medicaid or CHIP who hadn’t done the paper work. Fourth: They would do what corporations do when they have a big stock offering. They would create backstop insurance. If some of the stocks and bonds intially offered for sale are not sold on the open market, the investment firm that is handling the transaction has to buy them. Fiedler et al. would similarly subject the high income, uninsured to backstop insurance. (As described in the prior segment) When one of these people receives emergency care, the hospitals and doctors would be paid by the government. At income tax time the IRS would extract an appropriate“backstop” insurance premium fee.
The group didn’t have an answer for the one sixth of the country’s residents who were undocumented, but they thought the nation needed to create a path to citizenship. They didn’t believe their modifications would increase the amount the government had to kick in.2
MEDICARE-FOR-ALL– The “damn bill” Bernie Sanders wrote and 106 members of the House of Representatives are sponsoring . In an interview Sanders explained that his plan would eliminate private insurance, co-pays and premiums.
The person conducting the interview pointed out that an independent analysis suggested his plan would cost $34 trillion the first decade. Taxes will go up.
Sanders didn’t disagree but countered that another analysis concluded that if we do nothing– over the same time period we will spend $50 trillion dollars. “We spend twice as much per person as the Canadians and many other countries in the western world.”
When health care is
paid for by taxes, individuals will no longer spend $15,000 a year for
premiums. “If a person ends up in the
hospital and gets a bill for 50-80 thousand dollars –that’s gone. Co payments are gone. Out of pocket expenses are gone. The average American will pay less for care.”
Sanders would phase in his plan. “Over a four year period we would expand the most popular health plan in this country—Medicare.” The first year he would cover dental care, hearing aids and eye glasses, and he would lower the eligibility age to 55. The following year 45. The next year 35. “Then we cover everybody.6 ”.
The Sanders bill– As “unpacked” by Katie Keith in Health Affairs March 3, 2019: (details below–reference 8) Everyresident of the United States would be entitled to health care benefits; the bill would prohibit charging deductibles; coinsurance, copays, or similar fees for covered services. All standard health care that is part of the HHS national practice guidelines would be included.8
Elizabeth Warren would automatically enroll people under 50 in medicare. If they prefer other coverage THEY CAN DECLINE. She “identified trillions in revenue to finance a fully functioning Medicare for All system – without raising taxes on the middle class by one penny” (detailed in elizabethwarren.com)
Her plan BEGINS as high-quality public insurance that covers 90% of costs. It ALLOWS people to utilize improved ACA subsidies to PURCHASE coverage and reduce cost sharing. No premiums for kids under 18 or for people at or below 200% of the federal poverty level. People with earnings greater than “200% FPL, will pay a premium that gradually increases as a percentage of income, and is capped at 5.0% of income. Starting in year one, the plan will NOT have a deductible – but there will be caps on out-of-pocket costs. “In subsequent years, premiums and cost sharing will gradually decrease to zero.”
With regard to the 160 million people who get insurance through their work. If workers with employer coverage opt IN, their employer will pay an appropriate fee. Unions can NEGOTIATE TO INCLUDE a move to the Medicare for All option via collective bargaining. If they do their employers would pay a discounted contribution and pass the money they save to workers in the form of increased wages etc.”
It’s health insurance that doesn’t have high co-pays so peope can use it. (some of today’s policies are un-use-able in the absence of a catastrophe due to high co-pays.) It’s not Medicare for all who want it– but Medicare for all — UNLESS THEY DON’T want it. People don’t opt in. Bu if they have insurance they want to keep they can opt out.3
My path summarized: Private insurers work on a risk adjusted basis. If you live in a flood zone you can’t get flood insurance or it’s too expensive. Taking affordable insurance away from the low risk young and healthy would be–like taking away a “right”. Politically it’s a loser or “socialism”. (The French leader Macron’s attempt to “reform” the country’s pension system—a program many workers think of as a “hard earned” right, has prompted a “cacophonous response. Everyone is angry.”)
For-profit companies are a significant driver of the high
cost of health insurance. The Affordable
Care Act allows insurers to keep 15-20 percent of the premiums for
stockholders, bonuses etc. They call it
the Medical Loss Ratio. (When the
companies pay doctors and hospitals more than Medicare does, then raise the
cost of premiums, their gross income goes up– and they get to keep 15-20% of
the extra money.)
I would: A. allow
people with pre existing illness access Medicare. (We’ve done it before. On October 30, 1972, the U.S. government chose
a very expensive pre-existing
condition (advanced renal–kidney failure) and made its care a “right”,
paid for by Medicare. )
B. Give people over 50 access to Medicare; let
those who wish join. They would need to pay
for an age and income adjusted premium.
B. Raise the Medicare (payroll)
tax rate for wages above $150-200,000.
C. Each year decrease
the ‘Medical Loss Ratio’—the amount insurance companies get to keep by 2-5%. When it goes below 8% insurers will bow out
–or not.
DRUG PRICES: –When drugs are approved by the FDA they have to be safe and relatively effective. -In addition I’d require the FDA at the very time they approve a drug for sale in the U.S. –to establish the medication’s list price according to a formula.
The amount charged should be based on a company’s real cost (including
promotion and a percentage of company research) and a generous profit.
BUT my formula would NOT include development and creation costs paid for by charities and the taxpayer. And they can’t include the billions of dollars companies spend when they buy one another. (See the book for details.) And future price hikes should not exceed inflation.
HOW TO ACHIEVE UNIVERSAL COVERAGE: Brookings Institute Group led by Matthew Fiedler Ph.D N Engl J Med 2019; 380:1685-1688 https://www.nejm.org/doi/full/10.1056/NEJMp1901532
8. Medicare would pay for: All hospital services (including inpatient and outpatient hospital care, emergency services, and inpatient prescription drugs); ambulatory patient services;
primary and preventive
services (including chronic disease management);
prescription drugs,
medical devices, and biologics;
mental health and
substance abuse treatment services (including inpatient care);
laboratory and
diagnostic services;
comprehensive
reproductive, maternity, and newborn care; pediatrics;
oral health,
audiology, and vision services;
rehabilitative services
and devices;
emergency services and
transportation;
early and periodic
screening, diagnostic, and treatment services covered under Medicaid;
transportation to
receive health care services for persons with disabilities or low-income people
(as determined by the Secretary); and
Long-term care
services and support.
Doctors can’t bill or contract with people who are eligible for Federal
insurance.
There’s a long term care benefit.
All the money that currently flows to Medicare, Medicaid, government employees, and a few other programs would end up in a “Universal Medicare Trust Fund”. “The proposal doesn’t say If the bill passed the companies would presumably exit the market.4
According to the insurance information institute, in 2017 health insurers generated revenues of $670.1 billion. If the bill passed the companies would presumably exit the market.
The first five years
of the program one percent of the money would be used to help displaced health
insurance-related workers.
The proposal contains a technique for determining salaries, operating expenses, administrative costs, and much more. The federal department of Health and Human Services (HHS) would annually negotiate the prices to be paid for covered pharmaceuticals, medical supplies, and medically necessary equipment. The bill goes into a lot of detail about how these would work.
If the Secretary could
not successfully negotiate an appropriate price for a drug, he or she could
authorize a “competitive license”. The
original manufacturer would receive “reasonable compensation”. Drug manufacturers will be forbidden from
engaging in anti-competitive behavior.
States would be
allowed to set additional standards with respect to eligibility, benefits, and
provider standards so long as these standards do not restrict eligibility or
reduce access to benefits or services.
The bill would establish an Office of Primary Health Care within the Agency for Healthcare Research and Quality.
There’s a 2 year transitional Medicare buy-in option for U.S. residents under the age of 19 or 55 or older, or who are currently enrolled in Medicare.
In the summer of 2005, Charity Hospital, the country’s second largest, provided medical care to the poor and uninsured of New Orleans and had one of the nation’s busiest emergency rooms. Rebuilt for the sixth time in 1939, it had 2680 beds, and was a major teaching hospital for Louisiana State University. That August Hurricane Katrina struck the city and flooded the first floor of the structure. Aside for a few generators for breathing machines there was no power, no lights, and food was scarce. On more than one occasion the thermometer topped 100 degrees. Toilets didn’t flush. There was no water for hand washing and the port-a- potty at the end of the hall smelled. Observing from the forsaken building, a physician painfully watched each day as helicopters evacuated patients from the roof of the nearby Tulane Hospital, a facility that was 80% owned by the for-profit Hospital Corporation of America, “while our 250 patients were evacuated by twos or threes in boats”. It took nearly a week before the final 200 were rescued.19
Of the for-profit institutions, HCA, Hospital Corporation of America is the largest. The chain was started in Nashville in 1968 by a cardiologist named Thomas Frist. “The hospital he worked in was poorly run and equipped,” and he and a few colleagues decided to build another one. He met and partnered with Jack Massey, the man who developed the Kentucky Fried Chicken chain. They built Parkview hospital in Nashville and bought a second one. When Thomas junior talked to investors he encountered skepticism. They didn’t believe a doctor could be a good business man. The secret of his success, he once said, was the idea of bigness itself.
The company he founded has become quite large and has “164 hospitals and 106 freestanding surgery centers in 20 states and Great Britain”–and a “market cap” of over 9 billion dollars.
Another of the big four, Humana was established after a few Louisville realtors figured they could make money operating nursing homes. They chose the company name from a list of 500 submitted by a corporate identity consultant. After buying one, then a few hospitals they went public in 1968. By 1972 they were running 45 hospitals. In 1978 they took over a second hospital chain and more than doubled in size. Then in 2018 the company paid $4.1 billion for a 40 percent stake in 76 long-term acute care and rehabilitation hospitals operated by Kindred Healthcare.
Bob Appel founder of American Medical International worked for a medical diagnostics lab that served hospitals. When his employer had financial problems Appel purchased the lab and later started acquiring hospitals.
National Medical Enterprises, now Tenet was formed by three lawyers in 1967. One was quoted as saying “doctors don’t generally know how to run a business. A hospital is really just like a hotel. You just have to know the medical side.15”
Community health systems of Franklin Tennessee once owned 25 of the 50 hospitals that were the nation’s most expensive. In 2014 they controlled 200 hospitals and earned $18 billion in profits. Then they paid $7.5 billion for a for-profit chain “that had a slew of financial and legal problems”, and they started losing money. When their debt was close to $15 billion they sold 30 hospitals cheap and they are teetering.3
Currently about 1034 of the nation’s hospitals belong to one of several for-profit corporations. They have stockholders, earn money, and pay taxes. Their bottom line was boosted (and government revenues fell) in 2018 when the corporate tax rate dropped from 35% to 21%.
Our nation’s first, Philadelphia’s “Pennsylvania Hospital’, was founded in 1751 “to care for the sick-poor and insane who were wandering the streets.” The facility was the idea of a Quaker who was medically educated in Paris a century before physicians believed bacteria and viruses cause infectious diseases. He wanted to emulate Paris’ Hotel-Dieu, the continent’s second oldest. The Parisian facility was established by Saint Landry in 651 AD “to treat pilgrims and the poor.” By the early 21st century the facility had become central Paris’ “top casualty and emergency hospital.” It closed in 2013.12
In 1811 federal legislators established and funded a home and medical clinic for military veterans. Fifty years later, after half a million fighting men died of wounds and illness in our destructive civil war (1860-64),the government created a number of veterans homes. They “incidentally” also provided medical and hospital treatment. 50 years thereafter our nation entered the First World War (1917-18). 116,000 men lost their lives. Many more were wounded and disabled–and a number of facilities were built.
After they were officially launched in 1921, the Veterans Administration started building hospitals. By 1948 there were 125, and the VA currently says they operate1600 health care facilities.5 They once cared for all service men and women who had been on active duty, even briefly. After September 1980 the government began limiting the pool by requiring a “minimum length of service.” The VA and Indian health hospitals are directly and indirectly (through Medicare and Medicaid) federally funded.
Before Medicare was passed in 1965 U.S. hospitals were largely segregated. Black physicians often couldn’t get privileges to practice at hospitals dominated by whites, and in some of our leading hospitals people of color were cared for in the basement wards of white hospitals.
Established In 1927 in the segregated south, the non-profit Houston Negro Hospital provided work for black physicians, and care for African Americans.
In St. Louis a hospital for the cities black indigents opened its doors in 1937. It was named for the Homer Phillips, a black lawyer from Sedalia, a small town in the middle of Missouri that was built on the main east west railroad line. Raised in an orphanage, then by an aunt, Phillips became a lawyer at Howard University, and moved to St. Louis. “Intensely interested in the Negro doctor”, he felt “more opportunities would be available for these men of medicine if there were a separate hospital.” In 1922 St. Louis passed an $87 million bond issue and Phillips made sure the legislation designated one million of the dollars as funds for building a black run hospital. Once the city had the money, it wasn’t easy to get them to turn it over. For more than a decade Phillips fought “interests that sought to prevent the hospital’s construction.39 It’s doors opened in 1937, and 2 years later Phillips needed to get additional funding. The facility was inadequate. “Patients were crowded into dark corridors and their lives were often in jeopardy because of fire hazards.” By 1961 the institution had trained the “largest number of black doctors and nurses in the world, and it was a leader in developing the practice of intravenous feeding and treatments for gunshot wounds, ulcers, and burns. It closed in 1979.1
The hospital that provided a significant part of my medical training, St Louis City Hospital, was integrated and lost much of its clientele to more upscale facilities when Medicare and Medicaid became the law of the land. The facility existed until 1985; then it closed. City and county hospitals elsewhere (Cook County in Chicago, Bellevue in New York, San Francisco City Hospital, and Charity in New Orleans (to name a few) remain very much alive and well.
Cook County hospital in Chicago, the caregiver for the poor in our second largest city (committed to providing “quality care with respect and dignity regardless of their ability to pay”) gets close to 40 percent of its operating revenue from state and city taxes. Of the remaining 60 percent, a third of the money comes from Medicaid, and 9 percent from Medicare. I don’t know how much the institution gets from private insurance companies.
New York City has 11 publically funded hospitals plus clinics and nursing homes. With an annual budget exceeding $5 billion they provide emergency services and hospitalize close to a quarter of a million people a year.6
University hospitals, which are presumed to be “the best” by many, are staffed by esteemed professors who are often astute physicians and who write papers and books. These educational institutions provide complex services that require a team approach and interventions like liver, heart, and kidney transplants. Many of the researchers who teach future physicians survive on research money supplied by the NIH or pharmaceutical companies.
By the 1950s all of our large cities and many small towns had a modern day facility. The government had constructed and ran military, Veterans administration, and public health service institutions. Multiple hospitals were operated by religious groups or by university medical schools.
According to one analysis, U.S. hospitals have been merging at a rapid pace for a decade, forming powerful organizations that influence nearly every health care decision consumers make. The mergers have essentially banished price competition and raised prices for hospital admissions. In one analysis of 25 metropolitan areas, between 2010 and 2013, prices rose 11 percent and 54 percent.17
Public and university hospitals derive their funds from private and governmental insurance, from taxpayers, and from donors. The law says that if charitable organizations want to avoid taxes they must be operated exclusively for “exempt purposes”. None of the earnings can go to shareholders or individuals. They can’t try to influence legislation as a “substantial part of their activities.”
(The list of organizations that could potentially acquire tax exempt status is quite long. It includes groups that are: “charitable, religious, educational, scientific, literary, testing for public safety, fostering national or international amateur sports competition, and preventing cruelty to children or animals.” Etc…) 4
Some universities and charitable hospitals make a lot of money, and their profits are not taxed. The Affordable Care Act did not challenge their IRS exempt status. It did, however, add a few hoops.
The institutions are now required to have a financial assistance policy that’s written in “plain language” on their web site. The “audience should be able to understand it the first time they read or hear it.”
They (theoretically, at least) can no longer generate inflated bills, claim they spent an unrealistic amount of money caring for a sick person. Hospitals typically send out exaggerated bills knowing full well that Medicare or insurance companies will only pay a portion of them. They use the amplified numbers as a starting point for negotiations with insurers, and as a means of demonstrating how charitable they are. As part of the ACA non-profit hospitals should no longer be able to generate inflated tabs—charges that are higher than the amount insurance companies and Medicare really pay for the services. Additional charges–the portion of a hospital bill that Medicare and insurance companies don’t usually pay—can’t be pumped up.
Finally, when a recently treated person doesn’t pay their share of the costs, these institutions are supposed to “make reasonable efforts to determine whether the individual is eligible for financial assistance” before they sick their dogs on them– before they take legal action, sell a person’s debt or notify a credit agency.
In 2013, of the ten most profitable U.S. hospitals, seven were non-profit. They earned over $1.5 billion, and, of course, didn’t pay any taxes. They included a few big name institutions: Gundersen of La Crosse Wisconsin earned $300 million. Stanford’s teaching hospital had a profit of $225 million”, and the University of Pennsylvania’s hospital in Philadelphia made 184.5 million.” “The hospitals with the highest price markups earned the largest profits.” These institutions could have returned some of the tax derived revenues to the government. (Fat chance.) They could have increased the number of non-paying patients they cared for. Since the affordable care act went into effect, they’re often caring for fewer people who can’t pay. If we’re going to make health care affordable we should probably revisit the tax exempt status of some of these institutions.5
A few years back Senator Grassley considered “removing tax-exempt status from teaching hospitals and forcing them to do more for local low-income, urban communities.” The hospitals fought him and won.
Much of the care our hospitals provide takes place in one of the country’s 983 state and local government hospitals or in one of the 2845 community sponsored nonprofit institutions.
The people who live far from the cities are served by many smaller institutions that are the product of a community or creations of health care workers who had a dream. Some are financially struggling to exist. 7
In May 2020 the New York Times told how, as a result of the Coronavirus bailout, the non-profit Providence Health System received over $500 million in government funds. The company was sitting on nearly $12 billion in cash and was earning, in a good year, over $1 billion tax free from its investments in venture capital funds. Two other for-profit hospital groups, HCA and Tenet Healthcare, had billions of dollars in reserves and received $1.5 billion from the government. Ascension Health in St. Louis, a chain that had $15.5 billion in cash, was given $211 million. And the largest rural hospital system in eastern Kentucky got $3 million, enough for 2 weeks of payroll.
“Even before the coronoavirus, roughly 400 hospitals in rural America were at risk of closing,” and the 2000 rural hospitals that are in the black, on average, only have enough cash to keep their doors open for 30 days.” 36
In the last decade 113, mostly rural, facilities went out of business. 20 were in Texas, 12 in Tennessee and 7 each in Georgia and Oklahoma. Of the 283 rural hospitals that in 2015 were “vulnerable to closure”, those located in states that did NOT opt for Obamacare Medicaid expansion were especially hard hit. 16.5 percent of the hospitals in states that opted OUT were on the brink versus 8.5% in Medicaid and indigent patients than suburban hospitals.”
Providing quality health care to our urban population is much more than a hospital issue. 60 million Americans—13 million of which are children lived in rural areas. 5.3 million resided in completely rural counties, 24.6 million in the mostly rural counties and 30.1 million in mostly urban counties. Their numbers have been dropping. A non-profit: A Healthy Rural America is struggling with the problem.23
A third of the Health Care dollar, $1.1 trillion (2017) is spent on hospital care. The Affordable Care Act led to increased hospital revenues and kept a number of smaller hospitals alive. States that “expanded Medicaid” saw 7.4 percent more Medicaid discharges in 2014 versus 1.4 percent in non-expansion states.
Total Number of All U.S. Hospitals.18
6,210
Number of U.S. Community Hospitals
5,262
Number of Nongovernment Not-for-Profit Community Hospitals
2,968
Number of Investor-Owned (For-Profit) Community Hospitals
1,322
Number of State and Local Government Community Hospitals
972
Number of Federal Government Hospitals
208
Number of Nonfederal Psychiatric Hospitals
620
Other Hospitals
120
In 1981, a deranged 26-year-old man shot the president of the United States. A bullet hit a rib, and Ronald Reagan was in pain. At the time, neither he nor his aides sensed how close he was to death. As the presidential limousine sped to George Washington University Hospital, Reagan coughed up blood. When he tried to walk from the car to the emergency room, his legs collapsed, but his aides kept him from falling and dragged him to a gurney. A senior surgeon arrived on the scene and realized the man had lost a lot of blood, and was still hemorrhaging. An operating room was empty and, as a gurney occupied by Reagan was wheeled in, O-negative blood was pumped into his veins. The urgent surgery and transfusions were so successful that few realized Reagan had used up one of his nine lives.
The first U.S. level one trauma center was established in Chicago in 1970. By 2003 most states had at least one facility where surgeons, neurosurgeons, orthopedists, appropriate anesthetists and operating rooms are available 24 hours a day. Some facilities have helicopter landing pads.34 Others use nearby airports and bring the severely injured to a hospital by ambulance. 50 million Americans are unable reach one of these centers in less than an hour.
E.R.s in the U.S. hospital clock 136 million visits a year. Forty million of them are for minor injuries, auto accidents, and gunshot wounds.35 Sixteen million of the people who are seen are admitted to the hospital. People with myocardial infarctions who arrive by ambulance are sent to the catheterization/stent department. Women in labor are wheel chaired to the hospital delivery areas. The people with a new neurologic problem: a leg or arm that won’t move, inability to speak, loss of vision– are briefly assessed and routed to the CAT scan room. An X-Ray without contrast only takes a few minutes, and doctors need to be sure the acute brain damage was not caused by a cerebral hemorrhage before can attempt to dissolve a clotted blood vessel.
A few years back (according to a colleague) the physician-in-chief of Northern California Kaiser was visiting one of our ERs and was disturbed by waiting rooms full of people. Some had minor injuries that needed a quick fix; others who were quite ill, had to wait a long time before they were triaged. He decided something needed to be done and he had clout.
He met with the chiefs of our hospitals and an agreement was struck. After a person entered the waiting room and registered, he or she would be taken to an exam room and evaluated by a doctor, nurse and tech within 15 minutes. Lacerations had to be sewn shut, minor fractures casted, and a person sent home within an hour. Sepsis, strokes, and bleeding were treated promptly. Tests and consultations were ordered for problems of unclear significance and severity. Efficient competent evaluation might not always be possible but that was the goal.
Then Dr Pearl retired and waiting room wait time worsened.
San Francisco General Hospital is a hybrid. It’s a trauma center and a teaching hospital. The doctors who care for patients come from the University of California Medical center. The facility also operates the city’s “Community Health Network.” 80% of its $600+ million operating budget is paid for by Medicaid, Medicare, and private insurance, and it gets the other 20% from the city’s general fund. As detailed in an earlier chapter, in response to criticism for their crazy high fees they recently lowered and capped the amount people pay when they are ill and injured and need care. It’s too soon to tell if their billing approach will be viewed as a beacon for the rest of the country or as a hippy, odd ball gesture.
A few decades back “the general” developed a unique approach to its visitors who slept outside in unsheltered locations. Many suffered and died prematurely from diseases caused by alcohol, smoking, exposure, and poor sanitation. Violence, mental disorders and suicides were common. San Francisco General “identified individuals who had visited their emergency room five times in 12 months. With the help of attorneys and with a staff of case managers, a primary care physician, nurse practitioner(s), and a psychiatrist, they got many of the people permanent shelter, a primary care doctor, and “benefits.” It was quite a legal feat in people who are disabled by mental illness. In time, 70-75% of the homeless were housed, and emergency department use decreased 50-75%. That was a few years back, the homeless problem in Northern California has gotten worse and the funding has changed.11
In the 1960s intensive care units were created. By the end of the 70s each nurse in one of the units cares for one or at most two patients. Machines monitor blood pressure, pulse, and blood oxygen levels. Respirators filled lungs. When appropriate food is dripped into stomachs through naso-gastric conduits. Multiple IV tubes infuse bodies with nutrients and a variety of chemicals and blood products.
Nurses have always been “the glue that held hospitals27 together. Their numbers increased during the Second World War II.” At the end of the conflict RNs earned an average of $2,100 a year, somewhat less than most male workers. Their wages didn’t rise and their numbers started going down. There increasingly weren’t enough RN’s to do the job right and those who remained had to work longer and harder. To keep costs down hospitals froze their wages. These women were dedicated, right? They wouldn’t quit. By 1966 the average RN earned $5,200 a year.40
At the city hospital where I was a resident one nurse passed medications and tried to handle the needs of the ill on an entire ward. The women (and at the time they were all women) were energetic, amazing, and often exhausted. Their wages were so low that none of their nursing school graduates wanted to work at our hospital. When our few nurses went on strike in 1965 the papers thought their action was outrageous.
The idea that in America workers could strike if they were underpaid was challenged when the nation’s Air Traffic Controllers struck in 1981. President Reagan said they were federal employees and were breaking the law. He gave them 48 hours to return to work or be fired. His anti union stance changed attitudes. In a decade, major strikes plummeted from an average of 300 each year to fewer than 30. Despite an average annual inflation rate of 2.9% and a huge surge in productivity, the federal minimal wage, which was $3.35 in 1981, barely doubled in the 3 post-Reagan decades.
In the San Francisco Bay Area 2 types of union actions have continued to be effective. The interruption of BART commuter trains by striking workers always leads to jammed freeways and lengthy commutes. When the police struck a few decades back the chief went on T.V. and warned that criminals, murderers, and rapists would have a field day.
At Kaiser where I worked, nurses felt they were underpaid. They knew how to take care of sick or needy patients, but they soon learned that dealing with management was something else. Every 5 to 10 years or so their contract came up for renewal, they asked for a raise, management hung tough and the nurses decided they needed to strike.
That was fine with Kaiser. The insurance money kept coming in. People didn’t like to cross picket lines unless they were quite ill.
Before the strike started traveling nurses were hired, elective surgery was canceled, and the very ill were sent to other hospitals. I remember driving to work and seeing throngs of young and middle aged nurses carrying picket signs, and standing by the entrance of the parking structure. They were friends, colleagues. Many hated the thought of abandoning their patients and some believed strikes were unethical.
After three weeks of pacing in the heat of the day or under an umbrella nurses started coming back to work. Most had loans, rent, bills, and lived from one pay check to the next. When a majority of worses had returned to the job management offered a small raise and signed a long term contract.
Eventually the nurses hired a labor organizer named Rose Ann DeMoro and everything changed. In 1968 she declared a 2 day strike, and the hospital prepared. Critical patients were moved out, elective surgery was cancelled, and traveling nurses were hired. A few days prior to the date, the strike was cancelled, but it was rescheduled for a date 60 days hence.
Two months passed. As before, very ill patients were moved out, nurses brought in, and elective surgeries cancelled. This time the nurses struck for two days and no one lost much money. As the strike was ending the union announced it would soon strike again. Management understood what was going on and cried “uncle.” The nurses pay rose substantially and they later fought for and won the right to make improvements to the quality of care they provided.
Nationwide, one in five nurses belong to a collective bargaining unit. On average their wages are 20% higher than the pay of the nurses who are not in unions. In 2020 the average hourly wage of a registered nurse in half the states in our country was $28 to $34. The other half earned $35 to $48 an hour. In Hawaii and California the average hourly wage was $50 to $54.
Inside the large multispecialty hospital where I worked there is a large birthing wing. Large rooms accommodated doulas and invited family. Nurse midwives handled the uncomplicated vaginal deliveries. An anesthesiologist or nurse anesthetist was always on duty and performed epidurals. Needles are inserted into the lower back, into the space between the vertebrae and the membrane that surrounds the spinal canal and lidocaine, a numbing agent was infused. The drug blunted much of the pelvic pain of childbirth. An obstetrician was hanging around and was available for consultation and urgent C sections.
In the hospital’s basement 2 CAT scanners and 2 MRI machines created detailed body images far into the night. The pictures of the sliced body sections were immediately visible on every computer screen in the facility. A radiologist sat in a dark room, carefully checked the images, and looked for anything that didn’t belong. He or she dictated a report that was transcribed by trained worker in the facility, or increasingly by people in the Philippines, India, or some other country.
A multi bed outpatient recovery area was staffed by nurses. They prepared and observed patients before and after interventional radiologists performed biopsies or invasive procedures. The unit also served as the pre and post procedure area for people having an emergency heart catheterization. A cardiologist was always on call, no more than 15 minutes from the hospital, and available 24 hours a day, to catheterize and stent the coronary arteries of people who are probably having an acute myocardial infarction.
Gastroenterologists, who sometimes worked at bedside in the intensive care unit, had a dedicated in-patient procedure room, with equipment. If needed we would insert a scope and treat people whose upper GI bleeding was ongoing or those who had a bolus of food lodged in their esophagus.
There were medical, surgical, and pediatric intensive care units and a coronary care unit.
Hospital rooms had piped in oxygen and suction, a place where a partner or parent could spend the night and an annoying T.V. on the wall.
A special inpatient pharmacy provided a large range of medications, including specialized drugs and infusions, 24 hours a day.
Pathologists processed, stained, examined, and interpreted the significance of tissue that was removed from bodies. Samples were often sent “out” for molecular diagnostics (DNA/RNA analysis).
Phlebotomists drew blood and brought it to the lab where it was extensively tested. The labs also cultured and assessed stool, urine, blood, spinal fluid, sputum etc.
And there were clerks, social workers, discharge planners, janitors, patient transporters, painters, security people, guards, physical, occupational, and speech therapists, dieticians, telephone operators, IT personnel, people who provide food for the patient and staff, and engineers who regulate and repair the electrical, cooling-heating and other building systems.
In 2017 American hospitals were responsible for $1.1 trillion of the nation’s $3.5 trillion in health care expenditures, and an average day in the hospital was costing nearly $4 thousand.28
I was employed by a pre-paid group, and all the physicians and surgeons were salaried. The hospital had ten large operating spaces and the OR had a calendar that was controlled by a scheduler. Each area was manned between 8 AM and 3 PM by a hundred or so nurses, technicians, and others. In the late afternoon most of the rooms closed. The few that remained open handled the overflow. One was available around the clock for urgent cases. During the work day each of the designated areas was managed by a different surgical subspecialty, and had some unique equipment,
Gawande explained the importance of introducing the patient who will undergo surgery to everyone in the O.R., including the person who cleans the floor and the medical student. He thinks the presentation gives everyone permission to sound an alarm if they notice a problem. Before a case starts, all the people who might play a role gather around the patient and are introduced. Then a “time out” is called. The nurse or physician in charge would ask the patient their name and what they thought was about to happen, When indicated the involved breast or extremity was inked. (“In 1995 when a nurse told Florida Surgeon Rolando Sanchez he was cutting off the wrong leg, he kept going and she started to shake and cry. He felt he had gone too far. The leg he had started to remove couldn’t be repaired and there was no turning back.”) 29
A surgeon or team of surgeons usually performed all the cases in a morning or an afternoon block. If three hips were replaced that half-day, one surgical team usually did them all. After each operation, the room had to be cleaned and efficiently turned around. In bloody cases, like a hip replacement, soaked pads were not thrown on the floor. They were instead bagged, and the containers were tied and slipped into the hall outside the room. Following invasive surgery, when blood in the abdomen made it hard to be sure no foreign objects remained in the area, the sponges were counted before and after the operation. Post-operatively, people went to a recovery area where 20 to 30 nurses cared for them for variable periods of time. If a spinal anesthetic was used, the patient remained in the observational area until the numbness had worn off.
In fee-for-service facilities surgery accounts for a substantial part of hospital revenue. Akron General Hospital published what it charges on its website. The bill for using the operating room at their facility, which is part of the Cleveland Clinic, depends on “the complexity” of the procedure. Their billers created five intervention levels: For those on the lowest rungs the first hour costs $2718. Each additional half hour adds $1100 to the bill. For level 5 procedures—the most complex– the room cost is $4935 for the first hour and $2200 for each additional half hour.20
Free-standing facilities currently perform many of the “interventions” that were once done in hospitals: cataract surgery, colonoscopies, knee arthroscopies, cosmetic surgery, pain management, dental and ENT procedures. In 2019 there were 6100 ambulatory surgical centers in the U.S., and they performed more than half of that year’s 35 million operations and procedures.21
A 6 year old seemed cross eyed and saw an optometrist who realized the child had a 6th nerve palsy. The nerve that controls the lateral movement of his eye wasn’t working and that set off all kinds of alarms. He was immediately sent to an ophthalmologist. The physician detected evidence of brain swelling and ordered an emergency MRI. That night one of the two hospital pediatric neurosurgeons told the parents their son had a brainstem tumor. The child was admitted and started on high dose steroids to decrease the pressure inside the skull. A few days later two pediatric neurosurgeons at Oakland Kaiser Hospital made a small opening in the rear of the child’s neck and removed the back of a vertebra. They then sucked out the medulloblastoma cells (it is a friable malignant tumor) and rolled an MRI machine into the OR. It revealed a tiny trace of tumor had invaded his spinal canal. The vertebrae was replaced and fastened, and the wound was sewn shut.
Post operatively the child had obstructive hydrocephalus—fluid was not flowing from one chamber of the brain to the next one. It was possible he would need a shunt that transferred fluid from his brain to the space in the abdomen called the peritoneum. As a first step, under anesthesia a small hole was drilled in his skull and a thin sterile videoscope was passed through the brain into the fluid filled chamber in its middle. The scope was maneuvered through the narrow passages that connected the ventricles, the fluid filled brain chambers. Cobweb like tissue was blocking the flow of fluids and it was pushed aside. Fluid started circulating normally and a shunt wasn’t needed.
After the child recovered from the surgery his insurer paid ¼ to ½ million dollars for proton beam radiation to destroy the small segment of tumor that remained. It couldn’t be surgically removed without causing major neurologic damage. Protons give off most of their energy (in a quick burst) to a precisely focused part of the body. This type of therapy decreases the amount of radiation to healthy tissues around the treated area.
The child was sent to the “Seattle Proton Therapy Center a facility where 10-foot-thick, lead-lined concrete walls isolate a particle accelerator that harnesses and fires protons generated from hydrogen gas. It was one in a national wave of costly facilities funded a decade or so back by private investors and lenders. The Seattle facility treats 500 people a year. “In 2018, after a net loss of $81 million over the prior two years, its original backers were handed a $135 million loss as part of a negotiated Chapter 11 bankruptcy.14” But they were still in business. At one time there were 27 proton centers in the U.S. They were expensive to build and maintain and their services are not covered by all insurance providers, so those that are still working are struggling financially.
Elsewhere on the planet, there are remote government funded community hospitals, in low and very low income countries—like Malawi and Bangladesh. As described by the Harvard M.D. who spent time in Nepal, they are commonly located in far off corners of their nation and are the only options available to the poorest of the poor. With 50 to 100 beds they serve 100,000 to a million people, and their doctors can usually perform a few orthopedic and general surgical procedures and C sections. They have some X- ray capability, but commonly lack certain basics: In Nepal 15% didn’t have piped in water; 20% lacked electricity; 55% didn’t have gloves, and 30% were unable to provide oxygen to those who need it22.
REFERENCES:
Marketplace Medicine—the rise of the for-profit hospital chains by Dave Lindorff a Bantam Book, 1992
Privatization and Public Hospitals by Charles Brecher and Sheila Spezio 20th century fund press, 1995
Black Physicians in the Jim Crow South by Thomas Ward, University of Arkansas Press 2003
Wier LM, Hao Y, Owens P, Washington R. Overview of Children in the Emergency Department, 2010. HCUP Statistical Brief #157. Agency for Healthcare Research and Quality, Rockville, MD. May 2013. Kindermann D, Mutter R, Pines JM. Emergency Department Transfers to Acute Care Facilities, 2009.HCUP Statistical Brief #155. Agency for Healthcare Research and Quality. May 2013.
Inspired by the results, two California foundations started similar programs at six California public hospitals. One of them, Highland Hospital, the facility with the busiest emergency room in the county, targeted individuals who visited the ER ten or more times a year. A legal and health care team managed to get virtually all who were certifiably unable to work onto SSI. The $800 a month they received from the federal government was enough for a shared room and some food. Once the indigents had “benefits,” Medicaid, the federal government, paid for their medical care, and the state and county saved $2 million. But the start-up programs have largely ended, the funding has been used up, and in 2014, Obamacare kicked in and funding changed.
In the 2 decades –between 1990 and 2010, the percent of rural dwellers went from:
21 to 15 percent in the north east
28 to 24 percent in the Midwest
14 to 10 percent in the west and
31 to 24 percent in the south.
Children in rural areas had lower rates of poverty (18.9 percent compared with 22.3 percent)—Healthy Rural America puts the percent of children who live in poverty at 25%. In 2015 more country dwellers were uninsured (7.3 percent compared with 6.3 percent). According to Healthy Rural America, the rural population tends to be older, sicker, and poorer, and they are more likely to be uninsured and unemployed.
There’s a need to build a sustainable and diverse health care workforce. Rural dwellers have less access to health care workers and “critical access hospitals” It’s challenging to get patients and enough care givers to the right place at the right time. Transportation can be challenging; there’s a lack of access to high speed internet. And, as with all of medicine, people argue about how we are going to pay for care. . Phil Pollakof plp@sbcglobal.net
In low- and middle-income countries 50 % of remote health care facilities lacked piped water, 33 % lacked improved toilets and 39% lacked handwashing soap.
I was in the delivery room for his final performance–the last time an obstetrician named Bill Masters, a doctor who would go on to become a world famous sex specialist, helped a child slide through a woman’s birth canal. I don’t remember the baby’s sex or weight or its mother’s glee. But I remember Masters presenting the newborn to its mom with the flourish of a circus maestro, and I recall my fellow med student fainting. His wife was pregnant.
As a junior in medical school I spent three weeks catching babies at Homer G. Phillips, the black public hospital in North St. Louis. I and my fellow student were the only white guys in the facility. Napping in a sleeping room on the second floor we were periodically awakened by a nurse yelling “don’t push—don’t push” as the creaky elevator carrying the almost-mother slowly whirred upwards.
Shortly after my grandmother was born her mother died. In her day death was common when childbirth was complicated by “post partum bleeding, or infections” or when the baby was unable to get through the pelvis.
The U.S. has the unenviable honor of having the “highest rate of maternal mortality in the industrialized world.” —17.8 per 100,000 in 2009. It’s especially high for African American women.6
The global maternal death rate has decreased by 44% in the last 25 years, but each year in the world’s 24 poorest countries, 400 women die for every 100,000 live births. In recent decades most western countries have cut their death rates in half; in the U.S. the number of women dying almost doubled. In California focused healthcare significantly helped reduce the mortality rate. 5
Throughout recorded history women “midwives” have assisted other members of their sex give birth. In the late 1800s and 1900s physicians, virtually all of whom were men, moved in and took over. In 1915 40% of all births were attended by midwives and by 1935, 20 years later, close to 90% of births were performed by male physicians.
In the U.S. Thirty three percent of children are delivered by C-section. (9% of the women who give birth this way had prior C-sections.) The nurse midwife who brought me up to date explained that in her practice about seven percent of women are delivered by C-sections and only one in 400 women require an episiotomy, and incision to widen the birth canal.
Giving birth vaginally is usually painful and half of the deliveries performed by the midwife I consulted had epidurals. A derivative of Novocaine is infused into the space outside the lower end of the spinal canal. The drug usually controls the pain of child birth. When a physician delivers the frequency of an epidural nears 95%.
C-sections carry the risk of bleeding, infection, and of nicking the bowel and bladder. 7 When the mother has active vaginal herpes or the infant would have to come out feet or bottom first, vaginal delivery brings with it an extra possibility of harm that usually more than justifies the approach. But that’s not the reason for the “worldwide explosion.” In Mexico City C -sections are performed for 45% of births.7 In China the C-section rate was 35% in 2014.
At $10-15,000 a try, in vitro fertilization (and other forms of assisted reproductive technology) led to the birth of a million babies between 1987 and 2015. The Center for Disease Control keeps track of successful births after 37 weeks of single, live, normal weight children. The number depends on factors such as: was the embryo fresh or frozen? Did it come from donor or non donor eggs? How many attempts were made? and how old was the woman?13 Under ideal conditions the process is successful, per attempt, 21% of the time.4
Before Obamacare became law, pregnancy was commonly classified as a pre existing condition. Medicaid picked up the bill if the woman was sufficiently “low income”. But some of the uninsured earned a bit too much. After 2010 expectant women could purchase insurance and they couldn’t be charged more because they were pregnant. If they wanted marketplace coverage they had to “enroll in a health plan during the open enrollment period, set by either the employer or the feds.”
During the first seven years after the ACA (Affordable Care Act) became law 13 million pregnant women “gained access to maternity services.” Medicaid expansion played a role. (Medicaid also covered “contraceptive supplies, sexually transmitted infections, and “screening” for sexual violence and breast and cervical cancer.”) 1,2
In 2006 the 4.3 million births in this country rang up a bill of $14.8 billion. A vaginal birth in 2010 was costing between $5000 and $7000; C sections went for about $10, 000.
The care of low and very low birth weight infants contributed another $18.1 billion to the birthing price tag. Modern doctors have the incredible ability to keep not-quite-ripe small infants alive, and premature newborns account for half a million of the live births in this country. Some of these kids spend weeks in neonatal intensive care units at a cost, nationwide, of $26 billion. That turns out to be “about half of all the money hospitals spend on newborns.” 1.7 percent of newborns weighed less than a thousand grams when born and one half of one percent were under 500 grams. Eighty five percent of the infants “survived to be discharged from the hospital.”3.
Prenatally doctors and nurse midwives check pregnant women for diseases that can be transmitted to their new born–infections like HIV and hepatitis B. Obstetricians checking for fetal abnormalities usually perform the first fetal ultrasound when a woman is 18 to 20 weeks pregnant. Screening tests are also performed for genetic and developmental problems. The second decade of the 21st century saw the emergence of blood tests that analyze fragments of placental DNA floating in the mother’s blood. Fetal DNA and placental DNA are identical. By pregnancy week 10 the level of fetal DNA in the blood of the pregnant woman is usually high enough to perform an accurate test. The studies look for chromosomal abnormalities and they aren’t perfect. The alternative, amniocentesis, is “invasive” and can induce a miscarriage one half to one percent of the time. Near birth ultrasound exams are performed to check the baby’s position and detect problems like placenta previa, a situation where the placenta covers the opening of the cervix and prevents a normal birth.
The fear of malpractice haunts the birthing profession. Childbirth mishaps, mistakes, and bad outcomes still account for close to 10% of all malpractice suits, and the amount awarded to injured children can easily be a million dollars or more. It takes an immense amount of money to care for a damaged child for 80 years. Not surprisingly the malpractice insurance rates for gynecologists are among the highest. (see malpractice.9)
For a period of time health insurers were overly aggressive in their attempt to get women out of the hospital shortly after they gave birth. Congress reacted. The Newborns’ Act was signed into law on September 26, 1996. It includes important protections for mothers and their newborn children with regard to the length of the hospital stay following childbirth. (HMOs) that are subject to the Newborns’ Act “may not restrict benefits for a hospital stay in connection with childbirth to less than 48 hours following a vaginal delivery or 96 hours following a delivery by cesarean section.”
There are about 40,000 Ob/Gyn physicians in the U.S. When I graduated medical school (1962) most were men. In their early years in practice they delivered babies. As they and their cliental aged the doctors spent an increasing portion of their time tending to the organs of conception. That’s changed. By 2001 seventy two percent of the residents in the subspecialty were women. During the last 35 years our local medical school, the University of California in San Francisco, trained and deployed hundreds of nurse midwives some of whom practice at local hospitals. The safety of home deliveries on low risk women by nurse midwives has been documented time after time, but this approach still accounts for less than 30,000 of the babies born in the U.S. each year.
In addition to caring for women during the birthing years, gynecologists have traditionally been the primary care physicians of many otherwise healthy women as they age. Among other things these physicians pay a lot of attention to the organs of conception.
Cancer of the cervix is “worldwide the third most common malignancy in women.” It’s much less common in this country (11,000 cases a year) because many women have regular “Pap smears.” It’s a test that was developed by a New York cytologist named Georgios Papanikolaou. A Greek who finished medical school in Athens in 1904 then served in the army, Papanikolaou decided early that he wanted to be a researcher. He was 30 when he and his wife Andromache came to the U.S. They didn’t speak English and “had little money.” She got a job as a button sewer for a department store and he tried to sell rugs. His job only “lasted a day.” He ended up earning money during his first year in the country playing a violin in restaurants. Then he got a job in the anatomy department of Cornell Medical College. His wife was hired as his assistant.12 Using Andromache as a subject he studied the appearance of cells from the lower part of the uterus, the cervix, and he noticed cancer cells looked different. When he brushed, stained, and evaluated tissue that the end of the uterus was about to shed, he sometimes found “bizarre” changes that indicated a cancer was present. It took years till his findings were accepted, but he eventually was able to teach doctors to recognize changes that indicated part of the cervix was almost, but not quite malignant.10
Responsible for over 33,000 cervical and vaginal cancers annually in the U.S., human papilloma virus is sexually transmitted and usually causes no symptoms. Most infections clear within two years, but 14 million Americans are infected annually and 80 million are, at least temporarily, sexually “contagious.” In 2014 the FDA approved two shot vaccine that effectively prevents the disease. It works best when it’s given to young women before they are likely to be sexually active, and it covers genotypes 16 and 18 (responsible worldwide for 70% of cervical cancers) and 4 additional genotypes that account for 20%.11
Some parents feel that by immunizing their daughters they are saying we assume you will become sexually active, and that’s a message they’d rather not send
Early on the tools of the GYN trade relied on feel and a speculum. The uterus and ovaries were felt by trained fingers in the vaginal canal pushing up towards and equally aware fingers on the abdomen pushing down. When the exam was painful or the woman was large or tense the exam had limited value.
Shadows of the uterus and ovaries are now sometimes visualized using an abdominal ultrasound, a CAT scan, or by placing an ultrasound probe into the vagina and watching a T.V. screen. The probe charge, in one location (chosen randomly on the Internet), is $200 per exam. I don’t know if insurance companies will pay for the test in the absence of a clear indication. It has not, best I can tell, become “routine”, though actress Fran Dresher and others thinks it should be. The $6.5 million dollar bill President Bush signed in 2007 “authorized the development of a national gynecologic cancer awareness campaign” but did not mandate screening vaginal ultrasounds.
Gynecologists have long evaluated the inside walls of the uterus with an operation known as a D and C. They dilate or stretch the cervical area. Then a sharp instrument is placed inside the uterus and the lining cells are scraped off, collected, and examined under a microscope. The main indication for the operation is unexplained uterine bleeding which could be caused by cancer of the inner lining wall of the uterus. Nowadays there’s a thin narrow scope that can slip into the uterine cavity and allow doctors to look for abnormalities. In this country hysteroscopy is usually performed in anesthetized patients. In Australia and elsewhere it’s sometimes performed with light sedation and numbing agents.
Finally the gynecologists were pioneers in the use of a tiny incision and a laparoscope (see surgery) to evaluate ovaries, treat cysts, or tie fallopian tubes so a woman could avoid pregnancy.
Gynecologic surgery is a relatively large ticket item. In this country 600,000 women have hysterectomies annually. 180,000 (30%) of the operations are done for “fibroids” benign growths that can cause symptoms.8Some hysterectomies are performed in an attempt to reduce or eliminate lower abdominal pain. The discomfort is sometimes caused by endometriosis, a condition where the kind of tissue that normally lines the inner wall of the uterus is growing elsewhere in the pelvis. Abnormal cells are sensitive to female hormones and can bleed when women are having a menstrual period. The condition is the alleged cause of the discomfort suffered by millions.
Close to ten million women “have trouble controlling their bladders.” Surgery in addition to medication and pessary (a flexible device that’s placed into the vaginal canal) sometimes helps. Operations also treat prolapse, a condition where a uterus, stretched by prior child birth, drops into the vagina or bulges into the bladder or rectum.
Finally the fear of ovarian cancer leads to a lot of testing. This is a real and worrisome condition, but it’s not on the rise. By age 30 it strikes one in 15,000 and by age 60 afflicts no more than one woman in 1500. It’s hard to detect at an early stage and benign ovarian cysts found on an ultrasound commonly lead to a number of additional exams and a modicum of anxiety. Given our current system and abilities, experts tend to discourage routine screening.
Jamila Taylor and Maura Calsyn, “5 Ways the Senate ACA Repeal Bill Hurts Women” (Washington: Center for American Progress, 2017),
Heavy Menstrual Bleeding in Women with Uterine Fibroids. William D. Schlaff, M.D., et al NEJM January 23, 2020https://www.nejm.org/doi/full/10.1056/NEJMoa1904351?query=featured_home “Half of women with Uterine fibroids (leiomyomas have symptoms: heavy menstrual bleeding, which can lead to anemia, pelvic pain and pressure, urinary and gastrointestinal symptoms, infertility, and complications of pregnancy.” They sometimes affect a woman’s physical, psychological, and social well-being.”
One morning in the 1980s I attended a conference at the medical center, and heard about a tumor, Kaposi’s sarcoma, a cancer of old Italian men. It was affecting members of the gay community. Pneumocystis, a microbe that had lived harmlessly in most lungs for a millennium, was causing pneumonia in young men. Similar infections had previously attacked the lungs of kidney transplant recipients whose immune system was suppressed. Some had trouble swallowing and white dots of yeast covered their esophagus. Previously healthy young men and women developed a bizarre assortment of diseases. Many were quite ill, occupied many of our hospital beds, and were receiving multiple medications. For almost a decade everyone who contracted HIV eventually died.
In 1983 scientists in France and in the U.S. at almost the same time isolated the responsible virus. The microbe was colonizing, taking over, and ultimately destroying T lymphocytes, a vital constituent of the system that keeps a lid on many of the organisms that live in the body. As the virus destroys more and more of our defenders, the immune system loses its ability to control the indigenous microbes.
We soon learned of cases of the disease in 33 countries. Actor Rock Hudson died with AIDS and the Hollywood community rallied. Our blood supply was tainted. Ryan White, a kid with hemophilia had the condition and was not allowed to attend classes. A journalist who worked for the San Francisco Chronicle published a book called: “And the Band Played On.” The Gay community was particularly afflicted and decimated, and the book told of their struggle and “governmental indifference and political infighting”. Condoms were encouraged and needle exchange programs were initiated. Gay bath houses were attacked by the police in many cities. Laws were passed that forbade physicians from testing people for HIV without permission.
After the HIV virus wiped out most of a person’s T lymphocytes, their immune system was unable to control the bugs that normally inhabit a body and their disease had morphed into the full blown acquired immunodeficiency syndrome—AIDS.
The HIV virus, we later learned, is not highly contagious. You could shake hands or hug someone who had the virus growing in their body. Two principles of medicine, however, were turned on their head: In otherwise healthy people, infectious illnesses were usually caused by a single micro organism. When it was eradicated the person could stop taking antibiotics. In people with AIDS antibiotics often suppressed but failed to eliminate the creatures responsible for a disease. These individuals commonly required lifelong low doses of antibiotics to prevent a recurrence.
Also, when we identified the organism causing an infection (like Pneumocystis) we weren’t out of the woods. The creature had attacked the body because the immune system reached a low point. Additional problems were brewing.
Within a few years medical detectives in the Cameroon found chimp feces that contained Simian Immune Virus (SIV) with DNA that was identical to the DNA of the most common type of Human Immune Virus (HIV). The source of the epidemic was a chimpanzee infected with the simian immune virus.
In the early 20th century chimps were wild game– “bush meat” in parts of Africa. When wounded, the animals struggled. Presumably on one occasion a human was injured by a chimp he was killing. Blood containing the Simian Virus entered the hunter’s body and the virus survived and thrived. Later the pathogen was sexually passed to one person after another. Sometime in the early decades of the century an infected individual moved to Leopoldville, (now Kinshasa). In 1920 the town was the capital of the Belgian Congo and was full of migrants. Scientists figure that by the time the colony became an independent country (1960) an estimated 1,000 to 2,000 people were living with HIV. A physician of the day probably encountered many sick souls who had developed diarrhea, fever and wasting. There’s no reason to believe that anyone at the time suspected their symptoms were the result of a new virus.
As the Congo, now a new country, was getting started, UN aid workers and volunteers from Haiti were flown in to provide medical care and assistance. One of them presumably caught HIV, eventually went home, and the virus spread quietly in Haiti for a few years. Then unknowing carriers visited the U.S. and Europe and passed it on.1
After they identified the cause of the disease, scientists learned how the RNA virus methodically infects a cell and, uses a special enzyme it brought with it, (reverse transcriptase), to make a DNA version of itself. The DNA then integrates–becomes part of the host chromosome–becomes a gene.
BRIEF GENETIC TUTORIAL (again–sorry)
Our alphabet has 26 letters and we use them to make words.
The DNA of living organisms uses 4 letter alphabet. They “letters” are molecules called nucleotides.
Genes are strands of nucleotides. They tell a cell what to do and make and they occupy up to 3 percent of a body’s DNA. We aren’t sure what the other 97 percent of the DNA is there for.
Every cell in a person’s body has 3 billion pairs of DNA nucleotides.
They exist in groups called chromosomes. Each cell has 23 pairs of chromosomes.
The nucleus of every cell in the body contains all 20,000 genes. Some are turned on and some aren’t.
To summarize: The HIV virus knows how to create a DNA version of itself. That DNA becomes a gene and it commands the cell to make more HIV viruses.
R., a gay 35 year old carpenter, was renting an apartment I owned in the SF Bay area. I came by one afternoon and heard coughing from the house. R. let me in and told me he didn’t feel well and was having trouble breathing. His condition worried me and I suggested he visit a hospital. He went and the doctors made a diagnosis of Pneumocystis Pneumonia. He had AIDS. Treatment was started but he got worse and needed to be intubated. A tube was inserted through his mouth, passed his vocal cord, and into the main breathing tube. A respirator kept him alive for a week. It took a few weeks before R. recovered and was able to leave the hospital, but he knew AIDS was a death sentence. After he came home he moved out of the apartment, bought a house, fixed it up for his family and invited my wife and me over for Sunday afternoon Tea. He told us that he had long wanted have a home of his own before he died. He looked good, seemed relaxed, and was proud of what he had recently accomplished. We never saw him again.
The counter attack against HIV started when scientists at Burroughs-Wellcome synthesized compounds that might hinder the activity of the reverse transcriptase enzyme. In 1985 they sent eleven promising compounds to researchers at the National Cancer Institute, and people at the NCI identified a chemical that worked in the test tube. The drug was given to people with HIV, and their lives were prolonged.
25 months later the FDA approved the drug, and it was marketed by GlaxoSmithKline. The company sold 225 million dollars worth in 1989.
In the late 1980s and in the 1990s manufacturers started cranking out (and selling) anti HIV drugs. Some of the agents targeted protease, an enzyme that plays a role in the production of more viruses. The first Protease inhibitors became available in 1996.
Drugs that work against the enzyme that turns HIV RNA into DNA, (like turning a photograph into a negative) were created by Emory university professors. They discovered 2 important drugs (emtricitabine and lamivudine.) “Everyone was intrigued but skeptical about our work—no one realized the importance of what we had found,” Schinazi (the physician who developed the drug) said. He “pushed Emory University to file patent applications.” They did and less than ten years later the University was paid $540 million…a lot of money but considerably less than big Pharma often pays to control a significant medication. .
Two of the drugs that most effectively prevent and suppress the HIV virus were created in Prague Czechoslovakia by Anotonin Holy. An intuitive researcher, Holy had been sneaking promising chemical creations through the iron curtain to a colleague in Belgium named Erik De Clercq for 20 years. At the time a number of rules and regulations restricted trade between the Communist countries and the West. But Czechs were able to export the hops that Belgians used to make beer and they could import powdered Belgian milk. Somehow the chemicals got through. In 1981 De Clercq visited Prague. Holy took his friend to dinner and stuffed his coat with vials of newly developed compounds.
In the mid 1980’s the Bristol Myers head of virology was John Martin. A respected researcher, he had developed the herpes fighting drug, guancyclovir when he was in his 20s and was working for Searle. At the time pharmaceutical leaders were starting to pay attention to HIV and researchers were developing compounds. At one point Martin heard about a promising new group of antivirals that were discovered by a researcher in Czechoslovakia. Called “acyclic nucleotide phosphonates” they were just chemicals in a test tube. No one knew if they were safe or effective. But for some reason De Clercq in Belgium thought they were special. So Martin visited Prague and met Holy. As the two strolled through the city’s narrow streets and cobblestone alleys they got to know and like one another. Holy wasn’t a complainer. His lab facilities were limited but he managed to do his work and he had no desire to leave the country of his birth. When Martin returned to the U.S., a CIA officer tried to convince Martin to turn Holy into an “asset” and Martin declined.
In July 1989 Gorbachev allowed the nation’s of the Soviet Bloc to break away from Russia. The iron curtain fell, and commerce and travel between the East and the West became relatively easy. About that time Bristol Myers merged with Squibb and the company’s leadership and goals changed. The following year Michael Riordan the long suffering, optimistic CEO of Gilead, a failing startup, convinced Martin to jump ship and become one of his company’s new leaders. Martin (perhaps a little uncertain about his role in the new mega company) agreed and brought two of his best researchers with him. At the time a number of pharmaceutical manufacturers were trying to fabricate drugs that suppressed the HIV virus, but Gilead was not one of them. The chemicals Holy had created had been tested in Belgium and they effectively neutralized the HIV virus. But they needed tweeking before they would be ready for human consumption. Bristol Myers had planned to license and modify them. Gilead wasn’t a player.
Then in mid 1991, with the head of Squibb calling the shots, the newly formed mega company decided they weren’t interested in Holy’s chemicals. They didn’t want to take the risks and make the investment necessary to perhaps develop another HIV medication. Realizing Squibb’s error, Martin phoned Holy and convinced him to sign a licensing agreement with Gilead. In July 1991 Holy, Martin, and De Clercq met in a restaurant near the Eiffel Tower and signed a deal on a napkin. Holy’s nucleotide became the basis of several of the most potent medications that are currently used to prevent and treat HIV, and Gilead was finally an important player.
In 1995, influenced in part by well healed pharmaceutical companies, the World Trade Organization was formed. It required members “to honor 20 year patents on drugs”. Poor countries were given until 2005 to comply with the mandate. (Half the big drug makers are headquartered outside the U.S.).
In 1996 a three drug regimen was shown to successfully suppress the HIV virus. The disease could be controlled in advanced nations. But the companies that owned each drug’s patent charged what they thought they could get away with. The medications were too pricy for most people in the developing world.
As Nobel Prize winner Joseph Stiglitz explained: Patents are created for each nation’s needs. They give the inventor a monopoly for a number of years. When they are appropriately designed they promote innovation and societal well being. When they are not appropriately designed people die and innovation is suppressed.
Most nations allow people and companies to patent unique, non obvious inventions. When it came to medications, India had a different approach. The country gained its independence from England in 1947. In 1966 Nehru’s daughter, Indira Gandhi became prime minister. At some point she met with the head of the Indian drug maker—Cipla. He convinced her to allow inventors to patent the process –the way they manufactured a drug. But the drug itself could NOT be patented in India. That was the law in India before the country joined the WTO—the World Trade Organization. After India joined they changed their patent law. Drugs could now be patented.
In September 2000 Yusuf Hamied, the CEO of Cipla, was invited to the European Commission in Brussels for high level talks with health ministers and heads of large pharmaceutical companies. The meeting was supposed to discuss access to medicines, especially those that suppressed AIDS, in the developing world. At the large gathering, after the leaders of various companies made their remarks, Hamied spoke. Saying he represented the developing world and an opportunity, he offered to provide the three anti retroviral drugs that suppressed HIV at a cost of $800 a year; and/or to set up factories in other nations; and to provide needed medicines to pregnant women so they would not infect their unborn child. Founded in 1935 by Hamied’s father, Cipla is a major pharmaceutical company. His proposal was serious and significant. But his offer was ignored.
In the early 2000’s, according to Denis Broun M.D. of Unitaid, the powers- -that–be believed “Treatment for AIDS was something for the rich. It was unthinkable for Africans.” Yusuf Hamied felt the whole of Africa was being taken for a ride.1
A year after the Brussels meeting James Love, an AIDS activist called Hamied and asked how cheaply he could produce the three drugs that suppressed the virus. The key to pricing in medicine (according to Hamied) is the cost of the active pharmaceutical ingredients. If you can get them cheaply, the end product is cheap. Hamied told Love that Cipla would pay the cost of manufacturing a generic regimen. He would only charge for the material. Nevirapine would cost 65 cents a day. 3TC, lamivudine, 35 cents. And there would be no charge for d4T, Stavudine. The materials were too cheap. In other words the three drug regimen would cost $350 a year.
Donald McNeill of the New York Times felt the offer “was a watershed event.” He put the price of generics on the front page of the NY times, and papers around the world spread the news.
Shortly thereafter Peter Mugyenyi, a Uganda physician and director of the continent’s largest research and treatment center, decided to take matters into his own hands. “I knew where drugs were, and as a doctor it was my job to save my patients lives.” He contacted Cipla in India, and in defiance of patent laws ordered the drugs.
When the medications arrived at the airport they were impounded and the doctor was arrested. He refused to leave the airport without his medications. Eventually the authorities relented. Other nations acted. To many it seemed like the blockade for inexpensive drugs in Africa was broken.
In 2002 Kofi Annan, the diplomat from Ghana who was the Secretary-General of the United Nations, proposed a Global Fund to buy the drugs. The U.S. insisted that the fund could only buy branded medications or they would pull out.
Poor countries couldn’t and wouldn’t comply with the WHO directive. HIV was a killing their people. 143 countries favored relaxation of patent protection.
“In 2003 South Africa’s competition commission ruled that Glaxo Smith Kline and another company had violated the country’s anti competitive act. Glaxo was charging excessively high prices and was refusing to license their patents to generic manufacturers in return for reasonable royalties. The company eventually agreed to allow three generic manufacturers to make and sell three of its AIDS drugs,3 and the company took a 5% fee.
Prior to 2003, the U.S hung tough. Then the Irish singer Bono got together with one of the day’s more influential Republican senators, Jesse Helms, and attitudes changed. When they met the Senator was 80 and walked with a four-pronged cane. He was a rightwing evangelical Christian who had exploited racial prejudices in his election campaigns and had called homosexuals “weak, morally sick wretches”.
Bono, by contrast, had publically supported Greenpeace, Amnesty International, and had joined Jubilee 2000, a 40 country movement that advocated cancelling third world debt for the millennium. At one point the Jubilee campaign asked Bono to get the Baptist Nigerian President to write a letter to Baptist churches across southern US states. He was supposed to explain the Biblical principles behind debt cancellation.
The Baptist leaders listened, and Bono suddenly had access to a lot of strongly Christian Republicans. That’s why he was able to meet and speak with Jesse Helms. Helms had been very tough on the concept of foreign HIV drug assistance. “He’s a religious man”, Bono said, “so I told him that 2103 verses of scripture pertain to the poor, and Jesus speaks of judgment only once – It’s not about being gay or sexual morality, but about poverty. I quoted that verse of Matthew chapter 25: ‘I was naked and you clothed me.’ He was in tears. And later publicly acknowledged that he was ashamed…”
After the meeting vice president “Dick Cheney walked into the Oval office, and told President Bush that, ‘Jesse Helms wants us to listen to Bono’s idea.” That led to negotiations and Bush’s 2003 plan.
That January in his State of the Union message President Bush announced his policy towards HIV had changed. His words: “Today on the continent of Africa nearly 30 million people have the AIDS virus, and across that continent only 50,000 are receiving the medicine they need. Many hospitals tell people: “you have AIDS. Go home and die.” In an age of miraculous medicines no person should have to hear those words.”– “Anti retroviral drugs can extend life for many years. And the cost of those drugs has dropped from $12,000 a year to under $300 a year. Seldom has history offered a greater opportunity to do so much for so many. “
Bush would ask congress to spend $15 billion dollars over 5 years to combat the disease. Since its creation in 2003, the “President’s Emergency Plan for AIDS Relief (PEPFAR)” received more than $70 billion in congressional funds …$6.56 billion in fiscal 2017. The Trump budget plans to cut the amount the government contributes in 2019 by a billion dollars.
The under $300 number caught the drug industry by surprise, and they fought back. Within days the administration changed its approach. Rather than generic anti retro-virals the U.S. government money would be used to buy high priced branded drugs, and fewer lives would be saved.
As Bill Clinton later put it, “If you ran the numbers there was no way the money was enough to save the number who had to be saved in a hurry… it would never be enough unless they bought generics.”
Many of the drug manufacturers are headquartered outside the U.S. One hundred and twenty three nations (probably goaded by large corporations) signed an intellectual property rights agreement.-TRIPS, that “came into effect” in January 1995. It allows members “to promote access to medicines for all.” Clinton decided to ignore the politics of the situation and do the right thing. At the time India was a member of the World Trade Organization but patents issued before 2005 were still valid.9
In late November 2006 Bill Clinton announced an agreement between his foundation, two Indian drug makers: Cipla and Ranbaxy; Aspen Pharmacare, of South Africa, and Matrix Laboratories of Dubai. The companies agreed to make pills for children that combined three HIV drugs and cost $60 a year. 2 million children in Africa had been infected by their mother and only 10 percent were receiving drugs. Without treatment 80% would be dead by age 5.
The companies also apparently agreed that “The cost of anti-retroviral drugs (in general) was going to drop to $140 a year, and pills would cost 36 to 38 cents a day.” The cost of making the medicines would be paid for by a $35 million grant from an international drug-buying consortium and $15 million from the Clinton Foundation. The funds guaranteed the volume of drugs purchased would be “high enough to justify the lower prices.” “The large quantity orders for generics was critical to bringing prices for anti retroviral treatment in Africa below $100 per person per year.”
“After that the difference between branded and generic anti-retro-virals, and the scale of human tragedy in Africa made it impossible for donor funds to spend vast sums of money on expensive drugs. The global fund and Pepfar eventually committed themselves to buying generics, and the number of people treated exploded.”1
In 2017, per the U.N., 19.5 million people, more than half those infected, were being treated, but 2 million additional people had acquired the disease. Over 25 million HIV carriers lived in Sub Sahara Africa. That year worldwide 75% of people who carried the virus knew they were infected.4
The UN thinks they can end the epidemic if 90% of those infected know they are infected. Then 90% of those infected would need to take anti retroviral drugs that effectively lower the measurable blood level of HIV 90 percent of the time. Seven countries have achieved the 90/90/90 goal.
In 2019 the U.S. is still pretty far from getting HIV under control. One in six men who has sex with other men will eventually acquire HIV. Half are Latino or black. In 2015 there were about 6500 AIDS-related deaths in the U.S.
The CDC (Center for Disease Control) thinks that 1.1 million people are currently infected and 40,000 inhabitants will acquire HIV each year. 83-88% of those infected have been diagnosed, and 85% of the people regularly take medicine that controls the virus; only half take enough pills in the right dose.
People with “decent” health insurance are commonly required to pay two thirds of the cost.5 The estimated average annual cost of HIV drugs is about $20,000 ($360,000 lifetime.) In the appropriate age and income situations Medicare and Medicaid supply the meds. The non-profit Ryan White Foundation helps when people can’t afford the drugs. And there are federal programs for some populations.
Pharmaceutical companies have managed to keep the price of drug combinations relatively high by combining one or two relatively cheap anti-retro-virals with an expensive newer drug that is still patented. Some contend that people are more likely to take one pill that contains several drugs than they are to take a few capsules.
Most new infections can be prevented with a daily pill that contains two of the more effective anti-viral drugs, but it is not always covered by insurance.8
Anthony Fauci of the NIH is quoted as saying: “if we had a vaccine this effective-wow”. He was talking about a drug containing polymer that is implanted in a person’s body and slowly elutes significant quantities of a medication that suppresses HIV.
But we haven’t learned how to eliminate the HIV virus from a body. The HIV DNA has become one of the genes of too many T cells.
Tinderbox. By Craig Timberg and Daniel Halperin. Penguin Press. 2012—.
Fire in the Blood. Documentary Movie. Written and directed by Dylan Mohan Gray. 2013.
8. A 2010 therapeutic manual for doctors listed drugs that block the virus at several transitional sites. We had more than 10 reverse transcriptase inhibitors, 9 protease inhibitors, 2 entry inhibitors and an integrase inhibitor. All drugs had side effects. People who couldn’t tolerate one reverse transcriptase inhibitor often had no problem taking a different one. When a combination of medications was used, the viral biochemical assembly line was blocked in more than one location, and viral resistance was uncommon. Refractory HIV however, commonly developed when a person stopped and started the medications. That happens when people can’t afford their co-pay, when they live in a remote part of the world and don’t have access, or if they merely decide to take a “drug holiday”.
Blood the liquid that carries nutrition and oxygen to every corner of our body is a mixture of cells and protein rich fluid. Most of the cells are “erythrocytes” –red cells. As they flow through the arteries of the lung the tiny discs discard carbon dioxide and acquire oxygen. When they are propelled through the rest of the body the cells deliver oxygen and collect carbon dioxide.
We didn’t really start to understand the value and danger of transfusing the red solution until 1900 when a Viennese Physician and researcher, Karl Landsteiner, separated blood into its two components: Cells and serum. “Many but not all normal sera will agglutinate the red cells of other normal persons. Human beings can be separated into groups, the bloods of those of the same group being harmless to one another8.”
A physician researcher, Landsteiner was six when his father died. Raised by his mother Fanny, he was “so devoted to the woman that her death mask hung on his wall until he died.” An esteemed professor, Karl was living in Vienna, the capital of the vast Austro-Hungarian Empire when the First World War ended. His country had been on the losing side and the imperial lands were carved into many of the nations of modern day Europe. That winter there were shortages and Landsteiner’s laboratory wasn’t heated. One day “the Viennese poor cut down the trees around his house for firewood and tore away his fences.” Feeling personally threatened, Landsteiner moved with his wife and children, to Holland. During the next three years he lived and performed experiments in a “little cottage with a rose garden” in the seaside town, Scheveningen. He was assisted by a man-servant and a nun who was “very devout and frequently quit the lab for prayers or to serve as an organist in the chapel.” After accepting a position at the Rockefeller Institute, he moved his family to New York where he lived “on the floor above a butcher shop on a street with trolley cars.” Avoiding social activities, he spent his days in the lab, and read and thought at night “until the late hour.” “His energy was continuous and compelling, and no moment of idleness in the lab was tolerable to him.8” He was living in New York in 1930 when he received the Nobel Prize.6
In the early 1900s, while still in Vienna, Landsteiner identified three blood types: A, B, and O. They were based on the antigens on the surface of red blood cells, We now, of course, know that:
A person with Type B blood has “B” antigens on the surface of his or her red cells.
Their serum contains antibodies to blood type A.
If the person is transfused with Type “A” blood, the infused red cells will agglutinate—stick to one another and form a clump.
A person with Type A blood has “A” antigens on the surface of his or her red cells– and antibodies to B in their serum. If B cells are transfused the new cells will adhere to one another.
People who are transfused with incompatible blood got quite ill and can die.
Individuals whose red cells have both A and B surface antigens don’t have serum antibodies to either B or A. They can receive–be safely transfused with A, B, AB OR O blood.
The serum of Individuals with type O blood contains B and A antibodies. They can’t safely be transfused with A or B cells, but their red cells can be instilled into people with any blood type.
In 1937 Alexander Wiener added another red cell surface antigen, the RH, Rhesus factor to the equation.
During the First World War years (1914-1918) a series of doctors learned that when they added sodium citrate to blood it didn’t clot. With additional additives it could be stored for 2 weeks.
The notion that blood circulates and that it can be transfused was “based” on the observations of a Brit named William Harvey. In the 1600s he cut open a few living fish and snakes, and learned (and wrote) that the ancients were wrong. Blood didn’t come from the liver and slowly ebb through the body. Its flow was “propelled by the heart” and the red stuff traveled through tubes called arteries. In the 1800s a few doctors used a syringe to remove blood from one person and directly inject it into the vein of another.1 It helped some and harmed others.
The first blood bank was set up by the Russians in 1932. Doctors at Chicago’s Cook County Hospital are given the credit for opening the first American facility. It started to “save and store” donated blood in 1937. San Francisco’s Irwin Memorial blood bank was established 3 years later.
When blood, plus a chemical that prevents clotting is put in a test tube, the cells settle to the bottom and the plasma floats to the top. For blood loss or significant anemia packed red cells or erythrocytes can be transfused. Each tiny disc lives for 120 days. In transfused blood half the red cells are new and half old, so the average cell in a unit of blood should last 60 days.
In the test tube full of blood, immediately above the red cells there’s a thin layer of white cells and a stratum of platelets. The cells and particles only live a few days. White cells are an important contributor to our defense against infection. In transfused blood they can cause adverse reactions. When chemotherapy suppresses the bone marrow white cell levels can get quite low.
Platelets are particles that plug holes and help stop bleeding. Some chemotherapy drugs can significantly suppress their blood levels for a number of days. When the risk of bleeding is high enough platelets are collected from others and infused. Blood banks have machines that separate and collect platelets, then reinfuse the platelet poor blood back into the donor.
In 1940, a year and a half before the U.S. became combatants in the Second World War, London was being bombarded by Nazi planes. Many in the U.S. wanted to aid the wounded, and an effort to provide the cell free portion of the blood, the plasma, to the Brits was started in New York. Called Blood for Britain, the organizers attempted to collect thousands of units of blood, separate the cells from the plasma, and under sterile conditions ship the fluid across the Atlantic. It was a huge undertaking and the man in charge had previously only organized a group of people once. As a young man, he coordinated the paper routes of ten childhood friends who were delivering 2,000 newspapers a day.
When he was still a trainee the doctor who was chosen to coordinate the effort, Charles Drew, studied the preservation of blood products. He wrote a doctoral thesis titled “banked blood”, and he knew how to produce plasma that had a two month shelf life. Gathering, transporting and processing thousands of units of blood was a complex undertaking but Drew pulled it off and was able to send close to 15,000 pints of the precious fluid to the Brits. A black man, Drew was born in Washington D.C. and was an outstanding high school athlete. He was Amherst University’s most valuable football player in 1926, went to medical school at McGill University in Canada, and graduated in 1933. In 1941 he became the director of the first U.S. Red Cross blood bank. It was a big honor but he didn’t stay very long. He resigned because the organization labeled each unit of blood with the donor’s race and didn’t give the blood from a black donor to a white patient. He’s credited with saying “No official department of the Federal Government should willfully humiliate its citizens; there is no scientific basis for the practice; and people need the blood.” Drew returned to Howard University and became the chief surgeon at Freedmen’s Hospital.7
By the time I entered med school (1958) blood drives had come to my campus annually, and I had been a donor twice. The Red Cross proudly boasted that it saved the lives of wounded service men and women. People who were hemorrhaging or very anemic often needed transfusions. When I graduated in 1962 there were already 4400 hospital blood banks and 178 Red Cross and community facilities. I never knew what medicine was like before transferable blood was readily available.
In 1997 several San Francisco Bay area blood banks merged and called themselves Blood Centers of the Pacific. The non -profit corporations collected huge amounts of blood (200,000 units a year) from willing voluntary donors. They then checked it for blood type and for disease, fractionated the fluid into its various components, and sold– supplied it to more than 60 hospitals. Their annual budget exceeded $40 million.
The blood supply is relatively safe in part because of the outrage of an angry man. In the 70s a California legislator named Paul Gann capped our property taxes. That made him famous. But the legislation that bears his name, the Gann Act, has nothing to do with taxes. It deals with transfusions. It seems that around 1982 Gann had heart surgery and was transfused. 5 years later he discovered he had HIV. The blood he received came from someone who was infected with the AIDS virus. Either the blood donor had not been adequately screened or the blood Gann received was not tested carefully enough. Gann was furious and apparently felt: “there oughta be a law.” So he wrote one.
Prior to elective surgery California doctors must tell patients that they can store their own blood and have it available should they require a transfusion. Stock piling blood prior to planned surgery can be tedious and costly. But it’s intuitively better to get your own blood back than it is to receive that of another. It’s also the law, so if the patient wants it we do it. The act also says people can refuse blood from the “bank” and, instead get it from a donor they designate. The idea makes sense, but the blood from a friend or loved one is no longer safer than banked fluid. Before a unit of blood is given it must be tested for the usual suspects, and it’s logistically near impossible to collect, check, and process designated blood in an acute or urgent situation.
Before Gann’s outrage some blood bank executives argued that if they looked at blood too carefully they would have to reject many donors, throw away too many units. Doctors wouldn’t be able to treat the ill. People would die. After the Gann incident blood banks (which were pretty good at questioning people about risk factors) got serious about screening blood for HIV, HTLV, Hepatitis B, Hepatitis C, (and a few other illnesses such as mosquito born West Nile virus, Zika, Cytomegalovirus, Chagas, a parasitic disease whose normal habitat is Central and parts of South America, and Babesia, a parasite found in New England that is transmitted by ticks.)
We’re apparently NOT yet testing the 11 million units of blood Americans use each year for dengue, a disease transmitted by mosquitoes that’s common in South East Asia— or for Chikungunya, a West Africa disease that was responsible (between 2014 and 2016) for the fever and joint pain of 4000 American travelers. Most of them had recently visited a Caribbean island.5. And we don’t test for Hepaitis E, the most common type of hepatitis in India and parts of Asia.2
Before 1996 blood banks identified viral diseases by checking for the presence or absence of specific antibodies in the serum. When a virus invades a body, the immune system reacts and makes detectable antibodies. It was believed that blood that did not contain certain antibodies should not be infectious. To prove their blood was safe blood banks participated in studies on people who were transfused with blood whose antibody levels had been tested. 2.3 million transfusions were given during the study period and people were subsequently evaluated to see if they remained disease free. One in every 493,000 infused units caused HIV; Hepatitis C was seen after one in a hundred thousand transfusions, and Hepatitis B one in 63,000.3 Screening was good but imperfect. During the early weeks after a person is infected, the virus incubates and its number grow. It takes a while before measurable antibodies develop. So blood can be contagious when the antibody tests are negative.
Over time PCR technology improved and we were able to directly detect and measure miniscule amounts of virus. (PCR is like a Xerox machine for DNA. It allows technicians to make millions of copies of the original, to turn a tiny amount of stuff into a wad large enough to analyze and learn what we are dealing with.) In 1999 blood banks started using the technique to screen all 66 million units of blood that were transfused. Between 2006 and 2008, with PCR testing being used, the recipients of 3.5 million Units of blood were checked to see if they had been infected with any of three common chronic viral diseases. One in 1.85 million units of blood that were free of “measurable” viral particles caused an HIV infection; one in 246,000 transmitted hepatitis C, and one in 410,000 gave the recipient Hepatitis B. We’re not perfect yet.4
While blood is donated freely, screening the donor, and acquiring, testing and distributing the red stuff is expensive. A recent survey put the cost of a unit of transfused blood at $522 to $1,183. In most hospitals much of the blood is used at the time of surgery. Hospitals vary in size and in the numbers and the types of operations performed. So it’s not surprising that, in the same survey, acquired blood cost $1.6 million to $6 million per hospital annually.
The Tombstone in the Boston Cemetery marks the site of the “Inventor and Revealer of Inhalation Anesthesia: Before Whom, in All Time, Surgery was Agony; By Whom Pain in Surgery was Averted and Annulled; Since Whom, Science has Control of Pain.”
The demonstration of Ether’s effect occurred in a Boston Hospital in October 1846.4 One of the nation’s most active, Boston’s Mass General Hospital was, at the time, hosting up to two surgeries a week. They were performed in an operating room that was, in essence, a stage. It was surrounded by a steep amphitheater. People filled the seats and watched. One October day the doctor in charge, Dr. Warren told the onlookers “there is a gentleman who claims his inhalation will make a person insensitive to pain. I decided to permit him to perform his experiment.”
The dentist who administered the anesthetic, Dr. Morton, was described as being strikingly attractive and alternately optimistic and pessimistic.” He arrived 25 minutes late, took out his narrow neck flask, and filled its bottom with two liquids: Sulfuric ether and oil of orange. The second chemical was supposed to mask the ether odor.
The man who was about to undergo surgery inhaled “gas” through a mouth piece, and in 3 to 4 minutes he became “insensible and fell into a deep sleep.” He had a mass in his neck and the doctor quickly cut it out. When the operation ended Dr. Warren, the man’s surgeon, spoke to the rapt onlookers. Gentlemen, this is no humbug. People cheered, and the public took notice.26
During the Civil War battle of Fredericksburg, Morton decided to help. When a wounded soldier was about to undergo a limb amputation Warren “prepared the man for the knife, producing perfect anesthesia in an average time of three minutes.9”
Once operations could be performed without pain surgeons started performing them and a number of hospitals were built or expanded. Elective surgery became the cash cow that supported one institution after another.
In July 1868 William Morton was agitated because another doctor was trying to claim credit for his invention. He was in New York, the city was in the midst of a grueling heat wave, and Morton took his wife on a wild carriage ride through Central Park. Then he abruptly stopped the buggy, got out, and died. He was 48 years old.5
One hundred years to the month later I was asked to see a sick patient with jaundice. At the time I was the assistant chief medical resident at the San Francisco VA hospital, a collection of buildings on the edge of the Pacific that were usually blanketed in fog and cooled by a breeze from the ocean. The man I examined had yellow eyes, was weak, had no appetite and was lying in his bed. He recently had a hair transplant and otherwise had been well. He’d been put to sleep with halothane, the anesthesia of the day. Plugs of his hair were harvested from the back of his head, and planted up front.
The patient told me this had been his second transplant. He turned yellow the first time and thought he knew what was happening. He had witnessed fellow service men that got hepatitis when he was stationed in the South Pacific. He decided to not tell his doctor because he was afraid the physician wouldn’t perform the second set of hair transfers.
This was a few years before liver transplants were being done, so people with failing livers could not be rescued. The patient’s condition got worse, his abdomen filled with fluid, he sank into a coma, and he died. — And it happened because of a hair transplant.
Most anesthesiologists back then didn’t believe “so called” halothane hepatitis was a real entity and wouldn’t accept that the anesthetic they used could cause the problem. They had “never seen” a case of liver failure they couldn’t pin on one of their patient’s underlying conditions. Halothane was a smooth, well tolerated anesthetic. I was a budding gastroenterologist and I knew they were wrong. Turns out that halothane causes liver failure and death in one of 35,000 patients. Anesthesiologists needed proof and they got it in 1969 after an MD anesthesiologist visited the Yale hepatologist, Gerald Klatskin. The doctor said he turned yellow every time he administered halothane to a patient. Klatskin decided to test his theory. He biopsied the doctor’s liver. It was normal. Then the anesthesiologist inhaled halothane and his eyes and skin turned yellow. A second biopsy showed an injured liver. Klatskin published a report of the case, and U.S. anesthesiologists stopped administering halothane. It is still “widely used in developing countries.3”
Fast forward 40 years and I’m interviewing the chief of anesthesia at a local hospital. He’s telling that nowadays general anesthesia is safer than crossing the street. During the 50 years when the rest of medicine was inventing new operations and trying to cure more diseases, the top anesthesia thinkers were obsessed with safety.
They’d long since learned how to put a person into a state where the patient heard and saw nothing, was impervious to pain, and had muscles that were totally relaxed. When aroused some people had painful wounds, sensitive areas, inactive bowels, and bodily parts that didn’t function normally. Grogginess could last a while. But the recipients of general anesthesia had no memory of the trauma their body had endured. Doctors and dentists used diethyl ether and later chloroform as early as the mid and late 1840s. Over the decades drugs changed, but the overall effect has largely remained the same. One of the current anesthetics of choice is propofol, the drug that killed Michael Jackson. It’s administered as an intravenous drip. It starts and stops working rapidly and has a “low incidence of side effects such as postoperative nausea and vomiting and cognitive impairment.1 ”
Some operations are routinely performed using spinal anesthesia, a nerve block or a local infusion of lidocaine.
In addition to physicians, 43,000 nurses administer much of the anesthesia in this country. These nurses are educated, trained, licensed, and competent. In all but 15 states they are required to “work under a physician’s supervision”.
The anesthesiologist whose insights I’m channeling credits the emphasis on safety to the skyrocketing cost of malpractice insurance. It became the focus of a number of physicians who “passed gas” for a living in the 1980s. I’m sure doctors in the field thought their care was excellent and wondered why they were being singled out. But the numbers said it all. In 1974 three percent of all American doctors who bought malpractice insurance were anesthesiologists, and these were the very doctors who were responsible for 10% of all malpractice pay outs. Outsiders concluded that the care they provided was “below the standard”.
Malpractice is not a good way to judge medical quality. Doctors are sued when something major goes wrong and when the responsible physician is arrogant or seems to be hiding something. It’s also is easier to sue someone you have never consciously spoken to or interacted with, someone who has never become a real person with feelings and regrets.
Nonetheless rates were rising and something had to be done. The anesthesia societies embarked on something they called the “closed claim project.” They reviewed malpractice suits that had run their course, that had been litigated, settled or just dropped by the plaintiff. Discovering what went wrong did not create a legal or other risk for the involved doctor.
Data for events prior to 1990 revealed that in a third of the cases, the person whose families sued had died or had suffered brain damage. In 45 percent of these people the harm was caused by a “respiratory event”. When anesthesiologists induce coma they become responsible for the movement of air into and out of the lungs. They slide a tube through the mouth and pharynx, between the vocal cords, and into the bronchus. Then they aerate the lungs and the body. In 7 percent of the respiratory cases the anesthesiologist mistakenly slipped the breathing tube into the esophagus, the tube that transports food and drink to the intestinal system. It is located above the vocal chords at the lower end of pharynx. A sphincter at its top end keeps air from entering the gut and helps prevent regurgitation of esophageal contents.
In 12 percent intubation was difficult, and the body was deprived of air for a period of time. In another 7 percent the doctor got the tube in the right place but didn’t ventilate the lungs adequately.
25% of the law suits were the result of cardiovascular events, arrhythmias of the heart, a drop in blood pressure, and heart attacks.
Nerve damage due to poor positioning and compression of nerves caused 21 percent of the problems.
Anesthesiologists sometimes instill Novocain or alcohol into nerves in an attempt to mitigate chronic pain. If they injected a person who was taking blood thinners they sometimes precipitated bleeding; damage caused by the leaking blood prompted some of the legal action.
6% of the cases were prompted by burns caused by electrical cautery or by IV bags of fluid that were overly warmed.
There were people whose drop in blood pressure resulted in a loss of vision, individuals whose airways had been damaged during a difficult intubation, and a few who had back pain, emotional distress, or eye injuries. (Anesthesiologists work close to the eyes.)
79% of the problems were attributed to lack of vigilance. The specialty’s has an old saying: putting someone to sleep starts with seconds of panic, (intubation) and is followed by hours of boredom.
After the anesthesiologists learned what they were doing wrong they disseminated their findings, made recommendations, and general anesthesia became safer.
Anesthesiologists now have tools that make it possible to intubate almost everyone. Small flexible instruments containing long fiberoptic bundles, allow the anesthesiologist to see into dark corners. Some scopes have chips on their tips and send images to a TV screen. Anesthesiologists and anesthetists confirm the endotracheal tube is in the right place with a beside ultrasound examination and by measuring and monitoring the carbon dioxide level of air that exits the lungs. If the level gets too high ventilation may be inadequate. Since the blood of anesthetized people is enriched with oxygen, a high carbon dioxide concentration is more sensitive than low level of oxygen as an indicator of air movement problems. Complex machines that ventilate the patient regulate and monitor the movement of the gases. Sophisticated gear has valves and gauges that are routinely checked. Bells ring and beeps sound when something is amiss.
