SOLUTIONS 2

april 3, 2019 by stevefredman 

HEALTH INSURANCE: TRANSITIONING TO MEDICARE FOR ALL is a worthy goal for those of us who trust government.

For people who don’t believe our elected leaders are working in their interests or who prefer the marketplace approach, the single payer approach is a non starter. SO I SUGGEST A MIDDLE GROUND APPROACH.

BEFORE THE ACA, WHEN INSURANCE COMPANIES WERE ABLE TO EXCLUDE PEOPLE WITH “PRE-EXISTING CONDITIONS”: rates were low for the young and healthy, and employers could buy policies that gave them the option of offering plans where the business burden was substantial and co-pays were low OR arrangements that didn’t cost employers much, but whose high co-pays, in the absence of a major catastrophe, made them unuseable. When business was good employers could be generous. at other times they could reduce their overhead.

MY SUGGESTION: IF PEOPLE WITH PRE-EXISTING CONDITIONS COULD BUY INTO MEDICARE, OR IF CONGRESS CREATED A SEPARATE PROGRAM FOR THE ONCE UNINSURABLE–AND THE PLANS PROVIDED QUALITY, REASONABLY PRICED CARE—THEN FEES FOR THE YOUNG AND HEALTHY SHOULD FALL. AND MUCH OF THE DISPLEASURE WITH THE AFFORDABLE CARE ACT WOULD DISAPPEAR.

STEP TWO:   THE GOVERNMENT SHOULD DO WHAT THE AFFORDABLE CARE ACT FAILED TO DO.  THEY SHOULD GRADUALLY DECREASE THE MEDICAL LOSS RATIO—THE AMOUNT OF MONEY INSURANCE COMPANIES ARE ALLOWED TO KEEP FOR SALARIES AND STOCK HOLDERS. Medicare’s overhead is about 3%. The Affordable Care Act allowed the companies issuing the policies to keep 20% of the revenue they collected, and to do with it as they saw fit. Insurers didn’t need to allot more than 80% of their revenue to patient care.

SUGGESTION:  THE MEDICAL LOSS RATIO, THE AMOUNT COMPANIES KEEP, SHOULD BE LOWERED BY ONE OR TWO PERCENT A YEAR FOR AT LEAST 10 YEARS.  THAT GIVES EVERYONE TIME TO DECIDE WHETHER OR NOT THEY WANT TO STAY IN THE MARKET.

Disgracefully high out of network billing should not be allowed. MEDICARE strictly regulates the amount the government shells out to hospitals for the care they provide. The agency is constantly updating what it pays for an illness or operation. 98% of American hospitals accept the payments. In other words, regulation already exists. We know how much emergency and hospital care should and usually does cost. I believe a similar amount should be charged to people who are seen out of network or in an emergency room. Surprise bills that are outrageously high are wrong and are an unacceptable affront. .

THE ORIGINAL AFFORDABLE CARE ACT would have charged equipment makers a 4.6% tax.  this was negotiated down, then delayed for years.  The equipment business is complex and impossible to regulate.  if the U.S. wants to be able to afford to provide quality health care—and if we want to even out the costs of that care, then these companies, when profitable, should be taxed.

Health insurance is rarely used by some because they have a healthy life style, they’re young and they are lucky.  and because bodies have an innate ability to fight off invaders and heal wounds.

Some rarely seek medical help, because their co-pay is too high.  the only health plan they thought they could afford had a low premium; but the high out of pocket costs of seeing a doctor made the policy unusable–in the absence of a catastrophic illness or injury.

RECOMMENDATION:  in addition to taking care of the people with pre-existing conditions, we need a law or regulations that make health insurance affordably-useable.  I suggest caps on premiums and co-pays; i think out of pocket payments should be based on income—should mirror earnings. Hopefully, the cost of such a policy won’t  mean additional taxes.  I don’t really know how much money we’re talking about, but I suspect we can gather much of the needed revenue if we merely collect the taxes congress already authorized.

THE CORPORATE INCOME TAX: As part of the affordable care act, in 2010 congress created a health insurance tax (hit).  It applies to 50% of net premiums between $25 million and $50 million, and it applies 100% of net premiums in excess of $50 million.

Then congress enacted a one year moratorium on the tax. Revenues of $13.9 billion were not collected in 2017. 

That year congress also enacted a 1.5 trillion dollar tax cut and dropped the rate corporations pay from 35% to 21%.

The 2019 deal to end the government shut down included:

another 2 year delay in the 2.3 % medical devises tax.  That means the government will not collect $3.7 billion dollars.

And a three year delay on the “cadillac tax”, a 40 percent tax on high-cost employer insurance. Https://www.statnews.com/2018/01/22/congress-medical-device-tax/https://center-forward.org/basics/health-insurance-tax/

FOR PROFIT HOSPITALS that perform a modicum of charity work are tax exempt.  The ACA continued the exemption but required the hospitals to treat more people.

I don’t know why for-profit hospitals are allowed to avoid paying taxes.  They are corporations.  The rate they will pay has recently been nearly cut in half.

Charitable hospitalizations should, of course, be deductible.  Hospitals should generate a bill for the service rendered. The amount charged should be similar to the sum Medicare or insurance companies would actually pay. (inflated excessive charges should be treated as potential tax fraud.) And the institution’s outlay should be be deducted from the hospital’s gross income.  If an institution performs a lot of charity work and has no net income they would owe no taxes.  If they generate a large profit, they, like all other corporations, should be taxed.

The Affordable Care Act may or may not be salvageable. It would help if the country was allowed to collect the taxes already authorized by Congress, and if we treated for-profit hospitals as money making corporatioons who are nice guys, but who need to pay their taxes like the rest of us.

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previous postthe meteoric rise in the price of drugs

CHILDBIRTH

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 money and were charged.  In 2010 a vaginal birth was costing between $5000 and $7000; C sections went for about $10, 000.  If the child had a problem costs were much higher.  Modern doctors have the incredible ability to keep not-quite-ripe small infants alive.  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.”

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 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.”)    Jamila Taylor and Maura Calsyn, “5 Ways the Senate ACA Repeal Bill Hurts Women” (Washington: Center for American Progress, 2017), available https://www.americanprogress.org/issues/healthcare/news/2017/06/30/435357/5-ways-senate-aca-repeal-bill-hurts-women/

In 2006 the 4.3 million births in this country rang up a bill of $14.8 billion. 

(A C-section costs almost twice as much as a vaginal birth.) The care of low and very low birth weight infants contributed another $18.1 billion to the birthing price tag. 

1.7 percent of newborns weighed less than a thousand grams when born and .5% were under 500 grams.  Eighty five percent of the infants “survived to be discharged from the hospital.)  (N Engl J Med 2008; 358:1700-1711April 17, 2008)

Prenatally doctors and nurse midwives check pregnant women for transmissible infections like HIV and hepatitis B.  If the mother with HIV receives treatment and her viral load drops to undetectable levels, the infant won’t usually be infected.  Children born to women with hepatitis B need urgent immunizations and infusions of a special kind of gamma globulin, right after they are pushed out.  If the kids are not quickly treated they will develop a chronic infection in the liver and it will be with them for life. 

Obstetricians usually perform the first fetal ultrasound, checking for fetal abnormalities when a woman is 18 to 20 weeks pregnant.  Screening tests are performed for genetic and developmental problems.  In some cases an amniocentesis is recommended.  This invasive test carries a risk of inducing a miscarriage that is said to be half to one percent.  (The mere possibility of aborting any fetus for any reason can, in some locations, be politically unacceptable.) Near birth ultrasounds show the baby’s position and detect problems like placenta previa.  

Women “midwives” have helped other members of their sex give birth throughout recorded history.  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; 20 years later, in 1935, close to 90% of births were performed by male physicians. 

In the U.S. 33% 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 7% 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 was usually painful and half of the deliveries performed by  the midwife I consulted had epidurals; a derivative of Novocain was infused into the space outside the spinal canal.  The drug usually controlled the pain of child birth.  The rate of epidurals in physician deliveries approaches 95%.

C-section is commonly necessary, but it carries with it the risk of bleeding, infection, and of nicking the bowel and bladder.  Some studies, she explained, suggest there is a benefit from the vaginal squeeze.  Without it newborns seem to have harder time breathing on their own. 

There has been “a worldwide explosion” in the number of people having elective C-sections, and it of course, is a real operation.

Few doubt its appropriateness when the mother has a medical condition that makes surgery safer than a prolonged labor.  If the mother has active vaginal herpes, removing the infant through an abdominal incision helps protect the susceptible newborn.  With breech presentations, if the baby would have to come out feet or bottom first, vaginal delivery has an extra risk of harm and that usually more than justifies the approach.

Fetal monitoring is done in most modern hospitals; if the baby’s heart rate becomes abnormally slow or fast or if there is other evidence of fetal distress an urgent C-section is strongly considered.  My nurse midwife suspected that our current focus on every heartbeat triggers an excessive number of C sections. 

If the baby doesn’t seem to be fitting through the vaginal canal, and the labor is just pain without progress, a C section is obviously needed.  Unfortunately it’s usually not an option in most of Sub Saharan Africa, the part of the world where 98% of all maternal deaths occur.  The mothers that die are commonly in their early teens (12 to 13 years old).  The pelvis has not yet grown and matured. And it’s not large enough to accommodate a delivery; when a fetus can’t get through the vaginal canal and gets stuck mothers can die.

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.     

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 72 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 account 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.

The uterus is pear shaped and the tapered portion that has opens into the vagina is called the cervix.  Cancer of this area is “world wide the third most common cancer in women.”  It’s much less common in this country (11,000 cases a year) because many women have regular “Pap smears.”  The test was developed as the result of years of study by a New York cytologist named Papanicolaou.  In the 1950s he proved that when he brushed, stained, and evaluated tissue the cervix was about to shed, he sometimes found “bizarre” cells that indicated a cancer was present.  More significantly, he also identified and taught doctors to recognize cell changes that indicated that part of the cervix was almost, but not quite malignant. 

Early on the tools of the GYN trade relied on feel and surgical prowess.  A speculum allowed physicians to peek at and brush the cervix.  The uterus and ovaries were felt by trained fingers in the vaginal canal pushing up towards equally aware fingers that rested on the abdomen and were pushing down.  When the exam was painful or the woman was large or tense the exam had limited value.

In addition to palpating and interpreting, Gynecologists can now see the organs they are evaluating.  Shadows of the uterus and ovaries can be visualized by placing an ultrasound probe into the vagina and watching a T.V. screen.  It’s usually less uncomfortable than a pelvic and many doctors’ offices have the equipment and the expertise to perform the exams.  The charge, in one location (chosen randomly on the Internet) at least, is $200 per exam, and 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.  The canal between the cervix and the uterus narrows at the transition between the two zones; the first step of the procedure is to 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 endometrium, of the inner lining wall of the uterus. 

Nowadays there’s a thin narrow scope that can slip into the uterine cavity.  Doctors can actually see the inner walls can look for abnormalities.  The hysteroscope has allowed many to avoid having their linings scraped.  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 usually don’t cause symptoms.  (There are a slew of other procedures and surgeries that treat this abnormality; knowing they have uterine lumps seems to worry a lot of women.) 

Some 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) 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. 

           At $10-15,000 a try, in vitro fertilization (and assisted reproductions) led to the birth of a million babies between 1987 and 2015.  Under ideal conditions the process is successful, per attempt, 21% of the time https://www.pennmedicine.org/updates/blogs/fertility-blog/2018/march/ivf-by-the-numbers

            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 a Merck 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%. (uptodate)

It’s sometimes not given because some 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.

HIV

One Wednesday morning in the 1980s I attended the weekly GI conference at the medical center, and I heard about a tumor, Kaposi’s sarcoma, a cancer of old Italian men, that was turning up in the gay community.  Young men were getting pneumonia that was caused by a fungus that had lived harmlessly in most lungs for a millennium, a microbe called Pneumocystis.  We knew of similar infections in kidney transplant patients who were heavily immunosuppressed, but the bug was now infecting healthy people.  As time passed the medical world was turned on its head. Young ill men and women developed a bizarre assortment of diseases. Many were quite ill and they were occupying hospital beds, receiving multiple medications, and sometimes dying. 

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 in 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.

The HIV virus, we later learned, was not highly contagious.  You could shake hands or hug someone with AIDS. Two principles of medicine were turned on their head.  We had previously believed that most complex medical symptoms can be traced back to a single illness. In people with AIDS when we found the cause of one infection (like pneumocystis) we couldn”t stop looking. The immune system had reached a low point and additional problems were brewing. Antibiotics no longer cured infections; they suppressed them.

Years later medical detectives found chimp feces in the Cameroon that contained Simian Immune Virus (SIV) DNA that was an identical to the DNA of Human Immune Virus (HIV). A strain of SIV had crossed the species barrier, taken hold, and spread.

It presumably happened in the early 1900s. Chimps were bush meat, wild game in parts of Africa and when wounded, chimps struggled. A human who was killing a chimp was injured. Blood containing the Simian Virus entered his or her body, survived, and was passed on. At some point a person that he or she had infected moved to Leopoldville, (now Kinshasa).  In 1920 the town was the capital of the Belgian Congo and was full of migrants. By the time the colony became an independent country (1960) an estimated 1,000 to 2,000 people were living with HIV.  To a physician of the day a sick person with AIDS could have anything.  Diarrhea, fever, and wasting have many origins.  There’s no evidence that anybody, at the time suspected there was a new sickness.

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 and eventually went home.  The virus spread quietly in Haiti for a few years.  Then unknowing carriers visited the U.S. and Europe and passed it on.  .(Tinderbox by Craig Timberg and Daniel Halpern)

For over a decade almost everyone who had HIV died. Then scientists developed drugs that, when used in combination, turned a killer into a chronic, controllable malady.  And the entrepreneurs and corporations who made the life saving medications had to deal with their desire or need to make money and enhance stockholder value, while at the same time facing the desperate needs of millions of sick and dying people.

After they identified the virus, scientists methodically, learned how the HIV virus attaches to the cell and “punches” its way through the outer membrane, sheds its protective coat, and uses a special enzyme it brought with it, (reverse transcriptase), to make a DNA copy of the viral RNA.

Each phase the virus passed through was a potential area of vulnerability, a moment or point where a drug developed by a researcher could block the progress of the evildoers.

The counter attack started when scientists at Burroughs-Wellcome synthesized compounds that might obstruct 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 NIH 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 the virus brought with it when it entered the cell.  The first Protease inhibitors became available in 1996.

Nucleoside reverse transcriptase inhibitors, drugs that work against the enzyme that copies HIV RNA into new viral DNA, were created by Emory university professors.    They discovered FTC (emtricitabine) and a chemically similar compound, 3TC (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 drug.     .

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”.

In the U.S. combinations of the two or more drugs that are needed to control a person’s HIV usually costs between $1500 and $3000 a month.  People with “decent” health insurance are commonly required to pay two thirds of the needed dollars. http://www.gtp.autm.net/story/view/76http://www.gtp.autm.net/story/view/76 http://www.gtp.autm.net/story/view/76

In 2004 a small percentage of the people with HIV lived in high income countries.  In the U.S. HIV was becoming a well controlled chronic disease.  People in the rest of the world kept dying. By 2017 more than 36 million people (close to 2 million of whom are children) were infected.  Over 25 million HIV carriers lived in Sub Sahara Africa. That year world wide 75% of people who carried the virus knew they were infected.

Initially Drug companies tried to guard their exclusivity with all the money and influence they could muster.  In 1995 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.).

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.  The Bush administration initially thought the constraints should stand.

In 2001 Indian generic drug manufacturer, Cipla, announced that it would sell a generic copy of a triple-therapy antiretroviral for US $350 per patient per year.  The following year Shanghai’s Desano pharmaceuticals started producing a three drug regimen.  The cocktail was sold for $350 a year.  Other countries were ready to join in.

The South Africa Competition Commission found two drug companies guilty of anti competitive behavior.  Facing fines and maybe jail time the corporations struck a deal.  Several big pharmaceutical companies, including Glaxo, agreed to allow generic manufacturers to make and sell HIV drugs.  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 important 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.  He 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.

In 2017, per the U.N., 19.5 million people, more than half those infected, are being treated.  The UN thinks they can end the epidemic if 90% of those infected know they are infected.  And if 90% of them take anti retroviral drugs; and if 90% of people being treated take enough medicine to suppress the virus.   Seven countries, one of which is in Africa, have achieved the 90/90/90 goal.

In the U.S. people are treated with one of many combinations of drugs.  Most have NOT been generic; but that’s changing.   3 major drugs were FDA approved in recent years. In 2016 the agency authorized a generic version of Truvada, a pill that when taken daily by high risk individuals cuts the risk of infection by over 90%. The CDC recently estimated the average annual cost of HIV drugs was about $20,000 ($360,000 lifetime.)  Most Americans with HIV get their medication through their insurer, but they have to pay deductibles, and copayments.  That can be a problem.  In the appropriate age and income situations Medicare and Medical supply the meds.  The non-profit Ryan White Foundation helps when health plans are incomplete and people can’t afford the drugs.  There are federal programs that help needy women and children.  For the right population the Indian Service and the VA get involved.

In 2019 we’re still pretty far from getting HIV under control.  The CDC (center for disease control) thinks that in the U.S 1.1 million people are currently infected and 40,000 will acquire HIV each year.  83-88% of the infected have been diagnosed, and 85% of that cohort regularly takes medicine that controls the virus; only half take enough pills in the right dose. One in six men who has sex with other men will eventually acquire HIV.  Half are Latino or African American. In 2016, 18,000 people were diagnosed with AIDS and in 2015 there were about 6500 AIDS-related deaths.

Most new infections can be prevented with a daily pill that contains two of the more effective anti-viral drugs.  The CDC suggests that those at risk should take one of these pills each day.  The approach usually works, but it is not always covered by insurance, and that can be a problem.  The pill plus tests and doctor visits “should’ cost about t $10,000 a year.

In 2017 a little more than half of the 37 million people in the world who were living with chronic HIV were being treated and 2 million additional people were annually being infected. ttps://www.nejm.org/doi/full/10.1056/NEJMp1804306 .  (CDC website.)

HIV has been turned into a chronic, sometimes lethal disease.  Infected people are living full lives. But we have a ways to go. 

TRANSFUSIONS

In the 1600s a Brit named William Harvey cut open a few living fish and snakes and learned that blood flowed from the heart through tubes called arteries; in the 1800s a few doctors performed person to person transfusions that helped some and killed others.  We didn’t really start to understand the value and danger of transfusing the oxygen carrying red blood cells until an Austrian Physician, Karl Landsteiner identified the A and B antigens on their surface, and when Alexander Wiener in 1937 added the RH, Rhesus factor to the equation. We now know, of course, that when a person has antibodies to an antigen on a transfused blood cell, their immune system destroys the foreign red cells and the patient gets quite ill and can die.

During the First World War years (1914-1918) a series of doctors learned that when they added sodium citrate to blood given to dogs it didn’t clot; with additional additives it could be stored for 2 weeks.  (The occasional transfusions of the early 1900s were given directly for one person to another.) http://www.animalresearch.info/en/medical-advances/timeline/blood-transfusion/

The first blood bank was set up by the Russians in 1932, and doctors at Chicago’s Cook County Hospital are given the credit for, in 1937, opening the first American facility that “saved and stored” donated blood.  San Francisco’s Irwin Memorial blood bank started 3 years later.  

 A military physician named Charles Drew figured out how to separate plasma from red cells and store it.  He patented his technique, created and became the director of the first Red Cross blood bank, and ran a war time blood program for Britain.

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.

Blood is a complex fluid, part cells, and part protein rich fluid.  In the test tube the cells settle to the bottom and the plasma floats to the top.  For blood loss and significant anemia we transfuse packed red cells or erythrocytes.  They acquire oxygen in the lungs and transport it to all corners of the body; each cell has a 120 day life span.  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.  Just above the red cells in the test tube there’s a thin layer of white cells and a stratum of platelets.  Each lives but a few days.  Platelets are particles that plug holes and help stop bleeding.  In special situations they are concentrated and separately infused.  White cells are an important contributor to our defense against infection, but in transfused blood they can cause adverse reactions; as a result their numbers are commonly reduced by filtration.  The plasma contains proteins that, among other things, provide clotting factors. 

“All patients are screened for antibodies in their plasma/serum that might react with antigens on transfused RBCs and cause hemolysis, spontaneous rupture of red cells.”  Before blood is transfused some of the patient’s serum is mixed together with some of the red cells that are about to be transfused.  We need to make sure they won’t agglutinate, stick together.

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 was tainted, having come 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 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 blood.  Like all blood, before it’s 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, hepatitis B, Hepatitis C, (and a few other illnesses such as mosquito born West Nile virus Zika and Chagas, a parasitic disease whose normal habitat is Central and parts of South America.)

We’re apparently NOT yet testing the 11 million units of blood Americans use each year for:  Babesia, a parasite found in New England that is transmitted by ticks; or for dengue, a parasitic disease common in South East Asia, or Chikungunya, a virus, or Hepaitis E, the most common type of hepatitis in India and parts of Asia.  (NEJM Sept 28, 2017) 

Blood banks have machines that “dialyze off platelets, and then infuse the platelet poor blood back into the donor. 

When a virus invades a body, the immune system reacts and makes antibodies.  Before 1996 blood banks identified viral diseases by checking for the presence or absence of specific antibodies in the serum, reasoning that antibody free blood would not be infectious.  To prove they were right they did outcome 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; Hepatitis B one in 63,000, and HTLV one in 640,000 units.  (N Engl J Med June 27, 1996)  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.  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 the three 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.  (N Engl J Med January 20, 2011)

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. 

ANESTHESIA

Nowadays, he explained, 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 incidences of postoperative side effects such as postoperative nausea and vomiting and cognitive impairment.” http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1941092

The anesthesiologist whose insights I’m channeling credits the emphasis on safety to the skyrocketing cost of malpractice insurance.  It became the focus for 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 that was “below the standard”.

  Malpractice is not a good way to judge medical quality.  Doctors are sued when something major goes wrong and 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, which 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 top of the intestinal system.  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 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.  They confirm the endotracheal tube is in the right place with a beside ultrasound examination and/or by measuring the airway carbon dioxide level when the patient breathes out.  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. 

There are monitors for the carbon dioxide exiting 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.

Some operations are routinely performed using spinal anesthesia, a nerve block or a local infusion of xylocaine. 

In addition to physicians, 43,000 nurses administer much of the anesthesia in this country.  The people who perform the task are educated, trained, licensed, and competent. In all but 15 states they are required to “work under a physician’s supervision”.  On average they earn $84 an hour or $175,000 a year. https://www.rand.org/pubs/research_briefs/RB9541.html

BLOOD TRANSFUSIONS

BLOOD TRANSFUSIONS:  In the 1600s a Brit named William Harvey cut open a few living fish and snakes and wrote that blood flowed from the heart through tubes called arteries, and in the 1800s a few doctors performed person to person transfusions that helped some and killed others.  But we didn’t really start to understand the value and danger of transfusing the oxygen carrying red blood cells until an Austrian Physician, Karl Landsteiner identified the A and B antigens on their surface.  In 1937 Alexander Wiener added the RH, Rhesus factor to the mix.  (When a person has antibodies to transfused blood their immune system destroys the donated red cells and the patient gets quite ill and can die.)

During the First World War years (1914-1918) a series of doctors learned that when they added sodium citrate to blood given to dogs it didn’t clot; with additional additives it could be stored for 2 weeks.  (The occasional transfusions of the early 1900s were given directly for one person to another.) http://www.animalresearch.info/en/medical-advances/timeline/blood-transfusion/

The first blood bank was set up by the Russians in 1932, and doctors at Chicago’s Cook County Hospital are given the credit for, in 1937, opening the first American facility that “saved and stored” donated blood.  San Francisco’s Irwin Memorial blood bank started 3 years later.  

 A military physician named Charles Drew figured out how to separate plasma from red cells and store it.  He patented his technique, created and became the director of the first Red Cross blood bank, and ran a war time blood program for Britain.

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.

Blood is a complex fluid, part cells, and part protein rich fluid.  In the test tube the cells settle to the bottom and the plasma floats to the top.  For blood loss and significant anemia we transfuse packed red cells or erythrocytes.  They carry oxygen from the lungs to all corners of the body and have a 120 day life span.  Since half are new and half old, the average cell in a unit of blood should be around for 60 days.  Just above the red cells in the test tube there’s a thin layer of white cells and a stratum of platelets.  Each lives but a few days.  Platelets are particles that plug holes and help stop bleeding.  In special situations they are concentrated and separately infused.  White cells are an important contributor to our defense against infection, but in transfused blood they can cause adverse reactions; as a result their numbers are commonly reduced by filtration.  The plasma contains proteins that, among other things, provide clotting factors. 

“All patients are screened for antibodies in their plasma/serum that might react with antigens on transfused RBCs and cause hemolysis, spontaneous rupture of red cells.”  Before blood is transfused some of the patient’s serum is mixed together with some of the red cells that are about to be transfused.  We need to make sure they won’t agglutinate, stick together.

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 was tainted, having come 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 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 blood.  Like all blood, before it’s 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, hepatitis B, Hepatitis C, (and a few other illnesses such as mosquito born West Nile virus Zika and Chagas, a parasitic disease whose normal habitat is Central and parts of South America.)

We’re apparently NOT yet testing the 11 million units of blood Americans use each year for:  Babesia, a parasite found in New England that is transmitted by ticks; or for dengue, a parasitic disease common in South East Asia, or Chikungunya, a virus, or Hepaitis E, the most common type of hepatitis in India and parts of Asia.  (NEJM Sept 28, 2017) 

Blood banks have machines that “dialyze off platelets, and then infuse the platelet poor blood back into the donor. 

When a virus invades a body, the immune system reacts and makes antibodies.  Before 1996 blood banks identified viral diseases by checking for the presence or absence of specific antibodies in the serum, reasoning that antibody free blood would not be infectious.  To prove they were right they did outcome 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; Hepatitis B one in 63,000, and HTLV one in 640,000 units.  (N Engl J Med June 27, 1996)  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.  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 the three 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.  (N Engl J Med January 20, 2011)

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. 

VISION

During the last century vast strides have been made in our ability to prevent blindness and improve eyesight.  Worldwide, visual loss is sometimes caused by trauma.  In the impoverished parts of Africa many are losing their ability to see as a result of a number of conditions.  Famine and malnutrition caused by wars and droughts render many a surviving infant blind as a result of the absence of Vitamin A and the resultant dryness and scarring of the conjunctivae, the skin that surrounds eyes (Xerophthalmia). 

Poverty and overcrowding are also responsible for the spread of Chlamydia, a bacterium that infects the inside of the eyelids of some children.  The eye ball reddens, the upper lid is scarred, and vessels develop on the cornea, the outer lens.  The disease can be prevented with relatively cheap, widely available antibiotics like erythromycin and doxycycline.

River blindness was once the world’s second leading infectious cause of visual loss.

The current leading causes of blindness in this country, according to the NIH, are cataracts, glaucoma, macular degeneration and diabetic retinopathy.

Cataracts:  The eye like the microscope and the telescope needs two lenses, the cornea and the “lens” to create a sharp image.  Cataracts occur when the eye’s inner lens becomes cloudy and opaque.  Most develop slowly as we age, though they are sometimes seen in children for a variety of reasons.  Worldwide they are the leading cause of blindness and a they cause diminished vision in many. 

A century ago when the inner lens got so dense that a person couldn’t see, the once transparent tissue behind the iris was surgically removed.  (Apparently that’s still done in some countries.)  I still remember the days when people didn’t have cataract surgery until they were no longer able to see.  After the dense inner lens was surgically removed, thick glasses were required for vision.

Harold Ridley of England is the father of implantable lenses.  He treated members of the RAF whose airplanes were damaged by enemy fire and whose eyes were penetrated by pieces of the windshield.  The acrylic plastic caused no harm and that got Ridley thinking.  He started crafting lenses, from the material that was used to make airplane cockpits; lenses were implanted into eyes after he had removed a “cataract.”  A company in East Sussex (Rayner) manufactured the product and Ridley and a pupil perfected the surgical technique.  In 1981 the FDA approved the use of implantable lenses in the U.S. and American eye surgeons adopted the approach.  It’s now part of the bread and butter of ophthalmology. 

The last 50 plus years have witnessed the development  and modification of many replacement lenses.  And by 2015 9000 American ophthalmologists were replacing 3.6 million lenses a year.  world wide 20 million cataract surgeries are performed annually. https://www.reviewofophthalmology.com/article/thoughts-on–cataract-surgery-2015

In the U.S. most surgeons numb the eye, insert a small ultrasound probe, and phacoemulsify the dense lens.  Then they suck out the debris, insert a small plastic or silicone lens, and if necessary sew the incision shut.  My ophthalmologist at Kaiser Oakland told me she doesn’t specialize in cataract surgery; the eyes she deals with often have additional problems.  So on her surgical half days she only performs 9 operations.  Each takes 6 to 14 minutes.  The complication rate for Canadian surgeons who performed 50 to 250 operations a year was 8 in a thousand, and one in a thousand for surgeons who performed a thousand operations a year.  In poorer countries phacoemulsification is less common.  Most people who need cataract surgery are of Medicare age and the government pays $2500 per eye.  Special lenses can cost an extra $1500 to $2500.  

In the late 1990s it was estimated that 9.5 million people in India were blind as a result of cataracts and that 3.8 million people were losing their vision annually.

 In 1999 1.6 to 1.9 million surgeries were performed in a single year and plans were made to increase the numbers of operations that would be performed.  

In India, a land with over a billion inhabitants, cataract surgery took a giant step forward in 1983 when an American Doctor named David Green met a 58 year old eye surgeon named Govindappa Venkataswamy.  When they met again 5 years later the Indian physician had mortgaged his home, built an 11 bed hospital and was performing 5000 eye operations a year, 70 percent of them at no charge.  Given the need he was barely scratching the surface.  The cost of implantable lenses, $100 to $150 per eye was too high for the average Indian.

Green and the doctor established a nonprofit manufacturing plant in India and were able to produce an inexpensive quality lenses.  The company they founded, Aurolab, in 2016 manufactured 2.6 million intra ocular lenses, 10% of all produced in the world.  the majority are “distributed to NGOs in India and in developing countries.” 
In 2006 cataract surgery in India, Nepal, and Bangladesh was costing $20 and the lens was sold for less than $5.  The company is profitable. https://www.seva.org/site/SPageServer/;jsessionid=00000000.app272a?NONCE_TOKEN=D331A52171C42E9234E1E43A336A29B0&pagename=25_Years_of_Aurolab

https://www.mitpressjournals.org/doi/pdf/10.1162/itgg.2006.1.3.25 

The dramatic, painful eye of angle closure glaucoma is a medical emergency and can lead to visual loss. It’s relatively uncommon.

Open angle glaucoma, on the other hand is relatively common. Experts have learned a lot about the more common condition, but we don’t know what causes it. It’s no longer defined merely as a condition where the pressures inside the eye are too high.  Sometimes they are normal.  But the fluid inside the eye doesn’t move normally from one chamber to the next.  The retinal nerve layer thins; people lose peripheral vision and eventually can substantially lose much of their ability to see.

In the western world some ophthalmologists spend a year or more of their lives as a glaucoma fellow.  They learn how to perform and interpret tests, and when and how to perform one of many operations.  Sophisticated machines allow experts to photograph and follow the appearance of the layers of the retina, the nerve rich stratum that collects the focused light that our brain turns into images.  Gadgets that detect early loss of peripheral vision and that measure the pressure in the eye have entered the digital era. 

The drugs that control the pressure in the eye include beta blockers and prostaglandin inhibitors.  In 2004 when Pfizer had FDA provided exclusive right to the prostaglandin inhibitor Xalatan, they sold $1.23 million worth of the drug; they sold more the subsequent year.  In the U.S. (at the time) the “drops” cost about $80 a month; drugs manufactured by Pfizer purchased via e-mail through a Canadian pharmacy cost about $30 a month. 

Pfizer manufactures and sells its products worldwide.  We don’t know where the medications that are sold in the U.S. (through Canadian pharmacies) are manufactured, and we must assume they could be made in any of the company’s 43 manufacturing plants.  Pfizer manufactures drugs in Ireland, Puerto Rico, the U.S., UK, Germany, Amboise, France; Ascoli, Italy; Belgium and Perth, Australia. 

If medications do not prevent progressive loss of vision, laser surgery can increase the drainage of fluid; if that doesn’t work an older operation called a “trabeculectomy” can create “a new drainage path” through which the fluid in the eye can escape.

   In one study researchers checked the records of 113 Brits with open angle glaucoma who failed their last glaucoma appointment due to death.  (They had been followed for 7 to 25 years.)  About half had undergone surgery for cataracts and 45% for glaucoma during those years. “At final visit, vision was inadequate for driving in the UK in 47.1%. In 18.2%, this was due to glaucoma alone, while in 28.9%, other ocular pathologies contributed to poor vision.”  

AMD, age related macular degeneration, is a leading cause of vision loss in the U.S.  Something goes wrong in the layer under the retina, and the macula, the part of the eye that provides sharp, central vision, is damaged or destroyed.  The so called “dry” form of the disease mainly affects white people who are 80 or older; we have no effective treatment.                

The less common “wet” form of the disease is sometimes helped by laser coagulation or photodynamic therapy.   And we use Avastin, an antibody that “blocks” the growth of the new blood vessels.  When an ophthalmologists injects the medication into the eye of someone with wet macular degeneration, the disease process slows or turns off.  “Blindness is prevented in most patients, and the majority of treated patients go on to have some improvement in vision.”

The drug was originally developed to interfere with new vessels that were bringing needed nutrition and oxygen to an expanding cancerous growth.  Avastin plus other drugs slowed the enlargement of some of these tumors.  And small amounts of the antibody were being sterilized and used by eye doctors.  Because the quantity needed was small the drug was relatively cheap. 

   The company that developed Avastin then developed a second anti-VEGF antibody.  This time the molecule was smaller, but they used the same company lab (Genentech) and the same Anti-VEGF mouse. 

The new drug Lucentis (ranibizumab) was approved by the FDA for neovascular AMD in 2006.  (and for diabetic retinopathy in subsequent years.).  It goes for about $2000 an injection ($48,000 a year).  The off label drug Avastin (bevacizumab) costs $50 a shot.  When tested head to head the drugs were equally effective. 

In 2010 the manufacturer sold $2.9 billion dollars of Lucentis.  

Doctors in this country were prodded into using the more expensive drug by a law enacted by the U.S. government.  As a result of the 2003 drug law passed by the Tom Delay led congress in 2003, the fee doctors charge Medicare for injecting a drug can’t exceed 6% of the medication’s cost.  If Lucentis is used the doctor is paid $120 for his or her time and effort.  If Avastin is used the doctor can only charge $3.00 for his time.

Refractory problem:  At some point in most of our lives we can’t see well because our eyes defectively focus light on the retina, the layer of cells at the back of our eyeballs.  Some people are born with refractory errors.  Others find it increasingly difficult to read small print after they turn 40.  Wearable eye glasses have been used for many centuries. 

In the 1950s people started correcting their vision by placing a thin lens on the surface of their eye.  Contact lenses were initially small and had to be removed at night; then they lasted for days; now some are disposable and billions of dollars worth are used worldwide. 

n 1989 Gholam A. Peyman, an ophthalmologist and inventor patented Lasik, a laser and computer assisted device that allowed doctors to peal back a flap of the outer skin of the cornea, the front lens of the eye.  The inner corneal layer could then be altered with the beam of a laser, and eyes could focus better.  At the end of the procedure the flap was replaced.   In 2010 it was estimated that 8 million Americans have undergone the Lasik procedure at a cost of about $2000 per year

Finally, no sooner is one problem solved than a new one develops.  In a country where the incidence of obesity is increasing as a result of our high caloric diets and diminished activity, more and more individuals become diabetic.  People with longstanding diabetes develop a number of eye problems and can go blind.  In addition to cataracts, diabetes causes damage to the retina, the visual “screen” that is the back wall of the eyeball.  Forty percent of people who have longstanding diabetes and who are more than forty years old, develop retinal swelling or circulatory problems; 8 percent of them are at risk for serious visual loss.  Laser treatment often helps. (NEJM 2011;365:1520-6)

The treatment of diabetic retinopathy and the other complications of diabetes have a minor impact on the health care dollar, but the annually “economic effect” born by our citizens is estimated to be $620 million.  The worse the average blood sugar, in general, the more a person’s eyes are at risk.  And that’s part of the reason we need good primary care.  that’s why the TV ads talk about the Hemoglobin A 1 C, the blood test that tells us how good our average blood sugar is. 

MALPRACTICE

“In 1950s, physicians faced one claim of malpractice per 100 physicians per year; prior to 1970 medical malpractice suits were very rare.   that year an estimated 12,000 medical malpractice claims were filed but one third of them were warning files rather than true claims. In mid 1970s, four of five cases ended in favor of defendant; many awards didn’t cover the victim’s litigation costs. And many who had a meritorious case did not file a claim.” http://siteresources.worldbank.org/INTRUSSIANFEDERATION/Resources/Malpractice_Systems_eng.pdf

I’m not sure how far our approach to malpractice law suits has advanced in the last 50 years.  The care doctors provide has grown increasingly expensive.  Physicians and patients are taking more risks.  Doctors and nurses often seem to have poor people skills.  We may be good students, methodical, and technically proficient.  But too often we are running late.  Our schedules are too tight and we seem to be impatient.    

Errors happen.  The wrong medicine. The wrong dose.  Hospital bed sores.  A preventable fall that leads to an injury.  A sponge left in an abdomen.  Cancers that should have been discovered early are missed.  Harm at the time of birth that has lifelong consequences. 

The majority of physicians in a quoted survey said that when something goes wrong they provide “only a limited or no apology, limited or no explanation, and limited or no information about the cause.”   The article’s author, a physician who specializes in malpractice, thinks the problem is too often a physician’s  need to protect his or her ego and a system that allows doctors to blame shift.  https://www.statnews.com/2017/01/13/medical-errors-doctors/

I was a salaried doctor in a large physician owned group (Kaiser) for 40 years.  I was sued a few times, and it was emotionally painful.  I’d prefer to not judge myself.

I don’t really know what happens to physicians who practice fee for service medicine.  Some share small offices with one or several colleagues.  When sued I assume they are forced to deal directly with representatives of an insurance company. 

I never had to pay a malpractice premium.  We were big enough to be self insured (In the event of a multi-million dollar settlement—a severe injury that led to expensive lifelong care—an umbrella insurance policy kicked in.)

I wasn’t forced to deal with a representative of an insurance business or company lawyers whose chief tactic was delay and endless expensive depositions. 

Suits that alleged malpractice initially went to a fellow physician who was not always that sympathetic, but who usually was one of the groups brightest and best.  Our malpractice doctor typically spent half of their time dealing with patients.  After a lawsuit arrived on his or her desk, our colleague read the chart, evaluated the case, and reached a preliminary conclusion. 

In serious cases the group hired one or several outside experts and asked them to assess the case.  If outsiders thought we were negligent our people tried to settle.  They sometimes got opinions from additional experts.  Physicians who were paid for advising us could not become an expert for the plaintiff. 

All doctors who participated in the care of the injured person were always named, and everyone who was being sued was informed.   

A large medical-legal department handled the paper work:  release of information and the technical matters associated with lawsuits. 

Skilled, knowledgeable company lawyers gave advice and guided physicians through depositions.  But, when indicated, outside lawyers were hired to handle each case.      .

Kaiser patients signed an arbitration contract. Cases don’t go to a jury.  Judges are chosen by lawyers from each side.  I’m told the approach does not affect overall malpractice costs but it was easier on the psyche.

 When a plaintiff’s compensation is in excess of $30,000 the state of California gets involved.  If the case was arbitrated our group has to name the physician most responsible; the name is posted on a state web site.   If there was a trial and the money was awarded by a judge, the board of medical examiners gets to decide who to blame.    

Doctors responsible for higher settlements often have to appear before a really tough California medical board.  Most walk away with a reprimand, but about one in 10 have their license revoked or suspended.  .

Our tort system is based on blame and fault.   To prevail a plaintiff has to prove that the defendant owed a duty of care, that the defendant breached the duty, and that the breach caused an injury.” Plaintiffs’ attorneys usually work on a contingency-fee basis, taking a percentage of the award when they win and nothing when they lose. 

People must file suit within a year after they learn they were negligently harmed. 

The amount that’s paid for pain and suffering is capped in California at $250,000 per person.  There is no dollar limit on actual injuries. 

Numerous surveys have concluded that in most cases of negligence the doctor was not sued, and when doctors are sued the harm was usually NOT the result of negligence.

In one recent study (12,000 to 17,000 insurance policies a year), 7.4% of the doctors were sued at least once annually.  Most of the allegations were dropped or dismissed but 1.6% of those suing were paid some money.  The most targeted subspecialties were neurosurgeons, chest surgeons, and general surgeons.  On average 15 to 19 percent of them were sued each year.  (That turns out to be an average of a suit every 5 to 6.5 years.)  The least targeted physicians were generalists, pediatricians and psychiatrists.  They generally got legal notice every 20 to 40 years, or one to two times during their medical careers. https://www.mdedge.com/clinicalneurologynews/article/48642/health-policy/most-doctors-face-malpractice-claim-age-65

The number of “paid medical malpractice claims” decreased significantly between 2001 and 2016.  They went from 16,000 to 8500 a year, and the average payout “dropped about 23%”.  During that 15 year period the number of suits where people are paid more than half a million dollars didn’t change much;  they led to annual payouts of about $2.5 billion.  Between 2012 and 2016 as many as 60 in a million people filed malpractice claims in our two most litigious states New York and New Jersey.    http://truecostofhealthcare.org/malpractice_statistics/

Doctors typically claim that the fear of malpractice leads to unnecessary testing and plays a major role in health care costs.

“Many countries- like Sweden, Finland, New Zealand, Quebec Canada, and Australia, have a no-fault system”.  Compensation is based on proof of “causal” connection between treatment and injury. The structure allows patients to be compensated without proof of provider’s fault or negligence, and it encourages physicians to collaborate in their search for the cause of the injuries.  Although the application of no-fault system differs slightly in each country, the basic idea is to eliminate fault or blame and make the claim process simple so patients with meritorious cases could access the system easily.” http://siteresources.worldbank.org/INTRUSSIANFEDERATION/Resources/Malpractice_Systems_eng.pdf

It’s possible to get some sense of what would happen if American physicians could no longer be sued for medical malpractice.  Doctors in the military aren’t immune from patient complaints or administrative action, but the government can’t be sued.

In the 1940s a serviceman died after a surgeon “left a towel in his abdomen”.  The family sued and 1950 the U.S. Supreme court, in creating a “doctrine” called the Feres rule, said the government was not liable.  The decision was later extended to include anyone receiving medical care from “the government.”  The court rationalized the approach by discussing the special relationship that exists between service members and the U.S. and by pointing out that the laws of malpractice vary from state to state (which makes litigation complex.)  They noted that injured service members who were disabled were paid accordingly; and the judges feared law suits might affect military discipline.  The decision of the court has been challenged.  Additional suits have been filed, but the court did not choose to re hear the matter. 

In a recent article a few lawyers felt “repeal (of Feres) may not serve the best interests of service members.”  Most people who are harmed, they pointed out, don’t sue.  Without the threat of legal action, mistakes could be openly discussed, problems could be identified and the system could be improved.   We don’t know, they argued, that giving lawyers standing would make the care people received any better or safer.  “There is little empirical evidence,” they wrote that civilian malpractice litigation provides incentives to improve the safety of care.”

THE METEORIC RISE IN THE PRICE OF DRUGS

Gleevec was the first drug that targeted a cancer.  The way it was priced helped create a mindset.  

When I entered medical school, in 1958, aside from nitrogen mustard derivatives, chemotherapy for cancer, was virtually nonexistent.  In the subsequent decades a number of drugs that attacked rapidly growing cells, malignant or otherwise, were developed.  In the 1960s doctors started using combination of several of these drugs to cure some lymphomas and leukemias.  The drugs also commonly cured specific malignancies—like some metastatic testicular cancers and choriocarcinoma.   

They were toxic and often caused major side effects, but they worked.  When used in people with widespread cancers the medications caused tumors to shrink, and extended some lives. 

They were later used to destroy potential metastases. We knew that malignant cells from some of the surgically removed cancers had already seeded parts of the body. The “seeds” were not visible, not detectable; but we could identify the cancers that were at risk, the tumors that would statistically benefit from chemotherapy.  Our toxins eradicated some of these microscopic implants.

Then Gleevec (Imatinib), a drug conceived and fully developed over many years in the labs of big Pharma—was introduced, and our approach to fighting malignancies underwent a sea change. 

At $26,000 a year (in 2001) Gleevec’s introductory price was deemed “high but fair” by the Chairman and CEO of Novartis.  Then its price rose and kept rising. 

One of the first drugs that attacked cancer cells and left the rest of the body unharmed, Gleevec was the product of decades of research at the Ciba-Geigy labs in Basel Switzerland.  A research team funded by big Pharma spent millions of dollars chasing a dream, a theory, a hypothesis.  Alex Matter, a Swiss M.D. advocated looking for a small molecule that would get inside cancer cells and stop them from growing.

“Inspired by the likes of Louis Pasteur and Marie Curie”,  Matter was 12 years old when he began dreaming that he would one day be involved in the discovery of important new medicines.”  I don’t know if he ever practiced medicine, there’s not much written about his private life, but in 1983 he became a Ciba researcher in Basel Switzerland.  At the time he was apparently wondering what happens when the offspring of a normal cell turns out to be cancerous.  Could it be that one of its numerous tyrosine kinase enzymes, proteins that “function as an “on” or “off” switches, gets stuck in the “on” position, and causes the cell to grow and grow”?

Each part of the body is made up of cells.  Within each of these small units, traffic is directed down various metabolic pathways by enzymes called kinases.  These enzymes establish the functions of cells.  At the appropriate time they cause them to “grow, shrink, and die.”  Malignant tumors are often created when one of the kinases gets stuck in the pro-growth position.  The cells don’t die when they are supposed to, and the collection of abnormal cells gets bigger and spreads.

What if we could block the corrupting kinase without harming a cell’s other 90 or so kinases?  Could we cure cancer?  That was the dream.

Kinases have inlets on their outer surfaces.  When these are filled–plugged by a small molecule that “fits,” the cell dies.  Locating the bad kinase and plugging it with the appropriate small molecule, is a little like finding a needle in a haystack.  But that’s what the Swiss Geigy team lead by Alex Matter and Nick Lydon set out to do.  They started with a small molecule that they knew would selectively inactivate one and only one of the 90 or so kinases found in each cell.  Repeatedly altering the protein, they creeated new molecules and tested them one by one.  A few seemed promising.  Gradually they made dozens of blockers, each of which inhibited the activity of one and only one kind of kinase.  The project took years and must have been quite costly. Geigy funded the studies “reluctantly;” at the time Matter’s was told to keep investigating other approaches to cancer; the kinase program was supposed to be “very very small…hidden in plain sight. “

In the 1980s Lydon went to Boston in search of a cancer that might be susceptible to one of his kinase inhibitors.  He met Bryan Drucker, a physician who was studying chronic myelocytic leukemia.  For technical and legal reasons—lawyers for the drug company and the Dana Farber institute “could not find agreeable terms”–it took a few years before Drucker, then in Oregon, was able to obtain and test the kinase inhibitors.  When he did, he found a blocker that caused chronic myelocytic leukemia (CML) cells to die.

Most cases of Chronic Myelocytic Leukemia (CML) are caused by a genetic accident.  The tips of two chromosomes have “broken off”, switched location, and fused.  The resulting “hybrid” gene, called the Philadelphia chromosome, causes the abnormal cells to keep reproducing themselves. The defect had been elucidated and explained a decade earlier by a hematologist named Janet Rowley.

In the absence of a marrow transplant Chronic Myelocytic Leukemia (CML) was usually lethal.  If a person had an HLA identical sibling, and if they underwent a stem cell transplant, they subsequently had a 60-80% chance of surviving and being disease free five years out.  Without someone else’s’ bone marrow, half of the affected were dead in 3 years; less than one in 5 lasted 10.   http://www.bloodjournal.org/content/bloodjournal/82/3/691.full.pdf?sso-checked=true

But now a dream was being realized.  A small molecule could selectively inhibit an enzyme and control or cure cancer.  Turning the protein into a drug a human could use required proving its safety in animals, then people.  Several hundred million dollars needed to be spent before the company could market the medication.  And it would only help a few thousand people.

Novartis (the company created by the Ciba-Geigy—Sandoz merger) decided to give the chemical a shot, to see what it did to the cancer in question.  It proved to be amazingly effective.  Chronic myelocytic Leukemia wasn’t cured but it became a chronic disease, and an entirely new era of research was launched.

The first clinical trial of Imatinib mesylate (Gleevec), took place in 1998.  In 1991 the FDA approved the new medication and granted Novartis a 5 year monopoly.

Initially marketed for $26,000/year, its price was defended by the CEO of Novartis as being “high but fair”.  It then crept up by 10 to 20% each year.

When it first came out the company knew that CML patients who took a Gleevec pill each day were alive and well three years out.  But they worried because most cancers eventually become resistant to therapy.  And they were pleasantly surprised.  Gleevec and a slightly altered later iteration “changed the natural course of chronic myeloid leukemia (CML).  In 2015 a study of people who had taken the drug for 10 years found that 82% of them were alive and progression-free.”  Leukemia. 2015 May;29(5):1123-32.

Each year an additional group of people develop CML, and they, too, started taking a pill a day for the rest of their lives.  The cohort grew and by 2018 “an estimated 8,430 people in the United States” were living with the diagnosis.

initially (in 2001) costing $2200 a month, $26,400 a year, Gleevec’s annual price increases initially paralleled inflation.  In 2005 yearly boosts started exceeding inflation by 5 percent, and In 2009 they took off.  Gleevec’s annual cost was “$3,757 a month ($45,000 a year) in 2007,” passed $60,000 in 2010, and exceeded the $100,000 a year mark in 2013.  (Carolyn Y. Johnson, Washington Post; March 9, 2016. http://ascopubs.org/doi/full/10.1200/JOP.2016.019737 )

The company, no doubt, spent millions, maybe more than a billion dollars over the years bringing a great drug to market.  But even if the initial price reflected their research and development costs, it clearly had little bearing on the subsequent annual increase in the price point.  (Jessica Wapner: 2013 The Philadelphia Chromosome)

In 2015 Novartis sold $4.65 billion of the drug.) Between 2001 to 2011, sales of Gleevec world wide totaled $27.8 billion.  .  Its 2015 price in the U.K. was “$31,867, France paid $28,675 and Russia spent $8,370.”  https://www.theguardian.com/business/2015/sep/23/uk-cancer-patients-being-denied-drugs-due-to-inflated-prices-say-experts

In the U.S the 2014 annual list price for Medicare and American insurance companies was close to a $100,000.  Medicare is (by law) not allowed to negotiate.  Insurers and pharmacy benefit managers can bargain,; they sometimes obtain significant rebates and discounts.  However, more than half of a drug’s co-pay, the out-of-pocket money that comes directly from the person who need a medication,  “is based on the full list price.”   High list price do create a burden for many.   https://www.policymed.com/2017/05/new-analysis-shows-out-of-pocket-spending-based-on-list-price.html

India started allowing companies to patent drugs when the country joined the World Trade Organization.   That year, 2005, Novartis filed a Gleevec patent.  It was challenged.  “In order for a patent claim to be valid, it must propose a concept, idea, or item that is useful, novel, and non-obvious.”  India accused the company of evergreening,extending the life of the patent by making ever-so-slight adjustments to the compound, altering it just enough to warrant patent extensions without changing the underlying mechanism of the drug.”  The courts ruled the patent invalid on technical grounds.  Indian judges seem to be more in tune with the needs of their nation’s people than they are with the tricks used by the world’s wealthy to further enrich themselves.  https://smallbusiness.findlaw.com/intellectual-property/idea-must-be-useful-novel-or-non-obvious.html

Novartis researchers, looking for a molecule that was as effective as or better than Gleevec, modified the protein and tested some of their creations.  One of the new molecules, Niltotinib (Tasigna), did a better job at targeting the kinase in question.  It rescued some people whose disease no longer responded to Gleevec.  In new patients it more rapidly and effectively reversed the biochemical markers of chronic myelocytic leukemia. It was not better than Gleevec at halting disease progression–but it wasn’t worse.  In 2007 the FDA released Tasigna and Novartis started selling it.  A few years later a Canadian study showed that 5-6% of people treated with the new medication developed an arterial disease and had a heart attack, stroke, or some other “atherosclerosis-related disease.” And the FDA put a black box warning on the drug insert.  https://www.drug-injury.com/druginjurycom/2018/02/tasigna-atherosclerosis-peripheral-arterial-disease-ischemic-heart-cerebrovascular-events-adverse-drug-side-effects.html  https://www.nejm.org/doi/full/10.1056/NEJMoa0912614

The year Niltonib was approved it was costing people $6900 a month. (Median monthly payment). 7 years later, a month of medicine was costing $8806.  According to the watchdog web site FiercePharma, generic Gleevec was selling for as little as $40 to $50 a month in 2018.  That year Niltotinib was expected to revenues in excess of $2.5 billion.

Researchers for Bristol Myers Squibb created another drug that successfully controlled CML: Sprycel (dasatinib).  Like Niltonib it “produced a faster, deeper response” but didn’t make people live any longer.  When approved by the FDA it sold for $5477 a month.  In 2014 it’s monthly list price was $9300.

In the years following Gleevec’s release the culture around drug pricing evolved.  Repeatedly challenging the market—boosting their bottom line step by step– the Swiss corporation showed that prices could be raised significantly each year and no one in power was doing anything abut it.  Others followed their lead.

—————————–

Pharmaceuticals were never cheap. It always cost a lot of money to develop one of the century’s life altering drugs (or a me-too biosimilar) and get it to market.  The process is financially risky and the path to discovery is strewn with strike outs, slumps, and near misses.

When a company got a medicine to market they needed to make a profit.  That’s what businesses do.   And everyone wanted pharmaceutical companies to succeed.  We keep yearning for their next creation –the next great cure.

Congress passed laws and rules that motivated and helped Pharma.  And in the decades following the Second World War companies kept coming up with medications and pricing them in a responsible manner. Some entrepreneurs and leaders of industry got wealthy along the way, but most were not driven by money.  They wanted to make a difference.  When Roy Vagelos was head of Merck, the company “vowed to only increase prices in line with the Consumer Price Index, plus or minus one percent.  About half the industry followed suit.”  When some companies used loopholes in the drug laws to extend the patents of their successful drugs, Vagelos refused to join in.

Vagelos, a physician and academic lipid researcher, had become the company’s CEO in 1966.  Under his leadership Merck developed Lovastatin and Simvastatin, the first drugs that limited the body’s production of cholesterol.  The company then sponsored studies that proved that the drugs lowered the risk of heart attacks and death.

The company had started in Germany in the 1800s and opened its U.S. branch in 1891.  In its early days it made medicinal morphine and codeine, and it had been the birthplace of one of the first medical books for the masses, the Merck Manual.  While Vagelos was in charge one of the company’s labs developed a drug that killed a number of the worms that attacked cattle, sheep and horses.  Called Ivermectin it was marketed as a means of preventing heartworm in dogs, but it didn’t do much for hookworm or the parasites that attacked man.  Its commercial value was limited.  Further research on the chemical was suspended, and it was shelved until the day that Mohammed Aziz, a staff researcher, met with Vagelos and got permission to perform additional studies.  Aziz had been in Africa and had seen people infected with the filariae that caused river blindness.  100 million Africans were at risk for the condition and the parasite had blinded 18 million of them.  The invading worm existed in two forms: adults, which can be 6 to 15 inches long and exist as lumps under an infected person’s skin; and the filariae, a small organism that infiltrated the skin and caused intense itching.  The black fly that lived in the river spread the parasites from one person to the next.

People who had the problem were constantly scratching themselves.  When kids scraped their skin, then touched their lids, the microfilaria got into their eyes.  The subsequent eye inflammation, lead to scarring and blindness.  In some villages 25% of the inhabitants couldn’t see.  In an attempt to escape, many moved away from the river to less fertile ground and suffered from malnutrition.

Ivermectin, a Merck drug that had been one of the large pharmaceutical company’s financial failures, destroyed the filariae that attacked horses.  Aziz suggested it might have an effect on the creatures that blinded so many Africans.  Merck produced a quantity of pills, and Aziz went to Senegal to study their effect. Pinch biopsies of the skin of infected people showed huge numbers of the filariae.  Half of the people who were infected got a pill and the other half didn’t.  A month later a second biopsy showed the filariae had been eradicated from the people who had been treated.

Based on the positive results Merck spent years performing tests that proved Ivermectin was safe and effective.  Then they went to the African leaders and tried to sell it for a dollar a pill.  The government had no money.  OK, 50 cents a pill, a dime, the Merck representative said, but the government really didn’t have enough money.  The World Health Organization was spraying rivers with insecticides (though the black flies were already becoming resistant to the spray).  The WHO wasn’t interested. Officials in the U.S. State department and at the White House were excited but “the government was broke.”  (Ronald Reagan was president.)  The French were about to approve the drug. (There were cases in Paris that had originated in colonial Africa), but in the U.S. the FDA wasn’t interested.

Merck was in business to make money and to enrich its officers and stockholders.  But the drug was ready; these were the 1980s, and Roy Vagelos was a doctor as well as a business man.  The leadership at Merck decided they would provide the medication free of cost to anyone who would use it.  They had spent millions to develop the medication.  Providing it gratis would cost the company (and its shareholders) tens of millions of dollars, but Vagelos made the announcement and waited to see how the stockholders would react.  He claims he received a lot of positive feedback but he didn’t get one negative letter.  For years, thereafter, the best of the best researchers in the country wanted to come to and work for Merck.  And Vagelos stayed on as head of Merck for an additional 6 years.

When he reached the mandatory retirement age in 1994, Merck “was number one in sales, size, and marketing force”.  As a successor Vagelos recommended a number of Pharma savvy colleagues, but the world was changing.  The board chose a real business man—a non-scientist, Harvard MBA, and former CEO of a medical device company named Ray Gilmartin.    (The Merck Druggernaut)

In 2006 Novartis became the sole owner of Chiron.  “Novartis, the company that owned 42 percent of Chiron shares, paid $45 a share for the remaining 113 million shares”.  And the now Swiss corporation started acting like a real business. The company had been led by Bill Rutter, Chairman of Biochemistry at the University Of California Medical School in San Francisco.  His researchers discovered, sequenced and cloned the Hepatitis C virus and developed a genetically engineered vaccine for Hepatitis B.    https://www.sfgate.com/business/article/Novartis-to-buy-Chiron-Swiss-pharmaceutical-2598690.php

In 2017 Roy Vagelos, former CEO of Merck took part the great debate on the ethics of drug pricing and he wasn’t pleased with the way Pharma had changed.  He maintained that “The industry has a lousy image and it should, until it reforms itself”—and “He attributed Pharma’s failings to “a lack of understanding of what people respect, and a lack of respect for human beings.”  https://www8.gsb.columbia.edu/leadership/ethicsofpricing By Samantha Marshall  March 7, 2017.

Some think the astronomical increase in drug prices was the result of greed.  Others blame the trust that pharmaceutical companies built during the early post world war 2 decades.  The healthy didn’t seem to detect the dramatic rise in medication fees, and the ill were too demoralized to speak up.  Too few of the people in power seemed to be paying attention.  Unlike the frog that, if placed in boiling wate would have jumped out, the populace of the U.S., was plunked into cold water and we didn’t realize the liquid was slowly being brought to a boil.

I don’t believe the leaders of industry are to blame.  They just did what comes naturally.

During the early years of the pharmaceutical revolution, some  industry leaders were former doctors and researchers. Most were conscientious, and the public developed a hunger for more and more miracles.  Congress passed laws, and lobbyists for the industry fashioned loopholes that could be exploited.

Then companies became corporations with stockholders.  CEOs reported to boards of directors.  Pharmaceutical companies acted more and more like real businesses.  In house investigators with quirky innovate ideas and notions were reigned in.  Researchers were increasingly tasked to focus; to develop marketable products.

Drug pipelines were always a problem.  After a specified number of years best selling drugs would lose their exclusivity and generic competitive products would enter the market.  If the company didn’t have an emerging replacement, revenues and the price of the company’s stock would fall.

To maintain the bottom line industry leaders started raising prices.  “Dr. Vagelos traced the pricing problem back to the early 21st century when biotech firms first came out with targeted treatments for diseases that were otherwise deemed untreatable,”

The initial price increases must have pleased stockholders and boards of directors.  If industry leaders wanted to keep their jobs or get bonuses they had to raise prices the subsequent year, and the year after that.  If a CEO wasn’t willing to charge substantially more each year he or she could easily be replaced.

In addition there were loopholes in the laws rules that, if exploited, would give a company a few more years of exclusivity.  For a blockbuster drug that would mean at least an additional billion dollars of revenue per year.   Legal teams proved they were worth the big bucks when they took  advantage of these cracks in the system.  (If a football team is losing by a touchdown and its coach doesn’t try an onside kick or a Hail Mary pass during the last seconds of the game –he’s not trying to win, and he will be fired.)  Corporations were in the business of making money.  Failure of a corporate lawyer exploit the available legal gimmicks was akin to misconduct.

The increases started at companies with targeted treatments for cancer.  They “set the bar” that led to prices that “were many times more than most people’s yearly salaries, prices that were not necessarily related to value.”

The next few cancer fighting drugs were created and developed in the labs of pharmaceutical companies.  The skilled researchers had a general blue print, but their research involved a lot of trial and error.  The true costs, if they really matter, are a black hole.  But the market was established.  Competition based on price was not a serious option.  The cost of a successful drug was set at about $100,000 a year. 

The success of Imatinib-Gleevec showed researchers that it’s possible to develop small molecules that are highly specific to one of the hundreds of tyrosine kinase inhibitors…molecules that can inactivate a specific critical enzyme in chosen targeted cell.  There were a few known targets—so called low hanging fruit– and researchers in startups and in the labs of big Pharma started making thousands of molecules and testing them with their biologic assays.  Not that it was easy.  Developing a molecule that targeted a specific genetic alteration took time, luck, optimism, and money.

The two initial genetic alterations researchers around the world targeted were the ALK Fusion gene and EGFR:

The ALK fusion gene had been identified by Japanese researchers at the Division of Functional Genomics, Center for Molecular Medicine.  Jichi Medical University, Tochigi Japan.  The mutation is the cause of 5-7 percent of non small lung cancers.  The first tyrosine kinase inhibitor that targeted the gene was marketed by Pfizer.  It kept the cancer from progressing for an average of 4 months, but it didn’t make people live any longer.  Called crizotinib, (Xalkori) it was initially priced at $11,000 a month and its price didn’t rise much its first two years on the market.  But it was too much for the Canadians and Brits, and they decided it wasn’t cost effective.  (Do our politicians really want to negotiate with drug companies?  Can they take the political heat if government negotiators get tough and walk away from the table?)

The second tyrosine kinase inhibitor that targets this gene, alectinib was approved by the FDA in 2013.  Developed in Japan by Chugai (which is majority-owned by Roche) it “originated from the company’s screening program.”  It does, on average, make people with metastatic cancer live longer, and is often effective when criznotinib stops working.  It also crosses the blood brain barrier and can affect the growth of brain metastases.  Its current price is more than $13,000 a month.

The recently approved second generation Novartis ALK inhibitor ceritinib (Zykadia) was approved by the FDA in 2014, and, not surprisingly, costs $11,428 a month. ($8100 to $13,500 depending on dose.)

I have no reason to believe that pharmaceutical companies price fix.  But they all seem to know that charging less than $100,000 a year for a new cancer drug is foolish.  Politicians and the media have grown accustomed to the $100,000 plus a year price point.  Some may complain and wonder aloud how the price was set.  But in the end they must know.  New targeted cancer drugs always seem to cost about the same as the other similar drugs on the market.  And companies seem to choose a price that is the maximum they think they can (more or less hassle free) get away with. (The web says a month’s worth of alectinib costs $13,589.)

The other known cancer causing target…EGFR–(epidermal growth factor receptor) was discovered decades earlier and was known to cause uncontrolled cell division.  When it was found in some lung cancers, it too became a target for the right kinase inhibitor.

IRESSA™ (gefitinib), the first clinically available EGFR inhibitor, could slow the growth of lung cancer for months.  Developed in house by Astra Zeneca, it was the product of years of tedious expensive work.  It only helped 10% of afflicted Caucasians but 30 percent of Asians with lung cancer, especially non smokers, responded.   As a result Astra Zeneca did most of its marketing in Japan and China.  (The drug was available in 81 countries.)  By 2015 the medication was bringing in $500 million a year.  $23 million of the sales were in the U.S.  Chinese with lung cancer paid 7000 Yuan–11,430 a week for the medication.  After a decade the Chinese pharmaceutical company, Qilu, started making a generic version called Yiruike.

Cancer drugs outside the U.S. cost a lot and there are people, all over the world, who are willing to pay.  I suspect Astra Zeneca recovered its development cost..which must have been substantial.  I doubt that the drug made anyone rich.

Most of the targeted cancer drugs are made in the labs of big companies and we don’t know much about their research and development.  The Tarceva story provides a window.  An EGFR blocker, the medication was developed by OSI, a small pharmaceutical company located in Long Island, New York.  When Collen Goddard became its CEO in 1989, it employed 20 people and had a biology and a small molecule discovery group.  A Brit, its leader Goddard had previously been a researcher in Birmingham England and at the NCI (national cancer institute).

The startup was looking for a chemical that would modify EGFR.  They had a relationship with researchers at a nearby mega company, Pfizer, and people at OSI persuaded investigators at the big company to screen a number of their small molecules.  At the time Pfizer was evaluating molecules for a different cancer target: Her-2 neu, and they needed a “control.”  When they checked the compounds for OSI, Pfizer scientists identified Tarceva early on.   OSI subsequently kept the “lead rights” to the chemical and Pfizer had some ownership.

Pfizer agreed to give the drug to a few people with advanced cancer and see what happened.  They bailed when they learned the drug caused a rash.

About this time Pfizer was buying the company that owned Lipitor.  It was an expensive hostile takeover, and Pfizer gave their Tarceva ownership back to OSI—free.  (They later went on to acquire the company that owned Lipitor.)

OSI raised $440 million, ran clinical trials, and found out their drug, in fact, made some people with cancer live longer.

A few years back an athletic, non smoking friend had a nagging back ache that kept getting worse.  An MRI showed bony defects caused by metastatic lung cancer.  His brain was involved, and it was radiated.  The X-ray treatment caused terrible side effects–a month of no appetite or thirst.  When he recovered he knew he was not interested in conventional, toxic chemotherapy.  But he spoke of a dream– of sitting on a boat in the bay and fishing.  Would that be possible?  His tumor was positive for EGFR and he was given Tarceva.  His back pain improved, he got stronger, and he was able fish and enjoy life for about a year.  Then the tumors in his brain started growing. 

Genentech and Roche bought $35 million worth of OSI stock and commercialized Tarceva.

The internet says Tarceva costs Americans $2600 a month.  That’s more than the British National Health Service was willing to pay.  In 2007 the Swiss drug maker Roche negotiated and agreed to cut the U.K. price from $2766 a month to $2133 a month.  The Canadian online Northwest Pharmacy claims they get drugs from reputable factories in many parts of the world, then ship it directly to patients who mailed valid prescriptions.  Their price for brand name Tarceva 150 mg per month is $3174.  Their generic version goes for $1384 a month.  Approved by the FDA in 2004, it became a $94,000-a-year drug.  Genentech sold $564.2 million of Tarceva in 2011 and over a million dollars worth in 2016.  (An article in the LA times questioned its effectiveness) http://www.latimes.com/business/la-fi-fda-tarceva-approval-20170204-htmlstory.html

In India, in 2012, the Cipla pharmaceutical company produced a generic version of Tarceva, and lowered the price of the medicine from $459 dollars a month to $182 dollars a month.  The Delhi court ruled that the Swiss patent was valid, but that the generic product didn’t infringe. http://www.firstwordpharma.com/node/1031419?tsid=17#axzz4pCaI5OxA

http://www.medscape.com/viewarticle/830145 (peter Bach quote)

Some argue that pharmaceutical companies make the majority of their profit in the U.S; our high prices are subsidizing the rest of the world, and people in other countries aren’t paying enough.

Others contend that Pharma makes so much profit in America that they don’t have to bargain in good faith with other nations.  When a company has a new important drug and there’s no competition they can hang tough.  Negotiators can pay the asking price (with a small discount); or they can leave it.

 

THE 2019 SENATE HEARINGS

On Feb 26, 2019 the heads of 7 pharmaceutical manufacturers appeared before a congressional committee.  (The heads of Roche and Novartis—the Swiss—were notably absent.)   Senators were trying to learn why the cost of medicine was much higher in American than it was in any other advanced country.   At the end of her 5 minute interrogation Debbie Stabenow of Michigan seemed frustrated by the evasive non answers she was evoking, and she concluded that companies raise prices because they can. 

She was right and wrong.  I believe that drug prices are hoisted annually –given the system that congress created—because company CEO’s believe they have no choice.  They are accountable to stock holders; if the company is not profitable their jobs are in jeopardy.  Some drugs company researchers spend years developing, when tested, aren’t effective or are toxic.  Sometimes one of a company’s money makers is losing its exclusivity.  Generics are moving in. The other major players are charging more.  And when price increases stay below 10% and are some odd number, (like 6.9%), they didn’t seem arbitrary.  Most importantly, when pharmaceutical prices rise no one who matters seemed to care. 

Unlike many countries in the western world, America hasn’t instituted pharmaceutical price controls.  (Most advanced nations use a system called “reference pricing” to keep costs down.  They cluster medications that “have identical or similar therapeutic effects”.  Then the insurer pays the cost of the cheapest drug in each grouping (in some countries –like Italy), or the price of the average medicine in the collection (in Germany) https://www.nytimes.com/2015/10/20/upshot/to-reduce-the-cost-of-drugs-look-to-europe.html)

 Many of the CEOs that were in Washington that day seemed less than proud of their contribution to the price problem.  Some seemed anxious to lower prices and/or tie increases to inflation.  In return they wanted to stop giving discounts and rebates, or give them directly to the needy.  And if they were going to lower prices they wanted the other companies to follow suit.

Kenneth Frazier of Merck felt his company had a duty to be responsible in pricing practices and to contribute to solutions that address patient affordability.  He said that the previous year Merck had decided to not annually increase the net price of their portfolio by more than inflation.  And he pointed out that his company had deployed 70k doses of experimental Ebola vaccine in the Congo. 

Olivier Brandicourt, head of the French company Sanofi, said that two years earlier his company had pledged to keep price increases at or below the U.S. national health expenditure projected growth rate.  He talked about the gap between net and list prices.  Lantus, the company’s long acting insulin had seen a 30% decrease in net at a time when U.S. patients out of pocket costs had increased 60%.  He felt dealing with list price alone would not solve the problem of patient out of pocket costs.  

The new CEO of Pfizer apparently believed the group was not brought to Washington to provide certain senators with an opportunity to publically chastise big shots and show their voters they cared.  He thought the senators wanted suggestions.  His name was Albert Bourla and he was a Greek veterinarian who was a former director of Pfizer’s animal health group.  He stated he was “particularly humble to take part in such an important policy discussion within the U.S. Senate.  When he immigrated 18 years earlier he could never have imagined such an honor.”  And he told the senators–at the end of the session–that he had made it clear to investors: Pricing will not be a growth driver for the company now or in years to come.  (I wonder how long he will last.)

            Unlike the other CEOs he didn’t point out how many billions of dollars his company was spending on research, how they desperately wanted to discover and develop a new super drug for mankind—not for their bottom line.  And he didn’t talk about his company’s risks and failures.  His suggestions provide a decent summary of what everyone (aside from AbbVie) was saying.

Medical breakthroughs, he said, “won’t do anyone any good if patients can’t afford them, and unfortunately the horribly misaligned incentives within our health care system often makes medicines unaffordable for American patients.  We need to fix this.”  Pascal Soriot head of Astra-Zeneca stated “The government has to step up and change the rules.” 

Then—in part restating the thoughts of the other CEOs, Bourla presented four ideas. 

All rebates should go to patients.  (He implied the money was swallowed up by supply chain.)  His company paid $12 billion this year in rebates.  None found its way to patients.  If discounts were provided up front, seniors could save hundreds of dollars a year.

30 years ago congress passed a law that required drug manufacturers to “pay a rebate for all drugs dispensed to Medicaid beneficiaries.” In 1990 they added the “Medicaid “best price” rule—to help ensure Medicaid received the lowest price available for all prescription drugs.”  as part of the ACA, brand-name drug manufacturers are required to pay a rebate of at least 17.1%. “For brand-name drugs the ACA increased the minimum rebate amount from 15.1 percent to 23.1 percent.  The money is mostly “shared between states and the federal government based on states’ federal medical assistance percentage.  In 2016, Medicaid drug rebates totaled $31.2 billion.” https://www.americanactionforum.org/research/primer-the-medicaid-drug-rebate-program/ Tara O’Neill Hayes –Feb 7 2019).

Bourla repeated the longstanding dream of many in the health care field.  If a drug has less value it should cost less.  If a pill prevents heart attacks its price should be tied to the number of lives it saves.  Or—as Dr Peter Bach of Sloan Kettering pointed out — when Tarceva is used to treat lung cancer people live, on average, an extra year.  If it’s given to someone with pancreatic cancer their life is extended, on average, a week and a half.  The drug’s effectiveness varies but its cost doesn’t.   (So how would Bach and Bourla price penicillin, transfusions, or emergency heart stents?)

Bourla suggested capping seniors out of pocket medicines cost. Americans are increasingly paying a greater percentage of the cost of their medicines (14%) than they do for their time in the hospital (3%).  If someone doesn’t take a needed medication and as a result lands in the hospital, it’s more costly to the health care system.  (besides lids on drug costs will get some of the noisy voters off the backs of the companies and the legislators).

Finally Bourla touched on the problem that congress created and that only congress could fix.  Our laws are keeping Biosimilars off the American market.

Biosimilars are the generics of the day.  Half are mouse antibodies.  They come from special mice, creatures that were genetically altered.  When they were mere embryos some of their DNA was replaced with human DNA.  As a result when a protein—an antigen—is injected into one of the rodents, the creature makes antibodies that the homo sapiens immune system believes is human in origin.  When one of these “human-ish” antibodies is injected into a person our lymphocytes don’t destroy it.

Humira is a mouse antibody –it blocks—inactivates—one of the body’s important immune modulators—a molecule called TNF, tumor necrosis factor.  When TNF is blocked it’s like a jack knifed truck on the freeway.  The immune reaction is shut down.  To make a biosimilar to TNF trained researchers inject the molecule into a humanized mouse, harvest the antibody it produces, and test it..see if it’s safe and effective.  No two antibodies are, chemically speaking, exactly the same (they are not technically generics) But like Shakespeare’s rose, good biosimilars “would smell as sweet.”  They are as good as the original drug.   

In 2009 congress was sold a bill of goods.  They were told something like: we want to make it easier for biosimilars to enter the market.  We want to speed up the process.  So let’s make sure they work, that they are safe and effective.  But let’s not force them to go through extensive controlled trials.  Let’s speed up the process.  At the same time legislators were told we have to protect a company’s intellectual property.  We need to create some patent protections.     And our legislators took the bait and created a bizarre patent protection system that is virtually impossible to navigate.  Obama signed the bill.  And the die was cast. 

AbbVie used the patent protection process to keep four Humira biosimilars, competition, drugs that could have driven prices down, off the American market for 5 years.  (I contend that given the state of mind of most corporations, AbbVie leaders felt they were dealing with another widget and they had no choice.  The fruit was hanging and they picked it.)  The companies agreed that the four Humira biosimilars can be sold elsewhere in the world in 2018.  In the 9 billion dollar a year American market, thanks to our legislators, we’ll have to wait until September 2023.  

All drugs are “protected” by significant and insignificant patents. Pharmaceutical companies have long used insignificant patents –that their lawyers could allege were important–to keep generics off the market.  They repeatedly used a provision in the 1984 Hatch-Waxman act to delay the entry of competitors. And in 2010, in the guise of speeding biosimilars to the market, their lobbyists did it again. They shaped a new rule as an amendment to the Public Health Service act.  They titled it an innovation, and they slipped it into the affordable care act—Obama care.  And Ron Wyden, the senator who was most troubled when AbbVie used the loophole, voted for the bill.

As Bourla explained our law created “reverse incentives that favor higher cost biologics and are keeping biosimilars from reaching patients.  In many cases insurance companies decline to include lower price biosimilars in their formularies because they would risk losing rebates from covering higher cost medicines.”

Parenthetically Bourla suggested that the administration should obtain trade agreements that prevent foreigners from freely using American innovations.  He didn’t think Americans should pay less for drugs; he thought people in the other western countries should pay more.

 “The price control mechanisms of many nations are giving others a free ride on American innovations.”

Richard Gonzalez, the CEO of AbbVie was the target of Senator Wyden’s wrath; he did his best to avoid discussing the biosimilar elephant in the room.  He pointed out that since inception in 2013 his company had spent 50 billion dollars in research and had a hepatitis C drug that financially failed..that price was only a part of the problem and there’s no one solution.  That he would work with the committee and others.  That 81,000 patients got free drugs (for an unspecified period of time.)

 AbbVie, he explained, has 30,000 employees (and they need to eat). Senator Wyden, in turn, pointed out that Gonzalez’s salary was $22.6 million.  And he got a bonus of $4.3 million dollars.  Was, Wyden asked, the bonus was tied to the financial performance of Humira. Humira, it turns out, owns 126 Humira patents.  Most of them (I assume) have little nothing to do with the core drug.

           In September 2018 congress passed John Sarbanes’ Biosimilars Competition Act.  It is supposed to “shine a light” on backroom, “so-called “pay-for-delay” deals – often made in secret.  They must now be reported to the federal trade commission who, with the justice department, will review agreements, look for anti- trust and anti-competitive behavior and “punish bad actors.”  In other words if a company has a drug with an annual revenue of $20 billion and they keep other drugs off the market for 5 more years (and make an additional $50 billion in U.S. sales) they may be sued, and their lawyers may be forced to settle with the government, admit no wrong, and pay a fine of a few million dollars.  Great law.   

“By 2014” (according to a Harvard Public Health school intellectual-property consultant) “biologics were expected to account for half of all pharmaceutical sales.”  Their prices are often quite high.  The Biosimilars Act, signed into law by President Obama on March 23, 2010, gave biosimilars 12 years of marketplace exclusivity.  Standard medications were getting a 5 year monopoly.  At the end of those years (in the absence of legal gamesmanship) the first standard generic is allowed to compete. 

When a biologic drug’s 12 year reign ends, lawyers can do a lot of harm.  Before the new law was passed companies were able to legally block the first FDA approved generic for 6 months.  The 2010 legislations allowed the original owners of the medication to frustrate the manufacturers of the first biosimilar for up to 42 months. 

In summary: In 2010 our legislators erected an additional barrier to competition.  In the place of litigation “negotiation was encouraged”.  The bargaining rules (called a dance) are complex, Byzantine, and virtually incomprehensible.  And they allow the owner of the original drug to obtain an additional period of marketing exclusivity and royalties. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3008392/

In Humira’s case 4 companies were allowed to market their biosimilars in all countries of the world outside the U.S.  AbbVie keeps exclusive control of the American market.  That’s over $9 billion a year for 5 years.  And if congress doesn’t modify the rules we can expect high priced biologics for a long time.