Chapter 9. MEDICAL DEVICES

A friend awoke with chest pain and a cold sweat, and his daughter called 911.  The EKG in the ambulance showed evidence of an acute myocardial infarction.  Part of the heart muscle was dying. 

Developed in the early part of the 20^th century, the device the paramedics attached,the EKG, detects and records the flow of current as it travels along the heart’s “electrical” conduction fibers.  The up and down squiggles, the “wave”, has a distinctive pattern when a person is having a heart attack.  Like hieroglyphics on an ancient tomb, their meaning was baffling before Willem Einthoven learned how to interpret them.  A descendant of Spanish Jews who fled to Holland at the time of Spanish Inquisition, Willem was born in Java.  His father, a physician, died when Willem was 6 and a few years later his mother returned to the Netherlands. After college Willem went to medical school and he later became a professor of physiology at the University of Leiden, Holland’s oldest, a center of learning that was (according to local lore) created in 1575 by William of Orange for the town’s inhabitants after they were besieged by invading Spaniards and refused to surrender.  Married to a cousin and the father of 4 Willem was a gymnast and fencer.  He rode his bike to and from the university and often worked “until he was reminded to go home by his assistants upon request from his wife.”

After the computer in the ambulance interpreted the EKG, the paramedic radioed ahead, and the vehicle sped to a nearby hospital where a catheterization team was available 24 hours a day.  When they arrived the doctor and squad were ready to go. Within half an hour a mild sedative calmed the man’s brain and a cardiologist was advancing device one, a narrow rigid yet flexible tube he had been inserted through a groin artery. Under fluoroscopy the physician pushed and maneuvered the tip through the aorta– the body’s central blood vessel.  It quickly reached the coronary arteries– the vessels that drape over the surface of the heart and deliver oxygen to its muscles. The entrance to the coronary arteries is located in the aorta just beyond the point where it attaches to the heart.   

As we age, smoke and eat rich food, plaques develop on the inner wall of many of the arteries that supply oxygen and nutrition to our bodies.  These “barnacles” are full of inflammatory cells and fat.  When their fibrous cap ruptures the body tries keep the contents from escaping.  Platelets and clotting proteins pile onto the exposed gap.  If the reaction is large enough, like a jack knifed 18 wheeler, it can close down the highway– in this case obstruct the flow of blood.

Dye was injected into the coronary arteries and the occluded vessel was identified. Device one was removed and a second catheter, device two, was inserted and passed to and through the coronary artery occlusion.   This catheter had a strong balloon near its tip.  It was inflated, the narrowed area was forced open, and blood flowed and oxygenated the heart. A third device, a “stent”, a thin mesh hollow tube made of stainless steel and cobalt-chrome, was advanced to and through the vessel. Its outer surface was coated with a polymer that “carried” a drug that was slowly released.  The chemical helps preserve the stent’s patency. Blood now flowed through the tubing and the heart muscle was able to breathe again. 

A cousin dodged death.  Her surgeon had successfully clipped the bleeding brain aneurysm, the thin walled balloon like bulge in the wall of one of her arteries, but a few days later the cerebral spinal fluid that normally coats the outside of the brain wasn’t flowing.  Pressure was building in her head.  Her physician drilled a hole in her skull and inserted a thin tube into a liquid filled chamber in the center of the brain, the ventricle. He tunneled the other end of the tube under her skin and inserted it into her abdomen.  Spinal fluid poured out of the brain, and the force that was squeezing the brain decreased. 

The shunt, the small hose that relieved the pressure was created by an engineer in 1955.  He was the father of Casey, an infant who had hydrocephalus, too much fluid and pressure on the brain.  His doctors initially avoided the kid’s dad.  They didn’t want to deal with his reaction when they told him that his son was going to die.  John, the father, was 35, had been in Europe during the Second World War and was working in a hydraulics research laboratory.  When his only child was born with multiple congenital defects he watched as the infant underwent a number of operations.  Then his head started enlarging.  Liquid accumulated in the brain chamber, the pressure in the skull increased, and the doctors didn’t have a good way to treat it.  To decompress the situation, according to his troubled father, Casey was taken to “the torture chamber.”  A doctor would insert a needle through his fontanel, the area on the top of his head where the skull bones had not yet fused.  Using a syringe the M.D. withdrew fluid.  Doctors eventually talked to dad and explained that if they tried to fix the problem by inserting one end of a tube into the cerebral cavity, they would need to attach the other end to a vein.  Every time the child coughed or sneezed blood would flow up the tube, its hollow inside would fill with blood, and a clot would form. 

Holter pondered the problem.  He knew autos had pressure release valves. They used a ball that was displaced when the tension was high.  In people a similar approach would fail when the head was in certain positions.

Then Holter thought about the nipple on a baby bottle.  It only opened when the tension was high.  Then it closed.  Using it as a model he designed a pressure sensitive valve.  In place of a tip it had a “slit similar to the one on the nipple.  He hooked the valve to a rubber, later a plastic tube, and his device worked.  Unfortunately it lost its shape when the tubing was heat sterilized.  Then he learned that Dow made temperature resistant silicone tubing.  It didn’t take him long to sort out the details, and he created a pressure sensitive tube. 

In three weeks Holter solved a dilemma that had plagued doctors for more than a century and his invention “is still widely used.¹⁸” Before the doctors were able to put a device in Casey’s head the infant had a cardiac arrest that lasted 30 minutes and his brain was damaged.  With the shunt in place his very limited body survived five years.

At 96 a friend’s mother was clear minded and living alone when she fell and couldn’t get up.  Four hours later help arrived.  In the hospital physicians diagnosed and successfully treated sepsis caused by a urinary tract infection.  But when they examined her heart they heard a loud woosh of blood, a heart murmur.  A heart ultrasound revealed severe aortic stenosis.  The valve that swings open and closed when the heart contracts, the gate that allows blood to flow out of the heart and into the vessels of the body, had grown quite stiff.  Her days were numbered.  The valve could be surgically replaced, but she was old and frail.  Open heart surgery would be quite risky, but there now was another option.  A recently approved device, a replacement aortic valve could be inserted into a groin artery, slid up the aorta and through the old stiffened valve. Once in place it would, umbrella like, open and close each time the heart contracted. People in Europe had been using the device for 5 years.  At the end of that period of time the new valves were as successful as the surgically planted valves.  She opted for the new gadget and did well.

My wife’s cousin was in her 80s and lived on the second floor.  Her knees were arthritic and the pain of going up and down the stairs had become so intense that she seldom left home.  She had heard “horror stories” about knee joint replacement but dreading the thought of a nursing home, she bit the bullet.  Over the next year and a half each of her knee joints was replaced. The arthritic surface, the eroded area on the end of the bone, was sliced off and the raw area was “re-soled”.  The day after each operation she was able to walk.   Within months of the second procedure she felt normal, mobile, like she was ten years younger. 

The first really successful joint replacements were performed by a talented surgeon named Charnley.  A Brit with “febrile inventiveness and a powerful command of the English language” he helped care for the soldiers who were evacuated from Dunkirk, and spent most of the Second World War as a medical officer in Egypt.  When he was 46 and skiing in Austria, he met and married Jill the woman who became Lady Jill after Charnley was knighted.²⁰

In 1960, having established himself as an orthopedic innovator he turned an old T.B. hospital into a hip center.  A local medical equipment manufacturer, Thackeray’s, fashioned the “metal femoral stem and polyethylene cup (acetabular) component.” Charnley used acrylic bone cement as grout, not glue, and successfully produced a low friction prosthesis that when implanted allowed people with bad arthritis to walk without pain.  His achievement inspired a new approach to worn out joints.  According to Arthritis UK we’ve now gotten to a point where 80% of “cemented hips should last for 20 years” When or if they fail and a person is healthy enough to undergo repeat surgery, it’s usually successful. “The results are less good after each revision,but 80% of re-dos are good for 10 years.” 

While Charnley was developing his low friction hip, surgeons in various parts of the world tried to design workable knee replacements, and people with disabling pain were willing guinea pigs.  In 1969, feeling that he didn’t have a “reliable knee implant” New York orthopedist John Insall, “designed and developed 4 of the devices that are currently used.  A Brit, Insall was born in Bornemouth, a town on the U.K.’s south coast that boasts “seven miles of sandy beach and an exceptionally warm microclimate.”  He decided to go to medical school because too many members of his family were already in the military and police.  Turned down the first three times he applied, he graduated at the top of his medical school class, and worked for 2 years as a casualty medical officer.  Then he traveled to India to learn and work.  While there he wrote the hip transplant pioneer Charnley and asked for “an appointment as a House officer.”  ”Charnley wrote back “India needs doctors to treat fractures and tumors, not hip replacements.”  In 1963 war broke out between India and China and Insall left the country with eight dollars in his pocket.  He eventually became a hand surgeon at New York’s Hospital for Special Surgery (HSS).  Years later he met and played tennis with the engineer who helped him design the early knee prostheses.¹⁷ 

Currently over 700,000 American knees are restored annually.  Some think that by 2030, over three million Americans per year will get a new knee.  Four manufacturers make a majority of the implants.  Many of us have been saved from death, poor mobility, or disability at least once in our lives as a result of an amazing array of “devices”.²⁴

In 1895 a German researcher named Wilhelm Röntgen “noticed that when electric current was flowing through his Crook’s tube, a board on the wall that was covered with Phosphorus started to glow.”  He asked his wife, Anna Bertha, to place her hand in front of a photographic plate, activated the tube and visualized bones and a wedding ring.”²¹   An invisible wave had somehow passed through the walls of the sealed tube and through a human body.  He rechecked his findings a few times.  When he was convinced what he witnessed was real he announced his discovery to colleagues and the newspapers and it became a phenomenon.²⁶

He didn’t invent the sealed tube with the air sucked out of it.  Named for its creator it had been around for a few decades and was called the Crookes tube.  The wealthy British researcher who developed the device also happened to believe in the paranormal.  In his later life William Crookes tried to communicate with his dead wife through a medium and, along with Charles Dickens and Arthur Conan Doyle, Crookes was a member of the Ghost club.²⁷

In the years following the tube’s creation a few researchers had allegedly passed electricity through the airless device and had seen a weird glow, but they hadn’t discovered its significance.  Rontgen did and he became famous.  Not one of the creative geniuses of his day, Rontgen came from money so when he was expelled from a school in Holland for a boyhood prank he was able to go to get an education in Switzerland.  His wife was a waitress three years his senior who he met and fell for.  He was a good but not an amazing German researcher.  But he was the person who saw what other had seen, and wondered what was going on; and he made an important discovery.^1,25

Thanks to his invisible wave interventional radiologists are able to use a fluoroscope as a guide.  Slipping a needle through the outer wall of the abdomen or chest, they can jab it into the deep worrisome shadow that’s being biopsied. The beam, as we’ve learned has to be used sparingly.  Pulsing the x-ray lowers the radiation dose, and people who are exposed to the rays wear heavy lead aprons to protect themselves.  There is no absolutely safe dose of radiation.  When I was a medical student the head of radiology at Washington U was missing a few fingers.  They were damaged when he held people erect while taking x-ray pictures.

By the time I finished medical school x-ray films were taken from many angles.  Air (lung) was black.  Bone was white and tissue grey.  By altering the focus of our tube we could get a sharp view of various depths of a body.  As computing became faster and programs became increasingly sophisticated, algorithms were added.  Now, using advanced devices physicians can get deep detailed views of sections of the body, head and limbs. We can use x-ray beams (CAT scans) or strong magnets (MRI).  And we can visualize much with medical Radar, ultrasound machines.

In the last 70 or so years devices that allow interventional physicians to thread a catheter into a leg artery and advance its tip to the vessels of the brain, heart and abdomen have been created and modified. If the main abdominal artery, the aorta, is significantly bulging or enlarging, it can be replaced surgically, or it can be splinted by a device, a synthetic expandable stent graft that is inserted through a leg artery and becomes the aorta’s inner wall.“In 2003, the interventional approach passed open aortic surgery as the most common technique for repair of abdominal aortic aneurysm, and in 2010, the procedure accounted for 78% of the repairs of all U.S. aneurysms that had not already ruptured.¹³

The arteries of the brain are currently accessible.  Experts have learned how to thread hollow catheters through one of the four large arteries that supply blood to the region.  Two carotid arteries run on each side of the front of the neck.  Two “vertebral” arteries course through openings in the vertebrae of the spine. The vessels communicate and deliver blood to a ring of arteries on the underside of the brain.  An aneurysm, a weakness in the wall of an artery that becomes a bulge, isn’t that uncommon.  One in 50 of us will develop one.  Some say 1% others up to 3% will eventually rupture.  Half of the people whose aneurysms start bleeding die before they get to a hospital.  The other half stop leaking blood but the flow of can start again within a few days.  Surgically clipping a “ruptured” aneurysm is risky but it’s often necessary.  And a rupture can be prevented by filling the ballooned area with clotted blood.  Interventional radiologists have become proficient at inserting devices–small platinum coils, into aneurysmal defects. They detach, remain in the ballooned area, and a thrombus forms and fills the bulge.  The device that made it possible to disengage the wire was developed by an Italian neurosurgeon named Guido Gugliemi. Born and trained in Rome, Guido was the son of a physician and originally planned to be an electronic engineer.  In medical school he was drawn to the brain’s wiring.  He saw an area that “constituted of millions of relays and millions of wires that transmit electricity and are connected to one another.” As a neurosurgeon he witnessed and treated ruptured aneurysms.  Brain surgery was difficult and bloody. The engineer in him thought there must a way to use the interventional approach and induce a clot to form.  He wanted to insert magnets and use electricity, and a friend thought his idea might work. Guido got financing and moved to Los Angeles with his wife and children.  He checked out his approach and it didn’t pan out.  Deciding to stay in L.A., he used his knowledge of soldering and electricity to develop a detachable wire.  Turning the concept into a useable product required countless nights in the lab tweeking and testing his gadget.  He eventually was able to predictably insert and detach the coil.  His invention is currently used in 90 percent of the brain aneurysms that doctors treat.  Most of the aneurysms wouldn’t have ruptured and in some hospitals the device is probably over used.  After ten years in southern California Guido and family moved back to Rome.

In 1958 Earl Bakken Bakken created the first wearable battery-powered cardiac pacemaker.  He did it by modifying a circuit for a transistorized metronome, a gadget used by musicians to keep the beat.  He got the plans from a magazine called Popular Electronics.  The device was developed after a local heart surgeon named C. Walton Lillehei spoke with Bakken and asked him if it was possible.

The heart is a muscular cavity whose contraction is controlled by the special cells in the sino-atrial node.  One or more times a second they emit a quantum of energy.  The current flows down the main conduction fibers of the heart, reaches all the muscular filaments, and they shorten in unison.  After the cells have released their energy, sodium, potassium and calcium seep in and out and recharge the node. The power can’t be stored, so when the heart’s pacemaker is fully energized it discharges.  When our hearts don’t beat like they are supposed to, there are currently wide arrays of battery powered devices that take over and emit periodic mini jolts.  They are implanted on the heart’s outer surface or slipped into one of the upper heart chambers then attached onto the inner lining.  

 As a teenager Bakken was the “nerd who took care of the high school public address system, the movie projector, and other electrical equipment.”  After serving in the army signal corps during the Second World War, he married a medical technologist.  While courting her he hung out at the hospital and met doctors and others.  He repaired their broken devices and realized that hospitals need people to keep their medical equipment working.  He set up a shop in his garage and that’s where he made a wearable pacemaker that was the size of a few decks of cards.

          When he turned the first pacemaker over to the doctors they inserted it into the heart of an animal with heart block.   Dr Lillihei saw the gadget was working, removed it from the animal and planted it in a child whose ventricular septal defect  had just been sewn shut. 

The congenital opening between the two largest chambers of the heart, the ventriculo septal defect, is the heart’s most common congenital abnormality.  Doctor Lillihei, working at the Mayo Clinic started learning how to patch the gap in 1954 and by 1958 he had performed the operation a number of times.  While sewing in a patch, a suture can easily capture the electrical fiber that runs along the border of the heart defect.  When a surgeon ties the knot, the main fiber is constricted and the electrical energy can’t flow. Hearts stop beating or contract very slowly and children die.   .

It would be an understatement to say pacemakers have, over the last 60 years, become a big business.  There are multiple manufacturers in the U.S. Europe and Asia.  Over 200,000 devices are planted annually.  In the U.S. Cardiologists spend a lot of time, inserting them, checking battery life, replacing batteries if indicated, and remotely “interrogating” the devices and seeing how often and how well they worked. 

There’s also a pacemaker that’s inserted into the body of the occasional person who has recurrent ventricular fibrillation and survives.  The rhythmic catastrophe is usually seen when someone has an acute myocardial infarction or has a disease of the heart muscle, a cardiomyopathy.  Fibrils of the heart quiver and fail to beat in unison, the heart muscle doesn’t contract, blood stops flowing and a person drops dead.  .  

The arrhythmia can be treated with a sudden jolt of electricity.  The current brings all muscular activity to a screeching halt.  Fibrils of muscle rest for a second or two.  When they next shorten they tend to do so in unison and the heart starts pumping blood.  If a heart is shocked within the four minutes after it started fibrillating the brain isn’t usually damaged, and people have an excellent chance of surviving and continuing to be fully functioning individuals.

There are defibrillators in airports and many shopping centers.  They’re not pricey, and they are easy to operate.  But many are afraid to use them.  U.C. Berkeley put one near a volley ball court.  It’s in a locked case where no one can get to it if someone drops.  Hard to figure what they were thinking.

In the absence of a defibrillator we commonly resort to plan B and give CPR.  Our efforts push some blood through the system, but not nearly enough. 

My hospital required I retake a class in CPR every 2 years.  The last time I took the course the teacher said people who develop a lethal rhythm need to be shocked early.  If the jolt is delivered within a minute, 90% of people survive (presumably without noticeable brain damage).  After 2 minutes 75% survive and at 4 minutes only 55%.  

There are defibrillators up and down the halls of Chicago’s O’Hare Airport.  A survey performed shortly after they were installed found the gadgets had already been used 14 times, and 9 of those shocked came back to life. 

When someone witnesses a sudden death, confirms the heart isn’t beating, and has access to an AED –automated external defibrillator, they merely need to open the case and listen.

An automated recorded voice tells them what to do next: 

“Attach the electrode pads. 

Don’t touch the patient. 

Analyzing.  Shock advised. 

Charging.  Stand clear. 

Push the flashing button to deliver shock.  Stand clear.”

Most people who check out one of the brief You Tube videos on AED’s, automated external defibrillators, realize how simple their operation has become.  If they’ve seen episodes of the T.V shows like “ER” they’ve witnessed the drill a few times.  Which doesn’t mean it’s not frightening to perform the task on a live person. 

The devices that shock hearts have become more common but they aren’t ubiquitous and are only noticed by people who are tuned in.  A survey in a Netherlands train station (per a project manager from Kings County Washington) found that half the people questioned “couldn’t identify an AED”, and less than half of them wouldn’t consider using one of the devices. 

After 40 years 300,000 people are still dropping and dying each year and the survival rate to hospital discharge is 8.4%. 

Some people with damaged hearts have repeated episodes of Ventricular fibrillation.  Muscle cells periodically stop working as a group and their heart stops beating. A few wear pacemakers that shock the heart when it starts fibrillating.  Richard Cheney the former Vice President of the U.S. was one of those people.  He had the first of his five myocardial infarctions when he was 37 years old.  Unpopular in many circles, Cheney feared terrorists might try to assassinate him by remotely instructing his defibrillator to shock him, so he asked his doctor to replace his defibrillator with one that wasn’t remotely accessible.²²   When he was in his 60s his heart started failing, it didn’t propel enough blood with each contraction.  Doctors inserted one end of a tube into his left ventricle and the other end of the aorta.  Blood was pumped through it by a small electrical motor.  It helped for a while.  At age 71 Cheney received a heart transplant and did well.

When I was in medical school we were taught that most colon cancers originated near the lower end of the bowel and could be detected by a probing finger or by passing a well lit, metal, foot long, hollow sigmoidoscope through the anus.  Decades later doctors used snake like scopes with lenses connected to fiber optic bundles.  (The eyes of a fly are made up of thousands of individual visual receptors. They work together to create an image.)  Doctors learned how to guide the instruments around corners, view the entire large intestine, and biopsy or remove growths or tissue as needed. By the year 2000 our endoscopes had an optic chip near the tip and doctors monitored their progress on a T.V. screen.  The devices could be totally immersed in chemicals that killed any virus or bacteria that hadn’t been removed with vigorous washing.  Sedating drugs controlled the discomfort of the exam. 

In 1998 the 42 year old husband of a famous T.V. personality Katy Couric died of colon cancer.  She became a spokesperson for early detection of cancer by periodically screening the colons of people without symptoms, and colonoscopy became big business.  Gastroenterologists became skilled, could usually pass the scope to the far end of a colon in 5 to 10 minutes.  I typically performed  five or more procedures in a half day. A similar chip based scope allowed us to see the stomach and duodenum, treat bleeding vessels, and biopsy worrisome abnormalities.

The small intestine, the 9 to 30 foot long stretch of bowel between the stomach and the colon absorbs food and fluids and is essential to life.  It can be partially visualized with a scope, but passing the instrument is difficult and tedious. There’s a “capsule” that allows us to view the bowel another way.  It’s produced by a high tech company headquartered in a once sleepy Israeli town in the Jezreel valley, a village where, in the 1970s, immigrants from Yemen sold pita filled with falafel in the sun filled town square.  The small bowel device and its function are best understood by comparing it to an I-phone.  The phone can snap a picture and send it by text or Email to another I-phone half way around the world.  The Israeli company uses a camera and similar technology, packaged in a capsule.  The “pill” also contains a flash so it can take photos in the dark.  There’s a “transmitter and batteries that last 8 hours. “ 

A person with a potential small bowel problem swallows the gadget. As it passes through the stomach and lengthy small intestine it snaps two photos a second.  It can’t store the images, so it instantly transmits them wirelessly –like a text photo—to a receiver, worn on a belt by the patient who swallowed the pill. At the end of the exam the capsule is passed in the stool.  The storage disc is then plugged into a computer and a program turns the thousands of snapshots into a video that can be viewed and interpreted by a knowledgeable physician or technician.¹⁴

A medical “device”, according to the FDA, is something used to help “diagnose, treat, mitigate, or cure a human or animal disease or condition.  The category includes everything from instruments and apparatuses– to machines or implants.  Chemicals that don’t have to be metabolized to work are devices. Before they are sold in the U.S. “devices” must be registered, listed, and correctly labeled.   Production has to be performed “in accordance with good manufacturing practices.” If something goes wrong, if there is an adverse event, the FDA must be notified.³

Each year “over 4000 new, low-risk (class I) devices are marketed”.  They don’t need to be approved, but recalls and problems need to be reported to the agency. 

At the same time High riskdevices go through an extensive authorization process.  Annually 50 to 80 of them are approved by the FDA.

Most of the other 3500 devices that are “permitted” each year are minor modifications of an existing product. In terms of safety and effectiveness they are “substantially equivalent” to the currently used item.  The verification process they go through, called 501k, is not particularly stringent. Only 8 percent need “special controls and clinical data.”  “Bench testing “is sometimes adequate, and some gadget-tool-appliances have to be checked out “under conditions of clinical usage. “ When lasers for “cutting or ablation” of tissue replaced heated wire cautery, they were approved by the 501k process.

The substantially equivalent requirement has periodically been misapplied. On occasion a manufacturer obtained FDA clearance without revealing the actual use of the device.  At other times the FDA and manufacturer misjudged. The new product didn’t seem that different–but it was, and it should have been extensively tested before it was widely used.  In hindsight that probably was the scenario when the metal on metal hip prosthesis was approved.

For years surgeons had replaced painful arthritic hips by inserting a metal stem into the femur.  The socket in the pelvis was covered by a “plastic (polyethylene.)” insert.  It made sense to many that if both articulating surfaces were metal the joint would last longer and work better.  The manufacturer and FDA apparently decided that making the socket metal, not polyethylene, was a minor change—that the modified prosthesis was actually “substantially equivalent.¹⁶” It was not necessary to test people. Cobalt and chromium alloy prostheses received FDA clearance in July 2008 without a clinical study.  They were then implanted in 100,000 patients. Over time the metal on the articular connecting surface of the bone tended to erode.  Sometimes particles “migrated into the surrounding tissues and the bloodstream.   21% of the alloy prostheses had to be replaced or revised within 4 years and 49% within 6 years.”⁴ 

Also approved by the 501k process, transvaginal mesh was used when surgeons operated on pelvic organs that prolapsed, slipped down and were protruding into the vagina.    No clinical trials were conducted at the time, and sixty-one products were marketed between 1985 and 1996. Made of a type of plastic called polypropylene, their lattice corralled parts of the intestine or a bladder.   Over the years the mesh caused a number of complications “including pain, adhesions, bowel obstructions, and infections.” In January of 2016 the FDA issued a high risk warning, and in April 2019 the agency told manufacturers to stop selling the material.⁵

Manufacturers and clinical facilities have to report device-related deaths and serious injuries to the FDA.  In 2002 the agency received 2500 reports from clinical facilities and 3500 from consumers.

“Over 1000 devices are recalled each year.”  Half have low risk drawbacks.  Most of the rest are intermediate risk.  And 10 to 20 of the problems are serious.  Recalls require manufacturers halt production and dissemination of the devices, and they must alert clinicians.  Post recall doctors and nurses are supposed to keep an eye and ear out for difficulties with “Heart valves, joint prostheses, implants, cardioverters, defibrillators, respirators, infusion pumps, hemodialysis equipment, cutting and coagulation equipment, endoscopes, etc.”⁶

The FDA, via a new precertification program is working with industry to try to find a way to evaluate the effectiveness and safety of software as a device.”⁹ “81% of North American adults own a smart phone, and many companies are trying to use technology to monitor health and help manage certain chronic diseases.” Some devices can detect the heart rate; others the number of steps a person takes during a day. 

In 2020 a corona virus that modern man’s immune system had never previously encountered jumped from a bat to a man.  It often made people very ill and was extremely contagious.  At times it caused an infectious process that filled the lungs with fluid and made oxygenation impossible.  Many were saved by respirators that mechanically ventilated lungs for days to weeks.  But in hard hit areas like Italy and New York there weren’t enough ventilators for everyone who needed them.  The president, the press, and politicians of the time regularly attacked and blamed one another every time there was a mishap or an unheeded warning. 

The nation was caught shorthanded even though government officials had anticipated a potential need for the devices and had ordered many a few years earlier.  By April 20^th few had arrived.  The dearth of respirators was big news and people wanted to know who screwed up.

The blood that flows into the heart from the body enters through the right upper chamber, the atrium and progresses to the pumping chamber, the right ventricle. The ventricle pumps the blood into the lung.  The human lung is a collection of about 500 million tiny air chambers called alveoli.  A cubic millimeter of lung tissue contains about 170 of them. They are surrounded by thread like vessels, capillaries.  Erythrocytes, red blood cells stream through them. The cells deliver their carbon dioxide to the alveoli and collect oxygen. 

Air is sucked into the lungs when a vacuum is created by breathing– expanding our chest and lowering our diaphragms.  Earlier in the 20^th century when the muscles of a child with polio were so weak that the person couldn’t inhale, he or she was placed in a long sealed tube.  Their head hung out of the top. Multiple times a minute the machine created a vacuum and air was sucked into a person’s lungs. 

During the Second World War the military needed a device that forced air into the lungs.  Driving oxygen into the circulation allowed pilots to fly at high altitudes.  The devices were developed by Dr. V. Ray Bennett and Dr. Forrest Bird.  After the war each went on to develop forced air ventilators. One of the inventors, Forrest Bird, had a father who flew combat planes during the First World War and had taught his young son how to fly a plane. 

Positive pressure ventilators were commonly used in the 1950s for people with severe pneumonia who couldn’t move air into their lungs.  Over the subsequent 60 plus years Bird, Bennet, and others modified and improved the devices.  

Shortly after the 2003 SARS respiratory epidemic the department of Homeland Security decided to stockpile an additional 70,000 respirators.  They might be required in a moderate influenza pandemic. Before the government ordered the machines a panel of experts decided which bells, whistles and capabilities the respirators would need.  The machines on the market were costing $10,000 a unit and the group, presumably, thought they were overpriced.  They decided new respirators should not cost more than $3,000 each.  In 2008, the government asked companies to bid on the project.  As developer and supplier they chose Newport Medical Instruments, a small outfit in Costa Mesa, California, a company that was “small and nimble.” After the deal was inked the government gave Newport $6 million to develop the machines and said they would pay the rest when the devices were delivered.  Reading between the lines it sounds like the people at Newport knew they would lose money on the deal. “but would be able to make up for any losses by selling the ventilators around the world.”  

Research started and every three months, government officials visited Newport’s headquarters.  “There were monthly scheduled requirements and deliverables.”

In 2011, 3 prototypes were sent to Washington and the company planned to “file for market approval and start producing the machines in the fall of 2013.  Then the company was sold.  Established 45 years earlier by physicians, Newport Medical was Japanese owned.  Covidien, a company that was formed when Tyco “spun off” its health care division, purchased Newport for a little over $100 million.  Then Covidien wanted the government to provide additional funding and a higher sales price. The government said OK.  The U.S. gave Covidien an additional $1.4 million. The next year Covidien decided they wanted out the contract.  The deal “was not sufficiently profitable”   The government agreed and awarded a new contract for $13.8 million to the giant Dutch company Phillips.   In July 2019 the F.D.A. signed off on the new Philips ventilator, the Trilogy Evo. The government ordered 10,000 units in December, setting a delivery date in mid-2020.  In January 2020 a major coronavirus epidemic started spreading out of China.

On March 31, 2020 a Pennsylvania subsidiary of Phillips was producing the cheap portable ventilators but they didn’t deliver them to the U.S.  They sold them to other countries.  Called Trilogy Evo the ventilators were priced at $3,280 each. the company is currently negotiating with a White House team for43,000 additional ventilators.  In March 2020, invoking the defense production act, President Trump told General Motors to make the ventilators.

In 2017 the top 10 device makers had over $170 billion dollars in revenue and the top 30 took in more than $270 billion. Devices are responsible for roughly 6% of U.S. health care spending or about $200 million a year.¹⁰ 

Like pharmaceuticals –MRI machines, vascular catheters, endoscopes etc. are very expensive.  Little is known about how companies and hospitals negotiate.  A friend who purchased equipment for a chain talked about the days after the hospitals he worked for merged with another hospital group. He visited one newly acquired facility at a time and met with the local doctors.  They had attitudes and beliefs about which scopes, artificial joints, heart valves, etc. were easier to use, more effective, and more durable.  Some cared about the brand of material used to sew wounds shut. Since many surgeons could choose where they admitted their patients, where they performed their procedures, the hospitals needed their business.  At times my friend had to buy a brand of equipment that wasn’t perceivably better and was more expensive. 

Given our current system I think an attempt to regulate the cost of medical devices doesn’t make sense.  In Europe, on the other hand, medicine is commonly state run.  Administrators have a greater say and can more effectively use price as a bargaining factor.  Not surprisingly European nations pay less for medical devices than we do in the U.S.

To even out the costs and to help make health care affordable to all, Congress, as part of the Affordable Care Act (Obamacare), enacted a 2.3 percent medical devise tax.  It was briefly collected then put on hold, and recently was repealed. .   

The world’s largest device maker, Medtronic, the Minnesota Company with revenues of about $30 billion a year, spent a decade acquiring and integrating 20 smaller companies.  Then, in 2015, the American corporation purchased a company headquartered in Ireland called Covidien. As discussed earlier it was a 2007 spin off of Tyco.

After the merger was consummated Medtronic moved its official headquarters to Ireland.  According to The Street: Medtronic’s 49.9 billion acquisition of Dublin-based Covidien, the largest tax inversion deal ever — was going to leave shareholders with a big tax bill, while allowing the Minnesota-based company to pay little or no U.S. corporate taxes.

“It is not inconceivable that [Medtronic] may not be taxed at all.” on its U.S. operations, said Robert Willens, tax consultant and professor at Columbia University.¹¹

In 2018 Medtronic, now an Irish company, had net earnings of 3.104 billion,  Half the money came from sales to physicians and hospitals in the U.S. “Medtronic’s total revenues grew from $28.8 billion in fiscal 2016 to $30.6 billion in fiscal 2019.¹⁵ “

Chapter 10 SURGERY

55 Years ago, as an intern, I slept in a hospital provided room and worked most days.  Meals were free and I was paid $55 every 2 weeks.  When rotating through surgery I rolled out of bed between 5 and 6 A.M. and accompanied the cowboys of the hospital, the general surgeons, as they made in-patient rounds.  We ate breakfast and washed hands for 10 minutes by the clock.  Mornings were spent tugging on a retractor, stretching open the edges of the wound while a gall bladder was being removed.

Long skin incisions were usually needed when the surgeon was operating on someone who presented to the emergency room with severe pain and rigid abdominal muscles, or when merely touching the belly made the patient withdraw.  Sometimes we wondered if the appendix had ruptured?  Was blood pouring into the abdomen of a person who had been shot or stabbed?  Why did the X-Ray show air filling the abdomen?  Did an ulcer perforate?

The lengthy slash through the skin and the fat layer was followed by a pause to buzz (electrically cauterize) or tie off the severed ends of bleeding arterioles.  A series of additional gashes cut a path through layers of fat and muscle.  A scissors sliced open the peritoneum, the membrane that surrounds the organs.  The opening had to be large enough for the surgeons to see what they were doing and to get their tools and hands inside.  Sliding a large light over the opening, an assistant would aim the beam down the long, dark tunnel.  The smaller the gap, the more precise the ray had to be.  Deep inside tissue was cut, clamped, and sewn by skilled people using long handled tools.  Adhesions, fibrous tissue caused by prior operations, created matted intestines and made it hard to identify various organs, blood vessels, or nerves.  By slipping a hand into the cavity and palpating the edges of the liver, pancreas and other organs— by feeling for masses or abnormalities, the surgeon “explored the abdomen”.  Aware of “the possibility and consequences of failure,” the surgeons needed to be able to improvise when they had a complication or encountered something out of the ordinary.  The people doing the cutting had spent many of their waking hours practicing basic techniques like sewing and tying knots, and they were adept.  When I was a junior medical student one of my buddies bragged that the resident let him remove the patient’s appendix.  It made no sense at the time, and it still doesn’t.¹⁷

Man has long known how to “suture lacerations, amputate limbs, and drain pus.”   Prior to 1858 the people who cut and sawed learned their craft as apprentices.  When gangrenous or damaged limbs had to be amputated, resections were quick, bloody, and accompanied by loud shrieks. The fastest knife in England was wielded by Scottish surgeon Robert Liston. “Operating with a knife gripped between his teeth,” he could amputate a leg in two minutes. On one occasion he inadvertently cut off the fingers of someone holding a person down.  The stump end of the man’s fingers and the raw end of the hip got infected and both men died.

Elective surgery was uncommon.  Perforations or obstructions of the intestine were not approached.  In the U.S. and Europe, medical school learning was “wholly didactic: seven or eight hours of lectures a day, supplemented by textbook reading. Laboratory work was sparse, and there was no opportunity to work with patients.²⁸”

In the 1800s some surgical procedures were carried out in homes.  Doctors at a few prestigious hospitals performed operations on a stage that was surrounded by a semicircle of tiered seats. Observers apparently came to watch and perhaps be “thrilled by spectacular public performances.²⁴”

In the mid 19^th century we learned about and started using anesthesia to prevent pain.  Surgeons could now enter the abdomen or thorax, but they didn’t know what to do when they got there.  Operating rooms became “quiet and to the observer seemed tedious.” A number of new operations were developed and there were risks, failures, and deaths. Apprentices learned the techniques of one practicing surgeon, then struck out on their own. There were no blood banks or antibiotics.  It’s not clear how often the adage see one, do one, teach one was more than a tall story.^{25, 26}

In 1890, William Halsted, the son of a wealthy “tight-fisted, hard- nosed Presbyterian” started the nation’s first surgical residency program at Johns Hopkins University in Baltimore Maryland.  “Self trained, as were all U.S. surgeons of the day, he spent 1 year as an intern at Bellevue, 1 year as a house physician at New York Hospital, and then 2 years abroad as an observer.” While in Germany, Austria, and Switzerland, he saw how other countries trained young surgeons, and he realized the U.S. system was ineffective.  There was no mechanism for developing and passing knowledge on to other doctors.  Halsted developed the nation’s first residency program at Johns Hopkins Medical School. ³⁰

For many years Halsted trained many of the nation’s future teachers and professors.  The doctors on his service created and modified operations, and they taught one another. 11 of his 17 chief residents started training programs in hospitals in other parts of the country. 

A “bold aggressive surgeon” when young, Halsted was addicted to morphine and heroin when he came to Hopkins.  His operations were performed “almost excruciatingly slowly and meticulously.”  On one occasion he must have been under the influence because he stopped operating and asked an assistant to scoot over.  The man had been standing on his foot for the pervious half hour.”  Outwardly shy, Halsted was adamant about cleanliness, bleeding control and carefully reconstructing tissue.  He had quirks like shipping “dozens of his dress shirts to Paris or London every year for laundering.  His wife was only allowed to burn white oak and hickory in his fireplace.” In his operating room surgeons and nurses wore rubber gloves not to prevent infections but because one of the scrub nurses developed a rash when she immersed her hands in mercuric chloride.          

Dubbed the nation’s father of neurosurgery, Harvey Cushing, was born into status and privilege.  His father, grandfather, and great grandfather were all prominent Cleveland surgeons.  He was a descendent of the Puritans who landed in Boston 18 years after the Mayflower, and he was a descendent of the nation’s 4^th ever Supreme Court justice.  At Yale he was a gymnast and would somersault backwards with a lighted cigarette in his mouth.”   After medical school his money and influence allowed him tour Europe and meet and observe the world’s most prominent surgeons.  In 1913, after spending 4 years as one of Halsted’s surgical residents he moved to Boston.  When Harvard’s Peter Brent Brigham opened its doors in 1914 he was the hospital’s first chief of surgery and the founder of the country’s second surgical training program.

During the First World War Cushing performed surgery on soldiers with severe head wounds.  Up to 8 times a day he removed a part of the bone from the skull and exposed the brain.  Later at Harvard he learned and taught many others how to operate on brain tumors.  A talented surgeon, Cushing had removed 2000 brain tumors by the time he retired. His mortality rate was half that of his colleagues.

Described as “a man of ambition, boundless, driving energy, and a fanatical work ethic,” he also had “a penchant for self-promotion and ruthlessness.”  He insulted his residents and operating-room nurses for their errors and tended to blame others for his mistakes. Outside the hospital he paid little attention to his family and had no patience for women.  When “his oldest son, 22 year old William was killed in a traffic accident Cushing received the news in a telephone call in the morning, informed his wife, and continued to the hospital to perform his scheduled surgery.¹⁸ 

Two decades later in St Louis Missouri, Evarts Graham removed a lung that contained cancer and his patient survived.  Graham went on to become one of the giants of his era. 

Deciding at a young age that he would follow his father’s path and become a doctor, Graham went to Princeton, then Chicago’s Rush Medical school.  His father David, a professor of surgery at a women’s college and a hospital chief of staff, was well connected.  David presumably learned how to operate as an apprentice and he was not (according to his son) “by any means a polished or trained surgeon.”  I suspect he didn’t wear a mask when he operated because his son tells of how, prior to performing surgery, David Graham washed his hands then “washed his beard in antiseptic solution.” 

Evarts, ever ambitious, became the president of his class, performed 50 autopsies while in school, and wrote a number of journal articles.  In 1907 when most graduates “left school and became general practitioners,” he spent five months as a surgical intern.  He assisted his father, “occasionally performed operations under his dad’s supervision,” and at the end of his internship believed he was qualified. 

Joining a group of physicians in Mason City Iowa a town of 22,000, he was appalled when he learned that surgeons paid colleagues a portion of their fee for referring the patient.  Surgeons, he believed, should not be chosen on the basis of how much they pay the referring doctor.  Becoming embroiled in a campaign to end “fee splitting,” he was considered an upstart by some colleagues, and was the brunt of “personal attacks.” When the U.S. entered the First World War in 1917 he volunteered for the army and left town. 

Unable to become a battlefront surgeon because his vision was “defective”, he became an assistant Surgeon General.  Young and inexperienced, he was sent to Alabama and given orders to take charge of the local military hospital.  When he presented his papers to the facility’s medical commander, the doctor refused to step down.  He “didn’t give a damn about Graham’s orders” and called Graham a fly-by night major.  Evarts fought back, tried to label the Colonel a German sympathizer, and got the Surgeon General involved.  The hospital eventually became Graham’s, but the facility wasn’t sent to Europe until November 1918, the month the war ended.  Graham was in charge during the 1917 and 1918 influenza pandemic.  It devastated the world and killed more soldiers than the enemy fire had. 

While in the military, Graham studied empyema, pus that developed in the space just outside the lungs but inside the thorax, in some people who had pneumonia.  The smelly material had to be removed but “open drainage resulted in a high immediate mortality rate.”³² Graham was part of a group that figured out the safest time to draw off the fluid.  In civilian life the infected liquid was usually a result of pneumococcal pneumonia.  It typically appeared after the infection was improving, at a time when the lung was partially attached to the chest wall by scar tissue. Drainage was safe. 

In people with battlefield wounds the pneumonia was often caused by streptococcus.  The fluid appeared early, was massive and thin “like pea soup.”  Adhesions would not form for a few weeks   When a large amount of fluid was drained too early the mediastinum, the structure that encased the heart, often shifted dramatically and the good lung collapsed.  Many died.³⁵

After the war ended, based on recommendations from doctors in Chicago, Graham was chosen to be the professor of surgery at Washington University in St. Louis, a school that was growing and reorganizing.  In the early 1900s the university had been rated as “a little better than the worst”.  After the world war it received funding from Rockefeller and Robert Brookings, a St Louis millionaire who grew rich selling wooden spoons and bowls.  The school was hiring and paying full time professors.  No longer needing a private practice on the side, doctors were salaried and could devote all their time to teaching and research.  The concept was new, but Graham embraced it, his department developed surgical subspecialties, and the school flourished. After he successfully removed a cancerous lung Graham operated on two more cancer patients.  Both died.  Then 5 in a row survived.

An avid smoker Graham “openly scolded colleagues for suggesting that cigarettes caused lung cancer. “Yes, there is a parallel between the sale of cigarettes and the incidence of cancer of the lung, but there is also a parallel between the sale of nylon stockings and the incidence of lung cancer.” Shortly before he died of lung cancer in 1957 Graham publically conceded cigarettes were responsible for his malignancy.  In 1965 his successor Thomas Burford, a heavy smoker who operated on countless smokers with lung cancer told a Senate committee that he did not believe cancer was caused by cigarettes.  His death was in part due to emphysema caused by his heavy smoking²² 

In the early 20^th century surgeons increasingly learned how to remove tonsils, appendices, gallbladders, and cancers.  Other skills and techniques were acquired while caring for the wounded in First World War.  As the century wore on operating rooms became cash cows for many hospitals. 

In 1961, during my third year in medical school I spent a week with a physician in a small town an hour drive from St. Louis.   The doctor was a friend of the family and had removed my tonsils when I was 6.  Like most general practitioners of the day he cared for common injuries, delivered babies, and performed a few operations.  People who needed complex interventions were sent to an experienced surgeon in St. Louis.  For standard operations like hernias and diseased gall bladders a surgeon came from the big city once a week and operated in the local hospital.  The visiting surgeon earned a bit of money and taught the local docs who assisted him.  They scrubbed in and learned how and when to cut into an abdomen.  They needed to know because some problems couldn’t wait.  On occasion a patient’s condition was such that he or she might not survive if their operation was delayed for the few hours it took to travel to St. Louis and find an available surgical crew and operating room suite.   

Prior to the 1950s, with a few documented exceptions, the inside of the heart and major blood vessels were off limits. 

One of the “exceptions” occurred when bullets and shrapnel entered a soldier’s heart during battle.  During the Second World War, Dwight Harken, a battlefield surgeon wrote his wife about a time he used a clamp to grasp a piece of metal deep in a heart’s ventricle.  He felt the pressure force the fragment to jump out.  It was sudden and like uncorking a bottle of champagne.  “Blood poured out in a torrent.”  Harken sewed the opening in the muscle closed and the patient survived.  He later removed bullets and shrapnel from 56 wounds “in or in relation to the heart.” 

Son of a physician who made house calls on horseback and a former prize fighter, Harken was harsh, energetic, and aggressive.  He became a Harvard professor and at one point decided to fix “rusty” mitral valves.  That’s the gate that opens and closes when blood flows from the atrium (the collecting chamber) to the ventricle (the muscular compartment that forces blood out.) The valve can become calcified and stiff.  Harken thought he could pry the area open with a finger or cut it open with a blade that he inserted through an incision in the atrium.  In 1948 he operated on 10 patients.  In the process he sometimes loosened a blood clot, it traveled to the person’s brain, and they had a massive stroke.  Six of his first ten patients died.  Harken kept at it and 14 of the next 15 patients survived¹⁹.   

The other notable “heart exception” took place in the major vessels just beyond the heart.   The fetus receives oxygen rich blood from the placenta and shunts most of it around the lung.  .  A surgical resident named Richard Gross learned how to seal a detour between the upper aorta and the pulmonary artery that generally closes by the time a newborn is 6 weeks old.  When the ductus (we still call it by its Latin name) remains “patent” it puts pressure on the right side of the heart and the baby has problems. 

In 1938 Gross was a chief resident at Boston Children’s Hospital and he learned how to close the defect in dogs.  He wanted to try his technique on a child, but his chief of service “forbade” human surgery.  Gross waited till the chief was on vacation.  Then he operated on a 7 year old girl.  The anesthesia nurse who helped him “was scared to death.” The operation had been tried at another hospital and the child had died.  Gross’ patient did well, but the chief of service was “furious.” “Some accounts say Gross was fired.”  Years later when the chief retired Gross succeeded him. 

The son of a German immigrant, Gross was blind in one eye.  He had a congenital cataract.  To compensate for his lack of depth perception his father encouraged him to take clocks apart and put them back together.  The exercise helped him develop depth perception and motor skills and it “instilled a love for tinkering.”  A cardiac innovator he once said “an academic surgeon has to pull a new rabbit out of a hat every few years.²⁰”

In 1950 president Harry Truman called heart disease “our most challenging medical problem” and federal funding started flowing.   In 1947 the NIH was spending $4 million a year and by 1950 $46 million.  A number of medical schools wanted some of that money and recruited and hired talented physicians who were ambitious and wanted to make a difference. Two of the major programs were located 90 miles apart in Minnesota.

The major defects that were tackled early were openings between the heart’s receiving chambers, the right and left atria or between the heart’s pumping chambers, the right and left ventricles.  They couldn’t be sewn or patched shut because a surgeon couldn’t see what he or she was doing when the heart was beating and full of blood.  When the “defects” stayed open blood was pushed from the left to right side with each heart beat.  The left heart muscle is more powerful than the right.  Over time the atria or ventricle on right side gets would get full, then stuffed and stretched. 

By the time cardiac surgeons started tackling the problem started John Gibbon had spent 15 years trying to build a machine that could keep the body alive when the heart chambers were empty.  To work, his pump had to be filled with a lot of blood.  It was hard to sterilize and would periodically break down.  In 1935 using his machine Gibbon kept a cat whose heart wasn’t beating alive for 20 minutes.  That made the papers.  In the 1950s he was introduced to Tom Watson, head of IBM, and Watson asked one of his engineers to help Gibbon.  Three years later the Gibbon machine kept a young woman alive long enough for Gibbon, a surgeon, to sew shut a hole between the upper chambers of her heart.  His efforts and limited success showed that much could be done if surgeons had a good heart lung machine. 

The descendent of a long line of doctors Gibbon was the 6^th physician in the chain.  As a sophomore he wanted to quit medicine and become a writer, but his father talked him out of it and convinced him to use his writing urge to promote medical research. Graduating from medical school in 1927, he was an intern when a young woman who broke her leg developed a blood clot that traveled to her lungs and killed her. He thought he could have saved her life if he had a machine that bypassed the lungs, a “heart lung machine.”  In the 1930s as a Harvard research fellow, he tried to construct such an apparatus.  Harvard gave him a small grant.  The chief of surgery, who thought the project was nonsense, gave Gibbon lab space. 

A surgeon by day, Gibbon spent his evenings “in the little room in the cellar of the Massachusetts General Hospital.”  A nurse helped him.  They were together every night, and they eventually married⁹” and moved to Philadelphia.  The machine Gibbon developed was a conglomeration of a filter from here and a pump from Michael DeBakey, a future vascular surgeon.  DeBakey’s device, designed when he was a medical student, was based on the irrigation pump developed by the Sicilian Archimedes in the 2^nd century B.C. 

When the Second World War ended Gibbon became a medical school professor in Philadelphia.  After he successfully sewed an interatrial septal defect closed in 1953, Gibbon operated on 5 kids with holes in their hearts.   They all did and Gibbon “led a movement to have Congress ban or have a moratorium on heart lung surgery for an indefinite time.  It didn’t succeed.

By the early 1950s surgeons at the Mayo Clinic and 90 miles away at the University of

Minnesota started operating on kids with congenital heart defects.  Each group used a different heart lung machine and each center suffered through the tragic deaths of a number of children. 

 The University of Minnesota group was led by Walt Lillehei, a bright talented suburban kid whose father was a doctor.  During the Second World War Lillehei accompanied the troops that landed on the Italian coast, 35 miles south west of Rome.  The Germans allowed them to come ashore then mercilessly bombarded them for four months.  Seven thousand Americans and Brits were killed and 80,000 were wounded, missing, or hospitalized.  Lillehei “saw the horrors of modern warfare” and it may have had an effect on the way he emotionally dealt with death.

In 1945 he became one of the young surgeons at the University of Minnesota.   Wangensteen, the chief of surgery at the time, was the son of an immigrant farmer.  He had a photographic memory and was the best student in each class, but he didn’t want to be a doctor.  Then his father exposed him to the harsh reality of farming.  The summer before he was scheduled to enter medical school Wangensteen spent his days hauling manure.  At the end of the summer he decided “anything would be better than this.” When fall rolled around and classes began Owen was a medical student and excelled.  

The Mayo Clinic attempt to fix heart defects was led by a young surgeon named John Kirklin.  He graduated from Harvard Medical School In 1942 and was stationed in Missouri during the Second World War.  Before returning to Minnesota Kirklin visited Gibbon, and he brought a Gibbon heart lung machine and/or its specs with him to Minnesota.  He then convinced a few engineers to help him improve it. In 1955, after 9 of 10 dogs survived the machine, Kirklin used the heart lung bypass and operated on 8 kids with congenital heart problems. 4 died and Kirklin learned what he was doing wrong. By the end of the year Kirklin had sewn closed holes between the upper chambers of the heart in 29 additional kids without another death.

            Fixing the gap between the two ventricles proved to be risky. The wiring that stimulates the pumping chambers sits on the edge of the opening between the right and left pumping chambers. When the wiring is inadvertently tied off, the heart slows and sometimes stops beating. 

The Lillehei heart lung machine didn’t always supply enough oxygen and early on  surgeons got extra oxygen rich blood by connecting the arteries and veins of the patient with those of a parent.  That put two individuals in harm’s way.  Thomas Starzl was present during one of those operations and “witnessed a tragedy.”  A parent veins were pumped full of air when a pressurized bottle ran out of fluid and no one noticed.  Her heart stopped, she was resuscitated, and she had permanent brain injury.  Ultimately she died.”  After a few cases Lillehei stopped using cross circulation.  16 of the kids he operated on had ventricular septal defects and over half survived²³. 

In the early 1950s the heart-lung pump wasn’t very good and Bill Bigelow, a Canadian Surgeon told the world about hypothermia.  Bigelow began pondering the effect of cold on a body after he cut the fingers off a man who developed frost bite, then gangrene.  He, of course, knew that some animals hibernate and survive “cold dark winters by turning down their metabolism.” One day he awoke with the thought that maybe hypothermia could be used to “decrease the body’s need for oxygen and thus allow surgeons to operate on a heart.”  Working in a basement room in Toronto he learned how to control a dog’s shivering and lowered the animal’s body temperature to 68 degrees Fahrenheit. After waiting 15 minutes he warmed the animal.  It was unharmed.  He presented his findings at a medical meeting and John Lewis, a Minnesota cardiac surgeon was inspired.^33,34.

Working with dogs Lewis learned how to safely cool the animal and clamp the vessels that supplied blood to the heart.  In 1952 he slowly lowered the temperature of a 5 year old girl who had a hole between the atria of her heart.  When it fell below 86 degrees Fahrenheit Lewis blocked blood flow to and from the organ, opened the atria, and sewed the defect shut within 5 minutes.  During the next 3 years he repeated the operation in 60 more people²¹. 

In the spring of 1958 Dr. Albert Starr was running the only heart surgery team in Oregon, and was mainly performing surgery on kids with congenital defects.  He was “up to his eyeballs” in clinical work when a 60 year old engineer with a “background in hydraulics” Miles Edwards, arranged a meeting.  They talked about an artificial heart and decided to “start” improving the heart one valve at a time.  It took two years before they were able to implant an artificial gate that opens to let blood through, then closes to prevent it from pouring back in the chamber that ejected it.  The valve was handmade and acrylic.  Later valves were made of stainless steel, and still later a non corrosive material¹⁰.    By 2018, 182,000 metal and tissue heart valves were being replaced each year in the U.S.¹¹

Periodically a technique or technology shook things up and made surgery easier or better.  Doctors slowly adjusted, and the new gradually became the norm.

In 1984 Eddie Joe Reddick, the doctor who made surgeons alter their approach, moved to Nashville.  He came “in part because he loved the music.” The grandson of an Arkansas soy bean farmer, Reddick went to medical school, was drafted, and while in the army became a trained surgeon.  As a military doc, he used a long hollow tube with a light on its end, a laparoscope, to help a colleague locate and biopsy a liver.  He learned how to manipulate the instrument.  After he was discharged, he moved to Music City and wrote country music.  (His song, “I’m Listening to Hank” made it to number 70 on the country music billboard.)

As the new guy in Nashville he struggled financially for a while, and made a little money assisting gynecologists perform laparoscopic procedures.  Early scopes that allowed us to see areas deep in the abdomen were rigid metal tubes with tiny bulbs on the end.  Gynecologists could introduce a laparoscope, and insert grasping or sewing instruments through the scope or through adjacent tiny incisions.  They would watch through a magnifying lens as they tied fallopian tubes shut, biopsied suspicious growths, checked out ovarian cysts, or tore through adhesions. In the early 1960s, older models were gradually replaced by instruments that used quartz light rods.  A few decades later, video chips on their tips allowed surgeons and their assistants to see what was happening by studying TV monitors.  

In 1988 Reddick met a Georgia surgeon named McKernan at a medical meeting, and he was intrigued by his fellow doctor’s plan to remove a gall bladder using the laparoscope.  A few months later, McKernan found a willing patient and would have become the first American to remove a gall bladder through a tiny hole, but the stone in the “bile bag” was big, and McKernan had to make an incision to get it out.  Two days later, this time in Nashville, Reddick used a laparoscope. Assisted by a scrub nurse he excised a diseased gall bladder and pulled it out through the tiny hole.  He cut through tissue with a laser, and didn’t use a needle and thread to tie off the cystic duct and artery.  He clamped them shut with a homemade clip.  The patient recovered and went home in short order. 

People obsessed with detail are quick to point out that the two southern doctors were not the first to remove a gall bladder laparoscopically.  A surgeon in Germany named Muhe removed one in 1985.  His patient died post–operatively and there was a subsequent legal hassle.  Two Frenchmen removed gall bladders by this technique in 1988, but their colleagues apparently didn’t think it was a big deal, and they temporarily ended their venture. 

Reddick’s patients by and large got well quickly, and his complication rate was low.  He had the touch, the knack, the hidden quality that makes some surgeons really good.  But he didn’t come from a big medical school, wasn’t a professor, and I suspect he was looked down on by the men who gave lectures and wrote books.  Reddick published his results and wrote about the successes of McKernan and a doctor named Saye.  At a medical meeting the following September, he gave a talk and played a three-minute video of a gall bladder being removed laparoscopically.  In subsequent months, surgeons were invited to his O.R. to watch and assist.  A few came.  Some of the surgeons at his hospital were nervous and “urged that he not be allowed to perform the procedure,” but the hospital review board gave him the green light. 

Someone alerted the media.  The Wall Street Journal wrote an article about the medical maverick, and ABC World News ran a story that was seen by millions.  At a subsequent surgical meeting, a few instrument companies ran tapes of his surgeries in their booths, and crowds of doctors gathered around.  Then Reddick and Saye opened a training center in Nashville for doctors who had long since completed their formal training.¹

As skills grew and people recovered from their operations relatively quickly, surgeons increasingly removed stone–filled gall bladders that may or may not have been causing problems.  Within a few years, twice, then four times as many of the muscular sacs were excised annually.  Over the subsequent 20 years, surgeons learned to perform a slew of additional operations laparoscopically.  Inflamed appendices were removed, hernias were plugged from the inside, and cancer containing portions of colon were resected.  Renamed minimally invasive surgery, the approach was used to treat heartburn that was caused by the reflux of stomach juices and hadn’t responded to pills.  It was long known that the problem could be controlled by wrapping the upper stomach around the esophagus, but a surgeon had to get his or her hand into the narrow space under the rib cage.  Access was difficult, and the spleen (which was often in the way) was sometimes damaged.  The laparoscope made the procedure safer.  The minimally invasive approach was also used to turn many a large stomach into a receptacle the size of a shot glass, and to thus help obese people lose weight. 

Chest surgeons increasingly used scopes inside the thoracic cavity to identify and biopsy abnormalities, to remove parts of a lung or pleura, and to perform a number of procedures on the esophagus, the swallowing tube that runs through the back of the chest.  Problems that used to require a long incision and spreading of ribs could often be solved with VATS, –video–assisted thoracic surgery. 

Using a similar rigid scope and a camera, orthopedists entered knee joints without damaging the surrounding muscles and ligaments.  They repaired torn internal ligaments and injured cushions (menisci).  Some used the approach to mend torn shoulder rotator cuffs and to patch tears in the cartilage that lines the rim of the shoulder joint—the labrum.

Back surgeons call surgery performed through a small incision using a scope with a camera on it–minimally invasive surgery.  They are sometimes able to employ the technique to remove herniated discs and fuse vertebrae.  A few years back I had sciatica.  The pain was in the left leg and was caused by pressure on the nerve that traversed the space between my 4^th and fifth lumbar vertebrae.  The MRI showed a cyst was causing the problem.  A back surgeon inserted a scope, removed the cyst, the pain disappeared, and I went home. 

Ear, nose, and throat surgeons who wanted to visualize and remove head and neck tumors had approached growths with incisions made in the chin or neck.  Over time, they learned to put a thin video endoscope through the mouth and advance it until they saw the enemy.  Jaws were only “cracked” when a tumor had invaded.  Called “small field” surgery, the approach allowed experts to destroy tissue and control bleeding with cautery or the beam of a laser.  After a growth was removed, the remaining tissue was biopsied and pathologists could tell if cancer cells were left behind.  Less blood was lost, and vocal cord function was preserved.

Fiber optic and later video endoscopes and colonoscopies were used by gastroenterologists.  They allowed ENT doctors to better evaluate vocal cord paralysis and other benign laryngeal problems.  Plugged sinuses could be opened and debris sucked out.

Neurosurgeons used scopes to remove pituitary tumors.  The gland they tackled is normally the size of a grape; it hangs below the brain in a “bony hollow in the base of the skull.” Some of the organ’s small tumors produce hormones that cause harm in dramatic and weird ways.  Before a local neurosurgeon entered a patient’s skull, my ENT colleague would “shove” his scope through the nose and breech the wall between the adjacent sinus cavity and the brain.  The abnormal pituitary growth usually looked like the top of an ice cream cone.  A neurosurgeon would take over and remove all or part of the gland piecemeal.   

A company called Di Vinci developed flexible small internal robotic hands whose actions could be monitored through a three–dimensional viewer.  Surgeons maneuvered the appendages remotely, using external, space age, knob-dial–fingers.  Those who mastered the approach claimed their resections were more precise.  The technique required a person to visualize tissue a little differently, and there was a learning curve. 

Medicine, like industry, has innovators who can mentally visualize the “possible” and find a way to make it happen.  In 1964 Michael DeBakey a Houston doctor used a vein from a person’s leg to create a tube that bypassed a narrowing in one of the coronary arteries.  The vein allowed blood from the aorta to circumvent the diseased vessel.  He didn’t report it to the medical community until 1973, when he could prove the graft had remained patent.⁹“

“You learn on animals.  We did hundreds of bypasses on dogs and were 50% successful.  The first coronary bypass was an accident.  The patient was scheduled for an endarterectomy, separating the plaque (the deposit of cholesterol and fiber) from the inner lining of a diseased vessel.  We’d been doing the operation since 1964.  The nature of the first patient’s coronary artery blockage was such that we couldn’t separate the plaque.  His coronary arteries were so bad that we couldn’t get him off the table (and expect him to survive.)  So we did what we had been doing in dogs.  It was the first heart bypass. Fortunately it worked.  You have to take risks.  The first carotid endarterectomy was done on a man with recurrent episodes of temporary paralysis —TIA’s.  The carotid artery supplies blood to the brain and his artery had plaques.  He was a bus driver.  Surgery stopped his TIA’S. He lived for 19 years and died of a heart attack.  The first aneurysm of the aorta in the chest was causing pain.  We knew how to fix aneurysms in the abdomen and the man was hurting so he took the risk and agreed to surgery.¹³”

DeBakey virtually created vascular surgery.  The son of Lebanese immigrants and a combat surgeon during the Second World War, he “convinced the surgeon general to form what would become the mobile army surgical hospital MASH unit.”  Later, as a Baylor University surgeon, he revolutionized our approach to narrowed blood vessels.  “In 1953, he performed the first successful carotid endarterectomy;” (he cleaned out one of the arteries that supplied blood to the brain.) 

As a youth he liked working with his hands. He and his brother took apart car engines and reassembled them. His mother taught him to knit and sew and “By the age of ten he could cut his own shirts from patterns and assemble them.¹⁴”

He later used his boyhood skills to create a vascular graft from Dacron.   As he said in an interview: “When I went down to the department store … she said, ‘we are fresh out of nylon, but we do have a new material called Dacron.’ I felt it, and it looked good to me. So I bought a yard of it. … I took this yard of Dacron cloth, I cut two sheets the width I wanted, sewed the edges on each side, and made a tube out of it. .. . We put the graft on a stent, wrapped nylon thread around it, pushed it together, and baked it. … After about two or three years of laboratory work (and performing experiments in dogs), I decided that it was time to put the graft in a human being. I did not have a committee to approve it. … In 1954, I put the first one in during an abdominal aortic aneurysm. That first patient lived, I think, for 13 years and never had any trouble.²”  

Years later as a medical student at Baylor, TV doc Gabe Mirkin recalled that Debakey liked to visit the patients he had recently operated on at 5 AM.^{16  “}He often was accompanied by an entourage of more than 50 people composed of medical students, surgeons-in-training and some of the most famous surgeons from all over the world. Mirkin “saw first-hand his incredible drive for perfection. As medical students, we would often study at the medical school through much of the night, and I saw the light at his office stay on as he wrote papers often beyond 3:00 in the morning.”²⁷ 

Three years after his first wife died, the 67 year old surgeon met and married an attractive 33 year old German woman “who dabbled in acting and painting.”  When the pastor performing the ceremony asked if Debakey preferred to sit during the ceremony his bride said “he stands for hours for his operations.  He’ll stand for this.”  Debakey performed over 60,000 operations in his lifetime and became a surgeon to the stars.  His patients included the Duke of Windsor and the Shah of Iran. 

The transplantion of one person’s organs into the bodies of another is a story of surgery, immunosuppression, and delivery of care.  It’s in the game changer chapter.

Many of the tasks of general surgeons are now performed by interventional radiologists.  Over the last half–century our ability to see structures within the body increased dramatically.  X-ray doctors who call themselves “Interventionalists” use the fluoroscope and drain pockets of fluid, biopsy shadows that look like tumors, pass catheters through blood vessels, and perform complicated procedures that halt or prevent blood loss. 

Some interventionists perform TIPPS in people with cirrhosis and stretched out esophageal veins that bleed.  The livers of these individuals are scarred; blood from the intestines can’t flow into or through them, and the vessels that carry blood around the organ enlarge and can leak or rupture.  To decompress the situation, trained radiologists create a tunnel through the liver. 

Cataracts, cloudy eye lenses, are now removed and replaced with artificial implants in 6 to 14 minutes—then people go home.

Knees are resurfaced; hips are replaced- and people with the new joints walk out of the hospital the same day.

Video scopes allow gastroenterologists to screen colons and stomachs, to biopsy or remove abnormalities, control gi bleeding, remove bile duct stones, remove foreign bodies—and much more.

Our approach to combat injuries has changed.  In a recent war, surgical teams—surgeons, nurses, and medics, traveled in Humvees directly behind the troops.  When a soldier was wounded they would “focus on damage control, stop bleeding from the liver with sterile packs, staple perforated bowels, and wash out dirty wounds.”  Since blast injuries can cause bleeding from multiple locations, they would cut the abdomen open, pack areas at risk, and cover the area with saran wrap. When the surgeons had done their best–and always within two hours–the injured were flown by helicopter to a hospital less than an hour from the zone of combat.⁴

Worldwide “about 234 million operations performed annually.⁵

 ”44,000 and 98,000 patients die each year in the United States as a result of preventable medical errors. “Adverse events in surgery account for between one-half and two-thirds of all such events in hospitals and half are potentially preventable.”⁸

In 2007 Atul Gawande, a Harvard surgeon, wrote an article that promoted the use of checklists before during and after surgery.  He pointed out that even surgeons who are super-specialists sometimes neglect small details.   The idea of a directory of procedural steps had previously been developed by the aircraft industry, as a result of crashes that were caused by a minor oversight. ⁶ 

In 2008, the World Health Organization (WHO) published a 19-item checklist intended to be globally applicable, and hospital operating rooms became even more compulsive.  Are antibiotics or blood available?  Did we mark the breast or limb that we’re going to operate on? 

Between 2007 and 2008 the WHO checklist was used in 3733 surgeries in 8 hospitals in Canada, New Zealand, the U.S., England, India, Jordan and the Phillipines. The death rate fell from 1.5% to 0.8%, and inpatient complications decreased from 11 to 7 percent.⁷ The checklists, however, did not make a detectable difference in hospitals in Ontario Canada. They are increasingly being required by governments in certain U.S. states and in various countries, and they were mandated by the U.K. National Patient Safety Agency in 2009.⁸

A medical educator interviewed by Atul Gawande asserted the innately exceptional surgeon, the doctor who, as a trainee, can figuratively “see one, do one, and teach one” is pretty rare. For the vast majority competence is not the result of a God given skill.  It’s the result of diligence and by young doctors who keep practicing difficult tasks.    

And (Gawande again) “while the best possible care is more important than teaching novices, everyone is harmed if no one is trained.”  Not surprisingly in “teaching” hospitals, the poorest, the uninsured, and the demented” are disproportionally the responsibility of surgical trainees. That’s how it always was and still is.

CHAPTER 11  CHILDBIRTH

I was in the delivery room for his final performance–the last time an obstetrician named Bill Masters, a doctor who would go on to become a world famous sex specialist, helped a child slide through a woman’s birth canal.  I don’t remember the baby’s sex or weight or its mother’s glee.  But I remember Masters presenting the newborn to its mom with the flourish of a circus maestro, and I recall my fellow med student fainting. His wife was pregnant.

As a junior in medical school I spent three weeks catching babies at Homer G. Phillips, the black public hospital in North St. Louis.  I and my fellow student were the only white guys in the facility.  Napping in a sleeping room on the second floor we were periodically awakened by a nurse yelling “don’t push—don’t push” as the creaky elevator carrying the almost-mother slowly whirred upwards.

Shortly after my grandmother was born her mother died.  In her day death was common when childbirth was complicated by “post partum bleeding, or infections” or when the baby was unable to get through the pelvis.

The U.S. has the unenviable honor of having the “highest rate of maternal mortality in the industrialized world.” —17.8 per 100,000 in 2009.  It’s especially high for African American women.⁶

The global maternal death rate has decreased by 44% in the last 25 years, but each year in the world’s 24 poorest countries, 400 women die for every 100,000 live births.  In recent decades most western countries have cut their death rates in half; in the U.S. the number of women dying almost doubled.  In California focused healthcare significantly helped reduce the mortality rate. ⁵

Throughout recorded history women “midwives” have assisted other members of their sex give birth.  In the late 1800s and 1900s physicians, virtually all of whom were men, moved in and took over.  In 1915 40% of all births were attended by midwives and by 1935, 20 years later, close to 90% of births were performed by male physicians.

In the U.S. Thirty three percent of children are delivered by C-section. (9% of the women who give birth this way had prior C-sections.)  The nurse midwife who brought me up to date explained that in her practice about seven percent of women are delivered by C-sections and only one in 400 women require an episiotomy, and incision to widen the birth canal.

Giving birth vaginally is usually painful and half of the deliveries performed by the midwife I consulted had epidurals.  A derivative of Novocaine is infused into the space outside the lower end of the spinal canal.  The drug usually controls the pain of child birth. When a physician delivers the frequency of an epidural nears 95%.

C-sections carry the risk of bleeding, infection, and of nicking the bowel and bladder. ⁷ When the mother has active vaginal herpes or the infant would have to come out feet or bottom first, vaginal delivery brings with it an extra possibility of harm that usually more than justifies the approach.  But that’s not the reason for the “worldwide explosion.” In Mexico City C -sections are performed for 45% of births.⁷   In China the C-section rate was 35% in 2014.

At $10-15,000 a try, in vitro fertilization (and other forms of assisted reproductive technology) led to the birth of a million babies between 1987 and 2015.  The Center for Disease Control keeps track of successful births after 37 weeks of single, live, normal weight children.  The number depends on factors such as: was the embryo fresh or frozen?  Did it come from donor or non donor eggs?  How many attempts were made? and how old was the woman?¹³  Under ideal conditions the process is successful, per attempt, 21% of the time.⁴

Before Obamacare became law, pregnancy was commonly classified as a pre existing condition.  Medicaid picked up the bill if the woman was sufficiently “low income”.  But some of the uninsured earned a bit too much.   After 2010 expectant women could purchase insurance and they couldn’t be charged more because they were pregnant.  If they wanted marketplace coverage they had to “enroll in a health plan during the open enrollment period, set by either the employer or the feds.”

During the first seven years after the ACA (Affordable Care Act) became law 13 million pregnant women “gained access to maternity services.”  Medicaid expansion played a role. (Medicaid also covered “contraceptive supplies, sexually transmitted infections, and “screening” for sexual violence and breast and cervical cancer.”) ^1,2

In 2006 the 4.3 million births in this country rang up a bill of $14.8 billion.  A vaginal birth in 2010 was costing between $5000 and $7000; C sections went for about $10, 000. 

The care of low and very low birth weight infants contributed another $18.1 billion to the birthing price tag.  Modern doctors have the incredible ability to keep not-quite-ripe small infants alive, and premature newborns account for half a million of the live births in this country.  Some of these kids spend weeks in neonatal intensive care units at a cost, nationwide, of $26 billion.  That turns out to be “about half of all the money hospitals spend on newborns.” 1.7 percent of newborns weighed less than a thousand grams when born and one half of one percent were under 500 grams.  Eighty five percent of the infants “survived to be discharged from the hospital.”^3.

Prenatally doctors and nurse midwives check pregnant women for diseases that can be transmitted to their new born–infections like HIV and hepatitis B.   Obstetricians checking for fetal abnormalities usually perform the first fetal ultrasound when a woman is 18 to 20 weeks pregnant. Screening tests are also performed for genetic and developmental problems.  The second decade of the 21^st century saw the emergence of blood tests that analyze fragments of placental DNA floating in the mother’s blood.  Fetal DNA and placental DNA are identical.  By pregnancy week 10 the level of fetal DNA in the blood of the pregnant woman is usually high enough to perform an accurate test. The studies look for chromosomal abnormalities and they aren’t perfect. The alternative, amniocentesis, is “invasive” and can induce a miscarriage one half to one percent of the time.  Near birth ultrasound exams are performed to check the baby’s position and detect problems like placenta previa, a situation where the placenta covers the opening of the cervix and prevents a normal birth.

The fear of malpractice haunts the birthing profession.   Childbirth mishaps, mistakes, and bad outcomes still account for close to 10% of all malpractice suits, and the amount awarded to injured children can easily be a million dollars or more.  It takes an immense amount of money to care for a damaged child for 80 years.  Not surprisingly the malpractice insurance rates for gynecologists are among the highest.  (see malpractice.⁹)

For a period of time health insurers were overly aggressive in their attempt to get women out of the hospital shortly after they gave birth.  Congress reacted.  The Newborns’ Act was signed into law on September 26, 1996.  It includes important protections for mothers and their newborn children with regard to the length of the hospital stay following childbirth.  (HMOs) that are subject to the Newborns’ Act “may not restrict benefits for a hospital stay in connection with childbirth to less than 48 hours following a vaginal delivery or 96 hours following a delivery by cesarean section.”

There are about 40,000 Ob/Gyn physicians in the U.S. When I graduated medical school (1962) most were men.  In their early years in practice they delivered babies.  As they and their cliental aged the doctors spent an increasing portion of their time tending to the organs of conception.  That’s changed.  By 2001 seventy two percent of the residents in the subspecialty were women.  During the last 35 years our local medical school, the University of California in San Francisco, trained and deployed hundreds of nurse midwives some of whom practice at local hospitals.  The safety of home deliveries on low risk women by nurse midwives has been documented time after time, but this approach still accounts for less than 30,000 of the babies born in the U.S. each year.

In addition to caring for women during the birthing years, gynecologists have traditionally been the primary care physicians of many otherwise healthy women as they age.  Among other things these physicians pay a lot of attention to the organs of conception.

Cancer of the cervix is “worldwide the third most common malignancy in women.”  It’s much less common in this country (11,000 cases a year) because many women have regular “Pap smears.”  It’s a test that was developed by a New York cytologist named Georgios Papanikolaou.  A Greek who finished medical school in Athens in 1904 then served in the army, Papanikolaou decided early that he wanted to be a researcher.  He was 30 when he and his wife Andromache came to the U.S.  They didn’t speak English and “had little money.”  She got a job as a button sewer for a department store and he tried to sell rugs.  His job only “lasted a day.”  He ended up earning money during his first year in the country playing a violin in restaurants.  Then he got a job in the anatomy department of Cornell Medical College.  His wife was hired as his assistant.¹² Using Andromache as a subject he studied the appearance of cells from the lower part of the uterus, the cervix, and he noticed cancer cells looked different.  When he brushed, stained, and evaluated tissue that the end of the uterus was about to shed, he sometimes found “bizarre” changes that indicated a cancer was present.  It took years till his findings were accepted, but he eventually was able to teach doctors to recognize changes that indicated part of the cervix was almost, but not quite malignant.¹⁰ 

Responsible for over 33,000 cervical and vaginal cancers annually in the U.S., human papilloma virus is sexually transmitted and usually causes no symptoms.  Most infections clear within two years, but 14 million Americans are infected annually and 80 million are, at least temporarily, sexually “contagious.”  In 2014 the FDA approved two shot vaccine that effectively prevents the disease.  It works best when it’s given to young women before they are likely to be sexually active, and it covers genotypes 16 and 18 (responsible worldwide for 70% of cervical cancers) and 4 additional genotypes that account for 20%.¹¹

Some parents feel that by immunizing their daughters they are saying we assume you will become sexually active, and that’s a message they’d rather not send

Early on the tools of the GYN trade relied on feel and a speculum.  The uterus and ovaries were felt by trained fingers in the vaginal canal pushing up towards and equally aware fingers on the abdomen pushing down.  When the exam was painful or the woman was large or tense the exam had limited value.

Shadows of the uterus and ovaries are now sometimes visualized using an abdominal ultrasound, a CAT scan, or by placing an ultrasound probe into the vagina and watching a T.V. screen.  The probe charge, in one location (chosen randomly on the Internet), is $200 per exam. I don’t know if insurance companies will pay for the test in the absence of a clear indication. It has not, best I can tell, become “routine”, though actress Fran Dresher and others thinks it should be.  The $6.5 million dollar bill President Bush signed in 2007 “authorized the development of a national gynecologic cancer awareness campaign” but did not mandate screening vaginal ultrasounds.

Gynecologists have long evaluated the inside walls of the uterus with an operation known as a D and C.  They dilate or stretch the cervical area. Then a sharp instrument is placed inside the uterus and the lining cells are scraped off, collected, and examined under a microscope.  The main indication for the operation is unexplained uterine bleeding which could be caused by cancer of the inner lining wall of the uterus. Nowadays there’s a thin narrow scope that can slip into the uterine cavity and allow doctors to look for abnormalities.  In this country hysteroscopy is usually performed in anesthetized patients.  In Australia and elsewhere it’s sometimes performed with light sedation and numbing agents.

Finally the gynecologists were pioneers in the use of a tiny incision and a laparoscope (see surgery) to evaluate ovaries, treat cysts, or tie fallopian tubes so a woman could avoid pregnancy.

Gynecologic surgery is a relatively large ticket item.  In this country 600,000 women have hysterectomies annually.  180,000 (30%) of the operations are done for “fibroids” benign growths that can cause symptoms.⁸Some hysterectomies are performed in an attempt to reduce or eliminate lower abdominal pain.  The discomfort is sometimes caused by endometriosis, a condition where the kind of tissue that normally lines the inner wall of the uterus is growing elsewhere in the pelvis. Abnormal cells are sensitive to female hormones and can bleed when women are having a menstrual period.  The condition is the alleged cause of the discomfort suffered by millions.

Close to ten million women “have trouble controlling their bladders.” Surgery in addition to medication and pessary (a flexible device that’s placed into the vaginal canal) sometimes helps.  Operations also treat prolapse, a condition where a uterus, stretched by prior child birth, drops into the vagina or bulges into the bladder or rectum.

Finally the fear of ovarian cancer leads to a lot of testing.  This is a real and worrisome condition, but it’s not on the rise.  By age 30 it strikes one in 15,000 and by age 60 afflicts no more than one woman in 1500.   It’s hard to detect at an early stage and benign ovarian cysts found on an ultrasound commonly lead to a number of additional exams and a modicum of anxiety.  Given our current system and abilities, experts tend to discourage routine screening.

Chapter 12—sight

 

Blind as a bat– -Better than a poke in the eye—–

During the last one and one half centuries we’ve learned how to treat or correct most of the conditions that inhibit our ability to see.

One of them, Trachoma, has been a problem for mankind for thousands of years.  Hippocrates thought it made eyelids, look like cut ripe figs.  During the Napoleonic wars, it “raged” through the armies of Europe; and over the centuries it often occurred in clusters within villages or families.¹¹ Caused by a Chlamydia, a type of bacteria that lives and reproduces inside the cell of the host, it leads to scarring of eyelids, and causes eyelashes to damage the cornea.  Antibiotics kill the bug, but it tends to recur.⁹    The number of people who currently have “the late blinding stage of the disease dropped to 2.5 million in 2019.” 

The prevention of river blindness remains another work in progress. Found chiefly in parts of Africa, the condition is caused by a tiny parasite and is spread by black flies that “breed in fast flowing streams.” In the 1990s The African Programme for Onchocerciasis Control (APOC) successfully treated more than a million at risk people with the anti parasitic drug Ivermectin, and it made a significant difference. Globally, it is estimated that 18 million people are infected and 270,000 have been blinded by the condition.  It’s called onchocerciasis.⁶”

There’s little available data on infants who survive wars, droughts, suffer from malnutrition and develop a vitamin A deficiency.  The resulting dryness and scarring of the conjunctiva, the mucous membrane that coats the inside of the eyelids, can cause them to lose their ability to see.¹

The leading causes of blindness in this country are cataracts, glaucoma, macular degeneration, and diabetes.⁵

Cataracts:  To create a sharp image the eye like the microscope and the telescope needs two lenses. 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 diminished vision in many and are the leading cause of blindness.   

A century ago when a person’s lens got so dense that they couldn’t see, the structure was surgically removed.  Afterwards a person could see light and little more unless they wore thick glasses.  No on liked wearing Mr. Magoo glasses, and everyone hated feeling helpless when they woke and couldn’t locate their spectacles.  I remember the days when people didn’t have cataract surgery until they were literally no longer able to see.  The lens removal operation is, apparently, still done in some countries.

Harold Ridley of England is the father of the implantable lens.  The son of a physician he spent his early doctoring days working on cruise ships.  During the Second World War he spent 18 months in Ghana.  Later in Burma, he provided care for former British prisoners of war who had nutritional amblyopia, lazy eye. At some point he treated members of the RAF whose airplanes were damaged by enemy fire and whose cornea’s, the front lens of the eye, had been penetrated by pieces of the plane’s windshield.  The acrylic plastic did not cause an inflammatory reaction. Years later, he was removing a cataract and he recalls that one of his students remarked: “It’s a pity you can’t replace the cataract with a clear lens.” That got Ridley thinking.  He started crafting implants from the material that was used to make airplane cockpits and he implanted them into eyes after he removed an opaque lens.” “Sterilization of the lenses was a major problem and he was afraid to tell anyone.  Powerful colleagues had shown hostility to the idea of putting a foreign body in the eye.¹⁰

There was a learning curve but Ridley and a pupil perfected the surgical technique and a company in East Sussex (Rayner) manufactured the implant.  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.  By 2015, 9000 American ophthalmologists were replacing 3.6 million lenses a year.  Worldwide 20 million cataract surgeries are performed annually.²            

In the U.S. most surgeons numb the eye, insert a small ultrasound probe, and phacoemulsify (liquify) 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.  It was one in a thousand for surgeons who replace a thousand cataracts a year.  In poorer countries phacoemulsification is less common.  Most Americans 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 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 reconnected 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.  In the late 1990s it was estimated that 9.5 million people in India were blind as a result of cataracts and 3.8 million were losing their vision annually. 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.  In 2016 the company they founded, Aurolab, manufactured 2.6 million intra ocular lenses, 10% of all produced in the world.  The majority of the lenses are “distributed to NGOs in India and in developing countries.” The company is profitable.
          In 1999 doctors in India performed 1.6 to 1.9 million surgeries in a single year and plans were made to increase the numbers of operations that would be carried out. By 2006 cataract surgery in India, Nepal, and Bangladesh was costing $20 and the lens sold for less than $5.³

Glaucoma:  Often caused by elevated pressures in the eye, Glaucoma is a number of conditions that damage the nerve that transmits images from the eye to the brain. The dramatic, painful eye of angle closure glaucoma is a medical emergency and can lead to visual loss. It occurs relatively infrequently. Open angle glaucoma, on the other hand is relatively common. Experts have learned a lot about the more usual condition, but we don’t know what causes it, and it’s no longer defined merely as a condition where the pressures inside the eye are too high–though they commonly are.  The middle of the eye produces a watery aqueous fluid.  It flows through the pupil, enters the space in the front of the eye, and exits through the spongy tissue that surrounds the edge of the cornea.  In people with the condition fluid is over produced or doesn’t drain normally. 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 becoming glaucoma specialists.  They learn how to carry out 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. Beta blockers cause the eye to produce less fluid and Prostaglandin inhibitors promote drainage. In 2004 when the FDA gave Pfizer the exclusive right to the prostaglandin inhibitor Xalatan, they sold $1.23 million worth of the drug.  Before a generic competitor entered the U.S. market, a month’s worth was costing $80 a month.  Pfizer manufactures and sells its products worldwide and has 43 manufacturing plants in: Ireland, Puerto Rico, the U.S., UK, Germany, Amboise, France; Ascoli, Italy; Belgium and Perth, Australia. 

According to the World Bank, “almost half the world’s population — 3.4 billion people — live on less than $5.50 a day.  For them eye drops aren’t an option. Laser surgery can increase the outflow of fluid.  If that doesn’t work an older operation called a “trabeculectomy”, removing a bit of the mesh network the fluid pours through, can create “a new drainage path.”  In 20 percent of the people who undergo surgery the openings stop working during the first year and two percent fail each year thereafter.¹⁵

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.  During those years about half had undergone surgery for cataracts and 45% for glaucoma. “At final visit, vision was inadequate for driving in the UK in close to half. In 18%, this was due to glaucoma alone, while in 28.9%, other ocular pathologies contributed to poor vision.¹³”  

AMD, age related macular degeneration, is a major cause of vision loss as we get older.  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 and we have no effective treatment.                

The less common “wet” form of the disease is sometimes helped by laser coagulation or photodynamic therapy and is commonly treated with Avastin, an antibody that “blocks” the growth of the new blood vessels.  When an ophthalmologist 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.”

Before using it the doctor evaluates the patient.  He or she discusses the risks of injecting the drug, and explains downsides like bleeding and retinal detachment.  On the appointed day the patient is brought to the procedure room and checked.  The edge of the eye is injected with a numbing agent.  A second needle is then passed into the inner cavity of the eye, a chamber full of a gelatinous material known as the vitreous.  The medication is injected and the pressure in the eye is raised for a brief period of time.  Vision is temporarily blurry.  After a period of observation the patient can go home. 

A law caps the amount a U.S. doctor can charge for an Avastin injection.  It can’t be more than 6% of the drug’s price.  The small amount needed to treat an eye had a cost of $50, so the fee Medicare paid for the injection and observation was capped at $3.

Avastin was FDA approved as a drug that slows the growth of cancer.  When the FDA approves a medication for one indication (cancer), the company that produces and markets it is not allowed to talk about other possible ways the drug can make a difference.  Doctors who read the medical literature and learn a drug helps an additional–different condition, do have the legal right to use it for that condition. The doctor does not have to wait for the drug company or the FDA to act.  In spite of the economics eye doctors were injecting Avastin into the eyes of people with wet macular degeneration.  In 2006 the FDA approved a biosimilar, Lucentis.¹⁷ It was an almost identical antibody.  It blocked the growth of blood vessels, was made by the same company as Avastin, and it worked as well.  In 2014 the company was selling it for over $2000 a month, and doctors who used it in their office were able to charge $180 for the visit and the injection.¹⁶

Refractory problem:  At some point in most of our lives we can’t see well because our eyes are unable to focus light on the layer of cells at the back of our eyeballs, the retina.  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.

In 1965 Bausch and Lomb, bought the rights to contact lenses that were soft and were created in the kitchen of a Czech chemist.  Once they owned the product’s license the once American, currently Canadian company started a billion dollar industry.¹⁴

The man who developed the lens, Otto Wichterle, was a Czech dissident who was jailed by the Nazis in 1942.  In 1958 he lost his University job because he criticized the country’s Communist government. 

Once he was fired he continued his work on the kitchen table of his Prague apartment.  He used an instrument made from a child’s building kit (similar to an erector set) and a phonograph motor, and he produced four hydrogel contact lenses.¹⁷  When he put them in his own eyes they were comfortable.                  Ever a protester, Otto was expelled from the nation’s chemistry institute in 1970 because he supported Czechoslovakia’s attempt to become independent of Russia—the Prague Spring of 1968.  When the cold war ended Otto resumed his scientific activities.  In 1962 he patented his invention and produced an additional 5500 lenses.  At one point he met and learned to trust an American optometrist named Robert Morrison.  When he was harassed by patent attorneys Otto asked Morrison to come to Prague.  “Wichterle said, “Robert, I have decided that I must give patent rights to the gel to someone who can use them in the Western Hemisphere and, perhaps, in some other areas as well.¹⁸”   Ulitmately the US National Patent Development Corporation (NPDC) bought the American rights to the lenses from the Czechoslovak government for $330,000.  Then they sublicensed the patent to the Bausch and Lomb Corporation.  Wichterle was paid less than 1/10 of 1 % of the money, but he was now free to speak and travel and he had no regrets. 

In 1989 Gholam A. Peyman, an ophthalmologist and inventor patented Lasik, a laser and computer assisted device that allowed doctors to peel 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.  The inventor, Dr. Peyman, was born in Shiraz Iran and went to medical school in Germany.  He’s a constant innovator and has held more than 100 patents.  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. 

By 2010 close to 7 billion people lived on earth and about 32 million, one in 200 were blind.  An additional 191 million, one in 40, were visually impaired. 

Blood sugars usually have to be elevated for ten to 15 years before blood vessels on the surface of the retina become permeable and weepy and the amount of oxygen that reaches the cells of the eye decreases.  New vessels, signaled by VEGF, grow and impair eyesight.  “Left untreated, nearly half of eyes that develop proliferative diabetic retinopathy will have profound vision loss.”

Lasers are used to destroy the blood vessels that are overgrowing.  Sometimes the antibodies that block VEGF, the hormone that encourages new blood vessel growth, are injected into eyes.  In 2020, the Medicare paid $1000 to $1800 a session for the VEGF inhibitors that were FDA approved for use in the eye.