The Doctor Will See You Now

by Cory Franklin

  THE MAN WHO SAVED

  PITCHERS’ ARMS

  * * *

  There are a lot of pitchers in baseball who should celebrate his life and what he did for the game of baseball.

  —TOMMY JOHN ON DR. FRANK JOBE

  DR. FRANK JOBE, a humble but accomplished orthopedic surgeon, died in 2014 at the age of eighty-eight. He salvaged the careers of countless baseball players by pioneering the “Tommy John surgery,” a revolutionary elbow ligament repair. He was unquestionably the greatest orthopedic surgeon in professional sports history, the Babe Ruth of the profession. Dr. James Andrews, today’s leading sports orthopedic surgeon, said of Jobe in the Los Angeles Times, “Without his influence, baseball players’ sports-medicine care would probably still be in the Dark Ages.”

  But Jobe’s passing also raises questions about the evolution of medicine since 1974, when he first tried the experimental technique on Tommy John, an injured Los Angeles Dodgers pitcher. Four decades later, in a world where government and corporate bureaucracies strive to minimize practice variations among physicians and “evidence-based guidelines” dictate medical practice, would it be possible for a freethinking medical innovator like Jobe to introduce such a radically new, untested surgical procedure?

  The story of the first Tommy John surgery, technically known as ulnar collateral ligament reconstruction, is testimony not only to surgical excellence but also to the ineffable bond between a physician and patient. Jobe was the Dodgers’ orthopedist when John, a decent but not great pitcher, felt severe pain in his pitching arm. He suddenly could not deliver a pitch, and Jobe diagnosed an ulnar collateral ligament tear, a career-ending injury.

  John, disconsolate at the thought of life without baseball, was not just Jobe’s patient but also his friend. He implored the surgeon to try anything that would allow him to pitch again. Sympathetic to his friend’s plight, the doctor agreed and considered an operation that had never been tried on a baseball pitcher. Jobe had previously worked with polio patients, for whom surgeons transplanted tendons from other parts of the body to reinforce immobilized limbs. Could a transplanted tendon work on a major league pitcher, for whom the mechanical stress on the elbow is exponentially greater?

  Jobe discussed the operation with John, who was willing to try it. He took a tendon from the pitcher’s nonpitching arm and wove it tightly through holes drilled in the bone of the injured left elbow. In essence the transplanted tendon from John’s nonpitching arm became the new ulnar ligament for his pitching arm. Uncertain of how it would work, Jobe gave John a 1 percent chance of ever pitching again.

  Jobe’s pessimism turned out to be misplaced. John became a great pitcher with a twenty-six-year career, one of the longest in major league history. He won more games after his surgery than before. Buoyed by its success, Jobe taught the procedure to other orthopedic surgeons. Those surgeons have gone on to perform the operation on more than one thousand major leaguers, only a fraction of the thousands of minor leaguers, college and high school players, and other athletes who have had Tommy John surgery. Of particular note, David Wells had the operation as a minor leaguer in 1985 and pitched a perfect game for the New York Yankees in 1998.

  In medicine, like all else, timing is everything. Eight years before Jobe operated on John, another Dodger left-hander was forced to retire with the same injury at the height of his career. One can only speculate what might have been had Jobe committed earlier to do the procedure on the greatest of them all, Sandy Koufax.

  Today Jobe and John are both honored in each other’s profession. John’s name is ubiquitous in the orthopedic medical literature for the eponymous surgery, and Jobe was honored in a special contributors’ wing in the Baseball Hall of Fame. But would it be possible for Jobe to introduce the Tommy John surgery today? Corporatization and the government have drastically diminished the role of the individual physician. New barriers have been constructed between patient and physician.

  Consider this: Would hospital administrators or government watchdogs prevent Jobe from performing this new operation because it is not approved by the medical establishment that sets the rules? Would the profession dissuade Jobe from helping John without randomized controlled studies that take years to perform? Would medical center institutional review boards permit Jobe to operate? Would lawyer-drafted, unreadable twenty-page informed consent forms scare off John? Would insurance companies authorize payment for such an experimental procedure in future patients?

  In 1974, before persuading Jobe to try surgery, a desperate Tommy John considered consulting a knuckleball specialist to teach him that difficult pitch, which puts little stress on the elbow. Fortunately, John was a friend of a loyal, talented, and resourceful physician who was brave enough to challenge the medical orthodoxy and health care system of the day. It might happen the same way today, but just maybe today John would be told to learn to throw a knuckleball. And the next Frank Jobe would remain unknown.

  12

  THE WOMAN WHO PROTECTED US

  * * *

  They were writing letters and telephoning.

  They were very anxious to get their product on the market.

  It had been very successful in other countries and they felt there would be a big market in this country. Then quite suddenly, the news came from Europe about the deformities.

  —FRANCES KELSEY, MD, ON RICHARDSON-MERRELL’S DESIRE TO MARKET THALIDOMIDE TO PREGNANT WOMEN IN THE UNITED STATES

  IN THE LATE 1950s, German scientists developed a “wonder drug” for women that was supposed to alleviate the morning sickness, insomnia, and headaches of pregnancy. German studies touted the medication as safe, and it was distributed widely throughout Europe. The drug, thalidomide, became an immediate international success, and there was a move to bring it quickly to the lucrative American market. That would have happened had it not been for one physician working for the Food and Drug Administration (FDA), a brave woman largely forgotten today, named Dr. Frances Kelsey.

  She was suspicious of the haphazard European testing and resisted pressure for approval from the drug company, as well as from her superiors at the FDA. With only a month on the job at the time, her position at the FDA was already tenuous. However, with good science on her side, she stood fast against approval until further testing could prove thalidomide was safe to fetuses.

  In 1961, before American approval was obtained, her diligence was vindicated when the drug was shown to be linked to birth defects. Worldwide more than ten thousand “thalidomide babies” suffered missing or deformed arms and legs. Because thalidomide was never approved for use in the United States, fewer than fifty of those infants were born here. Kelsey single-handedly prevented a nationwide tragedy, provided a model for effective government drug regulation, and changed the culture and mission of the FDA.

  Over a half century ago, in a 1962 White House ceremony, President John F. Kennedy awarded Dr. Kelsey the highest honor an American civilian can receive, the President’s Award for Distinguished Federal Civilian Service. She was only the second woman to receive the award, and she was hailed publicly by President Kennedy for her valor. After she retired, the FDA named an award in her honor “to celebrate courage and decision-making.” She should go down as one of the great physicians and true heroes of twentieth-century American medicine.

  There is a teachable moment here. A fungal meningitis outbreak that swept the country in 2012 and caused at least sixty-four deaths was linked to spinal injections of a contaminated steroid. The Massachusetts company that prepared the contaminated steroid solution, the New England Compounding Center (NECC), engaged in a practice known as “drug compounding”: a pharmacy makes an individualized preparation of an approved medication for a specific patient according to a physician’s instructions. Drug compounding can be helpful to patients requiring precisely tailored medications, and compounding pharmacies can often supply them easier and more cheaply than major drug manufacturers. However, the FDA does not regulate drug compounding. In the NECC
case, the approved medication for back injections was suspected of being contaminated with fungus during the compounding process. Estimates are that as many as fourteen thousand patients nationwide received potentially tainted drugs, and more than seven hundred developed meningitis.

  Compounding has had problems before. The Institute for Safe Medication Practice has documented twenty-two significant drug compounding errors since 1990, involving seventy-one different drugs and more than two hundred adverse events. The NECC manufacturing disaster was the worst in the United States since 1937, when a company inadvertently mixed an antibiotic with antifreeze, killing more than one hundred people. Federal drug regulation demands a delicate balance.

  Overregulation can drive up the cost of drugs and create bottlenecks to useful medications reaching the public; this was a problem in the 1980s during the early years of the AIDS epidemic. Amid widespread criticism, the FDA eventually relaxed its standards to open the drug pipeline to effective AIDS medications. However, when regulators pay too little attention, the system is left open to serious medical tragedies such as the thalidomide episode and the fungal meningitis outbreak.

  That is why the medical community, largely silent on the issue until now, must demand stricter FDA oversight of the drug-compounding process. It’s time to recall the heroism of Dr. Frances Kelsey, the woman who saved the nation from a medical disaster decades ago with her attention to the importance of drug testing and oversight.

  13

  NEEDLES TO SAY

  * * *

  The reward for work well done is the opportunity to do more.

  —JONAS SALK

  IN THE EARLY 1950s, a polio epidemic ravaged North America and Europe. In circumstances largely forgotten today, people avoided drinking fountains, swimming pools, and movie theaters. Summer camps and schools were closed, and even with these measures, thousands caught the disease and died or were permanently disabled. Many spent months in iron lungs separated from friends and family.

  Then in 1955, physician-researcher Jonas Salk and his team developed a successful polio vaccine, and Salk was hailed as a national hero. Thousands of lives were saved, and thousands more were spared the debilitating effects of polio. Salk was on the cover of Time magazine—in the days when that was a true accomplishment, not a vacuous celebration of celebrity. Interviewed on the famous television program See It Now by Edward R. Murrow, Salk was asked, “Who owns the patent on this vaccine?” Dr. Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?”

  It was certainly a different era, but that story has a special resonance in my family. At the same time Salk was becoming a household name, my father, also a doctor, developed a far less dramatic medical innovation but one that nonetheless saved its small share of lives.

  At Cook County Hospital, my father had gained a reputation as an expert clinician and teacher. Doctors in those days spent many more hours in the hospital than they do now, and my father cultivated a hobby: refining ordinary medical instruments, making them easier for doctors and nurses to use. My father would tinker with the EKG machines and lab equipment, always looking for a way to improve them. One of his contemporaries observed that besides being a good doctor, he was “a clever gadgeteer.” In those days, there was no government regulatory scrutiny or review boards; if there were he probably would have taken up contract bridge.

  Aware of his reputation, several nephrologists from the University of Chicago came to visit him one day. They were the local experts at a new technique—diagnosing and treating kidney diseases by doing kidney biopsies. This involved inserting a needle into the kidney, cutting a small sample of tissue, and extracting it to be studied later under the microscope. Routine today, it was all very high tech at the time. But the technique had run into a problem—before World War II, two men, Vim and Silverman, had devised a crude biopsy needle, which was still employed, and their needle often failed to capture a sufficient amount of tissue to study.

  Undaunted, my father saw no difficulty. Within a short time, he modified the bevel on the needle, and the new tool became known as the Franklin modification of the Vim-Silverman needle or simply the Franklin needle. It was an immediate success. Sometime later a leading nephrology journal wrote, “The modification of the needle by Dr. Murray Franklin of Cook County Hospital in Chicago was minor but crucial. . . . For 15 years that was the standard renal biopsy needle used worldwide.”

  The elated nephrologists now did biopsies and published papers, eventually making Chicago the center of kidney biopsies and renal pathology in the world. Other medical centers quickly picked up on it. A nephrologist pioneering kidney biopsies at Vanderbilt University donated one of the first Franklin needles used there to the Smithsonian Institution’s National Museum of History, Medical Sciences Division. My father, barely fazed by these developments, went back to caring for patients and teaching residents.

  But the story was just beginning. Cook County Hospital also had a number of world-class gastroenterologists who specialized in liver diseases, and they had started doing liver biopsies to diagnose hepatitis and cirrhosis. They knew my father, who had done his postgraduate research in alcoholic liver disease, and they approached him to see if the Franklin needle would work as well for liver biopsies as it did for kidney biopsies. He told them matter-of-factly that since the liver was a larger, more accessible organ than the kidney, it should work even better on that organ—which is exactly what happened. The Franklin needle also became the standard liver biopsy needle, first in Chicago, then all over the world.

  Thousands upon thousands of liver biopsies were done as the Franklin needle became a routine hospital instrument everywhere. It was instrumental to our modern understanding of liver pathology. In the 1960s, ambitious researchers from all over the country even started doing biopsies of the lung with it (although it wasn’t as good a tool for lung biopsies). The market for the needle expanded even more when veterinarians started using it to biopsy organs in animals.

  By this time, my father had moved on from academic medicine and never personally used the needle again. He rarely gave it a second thought. Growing up, I don’t recall ever hearing him mention it. I was vaguely aware of it since my mother occasionally told my sister and me about “the Franklin needle” used in the hospital. My parents’ friends, some of whom were physicians, would mention it to us when we were young as something of which to be proud. But it still made little impression on us.

  That changed one afternoon when I was in medical school. I was on the wards at Northwestern Memorial Hospital as a junior medical student. My job was basically to follow orders. A classmate and I were sent by the gastroenterologist we were shadowing to bring him a liver biopsy kit with a Franklin needle. At first unaware, it finally dawned on me what he had asked for. Normally students are seen and not heard, but I piped up, “My father invented that needle.”

  He looked at me skeptically and eyed my name tag (thus confirming my impression that before that moment he hadn’t the faintest idea of what my name was—junior medical students, like Rodney Dangerfield, get no respect). After another skeptical moment, he beamed, “Your father is Murray Franklin? This needle revolutionized liver biopsies. You must be rich.”

  I felt an instant surge of pride that was quickly tempered by a sinking feeling. I certainly wasn’t rich, at least not that I was aware of, and suddenly I realized something might be amiss. For some reason, I conjured up the image of all those old blues singers who made classic recordings but made very little money, their profits siphoned off by managers and record companies. Returning to the gastroenterologist, I smiled and let the matter drop. He treated me with greater respect the rest of the month and gave me a better grade than I deserved.

  As I progressed in my medical career, I came into contact with more and more specialists who used the needle. I never talked about it, but I realized even small payments to the creator of such a widely used innovation might be substantial. I refrained from asking my fa
ther about it for another decade. And I thought of the question Jonas Salk asked Edward R. Murrow. When finally I did ask my father, his response was terse and matter-of-fact: “We didn’t patent things like that in those days.” I never mentioned it again.

  14

  AIR-CONDITIONING: A LIFESAVER

  * * *

  The rich get their ice in the summer, the poor get theirs in the winter.

  —LAURA INGALLS WILDER

  THE LAST THING in the world I want to do is to get on the wrong side of God, the Catholic Church, or any of my Catholic friends. But I feel compelled to say that Pope Francis, however infallible he might be in matters spiritual, is just plain wrong about air-conditioning.

  In his 2015 encyclical, “Laudato Si,” the pope wrote, “People may well have a growing ecological sensitivity, but it has not succeeded in changing their harmful habits of consumption, which, rather than decreasing, appear to be growing all the more. A simple example is the increasing use and power of air conditioning. The markets, which immediately benefit from sales, stimulate ever-greater demand. An outsider looking at our world would be amazed at such behavior, which at times appears self-destructive.”

  Coincidentally, July 2015 marked the twentieth anniversary of the Chicago heat wave that caused nearly eight hundred deaths citywide. The mortality at Cook County Hospital, where I worked, was disproportionately high because many patients were elderly, poor, and, most important, didn’t have air-conditioning in their homes.

  The majority of deaths during the Chicago heat wave were patients who were already ill, where excessive heat was a major contributing factor. Most patients’ cardiovascular systems could not stand the aggravating stress of five days of intense July heat. But two patients in particular stand out in my mind because both of them actually developed severe heatstroke and died while they were inpatients. When they were admitted, their body temperatures were normal, but they died because there was no air-conditioning in the hospital and their body temperatures subsequently climbed to more than 106 degrees.