This long history of learning how not to fool ourselves— of having utter scientific integrity—is, I’m sorry to say, something that we haven’t specifically included in any particular course that I know of. We just hope you’ve caught on by osmosis.
—RICHARD FEYNMAN TO CALIFORNIA INSTITUTE OF TECHNOLOGY GRADUATES
SCIENTIFIC INTEGRITY IS THE THEME of the Greek tragedies that in the last decade or so involved two of America’s most prestigious physicians. Both men worked for decades to reach the pinnacle of the medical profession; then both were brought low.
The first of the dramatis personae was octogenarian Dr. Sidney Gilman, chairman of neurology at the University of Michigan for over a quarter of a century from 1977 to 2004. A former professor at Harvard and Columbia and past president of the American Neurological Society, he authored hundreds of scientific papers, served on the editorial boards of key medical journals, and was a consultant to the Food and Drug Administration and several major pharmaceutical firms. Nearing the end of his chairmanship at Michigan, he was honored with the establishment of a neurology service at the university hospital and an annual lecture series, both named for him.
Then in 2014 Dr. Gilman found himself in a quite different role: key government witness in federal court. In a huge Wall Street insider trading trial, he admitted to providing confidential inside information about a new drug under development for Alzheimer’s disease to the hedge fund portfolio manager who was the defendant in the trial. The hedge fund company realized over a quarter billion dollars from the information.
As chairman of the safety monitoring committee testing the Alzheimer’s drug, Dr. Gilman was scheduled to present the study results at a scientific conference in Chicago. Twelve days before the conference, he deliberately leaked the results to the portfolio manager. The resulting stock transaction, and the relationship between Dr. Gilman and the defendant, attracted the attention of the Securities and Exchange Commission. The SEC subsequently indicted the manager and filed a complaint against Dr. Gilman. In exchange for avoiding prosecution, Dr. Gilman agreed to cooperate with the SEC investigation, testify in the trial, and pay nearly $250,000 to federal authorities. The affair forced him to resign his position at Michigan, and the institution severed its relationship with him. (The trader was ultimately convicted.)
Wayne State University law professor Peter Henning said the doctor may have been naive when savvy, big money Wall Street investors befriended him. Henning told the Ann Arbor Observer, “I don’t believe he thought through the consequences of his actions, what a black mark they would leave on his career. I mean, this is going to be what’s in the first paragraph of his obituary. . . . At one point he looked at the man in the mirror and convinced himself he wasn’t doing anything all that wrong.”
The second protagonist, in a separate case, was Dr. Charles Denham, a leader in the patient safety movement that has become the centerpiece of American medicine. Dr. Denham’s credentials were impeccable: He was a member of the President’s Circle of the National Academies of Science and editor in chief of the Journal of Patient Safety, and he was associated with the Harvard School of Public Health and Mayo Clinic College of Medicine and Science. He has chaired the Safe Practices Program of the Leapfrog Group, a consortium of Fortune 500 companies with billions of dollars in health care purchasing power. The required reading periodical for all health care executives, Modern Healthcare, named him one of America’s 50 Most Powerful Physician Executives several times.
His name also came up in the legal world in 2014 when the US Department of Justice accused a health care company, CareFusion Corp., of paying Dr. Denham $11.6 million in kickbacks while he served as cochair of a committee of the nonprofit National Quality Forum, which makes national practice recommendations on patient safety.
The Justice Department alleged the payments were meant to promote sales of a preoperative skin preparation and to market it for unapproved uses, in violation of the federal False Claims Act. In a public statement, a Justice Department spokesman said, “Corrupting the standard-setting process through kickbacks can affect the healthcare treatment choices that doctors and hospitals may make for patients.” Dr. Denham, facing no charges, admitted to being paid the money but disagreed with the characterization of “kickback.” CareFusion agreed to pay $40.1 million to resolve the allegations.
The medical community has been less than vigorous about policing these types of conflicts of interest. It strongly abjures trivial situations like pharmaceutical companies providing lunch for low-paid medical residents and students. Yet there is a remarkably laissez-faire attitude toward the potential bias of prominent physicians doing research for pharmaceutical firms or developing important nationwide medical guidelines, which may involve millions or even billions of dollars. A top university research physician recently confided to me that it is fairly common for physicians involved in drug trials and clinical guideline development to have significant conflicts of interest.
Every Greek tragedy has its chorus. In these particular cases, it is the late physicist Richard Feynman, one of the great scientists of the twentieth century and an avatar of scientific integrity. Feynman, a Nobel Prize winner, was the man who demonstrated the cause of the space shuttle Challenger explosion in a simple experiment on national television and was highly critical of the intellectual honesty of many involved in the project. He continually emphasized that scientific integrity is a principle of scientific thought that demands utmost honesty—in essence, leaning over backward intellectually to be honest. The Gilman and Denham cases suggest that in today’s medical environment, this approach is in jeopardy.
Forty-four years ago, giving the California Institute of Technology commencement address, Feynman made a timeless observation about scientific integrity: “The first principle is that you must not fool yourself—and you are the easiest person to fool. So you have to be very careful about that.”
33
PHYSICIAN, HEAL THYSELF
* * *
The biggest danger here is that it leaves a cloud over the patients and their families over whether they were put at some unnecessary risk. All of those questions are in their heads. . . .
When money is inserted into the equation, there is no trust.
—US DISTRICT JUDGE SHARON JOHNSON COLEMAN,
PRESIDING OVER A 2016 KICKBACK TRIAL
IS THE PSYCHIATRIC PROFESSION, and medicine in general, sinking in an ethical swamp? With greater scrutiny devoted to pharmaceutical companies’ payments to doctors, psychiatrists appear high on the list of beneficiaries among all medical specialties. Financial arrangements between psychiatrists and drug companies may be a factor in the recent rise in antipsychotic drug expenses for Medicaid programs, as well as the increasing use of expensive antipsychotic drugs, especially for children. The enormity of the conflict of interest problem is highlighted by three high-profile cases involving influential psychiatrists and large payments from the pharmaceutical industry.
The first case involved a weekly public radio program dealing with psychiatric issues and mental disorders, The Infinite Mind, heard in over three hundred markets with more than one million listeners. A congressional investigation revealed the psychiatrist who hosted the program, Dr. Frederick K. Goodwin, earned at least $1.3 million between 2000 and 2007 by giving marketing lectures for pharmaceutical firms, income that was never disclosed on the program. The companies who paid him often had a significant financial interest in subjects discussed on the show.
Dr. Goodwin received more than $300,000 in one year for promotional lectures dealing with medications that were frequent topics of discussion on The Infinite Mind. He rationalized the conflict of interest by blaming a change in the ethical environment for misunderstandings about his consulting arrangements. “It didn’t occur to me that my doing what every other expert in the field does might be considered a conflict of interest.” (An NPR spokesman said that had they been aware of Dr. Goodwin’s financial interests, they would not have aired the program,
and they removed the program from their satellite radio service.)
A second case was that of Dr. Charles Nemeroff, a prominent Emory University psychiatrist and the principal investigator for drug treatment studies of depression for the National Institutes of Health. He received over $2 million in consulting fees from the pharmaceutical companies involved in those studies. Although Nemeroff, as chairman of psychiatry at Emory, signed university documents pledging to accept no more than $10,000 a year from a single company, according to congressional investigators, he allegedly received payment far in excess of that. He voluntarily stepped down as chairman of the psychiatry department at Emory.
The third case involved Dr. Joseph Biederman, a leading child psychiatrist at Harvard Medical School and Massachusetts General Hospital. Biederman, a particularly influential figure in the field of bipolar disorders in children, worked in concert with a drug company that provided nearly $1 million to establish a research center at Massachusetts General. The center, besides aiding children with psychiatric disorders, had as one of its publicly stated goals to advance the commercial goals of the drug company. In addition Biederman neglected to disclose to Harvard over $1 million that he received from the pharmaceutical industry, a violation of Harvard’s disclosure policies.
Relationships between physicians and the pharmaceutical industry are an essential arrangement in the development and testing of new medications. Drug development would be impossible without physician input. But large payments to high-profile, influential physicians, especially when the payments are not disclosed to the public, raise serious questions. Are the recommendations these physicians provide to the medical community of newer, more costly medications made at the expense of nondrug therapy, generic drugs, and older, less expensive medications that may be equally effective?
In fairness to psychiatrists, they are not alone in this ethical morass. Cardiologists and many surgical subspecialties have become entangled in similar conflict of interest problems. The role of the “expert” physician as respected authority has made them an attractive target of the pharmaceutical industry. Insurance company restrictions, the consumer-based medicine movement, the Internet, relaxed restrictions on direct patient marketing, and the emphasis on practice guidelines by expert committees have all reduced the influence of individual physicians and their prescribing patterns. Big pharma realizes the bang for their promotional buck lies with prominent physicians who are professional leaders.
Will the medical profession pass the point of no return? Federal oversight and more disclosure rules are necessary but not sufficient. The government’s role, especially in private industry, is limited, and many times professional disclosure rules have simply permitted physicians to accept large payments as long as they are disclosed, in effect sanctioning ethically dubious arrangements.
If physicians are to retain the public confidence and maintain their own integrity, it will require a commitment by both professional leaders and the rank and file to create more ombudsmen in the medical community, a role currently assumed by a small vocal minority. Physician, heal thyself—at stake is the soul of the medical profession.
34
SIGNPOST UP AHEAD:
GOOD INTENTIONS
* * *
Hell is paved with good intentions, not bad ones.
All men mean well.
—GEORGE BERNARD SHAW
BENEFICENCE, the desire to do kind deeds, is the fundamental principle at the heart of medicine. Yet one of the painful lessons medicine teaches is that good intentions don’t always lead to good outcomes. Occasionally, the result of good intentions is terrible tragedy. Two separate medical incidents, one involving the Food and Drug Administration (FDA) and antidepressants and the other involving the United Nations Children’s Fund (UNICEF) and contaminated drinking water, are painful reminders of the lesson of unintended consequences.
In the past two decades, several large population studies have demonstrated an association, but not necessarily a cause and effect, between certain antidepressants and suicidal ideation/behavior in youths. Because patients who receive antidepressants have a higher risk of suicide than the general population, the studies were unable to establish conclusive causation attributed to the medications. The question remains: Were observed suicides the result of the prescribed medicines or the underlying condition? The FDA, acting in good faith, elected to issue a requirement that a black box warning, advising of a potential suicide risk, be placed on antidepressants prescribed for youths and young adults.
Several studies have suggested the black box warnings may have had the unintended consequence of placing more youths at risk of suicide. Researchers found the black box warnings resulted in a reduction in antidepressant prescriptions for adolescents and adults. They demonstrated an increase in youth suicides associated with the temporal decline in the use of antidepressants, a finding that may have also occurred in the Netherlands after a similar warning about antidepressant drugs was issued there.
One study author, Hendricks Brown, said, “The overall effect of these newer antidepressants is very likely that they reduce suicide risk considerably. Overall, the new antidepressants provide a large protective benefit. If there is any group of people who are adversely affected by taking these antidepressants, it has to be a very small group.” Brown said health policy decisions are sometimes based on limited information, and the FDA might have inadvertently placed more youth at risk by mandating the warnings. The issue of youth suicide and its causes is incredibly complex, especially in the era of social media. While the FDA was understandably cautious with its black box warning and beneficence was the goal, it may have been an example of good intentions gone wrong.
An even more tragic instance of unintended consequences was highlighted in 2010 in the Lancet. It involved what is believed to be the largest known case of mass poisoning in world history. In the early 1970s, the newly formed country of Bangladesh, formerly East Pakistan, was ravaged by a cyclone, famines, and political unrest. Much of the world first found out about the plight of the suffering populace when Beatle George Harrison organized the Concert for Bangladesh, the first charity rock concert.
At the time, the only drinking water available to most Bangladeshis came from ponds and shallow pits contaminated by human and agricultural waste. Diarrhea, cholera, and typhoid were rampant and killed thousands, especially children, every year. Western relief organizations headed by UNICEF embarked on a large-scale program to help Bangladesh by drilling millions of shallow tube wells that provided drinking water by hand pump.
The tube well drilling program drastically reduced the spread of gastrointestinal diseases and cut child mortality in half. For this it was hailed worldwide, but what no one realized at the time was that the groundwater feeding many of those tube wells contained extremely high concentrations of arsenic. The naturally occurring arsenic, leached from rocks as the result of runoff from Himalayan snows, could not be detected when the wells were dug. Millions of the Bangladeshis have been poisoned with the highly toxic, carcinogenic chemical for three decades as a result of the wells drilled in the 1970s.
Programs are currently underway to test for arsenic and dig deeper wells that tap safe groundwater, but Dr. Joseph Graziano, health professor at Columbia University, explained, “Bangladesh’s drinking water is one of the world’s most hazardous because of the presence of arsenic. An estimated 40 million people, roughly 30 percent of the population, are currently exposed to poisonous levels of arsenic.” Government efforts to reduce the arsenic exposure have been only partially successful, and millions still consume tainted water.
As these cases indicate, medical decision-making is a balancing act of risk and benefit. Decisions come with hidden variables and unknown facts. Unfortunately, this means some risks are poorly perceived. The familiar adage “the road to hell is paved with good intentions” may be an overstatement, but occasionally the signpost marked GOOD INTENTIONS leads down a tragic path. The safe road turns out to
be filled with danger.
35
CONCUSSION AND CONFLICT OF INTEREST
* * *
It’s just business. Nothing personal.
—VARIOUS SOURCES
IN A REVEALING SCENE from the 2015 movie Concussion, former Pittsburgh Steeler team physician Dr. Julian Bailes, played by Alec Baldwin, and county coroner Dr. Cyril Wecht, played by Albert Brooks, examine pathology slides of the brain of a retired player who died presumably as a result of repeated head trauma. Bailes explains to Wecht that National Football League (NFL) team physicians must administer all sorts of drugs to players, from painkillers to antidepressants, in order to keep them playing.
An outraged Wecht says disapprovingly, “It’s not medicine.”
Bailes explains, “It’s business.”
Concussion is based on the true story of Dr. Bennet Omalu, played by Will Smith, the forensic pathologist who discovered a unique type of brain damage, chronic traumatic encephalopathy (CTE), in several NFL players who died after retirement. The movie depicts a situation in which the NFL attempts to suppress Dr. Omalu’s findings, the implication being that the league had a conflict of interest because admitting the dangers of head trauma while playing football would be bad for business.
The movie is well done, but, typical of today’s Hollywood movies, there is little nuance in motives: Characters are either good (Omalu and his colleagues) or evil (the NFL and their representatives). Unlike real life, there is little middle ground.
One way the movie identifies the villains is that they are the ones with conflicts of interest—it’s about business. A former NFL commissioner (bad guy) is identified as having worked for a law firm that defends big tobacco. A player on the NFL compensation committee (bad guy) is called a “sell-out” by a player who was denied a settlement for his injuries. (That player on the compensation committee happened to be former Chicago Bear Dave Duerson, who later committed suicide, and his family has objected to how he is portrayed in the film.) In the movie, Dr. Bailes (good guy) is redeemed when he leaves his position as an NFL team physician and joins Dr. Omalu’s side.
The Doctor Will See You Now Page 11