When the issue is conflicts of interest in biomedical research, debate is generally centered not on whether to regulate but how much to regulate. Yet while state legislatures, medical schools and health care associations weigh in with varying ideas for oversight of doctors and their drug-rep-provided free lunches, one Harvard professor of medicine is organizing an opposing army.
Thomas Stossel, the American Cancer Society Professor of Medicine at Harvard Medical School, is spearheading a new nonprofit professional organization that is, according to Stossel’s preliminary description, “to be a forum for what we believe is a hitherto silent majority of individuals engaged in clinical service, medical education and medical innovation ready to oppose a small but well organized and well-funded coterie responsible for an anti-industry movement.”
The Association of Clinical Researchers and Educators (ACRE), slated to hold its charter conference this month, will be led by a steering committee consisting of physicians from Harvard Medical School, the State University of New York Downstate and the Mayo Clinic. Thomas Sullivan, president of Rockpointe, a medical communications company that organizes educational symposia, often with pharmaceutical sponsorship, for doctors is helping Stossel with the group's formative steps; ACRE will be logistically managed by Diann Rohde and Associates -- Rohde being a former vice president at the National Multiple Sclerosis Society. So far, funding for ACRE has been covered completely out of pocket, though Stossel said he welcomes industry participation and support. The tentative schedule for July’s meeting includes more than two dozen speakers – doctors, industry representatives, health and patient association officials -- and topics range from policy explanation to the value of collaboration between medicine and industry (for which, of course, Stossel makes no apologies).
According to Stossel, the perceived risks of physician-industry relationships are too often demonized instead of assessed for value. “The damages are imaginary or speculative,” he said, adding that in the “crescendo” of anti-business sentiment in science and medicine, “no one wants to sign up to be abused by The New York Times or Senator Grassley.”
Sen. Charles Grassley of Iowa has certainly been at the forefront of the crusade against conflicts of interest in medicine -- making public revelations of wrongdoing and proposing stricter regulation through legislation -- and some of those high-profile conflict of interest cases have indeed inspired tighter scrutiny.
Harvard Medical School, for example, is reviewing its conflict of interest policies after Grassley last year uncovered that psychiatrist Joseph Biederman of Harvard-affiliated Massachusetts General Hospital received $1.6 million from companies that produced the drugs he used to treat children for bipolar disorders. Part of the push for review of conflict of interest policy came from Harvard Medical students who lobbied for faculty to be subject to a full disclosure policy. Also last year, the National Institutes for Health froze funding for an Emory University depression study because of a conflict of interest involving Charles Nemeroff, chairman of the psychiatry department and the study’s principal investigator. Nemeroff collected, but mostly did not disclose, about $2 million from pharmaceutical companies that, in some cases, produced the products he was using in his research.
According to Avi Markowitz, cancer research chair and professor at the University of Texas Medical Branch’s Comprehensive Cancer Center, and also the associate clinical director of oncology clinical trials there, those high-profile cases are not indicative of a widespread ethical problem in medicine or medicine-related industry.
“There’s a normal distribution of human behavior,” said Markowitz, who sympathizes with Stossel’s cause and is slated to speak at the charter ACRE meeting in July. “You’re going to have sleazy people here and there. Are regulations going to stop these people? No. But that should be caught if you have appropriate disclosure.
“Frankly the stuff at Harvard,” he continued, “I don’t know how that stuff can happen and people not know. The way to deal with that is not to say that [doctors] can’t [work at all with industry]. The appropriate response is, who was supervising them and didn’t catch it? Or did, but didn’t do something about it?”
Moving beyond disclosure requirements to bans on certain physician-industry relations, though, is exactly the direction some officials are moving -- which Stossel sees as a slippery slope to "totalitarianism" in medicine. Vermont passed a law this June that, along with requiring drug and medical device makers to publicly disclose the amounts of money given to health care providers and the names of those providers, will ban nearly all industry gifts to doctors, nurses, medical staff, pharmacists, health plan administrators and health care facilities.
While Vermont’s law is certainly more stringent than most, other states have similar rules on the books: Minnesota requires pharmaceutical companies to report payments to doctors and Massachusetts, as of last year, limits the kinds and amounts of gifts health care providers can receive (with mandatory disclosure of payments over $50).
Apart from state-mandated regulations, university membership groups are endorsing stricter federal requirements for biomedical research -- the Association of American Universities and the Association of American Medical Colleges in June recommended that the government up reporting requirements for those involved in biomedical research -- and individual institutions are adding their own regulations as well. The University of Wisconsin, for example, recently began requiring its doctors to fully disclose specific dollar amounts of payments received from industry-related activity -- replacing a prior policy that allowed for payments exceeding $20,000 to be reported just that way.
For Stossel, the more minor regulations regarding doctors’ acceptance, for example, of pens and meals -- the “low-hanging fruit” -- is where the regulation trend started, but has grown egregiously in a way that is “disrespectful” to physicians and industry alike.
“The pens, the meals, who’s going to fall on their sword for that?” he said. “But when that’s done, now you’ve admitted you have a corruption problem.”
But what’s more important, he says, is that “influence, on balance” is not detrimental to patient care. “For me as a patient,” he said, “when some surgeon is up to her elbows in my abdomen, I don’t care who’s paying her, I just want her to be good.”
And as far as making doctors -- and their tools -- better, Stossel contends, physician-industry partnerships are beneficial because “in order for doctors to be on the cutting edge, they need to be close to business.” Most of the recent major positive advancements in science and medicine -- discovery and development of new medications and new medical devices -- have been gained in part from industry, Stossel said.
And not only that, Markowitz said, but the research done through industry-sponsored trials is often even more rigorous and vetted than research done through trials outside of industry presence. Markowitz shared a story about a small mistake in dosage in one of his patient trials being conducted under the purview of the National Cancer Institute -- something that was not harmful to the patient, but negatively impacted trial efficiency. “Those little things will happen” in trials that are both industry-sponsored and not, he said, but they are more likely to be quickly caught and corrected under industry’s watchful eye where “the scrutiny and manpower is so much greater.”
Those behind the movement toward tighter regulation on relationships between medicine and industry generally acknowledge the societal benefits of such partnerships, but also claim, as an April report by the Institute of Medicine points out, that “[s]uch conflicts present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust.”
While Stossel calls the IOM’s justifying evidence simply speculative, Bernard Lo -- chair of the committee that produced the institute's conflict of interest report, and a professor of medicine and director of the program in medical ethics for the University of California at San Francisco -- cites “carefully reviewed empirical evidence” as the backbone of the institute’s regulation recommendations.
“In medical research, there are numerous documented examples of bias in research design and reporting associated with industry sponsorship of clinical trials. In clinical care, there are studies suggesting that use of drug samples and attendance at drug company presentations is associated with prescribing that is inconsistent with evidence-based practice guidelines and with the physician’s own preferred prescribing choices,” Lo said in an e-mail, adding that participation of medical school faculty in speakers’ bureaus, at least where content is provided solely by industry sponsors and not analyzed by the faculty, might also undermine the mission of academic health centers to teach critical thinking and independent appraisal of evidence.
“The evidence overall is suggestive rather than definitive,” Lo said, “but addressing conflicts of interest is a matter of preventing undue influence, bias, and loss of public trust, rather than trying to remediate proven cases of bias.”
But for those in Stossel’s camp, including Markowitz -- who will present at ACRE’s charter conference on the value of collaboration between medicine and industry -- what the IOM report suggests is that doctors should be presumed guilty until proven innocent.
“There has been a McCarthy-style witch hunt going on here. I believe the standard should be that you’re innocent until proven guilty,” Markowitz said. “Can I tell you everybody is on the up and up? No. But there are people in every profession who will behave dishonorably, and no rules anywhere will stop those people from doing that.”
The most egregious cases making recent headlines -- the Nemeroffs and Biedermans -- are not excusable, Markowitz said, but are bound to happen with or without more extensive regulation of the physician-industry relationship. Bad apples are a fact of life, he said.
Where the two camps -- those who would call physician-industry relationships conflicts of interest and those who might not -- might find room for compromise is in financial disclosure guidelines. The IOM’s report called for doctors to report their industry-related earnings as an essential “first step” in identifying and responding to conflicts. While the IOM goes further in suggesting restrictions on the ways doctors ought be allowed to collaborate with industry, and Stossel and Markowitz mostly cringe at those recommendations, that first step of financial disclosure is generally not in dispute.
Both Stossel and Markowitz said they have drawn income from industry-related activity -- Stossel added he’d be happy to disclose the figure if “we level the playing field by publicizing the salaries, bonuses and board fees of academic administrators and high-profile medical journal editors who are demanding or making the disclosure and prohibition rules.” Stossel did say that he has advised biotech companies, participated in speaking engagements and has “licensed to a company and made money” off his research. “That’s what I went into this business to do, to do something creative to help patients,” he said.
Henry Black, clinical professor at the New York University Langone Medical Center and another speaker slated for ACRE's July conference, said full disclosure is "perfectly fine" -- that patients could decide for themselves if industry-related income implies bias -- but that now, because of a heightened public attack on conflicts of interest, "people assume if you get any money you're dirty."
Markowitz, who said that over the course of a quarter century he’s worked with a majority of the major players in pharmaceutical development, fully supports financial disclosure requirements (on top of his $350,000 salary, Markowitz said he’s made as much as $30,000 in a year from work with industry, while in most years he collected half that). Speaking freely about his non-salary income, Markowitz did add a caveat: “If you want me to do it, shouldn’t you make the politicians do it? The journalists?”
Markowitz also added that an arbitrary cap on how much a physician can receive is unreasonable. If a physician is accurately reporting his industry-related income, Markowitz said, the level of scrutiny of that doctor’s relations will naturally intensify with higher reported amounts.
It’s far from dirty money, Stossel says -- in fact, he added, he takes a biannual trip to a remote village in Zambia to see about a thousand people in need of health care: “And I can afford to go because of my ill-gotten commercial gains.”
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