ARTICLE IN BRIEF
An MS patient decides to choose another neurologist after she learned that his financial interests with industry might have shaped his treatment choices. Other neurologists weigh in on the potential impact that new disclosure laws might have on the physician-patient relationship.
“Last year, four years after showing initial symptoms of multiple sclerosis (MS), I walked out the door of one neurologist's office and, after several months of searching, switched to a different doctor. It was the final act in a series of events that had gradually eroded my trust in the first neurologist's judgment, which I believe was colored by his financial relationships with drug companies who manufacture and market medicines for MS patients.”
So began Maran Wolston, a doctoral candidate in philosophy at the University of Minnesota, as she recounted her experience in the story, “An MS Patient Loses Trust When She Finds Out Her Doctor Is Paid By Drug Companies,” published in Health Affairs this past December. In the article, Wolston chronicled a series of revelations that eroded her confidence in her care. In short order, she learned that her neurologist had received more than $300,000 from drug companies, one of which had sponsored the clinical trial to which she had been enrolled, and another that manufactured the drug her doctor had prescribed. The sum had included compensation for “speaker fees” and for “promotional/ marketing consulting services.”
Wolston acknowledged that that given her background in medical ethics — she had taught courses on the subject as an adjunct professor at a community college — she was familiar with the potential conflicts of interest that exist for physicians participating in clinical pharmaceutical trials. She looked up her neurologist in a database provided by the Minnesota Board of Pharmacy displaying pharmaceutical company payments to doctors spanning from 2002 through 2010. By next year, any patient in the United States will be able to do this search, thanks to the creation of a national physician payment database developed under the Physician Payment Sunshine Provision of the Affordable Care Act. Even now, several states have mandatory marketing disclosure laws; anyone can access the ProPublica database, Dollars for Docs, and search by physician to find the disclosed payments made to health care practitioners by 12 pharmaceutical companies.
While proponents of the new legislation believe that the archive is sorely needed because greater transparency will allow patients to decide whether they need to consider their physicians' conflicts of interest, others are concerned that it will deter physicians from working with industry, a relationship many believe is necessary for fostering innovation and improving care.
SHOULD INDUSTRY RELATIONSHIPS BE AVOIDED?
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“There are many legitimate relationships with industry, and I would argue that these are necessary,” said John R. Corboy, MD, professor of neurology at the University of Colorado School of Medicine and co-director of the Rocky Mountain MS Center at Anschutz Medical Campus. Physicians, if they act properly, are the only non-pharma intermediaries that stand between the companies and the public.
“If we don't participate in the trials, in the design, in the publications, will the public ever believe any research findings?” he asked. “The key is for the public to encourage scrutiny, and for physicians to not sell their souls. Whatever the neurologist [described in the Health Affairs article] did, he appears to have left the impression that he was not working for the patient, but rather for pharma. So, he failed the patient smell test; it's all about trust.”
“I've had many interactions with pharma, all above board, all disclosed in numerous locations, and all legitimate business relations,” said Dr. Corboy, who serves on the editorial advisory board for Neurology Today. He added that he doesn't do canned talks, doesn't receive money as per-patient inducements to enroll people in studies, and won't write articles that are ghost-authored. “I don't have a clue how someone would receive $300,000 dollars from industry,” he said alluding to amount received by the neurologist cited in the Health Affairs story. “I highly doubt I have received half that much in 20 years total, for any advising or consulting services.”
CLINICAL TRIAL INDUCEMENTS
While the subject of physician-industry relationships is complicated and multifaceted, Wolston raised three particular grievances in her story: that her neurologist received an inducement for her clinical trial, that he exhibited a prescribing preference created by receiving money from pharma, and that the role of the drug company-provided nurses lacked transparency and compromised her care.
Criticism of clinical trials hits a chord with many neurologists who are committed to scientific research. Fred D. Lublin, MD, the Saunders Family Professor of Neurology at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai School of Medicine, argued: “I don't view such payment as an inducement, but rather contracting for payment of work involved in recruiting individuals, ensuring that they meet certain criteria. Patient participants in clinical trials should be made aware of these contracting arrangements.”
Dr. Corboy noted, however, that many people consider it unethical to accept a per patient enrollment fee. While he concedes that the issue is complex, he likens it to how the Supreme Court defined pornography: “You know it when you see it.” He likewise believes that financial incentives are improper when they are targeted towards patients. While some researchers point out that clinical trials provide a mechanism for uninsured patients to get medical care, Dr. Corboy noted that this dilemma only adds another conflict of interest.
“By definition you've stepped into a situation in which vulnerable patients are tempted to accept on the basis of financial need. But what happens if those patients suffer an acute attack and require treatment or hospitalization while on the trial, will they be able to pay for that? How can you ignore treatment?” he asked. Indeed, Dr. Corboy observed that mistakes may occur even without inappropriate inducement on the physician or patient side — such as, for example, when physicians have incorrectly treated patients with the wrong diagnosis or at the wrong stage of the disease. Offering a financial incentive just makes this scenario even more unfortunate, he said.
But when it comes to the question of drug selection — there are seven FDA-approved MS drugs to choose from, he noted — there is not much comparative data to help neurologists select one over another. “So it's not unusual for patient prescribing recommendations to be based on neurologist experience with clinical trials,” he observed. “It would be hard to fault someone who had gained a comfort level with a certain drug during that experience and has a bias towards it, no matter how inadvertently it had been created.”
Nevertheless, Dr. Corboy has also seen clear examples of outright shills and, he admitted, such situations are hard to enforce. He cited the case, for example, of a colleague who gave an MS talk that was blatantly biased and appalling to the entire audience. And he said he worries that the most heavily conflicted physicians may be the least likely to disclose their conflicts. “The current system relies on the integrity of individuals involved to offer the appropriate level of disclosure, but we haven't created a system that includes an investigative arm that checks our bank accounts, for example,” he said.
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It's also not clear that greater transparency will have an impact on neurologists' activities. “I've heard some physicians claim that they take money from all the companies so they have no bias,” said Christopher T. Bever, Jr., MD, associate chief of staff for research and development and director of the MS Center of Excellence-East, VA Maryland Health Care System. Those physicians are unlikely to modify their behavior, he added.
Dr. Bever is encouraged by the new “sunshine” legislation. The current situation undermines patient trust in physicians because no one really knows if their physician is receiving payments from the companies whose drugs or devices they are recommending, he said. “With disclosure, patients will know which physicians are receiving payments, who is paying them, and how much money is involved,” he explained. While he predicts that in the short run there may be a negative reaction about the amounts of money some physicians are receiving, in the long run he believes that disclosure will increase the level of trust.
WHAT ABOUT PHARMA NURSES?
Although Wolston was initially grateful for her nurses' guidance, she later became suspicious of their motives when she developed increasingly worse local side effects, but was encouraged to continue on the drug. She subsequently discovered that the organization, Shared Solutions, was a subsidiary of the pharmaceutical company that made her drug.
While neurologists like Dr. Corboy, who work at large MS Centers, are able to hire their own nurses to follow up with patients and handle medication issues, many neurologists in practice are unable to hire dedicated staff to handle the volume of calls that occur when side effects arise. So, they often rely on pharma-employed intermediaries to provide nurses to answer patient questions regarding medication. “Their motivation is to keep the patient on that particular drug,” Dr. Corboy pointed out. “It's a utility for us, but by signing off our patients for these services, we may be compromising their care.”
“The physician and Shared Solutions should have clearly identified their roles,” said Daniel G. Larriviere, MD, chair of the AAN Ethics, Law and Humanities Committee and a member of the Neurology Today editorial advisory board. “To properly respect the patient's autonomy and to allow her to make informed decisions, all parties should have clearly identified their roles,” he said. “Although disclosure does not solve all problems, it is something.”
Dr. Larriviere believes that the disclosure of the information worked as it should have in Wolston's case: once she learned of the relationship between her physician and the pharmaceutical industry, she opted to choose another physician without such ties. He also suspects that the realities of the marketplace will shape physician behavior.
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“As these databases become more widely known and utilized by patients, patients will determine whether the relationship is appropriate or not, and physicians will have to change their practices accordingly or risk losing business,” he said. “For those involved with industry who believe in the value of what they do, that will mean more aggressively disclosing their interests and activities up front, and providing the patient with the opportunity to ask questions and satisfy themselves about the propriety of the relationship. For others, that will mean divesting themselves of relationships that are difficulty to justify.”