Lisa Rosenbaum, MD recently published an article entitled “Reconnecting the Dots—Reinterpreting Industry-Physician Relations,” in The New England Journal of Medicine. Rosenbaum’s article provides a refreshingly balanced analysis of financial conflicts of interest in medicine. “Although most observers agree that we must mitigate the risk of bias introduced by these relationships, the benefits wrought by interactions between physician-scientists and industry at the basic or translational research level are equally clear,” she states. “The question, then, is how to best manage conflicts of interest while preserving the collaborations on which medical advances depend.”
Collaborations and Conflicts of Interest
“Physician-industry interactions have been critical to the development of a large percentage of the medical products that allow physicians to prevent heart attacks, cure cancers, and restore mobility to the elderly,” Thomas Stossel, M.D., a distinguished Harvard hematologist and research recently noted. “Despite such progress and the role of physician-industry interactions in fomenting it, physicians are reducing or severing their relationships with biopharmaceutical and medical device companies out of fear that their patients will mistakenly view such interactions as a sign of corruption, rather than expertise.”
To this end, Rosenbaum sets out to find a “reasoned approach” to physician-industry interactions that acknowledges both the benefits of the collaboration, while recognizing the risks of bias involved. To lay the foundation of her paper, she starts off by describing the release of “controversial new cholesterol guidelines” in November 2013, which expanded the target population for preventative statin therapy. The criticism against the guidelines was swift, she noted from experience, from those who believed that the primary beneficiary of these guidelines would be the pharmaceutical industry.
In a New York Times op-ed, for example, a cardiologist and another physician and industry critic argued that making more patients eligible for statin therapy would “benefit the pharmaceutical industry more than anyone else.” Objecting to using statins for primary prevention, they drew from a medical journal article that one of them had coauthored emphasizing the frequency of side effects. This frequency turned out to be exaggerated, necessitating an erratum in the journal. Yet no one was questioning the editorialists’ credibility in the public press; rather, the editorialists challenged the credibility of the guideline writers: “The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.”
Rosenbaum’s article provides a counter to such industry-skeptics, who are often amazingly uncritical in their dismissal of important industry-collaborative efforts. “One could argue that people also deserve to know that statins are, in many cases, the best drugs we have to prevent cardiovascular disease and that the committee had spent 5 years reviewing the evidence to identify the patients who would benefit most,” she writes.
She also outlines the steps taken to avoid the introduction of conflicts into the guidelines, given that 7 of the 15 committee members did have current or previous industry ties:
- First, the members with current industry ties were not allowed to vote on the quality of the evidence statements or the recommendations, and none of the members without industry ties have developed ties since the guidelines were published.
- Second, because of past concerns about conflicts, the committee used an independent contractor, appointed by the National Heart, Lung, and Blood Institute, to choose the studies on which the recommendations were based.
- Third, though the controversy centered on primary prevention for people whose 10-year risk of a cardiovascular event exceeds 7.5%, the guidelines make clear that this cut point is merely a threshold for initiating discussion about statins, rather than a mandate to start treatment with one.
- Fourth, the resulting guidelines are actually no boon to companies selling patent-protected drugs: most statins are available in generic versions, and the guidelines recommend against using (patent-protected) drugs that improve lipid levels but that hadn’t, at the time of guideline writing, been proven to improve outcomes.
Despite laying out the facts behind the guidelines, Rosenbaum notes: “the greater difficulty is that whereas a rational approach to regulating industry interactions requires careful parsing of such nuances, our general feelings about industry interactions, as the easy dismissal of the statin guidelines illustrates, can be impervious to relevant detail.”
On cue, a response to Rosenbaum’s article in Health News Review did indeed seem impervious to the details: “Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs.” The article’s conclusion? “Don’t trust what comes out of a drug company (or medical journals?) and verify, verify, verify.”
One of the many interesting points Rosenbaum raises in her article is that discussions of bias have been limited to the financial. In fact, she argues, bias is perhaps strongest and most risky when scientists or doctors have a professional stake in the outcomes of their research: discovering a breakthrough, developing novel treatments, publishing journal articles, etc.
Rosenbaum does not gloss over the harm greed can cause, outlining the misleading Vioxx studies that minimized the drug’s risks and ultimately resulted patient harm. However, she believes an overemphasis on a drug’s risks can be harmful as well. “Vioxx’s continued relevance to our management of physician–industry interactions lies in the lingering impression that some companies will do anything to profit, even if it means suppressing evidence to patients’ detriment — an impression reinforced by subsequent Big Pharma scandals,” states Rosenbaum.
Perhaps the most memorable two paragraphs of Rosenbaum’s article are when she pinpoints the reasons behind many deep set suspicions of industry:
For the many physicians whose primary interactions with industry are of the marketing variety, the beneficial nature of other industry relationships may lack emotional traction. We see the attractive pharmaceutical reps in our offices. We eat the lunches (or walk away hungry). Our patients, heeding the “Ask your doctor” mantra of drug ads, request medications we may not believe should be prescribed. We hear that our prescription habits are being monitored so that we can be targeted for better sales. And we observe colleagues, their suits sharp, their skin tanned from a free Hawaiian vacation, their children’s college education covered, and though we may take some satisfaction in eschewing pharmaceutical largesse, still, for some, the resentment burns.
By contrast, how visible to us are physician-scientists whose National Institutes of Health grant applications go unfunded, and who therefore increasingly rely on industry support for their laboratories? Does it cross our minds, when we prescribe statins after a myocardial infarction, how much collaboration between industry and physician-scientists was required to develop them? When we read an editorial by someone who is “conflict-free,” do we wonder whether someone else whose industry ties prevented authorship might have had unique expertise to share? Of course, the fact that the benefits of industry interactions are often imperceptible does not excuse the more easily imagined offenses. But the visibility imbalance helps explain why our aversion to certain industry behaviors deeply colors our overall impressions of industry.
Read Rosenbaum’s full article in the New England Journal of Medicine here.