Life Science Compliance Update

May 19, 2015

"Reconnecting the Dots — Reinterpreting Industry–Physician Relations" Provides A Balanced Look At Physician-Industry Collaboration and Conflicts of Interest


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.  


May 08, 2015

Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation


Long a champion of physician and industry collaboration, Thomas Stossel, M.D., has published a new book entitled Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation. In it, Stossel, a distinguished Harvard hematologist and researcher, decries the conflict of interest movement as detrimental to medical progress and ultimately the patients who would benefit from new, innovative therapies.

Writing about conflicts of interest has been an increasingly surefire way to get published—the Journal of the American Medical Association even has its own conflict of interest category. What’s often missing from both sides of the mostly academic “COI” debate, however, is a relation back of nebulous concepts to what is important: tangible medical innovations and patient well-being.

One of the reasons Dr. Stossel’s writing is so engaging is that he bucks this trend by illustrating in plain language what is at stake. “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,” he writes.

Over the course of my career, medicine and industry have together made spectacular progress against diseases. Cardiovascular deaths are down 60 percent, HIV has been converted from a death sentence to a chronic disease, and cancer mortality is at a historic low. 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.

In addition to the large amount of ink being spilled in academic journals on COI, Stossel characterizes a number of recent legislative measures as being similarly “pharmophobic.” He points specifically to the medical device excise tax and the Physician Payments Sunshine Act, which requires pharmaceutical and device companies to report any payments to physicians and teaching hospitals of more than $10. These payments are reported on a publicly accessible website, “with minimal explanations,” he notes, which “stigmatiz[es] relationships that are critical to the development and dissemination of new medical products.”

“[O]ne of the highest-paid physicians in the Sunshine database is a world-famous vascular surgeon who received royalties for his invention of multiple aneurism repair devices,” Stossel illustrates. Similarly, "Paul Offit, who invented the rotavirus vaccine that is believed to have reduced the incidence of hospitalizations for rotavirus-induced diarrhea by more than 85 percent among U.S. toddlers since its addition to the childhood-vaccine schedule in 2006, is often maligned for his industry ties." Stossel concludes: “Such cases, along with research grants for clinical trials, dominate the largest payments documented under the Sunshine Act. They are unequivocally beneficial and should not be stigmatized in this manner.”

Dr. Stossel’s book also aims to illustrate just how important private industry has been to these amazing breakthroughs. Again, he is the perfect spokesman for this. “I’ve done medical research for most of my career, and people say that I’ve been successful at it," he notes. “I hope that this research will save lives someday, but only drug and device companies can make that happen.”

He writes:

Publicly supported academic research certainly advances medical knowledge. But converting that knowledge to clinical benefits isn’t straightforward. Helping patients justifies public research funding, but obtaining such funding depends far more on impressing grant review committees with the novelty and virtuosity of research than with its practical medical applications. I know, because following these precepts has certainly contributed to my success. I have had continuous government research funding for over 45 years, have published research papers in prestigious scientific journals, won prizes, and been elected to elite scientific societies. Yet no one has lived one second longer or better as a direct result of my research.

But regulations, largely stemming from the conflict of interest movement has only served to impede medical innovation. “Regulations always slow things down, and compliance and enforcement divert precious funds from research and development,” states Dr. Stossel. “It takes on average 16 years and costs over $2 billion to get a new drug approval by the FDA.” This delay matters:

For patients desperate for new treatments and cures, such delays can be lethal. Marketing restrictions mean doctors don’t learn about drug and device advances. Delays or prevention of potentially innovation-promoting relationships between researchers and industry have been documented. The myth that device and drug development isn’t difficult and expensive encourages enactment of taxes on companies and calls for price controls. Both inhibit innovation.


Dr. Stossel stands as a rare counter to the COI movement, and provides years of experience and patient-centered arguments to back it up.  Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation is out now and available here. Also, read  a Q&A with Stossel about his book.

In full disclosure, Thomas Sullivan, Editor of Policy and Medicine is listed in the preface to Pharmaphobia, he receives no remuneration from the sales of this book or his work with Dr. Stossel.  

February 27, 2015

New Poll Shows Majority of Americans Are Concerned About Pace of Medical Progress


According to America Speaks, a compilation of public opinion polls commissioned by Research!America, the majority of Americans agree with the central tenets of the 21st Century Cures Bill

"Majorities across the political spectrum say it is important that the new 114th Congress takes action on assuring the discovery, development and delivery of treatments and cures for diseases in the first 100 days of the legislative session (75% Democrats, 64% Republicans and 60% Independents)," states Research!America. "As Congress considers numerous proposals in support of research, including the 21st Century Cures draft legislation aimed at speeding the delivery of lifesaving treatments to patients, it is notable to see public support in favor of accelerating medical progress."

Speed Drug Approval Pic

The report found that an increasing percentage of Americans say the U.S. Food and Drug Administration (FDA) should move more quickly in order to get new treatments to patients, even if it means there may be risks. In 2015, 38% favor faster regulatory review, compared to 30% in 2013 (see the graphic to the left). Meanwhile, 25% say the FDA should act more slowly in order to reduce risk, even if it means patients may wait longer for treatments.  Another 19% are undecided on this question and 18% do not agree with either position.  

When it comes to rising health care costs, 46% say research to improve health is part of the solution, while 28% are not sure and 26% say research is part of the problem. Meanwhile, 41% say that the roughly 1.5% of government spending allocated for biomedical and health research is not enough. Nearly one-third (29%) say it is about right, 21% are not sure and 9% say it is too much.

Furthermore, 44% say they are willing to pay $1 per week more in taxes if they were certain that all of the money would be spent on additional medical research, while 32% say no and 24% are not sure.

Currently, only 27% of Americans believe the U.S. has the best health care system in the world, but more than half say it is important that the U.S. is a leader in medical and health research. Furthermore, confidence in the current system in the U.S. for evaluating the safety of vaccines and recommendation for when they should be given dropped to nearly half, compared to 85% in 2008.


Among the polling results:

  • 70% of Americans agree basic scientific research that advances the frontiers of knowledge, even if it brings no immediate benefits, is necessary and should be supported by the federal government.
  • 80% of Americans say it’s important that elected officials at all levels listen to advice from scientists.
  • 78% of Americans say it’s important that our nation supports research that focuses on improving how our health care system is functioning.
  • A plurality (44%) say they’re willing to pay more in taxes if they were certain that all of the money would be spent on additional medical research, and
  • More than half (53%) say it’s important to make the R&D tax credit permanent
  • 56% of Americans favor expanding federal funding for research using embryonic stem cells.
  • More than half (55%) of Americans are willing to share their personal health information to advance medical research. An even higher percentage (60%) say they will share personal health information so that health care providers can improve patient care, and 46% percent are willing to share information so public health officials can better track disease and disability and their causes.
  • 73% of Americans say the federal government should assign a higher priority to improving education focused on science, technology, engineering and mathematics (STEM) and careers in those fields.
  • Studies show that certain health problems such as diabetes, heart disease and infant mortality happen more often among minorities or citizens with lower incomes. More than two-thirds of Americans (69%) say it is important to conduct medical or health research to understand and eliminate these differences.

 View the full report:  Download AmericaSpeaks Volume 15

Research!America notes that their online polls are conducted with a sample size of approximately 1,000 U.S. adults, age 18+, with a maximum theoretical sampling error of +/- 3.2%. Data are demographically representative of adult U.S. residents. Polling in this publication was conducted by Zogby Analytics.



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