Life Science Compliance Update

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May 18, 2010

Boston Review: Boston Unscientific -- Selling Fiction

In its May/June Issue, Boston Review takes a narrow approach at examining the important work and collaboration between industry and physicians.  Instead of offering balanced perspectives, different points of view, and a scholarly debate based on evidence, the magazine—which claims to be “nonpartisan”—chooses eight (8) authors who uphold the belief that “Big Pharma, is Bad Medicine.” In comparison, they only offer one spot for an author who discusses the “value of academic-industry relationships.”

The main article, written by Marcia Angell, M.D., was an adaptation of a lecture she gave at Harvard University’s Edmond J. Safra Foundation Center for Ethics as part of a lecture series focused on Institutional Corruption.

Dr. Angell-Relman

Her comments focused on the impact the drug industry has had on academia, clinical trials, conflicts of interest, and CME. In covering each of these issues, Dr. Angell asserts that industry funding is harmful, and recommends extreme measures, which basically eliminate any source of funding from industry.

She also agrees with other authors (David Bollier, alternative medicine professor Adriane Fugh-Berman, Howard Brody, Dan Brock, and Suzanne Gordon) who believe that financial conflicts of interest are a serious impediment to good medical research, education, and clinical practice. This idea however is questionable because Dr. Angell herself acknowledged that “industry and academia are partners, both benefiting from public support.”

And with regards to CME, “no published studies have addressed the relationship between commercial support and perceived bias in accredited CME activities.” To the contrary, there are various studies that show the exact opposite.  Clearly then, Dr. Angell’s comments and recommendations seem premature at this point, especially when critics of industry support offer no solution to account for the 50% of industry funding for CME that would be lost.


Dr. Angell also agrees with Dr. Fugh-Berman that “drug companies rely on physicians to sell diseases.”  Is cancer, heart disease, obesity, diabetes, or other chronic illnesses made up? No. And unfortunately, every American has been touched one way or another by these diseases. It is highly unlikely that those who suffered from these illnesses and their families believe the disease was sold to them when their loved one quickly began to disappear.  Rather, any of those family members of friends would have welcomed industry representatives, physicians and researches with open arms if it meant a new treatment could give their loved one more time.


Even more problematic is how casually Dr. Angell agrees with Dr. Fugh-Berman that drugs are created to prepare a new class “for a new drug or a new use for an old one” ignores the regulatory process that companies have to go through. It also ignores the significant amount of research and legal usage of off-label prescriptions that physicians help patients with, many of which have been clinically proven.


Her suggestion, along with Brock, and Fugh-Berman, to eliminate industry funded teaching because the budget for such activities comes from marketing is misinformed. Many companies have specific and separate budgets and committees for awarding educational grants. Not to mention the fact that providers who accept educational grants from industry must comply with FDA and ACCME regulations which prohibit industry control.  Additionally, CME providers and various institutions that provide CME enforce strict policies that do not let industry funding control the content of such programs.  

In trying to attack just about every kind of health care provider, Dr. Angell asserts that nursing is now “being contaminated by the pill pushers,” based on the idea that nurses are “tired of being overshadowed and under-valued by their physician colleagues,” is extremely troublesome. With the recent numbers showing a severe shortage of physicians over the next decade, and a rapidly growing elderly population, nurses and physicians assistants will be relied on increasingly. As a result, their training, knowledge, experience and basic understanding of treatments and medicine are crucial in assisting overworked and underpaid physicians.  The only thing nurses are tired of is watching their patients be left with no treatment options because the FDA is too slow to approve new clinical trials and drugs.

Accordingly, her belief that academic medical center policies are inadequate is also misplaced.  In her opinion, the only acceptable policy would be to strictly prohibit all interaction of physicians in academia with industry.  Such a policy would hinder innovation and research, and would leave numerous clinical trials and important studies without funding.  Not to mention, those in industry who depend on supplemental income for various reasons would be deterred from working in academia. 

While she believes that “disclosure does not eliminate conflicts,” this should come as no surprise because overwhelmingly, work with industry is simply not a conflict.  It is an ethical relationship, the products of which have saved millions of lives and made people healthier and live longer for decades. 

Despite a few recent cases—the majority of which deal with off-label marketing—policies in existence do prohibit conflicts and manage them effectively.  With oversight from various agencies such as the FDA, ACCME, NIH, and individual association and institution policies, limitations on such relationships are the practice in today’s health care industry, and this trend will continue to grow with the recent passage of the Sunshine act.

As a result, her notion that “serving as a director of a drug company constitutes a dual loyalty” is contrary to the widely accepted belief that working with industry is a “commonality of interests.”  As Dr. Stossel pointed out, in “medicine, there is an alignment of interests, and it is win-win (physician-industry collaboration) if it adds value.”

What critics like Dr. Angell and Dr. Fugh-Burman do not realize is that the responsibility for determining bias once these relationships are made public is up to the individual patient.  The last thing a sick or unhealthy patient wants to hear is that after years of prescribing a drug, their doctor cannot prescribe it to them because their physician gave a speech about the drug.  Patients have the right to choose what risks and benefits they will weigh in determining their treatment options, and taking that away from them for what some think appears to be bias is problematic. 

Consequently, critics and those who wish to regulate industry-physician relationships must take a step back, and allow the recent developments—the Sunshine Act, companies posting payments, and numerous policies at academic medical centers—to sink in.  This is particularly important because almost every “study” or piece of “evidence” by critics about industry relationships calls for “more research.” 

Patients need time to learn about these relationships and ask their doctors specifically, without being bombarded with negative media attention—such as the articles in this issue—that only cover one side of the argument.  It’s not just a coincidence that 94% of physicians work with industry.  Medicine and physicians depend on industry support for education, innovation, research and giving patients the best available options.

Despite numerous articles which have pointed to the results of academic-industry-physician relationships, and even research that shows no bias when industry funding is present, Dr. Angell conveniently ignores these facts.  Instead, she chooses her own experiences to disagree with Dr. Korn’s recommendation that a “nuanced” approach for relationships with industry should be used because they facilitate the development of new treatments.

Her reasoning for not taking a “nuanced” approach is her opinion that “collaboration with industry on research does not require the personal enrichment of the researchers, nor does it require that faculty have myriad irrelevant financial associations with industry.”  Does taking a risk worth $1 billion, years of research and close to impossible odds of success sound much like “personal enrichment for researchers?”  Financial associations that exist within the drug industry are no different than any other industry, except of course the outcomes save millions of lives.

Dr. Angell is “also unsympathetic to the notion that the public is somehow responsible for making academic medical centers behave badly.”  She quickly brushes away the fact that Americans want better, faster, cheaper, and more options for treatments, at a time when resources are non-existent, and agencies like the FDA have 200 vacancies, and CMS still does not have a commissioner almost three years later.  The reality is the public expects more of science, and rightfully so, and pharmaceutical professionals have the public’s best interest in mind, they are just being slowed down by the pace of government.

If Dr. Angell’s call against industry was not enough, the Boston Review also included an article “Selling Disease” by assistant professor of alternative medicine Adriane Fugh-Berman, M.D. to carry out a coordinated attack against the valuable relationships of industry and academia, and CME.  

The article which amounts to a fictional account of pharmaceutical companies supporting CME to educate physicians on a fictitious disease, is a remake of a 2002 BMJ article.

The alternative medicine crowd understands that if you are going to be successful in discrediting medicine you can’t do it based on scientific evidence so why not just make up stories that perhaps readers will believe. This is especially true if all they are told you are a professor of family medicine in the article sideline and not give your true job. 

Dr. Fugh-Berman espouses that educating physicians through CME about medicine is corrupt.  This is an attempt to limit the information on new medications that physicians receive and give to their patients.  This way if physicians aren’t learning about medicine then patients can educate their physicians about alternative medicine. 

Ultimately, it is up to the patient to choose between a doctor who has no direct knowledge of a drug or a doctor who has prescribed that medicine for years, and as a result, has used their experience working with industry to share their knowledge.  With all the public information being readily available to patients, they should be the ones who ask their doctors about the medicines they are prescribing and why.  The last thing physicians and patients want is to take away valuable research and data because if doctors do not learn about these drugs and treatments, what options will patients have left to choose?

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