A recent article in PLoS Medicine examined the role ghostwriting played in recent litigation against Wyeth, where more than 14,000 plaintiffs brought claims related to the development of breast cancer while taking the menopausal hormone therapy Prempro (conjugated equine estrogens [CEEs] and medroxyprogesterone acetate [MPA]).
The author of the article, Adriene Fugh-Berman, M.D., who directs PharmedOut, a radical group calling for the end of commercially sponsored continuing medical education (CME), had a very significant “competing interest” listed in the article. Specifically, she was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper. In other words, she was a “hired legal gun.”
What is problematic about this so called competing interest is that as a hired expert for the plaintiff, her position automatically assumes a bias against a certain position, in this case, against a pharmaceutical company (no surprise there).
For someone whose whole career and theory rests on the premise that relationships with outside sources can create bias and potential conflicts of interest, Dr. Berman violates her very own principle in this article, which basically acts as a summary of the expert witness testimony she was paid to offer, although she claimed she was not paid for her research of this paper.
Consequently, the article rests on the review of some 1500 documents revealed in the litigation, which Berman asserts, “Provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals.”
Among the documents reviewed, she asserted that “dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HT), and to cast raloxifene and other competing therapies in a negative light.”
Using the example of this case, Berman goes on to claim that there is “growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs.” While she does not specifically cite to which “highly promoted drugs” are being ghostwritten about, she maintains that “the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.”
In doing so, she massively broadens the definition of ghostwriting to encompass participation of professional writers in soliciting, drafting or editing of papers. The fact is that such writers provide assistance to academics as well as commercial entities (just as speechwriters abet politicians). If this writing assistance is good, and the academic author takes advantage of the help of writers yet assuming authorship vets the product, the assistance adds value or at least reflects the authority’s considered opinions. Then, the burden of proof falls on the critics to prove otherwise.
Along the same line of reasoning, she noted that “physician-investigators should create and uphold a standard where relationships with industry are regarded as unsavory rather than sought after.” In that regard, she wants the profession of medicine to “denormalize relationships with industry and avoid the role of corporate pawns in the future.”
These extreme generalizations are misguided because they attempt to group together all relationships with industry and physicians into the same category based on the instance of one case in litigation. Such a tactic is problematic because it undermines the successful relationships in the past and present, which have produced significant breakthroughs in medicine. It is also harmful to the future of such relationships because it casts a shadow of doubt about the legitimacy of such partnerships, which is unnecessary considering all the changes in transparency and disclosure.
This will have the impact of chilling the willingness of researches in academia to participate in clinical studies or commercially sponsored research or CME. When that happens, the results will be exponential because thousands of patients, whose health or lives would have been improved by the education or discovery from such commercially supported activities, will remain unchanged.
Without a consideration of the benefits industry collaboration produce, in her “competing” role as a paid expert witness for the plaintiff it is clear from this article that Berman’s main goal was not only to convey what she had been paid to find but, to take those findings to support her own mission against ending industry support of almost everything in medicine. How she plans to pay for all the research, training and education once such funding is gone remains a mystery.
Her article is blind to the fact that the overwhelming majority of practicing physicians, in all realms of medicine, follow strict ethical guidelines regarding research, publication, education and training. Their ethical behavior is demonstrated by the high level of support Americans have in the profession of medicine as demonstrated by numerous surveys such as the Harris polls. The only people who see doctors who work with industry as corporate pawns are those who are paid to, like Dr. Berman.
Another fairly troubling problem is that Dr. Berman is not is a clinical expert on hormone replacement therapy (HRT). In fact, the background (Google and PubMed) of the author shows that she teaches “alternative medicine” in general and “natural” hormones in particular. If true, an attraction to nutriceuticals and, more to the point, an animus against pharmaceuticals, is not surprising, and it’s no wonder then that such an individual was sought out by anti-pharma litigants.
So then, what is the difference, in the context of “promotion,” between professional writers scripting academic authors and plaintiffs’ lawyers scripting an academic to demonize professional writers? What is the difference, in the context of “promotion,” for PLoS (and the New York Times) to accommodate such demonization as academic scholarship (or furthering “public health”), when it “promotes” the cache value of PLoS — as evidenced by Nature’s hyping it?
Doctors should continue to seek work with industry because the benefits from these partnerships far outweigh the “unsavory” consequences which Dr. Berman was paid to advocate for. And with more and more companies coming under corporate integrity agreements, and coming into compliance with regulations from Congress, federal agencies, and institutions, it’s unlikely those unsavory consequences will exist much longer.
Accordingly, generalizing relationships between physicians and industry from one negative case will only end up hurting more patients by limiting the roles and experience doctors can achieve by working in collaboration with industry. Doctors need the freedom to conduct their research, education, training and clinical practice without restrictions that make such activities wrong because of a few errors. A handful of space shuttles have been destroyed during their missions. Do we stop exploring space? No. Likewise, while some mistakes have occurred between industry and physicians, this does not justify impeding scientific research, collaboration and discovery.