Provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals
Unregulated Marketing through Medical Journals
Adriane Fugh-Berman examines documents unsealed in recent litigation to investigate how pharmaceutical companies promoted hormone therapy drugs, including the use of medical writing companies to produce ghostwritten manuscripts and place them into medical journals.
- Some 1500 documents revealed in litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals.
- 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.
- Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.
- Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, 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.
Medicine, as a profession, must take responsibility for this situation. Naïveté is no longer an excuse. Perhaps physician-investigators should create and uphold a standard where relationships with industry are regarded as unsavory rather than sought after. Academic institutions and medical journals should take a hard line on ghostwriting. Patient care will benefit if physicians draw together as a profession to denormalize relationships with industry and avoid the role of corporate pawns in the future.
It is illegal for pharmaceutical companies to promote a marketed drug for off-label use, i.e., for uses other than those approved by the U.S. Food and Drug Administration (FDA) or equivalent national agencies. Articles in medical journals, newsletters, and magazines, however, are not considered promotional. As an industry article states, “Peer-reviewed publications offer pharma companies shelter from often-stormy regulatory waters. FDA views published articles as protected commercial speech so doesn’t regulate their content”
In the absence of data (or in the presence of data adverse to marketing goals), review articles in medical journals are crucial vehicles for encouraging off-label uses, promoting unproven benefits, and for downplaying harms. Narrative reviews summarize and analyze prevailing literature and often offer clinical recommendations. Commentaries and other opinion pieces are also highly valued because they provide clinical direction, and are usually not peer-reviewed. Presentations at medical meetings are important for the same reason
As shows, DesignWrite helped to produce numerous ghostwritten reviews and commentaries, including articles designed to promote the off-label use of Prempro for preventing Alzheimer’s disease, Parkinson’s disease, age-related macular degeneration, and wrinkles. The scope of these articles is summarized . The DesignWrite documents avoid discussing off-label marketing, but noted that reviews can “Disseminate messages that fill the gaps not addressed by current studies”. Another document noted that the “Strategic Publications Team” should “Identify data gaps” and “Fill the gap with review papers”