Where did the medical community get the idea that Vioxx, Trovan and Baycol were safe and the benefits of Prempro, Neurontin and bisphosphonates outweighed their risks? From research published in medical journals written by drug companies or drug-company funded authors.
Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged, and an elaborate “publication plan“ emerges, developed by the drug company’s marketing firm. For example, at least 50 articles promoting hormone replacement drugs like Prempro were planted in medical journals by Pfizer’s (then Wyeth) marketing firm DesignWrite, according to documents posted on the University of California, San Francisco’s Drug Industry Document Archive.
“Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” one such article in the Journal of Women’s Health, planted by DesignWrite, is titled — concluding that there is not. A second paper, supplied by DesignWrite and appearing in the Archives of Internal Medicine, is titled “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.” A third, also from DesignWrite, in the Archives of Internal Medicine, is titled “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.” Though the marketing firm’s “science” is egregiously flawed — HT has strong links to breast cancer, heart disease and Alzheimer’s — the papers have not been retracted.
Another example is Parke-Davis/Pfizer’s publication plan to make seizure drug Neurontin become the prescribed drug of choice for migraines, bipolar disorder and other conditions for which it was not approved. In just three years, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin including a supplement to the prestigious Cleveland Clinic Journal of Medicine that Parke-Davis made into 43,000 reprints for its reps to disseminate.
Researching, writing and submitting papers to medical journals — and reworking and finessing them if accepted — is a demanding, time consuming job which drug companies have made into pay dirt. Court obtained documents at the UCSF Drug Industry Document Archive show drug companies’ “publication plans” for their products — elaborate grids with the names of journals where papers have run, are slated to run, have been submitted and have been resubmitted, the marketing firms apparently not taking “no” for answer. Do the journals know they are part of such machinations?
As hot new drug classes are rushed to market and net billions in a few years only to crash and burn from undisclosed risks and lawsuits (think: SSRI antidepressants, atypical antipsychotics, long acting beta agonist asthma drugs (LABAs) and antiepileptic drugs) some blame journals for publishing marketing disguised as science and serving as de facto medical stenographers. In addition to ad sales, journals can earn hundreds of thousands of dollars from reprints of articles that the drug companies want to disseminate.
Under criticism, medical and scientific journals have tried to improve their disclosure of authors’ financial links to industry — but not too hard. Often the disclosures are relegated to a barely readable paragraph linking authors identified by initials not names to 60 or more drug companies. Worse, the disclosures don’t appear in abstract databases like PubMed but are hidden behind a financial firewall available only to paid subscribers who have access to the full articles.
But planting drug industry-funded papers that extol new drugs or smooth over safety concerns is too lucrative for journals or drug companies to quit. The latest case is TNF (tumor necrosis factor) blocker drugs such as Humira, Remicide, Enbrel and Cimzia which are the drug industry’s new profit center now that so many blockbuster pills have gone off patent.
The conditions such biologic drugs treat — rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis — are rare but drug companies now call them under-diagnosed and offer quizzes to help patients self diagnose. Watch out. Worse, papers written by drug industry-funded authors are appearing in journals to minimize the many dangerous side effects that accompany TNF blockers because they suppress the immune system. Recently research by drug industry-funded authors has appeared in medical journals to dispel data linking TNF blockers to increasing incidences of hospitalizations, malignancies, cardiovascular events and Herpes zoster. Looks like another publication plan.
Martha Rosenberg is a Chicago-based health reporter whose work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune, Los Angeles Times and Consumers Digest. She is the author of Born With a Junk Food Deficiency.