Medical providers, insurance companies and well-informed medical consumers know that drugs, devices and treatments aren’t considered best-practice—or even credible—unless and until research has been conducted, the results reviewed by scientific peers and the results published in a reputable journal.
So how was it, health reporter Martha Rosenberg asks on KevinMd.com, that blockbuster drugs such as Vioxx (an arthritis drug withdrawn from the market in 2004 because of heart risks) and Baycol (a cholesterol drug withdrawn in 2001 because of muscle degeneration) were deemed safe, and that their benefits outweighed their risks?
These, and many others, Rosenberg writes, passed peer muster after journal reports were published that were written by drug companies or their hired writing hands. Gee, if you’ve spent millions developing a drug and you’re given license to appraise its effectiveness and safety, wouldn’t you make sure the story had a happy ending?
We regularly write about drug company conflicts of interest, and Rosenberg’s post adds to this stinky body of “knowledge.”
“Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged,” she writes, “and an elaborate ‘publication plan’ emerges, developed by the drug company’s marketing firm.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…” You can read that document, courtesy of the University of California, San Francisco’s Drug Industry Document Archive.
One of DesignWrite’s articles published in the Journal of Women’s Health was called “Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” The answer was “no.” Another DesignWrite offering appeared in the Archives of Internal Medicine, “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.”A third, also from DesignWrite, in the Archives of Internal Medicine, championed “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”
Rosenberg calls the marketing firm’s so-called science “egregiously flawed.” Hormone therapy has a demonstrable association with breast cancer, heart disease and Alzheimer’s. Still, the papers have not been retracted from the journals, two of which are published by the American Medical Association.
Parke-Davis/Pfizer also engaged in planned research plants with regard to its anti-seizure drug Neurontin. It wanted to expand the drug’s use to people suffering from migraines, bipolar disorder and other problems for which it had not been given FDA approval. Such “off-label” uses are the prerogative of practitioners, but manufacturers are not allowed to promote them for any use not approved by the FDA.
We wrote about the unethical use of fake Neurontin trials a couple of years ago in our blog, “The Difference Between Pharmaceutical Research and Marketing Blurs Yet Again.” Rosenberg notes that within a three-year period, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin, and made 43,000 reprints from one for dissemination by its sales representatives.
“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. … ‘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?” Rosenberg asks.
Not only is iffy science given cred by these journals, the stench of conflict grows stronger when you realize that journals make money off such dreck when they license reprint rights for drug company promotion.
Several years ago, when it came to light that some researchers were subsidized by companies whose products they were testing, journals loudly announced they were raising their standards, scrutinizing submissions and adding disclaimers to address even the appearance of conflicts of interest. But, says Rosenberg, “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.”
So if John Q. Public wants to read a full study, he must shell out a meaningful amount. And that’s for only one journal.
Rosenberg is not optimistic that this status quo can be changed any time soon. The problem, of course, is that it’s just too lucrative for both journals and drug companies to stop scratching each others’ backs at the cost of patient safety.
She highlights a well-established class of drugs called TNF blockers that includes Humira, Remicide, Enbrel and Cimzia. They treat various forms of arthritis formerly considered fairly rare, but promoted to “under-diagnosed” by their manufacturers in the hope of enlarging their market to people with a tenuous, at best, connection to them.
She warns consumers about taking their planted “quizzes” to encourage self-diagnosis, and practitioners about ghostwritten journal stories that minimize the drugs’ dangerous side effects, including suppression of the immune system.
As Rosenberg writes, “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.”
And another strike against patient safety.