After the FDA approves a new drug, it rarely faces follow-up studies that might reveal serious and possibly fatal side effects. Some dangers remain hidden for years until an accumulation of disasters sparks lawsuits. Faced with litigation, corporations must cough up data – and sometimes choke on it.
A suit against drug maker Wyeth freed 1,500 documents that yielded “unprecedented insights into how pharmaceutical companies promote drugs,” wrote Adrianne Fugh-Berman in a September study in PLoS Medicine. The 14,000 plaintiffs who took the menopausal hormone therapy (HT) Prempro claim that Wyeth distorted study results and hid evidence of harm. Some patients traded the temporary inconvenience of hot flashes for the permanent inconvenience of death.
It was not as if Wyeth didn’t have reason to suspect serious risk. In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use. To counter this side effect, Wyeth added progesterone and created Prempro. But the new combo not only failed to prevent cardiovascular disease, it increased the risk of breast cancer, stroke, dementia and incontinence, according to the 2002 Women’s Health Initiative study.
For decades Wyeth had promoted HT and the diseasification of menopause through tried and true schemes: First, it redefined a normal process – in this case aging and menopause – as an illness treatable with drugs. After cherry picking studies, some conducted off-shore, it hired specialized companies to ghostwrite favorable articles for medical journals, and paid doctors to sign their names – thus creating the impression that independent researchers, not hacks-for-hire, had authored the articles.
“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,” Fugh-Berman concluded.
DesignWrite, Wyeth’s hired ghostwriting outfit, boasts “long experience in blending scientific and clinical issues with marketing needs.” It cranked out more than 100 articles and presentations for journals and symposia touting Prempro’s virtues, and then paid prominent doctors and researchers who contributed little more than their names.
A particularly lucrative medical market, with a history of recalls and scandal, is the $200 billion U.S. medical device industry for replacement joints, pacemakers and CT scanners. Fugh-Berman’s study of conflicts of interest, using disclosures forced by government investigations, revealed that in the year ending in January 2009, five medical device companies doled out 1,654 payments to orthopedic surgeons and researchers that totaled more than $248 million. Fewer than half the experts who published articles dealing with the “donor” company’s products disclosed their financial relationship.
Big pharma’s stake in cooking the books is obvious, but why are medical journals complicit? One reason is that unlike most of the web, most medical journal sites protect their material behind a sturdy pay wall, and may charge up to $40 per reprint. Drug companies sometimes buy up thousands of product-favorable reprints to distribute free to doctors, thereby providing a cash incentive to journals that publish articles likely to be reprinted.
If journal articles are insufficiently laudatory as marketing vehicles, drug companies can turn to supplements. Separately bound, these publications bear the journal’s name, but are industry produced and rarely peer-reviewed. Wyeth, for example, mailed its pro-Prempro supplement with the journal Women’s Health in Primary Care to 128,000 physicians.
In 2000, big pharma firms spent more than $15.7 billion promoting prescription drugs in the United States. Like other mega corporations, they have great advantages over citizens: They are rich, powerful, protected by laws and tax rules, and given the rights of people while shielded from many of the responsibilities. On our side, we have timid or weak politicians and bureaucrats, activist organizations and the ability to sue. Unfortunately, lawsuits tend to punish rather than prevent. But the deterrent effect of large settlements, the bad PR and the discovery of data and records are nonetheless components in mitigating the epidemic of corporate greed.