Magazine article In These Times

How to Manufacture a Disease

Magazine article In These Times

How to Manufacture a Disease

Article excerpt

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, Parkinsons disease, vision problems, and wrinkles," Fugh-Berman concluded.

Design Write, 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. …

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