(Article changed on October 13, 2012 at 19:19)
(Article changed on October 13, 2012 at 18:43)
The year 1999 was a good one for the drug company Merck. In its 64 page annual report, it predicted that the arthritis medicine Vioxx ("Our Biggest, Fastest, and Best Launch Ever!") would also prevent Alzheimer's disease and colon cancer. It announced it was seeking approval to market the asthma drug Singulair to two-year-olds. And it forecast that 40 million women would take its new osteoporosis drug, Fosamax, as Merck continued to "help educate both doctors and patients" about the bone disease.
It turned out Merck spoke too soon. Vioxx was withdrawn in
2004 for doubling stroke and heart attacks in long-term users; Singulair now
carries FDA warnings about "neuropsychiatric events" and Fosamax is
suspected of doubling the risk of esophageal cancer, causing bone fractures
instead of preventing them and causing heart problems, intractable pain and
jawbone death. Oops.
There's plenty of ka-ching in selling "strong bones" products for the same reason there was plenty of ka-ching in selling "hormone replacement" products: one-half the population is female, and no one wants to look old. Of course, "avoiding hot flashes" really means "still looking hot" in hormone marketing terminology, and "avoiding fractures" really means "still looking hot" in bone product marketing lingo. That's why attractive women like Meredith Vieira from the Today show and former Charlie's Angel Cheryl Ladd and actress Sally Field push bone drugs, just as model Lauren Hutton pushed hormone replacement therapy.
To cash in on Fosamax, the first in the bisphosphonate bone
drug class, Merck decided to market the dangers of osteoporosis "far
beyond ailing old ladies." It hired researcher Jeremy Allen to whip up
fears of "osteopenia," the risk
of osteoporosis, as a health epidemic to sell bone drugs and planted bone scan
machines in medical offices across the country, says National
Public Radio. Allen created the faux "Bone Measurement Institute"
which also maneuvered Medicare reimbursement for the scans. By 1999, there were
10,000 bone scan machines in medical offices, said the Associated Press, when
there had been only 750 before Fosamax.
Like its trouble-laden drug Vioxx, Merck's Fosamax flew out
of the FDA. It received only a six month review before its 1995 FDA approval.
(The government also helped its promotion with
the HHS secretary herself, Donna Shalala, participating in a 1998 rally kicking
off free bone
density screenings to be offered in 100 cities.)
But the wheels soon came flying off the bone drug. Patients
experienced esophageal "irritation"
and the warning to stay upright for one full hour after taking Fosamax,
eating or drinking nothing was added after
approval. One woman who took Fosamax but remained upright for only 30 minutes,
not 60, had to be admitted to the Mayo Clinic with "severe ulcerative
esophagitis affecting the entire length of the esophagus" and had to be fed
intravenously, according to the New England Journal of Medicine.
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