(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 Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long-term users; Singulair now carries FDA warnings about "neuropsychiatric events" and Fosamax is suspected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.
I better get a bone scan by Martha Rosenberg
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.
Next, dentists and oral surgeons discovered after simple tooth extractions and other in-office dental work, the jawbone tissue of patients on bisphosphonates would sometimes not heal but become necrotic and die--a condition called osteonecrosis of the jaw(ONJ), The necrotic condition did not take long to manifest "even short-term oral use of alendronate [Fosamax] led to ONJ in a subset of patients"--wrote a dental journal but it somehow slipped through Fosamax's two, three-year clinical trials on which its FDA approval was based. Doctors, dentists, and pharmacists were enraged at what looked like deliberate obfuscation by Merck.
And there were second, third and fourth opinions about Fosamax! According to an FDA epidemiologist writing in New England Journal of Medicine in 2009 there were 23 incidences of Fosamax-associated esophageal cancer in the US and eight deaths and 27 incidences of cancer in Europe and Japan and six deaths.
Next reports in medical journals linked bisphosphonates to the risk of developing atrial fibrillation, or a chronically irregular heartbeat and to severe bone, joint or muscle pain. "In the most serious cases, the pain was so severe that patients could not continue their normal activities," wrote the FDA in a press release. "Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution." Clearly, the FDA was trying hard to avoid the word irreversible.
Finally, in a development that suggests tremendous medical ineptitude if not duplicity, bisphosphonates were found to sometimes cause the very fractures they were supposed to prevent. The thigh bones of patients on bisphosphonates have "simply snapped while they were walking or standing," after "weeks or months of unexplained aching," reported the New York Times in an article called "Drugs to Build Bones May Weaken Them."
It should be embarrassing to the medical establishment that a prominent drug company and the FDA "discovered" severe side effects after years of patient use and that bone scans are still merchandised though they are of no value to 90 percent of women, according to the New England Journal of Medicine. It should be further embarrassing that Merck was allowed to make $3 billion a year off a drug that many say would not have been approved had clinical trials lasted longer. Its patent expired in 2008.
Now Merck is about to launch a new drug for osteoporosis called odanacatib which has already intrigued the money men on Wall Street. "Odanacatib may be a viable alternative for patients who need continued therapy and who want benefits beyond what they received from bisphosphonates," a senior Merck research executive told Reuters without a hint of irony. END
Martha Rosenberg's first book, Born With a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health, is available in bookstores, libraries and online.