Women Reported Fractures Caused by Bone Drug Long Before Health Industry
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In 2008 the FDA issued a warning that women on bisphosphonates developed "incapacitating bone, joint, and muscle (musculoskeletal) pain," from which some did not recover.
And later that year FDA reports of Fosamax-linked esophageal cancer appeared in the New England Journal of Medicine.
Bisphosphonates enjoyed a boost when hormone therapy (HT), whose one "strong" point was preventing osteoporosis, was discredited in 2002. Like HT, bisphosphonates are promoted as one-size-fits-all medication for middle-aged and elderly women -- and like hormone therapy, they apparently cause the conditions they are supposed to prevent. (HT causes, instead of prevents, cardio and cognitive problems.)
"The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures," says an FDA alert posted last week about two large observational studies of the drugs.
"Postmarketing surveillance and the determination of the real-world safety profile of prescription drugs is arguably flawed," says an article in the June 22, 2009 issue of Archives of Internal Medicine, adding that "Patient-oriented Web sites may provide an opportunity to identify potential adverse effects early in a drug's postmarket history."
Say that again. Patients on askapatient shared their intractable pain, atrial fibrillation, fractures, osteonecrosis and even esophageal cancer on Fosamax years before medical journals, the FDA and ABC news "discovered" the side effects.
"My mother was taking Fosamax from 1995 until 2005 for osteoporosis. I believe she was part of a clinical trial," wrote a woman on askapatient in 2006. "She had severe esophageal ulcerations, nausea, jaw bone loss and vertigo from the inner ear. She was told to continue the drug. October 2005, she began to have trouble swallowing, she was initially told it was anxiety, but was then diagnosed with esophogeal cancer and died nine months later in July 2006, she was 80 years old."
While critics of askapatient's anecdotal reports might call the ratings biased, assuming people would rather pan than praise, plenty of drugs and drug categories receive high and mid-range scores. In fact, the average score across the board for all 100,000 ratings appearing on askapatient, which takes no drug advertising from pharmaceutical companies, is 3.0, "somewhat satisfied."
And how objective are medical journals?
An article that established Fosamax's safety after the public used/tested the rushed-through drug in unwitting "clinical trials" ("Ten Years' Experience with Alendronate [Fosamax] for Osteoporosis in Postmenopausal Women" in the March 18, 2004 New England Journal of Medicine) was funded by Merck, as were nine of its 11 authors.
In fact, one author, Arthur C. Santora, reported "holding equity in Merck," according to the journal, and received "several US and international patents as inventor related to the use of bisphosphonates that are assigned to Merck."
Martha Rosenberg frequently writes about the impact of the pharmaceutical, food and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune and other outlets.