Drugmakers are reviving the marketing of anti-fracture bone drugs for the same reason they are reviving the "disease" of menopause: A new generation of women is unaware of previous harms and can be tapped.
Medical journals, documentaries and even previously feminist groups now claim not treating menopause as a disease is "sexist" versus the four decades of sexist menopause "treatment" that killed thousands.
The February 11 issue of the Journal of the American Medical Association (JAMA) devotes many pages to the revival--"screening for osteoporosis to prevent fractures"--including a review that concludes that, "Osteoporosis treatment with bisphosphonates or denosumab (Prolia) over several years was associated with fracture reductions and no meaningful increase in adverse events."
But the across-the-board exoneration ignores key bisphosphonate findings from the last years and imperils a new generation of women.
1. Bone Scans Were a Documented Drugmaker Marketing Tool
It was drugmakers not public health agencies who planted bone density machines in medical offices across the US, established the "Bone Measurement Institute" to make "osteopenia" a health risk and got bone scans Medicare reimbursable. They increased the number of bone density machines in medical offices and clinics to 10,000 when it had been 750.
2. Osteopenia and T Scores Were Made Up
Dartmouth Medical School professor Anna Tosteson, MD, says she attended the 1992 World Health Organization (WHO) meeting in Rome, where the term "osteopenia" was literally invented. Scientists in the room acceded to the term simply because wanted to adjourn for the night, she told National Public Radio (NPR).
Bone density units so popular today, "T scores" from DXAs, were similarly capricious wrote Susan Kelleher in the Seattle Times: The units had "boundaries so broad they include more than half of all women over 50."
3. Fosamax Was Approved Before Esophageal Harm Was Revealed
Merck's Fosamax, the first bisphosphonate bone drug approved for osteoporosis, flew out of the FDA in1995 with only a six- month review. Six months later, 1,213 adverse-effect reports had been relayed to Merck, which included 32 hospitalizations for esophageal effects, some "severe" and more.
In a 2009 New England Journal of Medicine (NEJM) article, Diane Wysowski, an FDA epidemiologist, reported 23 incidences of Fosamax-associated esophageal cancer in the US and eight deaths and six deaths in Europe and Japan. Subsequently, an article in BMJ reported that patients double their risk of esophageal cancer on bisphosphonates.
4. Merck Knew About Jaw Osteonecrosis Risks But Remained Silent
Merck knew Fosamax could cause osteonecrosis of the jaw (ONJ) when dentists contacted them according to legal documents but pretended surprise. None of the bisphosphonate-injured patients had received radiation in the jawbone area, said dentists and surgeons, and the lesions were unhealed by antibiotics. Jaw removal, bone grafts and tracheostomies ensued.
5. Bisphosphonates Caused Fractures
After the Fosamax patent expired and me-too drugs concluded their aggressive marketing, FDA hearings were held to address the fractures caused (not prevented) by the drugs, some occurring for no apparent reason.
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