Big Pharma Shamelessly Shills Dangerous Bone Drugs You Don't Need
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If you feel like everyone is warning you about your bones and imminent osteoporosis, you are right. Boniva, an osteoporosis drug which actress Sally Field says helps women "stop losing and start reversing" bone, is one of the top 20 most advertised drugs. Bone drug Evista was personally promoted by former FDA deputy commissioner for medical and scientific affairs under George W. Bush, Scott Gottlieb. And "novel" bone drug Prolia, also called a Frankendrug, received a Best New Drug award this week at the 2010 Scrip Awards ceremony.
While most of the world is now aware of the risks of osteoporosis, the problem with the bone drugs is: they may not work and women may not need them.
According to National Public Radio, Merck hired a company to whip up fears of "osteopenia," the risk of getting osteoporosis, to get women to take Fosamax, the first bisphosphonate bone drug launched 15 year ago. The hired guns creating the faux "Bone Measurement Institute," planted bone scan machines in medical offices and pushing the Bone Mass Measurement Act which made scans Medicare-reimbursable. By the end of the 1990s the "disease" of osteopenia had increased seven fold according to the Associated Press.
Even the term osteopenia, created by World Health Organization, was co-opted. It was never meant to be "a disease in itself to be treated," says Dartmouth Medical School professor Anna Tosteson who attended the WHO meeting, and the osteopenia diagnostic criteria were decided arbitrarily because the scientists were tired and wanted to adjourn.
Like Merck's Vioxx, Merck's Fosamax was launched ahead of schedule and its side effects -- esophageal erosion, bleeding, inflammation and perforation (why patients have sit or stand for an hour after a dose) -- only emerged when the drug was reimbur$able. In fact, Merck was forced to send out Dear Doctor letters months after Fosamax' 1995 approval and the FDA threatened to revoke approval altogether until Merck's head of research at the time, Edward M. Scolnick, convinced it to simply add a warning.
At the same time the clinical picture of bisphosphonates (Roche and GSK's Boniva and Procter & Gamble's Actonel followed) worsened.
It turned out the same mechanism that stops bone loss, suppression of the body's bone remodeling action, can cause bones to become brittle and at risk of breaking because they are not renewed. Since 2006, so many medical journal articles have chronicled spontaneous breaks of thigh and other bones on bisphosphonates, the FDA ordered a fracture warning to appear on the drugs' labels in October. Over a dozen women report their bones breaking while taking bisphosphonates on the drug rating site askapatient.com.
And there are other morbid perks with bisphosphonates.
Dentists and oral surgeons discovered that after simple office procedures patients' jaw bones would not heal but become necrotic and die. Whether Merck hid the jaw bone data, as some dentists claim, or didn't know because only two, three-year Fosamax studies were conducted, many dentists refuse work on bisphosphonate patients and an FDA-mandated jaw bone death warning went on the label. (Some Merck doctors blamed the jaw bone death on "bad oral hygiene.")
Intractable pain and atrial fibrillation, chronically irregular heartbeat, were reported with the bisphosphonates in medical journals and the FDA reported 23 US esophageal cancers and 27 in Europe and Japan in 2008. (Why does FDA put esophageal, fracture and jaw bone warnings on a drug also linked to cancers rather than simply withdraw it?)
But even as the FDA warned about bisphosphonate fractures last month, full page color ads in the New York Times offered women a new bone option: Evista, a Selective Estrogen Receptor Modulator (SERM) similar to the breast cancer drug Tamoxifen.