Big Pharma Still Tries to Push Dangerous Drug Class

Martha Rosenberg

Bisphosphonate bone drugs are among the most harmful and misrepresented drug classes still on the market. But that has not stopped Pharma-funded medical associations like the American Society of Bone and Mineral Research, the National Osteoporosis Foundation and the National Bone Health Alliance from periodically wringing their hands over low sales. 

This week the New York Times repeats the industry lament. “Currently, many people at risk of a fracture — and often their doctors — are failing to properly weigh the benefits of treating fragile bones against the very rare but widely publicized hazards of bone-preserving drugs, experts say,” it writes. Hip fractures among women 65 and older on Medicare are rising says the piece and Medicare reimbursements for bone density tests are falling. “Doctors who did them in private offices could no longer afford to [do them] which limited patient access and diagnosis and treatment of serious bone loss,” says a doctor quoted in the article which sounds like a Pharma plea for tax-payer funding.

But here is the back story.

The first bisphosphonate bone drug approved for osteoporosis, Merck’s Fosamax, received only a six month review before FDA approval. When its esophageal side effects were revealed, the FDA tried to unapprove it but Merck got the FDA to settle for a warning label that told patients to sit upright for an hour after taking the drug. Six months after Fosamax was approved, there were 1,213 reports of adverse effects including 32 patients hospitalized for esophageal harm. One woman who took Fosamax but remained upright for only thirty minutes was admitted to the hospital 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 (NEJM).

Soon bisphosphonates (which include Boniva, Actonel and Zometa) were shown to weaken not strengthen bones by suppressing the body’s bone-remodeling action. Yes bone loss is stopped but since the bone is not renewed, it becomes brittle, ossified and prone to fracture. More than a decade ago, articles in the NEJM, the Annals of Internal Medicine, the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopaedic Trauma and Injury warned of the paradoxical drug results. One-half of doctors at a 2010 American Academy of Orthopaedic Surgeons annual meeting presentation said they’d personally seen patients with bisphosphonate-compromised bone. “There is actually bone death occurring,” said Phuli Cohan, MD on CBS about a woman who’d been on Fosamax for years.

By 2003, dentists and oral surgeons found that after simple office dental work, the jawbone tissue of patients taking bisphosphonates would sometimes not heal but become necrotic and die. They had received no warnings though Merck knew about the jawbone effects from animal studies since 1977.

“Up to this point, this rare clinical scenario was seen only at our centers in patients who had received radiation therapy and accounted for 1 or 2 cases per year,” said the authors of an article titled “Osteonecrosis of the Jaws Associated with the Use of Bisphosphonates: A Review of 63 Cases,” published in the Journal of Oral and Maxillofacial Surgery.

Despite reports of ulcerative esophagitis, bone degradation, fractures and jawbone death Merck aggressively promoted Fosamax. It hired researcher Jeremy Allen to plant bone scan machines in medical offices across the country to drive sales and to push through the Bone Mass Measurement Act which made bone scans Medicare reimbursable paid by you and me. Hopefully that is changing.

Blaming hip fractures on not enough people taking bisphosphonates is not a new tactic for Pharma. It blamed increasing suicides on not enough people taking antidepressants (even when as much as a fourth of the population takes antidepressants). Get ready for Pharma to blame obesity on not enough people taking prescription obesity drugs. The ruse is even more dishonest because many popular drugs people are taking like GERD medications really do thin bones. First do no harm.