It is a big problem said the Pharma-linked American Society of Bone and Mineral Research, the National Osteoporosis Foundation and the National Bone Health Alliance recently in a press release. Women are not taking the bone drugs made by our drug company sponsors just because they are linked to esophageal cancer, jawbone death, heart problems, intractable pain and the very fractures they were supposed to prevent! Not only is "untreated osteoporosis" a "public health crisis," said the press release, our Pharma sponsors aren't making any money!
According to the British Medical Journal, the National Osteoporosis Foundation is sponsored by Bayer Healthcare, Lane Laboratories, Mission Pharmacal, Novartis, Pharmavite, Pfizer, Roche, Warner Chilcott and Eli Lilly. The American Society for Bone and Mineral Research is sponsored by Pfizer and Eli Lilly. The National Bone Health Alliance is a public- private partnership that is an offshoot of the National Osteoporosis Foundation and recently rolled out guidelines that widen recommendations for bone 'treatment" to include 86 percent of women over 75 years.
Many drug safety advocates wondered why drugs like Fosamax, Boniva, Actonel and Reclast, called bisphosphonates, were approved. Soon after approval, they were linked to extremely serious and foreseeable side effects. For example, if patients did not sit upright after taking their med, they could end up in the ER with esophageal damage--so the label was changed to warn patients to stay upright after taking their bone drug.
Court documents show that Merck, who made the first bisphosphonate, Fosamax, knew about jawbone death since the 1970s but marketed the drug anyway. But it was dentists, not Merck or the FDA who revealed the egregious side effect as they saw it develop in their patients. Jawbone death sometimes required a tracheostomy (an incision in the windpipe), bone grafts and even jaw removal. No, you will not look like Sally Field who hawked Boniva. In 2013, Merck agreed to pay $27.7 million for multiple Fosamax lawsuits.
Pharma also knew about the cancer. There were 23 U.S. esophageal cancers and 27 in Europe and Japan linked to the drugs reported the FDA in 2008 in a major medical journal. Pharma knew about the fractures because the mode of action of bisphosphonates--suppression of the body's bone remodeling action--was well known to cause bones to become brittle and break because they were desiccated and not renewed. Beginning in 2006, so many medical journal articles chronicled spontaneous breaks of thigh and other bones in bisphosphonate patients, the FDA ordered a fracture warning to appear on the drugs' labels. The drugs literally caused what they are supposed to prevent.
"We report atypical skeletal fragility in three subjects after long-term, combined anti-remodeling therapy," reported a 2008 Journal of Clinical Endocrinology & Metabolism study. "An Emerging Pattern Of Subtrochanteric Stress Fractures: A Long-Term Complication Of Alendronate [Fosamax] Therapy?" said an article in Injury. "Low-Energy Femoral Shaft Fractures Associated With Alendronate Use," said the Journal of Orthopedic Trauma.
Bisphosphonates are like many aggressively marketed drug classes--statins, PPIs for GERD and of course COX-2 inhibitors like Vioxx--that neither Pharma or the FDA warned patients about while billions were made. When the blockbusters went off patent (or in the case of Vioxx and Bextra, were withdrawn) both Pharma and the FDA then said the drugs weren't as safe as we thought. Sorry about that.