The drug industry is employing several tricks to stay a Wall Street darling. Drugs priced at five and six digits like the Hepatitis C drugs, genetically engineered, injected drugs from Chinese hamster ovary cells (like Humira) and convincing healthy people they are “at risk” of serious diseases. All tactics are seen with newer bone drugs.
In 2010, the FDA approved Prolia, or denosumab, an injected drug made from GE hamster cells (“monoclonal antibodies”) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Since then, in a phenomenon known as “indication creep,” Prolia has been approved for several other conditions.
Monoclonal antibodies, sometimes call MoAbs, suppress the immune system and invite lymphoma and other malignancies including rare ones, infections like Legionella and Listeria, superinfections and fungal infections. (A MoAb patient recently got Hansen’s disease, once known as leprosy.)
But MoAbs are big business for Big Pharma because they’re expensive and more resistant to generic competition than pills. Prolia maker Amgen deployed 1,000 reps to sell the drug despite the fact that during clinical trials, subjects developed cervical, ovarian, pancreatic, gastric, thyroid and breast cancers. Ten people were hospitalized with the skin infection cellulitis during trials and one died. Three more needed hospitalization for pneumonia after only one dose. Not only was Prolia approved despite its trail of harm, but it was also approved early.
Until 15 years ago, bone drugs were not a priority of the drug industry because hormone replacement therapy (HRT) had become practically a right of passage for older women. While HRT did prevent osteoporosis, it was also found to increase the risk of breast cancer, stroke, blood clots, hearing loss, gall bladder disease, urinary incontinence, asthma, the need for joint replacement, melanoma, ovarian, endometrial and lung cancers, non-Hodgkin’s lymphoma and even dementia according to medical findings. In the first year that millions of women quit HRT in 2003, U.S. breast cancer fell seven percent and 15 percent in women with estrogen-fed tumors. HRT had actually been causing cancer.
When women quit HRT, drug makers debuted bisphosphonates like Fosamax and Boniva, designed to replace those patients lost when HRT blew up. The marketing term “osteopenia” (the risk of osteoporosis) was invented and drug giants put bone density measuring devices in doctor offices, to scare women into taking bone drugs.
But the bisphosphonates soon revealed risks of their own: jaw bone death (osteonecrosis) in which some women had to have their entire jaws removed, esophageal cancer and causing the very fractures they were supposed to prevent.
Now, drug makers have a launched another Prolia like drug called Evenity that costs $21,000 a year—a price that even ten years ago would have been unthinkable. Evenity (romosozumab), a MoAb, was rejected by the FDA in 2017 for its link to heart attack and stroke and approved only because a warning was added. After a year of Evenity treatment, patients must return to the dangerous other bone drugs it supposedly replaced.
People worried about what they could do about thinning bones besides taking Pharma’s drugs that cost thousands a year and have dangerous side effects. There is growing evidence the excess acid supply of a Western diet is an osteoporosis risk factor—that is why people in countries without traditional Western diets seldom have osteoporosis. Nutritious, non-GMO food should be the start for everyone concerned about their bones—along with weight-bearing exercises and Vitamin D and calcium supplements when needed.
Finally, people should resolutely avoid SSRI antidepressants, GERD meds (proton pump inhibitors) corticosteroids other aggressively marketed Pharma drugs which weaken bones whenever possible. As is often the case, many of these drugs were rushed to market before the consequences of their long term bone weakening were documented.
Despite aggressive advertising, Pharma’s high-priced bone drugs are a poor substitute for a good diet and healthy living.
Martha Rosenberg is the author of the award-cited food exposé “Born With a Junk Food Deficiency,” distributed by Random House. A nationally known muckraker, she has lectured at the university and medical school level and appeared on radio and television.
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