Pharma and New York Times are "Puzzled" by Bone Drug Fractures--But Patients Aren't
"I broke the left femur (shattered it 2 times in 2006 and 2007)," while on Fosamax writes a 72-year-old patient this week on askapatient.com. "I now walk with a walker and the Dr. says it can never be repaired." "I twisted my left leg while shopping & broke left femur in two places, requiring surgery, pins and a rod," wrote a 61-year-old patient on the site after taking Fosamax for 13 years. "Then in 2/08 I jarred same side foot coming off a step & developed a stress fracture that won't heal. I now have a stress fracture on the right side femur after walking on the beach." "After six years of taking Fosamax, I slipped in ice in my driveway and broke my femur (thigh bone). Two years later, still taking Fosamax, I fell in the snow and my other femur snapped before I hit the ground," wrote another woman. "I did nothing really physical except water therapy, yet I have a break" in the 3rd lumbar vertebrae posts a 67-year-old patient who had been taking Fosamax for 14 months. In 874 patient ratings since 2001, women as young as 32 recount being advised by doctors to take Merck's Fosamax, approved in 1995, and other bone drugs called bisphosphonates. Many were scared into using the drugs by readings from bone density machines now known to have been planted by drug companies and by encroaching "osteopenia," the risk of osteoporosis--a term made up by pharma. On a rating scale of 1 to 5 with 1 defined as "Dissatisfied. I would not recommend taking this medication," Fosamax receives an average score of 1.5 on askapatient. Procter & Gamble's bisphosphonate Actonel also rates a 1.5 and Roche and GSK's Boniva earns a 1.3, the lowest of any drug reviewed on askapatient. (Are you listening Sally Field?) Bisphosphonates preserve and remineralize bone by turning off bone remodeling-- creation of new bone--that would normally occur. But as early as 2004, Gordon Strewler, MD in the New England Journal of Medicine and Susan M. Ott, MD in the Annals of Internal Medicine warned the remineralized bones could become brittle and fracture-prone and that the drug may actually cause what it is supposed to prevent. A 2005 article in the Journal of Clinical Endocrinology & Metabolism called "Severely Suppressed Bone Turnover: A Potential Complication Of Alendronate Therapy" warned of patients on Fosamax having "increased susceptibility to, and delayed healing of, nonspinal fractures." And articles citing "atypical skeletal fragility," "subtrochanteric stress fractures" and "low-energy femoral shaft fractures" on bisphosphonates have appeared in the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopedic Trauma and the journal Injury. This month, ABC News' Richard Besser, MD, former acting director of the Centers for Disease Control and Prevention (CDC), reports on women's bones breaking from little or no impact on Fosamax and interviews the newly appointed FDA deputy commissioner Joshua Sharfstein, MD. Like Vioxx, Merck's other block buster whose side effects emerged after it was used/tested on the public, Fosamax was launched a month early thanks to its collegial relationship with the FDA. In fact the FDA waved Fosamax through so quickly--six months after its new drug application--Merck had to send a Dear Physician letter months later warning of esophageal side effects "of greater severity than we observed in our controlled clinical trials." Oops. And that's not all the "controlled clinical trials"--two 3-year studies--missed. Soon reports of osteonecrosis of the jaw surfaced--actual death of the jaw bone--and articles in the Archives of Internal Medicine and the New England Journal of Medicine reported that atrial fibrillation, a chronically irregular heartbeat, was twice as common in women taking bisphosphonates. In 2008 the FDA issued a warning that women on bisphosphonates developed "incapacitating bone, joint, and muscle (musculoskeletal) pain," from which some did not recover. And later that year FDA reports of Fosamax-linked esophageal cancer appeared in the New England Journal of Medicine. Bisphosphonates enjoyed a boost when hormone therapy (HT), whose one "strong" point was preventing osteoporosis, was discredited in 2002. Like HT, bisphosphonates are promoted as one-size-fits-all medication for middle aged and elderly women--and like hormone therapy, they apparently cause the conditions they are supposed to prevent. (HT causes, instead of prevents, cardio and cognitive problems.) "The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures," says an FDA alert posted last week about two, large observational studies of the drugs. Oops. "Postmarketing surveillance and the determination of the real-worldsafety profile of prescription drugs is arguably flawed," says an article in the June 22, 2009 issue of Archives of Internal Medicine in an understatement, adding that "Patient-orientedWeb sites may provide an opportunity to identify potential adverseeffects early in a drug's postmarket history." Say that. Patients on askapatient shared their intractable pain, atrial fibrillation, fractures, osteonecrosis and even esophageal cancer on Fosamax years before medical journals, the FDA and ABC news "discovered" the side effects. "My mother was taking Fosamax from 1995 until 2005 for osteoporosis. I believe she was part of a clinical trial," wrote a woman on askapatient in 2006. "She had severe esophageal ulcerations, nausea, jaw bone loss and vertigo from the inner ear. She was told to continue the drug. October 2005, she began to have trouble swallowing, she was initially told it was anxiety, but was then diagnosed with Esophogeal cancer and died nine months later in July 2006, she was 80 years old." While critics of askapatient's anecdotal reports might call the ratings biased, assuming people would rather pan than praise, plenty of drugs and drug categories receive high and mid-range scores. In fact, the average score across the board for all 100,000 ratings appearing on askapatient, which takes no drug advertising from pharmaceutical companies, is 3.0, "somewhat satisfied." And how objective are medical journal? An article which established Fosamax's safety after the public used/tested the rushed through drug in unwitting "clinical trials"--"Ten Years' Experience with Alendronate [Fosamax] for Osteoporosis in Postmenopausal Women" in the March 18, 2004 New England Journal of Medicine--was funded by Merck, as were 9 of its 11 authors. In fact one author, Arthur C. Santora, MD, reported "holding equity in Merck," according to the journal, and received "several US and international patents as inventor related to the use of bisphosphonates that are assigned to Merck."