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Women Reported Fractures Caused by Bone Drug Long Before Health Industry

Fosamax users were flooding message boards with complaints months before mainstream media picked up the story. What's wrong with this picture?
 
 
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"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 third 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 Big 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, doctors Gordon Strewler in the New England Journal of Medicine and Susan M. Ott in the Annals of Internal Medicine warned that 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' Dr. Richard Besser, 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.

Like Vioxx, Merck's other blockbuster 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 -- that 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 three-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.