In March, the New York
Times reported that researchers were "puzzled" by the role of bisphosphonate
osteoporosis drugs like Fosamax in "rare thighbone fractures."
Patients, on the other
hand, are neither puzzled nor do they believe the fractures are rare.
"I broke the left
femur (shattered it 2 times in 2006 and 2007)," while on Fosamax writes a
72-year-old patient 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
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
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
A 2005 article in the
Journal of Clinical Endocrinology & Metabolism, titled "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.
Last 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
And later that year
FDA reports of Fosamax-linked esophageal cancer appeared in the New England
Journal of Medicine.
enjoyed a boost when hormone replacement therapy (HRT), whose one
"strong" point was preventing osteoporosis, was discredited in 2002.
Like HRT, 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. (HRT 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 month
about two, large observational studies of the drugs. Oops.
surveillance and the determination of the real-world safety 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-oriented Web sites may provide an opportunity to
identify potential adverse effects early in a drug's postmarket
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
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
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 nine 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
Martha Rosenberg is a Chicago
columnist/cartoonist who writes about public health. She may be reached at firstname.lastname@example.org.