drug Fosamax has been on the market for a little over 10 years now. Drug maker
Merck promoted it heavily by selling women the fear of a disabling hip fracture
and the necessity of regular bone-density tests. Merck's initial TV advertising
campaign featured a slim woman in her mid-40s, conveying the notion that
testing was appropriate for women in this age group.
Fosamax belongs to a
drug class known as bisphosphonates. Novartis's Aredia and Zometa injections
are the two intravenous versions used in chemotherapy, and Merck's Fosamax and
Procter and Gamble�s Actonel are the most commonly used oral versions of the
tablet form is commonly marketed to prevent and treat osteoporosis in
post-menopausal women. Stronger forms are used to manage advanced cancers that
have metastasized to the bone. For cancer therapy, the drugs are given
intravenously, and usually for long periods of time.
For many years,
estrogen therapy was used to prevent osteoporosis, until 2002, when a study by
the Women's Health Initiative said that estrogen posed more risks than
benefits. When the study revealed that hormone therapy carried slight, but
measurable, heart and breast cancer risks, prescriptions for bisphosphonates
shot up 32 percent, according to IMS Health, which monitors pharmaceutical
Fosamax may improve bone density, experts say when it comes to fracture
prevention, its benefit is modest at best. In fact, some researchers say that
when taken for more than 10 years, Fosamax will actually make bones more
brittle and thus, more susceptible to fracture. And even if patients stop
taking the drug, doctors say it can stay in the body for up to 10 years.
In a 2004 letter
published in the Annals of Internal Medicine, researcher Susan Ott, MD, of the
University of Washington wrote: "Many people believe that these drugs are
'bone builders,' but the evidence shows they are actually bone hardeners."
In a December 13,
2004, press release, doctors at Long Island Jewish (LIJ) Medical Center
announced that they had discovered a link between a common chemotherapy drug
and a serious bone disease called osteonecrosis of the jaw (ONJ).
published in the Journal of Oral and Maxillofacial Surgeons, prompted both the
FDA and Novartis to issue warnings to physicians and dentists about the risk
for the potential adverse effect.
According to LIJ,
�ONJ is a condition in which the bone tissue in the jaw fails to heal after
minor trauma such as a tooth extraction, causing the bone to be exposed.� The
exposure, the doctors said, can eventually lead to infection and fracture and
may require long-term antibiotic therapy or surgery to remove the dying bone
The chief of the
Division of Oral and Maxillofacial Surgery at LIJ, Salvatore Ruggiero, DMD, MD,
said they conducted the study after they noticed a cluster of cancer patients
with necrotic lesions in the jaw, a condition they previously saw in only one
or two patients a year.
In conducting a
review of the patients� charts, the doctors found that the 63 patients,
diagnosed with ONJ over a three-year period, shared one commonality, they all
had received long-term bisphosphonate therapy.
Of the 63 patients
diagnosed between February 2001 and November 2003, fifty-six were cancer
patients who had received infusions of bisphosphonates for at least a year, and
seven other patients had been receiving long-term oral therapy for osteoporosis.
developed ONJ after normal bone trauma,� the press release said, �such as a
tooth extraction, while receiving bisphosphonate therapy.� Rather than healing,
the bone began to die, and a majority of the patients required surgery to
remove the diseased bone.
Another study quoted
on April 4, 2006, by United Press International, found more than 2,400 patients
who were taking the injected form of bisphosphonate had suffered bone damage to
their jaws since 2001.
In addition to the 2,400
patients who were taking the injected form, the study found 120 patients taking
the oral form of the drug who had been stricken with such incapacitating bone,
joint, or muscle pain that some became bedridden and others required walkers,
crutches or wheelchairs.
While the number may
seem small when compared to the estimated 39 million oral prescriptions written
in 2005, health experts told The Los Angeles Times that the problems may show a
uncovered about 1,000 patients (with jaw necrosis) in the past six to nine
months alone, so the magnitude of the problem is just starting to be
recognized," Kenneth Hargreaves, of the University of Texas, told the
quite sure what we're dealing with over the long haul,� Dr Susan Ott, told the
Times. �Side effects like this should make ordinary, healthy women think
twice," she warned.
Christopher Loder, a
spokesman for Merck, claims that ONJ with Fosamax is "exceedingly
But while this may
appear to be true, experts say it is always good to consider that at least 90
percent of drug side effects go unreported to the FDA, so the actual number of
people stricken with ONJ is likely to be much higher.
In a statement,
Merck said that in �all of our controlled clinical trials with Fosamax, which
involved more than 17,000 patients, including some that were 10 years in
duration, we had no reports," according to the April 3 LA Times.
However, a closer
look at the results of Merck studies casts a shadow on their favorable outcomes.
For instance, Merck virtually controlled everything about a 2002 Annals of
Internal Medicine paper praising the use of Fosamax. The paper�s lead author
was Susan Greenspan, a Harvard Medical School professor and director of the
Beth Israel Deaconess Osteoporosis Prevention and Treatment Center at the time.
As it turns out,
Merck paid for the recruitment and participation of all 327 clinical trial
subjects; the company collected the data from 25 separate facilities; Merck
employees handled �coordinating the early phases of the study� and provided
�expertise in study conduct,� and in the end, Merck retained control and
ownership of the research itself.
Admittedly, most of
these details are revealed in the Annals article�s disclosures and
acknowledgments, but such qualifications rarely appear in articles on web
sites, where many people learn about trial results.
The year before Dr.
Greenspan's paper was published in 2001, Fosamax sales barely reached $1
billion. The following year the drug had sales of $2.7 billion.
On April 10, a lawsuit
was filed against Merck, in a US District Court in Fort Meyers, Florida,
alleging Fosamax is a defective product because it can cause osteonecrosis of
the jaw, and also alleging that Merck concealed the drug�s dangerous side
effects from doctors and patients.
The lawsuit alleges
that the FDA asked Merck to add a ONJ warning to Fosamax's label in August of
2004 and that it has yet to comply with that request.
Merck claims it
received a request from the FDA to update the label in January 2005, and says
the warning was added in July 2005. However, the "label" referred to
is actually a 22-page document that is provided to pharmacies that fill prescriptions
for Fosamax, and the warning does not appear until page 13.
The attorney in the
Florida lawsuit is seeking class action status and the suit reportedly may
represent more than 10 million Fosamax users.
Fosamax is Merck's
second best-selling drug with revenues of $3.2 billion in 2005, according to an
April 12 Associated Press press.
But analysts note
that Merck is already bogged down with thousands of Vioxx lawsuits and many
estimate the total bill for Vioxx related suits may reach between $20 to $30
Robert Hazlett of Suntrust Robinson Humphrey says that Merck has the resources
to pay damages in the tens of billions of dollars. The company, he told CNN
Moneyline, had $16.7 billion in cash and investments on its balance sheet as of
the end of December 2005.
injured parties can be found at Lawyers and
Evelyn Pringle is a columnist for Independent
Media TV and an investigative journalist focusing on exposing corruption in government.