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OpEdNews.com

 

Original Article at

http://www.opednews.com/articles/genera_evelyn___060415_fosamax_does_m

ore_ha.htm

 

 

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April 15, 2006

 

Fosamax Does More Harm Than Good

 

By Evelyn Pringle

 

The osteoporosis drug Fosamax has been on the market for a little

over ten 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 drugs.

 

Bisphosphonate in 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 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%,

according to IMS Health, which monitors pharmaceutical trends.

 

However, although 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 ten 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).

 

The discovery, 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 tissue.

 

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 2 patients a

year.

 

In conducting a review of the patients' charts, the doctors found

that the 63 patients, diagnosed with ONJ over a 3-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.

 

" The patients 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 trend.

 

" We've 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 newspaper.

 

" We're not 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 rare. "

 

But while this may appear to be true, experts say it is always good

to consider that at least 90% 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, 2006 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 Greenspans 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, 2006, a lawsuit was filed against Merck, in a US

District Court in 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, 2006, article by the

Associated Press.

 

But analyst 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 billion.

 

However, analyst, 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.

 

Information for injured parties can be found at Lawyers and

Settlements:

 

http://www.lawyersandsettlements.com/articles/fosamax.html

 

Evelyn Pringle

evelyn.pringle

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