"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.
