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When two stories from reputable sources hit the news at the same time, the news can have a profound effect. So, when news broke linking Merck & Co.'s osteoporosis drug, Fosamax, with both esophageal cancer and osteonecrosis on December 31, 2008 and January 1, 2009, there existed a potential for a serious effect for the demand of the drug and for lawsuits resulting from the drug's use.
Fosamax Linked to Esophageal Cancer and Osteonecrosis
The first news story was a letter that was published in the New England Journal of Medicine by an official from the FDA. The letter found a connection between 23 cases of esophageal cancer and use of the Fosamax drug. Eight fatalities occurred in those 23 cases. The FDA did not find a similar link between esophageal cancer and other types of oral bisphosphonates.
As if that news wasn't enough to create concern, another study was released in the Journal of the American Dental Association just hours later. That study found a link between oral bisphosphonates, including Fosamax, and a serious and painful condition called osteonecrosis or dead jawbone disease.
Public Reaction to the News
The public reaction to the FDA letter and the American Dental Association study was understandably one of concern. Patients wondered if they should continue on Fosamax or if the risks of the drug now outweighed the potential benefits, especially considering the fact that there are other effective osteoporosis drugs on the market. Physicians wondered the same thing and some publicly told US news organizations that they planned to strongly consider prescribing different medications.
Merck's Response to the News
In light of the public's reaction to the news and the serious nature of the news, Merck, the manufacturer of Fosamax, could not remain silent for long. The company quickly issued a statement calling into question the methodology and accuracy of the American Dental Association study. Merck labeled the study as unreliable and claimed that it had “material methodological flaws and scientific limitations” that made the study's conclusions scientifically unreliable. Merck's response also pointed out that in larger controlled studies of more than 17,000 participants there were no cases of osteonecrosis of the jaw.
A Merck spokesperson told ABCnews.com that he couldn't speculate on the effect that these two studies would have on public opinion but urged people to contact their personal physician with questions.
While Merck has not addressed the esophageal cancer study with the same detailed remarks as the osteonecrosis study, the company is likely to focus on the extremely small number of esophageal cancer cases compared to the number of people who have taken the Fosamax drug without developing cancer. The FDA cites just 23 cases in 13 years while tens of millions of patients have taken Fosamax during that time. That said, problems with the esophagus are not unknown to Merck and the risk of esophagus problems is prominent on the drug's website and side effect warning pamphlets.
Despite Merck's response, the warnings presented by the FDA and the American Dental Association should be heard by all patients who take Fosamax and their prescribing physicians. In the absence of a clear answer, caution is necessary and the side effects associated with taking the drug must be carefully weighed against the benefits.