Over the last 10 years, tens of millions of people have taken Fosamax believing it would prevent bone deterioration. The drug seemed safe enough at first but in recent years it has been linked to a serious disease that causes death to the bone in the jaw called osteonecrosis of the jaw (ONJ). The disease is an extremely serious condition and symptoms include, but are not limited to:
Pain, swelling, or infection of the gums
Loosening of teeth
Poor healing of the gums
Numbness or the feeling of heaviness in the jaw
Partial or complete loss of the jaw bone
This is another case where the risks of a drug are high while the efficacy is questionable. Experts now say that Fosamax may improve bone density, but when it comes to fracture prevention, its benefits are minimal. In fact, some say that if taken for more than 10 years, the drug can actually make bones more brittle and increase the risk of fracture.
Fosamax has been on the market since 1995. Actonel came on the market in 2001 and Boniva arrived last year. As more Fosamax was sold and more bisphosphonates came on the market, more and more injuries showed up. Experts say to just wait and see what happens over the next 10 years.
Fosamax is the world's top-selling bisphosphonate. It is Merck's second best-selling drug, with sales in 2005 of $3.2 billion, according to the Associated Press. In the US alone, more than 22 million prescriptions were written last year, according to the drug research firm IMS Health.
Boniva was developed by Hoffman-LaRoche, and is co-marketed with GlaxoSmithKline and can be taken once a month while its competitors must be taken weekly.
Novartis's markets Aredia and Zometa, the two intravenous versions used in chemotherapy. Nearly 3 million cancer patients have been treated with intravenous versions of the drugs.
None of these greedy drug makers are going admit that these drugs cause ONJ and throw in the towel as long a $3 billion pot is up for grabs in the US alone. According to Business Week Online, on May 15, 2006, the "global osteoporosis market is at $6 billion in annual sales today, and with a rapidly graying population, it's growing 25% a year."
This class of drugs represents an infinite goldmine for their makers. Advertising to women in their 40s and on up to death, has created a massive market.
"The pharmaceutical industry has every desire that a patient who starts on a bisphosphonate would take it for life," said Dr. Robert Gagel of the MD Anderson Cancer Center in Houston to Gina Kolata of the New York Times. "The bone community, of which I am a member, has always been a bit suspicious of that viewpoint," he noted.
Fighting over this goldmine has got the giant drug makers taking pot-shots at each other. Amgen's osteoporosis drug, Denosumab, is getting ready to come on the market in the next few years, and Amgen is already paving the way to push Fosamax's market share lower.
"At an analyst meeting earlier this year," according to Business Week, Amgen "presented research showing that 70% of patients taking top-selling osteoporosis drugs such as Merck's Fosamax drop out in the first year of treatment because of heartburn, ulcers, and other side effects."
Roger Perlmutter, Amgen's executive vice-president for research and development, pointed out the concerns that Fosamax may cause ONJ.
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