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Another class of drugs is being over-marketed while its horrendous risks are being under-reported. This time it is Fosamax and its sister drugs that are the cash cows for Merck and drug manufacturers. So what if the cash cows cause the jaw bone to die.

Evelyn Pringle: Cases Against Merck For Fosamax Jaw Bone Damage Growing

Medical professionals need to recognize that Fosamax has only been on the market for a little over a decade and other bisphosphonates for even less time. The injuries showing up now are often the result the massive marketing of this class of drugs to relatively young persons who in many cases did not need them to begin with.

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.

And stopping the drug is not the answer because Fosamax remains in the body for years after patients stop taking it. Some dentists are even refusing to treat patients who are on this class of drugs, fearful that dental work such as a tooth extraction may bring on a case of ONJ.

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.

After its launch, Actonel became the fastest product in Proctor & Gamble’s history to reach $1 billion in sales.

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.

…although Merck is already in the battle of the century defending Vioxx lawsuits, the company is now facing a full frontal attack from Fosamax lawsuits. In April 2006, Linda Secrest, filed a lawsuit in federal court in Florida, accusing Merck of failing to warn doctors and patients that Fosamax could hamper blood flow to the jaw.

The lawsuit alleges Secrest began taking Fosamax in 2000, and was diagnosed with jawbone death in 2005 and that the condition is irreversible.

The complaint seeks to represent more than 10 million Fosamax users and the lawsuit is the second of about 200 lawsuits that Secrest’s attorney, Tim O’Brien, told Bloomberg News on April 11, 2006, that he plans to file.

A study cited 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, and an additional 120 patients taking the oral form of the drug had been stricken.

The debate over ONJ first gained momentum in 2003 when Dr Robert Marx, chief of oral and maxillofacial surgery at the University of Miami, wrote a paper in the Journal of Oral Maxillofacial Surgery and referred to osteonecrosis of the jaw as “a growing epidemic.”

Dr Marx reported 36 patients who had experienced “painful bone exposure,” and “were unresponsive to surgical or medical treatments.”

The 36 patients had two things in common. They all had cancer and they were all treated with bisphosphonates.

A little over a year ago, on May 13, 2005, Dr Marx told USA Today that he was aware of at least 40 or 50 cases of ONJ nationwide in patients who had taken Fosamax.

Attorneys say Merck is going to have a hard time trying to defend Fosamax cases by saying something else caused ONJ, as it has in Vioxx cases, because so few things cause the disease.

In a nutshell, the lawsuits against Merck allege that the company aggressively marketed Fosamax as safe, despite knowing about the potential and dangerous ONJ, without warning doctors and prospective patients about it.

In addition, attorneys say, a jury in a Fosamax case may be swayed by viewing first-hand a disfigured plaintiff suffering from ONJ.

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