Did Merck Know about Zocor's Dangers?
Since the Food and Drug Administration (FDA) announced restrictions on prescribing 80mg doses of Zocor (generic name Simvastatin), many have questioned whether Merck, the maker of Zocor, knew about the drug’s potential to cause severe muscle damage without providing more warning to patients.
Since the Food and Drug Administration (FDA) announced restrictions on prescribing 80mg doses of This is not the first time Merck has been accused of withholding information about negative results of its drugs in medical studies. In 2004, after heavily promoting its blockbuster drug Vioxx, Merck voluntarily pulled Vioxx off the market, because studies revealed the drug increased the risk of heart attacks, blood clots, and strokes in patients.
Lawsuits against Merck popped up all over the country, with one of the first in Angleton, Texas. In that case, the jury awarded the plaintiff, the widow of a man who had taken Vioxx, $24.5 million in mental anguish and economic losses. Additionally, she was awarded $229 million in punitive damages after the jury found that Merck had acted recklessly in selling Vioxx, despite having knowledge of the drug’s heart risks. However, the trial court reduced this based on Texas’ cap on punitive damages.
In other cases across the country, plaintiffs’ lawyers argued that Merck knew about the dangers Vioxx posed, but attempted to conceal those dangers from the public and doctors. In fact, a congressional committee found that Merck instructed its sales people not to address negative research findings when talking with doctors. Overall, the company’s goal was sales, not education.
Now people are asking whether Merck knew about the dangers associated with 80mg Zocor, but failed to disclose those dangers.
Dr. Steven Nissen of the Cleveland Clinic was the first doctor to link Vioxx to an increased risk of heart attacks and strokes in 2001. Unfortunately, it wasn’t until three years later that Merck actually pulled the drug off the market. Dr. Nissen is now calling on the FDA to take the 80mg dose of Simvastatin off the market. He says that the Zocor label change is too little too late, especially since many experts have been worried about the 80mg dose for years. Dr. Nissen stopped prescribing the high dose drug in 2004, noting that the risk associated with it is clear and has been known now for several years.
Nearly 10 years ago, the FDA required Merck to change its label for Zocor to warn patients about the risk of rhabdomyolysis. In 2004, a large study, known as the A to Z Trial, found that there was a higher rate of muscle damage, including rhabdomyolysis, in patients taking Simvastatin. Four years later, a second study, known as SEARCH, found that out of 6,000 patients taking the 80mg dose, 53 developed muscle damage, while only three patients developed muscle damage while taking the 20mg dose. The FDA has even admitted that of the 148 deaths reported from rhabdomyolysis, about half were patients taking 80mg of Simvastatin.
Although the FDA is not allowed to factor cost into its decision to keep a drug on the market, in a recent interview, a representative for the FDA said one of the benefits of Simvastatin was that it was the cheapest, most powerful statin available to patients. So it was difficult for the FDA to pull a drug off the market that cost a mere $0.04 a day, when other cholesterol-lowering medicines cost upwards of $1.20 a day. Dr. Nissen says that Simvastatin was pushed by pharmacies to save costs, despite the risks associated with taking the drug.
The FDA does not know how many patients taking 80mg Simvastatin have suffered muscle damage, but recent estimates suggest more patients than first thought could be suffering from the side effect.
One thing is clear: if Merck hid the dangers of Zocor, lawsuits brought across the nation will uncover these deceptive practices.
Merck was granted a patent in 1989 for the coadministration of CoQ10 along with Zocor (US patent 4933165). This is because it became known to them that Zocor dramatically reduces CoQ10 which is needed by the mitrochondria for proper funtioning. However they never used their patent. Perhaps they were advised it would be a clear sign of the dangers of Zocor. On the other hand Zocor was selling very well indeed so why tell anyone about this anyway.I want to proceed with a suit against Merck for ongoing myopathy and myalgia continuing 17 months after discontinuing Zocor.