U.S. News & World Report reports the very unsettling news that Merck, the manufacturer of defective arthritis drug Vioxx, knew that the drug caused serious health risks years before it was taken off the market. People who took Vioxx to relieve the discomfort of arthritis were at increased risk for stroke, heart attack and other serious health issues that could result in death. Merck had claimed their drug was perfectly safe to take regularly, but by the year 2000, there was mounting evidence of the dangerous side effects of the drug within a year of it being approved for sale in 1999.
Despite plenty of evidence that people who took Vioxx experienced serious side effects, the drug remained on the market because independent investigators did not have access to clinical trial data that would have raised red flags about the dangers of taking the drug. Merck officials still defend the safety and effectiveness of Vioxx, evidenced in a statement recently released by the company: “Merck believes the article published in The Archives of Internal Medicine in today’s issue related to Vioxx used unreliable methods and reached incorrect conclusions.”
“Merck acted responsibly—from researching Vioxx prior to approval in studies with approximately 10,000 patients to monitoring the medicine while it was on the market—to voluntarily withdrawing the medicine when it did,” the statement said. “Our decisions were based on the data from well-controlled clinical trials.”
In addition to questioning the validity of Merck’s assertions about their drug, the authors of a study on the Vioxx recall also criticized the process by which drugs are approved in the U.S. They claim that the clinical trials conducted by drug manufacturers to gain approval from the U.S. Food and Drug Administration are too short and are not designed to discover potential safety problems in the overwhelming majority of cases.
“There is no mandate to publish the trials, so if you don’t have access to the FDA records, you don’t know what the drug risk is,” one author of the Archives of Internal Medicine report said. “Once it’s approved, maybe or maybe not, the trial continues to be studied, and even then, there is no mandate to publish the findings.”
The group conducting the investigation aimed to vet the truth of a statement that Merck’s chief executive officer made before a U.S. Senate committee in November 2004. He said clinical trials indicated that there was no difference in increased risk of ‘heart events’ between people taking Vioxx and those given a placebo.
Further analysis indicated that those who took Vioxx during those trials were at a 35 percent higher risk for heart events compared to those taking the placebo. As more trials were conducted and completed in April 2002, that risk climbed to 39 percent of patients taking Vioxx. Clinical trials conducted in September 2004 indicated risk for cardiovascular events had risen to 43 percent.
James O. Cunningham
Since 1977, personal injury lawyer James Cunningham has provided effective legal advocacy to people who are injured through the negligent actions of another person or entity throughout the Central Florida area. He fights to obtain recoveries for his clients’ physical and emotional pain and suffering and pursues his clients’ personal injury cases with a commitment to excellence and impeccable preparation.
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