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Consumer Safety

WHEN DRUGS HARM PATIENTS
(The Story of Vioxx)

     On September 30, 2004, giant drug manufacturer Merck & Co. announced the largest prescription-drug withdrawal in history -- a worldwide voluntary recall of the popular pain medication Vioxx (rofecoxib). According to the company’s press release, its decision was based on data that showed that patients taking Vioxx had an increased risk for cardiovascular events such as heart attack and stroke, beginning after 18 months of use. Considering the millions of patients who were taking the drug chronically, we are facing an enormous public health issue according to medical experts who reviewed the trial data.

     By the time it was withdrawn, an estimated 80 million people worldwide had taken Vioxx, including 10 million in the United States. A memo posted by the US Food and Drug Administration (FDA) on its website on November 2, 2004 suggests that Vioxx may have contributed to almost 28,000 heart attacks in the US between 1999 and 2003. With Merck’s aggressive marketing, Vioxx has cornered a major portion of the Cox-2 Inhibitor market. After five years successfully manufacturing Vioxx, Merck has earned approximately $8 billion in profits.

     Vioxx was introduced in the United States in 1999 and since been marketed in 80 countries. It is a is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) recommended for treatment of many types of pain, including osteoarthritis, acute adult pain and painful menstrual cycles. Known as a Cox-2 Inhibitor (because they inhibited the Cox-2 enzyme in the body as opposed to NSAID which inhibit Cox-1 and Cox-2 enzymes) Vioxx was approved by the FDA in 1999 and hailed as a miracle drug.

     According to Merck, it decided the recall after a clinical trial produced strong data of increased risk for serious heart problems. However, this was not the first clinical trial that raised suspicion about Vioxx. Results of the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, sponsored by Merck and released in March 2000, also indicated increased risk of cardiovascular events compared to other pain killers.

     After analyzing the results from 18 clinical trials and 11 observational studies - many completed before 2001 - Peter Juni of the University of Berne, Switzerland, and his colleagues believe that the decision to recall could have been made much earlier. Pulling studies from published and unpublished trials from the FDA database representing 20,000 patients, Juni and his colleagues found a two-fold increase in heart attack risks. They also found that the risk extends to short exposure to the drug – contrary to Merck’s assertion that risk attaches only to long-term use. “If we can do this kind of analysis, it’s difficult to see why it wasn’t done by the drug company or the licensing authorities years ago,” says co-author Matthias Egger.

     Critics blame both Merck and the Food and Drug Administration (FDA) for failing in their responsibilities to the public. In a critical review published in the New England Journal of Medicine, Eric Topol, M.D, believes that if both of them heeded the warning signs along the way, this debacle could have been avoided. He points out that although the drug was approved in 1999 on the data submitted to the FDA, the data were not submitted to a peer review journal until the following year.

     It was not until February 2001 that the FDA Arthritis Advisory Committee met to discuss concern about the potential cardiovascular risks associated with Vioxx. Their primary conclusion was that it is mandatory to conduct a trial specifically assessing cardiovascular risks and benefit of these drugs, particularly in patients with established coronary artery disease. Unfortunately, such trial was never done. The FDA has the authority to mandate that a trial be conducted, but never took the initiative.

     In a published commentary, medical journal editor Richard Horton calls the licensing and use of Vioxx “public health catastrophes.” Why clinical investigators studying Vioxx did not do more to raise concerns is a fair question that needs to be answered. “We must not diminish the importance of the covenant of trust that society has established with powerful commercial and governmental institutions. For with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest,” according to Horton.

     Patients who suffer harm as a result of taking drugs that were meant to help them need to consult consumer attorneys who are experienced in product liability cases to determine what remedies are available to them under the law.

© Law Offices C. Joe Sayas, Jr.