Merck Inc Case Study

Is Merck Inc. fully to blame for misleading the public about the safety of the pain medication Vioxx? This is the question that my research paper will examine by pulling the opinions of experts in the subject along with my own opinion. This issue impacts the company, the employees, owners, creditors, regulators, and communities. This is a very complex issue concerning the deaths of some, a company's very existence, along with millions of dollars.

On September 30, 2004 Merck & Co., Inc. announced that they would voluntary withdrawal Vioxx from the market worldwide. "Vioxx is a COX-2 selective non steroidal anti-inflammatory drug (NSAID). It is a prescription medication used to relieve signs and symptoms of arthritis and acute pain, which is only to be used by adult patients." (REF) The FDA did not require Merck to withdraw its product from the market however; it was an independent decision on Merck's part. (Hopkins) The FDA does share the same safety concerns for patients taking Vioxx and especially for those that take the drug regularly. After Merck pulled the drug off the market, the FDA issued a public health advisory concerning the use of Vioxx.

An argument can be made that this is indeed Merck's fault. Vioxx made it onto the market with a 17-15-majority vote. Even though Vioxx made its way to the market much controversy swirled around its introduction to the public. Ten of the thirty-two experts on the FDA COX-2 advisory panel that evaluated these drugs had what the Center for Science in Public Interest considered "affiliations" with the drug companies. (Adams) These experts that were considered "affiliates" did receive consulting fees, research support and speaker's fees.

Throughout my extensive research I was not able to find any information that linked any of these "experts" to Merck's more than anyone else. Why should this be a concern now? The only answer to that is because of lawsuits and money. In accounting companies cannot have someone in house audit the financial statements and sign off on them. Is the pharmaceutical industry that far behind? The only reason it is a problem now because there are millions of dollars at stake, which I recognize is a huge deal. My point is that if there was ever a concern about personal interest affecting someone decision that should not have been allowed on the board. Now Merck is paying the price for the FDA mistake.

"As the Center for Science in the Public Interest noted, 'This would appear to be a direct violation of the Federal Advisory Committee Act, which prohibits scientists with direct conflicts of interest from serving on panels offering advice to federal regulatory agencies." (Jubak) If those ten votes that were submitted by the experts on the panel would not have voted "yes" for the drug then Vioxx would not have ever made it on the market, it would have easily would been outvoted 15-7. Merck's legal problems became worse when "Sandra Kweder, deputy director of the FDA's office of new drugs, testified before the Senate Committee on Health, Education, Labor, and Pensions. She testified that Merck was initially willing to change the Vioxx label that would have enlightened heart risks to patients." (Barrett) She said, "more than a year passed... between the time an FDA advisory panel recommended that the cardiovascular risks of Vioxx should be emphasized on the drug's label and the actual change to the label. Kweder called that period, February 2001 to April 2002, unusually long." Merck was spending time fighting to keep the label as it was thus delaying the needed change while patients were beginning to fall ill and starting to die off.

The company took all the appropriate steps to clear the product through the U.S. Food & Drug Administration that is why Merck is making the claim that they cannot be held responsible. The FDA has put its own reputation on the line along with their expertise and all of this is going to be known throughout the hearings. The FDA put its own competence on the line when they approved Vioxx for safety and efficacy. This is Merck's strongest defense against these lawsuits. Certainly, the FDA felt that the rewards out weighed the risks when they decided to approve Vioxx.

"Even in the case of Vioxx, the likelihood that an individual taking the drug would have a heart attack or stroke is relatively small. In a study of 2,600 patients, there were 15 cases of reportable heart attacks or strokes per 1,000 patients among those who took Vioxx for longer than 18 months. Among those who took a placebo, there were 7.5 heart attacks or strokes per 1,000 patients. And those who took Vioxx for less than 18 months had no increased cardiovascular risk." (Petersen) So a patient that was taking Vioxx instead of a placebo was actually less than 1 in 100 more likely to have a heart attack (unless taking it for over 18 months). The mere fact is that people that are taking placebo are already dying. It is not as if Vioxx came out and then all of a sudden people begun to die because of pain medicine. Maybe it's the people in sample, it is certainly possible, or perhaps the sample size for this tests were not large enough? One of the hardest dilemmas for regulators is to solve is at what point does the damage exceed the overall reward of the drug. Where is that line drawn?

In another test, "In June 2000, Merck submitted the findings of this research to the Food and Drug Administration. It was a comparison of results for 4,047 patients given Vioxx and 4,029 given naproxen (Aleve). The results: five patients on Vioxx died of heart attacks and four on naproxen died of heart attacks. In other words, there was one extra death from a heart attack out of 4,000 people on Vioxx." (Petersen) This study shows a very small risk between the two. What the article also goes on to say is that, "making the risk of actual usage even smaller is the fact that all the results were at double the maximum recommended daily dose for Vioxx." It appears that there is not very significant difference in the numbers between the two. However, anyone can buy Aleve or Advil whereas a doctor must prescribe Vioxx to you. This should let Merck off the hook in my eyes even with the old label that was on the bottle. If you doctor prescribes it to you surly he would describe to you the possible affects and inform you of the risks you are putting yourself into or that he is putting you into. If anyone would know of possible heart problems you could have or even a family history of them who would know better than your doctor.

I am sure there are people that do