Merck Case

Merck: Managing Vioxx

Abhilash Sikenpore

 “Whatever is my right as a man is also the right of another; and it becomes my duty to guarantee as well as to possess.” 
― Thomas Paine, Rights of Man

Merck an American pharmaceutical company and one of the largest pharmaceutical companies in the world has disappointed many people with “Vioxx” drug for the treatment of pain and inflammation in the past. Worldwide sales of Vioxx were $2.5 billion in 2003. The patent on Vioxx was set to expire on Dec 24, 2013, giving it approximately nine more years of profits. Merck on withdrawing Vioxx from the market and losing 9 years of patent life lost approximately $11.5 billion. (To find the total expected profits it is necessary to solve the markets expected internal rate of return for Merck. (Calculation at the last page))

 The first issue was to release Vioxx in the market or not. The company evaluated its other products and their market life cycle before taking any decision. Four of Merck products patent were going to expire in 2000 and 2001. This was one of the main reasons that Merck didn’t delay in the introduction of Vioxx. Also Vioxx was an important drug for Merck because it was to compete with Celebrex, Pfizer’s new drug to treat arthritis pain. Due to the fear of losing the sales to its competitor they took a decision to release it.  

The main ethical issues in the launch and marketing of Vioxx were the nature of clinical trial research which were approved without disclosing its side effects about the cardiovascular risks involved. The other  was the training of the sales representatives with the game called “Dodge ball Vioxx” where they were trained how to answer the questions related to cardiovascular risks if asked by doctors and physicians while marketing. I think they should have been more open and truthful about Vioxx and explained side effects caused by it. They could have actually waited for their long term results to come before just putting it in the market for sale. The action of being truthful to the questions asked by the doctors would have been ethical if they wanted to help the people with severe arthritis. They should have waited for its launch as they were still under the testing stage for its long term effects.

As far as the issue with the clinical trials is concerned, I think the doctors who were doing the tests and signing the reports before the publication (Saul 2008) lined up by Merck should have refused to sign them as it was not ethical in their profession to not disclose something dangerous found in their medical study. Doctors are known for their morals and the ethics and it would have been ethical had they reported the real observations to the FDA and stood against Merck officials.

Merck while doing the VIGOR (Vioxx Gastrointestinal Outcome studies) to test the efficacy and safety of Vioxx compared to its top competitor Aleve. Merck had come across some safety concerns regarding the cardiovascular issues which were not brought to light. On the Data Safety and monitoring Board (DSMB) request for giving a detailed reports of the safety analysis reports on the cardiovascular events that had occurred before the study was to be published , the top Merck officials pushed it aside. They tried to present the risks in such a way that they appeared common to all drugs that function as COX-2 inhibitors.  This was highly unethical as they were just concerned about the shareholders interest and they forgot the risks involved with the drug in a long term. In my view Merck should have presented all the past reports, hired more doctors to do more research and try and fix the issues. They should have withdrawn Vioxx immediately from the market until they had properly resolved the cardio vascular issue. It was irresponsible behavior on Merck part to seek market approval for a drug that had some warning signs of cardiovascular risks but due to shear interest of the company and their shares, Merck kept their aggressive marketing of Vioxx going on, which in my opinion was highly unethical for a reputed company like Merck.1