Merck, the FDA, and the Vioxx Recall
In 1999 the Food and Drug Administration (FDA) had approved Vioxx, what would become Merck’s “blockbuster” drug. Although the FDA had approved the drug there was uncertainty of the safety of drug. Vioxx was approved to treat a variety of conditions, such as osteoarthritis and acute pain, but there was also a chance that it would increase cardiovascular problems. What I found most interesting about this case was the changes in how drugs are brought to consumers, from how they are approved to how they are informed of the drug.
Strengths
Merck was heading in the right direction with its drug Vioxx. They wanted the drug to be a “blockbuster”, used for multiple symptoms and everyday use. Merck used direct-to-consumer advertising to fuel sales of Vioxx. Vioxx seemed to benefit stakeholders on both ends of the spectrum, until it was found to cause cardiovascular problems. Merck did continue to research the effects of its drug and eventually voluntarily withdrew Vioxx. This is a strength in that they made the right ethical decision to withdraw the drug, even though it did take almost 5 years.
Weaknesses
Merck’s weakness would be that it did not research its drug thoroughly enough for possible problems before seeking approval from the FDA. The FDA etimates that 139,000 people in the United States had had a heart attack or stroke as a result of taking VIoxx. This could have been prevented if Merck had properly researched the drug or recalled it in a more appropriate time.
Opportunities
Prescription drug companies can have their drugs reach the market much faster than in the past. Approval time from the FDA went from 27 months in 1993 to 14 months in 2001, saving a company an estimated $41.7 million in lost revenue a month. This would benefit internal as well as external stakeholders. In 1997 the FDA allowed drug companies to advertise directly-to-consumers (DTC), which proved to be very beneficial to the drug companies. According to the Harvard School of Public Health, each dollar spent on advertising led to $4.25 in sales.
Threats
I believe that both the opportunities that the drug industry has can be threats to the drug company as well. DTC advertising puts pressure on doctors to prescribe a drug that may not be best for a patient. “There is a desire on the part of physicians, as there is on anyone else who provides service, to keep the customer happy”. The other problem is with the FDA more expedited process of approving drugs. Is putting a new drug out there faster really beneficial to anyone? If proper measures are not taken to ensure the safety of a drug, it could potentially do more harm than good. Costing companies millions of dollars in research and potentially causing consumers their lives.
Recommendations
Drug companies need to thoroughly research the drugs that they put out into to the market to ensure their safety. As well as address any concerns that might appear through extended use of their drugs. When companies advertise their drugs they should be forthcoming about the potential hazards as well as let consumers know that doctors should have the final say in what might be best for them.