The Food and Drug Administration (FDA) has received mixed reviews for its regulation of prescription drugs. Is there a conflict of interest in having the same authority in charge of both approving and recalling drugs?
A drug must go through an extensive process before being approved and sold. First, the company conducts a series of clinical trials in animals, then in humans. The FDA closely monitors these phases in order to assess the efficacy and safety of the drug. If the drug satisfies all of the FDA’s criteria and proves that benefits outweigh risks in humans, it is approved. The FDA then continues to monitor the drug’s efficacy and safety while on the market because, if risks outweigh benefits in the general population, they are authorized to recall the drug.
One of the most well-known and controversial recalls in the past is that of Vioxx.
Vioxx, an anti-inflammatory drug produced by Merck, was indicated for treating acute pain in adults caused by arthritis or migraines. When first introduced to the market, Vioxx was one of Merck’s best selling drugs; however, when safety reports showed that Vioxx increased risk of heart attacks and strokes, the drug was recalled in 2004. The Wall Street Journal reported that according to the FDA, Vioxx’s approval in 1999 led to 27,785 reported heart attacks and sudden cardiac arrests, which could have been avoided with the use of Celebrex, the competing anti-inflammatory drug by Pfizer.
Was it ethical for Merck and the FDA to keep Vioxx on the market for so long?
It was ethical for Merck and the FDA to keep Vioxx on the market for so long if:
- Merck and the FDA did not know Vioxx was not safe before approving it in 1999
- Merck and the FDA were not aware of the cardiovascular effects Vioxx could cause
- Merck and the FDA were displaying utilitarian ethics
Merck removed Vioxx from the market on September 30, 2004, after the VIGOR study, which indicated that there was a higher risk of heart attacks and strokes in patients who took the drug compared to the placebo. In April 2000, however, the FDA required Merck to add information about the cardiovascular risk to the product label. So, why did it take so long for the FDA to pull Vioxx from the market?
According to Dr. Grahm, when “the FDA approves a drug it is also saying that the drug is safe and effective. When a serious safety issue arises post-marketing, FDA officials’ immediate reaction is almost always one of denial, rejection, and heat.” After the VIGOR study was presented to Merck, they conveyed a message to nearly 3,000 of their sales representatives, ordering them to not discuss the VIGOR study results even when questioned by physicians. Instead, their representatives were advised to show these physicians a pamphlet called “The Cardiovascular Card,” which was prepared by Merck’s marketing department. “The Cardiovascular Card” did not include any negative results from the VIGOR study, but instead presented a pooled analysis of preapproval studies, in which low doses of Vioxx were used for a short period of time. These preapproval studies did not test any risk of cardiovascular problems, causing many physicians to wonder if Merck was delaying the recall of Vioxx for personal gain.
Merck reached an out-of-court settlement for all lawsuits filed against them and apportioned $4.85 billion among 44,000 claimants.
It was not ethical for Merck and the FDA to keep Vioxx on the market after being presented with sufficient evidence proving that long-term use increased the risk of heart attacks and strokes in patients. Although Merck and the FDA were not aware of the risks before the drug was approved, they did not display utilitarian ethics when first presented with ample data demonstrating harm to patients.
For more information on this issue, contact the Kulkarni Law Firm.