The recent recall of Vioxx generated an enormous amount of attention on the Food and Drug Administration (FDA) and the approval process of pharmaceuticals. Particular scrutiny arose over examining clinical trial data on existing drugs and how the FDA needs to improve its monitoring of drugs already on the market. The culmination of this scrutiny and public debate was the announcement February 15, 2005 of the FDA's Drug Safety Initiative. Three short days later, further analysis on Vioxx and other non-steroidal anti-inflammatory drugs (NSAIDs) of the COX-2 class, revealed that these drugs should remain on the market, which brings up the question of was all this debate and change really necessary and who does it really protect?

The well-documented saga began September 30, 2004 with Merck's voluntary recall of their blockbuster drug Vioxx. The arthritis and acute pain drug had estimated worldwide sales of $2.5 billion and was prescribed to an estimated 1.9 million patients in the United States in 2003. Even though the drug was approved and marketed in the United States in 1999, Merck was continuing clinical trials with Vioxx in other diseases. It is very common for drugs to be studied in multiple diseases and also common for drugs already approved to be studied in new indications. A three-year trial evaluating Vioxx in prevention of recurring polyps produced the now infamous data that Vioxx increases cardiovascular risk such as heart attacks and strokes.

Consumers, doctors and politicians all questioned how a drug this widely used could be so harmful and how could the FDA allow a drug like this to be approved. Shortly after that reaction came anecdotal evidence from prior trials that this outcome should have been foreseen and some data that implicated other Cox-2 inhibitors like Bextra and Celebrex from Pfizer, shared the same risks as Vioxx. Pfizer defended its products and never hinted at a voluntary recall until more information could be obtained. Meanwhile, over-the-counter drugs started advertising their safety over Cox-2 inhibitors and tried to win the public over with their advertising campaign.

As the lawsuits began to mount for Merck, politicians and consumers demanded change at the federal level to ensure safe drugs and to ensure continued and better monitoring once a drug is on the market. On February 15, 2005 the FDA released their concept for the Drug Safety Initiative, a new program to ensure consumer safety. The initiative is composed of two major portions; create an independent Drug Safety Oversight Board (DSB) to monitor drug safety issues and open more lines of communication with the public and healthcare professionals. The DSB will be composed of FDA members, other Department of Health and Human Services officials, medical experts and representatives of consumer groups. This group will monitor the safety of drugs on the market and make informed decisions with all the data present. The new lines of communication are to be highlighted with the creation of a Drug Watch webpage that will contain the latest safety information regarding drugs on the FDA watch list.

Three days after the release of the Drug Safety Initiative, an advisory panel ruled in favor of keeping Celebrex, Bextra, and Vioxx on the market. This advisory panel consisted of FDA consultants from various medical and public health institutions, patient consultants and representatives from the National Institute of Health. These panel members voted 31-1 to keep Celebrex on the market, 17-15 in favor of Vioxx and 17-13 in favor of Bextra. This independent panel is not the same format as the DSB but the idea was the same. This independent panel suggested strict "black box” warning labels for all three drugs but still said they could remain on the market. The FDA does not have to adhere to the recommendation of this committee but typically they follow their advice.

Looking at the events of the past five months, one has to now wonder if the creation and placement of the DSB and other changes at the FDA will protect investors more than the public. The original public outcry was about the safety of Vioxx and how the FDA (and Merck) could allow it on the market. With the independent panel of experts believing Vioxx should remain on the market but with stricter warnings, it begs the question, was all this necessary and whom do these changes really benefit?

Patient safety is probably not going to benefit much if at all from the changes at the FDA. Prior to the formation of the DSB, the burden of continued monitoring fell in large part to the pharmaceutical company due to legal worries. Patient safety and the fear of litigation is what drew Merck to pull Vioxx off the market. That drastic and major reaction by Merck caused its shares to fall over 30% from its pre-recall value. For a company to take such a drastic step, highlights the fear pharmaceutical companies have over litigation. The DSB is now placing more of the burden of drug safety on them and this protects the financial interests of pharmaceutical companies because they may not have to act so proactively. If the DSB supports continued marketing of a particular drug, then this lowers the company's legal risk. Now that the independent counsel has approved keeping Vioxx on the market, some of Merck's litigation risk has diminished.

The new initiative from the FDA does not really protect consumers any more than in the past, the only thing that has changed is the shifting burden of drug monitoring. Responsible pharmaceutical companies have always monitored their drugs because of the enormous liability issues that surround a poor product. As evident with Vioxx, a company will pull a $2.5 billion product off the market to try and save itself from some litigation. Now that the burden is on a government oversight committee, we cannot expect unsafe drugs to be found any quicker or examined anymore thoroughly than the prior system. If the DSB was in existence prior to the recall of Vioxx, we might have seen a greatly different story unfold. A story in which Vioxx was never removed from the market but just new warnings added. A story in which Merck's shares do not fall 30%. This story shows the same amount of protection for patients as the real story but also protects the value of Merck. This new drug safety initiative might potentially protect companies but may do little to increase patient safety.

For further information please contact:

Katja Feick
Corporate Communications
+44 (0) 207 915 7856
Katja.Feick@frost.com

www.medicaldevices.frost.com