Implication of FDA decision on Vioxx, Celebrex, Bextra

The latest news that Vioxx sales may resume in the United States and that Celebrex and Bextra can stay on the market with black box warning may sound like good news for Merck and Pfizer but it has shocked and confused a lot of people. At first instance, this decision by the FDA panel seems heartless and callous. How could any scientist vote for keeping a drug on the market when according to the FDA, 140,000 Americans have been injured by Vioxx alone? And in another estimate by Public Citizen, 100,000 deaths and 2.1 million serious injuries a year result from adverse reactions due to Celebrex and Bextra.

So let us analyze what has really happened here and how it will impact the those injured and family members of those deceased after taking any of these three drugs. We are also hopefully answering all the emails that we have received from our readers.

What did the FDA panel really say?

• All three drugs in the Cox-2 class, that is, Vioxx, Celebrex and Bextra have serious side effects, particularly on the heart. In other words, the panel said today what Merck or Pfizer never told the patients. A drugmaker should disclose every single piece of information that it knows about the drug. Both Merck and Pfizer failed in their duties to inform doctors and patients, and instead, fought Coke-Pepsi style marketing battles. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battles)
• Just because the drugs may be sold does not mean that they are as safe as they were made out to be by Merck and Pfizer in their direct-to-consumer advertisements for Vioxx, Celebrex, and Bextra. What the scientific community has said is that these drugs do have benefits as well as risks and as long as patients and doctors understand both they can jointly decide what is best for them. (Related article: European Medicines Agency also leaves Vioxx, Celebrex, and Bextra on the market but with strong warning and restrictions)
• Doctors understand that there is simply no drug without side effects. Doctors like to have more choices so that they can determine what is best for their patients.

How does it impact patients of Vioxx, Celebrex, and Bextra?

• Actually there is plenty of research that came out during the panel hearings that validates what arthritis patients (and family members of those who died due to any of these drugs) have known for a while - that these drugs injured them. If these people would have known what came out in three days of hearings, they would have either not taken these drugs or taken them knowing what the risks are. (Related article: Vioxx doubled heart risks, study finds)
• Merck and Pfizer are still liable for any injuries that their drugs caused. The fact that the panel agreed today that these drugs do increase possibility of heart attacks and strokes makes their case more solid. Having these drugs on the market changes nothing insofar as Vioxx litigation is concerned.
• While Merck will argue that Vioxx alone is not the culprit and try to drag Pfizer into the legal mess, it does not change the fact that Merck made a product that injured Americans and people all over the world.

Recommended article: Merck knew of Vioxx side effects