Gardasil, a vaccine for the prevention of cervical cancer, has been associated with a range of health problems. Girls and women on Gradasil have reported, among other things, nausea, headaches, dizziness, vomiting, paralysis, and death. The FDA has received reports of 15 deaths; 10 of these reported were confirmed.
But it is important to note that the CDC does not believe any of these deaths were linked to the Gardasil vaccine. The fact that there is an association between health problems and Gardasil does not necessarily mean that there is a causal relationship.
There have been a lot of adverse reports of patients on Gardasil. That is never a good sign. But more than 8 million people have received the vaccine since 2006. So while a lot of lawyers are talking about Gardasil as the next great class action, it is more prudent to wait to see how all of this flushes out. Time will tell if these adverse reports are from the Gardasil vaccine or because 8 million people taking a vaccine means that, regrettably, a lot of people are going to have bad outcomes unrelated to the vaccine. And if there is a relationship between Gardasil and these reports, the next question is going to be do the benefits outweigh the risks. Maybe these lawyers advertising on the Internet are right that Gardasil is the next great class action. But we are at least 3 steps short of that answer and I think at this point in the game, it is irresponsible for lawyers to be filing lawsuits without a lot more information that is going to take time to develop. The important this is that researchers continue to look at these issues and get answers.
For the short term, Gardasil will remain the only game in town until Glaxo’s gets approval for its Cervarix cervical cancer vaccine. Glaxo announced today that it does not expect to obtain approval for Cervarix until late 2009, in spite of earlier reports expecting an earlier FDA approval.