MS Drug Tysabri May Be Tied To Other Serious Side Effects
Great. Now Wall Street analysts’ analyses of spontaneous adverse event reports are being reported by the mainstream press. The WSJ story (“MS Drug Tysabri May Be Tied To Other Serious Side Effects.” By Sylvia Pagan Westphal. The Wall Street Journal. August 29, 2005–no longer available online) reports that Dr. Steve Harr from Morgan Stanley described reports of serious adverse events usually associated with immunosuppression among Tysabri users. It doesn’t say whether Harr contacted any experts to help him interpret the data. Once again, this is an example of what can happen when spontaneous adverse event reports are made accessible to the public without FDA qualification. Anyone can currently ask for and receive AERS reports for any marketed drug in the U.S. The data are sent, after some delay, without FDA interpretation, leaving the recipient to determine what the data mean for herself. The recipient is free to report his interpretation publicly. We’ve seen already what happens when these data are interpreted by groups with an agenda, such as investigative reporters and Public Citizen. Now, imagine what will happen if FDA follows through on its proposal to disclose such events in near real-time on its website. I’ve warned readers about this before. If the industry doesn’t lobby harder to stop it, it will happen. Don’t get me wrong, I’m in favor of a more transparent FDA. But I’m not in favor of disclosing information for information sake. Information without interpretation and context can do more harm than good. FDA’s Office of Drug Safety, and its new drug safety oversight board, are in the best position to provide this interpretation and context. If transparency is what FDA and Congress want, they must take responsibility for ensuring that drug-safety information is accompanied by guidance. If FDA can’t handle the task with its internal staff, then they will have to contract it to a third party. Otherwise, investors are in for a very bumpy ride as new data are disclosed, and the public at large is in for a very confusing period when they and their physicians will not know what to believe about their medications.
