sign me up for a sugar pill

It's midterms, which means my awareness of the world has shrunk to the space between my coffee pot and desk, but a friend insisted that I pay attention to this story right now - and I'm glad he did. PLoS Medicine has just published a report titled Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration; granted, it's one of those titles that doesn't immediately tell you what it's about (and since I'm in the middle of preparing a few abstracts, as well, my brain is itching to red pencil it, but I digress). So what is this unwieldily-titled paper about? According to the succinct title The Guardian gave their report of the issue, it's simple: prozac, used by 40 million people, does not work. From that article,

Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.

When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs.

The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.

Kirsch and company go on to emphasize that counseling should be the first choice, and medication a very last recourse. But the researchers also go on to emphasize that this raises broad questions about drug data reporting and drug licensing; in an article at BBC News, Dr. Tim Kendall argues that drug companies should be forced to publish all their data, regardless of conclusion - something that many people have been arguing for years, and has come up in this blog recently.

Part of the reason that this is a new, and believed to be groundbreaking study (at least by the researchers) is that Kirsch and colleagues requested the full set of trial data on four drugs (prozac, seroxat/paxil, effexor, and serzone) from the FDA via the freedom of information act; two newer drugs (celexa and zoloft) were excluded because the full information wasn't yet available via the FOA. They argue that this additional and unpublished research shows that there is simply no benefit to the drugs.

Now it should go without saying that this is a research study, and anyone taking these drugs shouldn't decide to stop taking them without first consulting your prescribing physician. That said, while I take an anti-depressant that's not on the list, under the theory that it will decrease the pain I experience by increasing the dopamine in my brain, I think I'll be printing out the PLoS Medicine report and taking it in for a discussion with my own doctor.

Perhaps most to the point, I do agree with the researchers and commentators who say that this, more than anything, emphasizes that all research collected on a medication should be reported - positive, negative, or neutral. It's becoming obvious that we can't trust the FDA to make decisions on the effectiveness of these drugs; that doctors and patients are going to have to become the experts, or at least have all the data at their fingertips in order to make their own informed decisions.

And with that, I ought to get back to midterms. See you all in another day; I've got a collection of things to bring up once I'm out from under this epistemological cloud.
-Kelly

Closing the Loopholes for Big Pharma

Today's New York Times reports that about a third of the studies done on Paxil and Prozac went unpublished and (not surprisingly) if those studies were included these drugs were much less effective than when only the positive studies were published. http://www.nytimes.com/2008/01/17/health/17depress.html?
This is only the latest in a series of revelations about the way that pharmaceutical companies (“Big Pharma”) control the data about new drugs which they make available to the FDA in seeking approval and then to the public. No one disputes that these failures to disclose are harmful to the public’s health. Doctors prescribing drugs and using medical devices must have complete information in order to make the best treatment decisions. However, what is lost amidst the hand-wringing is that there is a very simple way to end this pattern and to make this information available to those who need it: require that all information, positive and negative, about drugs submitted for approval to the FDA be made available to a public data base. Current regulatory changes to require greater disclosure are inadequate because if there are any places left to hide negative data, Big Pharma will find a way to get there. Moreover, the arguments that it is somehow unfair to require companies to benefit from information about what doesn't work makes no sense because companies would only have to disclose AFTER they decide it is worth submitting the drug for approval.

Pharmaceutical companies are businesses like any other and are entitled to make a profit and to keep business information private—but only to the extent that it does not harm the public’s health. Having a drug approved for sale in the United States by the FDA is a privilege and it should come with the responsibility of making available all the available information—not just the information which the company chooses to disclose.

While it has always been the case that pharmaceutical companies were able to hide negative results in studies they conducted themselves, the need is much greater following a recent Supreme Court decision, Garcetti v. Cebalos, which held that government employees do not have First Amendment protection for divulging information—even information vital to the public’s safety-which they learn at work. Most people do not know that a growing number of research companies conducted by pharmaceutical companies are channeled through academic medical centers. While Garcetti v. Cebalos, did not involve research scientists it clearly suggests that a medical researcher at a state university which conducts drug trials for pharmaceutical companies could put his or her job at risk by divulging negative results. This silencing of whistleblowers means that without specific legislation that requires the disclosure of all data, wherever acquired, companies can continue to shield negative results from public view.

Of course is o.k. for pharmaceutical companies to make a profit, just as it is for auto companies, but when the product is one that can endanger the public’s health there must be a requirement of full disclosure.


Jennifer S. Bard, J.D., M.P.H.
Alvin R. Allison Professor of Law and Director, Health Law Program Texas Tech University School of Law Associate Professor (Adjunct) Texas Tech University School of Medicine
1802 Hartford Avenue
Lubbock, Texas 79409-0004
Jennifer.Bard@ttu.edu
806.742.3990, ext. 349


http://www.nytimes.com/2008/01/17/health/17depress.html?ex=1201237200&en=bff3cb16e49ff5f0&ei=5070&emc=eta1