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Today's New York Times reports that about a third of the studies done on Paxil and Prozac went unpublished and (not surprisingly) if those studies were included these drugs were much less effective than when only the positive studies were published.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

Should Children be Vaccinated against Addiction?

blog.bioethics.net points to an article in Time on the new "cocaine vaccine" and asks whether it should be given preemptively to children.

Basically, the "cocaine vaccine" works by stimulating the body to produce antibodies that bind to cocaine molecules, preventing them from binding to the receptors in the brain that, when activated, produce the "high" from the drug. As a result, the "high" is negated or greatly reduced, which removes the incentive to continue to use the drug.

While I see the potential for this treatment to help addicts overcome cocaine addiction, the talk of giving this preemptively to children worries me. Beyond the issues of informed consent mentioned, I have concerns about using any treatments that could affect brain receptors in children unless it is medically indicated. Psychoactive drugs affect us because our brains have receptors that respond to particular drug molecules; these receptors probably have some other function in normal life. Stimulating the body to produce antibodies that bind to drug molecules to inhibit them from binding to our receptors could have adverse impacts on the natural auto-stimulation and regulation from our bodies. In children whose brains are still developing (and will go into overdrive during puberty), we cannot safely anticipate what the long-term effects on neurotransmitters and brain activity could be.

Because the vaccine has been show to be effective on adults, and because there is usually sufficient time to respond to cocaine addiction, I do not feel that vaccinating children in this case is justified.

And because I still am bitter about the controversy over the HPV vaccine: aren't moralists worried that giving the cocaine vaccine to children will tell them it's okay to start doing drugs?