Nature Medicine | Spoonful of Medicine

Putting the FDA on the spot

Prescription drugs occasionally have unintended and devastating outcomes—think Vioxx, the blockbuster painkiller that was pulled from the market when research suggested it might increase the risk of heart attacks and stroke .

Until now, patients have had legal recourse against pharmaceutical companies that they believe failed to provide adequate warnings on product labels: they can sue these companies in state courts. But a new case facing the Supreme Court threatens to scrap this privilege and broaden the legal shield protecting pharmaceutical companies. The Court is expected to hear Wyeth v. Levine on 3 November. The case concerns a woman who lost part of her arm to gangrene following an injection with the company’s anti-nausea drug Phenergan. She claims that Wyeth’s product labeling failed to adequately discourage patients from administering the drug through injection.

If the drug company prevails, consumers will be denied legal redress, the pharmaceutical industry will be off the hook, and the burden of ensuring proper product labeling will fall almost entirely on the Food and Drug Administration (FDA). With all due respect, isn’t this a lot to expect from the FDA, an agency known for being underfunded and backlogged with products awaiting approval? As editors of the New England Journal of Medicine have pointed out, FDA approval is typically based on short studies that fail to reveal long term health consequences. Furthermore, the agency relies heavily on the goodwill of drug companies to reveal potential safety problems, lacking the subpoena power required to make them tell all. If Wyeth rules in favor of the industry, will this not redirect lawsuits onto the FDA?

Drug companies know the most about their drugs—after all, they developed and tested them—so they should be responsible for informing patients of risks. What do you think?

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    Sergio Stagnaro MD said:

    Such as problem is really difficult to resolve, when the interest of all individuals, i.e., drug companies and patients, is central. Every drug, if it’s such, must be burden by beside effects, sometimes dangerous. In addition, we must remember that the statement “post hoch ergo propter hoch” not always is right, according to Hume! In spite of the above mentioned remarks, in my opinion, if all physicians around the world would know precisely both Biophysical Semeiotic Constitutions and related inherited real risks, harmful results should be less numeorus. For instance, in absence of CAD Inherited Real Risk (Stagnaro Sergio. Bedside Evaluation of CAD biophysical-semeiotic inherited real risk under NIRLED treatment. EMLA Congress, Laser Helsinki August 23-24, 2008. “Photodiagnosis and photodynamic therapy”, Elsevier, Vol. 5 suppl 1 august 2008 issn 1572-1000; Stagnaro Sergio. Role of Coronary Endoarterial Blocking Devices in Myocardial Preconditioning – c007i. Lecture, V Virtual International Congress of Cardiology. http://www.fac.org.ar/qcvc/llave/c007i/stagnaros.php; Stagnaro Sergio. Biophysical-Semeiotic Inherited Coronary Real Risk, conditio sine qua non of CAD.17 August 2007. http://www.annals.org/cgi/eletters/0000605-200708070-00167v1#19068 ; Stagnaro Sergio. Bedside recognizing Inherited CAD Real Risk. http://www.natura.com 21 May, 2008. http://network.nature.com/forums/pmgs/1587?page=1#reply-4262; Stagnaro Sergio. Bedside Recognizing CAD Inherited Real Risk and silent CAD with Biophysical Semeiotics. Lipid in Health and Disease. (29 May 2008) http://www.lipidworld.com/content/7/1/19/comments#299588; Stagnaro Sergio. Clinical Medicine Scientific Advances in Primary Prevention. The Lancet. July 03 2008. http://www.thelancet.com/journals/lancet/article/PIIS0140673608609253/comments?actionview&totalComments=1),even Vioxx could not bring about heart disorder.