March 25, 2005

Medical Ethics

Here are two questions that practitioners of the budding field of amateur medical ethics might want to ask in front of a camera some day soon...

First, why is it that if the US has such excellent quality controls on pharmaceuticals, such that we can't even trust American companies' products made for other countries because their packaging is different, this got overlooked, emphasis mine:

WASHINGTON -- March 24 -- Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately remove pemoline (Cylert), a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD), from the market because it is known to have caused at least 21 cases of liver failure, including 13 resulting in liver transplantation or death.

In its petition, the consumer advocacy organization noted that the drug’s unfavorable risk-to-benefit ratio has led to its withdrawal in the United Kingdom and Canada while the FDA instead opted for two separate black box warning labels that a 2002 FDA study shows were ineffective in reducing the drug’s risks. “In light of this evidence of unique liver toxicity without evidence of unique therapeutic benefit, we contend that the only responsible course of action is to remove this dangerous drug from the market,” states the petition. ...

Second, maybe they could ask about this charming proposal, which was suggested last year though it has yet to go into effect. Emphasis mine again:

LONDON (Reuters) - The U.S. Food and Drug Administration is flouting ethical practice by proposing that international guidelines protecting patients need not apply to clinical trials conducted abroad, critics said on Thursday.

Peter Lurie, of consumer group Public Citizen, and Dirceu Greco, of the Federal University of Minas Gerais, Brazil, said plans to exempt overseas trials from the Declaration of Helsinki were an example of Washington ignoring global rules. ...

Where's the outrage against an FDA that allows a liver damaging drug to be given to young children and wants to release pharmaceutical companies from international obligations to their human research subjects? There is an enormous vacuum of giving a s*** about things that count, and the sucking sound emanating from Florida gives a pretty clear indication of the source of this wasteland of useful attention.

Posted by natasha at March 25, 2005 12:49 AM | Health/Medicine/Health Care | Technorati links |