Friday, September 28, 2007

Quote of the Day: "rats and mice get greater protection as research subjects in the United States than do humans"

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania. Dr. Caplan is quoted in the NY Times today, in response to a report due to be released Friday by the inspector general of the Department of Health and Human Services, Daniel R. Levinson. The report finds that Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials.

Art points out that "Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research."

"Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been."

To read the full article, click here.

[Editor's note: Art has written an MSNBC column about the report -- here's an excerpt:
"When a bridge collapses in an American city or a mine implodes, it does not take long before government gets in motion to figure out what to do about the problem. We see the carnage and demand action.

When a federal agency charged with protecting your health and safety is found grossly deficient, the response, sadly, is mainly talk.

When a bridge collapses in an American city or a mine implodes, it does not take long before government gets in motion to figure out what to do about the problem. We see the carnage and demand action.

When a federal agency charged with protecting your health and safety is found grossly deficient, the response, sadly, is mainly talk.

That is because it is hard to see where the victims are and, without them, it is hard to get the problem fixed. But when it comes to the Food and Drug Administration, we had better demand repairs.

A new report from the inspector general of the Department of Health and Human Services paints a very grim picture as to how well the FDA protects Americans who are subjects in human experimentation. The FDA is called on the carpet for not knowing how many experiments are actually being done in the United States. The report also faults the FDA for inadequate audits of research sites and a failure to ensure compliance with its orders when FDA inspectors find something amiss at a research site.

The problems discussed in the report are not new. They have been festering for years. Who is to blame?" The rest can be read here.

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