Tuesday, April 29, 2008

Report: Risky tests of blood substitutes allowed

The products in question here are very different from each other...

Pooling data would make almost no sense...safety trials would be a good idea, which the FDA strongly recommended, and they enforced their own recommendation...check the timing of Biopure's stock dropping several years ago as compared with the FDA response letter...

other details gets washed over in this article as well...

FDA permitted human testing despite warning signs, report charges

CHICAGO - Experimental blood substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue despite warning signs, says a scathing new report.

The U.S. Food and Drug Administration fell short, the report contends, even as red flags popped up during studies by five biotech companies. Rules barred the agency from releasing company trade secrets, and that kept some information hidden and may have led to unnecessary heart attacks and deaths, wrote the authors, who are government scientists and consumer advocates.

“There shouldn’t be secret science,” said the lead author of the report, Dr. Charles Natanson, of the National Institutes of Health Clinical Center. Safety data need “to be made public expeditiously so science can build on the mistakes” of previous research, he said.

link to full article

No comments: