ROBERT SIEGEL, host:
The Food and Drug Administration is under fire again, this time for a series of studies on experimental blood substitutes that the agency oversaw. A new analysis shows the artificial blood products were dangerous, and its authors say the FDA should've figured that out years ago.
NPR's Richard Knox reports.
RICHARD KNOX: The authors of the new analysis have been troubled for years by signs that experimental blood substitutes caused more harm than good.
When Dr. Charles Natanson of The National Institutes of Health heard recently that another trial was in the works, he decided to go back and look at the known results of prior studies.
Dr. CHARLES NATANSON (Senior Investigator, Critical Care Management, National Institute of Health): By the year 2000, it's pretty clear that the four agents that have been tested to that date produced the 30 percent increase in mortality, and a threefold increase in heart attacks.
KNOX: The analysis was published online by the Journal of the American Medical Association. It comes on the eve of a two-day federal conference on the safety of blood substitutes.
A blood substitute would be a huge boon for treating trauma on the battlefield and in emergency rooms, and a successful one would be worth billions to any company that develops one. Many have tried none has really succeeded yet, although South Africa has approved one.
Insiders have long been worried about the safety of blood substitutes such as Dr. William Hoffman of Massachusetts General Hospital. A decade ago, he was chief medical officer of Biopure. Biopure is a company that has staked its existence on artificial blood.
Dr. WILLIAM HOFFMAN (Chief of Cardiac Surgery Intensive-Care, Massachusetts General Hospital): I was analyzing the safety database in the summer 1999. In that analysis, we were seeing a few heart attacks in the ongoing study, and I asked them to stop the ongoing study. And they wouldn't, so I stuck with the company for a few more months to try to get them to do the right thing, they still wouldn't, and I left in early winter months of 2000.
KNOX: The FDA is supposed to get prompt notice of serious problems among patients participating in drug trials, certainly that includes heart attacks and deaths. Consumer advocate Dr. Sydney Wolfe is a co-author of this week's analysis, he says FDA officials could have picked-up on the signals that troubled Hoffman.
Dr. SYDNEY WOLFE (Director, Public Citizens Health Research Group): There was enough information from studies on a variety of products by 2000 that they could have done the same kind of analysis that we've done now. If they had done it, the conclusion would have been these products are doing more harm than good, and at least one or more of the trials that were allowed to go forward would not have been allowed to go forward.
KNOX: Authors of the new study estimates that the experimental blood substitutes caused 10 heart attacks and eight deaths among the thousand people who participated in FDA-approved studies over the past eight years.
Dr. Jay Epstein, whose in charge of reviewing blood substitutes at the FDA, says the agency carefully considered all of potential risks and benefits.
Dr. JAY EPSTEIN (Director, FDA's Office of Blood Research and Review): We don't concur that a prior analysis would have changed FDA's assessment or resulted in stopping all studies in the year 2000.
KNOX: Companies that make experimental blood substitute say it's not valid to pull results of different studies because their products are all too different. Companies closely guard the results of ongoing studies; negative results can sink stock prices, and the FDA never talks about data on products in its pipeline.
Natanson says secrecy can be dangerous. He says the larger aim of the new analysis is…
Dr. NATANSON: To change the culture of secret science, to have the federal regulations changed such that the results of clinical trials are not trade secrets.
KNOX: The best way to protect study participants and the wider public, he says, is prompt disclosure of problems by companies and the FDA.
Richard Knox, NPR News.
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