I've written again and again about what many consider to be an unethical study of an artificial blood product called PolyHeme that was tested nationally, including in North Carolina. Today in the Journal of the American Medical Association, researchers released an analysis of the PolyHeme study and other similar studies on artificial blood products that have been conducted over the last couple decades. They conclude after looking at data from all the studies (they had to sue to get some of the information) that:
there was an overall 30% statistically significant increase in mortality risk. There was also a statistically significant 2.7-fold increase in MI [heart attack] risk associated with these products.
The researchers were most concerned that the FDA, through data not released to the general public, was aware of these risks as early as 2000, yet allowed trials – including the one in NC – to go forward. The NC Polyheme study is singled out by the researchers for special mention:
First, the FDA gave approval for this trial in trauma patients even though the FDA presumably had unpublished data showing a significant increase in MIs in the prior PolyHeme trial in vascular surgery patients; the FDA had the results from trials involving other HBBS products also showing harm; and the FDA had placed a clinical hold on a Hemopure trauma trial because of serious adverse events in previous, mostly unpublished, trials of this HBBS. The results of the PolyHeme trauma trial were made public in a company press release in 2007 and showed nonsignificant increased mortality risk and a significant increase in MI risk among patients who received PolyHeme. Second, the failure to publish the results of the earlier PolyHeme vascular surgery trial and previous trials of some other HBBSs meant that thorough review of previous trial results by institutional review boards reviewing the PolyHeme trauma trial at the many participating sites was not possible.
Let me sum up in one word – outrageous. The sites, like Duke University, where this trial was conducted in NC need to undertake a serious review and discussion with community members to avoid this sort of thing happening again. Basically, study trauma patients in Durham were involuntarily put at risk of serious heart attacks and this risk was known to the FDA, the company contracting with Duke, and perhaps others. Finally, NC should go back to its previous rule of prohibiting involuntary experimentation on human subjects like was done in the Polyheme trial. Private companies apparently used a compliant FDA to hide adverse data so they could keep testing dangerous products. This puts all research in health care at risk and is a sad commentary on the relationships between big money, research institutions, and the government organizations meant to protect the public.