FDA Sued over Secret Hearing on Artificial Blood Product

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July 13, 2006 5:36 PM

The consumer group Public Citizen has filed an emergency lawsuit to stop the FDA from holding a closed door meeting on an artificial blood substitute called Hemopure.

The FDA is scheduled to meet tomorrow to weigh whether to allow Biopure, the maker of Hemopure, and the U.S. Navy to conduct a clinical trial on emergency trauma patients without their consent.  Public Citizen's lawsuit, filed in U.S. District Court in Washington, D.C. last night, asks for an immediate order to either stop the closed-door meeting or to open it to the public.

The FDA has said it closed the hearing to protect confidential company information.  But according to its lawsuit, Public Citizen says it was informed by Biopure that "little if any of the information" discussed would involve trade secrets.   

According to Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, "The public has a right to know what happens at this meeting, and I should have a right to attend and to participate in the discussion concerning the testing of this product." 

The FDA had rejected previous proposals to allow non-consent trials with Hemopure after earlier studies showed higher rates of heart problems among Hemopure patients.  Biopure says its product is safe.

The FDA's meeting comes at the same time another blood substitute product, Polyheme, is being tested in about 20 cities across the country without the consent of test subjects.  Safety concerns have also been raised about Polyheme after it was revealed 10 out of 81 patients from an earlier trial suffered heart attacks; two of those patients died. 

The maker of Polyheme, Northfield Labs, has attributed those results to a flawed trial design where doctors gave too much fluid to the Polyheme patients. Northfield also says an independent monitoring committee has periodically examined safety data from the current trauma trial and has allowed it to proceed.

Denver is out of the Polyheme trial.  See an updated list of those cities now participating in the trial.

As of Thursday afternoon...

The FDA has called off a controversial closed-door hearing set for tomorrow on whether to allow an experimental artificial blood product, Hemopure, to be tested on trauma patients without their consent. 

The action comes after the consumer group Public Citizen sued the FDA in an attempt to either stop the meeting from taking place or to open it to the public.   

An FDA spokesperson said the Hemopure meeting will be rescheduled at a later date as an open hearing.