US senator questions FDA-approved blood study
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A key Senate Republican pressed the U.S. Food and Drug Administration on Thursday for details on its role in the clinical trial of an experimental blood substitute being tested on trauma patients in 18 states, in some cases without their consent.
Senate Finance Committee Chairman Chuck Grassley asked the FDA to make a full public disclosure about the clinical trial of Northfield Laboratories Inc.‘s PolyHeme blood substitute, after its safety was called into question in a Wall Street Journal article.
“It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential ‘guinea pig’ without providing a practical, informative warning to the public,” the Iowa Republican said in a letter to acting FDA Commissioner Andrew von Eschenbach.
The Wall Street Journal reported on Wednesday that Evanston, Illinois-based Northfield was conducting the trial under a rarely used FDA regulation allowing waivers of the informed consent typically required in clinical trials—provided the trial is accompanied by a community outreach program.
The article described a previous clinical trial of PolyHeme, in which about 12 percent of patients on the product suffered heart attacks and two out of 81 patients died. The trial results were not published, the newspaper said.
Northfield said on Wednesday it had disclosed full data from that trial, which closed in 2000, to the FDA. The company said publishing the data would have shown PolyHeme could not be isolated as the cause of the serious adverse events that were observed.
Last April, the company said an independent safety panel gave the green light for its late-stage testing to continue, after a review of death rates in the study.
In his letter to the FDA, Grassley expressed concern that patients could be subjected to the experimental blood product unless they were wearing a wristband that says they decline to participate in the study.
Many people probably do not know how to get the wristband, he added.
“Why should Americans have to wear a bracelet at all times to protect themselves from a government-sanctioned medical experiment if they happen to get into a car accident?” Grassley asked in a statement releasing the text of his letter.
Grassley asked the FDA to provide his committee with a detailed briefing on the PolyHeme study no later than March 8. His panel has oversight of the Medicare and Medicaid programs, which pays for drugs and other FDA-approved products used by old, disabled or poor beneficiaries.
An FDA spokesman did not immediately respond to an e-mail request for comment.
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