FDA doesn't like bright lights

As follow up to previous coverage on the fake-blood 'near-controversy', mentioned here, here and here, apparently the FDA isn't too keen on letting the public know what happens. Shame on the FDA. Whatever happened to transparency in government? Oh, right, the Republicans reflexively reject it, regardless of circumstance or merit.

WSJ.com - FDA to Weigh Test Of Blood Substitute Out of Public View

The Food and Drug Administration plans a closed-door safety hearing on the Navy's proposed test of a blood substitute in civilian trauma patients even though the product's maker says it is willing to open the hearing to the public.

In a public notice, the FDA cited “trade secret and/or confidential information” for its barring the public from the hearing scheduled for Friday. Yet officials of Biopure Corp., which makes the blood substitute, say the Cambridge, Mass., company doesn't harbor any trade secrets that would prevent making the meeting of an FDA advisory committee public.

“We have no objection to holding an open hearing,” Biopure Chief Executive Zafiris G. Zafirelis said in an interview. He said his company is willing to sign a waiver saying it doesn't object to any issues or facts becoming public in such a hearing.

The Navy, the study's sponsor, declined repeated interview requests, and Biopure officials said the Navy hasn't agreed to terms under which the hearing could be public.

“Now that we know the company isn't objecting, but only the military, I am 10 times more worried than I was before” that the hearing isn't public, said Sidney M. Wolfe, director of Public Citizen Health Research Group. He termed it “suspicious” that the Navy wants the meeting closed.

What the hell does that mean, anyway? Sounds fishy to me.

Some doctors involved in the issue say the FDA is wary of a public hearing because it could prove embarrassing for the agency. While Biopure maintains its product is safe, earlier research conducted in surgery patients linked Hemopure to a relatively high rate of hypertension and serious cardiac events, including heart attacks. FDA documents show the product, which is derived from cow's blood, also has been linked to a high rate of strokes and ministrokes, compared to patients receiving donor blood.

Yet, the FDA already has allowed a nonconsent trial in trauma patients of a blood substitute made by Northfield Laboratories Inc. of Evanston, Ill. That study is nearing its completion. In an earlier surgery study, Northfield's blood substitute, called PolyHeme, was linked to 10 heart attacks among 81 patients who got the material, versus zero heart attacks among 71 patients who got blood. Northfield said its product wasn't responsible for the heart attacks.

“There's some embarrassment at the FDA over how the blood-substitute issue has been handled,” said William Hoffman, a former medical director at Biopure who now is director of cardiac-surgery critical care at Massachusetts General Hospital and who has worked on blood substitutes for years. “It's because Northfield had the same safety issue, and they let Northfield go ahead. There appear to be conflicts within the FDA about whether to go ahead” with the Navy/Biopure research.

Sounds to me like someone at the FDA (or their bosses in the White House) has a financial interest in this matter. Otherwise, why the sudden change of heart?

There are also signs that the FDA's internal stance toward Biopure's product has shifted. In the past year, according to people familiar with the events, the agency has assigned three senior agency officials to oversee the work of the original FDA reviewer of the substitute. Also, the FDA in recent weeks has disinvited two doctors, known to be critical of blood substitutes, who originally had been slated to be consultants to the advisory committee.

The FDA's stance “seems like nonsense,” said Brian Wolfman, director of the Public Citizen Litigation Group. “They have to give some specific reason causing this meeting to be shut down.”

Tags: corruption, /FDA