<<BPUR>>
There's a bit more color in the NY Times article:
The severity of any reported adverse responses was scored by a panel of doctors selected by Quintiles Transnational (news/quote), a clinical trial management company, without any involvement of Biopure. The reviewers were not told which patients had received which treatment.
The statistical analysis of the blind scoring was performed for Biopure by another independent contractor, Red River Statistics. Biopure declined to discuss the details or extent of adverse reactions for either Hemopure or the human blood, saying only that it had met the F.D.A.'s requirement that Hemopure not increase the overall risk to patients.
Analysts said that the results announced yesterday should at least temporarily deflate the large contingent of short-sellers of Biopure's stock. In recent weeks, such skeptics had borrowed and sold an unusually large portion of the shares in public hands in anticipation that the safety results had been disappointing and that the stock would tumble once they were reported. Shares of Biopure had fallen nearly 50 percent from their high of $32.70 in May to $16.66 last Thursday.
The doubts had been fueled by reports published in May and this month by the TheStreet.com (news/quote) suggesting that Hemopure patients were encountering unacceptably high rates of kidney failure. Carl W. Rausch, the chairman and chief executive, said yesterday that the rate of serious urinary and kidney reactions during the trial was 1 percent to 2 percent for both the patients receiving Hemopure and those receiving transfused blood.
Note that the rebuttal from TSC:
One of these doctors with first-hand knowledge of the product said today's announcement from Biopure does not change his view that Hemopure is unsafe and stands little chance of gaining FDA approval. He says the method of statistical analysis used by Biopure easily obscures the significance of major side effects with Hemopure, allowing the company to claim the product met its statistical safety goals.
But when the FDA takes the covers off the study results and looks at individual patients and their experiences using Hemopure, they will reach a different conclusion, the doctor said
seems quite weak to me. I am informed that this blinded, individual patient analysis is in fact the gold standard. (And note that this detailed patient by patient comparison is typically what the FDA itself often does when it wants to look deeply at adverse effects, just as the rebuttal says).
Note that the language "no less safe than blood" was reportedly crafted by the FDA, not the company.
Peter |
