Last week I reported on the FDA's approval of a device that did not pass clinical trials. Today, I learn in today's Wall Street Journal that the FDA is approving a clinical trial of a blood substitute, the first trial (and the last reported trial) in which ten of 81 patients who received the blood substitute, PolyHeme, had heart attacks within seven days. None of the control group of 71 had a heart attack. Further, those who took Polyheme also suffered from heart rhythm aberrations and pneumonia almost twice as often as the control group.
I say 'last reported trial' above because the company, Northfield Laboraties, shut down a larger study saying it was taking too long to finish. Doctors who had used the product asked for a report of the trial, which began in 1999, but were told only about the doctors' own patients.
In marketing material to convince people to join the trial Northfield has statements saying that the product has not caused any damage previously.
This is certainly not the FDA I know.
2 comments:
Al,
I'm just going to say this once. You were completley duped by the WSJ article and the short sellers that wrote this hack job. The product has saved hundreds of lives with zero, zilch, nada, no side effects. Read this link and then think why over hundreds of doctors have signed on to this tiral all withthe knowledge of previous trial results.
http://holmesreport.blogspot.com/2006/02/this-is-why-no-one-trusts.html
Please post a reply.
Regards
Apparently, the desire to be secretive about one's activities as they apply to Ployheme extends to people who disagree with the Journal's story and my interpretation of it. You choose to remain anonymous. Northfield refused to explain why the trial was abruptly shut down. Why the secrecy?
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