Biopure Corp. wants to market its blood substitute in Europe for orthopedic surgery, though its own study of orthopedic-surgery patients linked the product to high rates of hypertension, serious cardiac events and fluid in the lungs.
The Cambridge, Mass., company said it initially is seeking marketing approval in the United Kingdom and if it gains approval, it "may seek" marketing authorization throughout Europe. Biopure said it bases its application in the U.K. on "new analyses of existing data" from its 688-patient orthopedic-surgery trial and a 160-patient general surgery study, as well as on studies of the blood substitute in animals. The company said it has built a database involving 1,500 patients, of whom more than 800 received the blood substitute, called Hemopure.
Food and Drug Administration documents made available to The Wall Street Journal show that, in orthopedic and general-surgery studies conducted by Biopure, patients on the blood substitute experienced a higher rate of strokes and mini-strokes than did patients getting donor blood. The records also show the FDA itself found "numerous imbalances" in which blood-substitute patients had more "adverse events" occurring to them than did people who got donor blood.
Biopure says its product is safe and that it disputes some of the FDA's calculations of side effects in Biopure research. However, Biopure officials have said in recent interviews that a published medical abstract on the research, from the UCLA School of Medicine and elsewhere, is accurate. This short paper showed, among other things, that people in the Hemopure group had more cardiac "serious adverse events" than did patients getting donor blood (6% versus 2%).
Also, in a draft written response to the FDA made available to this newspaper, Biopure acknowledged the Hemopure patients in the orthopedic-surgery study had more cases of hypertension, fluid in the lungs, and cardiac arrest or heart failure than did patients getting donor blood.
William Hoffman, who was medical director of Biopure during the study, said he came to the conclusion from the study that Hemopure was "harmful."
"There are no human data, in my opinion, that support the use of Hemopure or any blood substitute as a safe alternative to red blood cells in elective surgery," said Dr. Hoffman, now director of cardiac-surgery critical care at Massachusetts General Hospital.
The FDA has scheduled an advisory-committee meeting Friday on a U.S. Navy proposal to test Biopure's blood substitute in U.S. civilian trauma patients. The FDA said it plans to bar the public and media from the meeting, citing "trade secret" information. Biopure officials have said there are no trade secrets preventing an open hearing. The Navy didn't respond to a request for comment.
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