We've been fascinated by this creepy clinical trial for a while.
Blood substitute `a disaster' in trial Northfield still plans to seek FDA approval
In a potential blow to the future of an Evanston-based biotech company, a clinical trial showed Tuesday that its key product, an experimental blood substitute, performed worse than standard treatments in patients who suffered traumatic injuries.
In a trial of 712 patients, Northfield Laboratories Inc. reported 13.2 percent of the 349 who had been given Northfield's product died, compared with deaths of 9.6 percent in the control group of 363 who received either saline solution in the ambulance or blood in the hospital.
“No matter how they slice it, it's a disaster,” said Martin Shkreli, a hedge-fund manager at New York-based Elea Capital, which invests in health-care companies and sold its Northfield shares earlier this year. “If you look at the absolute number of deaths, it kills more patients than saline does.”
In the trial, 46 in the group receiving the blood substitute Polyheme died, while 35 in the control group died, according to Northfield Laboratories.
Northfield has been working for more than 20 years on a potentially lucrative blood replacement that could save lives in trauma situations by carrying oxygen through the body, which the saline used during emergencies now cannot do. A blood substitute also would be easier to transport, especially to battlefields and accident scenes, and does not require the sometimes-complicated matching process real blood does.
Not to say that fake blood wouldn't be useful in certain scenarios (war zones, for instance), but Northfield seems to have a reckless approach towards figuring out the details. Probably because they've been working for so long: they want to recoup costs, one way or another. Is Halliburton a big investor?
Recently, an FDA panel decided against endorsing a clinical trial of Biopure Corp.'s Hemopure blood substitute, the only other major contender in the market, because it was going to use the same disputed method of testing without the patient's consent as Northfield did. The panel's vote came despite pressure from the U.S. Navy, which had agreed to conduct the tests for Biopure on civilian trauma patients.Industry analysts say the controversy over blood-substitute development makes Northfield's attempt to gain approval more challenging.
“Clearly, I think the news is very negative for them,” said Eugene Trogan, a biotechnology industry analyst with Morgan Joseph & Co.
What's more, Northfield has met with increasing criticism from consumer groups, influential members of Congress and medical ethicists, who said participants in the company's trial were not given adequate notice or enough information about the Polyheme no-consent trial. Such criticism makes company observers wonder about the product's future.
Tags: health
Strangely, considering the market's reaction, if you look at the details, the study supplies evidence that the stuff works--if you take out the cases that were not following protocol, about 20%. Perhaps, some folks in ambulances gave PolyHeme instead of salt water in some worst cases because they believed in it and wanted to save the life of a badly injured person. It does not work better than saline and then matched blood, but does not seem to be statistically worse either. So there may still be a case for it when blood is not quickly available. Not clear if the FDA will buy the logic. The markets says it will not, but that does not mean the product does not do the job. More will be known in about 6 weeks.