David White

Updated FDA Decision Calendar: Five Decisions Before Year-End

I have copied below an excerpt from the Nov. 2008 Journal of the American College of Surgeons about PolyHeme:

Seven hundred fourteen patients were enrolled at 29 urban Level I trauma centers (79% men; mean age 37.1 years). Injury mechanism was blunt trauma in 48%, and median transport time was 26 minutes. There was no significant difference between day 30 mortality in the as-randomized (13.4% PolyHeme versus 9.6% control) or per-protocol (11.1% PolyHeme versus 9.3% control) cohorts. Allogeneic blood use was lower in the PolyHeme group (68% versus 50% in the first 12 hours). The incidence of multiple organ failure was similar (7.4% PolyHeme versus 5.5% control). Adverse events (93% versus 88%; p=0.04) and serious adverse events (40% versus 35%; p=0.12), as anticipated, were frequent in the PolyHeme and control groups, respectively. Although myocardial infarction was reported by the investigators more frequently in the PolyHeme group (3% PolyHeme versus 1% control), a blinded committee of experts reviewed records of all enrolled patients and found no discernable difference between groups.

As you can see from the last comment, the committee of experts found no discernable difference between the controlgroup and the PolyHeme test group. This also brings up another salient point. EMT's could give PolyHeme blood substitute to patients with blood loss, without typing being necessary. This might save a lot of lives. They could carry a supply of PolyHeme, but they could not easily carry an adequate supply of different blood types.

Updated FDA Decision Calendar: Five Decisions Before Year-End

I probably should add that there are likely many WHO sponsored medical sites in third world countries that would love to have a guaranteed non-contaminated supply of blood (or blood substitute) that was not too expensive. Do you think they always have the facilities to do complete checks on blood contamination in African countries with rampant AIDS. If you didn't have AIDS, would you rather take a chance on random blood, or would you prefer to take a slight chance on complications by using a blood substitute?

Updated FDA Decision Calendar: Five Decisions Before Year-End

About 5: You may be correct in your overall statement here. However, you are citing information about all pooled studies, not about this particular blood substitute. I would be more interested and more persuaded by information about this substitute in particular. The FDA did grant NFLD priority review status for PolyHeme yesterday (or at least it was announced yesterday). Also there are many times hospitals that are low on blood. There are also many operations in which there is a very low possibility of heart related problems. The blood substitute could be used in low risk cases, while the whole blood could be reserved for high risk cases. This would greatly reduce the likelihood of problems. Also it might go a long way to solving the blood shortage problem experienced by many hospitals.

As a second point, we would not have airplanes now if someone wasn't willing to take a chance on the early, very questionably safe planes. I have not heard that PolyHeme is particularly dangerous. It seems likely it is more dangerous than I had thought. However, one does expect progress over time. Using generalizations to bad mouth PolyHeme in particular seems less than fair to NFLD. If you have information specific to PolyHeme, I would be very interested to hear it.

It does seem that there will eventually be a blood substitute. Perhaps PolyHeme will be the first. However, saying "space flight to the moon or to Mars" is impossible is simply recalcitrant thinking. Whether or not you are eventually correct about NFLD as an investment, specific information about the specific company and the specific product is always preferred. To completely deny a company's invention by generalized inuendo (even from JAMA) is unthinkable. Again if you have specific information about NFLD's product, please present it.