FDA Has Egg On Its Face…Again (NFLD)

The Wall Street Journal reported in Wednesday’s edition that a previously halted study of Northfield Laboratories’ (ticker: NFLD) synthetic blood product, Polyheme, showed 12 of 81 patients who received Polyheme suffered heart attacks with two of those patients dying whereas none of the patients who received real blood experienced a heart attack. To make matters worse, the company never revealed the results and the FDA approved a subsequent pivotal study that allows patients to be given Polyheme without the patients’ consent. This revelation begs numerous questions: Why didn’t the FDA review these data? Why did Northfield sweep the data under the rug? This will put more scrutiny on the FDA, which is already under the microscope for a laundry list of real and perceived lapses at the agency, including the Vioxx debacle and last week’s New York Times article questioning the approval of an implantable device for depression.

The Polyheme study referred to in the WSJ article was a controlled study comparing Polyheme versus real blood in patients undergoing surgery to repair aortic aneurysms. In 2001, the company abruptly halted the study citing slow enrollment. This is a plausible reason given only 152 of the projected 600 patients had enrolled in the study during a four year period. However, the fact the data on the 152 patients where never reviewed or published and the data were never submitted to the FDA raises numerous questions. According to internal documents cited in the WSJ article, Polyheme not only resulted in an increase in heart attacks but patients treated with Polyheme also show increased incidences of heart arrhythmia and pneumonia.

Dr. Stephen Gould’s, Northfield’s Chairman and CEO, is of the opinion that some hospitals gave patients both Polyheme and real blood resulting in hypertension that led to the heart attacks. Some experts, however, disagree. Given the toxicity of hemoglobin outside the confines of the red blood cell – free hemoglobin is known to cause inflammation in blood vessels that in turn can lead to heart attacks – many physicians speculate that polymerized hemoglobin may still cause inflammation albeit at a lower level that free hemoglobin despite claims made by the company. The fact that heart attacks and pneumonia have a common denominator – inflammation – suggests something more than the excessive fluid claim made by Dr. Gould, and the fact the company did not come clean with this data implies they have something to hide.

But where is the FDA in all this? Knowing the company had data on these 152 patients, why didn’t the FDA request this data, especially before approving the ongoing trauma study that does not require patient consent to be treated with Polyheme? There is a lot explaining to do both at Northfield and at the FDA. Stay tuned…I think the WSJ journal article is just the beginning.

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Comments

[BioBlogger]

I agree with many of the comments to my post. There are certainly two sides to this story. A very interesting fact pointed out by Northfield was that Polyheme patients had, "...60 percent of their blood volume withdrawn versus 30 percent of the control group. In keeping with the protocol, the PolyHeme group also received substantially more fluids than did the controls resulting in complex issues with fluid management in those patients." However, I am still concerned about the safety issues brought up in the article especially in light of the fact the trauma trial does not require patient consent, but in hindsight I do think the WSJ embelished the issues.