Heparin Contaminant Attacks the Most Ill

This has been an active week on the news front of heparin, with House hearings. Baxter and SPL's CEO, testified as did officials from the FDA, to the House Subcommittee on Energy and Commerce. But seemingly lost in the shuffle of all the finger pointing is this seemingly insignificant line from the New England Journal of Medicine article:

"Patients undergoing dialysis who are also receiving heparin therapy are already at high risk for hypotension because of their exposure to the dialysis membrane, which can also activate the contact system, and their treatment with angiotensin-converting–enzyme inhibitors, which inhibit bradykinin degradation. Exposure to OSCS-contaminated heparin may further increase the risk and could potentially trigger an adverse event."

See: The New England Journal of Medicine last week published a study out of MIT which establishes a clear causal link between the contaminant identified by the FDA to have been found in the tainted Heparin and allergic reactions/anaphylactic shock. See the New England Journal of Medicine, April 23, 2008: “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System” Takashi Kei Kishimoto, Ph.D., et. al. The full text of this research can be found at http://content.nejm.org/cgi/content/full/NEJMoa0803200v2#F2

In jargon of the news media, the NEJM buried the lead. The lead here is that the reason that this entire scandal broke is that the Heparin was contaminated with a product that would likely only kill or injure the very sick. As I understand the research, one third of pigs had a measurable response to the actual Baxter product that was recalled. But pure OSCS had a much more severe reaction. All of the healthy pigs survived the recalled product where there was only about 25% OSCS. It may only be that only 1% of those getting intravenous heparin would have a noticeable allergic reaction to the contaminant. But since dialysis patients are already hypotensive (low blood pressure), they were extremely vulnerable to the OSCS. If it had not been for that extreme vulnerability and the genius of one doctor at the CDC, this contamination might never have been discovered.

Don't take the FDA's pronouncement of 82 deaths as representative of the extent of this problem. As dialysis patients are already hypotensive, until the FDA announced the problem, heparin allergic reaction was not part of the hypotensive differential. If all of the people who had low blood pressure events over the preceding 12 months had their medical records pulled and differential reexamined, that number might increase dramatically.

I would like to challenge the NEJM research panel, or those doing collateral research to pull 100 charts from dialysis related deaths between January 2007 and November 2007 and determine what additional percentage could be related to an allergic stimulated hypotensive pathology.

Attorney Gordon Johnson

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