Andy Zajac from the Chicago Tribune's Washington Bureau has an interesting blog out this week, entitled FDA: Questions of protocol, conflict.

Apparently when the FDA decides to make an announcement now, they call up a reporter. That is exactly what they did when they wanted to announce that Janet Woodcock was no longer handling the generic low molecular weight heparin dispute involving Momenta and Amphastar. The FDA is used to dealing like that. Their deals with Baxter involving life or death decisions are done behind closed doors and involve conference calls with Corporate lawyers and FDA officials from which the the public is locked out. The results of their "investigation" remain locked up in Rockville, MD.

Even though it knew its heparin was causing harm, Baxter, which had 50% of the market, continued to sell its contaminated wares, making profits in doing so while the FDA did nothing. How was it that fifty percent of this country relied on the heparin from one manufacturer that was made in a factory never inspected by the FDA, and not subject to purity standards?

In his latest blog Andrew Zajac points out that Amphastar was put to a higher purity standard than Janet Woodcock's friends at Momenta. And of course the purity standard was much higher than that required of Baxter, although when it finally inspected the Chinese facility the FDA shut it down for lack of a purity standard.

Meanwhile, apparently the New England Journal of Medicine has realized it has been conned as well. Ram Sasiskeharan, the Momenta Director and consultant to the contaminated API manufacturer, SPL, has now admitted, and the NEJM has disclosed, that he held a patent on the use of heparin modified by chondroitin sulfate, dermatan sulfate, and other "GAG" mixtures. The latest disclosure can be found here.

A fair reading of the patent makes it look awfully suspicious... but it was probably just a coincidence. SPL was selling mixtures of contaminated GAGs and Ram was claiming patent rights on how you could measure the affects of the GAGs on patients, including analphylactoid responses.

Also probably a coincidence that Baxter's consultant from RPI had published the recipe for OSCS in 1998. Of course both Ram and Dr. L told the FDA that it was something else entirely. Chitin. Chondroitin E. What would they know about NMR and CE? What would they know about sulfation of GAGs? What would they know about OSCS?

Zajac, like others, points out that the Heparin Contamination is still not resolved:

--The Chinese heparin crisis remains an open book. The source of the contaminant has never been identified, and the tainted drug, marketed by Baxter International, of Deerfield, Ill., has spawned at least 650 lawsuits which have yet to be tried. The crisis remains a powerful illustration of the FDA's inability to monitor an increasingly globalized drug ingredient supply chain.

When will the FDA publish its final report? If it does not intend to do so, it should at least release the results of its inspections and testing. Its failure to do so continues to protect powerful Big Pharma who continue to avoid responsibility while raking in the profits. Its failure to do so continues to permit and encourage Big Pharma to do as they please, the public be damned.

Is that a conflict of interest?

Labels: Baxter Heparin, contaminated heparin, FDA, Heparin, Zajac