Chinese Puzzle - Pharmaceutical Executive


Chinese Puzzle

Pharmaceutical Executive

Cooperation? Or Not?

Both FDA and SFDA were going to pains to emphasize how closely they were cooperating on the heparin investigation.

This was curious. On February 28, FDA announced that despite conditions indicative of lousy QC and GMPs, there was no smoking gun in the already-shuttered SPL plant in Changzhou. Agency inspectors were heading upstream in the supply chain, to the consolidators and suppliers, including the rural mom-and-pop workshops. Some experts say, given the shortage of pig intestines due to the "blue ear" epidemic, these operations currently provide wholesalers with as much as 70 percent of China's crude heparin.

Reporters from both the Times and the Journal had already gone upstream, filing stories from makeshift household workshops where men and women in aprons and gloves hand-process pig intestines into pulp for raw heparin and sausage casing. Photos testified to their unsanitary conditions. As for QC, one of SPL's wholesalers told the Times that his firm had never been inspected and that he, in turn, had no right to inspect "the pigs or intestines or facilities" in the small villages where he purchased much of his crude heparin. "We are not the government," he said.

Weeks passed. Readers of the news may have imagined intrepid FDA inspectors, led by a closely cooperating SFDA official, trudging unpaved, muddy roads from village to village to interview blood-covered workers. But, in fact, FDA never gained access to the unregulated upstream supply chain.

On March 19, the Times broke the case wide open by nailing down the contaminant. It reported that independent scientists agreed that the look-alike molecule was an apparently meticulously tweaked version of chondroitin sulfate, a cheap dietary supplement made from animal cartilage and widely used in China for joint pain. "A child could tell you it's counterfeiting," Dr. Jawed Fareed, a professor of pharmacology at Loyola University, told the Times. "This is a deliberate act of chemically manipulating a heparin-like substance and mixing it with heparin to increase the yield."

It took FDA only two hours after the Times story appeared to announce the same findings. Dr. Janet Woodcock, veteran head of the FDA's Center for Drug Evaluation and Research, reported that the copycat heparin had been chemically modified, was much cheaper to produce than pure heparin, and did not come from a natural source. Although these facts together almost scream counterfeiting, Woodcock hung tough. "We cannot rule in or out whether this was accidentally or deliberately introduced into the product," she said. "We are investigating how it got in." She also said that further testing is required to determine whether over-sulfated chondroitin sulfate is responsible for the deaths and allergic reactions.

Then she made a special point of praising "Chinese officials' cooperation in this investigation," contrasting it favorably to their stonewalling during the pet food scandal. Visas were sped through, data shared.

But according to one source close to the investigation who spoke on condition of anonymity, Chinese officials were their usual difficult selves, right down to delaying visas: "It was clear from the start that China has a different agenda than FDA in getting to the bottom of this."

Nor does FDA's happy version jibe with Baxter chief science officer Norbert Reidel's pointed plea for access in a Baxter press release that same day: "We're at a critical juncture in the investigation and further progress can be accelerated with the cooperation of the consolidators and workshops."

Wang Fei-ling suggests that it's local officials, not SFDA, who have the different agenda. "The last thing any local government wants is an investigation that will probably implicate them in all sorts of bribes and kickbacks," he says.

But now that the SFDA is in gear, a major criminal investigation will likely push everything else off their agenda.


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