Monday, November 03, 2008

NaBloPoMo, Day 3: Scarier than Halloween

You may know by now reader, that I have a special interest in the FDA and the pharmaceutical industry. Check some of my past rantings here, here, here, here, and here. This week's NYT Magazine features an excellent investigative article by Gardiner Harris, The Safety Gap about the current state of the FDA in light of the pharmaceutical industry's mass exodus to the last bastion of cheap and unregulated manufacturing, China.

Take the time to read this. I know, "reading" is so out of vogue these days what with blogging and microblogging keeping us informed about Brangelina's ever-expanding brood. I look forward to an Obama win if for no other reason than to help shift the public discourse away from "drill baby drill" to more thoughtful policy statements. Cringe. Why some Americans are so proud to sound so stupid, I'll never understand.

Back to our story. Maybe once upon a time the only drugs you took from China were those unpronounceable supplements sold at health food stores whose contents were mysterious but sure kicked a cold's ass. Two I have taken are here and here and while they were effective, I'm not sure I would take them now for fear of some additional unwanted ingredient, like lead. But now, we're all consuming drugs made from China, everything from aspirin (almost exclusively made in China) to the blood thinner Heparin. Unlike Chinese-labeled herbal supplements, it is highly unlikely that you would ever know the provenance of these drugs.

You may not be surprised to hear that the news for drug safety is not good. The FDA, already tasked with a ridiculous amount of responsibility, is under resourced, operating with antiquated systems and processes, has been left in the dust by the overseas move of these operations. In fact, many Chinese plants have never been inspected. Yet the push is stronger than ever for cheaper drugs (cheaper everything really--check out Wal-Mart: The High Cost of Low Price about the Wal-Mart presence in China) thanks to the sorry state of health care in this country.

The FDA plans to open its first office in China next year. About time, since as Harris notes:

China’s leap to one of the biggest suppliers of pharmaceutical ingredients in the world happened over the last decade, as the Chinese government subsidized the construction of manufacturing plants that have undercut prices everywhere. Generic drug makers in the United States, where price competition is fierce, were the first to seek cheaper drug ingredients in China. Last year, generic drug applications to the F.D.A. listed 1,154 plants providing active pharmaceutical ingredients: 43 percent of them were in China, and another 39 percent were in India. Only 13 percent were in the United States. Branded drug makers, with their fatter profit margins, resisted buying ingredients from China for years, but with their businesses now suffering, even major pharmaceutical companies like AstraZeneca, Bayer, Baxter and Pfizer have announced deals to outsource manufacturing to China.

I have been writing about the drug industry for more than a decade, but I have rarely written about a subject that both branded and generic drug makers wanted to discuss less. Nearly all of the industry executives who spoke for this article did so anonymously. Even the Generic Pharmaceutical Association, a normally loquacious trade group, was largely silent on the issue. Not one of them, it seems, wants to talk too much about the difficulty of regulating factories across several times zones, 6,000 miles and a vast linguistic and cultural divide.
I can't say I'm surprised that no one wants to talk about this. But I'm sure I wasn't the only one who nearly fell off her chair after seeing the conditions under which Heparin is processed in China. The impact on consumers goes far beyond typical outsourcing complaints about the accents of help desk folks. Yet an unchecked profit motive makes it unlikely that the pharmaceutical industry will voluntarily do their own inspecting and instead point to the FDA as falling down on the job.

Hopefully an Obama administration will bring a more regulation-friendly environment. Like many, I have a strong desire to not be killed by that which is supposed to help me. Yet as I learned the other day, we owe much of the current financial crisis to the dismantling of the 1933 Glass-Steagall Act, a firewall that had been put up between investment and consumer banking, which happened under the Clinton administration. Thanks, Bill! Hope we do better this time around.

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