This morning’s New York Times reports that the FDA is now echoing what many scientists and industry experts have been saying for weeks: the contaminated stores of heparin that have been associated with 81 deaths and 785 severe allergic reactions in the U.S. was likely adulterated on purpose. In March, the FDA issued a major recall of heparin following increasing reports of adverse reactions and deaths connected with the drug.
Tests have shown that heparin components made by a company in China (Changzhou SPL) were contaminated by a manipulated form of a dietary supplement, oversulfated chondroitin sulfate. Because the cheaper additive resembles heparin, routine screening didn’t reveal the contamination. Contaminants comprised up to a third of some heparin samples that were tested. Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center explained, “[I]t does strain one’s credulity to suggest that might have been done accidentally.”
Heparin is a blood thinner used in dialysis, heart surgery and other medical treatments. Components, known as active pharmaceutical ingredients or APIs, of the drug were made by the Chinese company and then used by Baxter International to manufacture the final product.
Earlier this week family members whose loved ones had died after receiving the drug spoke before a Congressional subcommittee, as did FDA officials and leaders of Baxter International, who support the claim that the heparin ingredient was deliberately contaminated.
The incident has caused a major uproar on Capitol Hill with members bearing their teeth for cameras. As recent commentary in the New England Journal of Medicine notes, the target of their ire is the FDA, the federal agency in charge of regulating “$1 trillion of consumer products or 25% of the U.S. consumer economy” with a budget of “$1.57 billion — less than 75% of the budget for the school district in its home county in Maryland.” The FDA doesn’t have anywhere in the ball park enough to cover the inspection needs of today’s global marketplace. At best, the agency has the manpower and funding to inspect 7% of foreign drug/API manufacturers. Despite switching to a risk-based model to prioritize inspections, the inspection system is fraught with issues, including an inability to perform inspections without notification and limitations in inspection thoroughness because of inadequate translation services.
While the FDA is being grilled over hot coals, little if any complaint is being directed at Baxter International itself, the company that outsourced the production of the heparin components in order to enhance its profit and not conduct its own inspections to ensure safe manufacturing practices. Before the anti-capitalist accusations start slinging our way, it’s important to note that we have nothing against companies making money. (Shouldn’t that be obvious?) But the question of the day is who will protect consumers from the deleterious effects of adulterated drugs? Call us what you will, but we believe people should be able to take the drugs they need without wondering if they’re getting what the label says they’re getting or if they’re playing a medical version of Russian roulette.
And as for the argument that the companies will choose to ensure safe practices in order to avoid lawsuit? Well, the heparin controversy is case in point to show companies don’t always operate on those principles. Some do, some don’t. And it may only get worse. As another commentary from last week’s NEJM noted, this February the Supreme Court ruled that FDA approval of medical devices “precludes lawsuits brought by patients against the manufacturer over adverse events in state courts.” As a result of this ruling, patients cannot bring a lawsuit (or truly expect to win one anyway) when harmed by a medical device that the FDA has previously certified as “generally safe and effective.” The Supreme Court will hear a “similar case” regarding pharmaceuticals later this year. This should get interesting.
We aren’t, are not, in no way, shape or form, arguing against a free market. But the “market,” as we know, serves people – mothers, fathers, kids, grandparents, neighbors and friends. We simply can’t have it every way: no inspection responsibility for manufacturers, no real money or authority for a federal regulation agency, and (potentially, later this year) no recourse for patients and their families.
With more than 80% of drugs or pharmaceutical components now made in other countries (primarily China and India) the problem isn’t going to magically dissipate into the atmosphere (although it might disappear into the back pages of newspapers for a while as other events grab the media’s attention). Fixing this debacle takes some hard questioning about how we want our system to operate. The question becomes: who should we trust as we swallow that prescription? Bottom’s up!
Tell us what you think.
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