The blood thinner heparin is one of the most commonly-used drugs in America. It’s used daily in hospital surgeries and for kidney dialysis patients. But a safe supply of this critical drug fell into jeopardy last winter in a catastrophe that illuminated severe problems caused by the fact that most ingredients for American drugs now come from foreign sources. Unfortunately, these sources are not being adequately monitored by either the pharmaceutical industry or the Food and Drug Administration. According to the FDA, at least 55 people may have died from the contaminated heparin. However, the numbers may be much higher. So far the FDA says it has only been able to definitively link three deaths to specific lots of the tainted drug.
Heparin used to be primarily produced by the pharmaceutical giant Baxter, but that company recalled its entire stock, nearly half the nation’s supply, after the deaths from contaminated heparin. A number of smaller companies also recalled their supplies. To date, Baxter says it has received 955 reports about contaminated heparin in 2008.
It’s evident that the FDA simply can’t perform its regulatory responsibilities for a number of reasons. Obviously, lack of staff and inadequate budgets are part of the problem. But the root cause is much deeper. The laws under which the FDA operates are much too weak and favor the drug industry. Investigations into the deaths related to heparin pointed to China, where the raw ingredient for heparin originates. According to the FDA, someone there spiked the crude heparin with a counterfeit look-alike drug to increase profit. Former FDA commissioner William Hubbard made this observation:
I see these foreign drugs as essentially a string of time bombs. Heparin has gone off, and there will be more until we fix the problem.
It should be noted that Heparin isn’t the only drug that’s manufactured overseas. Roughly 80% of all the raw ingredients for America’s drugs now come from foreign countries. According to Hubbard, China and India will be “the breadbasket of raw materials, creating the raw materials for the rest of the world.” Heparin may be used in high-tech medicine, but the raw material is literally hand-wrung from pigs’ intestines in crude agricultural workshops. And it appears that the process is virtually unregulated.
FDA Commissioner Janet Woodcock says the FDA is taking a “much closer look” at the safety of drugs that come from overseas, but the administration is woefully underfunded to safeguard America’s drug supply. Commissioner Woodsock made this interesting observation:
The FDA can only inspect less than 1% of imported foods and drugs. For example, [the FDA] can go to virtually none of these foreign drug manufacturers because it simply does not have the staff to do so. We don’t have the resources to do that, nor should it be our primary responsibility.
In fact, the FDA never even inspected Baxter’s supplier “SPL” in China because it couldn’t find it. The plant wasn’t inspected because there was a mix-up between that plant and another one. The bottom line is the pharmaceutical companies are left to police themselves. For example, Baxter did conduct its own inspection last September and gave itself a passing grade, just months before Americans began dying from contaminated heparin. Congress must protect American citizens and that will require a complete overhaul of the FDA, with increasing funding and staffing, and passage of needed legislation to give the agency authority to do its job.
Source: ABC News
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