Tainted Heparin: The FDA Let You Down

Washington, DCIt is thought that in the aftermath of the tainted heparin scandal, a total of 83 people lost their lives, linked to tainted heparin from China. One of those deaths may have been that of an eight-month-old baby. Julien Oryschaks died on November 19th, 2007. The baby's parents think contaminated heparin played a role in their infant son's death.

But they also think something else, which is a thought shared by many: A suspicion, bordering on accusation, that the US Food and Drug Administration (FDA) has been for years incapable of riding shotgun on a drug industry that is becoming increasingly globalized.

The FDA will soon be under new leadership after former FDA Commissioner Dr. Andrew von Eschenbach stepped down in concert with the culmination of the Bush Administration. President Barak Obama will be installing new leadership soon together with, it is assumed, an updated set of marching orders that will serve as the underpinnings for a reformed FDA.

Over the last 18 months criticism of the FDA has intensified thanks to a number of damning events, not the least of which has included contaminated pet food, lead in toys, bad tires, tainted tooth paste and numerous food recalls. Much of the trouble has originated with low-quality imports from China, but not all. There has been trouble with high-end drugs that have nothing to do with China, and one needs only to cite the Trasylol debacle as worthy proof of that statement.

However, it was tainted heparin, a blood thinner that is administered through heparin syringes to a wide range of patients that really got the sabers rattling at Congress. The target was the FDA, and its lack of oversight.

The primary regulator of drugs and food products—anything that is ingested by Americans in this country—is the FDA. That's a substantial mandate in itself. However, in the last two decades the sources for much of the food and drug production have gone global and to countries that may not necessarily have the standards for quality control that would ordinarily be found in a roundly-developed superpower like the US.

The problem is that the agency charged with the mandate to administer that oversight, has not kept up with the global growth. Or at the very least, it has not been allowed to.

Issues over food inspections have been brought to the fore with the current peanut butter salmonella case. However, the FDA's dropping of so many balls extends to the nation's drug supply, and tainted heparin. It was admitted by an FDA official at the height of the tainted heparin scandal that the plant in China found to be the source for the tainted heparin, had not been inspected by the FDA prior to giving its approval to commence manufacturing.

The most damming thing, critics say, is that while the FDA's responsibilities were increasing, there was never any request from the FDA for additional funding—at least during the 8-year run of the Bush Administration. It wasn't until after the tainted heparin debacle that heightened criticism of the FDA by Congress prompted von Eschenbach to ask for an additional $275 million in funding, according to reports.

"He had been so reluctant until then" to ask for more money, said William Hubbard, a former top FDA official and now an adviser to the Alliance for a Stronger FDA. "During the Bush administration, they were told more regulation is not something we want to do."
The FDA's Science Board recommended last year that the agency's budget should be nearly doubled—from about $1.9 billion to $3.7 billion.

And that would be just to keep up, let alone grow the FDA in anticipation of even further globalization of food and drugs.

Heparin is a blood thinner prescribed to hundreds of thousands of patients a day, in the United States. It is often prescribed for newborns. Kidney dialysis patients use heparin as well.

The tainted heparin problem originated with the inclusion of a heparin mimic that was mixed in with real heparin presumably to lower costs and increase yields more economically at the supply end.

While heparin is valued at about $900 per pound, the heparin mimic eventually found comes in at $9 per pound.

The tainted heparin story has emerged in tandem with the revelation that much of the raw heparin used in the manufacture of refined heparin, originated with unregulated cook houses where the intestines of pigs are processed and cooked to produce raw heparin. There had also been a shortage of swine, after an epidemic of blue ear disease depleted swine stocks in the Republic.

However, the FDA was unable to anticipate the problem through routine and thorough inspection of both production facilities, and product coming into the US from foreign shores. The agency's response was, therefore, reactive once the problem was discovered, and patients were becoming sick.

The contaminant, oversulfated chondroitin sulfate, does not occur naturally in the human body, and thus its behavior when introduced to the human body, and the body's reaction to it, was a mystery that played out via hundreds of illnesses and more than 80 deaths.

Little wonder the run on heparin attorneys continue, as families seek to right a wrong borne of potential greed from afar, and lack of oversight at home.