FDA funding lack highlighted by Heparin incident

September 15, 2008

The author believes that the FDA should be given more funding to beef up its inspections of foreign sources of drugs.

Key Points

Heparin is a blood thinner used every day in every hospital in the United States as well as in clinics and other facilities that perform kidney dialysis. The incentive for using ingredients from China appears to be a lower price, but the motive in this case is not known with certainty. The choice was between raw material at $900 a pound for good quality compared with $9 a pound for the ingredient actually used. One could expect that any reasonably competent purchasing agent should be suspicious of a competitive bid at 1 percent of another supplier's price.

With the globalization of the economy, including pharmaceuticals, we find that some drugs or raw materials are obtained from foreign countries.

This is not the first incident of patients ingesting poisonous products from China. In 1996 at least 100 children died in Haiti from medicine laced with diethylene glycol, an impurity produced in the manufacturing of glycerin which is used in many liquid medicines.

This event caused the World Health Organization in Geneva, Switzerland, to convene a group from more than a dozen countries that met over three days in May 1998. I was privileged to be an invited observer at that conference, which adopted international standards for the control and safe trade of starting materials for pharmaceutical products.

A reading of that document reveals that these standards were disregarded during the manufacture of the heparin that caused the recent deaths and injuries.

Diethylene glycol as a contaminant is a well-known hazard in the making of drug products, as it caused more than 100 deaths from elixir sulfanilamide in 1937. This caused a complete rewrite of the federal drug laws and led to the creation of the FDA.

The fact is that FDA relies on manufacturers to meet federal standards, and that policy certainly needs review, particularly when many medicines now have foreign sources beyond the reach of FDA.

When I entered pharmacy a long time ago, a major drug company had an advertising campaign using the phrase "The dose you take is never tested," and that is true today. Federal law does require that batches be tested, and that should ensure the quality of individual doses. But when serious problems arise, as they have with heparin, and quality shortcuts are discovered, it is only after many injuries and deaths.

While in widespread use, heparin is not included in the top 200 drugs consumed in the United States. Other drugs, such as the anticholesterol drugs and antacids, are used by many millions of people daily. Inserting a toxic ingredient in any of these products would be an effective means of overwhelming our healthcare system by sending millions of people into hospitals in a few days.

FDA has been underfunded for many years, and every indicator points to more transnational trade. The next Administration and Congress must address the need for full support of FDA if we expect to prevent future incidents of the kind caused by substandard heparin. It should also be a priority for presidential candidates.

DAVID WORK is the executive director emeritus of the North Carolina Board of Pharmacy.