CHAPEL HILL - In the aftermath of the 9/11 terrorist attacks on New York and Washington came many warnings of other potential targets and terror tactics. One such alert concerned the possibility of inserting toxic substances into prescription drugs in the manufacturing process. This would produce widespread injury and death across the country, with no apparent cause.

Several articles connected this possible result to generic drugs, which caused me to dismiss such claims as disinformation from the brand-name prescription drug industry.

That view was more prescient than I then believed, but for a different reason.

There have been recent reports of injuries and deaths due to the use of the prescription drug heparin, a medication marketed by Baxter Laboratories, a large manufacturer with a good reputation. This product was contaminated with a toxic substance from China.

Couldn't that be seen as a fulfillment of the original prediction?

Hundreds of patients have been injured by oversulfated chondroitin sulfate found in the heparin. More than 80 deaths have been attributed to this tainted drug.

Heparin is a blood thinner used in hospitals in the United States every day, as well as in clinics performing kidney dialysis and in other facilities. The incentive for using ingredients from China appears to be a lower price -- there's no known terrorist involvement. 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 charge.

(Baxter and other makers of heparin have recalled the drug.)

With the globalization of the economy, including pharmaceuticals, we find that some drugs or raw materials are obtained from foreign countries. Standards require that drugs obtained from these sources must come from locations inspected by the Food and Drug Administration. But neither the FDA nor Baxter had inspected the site where the flawed drug was produced prior to the injuries and deaths.

The FDA's position at this time is that this was an intentional contamination, but that it is not yet proven. However, with up to a third of the material in some batches being contaminated, it stretches credibility to suggest that it was accidental.

This is not the first incident of 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, used in many liquid medicines. This was a well-known hazard in the making of drug products, as it caused over 100 deaths from the elixir Sulfanilamide in 1937. That incident caused a complete rewriting of federal drug law, including the creation of the Food and Drug Administration.

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." That is still true today. The FDA does only occasional spot checks for drug strength and purity. Federal law does require that companies test batches, and that should assure the quality of individual doses. But when serious problems arise, as they have with the heparin in question, and quality shortcuts are discovered, it is only after many injuries or deaths.

FDA reliance on manufacturers' meeting federal standards requires complete faith in the integrity and ethics of drug companies. This is a policy that certainly needs review, particularly when many medicines now have foreign sources beyond the reach of FDA.

Although in widespread use, heparin is not included in the top 200 drugs consumed in the United States. Other medications, such as 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 sabotaging our health-care system by sending millions of people into hospitals in a few days.

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

(David Work is retired as executive director of the N.C. Board of Pharmacy.)

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