- The Washington Times - Monday, March 31, 2008

ANALYSIS/OPINION:

The FDA believes it has discovered the contaminant in the blood-thinning drug heparin that has caused hundreds of allergic reactions and 19 deaths. It appears to be a cheap, plentiful substance that is made from animal cartilage. Mimicking heparin in chemical tests and falsely giving the impression of larger amounts of the drug, it was added in China, a common source of crude heparin precursors.

This adulteration of heparin is reminiscent of two other recent, widely publicized, lethal examples of intentional tampering with Chinese food or drug ingredients intended for export. One was the contamination last year of dog food by a substance called melamine, which was deliberately added to an ingredient in pet food that sickened and killed cats and dogs across the United States and in other parts of the world. It was added to fake higher protein levels in the final product. Also last year, lethal Chinese-made diethylene glycol, mislabeled as non-toxic glycerin, was mixed into anti-fever medicines for children, killing at least 100 in Panama.

These incidents are only the tip of a very dangerous iceberg. It’s a bitter pill to swallow, but you can no longer be sure what will actually be in your next medicine vial.

It is thought that 10-15 percent of the world’s drug supply (and approximately half that much in the United States, according to a 2003 World Health Organization estimate) is counterfeit. The FDA has increased the number of its investigations of domestic counterfeiting (which can involve ingredients from abroad) several-fold during the past decade.) These incidents encompass not only products that are completely fake, but also those that have been tampered with, contaminated, diluted, repackaged or mislabeled in a way that misrepresents the contents, dosage, origin or expiration date. Spurious ingredients have included cement, gypsum, talcum powder, sawdust, industrial solvents and even yellow highway paint.

The perpetrators include not only greedy businessmen trying to increase their profit margins but also big-time organized crime entities, such as the Russian mafia, Chinese triads and Columbian drug cartels, as well as terrorist groups such as Hezbollah, the Irish Republican Army and Spain’s separatist organization ETA. They are adept at duplicating the appearance of pills and capsules and even the security measures on the packaging, including serial numbers on the blister packs and holograms. Without actually performing sophisticated chemical or spectral analyses, the counterfeits may be virtually impossible to identify.

The risks to an individual patient are obvious if a sugar pill is substituted for treatment of a cardiac arrhythmia or cancer, or for an anticoagulant (blood thinner), but there are risks as well to society at large if the product is intended to treat an infectious disease such as tuberculosis, malaria, HIV/AIDS or flu. The use of diluted or degraded antibiotics or anti-viral medicines — which results in administration to patients of a dose that is not lethal to the microorganisms — gives rise to drug-resistant mutants, the proliferation of which makes infections harder to treat in all patients. In other words, the presence of counterfeits can actually compromise the overall usefulness of certain critical drugs.

The body count is hard to estimate, but is certainly in the millions. A 2004 study found that more than half of the anti-malarials being sold in Southeast Asia contained incorrect levels of the active ingredient, and as much as 85 percent of the malaria drugs in Nigeria are thought to be ineffective. Substandard therapy has caused the disease to become more quickly resistant to a succession of drugs, which has contributed to a doubling of malaria deaths worldwide over the last 20 years, to more than 1.5 million people per year. In dozens of drugs in the United States — including anti-HIV medicines, cholesterol-lowering agents, and anti-arthritis medications — dangerous substances have been substituted for the active ingredient.

How do fraudulent medicines enter the drug supply? Primarily by counterfeiters taking advantage of an alternative to the mainstream pathway of pharmaceutical manufacturing and distribution through which drugs normally move linearly from manufacturer to distributor to pharmacy to patient. But also — as in the cases of China-based adulteration described above — by unscrupulous middlemen providing toxic materials to legitimate, unwitting U.S. companies.

Drug counterfeiting is a form of terrorism: It should be a high priority for both governments and individuals.

Henry Miller is a physician and fellow at Stanford University’s Hoover Institution. He was an official at the Food and Drug Administration from 1979 to 1994.

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