The Substandard Fight Against Substandard Drugs

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Substandard drugs put millions of lives at risk every day. Last year, at least 95 Americans died after taking contaminated heparin. While such unfortunate events help raise public awareness, they do little to change the tack of international drug safety authorities. And while such officials devote tremendous resources to anti-counterfeiting activities, they remain soft on drug manufacturers that cut corners and take advantage of the lax safety standards in developing countries.

This must change. Whether a drug is deliberately counterfeited, or just poorly manufactured, the public health risk is just as great. In some cases, it can be greater.

A tablet containing only chalk puts the individual at risk. A tablet containing some active pharmaceutical ingredient -- but not enough to cure a patient -- can breed drug-resistant strains of a disease. This can doom an entire class of drugs and lead to many more deaths in the end.

At its meeting this week (Jan. 22-29), the World Health Organization's Executive Board has an opportunity to call the world's attention to the fight against substandard medicine. It should expand the mandate of its counterfeit drug-fighting taskforce to take aim at substandard medicines as well. Further, it should affirm its support for member states that aggressively confront substandard drugs -- and stop turning a blind eye to those that do not.

The almost-exclusive focus on counterfeits by drug safety authorities to date is understandable. Counterfeits pose an enormous public health risk. Drug counterfeiting operations are destructive, patently illegal, and used to finance criminal and terrorist networks across the world. It's easy to make the case to UN member states and the public that counterfeiters should be dealt with.

The focus on counterfeits can also be explained by the motivations of those involved in combating poor quality drugs. Drug companies care about counterfeits because they threaten brand integrity, cut into profits, and undermine incentives for research. Substandard drugs, on the other hand, are quite often poor-quality copies of off-patent medicine. So they don't harm drug company profits quite as much.

Enforcement agencies like Interpol are more concerned with counterfeit drugs because of the criminal nature of the producers. Substandard drug companies, by comparison, are in most cases legal operations. Their wares are the result of ignorance or carelessness in production, not deliberate deception.

Disturbingly, the number of substandard pills is increasing. There are many reasons for this.

Aid agencies want to distribute high-quality drugs -- but they also want to treat as many patients as possible. This motivates some groups to buy the lowest-cost pills available, even if the meds haven't met international safety standards.

Using international taxpayer funds -- funneled through the Geneva-based Global Fund to Fight AIDS, TB and Malaria -- the Kenyan Government in 2007 contracted with Indian company Ajanta for 7 million antimalarial pills. The pills had not been approved by a stringent regulatory authority, and also arrived later than the June 2008 delivery date, which caused stock outs. This would have endangered the lives of hundreds of children had the U.S. Government not intervened with approved medications in the nick of time. Numerous other HIV and malaria medications from India, China and even Europe are being delivered with our taxpayer money -- but without acceptable provenance -- to African nations.

The nations that receive pills from aid groups also want high-quality medicine. Many are unable to finance drug safety enforcement efforts or the scientific testing needed to identify substandard pills. HIV medication, for example, can pass basic lab tests, but only the best are actually bioequivalent to the original product. And few African nations can properly assess bioequivalence in the first place.

Making matters worse, many poor governments are turning to local drug production to create jobs, generate tax revenue, and increase political support. While this might boost the quantity of medicines, most poor nations lack the regulatory infrastructure needed to ensure that locally manufactured pharmaceuticals are safe and effective.

Since its creation three years ago, the WHO's counterfeit drug-fighting team, the Medical Products Anti-Counterfeiting Taskforce (IMPACT), has done much to focus international attention on the dangers of fake drugs. But the organization has effectively ignored substandard drugs. As an arm of the WHO, IMPACT is charged with ensuring the "attainment by all peoples of the highest possible level of health."

That most certainly includes helping ensure that substandard drugs stay away from those who are sick. So their mandate must be expanded.

When the WHO's Executive Board meets this week, let's hope substandard drugs make the agenda. The health of millions depends on it.

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