Report: Action Needed To Wipe Out Fake And Substandard Drugs

A blue-ribbon panel is urging stronger regulation of pharmaceuticals around the world to combat the growing problem of fake and poor-quality medicines.

The quality problems and fake medicines have affected Americans. Fungal contamination of steroids made by a Massachusetts pharmacy, which sickened more than 700 people and killed 46, is one recent example. Other U.S. patients have received fake cancer drugs and medicines obtained over the Internet with little or no active ingredients.

The problem extends to more than 120 countries, the Institute of Medicine report says, and has done incalculable damage to efforts to control tuberculosis, malaria, AIDS and other diseases.

No one knows exactly how big the problem is, but Lawrence Gostin, chairman of the IOM committee that issued the report, says it's been getting steadily worse. "Whatever the magnitude is, it's huge and growing," he tells Shots.

The National Academies of Science, of which the IOM is part, was commissioned by the Food and Drug Administration to look at how to protect people against fake and substandard drugs.

The root cause for the problem is that there's so much money to be made. "It's actually more profitable to supply illegitimate drugs than cocaine or heroin," Gostin says. "And so you're seeing more and more sophisticated drug suppliers."

The report is replete with scandals and horror stories — some previously publicized, others obscure:

• Kansas City, Mo., pharmacist Robert Courtney made millions selling highly diluted and adulterated cancer drugs to patients and physicians for more than a decade, until he was convicted and sent to federal prison.
• A Belgian named Manuel Calvelo ran a global Internet business peddling more than 40 popular drugs — from Viagra to Lipitor to Xanax — that proved to be fake.
• A fake version of Avastin, a costly and widely used cancer drug, found its way from a manufacturer in Turkey to 76 physicians' offices in 22 U.S. states. Through a scam that the IOM committee says is common, the fake drug appeared to have come from Canada.
• Medicines distributed in Darfur, Sudan, and in post-tsunami Sri Lanka as part of humanitarian relief efforts were contaminated with fungal spores, outdated or otherwise adulterated. "The chaos inherent in humanitarian emergencies often leads to a proliferation of fake, substandard and otherwise poorly regulated medical products," the IOM report says.

"What we're seeing in the United States — and doubly so in developing countries — is a race to the bottom," Gostin says.

The panel says Congress needs to authorize the FDA to trace the authenticity of medications from raw ingredients to manufacture and through the distribution chain all the way to retail pharmacies.

The 300-page report also calls on the FDA to work with state licensing boards to regulate and report pharmacies like the problematic Massachusetts firm and launch a national database to report violators.

On the international level, the IOM panel calls on the World Health Organization to develop a global code of practice for pharmaceuticals. Among other recommendations is that the World Bank and other agencies provide low-interest loans to medium and small pharmaceutical companies in developing countries to beef up their equipment, supply chain and quality-control systems.

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