A Second Opinion

Roger Bate ("The Deadly World of Fake Drugs," September/October 2008) correctly identifies the serious threat to patient safety that substandard counterfeit medicines pose. But one of his prescriptions — that health professionals consider sacrificing broad public access to treatment in favor of purchasing more expensive brand-name drugs — is bad medicine indeed.

Bate, a resident fellow of the American Enterprise Institute, failed to disclose that his organization receives substantial funding from brand-name pharmaceutical companies, including the Eli Lilly and Company Foundation and the Bristol-Myers Squibb Foundation. Bate is also a fellow at the Institute of Economic Affairs, which employs on its board of trustees a former chairman of SmithKline Beecham who is currently a member of GlaxoSmithKline’s board of directors.

Brand-name pharmaceutical companies stand to benefit substantially from some of Bate’s proposals. For example, he claims humanitarian groups must choose between "expensive, safe drugs that treat fewer patients, or cheaper drugs that might not work." This false dichotomy excludes the many affordable generic medicines that have undergone rigorous testing at the World Health Organization and other major drug regulatory authorities.

Bate asserts, with no supporting evidence, that "[humanitarian] groups often purchase copy drugs from China and India that have not been tested properly." But estimates suggest up to 80 percent of the raw materials used by the U.S. drug industry are imported. Half of these also come from China and India, and the U.S. Food and Drug Administration is rarely able to inspect these plants. Expensive brand-name drugs are not categorically safer.

Counterfeit medicines are a subset of a larger drug-quality problem. Relying on brand-name drugs won’t solve it. Bate’s suggestion would enrich Big Pharma while leaving the millions who rely on low-cost, high-quality generic medicines without treatment of any kind.

–Peter Maybarduk
Attorney
Access to Medicines Project
Essential Action
Washington, D.C.

Roger Bate replies:

Peter Maybarduk mischaracterizes my arguments, denies a real problem, and scurrilously implies my arguments are dictated by money.

Even major donors such as the Global Fund to Fight AIDS, Tuberculosis and Malaria buy drugs not approved by stringent agencies like the U.S. FDA or the World Health Organization. Given the inadequacies of testing regimes in most developing countries, where these drugs are produced, substandard drugs pass through the system.

The corrupt national drug producer of Thailand, applauded by many nongovernmental organizations and initially supported by the Global Fund, was forced to shut down because of low-quality products. However, these same medicines were administered to thousands of HIV/AIDS patients by NGOs and the Thai government. No public apology was ever made for buying these substandard products. Chinese and Indian producers have widely varying standards. The best companies in these countries have drugs approved by the World Health Organization and the FDA. I support these drugs, not just brand names as Maybarduk suggests.

But problems remain with most drugs produced in China and India. U.S. companies do import their ingredients, but unlike American patients, they can assess if the imports are defective. Yes, occasionally they make mistakes, and the nearly 100 Americans who died from Chinese heparin were a tragic and rare example. Imagine the death toll if the FDA had allowed importation of the unsafe final products routinely used in the developing world.

The American Enterprise Institute has hundreds of corporate supporters accounting for only about 20 percent of its budget. None can contract for specific work. The vast majority of funding for my investigations of counterfeit drugs was grants from the Ohrstrom Foundation and Legatum Institute — neither of which creates a conflict of interest. As to the Institute of Economic Affairs, I am an unpaid fellow, and my only mention of GlaxoSmithKline was highly critical of the company. The funding of Maybarduk’s organization doesn’t interest me, but his advocacy of poor medicines for the poor worries me greatly.