In a letter to President Bush, U.S. Sens. John McCain, R-Ariz., and Ted Kennedy, D-Mass. urged the administration to buy generic drugs for treating AIDS patients around the world, on the false assumption that doing so would mean the administration was buying "the most economical and effective drugs" for those patients.
The senators leapt to that conclusion because generic drugs have been "prequalified" by the World Health Organization. The two men suggested in the letter that WHO's methods and standards "meet or exceed those used by respected regulatory agencies around the world," and they said they were "unaware of any reason to question the WHO's findings."
But is that faith in the WHO deserved? Hardly.
To begin with, unlike the Food and Drug Administration and other regulatory agencies, WHO doesn't do its own drug testing nor can it certify the safety testing done by others.
That is one reason on every AIDS drug prequalified by WHO it makes the following disclaimer:
Inclusion in the list does not constitute an endorsement, or warranty of the fitness, of any product for a particular purpose, including in regard of its safety and efficacy in the treatment of HIV/AIDS.
Indeed, the so-called fixed-dose-combination drug, which combines three AIDS drugs into one pill, prequalified by the WHO, has never been tested by a regulatory body. Simply because each drug, being taken by itself, has proven safe, doesn't mean that a pill in combination is necessarily safe or healthy.
Such untested drugs can be even more dangerous because this generic FDC might create new drug resistant strains of the HIV virus. Dr. Terrence Blaschke, professor of medicine and molecular pharmacology, at Stanford Medical School has warned about "the risk of suboptimal therapy, which can accelerate the emergence of drug resistance HIV."
The senators are even wrong in another area -- that the generic AIDS drugs are cheaper, or more economical, than the patented drugs they would replace. Looking at the latest international price comparisons done by Doctors Without Borders, an activist global health organization, of the three FDCs made by both generic and innovator companies, the two patented FDCs are cheaper than the generics, and the third patented drug is less than the average price of all the generics. Single dose generic and patented AIDS drugs are also comparable in price, contrary to the senators' views and activists' rhetoric.
The controversy over the price of AIDS drugs and the constant focus by WHO on cheap generics, regardless of whether they have been shown to work, has already caused real damage. To take one awful example as reported in the medical journal The Lancet: The Global Fund -- with WHO concurrence and even USAID encouragement -- approved more than $41 million worth of malaria drugs simply because they were cheaper than the patented one. These "cheap generics" have proven ineffective in treating most malaria cases; worse, childhood malaria deaths are likely to double from children taking these drugs.
U.S. Rep. Jim Kolbe, R-Ariz., chairman of the House Appropriations Subcommittee on Foreign Operations, Export Financing and Related Programs, has made global AIDS treatment a priority. Kolbe has been clear that the United States should not "simply write a blank check."
Since the United States is the largest bilateral contributor to the WHO and the Global Fund, it's time for Kolbe to hold hearings on these donor organizations, including our own, to see if the accusations of "medical malpractice" by researchers writing in The Lancet, are true.
In the meantime, some good advice for Sen. McCain, who should know better, is that they should look closely at what they are prescribing for AIDS patients, lest their leap carry the victims of AIDS to their deaths.
This article also appeared on Tech Central Station on April 23, 2004.