In combating the global AIDS epidemic, the high price of drugs has often been blamed for the staggering number of victims in developing nations. Activists urge the U.S. to buy "cheap, generic" drugs for its overseas assistance programs.
In their zeal to do good, they may be doing harm, as cheap drugs may be neither safe nor effective drugs. Contrary to conventional wisdom, the main "cheap generic" AIDS drug approved by the World Health Organization (WHO)and advocated by activist groupsis not even a generic drug at all. The drug, Triomune, is a fixed-dose combination drug. Its manufacturer combined three AIDS drugs into one pill, on the good theory that, with fewer pills to take, patients can more easily comply with the recommended treatment.
Yet that sound theory may not yield the best practice. A real generic drug must be an exact replica of an established innovator or patented drug which has made it through all the safety and efficacy tests. This is not the case with Triomune. There is no innovator drug with the same three ingredients in Triomune. Thus, no one knows if the three drugs combined into that single pill work safely or effectively as the three pills separately, or as other tested combinations.
Combining pills can change absorption and excretion rates. Or the combined drugs may compete for the same receptor sites. Moreover, if, after widespread use, a problem arises, we can't tell which of the three combined drugs causes it.
This is not just fear-mongering. Recently, the FDA put one of Triomune's three drugs on its Medical Product Safety List. Nevirapine, as it is called, apparently causes "severe, life threatening and in some cases fatal" problems stemming from liver toxicity. Another danger with the use of insufficiently tested drugs, warns Dr. Terrence Blaschke, professor of medicine and molecular pharmacology at Stanford Medical School, is "the risk of sub-optimal therapy which can accelerate the emergence of drug resistance HIV."
Since there is no evidence that Triomune meets the requirements for a generic drug, it is what scientists call an "investigational new drug" or a "copycat drug." These, by definition, lack the sufficient clinical testing to demonstrate interchangeability with patented drugs.
Research and development should continue on fixed-dose combination products. Before they pass the test, however, it's best for AIDS patients to take proven safe and efficacious drugseven if they're not the cheapest around.
But, then again, they may be. Again, contrary to the activists' rhetoric and to conventional wisdom, many patented AIDS drugs are now no more expensive than the generics. This fact of the marketplace makes the issue of "cheap generics" more one of placards than facts.
But price is a lesser consideration when considering a staggering number of lives, those of AIDS victims in Africa and throughout the Third World. For their lives, real generic AIDS drugsthose based on known patented innovator drugsare needed since the drugs are of proven reliability and safety.
Otherwise, real damage results. To take one awful example: The Global Fundwith WHO concurrence and even U.S. AID encouragement approved more than $41 million worth of malaria drugs simply because they were cheaper than the patented one. Sadly, these "cheap generics" have been shown to be ineffective in treating most malaria cases.
Even worse, childhood malaria deaths may at least double from children taking these drugs, as opposed to those which work. Ghanaian epidemiologist, Dr. Fred Binka, put it most poignantly, "In poor countries like ours, children have only chance. They struggle just to visit a health service, and if they get the wrong drug the first time, they just to visit a health service, and if they get the wrong drug the first time, they are then found dead."
The Administration should indeed shop wisely for its AIDS drugs, to reach the most people most effectively. That means buying safe, genuine generic and patented drugs. The price of cheap, untested drugs is way too costly.