Sally Satel, a physician, is a resident scholar at the American Enterprise Institute.
The World Health Organization is racing to get medication to millions of people infected with HIV/AIDS. The organization’s “3 by 5 plan” — which aims to treat 3 million people, mostly Africans, by the end of 2005 — is an ambitious one. But maybe WHO should slow down before it causes harm to those it seeks to aid.
A red flag went up last month when WHO announced that two medications on its list of approved HIV drugs did not meet quality standards. The drugs were antiretrovirals made by Cipla, an Indian manufacturer whose major business is copying pharmaceuticals invented and patented by other companies, mainly in the United States.
The problem? The raw data from tests conducted by an independent company (hired by Cipla) to evaluate two of Cipla’s HIV drugs — drugs that WHO endorsed — failed to prove that those drugs would deliver as much medication to a person’s system as the gold-standard, patented form of the pills.
In the case of HIV/AIDS medications, low concentrations in blood and tissues make it harder to keep the virus from multiplying and creating mutant forms, some of which will no longer respond to medication. When these mutated forms multiply within an individual or are transmitted to another person, resistant strains spread and the disease becomes harder to contain.
Since the two Cipla-made drugs were approved by WHO in 2002 and 2003, thousands of Africans have taken them. The longer that patients are exposed to inadequate doses, the greater the chance for drug-resistant HIV strains to develop.
To what extent has this already happened? Who will contact these individuals and tell them to discontinue the medications? And what medications will they take in place of these drugs?
How WHO will handle this problem is not the only question the organization faces. Some global health experts also worry that it is promoting a questionable treatment in the form of a pill called Triomune, also made by Cipla, as its first-line medication in the “3 by 5” initiative.
Triomune contains three standard HIV drug compounds (lamivudine, stavudine and nevirapine), each at a fixed dose and combined together in one pill. WHO officials say a combination pill is easier to distribute and more convenient for users. Many Western HIV/AIDS patients take up to 20 pills over the course of the day, so ease of administration is no small matter.
But there are potential problems. WHO does not test drugs, and Triomune has not been approved by the U.S. Food and Drug Administration because Cipla has not submitted it. This is especially puzzling in light of the FDA’s recently announced intention to expedite approval of fixed-dose antiretrovirals made by foreign drug companies.
Many health experts are rightly skeptical of a one-size-fits-all approach to a complex disease that doctors in the West routinely treat with a flexible armament of drugs, adjusted to each patient according to that individual’s needs.
Specific drugs are switched often or their dosage strengths adjusted depending on side effects, progress of the disease and other medical problems the patient suffers.
A doctor’s freedom to custom-tailor a cocktail is essential so that the resulting medicine does not interact badly with other drugs or exacerbate a particular medical condition also suffered.
In rural Africa, where sophisticated medical care is lacking, a calculable percentage of patients will become very sick or even die from the nevirapine component of this three-in-one drug. Thus the dilemma: the need to balance drug-related deaths and illness from using Triomune against the numbers of people who would go untreated altogether if aid agencies adopted a flexible but more expensive strategy.
As attention turns to the International AIDS Conference in Bangkok next month, WHO must regain the world’s confidence and not foist unproven drug therapies on the world’s poor and sick.