December 9, 2004
by Carol Adelman
The World Health Organization and Doctors Without Borders, both headquartered in Geneva, have saved many lives. But they have endangered almost as many with their strategy of using unproven and outmoded drugs in developing nations to combat AIDS and malaria.
These AIDS drugs are cheaper and, like European generic drugs, are supposed to be just as effective. But they are not. Laboratory tests cannot confirm that these drugs -- which have not been approved by European or U.S. health authorities -- dissolve properly into the bloodstream to lower virus levels.
So why are the poor receiving second-class medicine?
For many years these organizations have insisted on buying the cheapest drugs on the market, while ducking safety and efficacy concerns. Part of the argument was ideological: Patented drugs were seen as profiteering, while cheap generics were seen as cost effective and favoring developing nations. To be sure, WHO policies saved money and, in theory, allowed more people to be treated.
But now that legacy is catching up with the WHO and NGOs like Doctors Without Borders. Focusing on the cheapest drugs has caused real damage in the case of malaria. The Lancet, a London-based peer-reviewed medical journal, reported in Jan. 2003 that the WHO, along with the U.S. Agency for International Development, approved the purchase of $41 million (€30.9 million) worth of generic, unproven malaria drugs simply because they were cheaper than the patented one. Yet, these "cheap alternatives" were ineffective in treating most malaria cases because of drug resistance. Childhood malaria deaths may have doubled from the use of these drugs, according to the researchers.
In addition to the dangers of outmoded drugs, knockoff AIDS drugs -- made mainly in India -- can kill in other ways. The chilling fact of substandard drugs is that they are the largest cause of drug-resistant strains of HIV and AIDS. Poor copies of AIDS drugs deliver a weak dose to patients, allowing the virus to adapt and then mutate. If these new strains make it to the developed world, there are no available drugs to treat them.
The co-discoverers of HIV, Robert Gallo and Luc Montagnier, are very clear about the importance of treatment standards, cautioning, "If compliance and careful follow-up of patients is not achieved, we will see a dramatic increase in multidrug-resistant HIV mutants whose further spread will only exacerbate the epidemic."
With the grim results of its failed policies becoming more apparent, the WHO asked the Indian drugmakers to provide laboratory tests that prove bioequivalence, or the similar potency of their drugs compared to patented drugs. But the companies could not. They came up with discrepancies in the documentation and failed to prove the efficacy of their medicines. As a result, this summer the WHO delisted five AIDS drugs produced by two Indian drug companies, Ranbaxy and Cipla. While the WHO now says two of those drugs are O.K. now, it has disclosed none of the details behind this change in position.
To their credit, Ranbaxy and another Indian drug company, Hetero, voluntarily withdrew all of their pirated AIDS drugs from the WHO prequalification list.
The Cipla, Hetero and Ranbaxy products are AIDS drugs that are copies of innovative, patented drugs. They have never even been submitted to the European Medicines Agency or the U.S. Food and Drug Administration for approval, let alone received it. Yet these are the same drugs that were recommended by the WHO up until the delistings and recent withdrawals. Sadly, Doctors Without Borders has continued to use these drugs.
In fact, the WHO cannot even independently certify the quality of drugs. It is not a regulatory agency, nor does it have pharmacology experts or regulatory infrastructure to test and certify drugs. On every AIDS drug the WHO "prequalifies" for poor Africans, 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."
Despite the lack of proof of potency, the WHO still can't get it right. It insists that the irregularities in the lab results "do not undermine the proven pharmaceutical quality of the medicines -- including their purity and stability..." To add to this delusion, the WHO's coordinator for safety, quality and efficacy of medicines, Lembit Rago, takes pride that "WHO procedures are ultimately improving medicines monitoring mechanisms, which will, in the long term, ensure better quality treatment."
But, what is the cost of this "long term?"
Developing nations are taking a closer look at this and now demand the same quality drugs as those used in the West. South Africa's Medicines Control Council labeled one of Cipla's drugs "undesirable." Ugandan physicians, nurses and pharmacists wrote to U.S. Secretary of Health and Human Services Tommy Thompson in May: "We strongly reject provision and dispensing of untested fixed-dose combinations."
As Thompson Ayodele, director for the Institute of Public Policy Analysis in Lagos, Nigeria, wrote in a letter to the Financial Times in April: "The extent of the HIV epidemic and the emergence of resistant strains makes the need for testing more, not less acute. HIV medicines, whether original or generic, should meet the most stringent rigorous clinical and testing reviews. If the proposed drugs are rejected by pharmacies in Brussels, Geneva, London, Tokyo or Washington, accepting the use of the same drugs in Africa, with little resources and lack of equipment to do a proper clinical and scientific evaluation, may further compound the woes of HIV/AIDS victims."
The removal of these drugs from the WHO list is a victory for poor AIDS patients throughout the world. The U.S. government, along with private think tanks and scientists, has long expressed concern about the quality of these drugs. In fact, the FDA set up a special fast-track system to verify drug efficacy. While none of the companies producing the cheap copy drugs submitted them for this review, at least the WHO and two of the Indian drugmakers, Ranbaxy and Hetero, finally have done the right thing for AIDS patients in poor countries.
Ranbaxy is to be commended for voluntarily pulling its products, issuing recall notices and offering immediate credit. The company also sent letters to health-care providers asking them to identify patients using their drugs and report adverse effects. Ranbaxy even offered to provide alternative drugs.
The WHO should do as much and use this experience to develop recall procedures for taking other unproven drugs off its approved list, should such removal prove necessary. In addition, determining possible adverse reactions among patients can only be achieved through postmarketing surveys in the field. While the WHO can mandate these procedures as a condition of prequalification, the responsibility to conduct and finance them should rest with the manufacturers themselves.
Most importantly, the world needs to know how we got to this deplorable stage -- the disregard for health-care standards that the WHO was created to foster. Since stringent regulatory authorities in developed countries have substantial experience with recall procedures, postmarketing studies and enforcement mechanisms, the WHO needs to convene an independent panel of experts from these members and seek their guidance before it continues with business as usual.
It's high time we give the world's poor the very best medicine that the world has to offer. The cost of the status quo is too painful to bear.
This article appeared in the Wall Street Journal Europe on December 9, 2004.
Carol Adelman is a Senior Fellow at Hudson Institute and director of Hudson's Center for Global Prosperity. She served as a career foreign service officer for ten years and as an assistant administrator from 1988-1993 at the Agency for International Development (USAID).
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