From the December 4, 2008 China Post
December 4, 2008
by Jeremiah Norris
Today is annual World AIDS Day, when health activists lobby their governments to spend ever larger sums and to achieve "universal" anti-retroviral treatment by 2010. This ambitious target will only be met if political considerations continue to trump science and to endanger HIV-AIDS patients.
The World Health Organization (WHO) is the brains behind this "universal" supply of ARVs for 9.7 million HIV-AIDS patients by 2010. It is based on the massive use of copy drugs from India, bringing the numbers of patients in poor countries on treatment up from virtually none in the early 2000s to 3.5 million today.
While activists have applauded the speed of this "scale-up," it creates dangers. Many of the copies recommended by WHO are untested so patients cannot be certain that they act on the body in exactly the same way as the original (called bioequivalence). If the level of active ingredient is not absolutely correct, it can accelerate drug resistance and the mutation of the AIDS virus. Under Indian law, drugs manufactured for export do not have to prove bioequivalence with the patented original.
This is well-known to the authorities. The WHO issued a Disclaimer, stating that its recommendation of a drug does not "constitute an endorsement or warranty of the fitness, by WHO of any product for a particular purpose, including in regard of its safety and/or efficacy in treating HIV/AIDS." But in real life the WHO's list is followed by many poor countries that cannot carry out drug evaluation themselves.
In 2004, the WHO had to cease recommending 18 of the Indian ARVs on its list because of quality fears, although some were later reinstated.
The Global Fund to Fight AIDS, Tuberculosis and Malaria, the main funding body for AIDS treatment, is equally lax about drug quality. Its "Option C" procurement guideline authorizes drugs "not reviewed by a regulatory authority," justifying this by lower prices and "political considerations" such as bolstering the fledgling African pharmaceutical industry.
The Clinton Foundation serves as a procurement agency for the Global Fund and for UNITAID, a U.N. scheme which raises monies for AIDS, TB and malaria via an airline tax. The Foundation claims its tests on the drugs it buys have not revealed any safety problems.
But the Foundation is procuring a copy of the widely-used ARV Liponavir+Ritonavir (LPV/r) from an Indian firm. It has been submitted to the FDA for certification as a "true generic" but no approval has been forthcoming although the original is already approved.On September 29, the WHO released a price report on LPV/r in sub-Saharan Africa. The unit price for the non-approved drug was 50 US cents; the unit price for the approved drug was 36 cents.
The WHO, the Global Fund and the Clinton Foundation therefore sanctioned a drug that was not only unapproved and potentially sub-standard but also more expensive. This is perverse in the extreme.
The consequences of such AIDS politics are starting to appear. In July, the director of infectious diseases at Belgium's Saint Pierre University Hospital told the Financial Times of his shock after examining 100 AIDS patients in the Democratic Republic of Congo: 30 of them had virus strains that resisted the standard medicines. "We are creating a virological time bomb," he said.
Brazil is often held up as the model for universal AIDS treatment. It too has based this largely on cheap, untested copy drugs. In July, the government acknowledged that one third of the 190,000 AIDS patients under treatment were in what it called "a more advanced stage"--but medical studies had already shown even higher levels of drug-resistance.
In Asia, Thailand's government-made GPO-vir has generated 12.5% resistance, the government admitted in April this year, up from 10.5% in 2006--although medical studies put it closer to 50%. Even the Global Fund has withdrawn support for GPO-vir but the drug-resistance has started and it is still distributed by Medecins Sans Frontieres.
These alarming figures show what will happen under current policies. If donors reach the U.N. target of putting 9.7 million on AIDS treatment by 2010, then 3.2 million would reach an "advanced stage of this disease," needing drugs that are two or three times more expensive to buy and far more expensive to administer.
Creaking African health systems will be put under intolerable pressure by millions of drug-resistant patients requiring expensive in-patient care. This growing mass of patients would soon need not only all the money currently spent on AIDS but the total of present foreign aid too.
The WHO and its partners have focused on the politically-correct quick-win without regard to the consequences. The Global Fund's donors and WHO member states must demand a stop to practices that threaten entire health programs and patients' lives.
Jeremiah Norris is a Senior Fellow and Director of Hudson Institute's Center for Science in Public Policy. He specializes in public-private partnerships in development assistance, trade and development, and global AIDS, tuberculosis, and malaria policies.
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