TCS Daily


AIDS Policy in Shambles

By James K. Glassman - November 18, 2004 12:00 AM

The strategy of fighting AIDS in Africa with questionable generic drugs made in developing countries now lies in shambles as an Indian company withdrew its medicines last week because it can't guarantee they are potent enough.

It's time now for the United Nations and its number-one financial angel, the United States, to reverse a policy that has not only failed to slow the AIDS epidemic but is almost certainly making people sicker.

The use of unverified generics -- which are copies of drugs developed and patented by research pharmaceutical companies in the United States and Europe -- has been aggressively promoted by U.N. agencies like the World Health Organization and by non-governmental organizations like Doctors Without Borders, based in Paris, and the Clinton Foundation, established by the former president.

The WHO and NGOs have been claiming that generic companies in India, South Africa, Thailand and elsewhere can make sophisticated multi-dose combinations of AIDS drugs by cobbling together patented medicines. Instead, the generic makers are turning out to be the gang that can't copy straight.

The ostensible reason for the WHO strategy is cost, but the research firms sell drugs in Africa at big discounts or give them away. A study by the Hudson Institute found that, on average, patented drugs cost less than generics in poor countries.

The real reason for the strategy is vicious political animosity toward the United States and the research pharmaceutical companies. Such antagonism can kill.

At the root of the current debacle is a simple question: Do people sick with AIDS in Kampala and Kinshasa deserve the same medicines as patients in Copenhagen and Chicago?

Of course they do. But U.N. agencies and their NGO pals don't act that way. The WHO maintains a list of about 90 drugs that it "pre-qualifies" for relief agencies. But the list is maintained by a tiny staff with no facilities for testing, and the WHO does not warrant safety or effectiveness. Drugs on the list are now floating all over Africa.

By contrast, American authorities have insisted on spending the $15 billion from President Bush's global AIDS program, the world's largest, only on drugs -- generic or patented -- that meet the standards of the U.S. Food & Drug Administration.

The FDA even set up a fast-track process to speed approval of AIDS drugs made in developing countries. But, so far, there have been no takers -- a fact that arouses suspicions about the generics.

On Nov. 9, the Indian firm Ranbaxy, considered the best of the generic makers, withdrew all its AIDS drugs from the WHO list. That action followed WHO de-listings in spring and summer of five drugs made by Ranbaxy and another Indian company, Cipla.

The moves vindicated U.S. policy, but the cost to sick Africans -- and to the reputation of the WHO -- is devastating. In addition, legal sources say NGOs that have been distributing the generics could face lawsuits from affected patients.

No one knows how many people have been taking deficient medicines. There is no effective system to alert these patients or to get them on other therapies -- the procedure in the U.S. and Europe.

The WHO has taken a cavalier attitude toward recent blunders, stating that, while "in principle," patients should get off the de-listed drugs, they don't have to. And, incredibly, Daniel Berman of Doctors Without Borders told the Washington Post, "We are not worried about the safety of our patients....We can't make an equation that if a drug is removed from the list it's not a good drug."

The danger extends beyond Africa. A poorly made copy of a patented drug may deliver a dose of medicine so weak that the virus could adapt to it through mutation and become resistant. These new viruses would require far more expensive drugs -- or drugs that don't even exist today. Such strains could migrate to countries like the U.S., where AIDS deaths have declined significantly, thanks to medicines developed in the late 1990s.

Last summer, the respected American Foundation for AIDS Research sternly warned that a flood of untested generics, made by more than two dozen companies in developing nations, "could lead to widespread misuses and eventually to drug resistance, eradicating years of progress."

That worry is fast becoming reality. At the very least, Congress should investigate the U.N. strategy and reconsider American funding. Stubborn advocates of the current policy must stop playing deadly political games with the world's health.


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