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The Debate Over Generic Drugs To Fight HIV/AIDS - 2004-03-26


The humanitarian group Doctors Without Borders is accusing the Bush Administration of trying to “shut out the use of quality, effective generic AIDS medicines.” It says the US “plans to limit its global AIDS financing to brand-name pharmaceutical products.” However, the administration strongly denies the charges, saying it is concerned about the quality, safety and effectiveness of the medications.

Doctors Without Borders says generic AIDS drugs are four to five times more affordable than brand name drugs. It’s currently treating about 11-thousand people with anti-retrovirals, with about half receiving what are called Fixed Dose Combinations, or FDC’s. That is, several AIDS drugs are combined in perhaps one or two pills. It makes it easier for HIV/AIDS patients to adhere to their treatment regimen. Doctors Without Borders says it has had very good results in its treatment programs as a result.

However, the group says the Bush administration is pressing for the use of more expensive brand name drugs, which could make Fixed Dose Combinations unaffordable. It says the United States will question the quality of FDC’s at a meeting in Botswana scheduled for March 29th and 30th.

Ellen ‘t Hoen is head of the group’s Access to Essential Medicines Campaign. She says the World Health Organization has a program that helps ensure the quality of the generic drugs. It’s called the Pre-Qualification Project.

"What it does is look at the dossiers of the medicines. Companies can apply for WHO pre-qualification. And the WHO will go to the companies, it will visit the companies, it will look at the dossiers and it will assure that those drugs that are submitted to the WHO pre-qualification are indeed of the same quality as the originator drugs."

She says a number of the Fixed Dose Combinations produced by the generic companies in developing countries have been pre-qualified by the WHO. She says these are the FDC’s used by Doctors Without Borders.

Supporting the medical group in its criticism of the Bush Administration is Sharonann Lynch of the activist group HealthGap. She accuses the Bush administration of supporting the big pharmaceutical companies.

"Despite international support for the standards by the WHO on quality AIDS drugs, the Bush administration intends to block countries from using US money to buy the fixed dose generic medicines, although these drugs are quality assured and at least four to five times cheaper than the brand name products. If the administration is successful, desperately needed money will be wasted on overpriced products and fewer dying people will get the treatment they need to live."

However, the Office of the US Global AIDS Coordinator rejects the charges. Tom Flaven is spokesman for the office.

"The United States has committed 15 billion dollars to battle HIV/AIDS globally and currently particularly in Africa. We are very concerned that people get the best quality medicine, safe and efficacious, at the lowest possible price. We are completely open to any manufacturer who can provide us drugs that have those qualities. The WHO runs a wonderful system for pre-qualification, but it’s voluntary. They can’t share the company data. We are not going to buy pills unless we see the data about the safety and efficacy of those pills because we feel responsible for the people who are taking them."

Mr. Flaven says any generics must have bio-equivalence. That means when it gets into the body it acts exactly the same way as the brand name version.

The spokesman for the US Global AIDS Coordinator denies the Bush Administration only favors the big pharmaceutical companies.

"That’s not the case at all. If that were the case, we would have gone and said we will only use FDA (Food and Drug Administration) approved drugs and never bother to hold a meeting like this in Botswana. But instead we opened it up to the world and the world is advising us. We had a planning meeting for this particular conference with 25 nations represented, 12 from Africa. And these were regulatory people from all over the world, including the gentleman who runs the pre-qualification program for the WHO. In addition, that gentleman will be the co-chair of the meeting with Precious Matsoso, who is the head of the Medical Control Council in South Africa. So there is no intent to hurt the WHO. There is only intent to help Africa."

He says the Botswana meeting will try to produce a resolution on the necessary principles to evaluate the safety and efficacy of the drugs being manufactured. These include AIDS drugs from India, as well as any that may be produced in African countries.

Mr. Flaven says the resolution must adhere to the Hippocratic Oath – first do no harm.