Associated Press (Mar 29, 11:36 AM) GABORONE, Botswana (AP) -- Health experts and U.S. government officials discussed the fate of millions of AIDS patients at a conference convened Monday to consider approval of generic, combination drug therapy.
The U.S. Department of Health and Human Services, World Health Organization, the Joint U.N. Program on HIV/AIDS and the Southern Africa Development Council opened the two-day conference in Botswana's capital to discuss the safety, effectiveness and approval process for Fixed Drug Combinations.
These are a combinations of antiretroviral drugs made into one pill making it easier for patients to stick to their treatment regime. Being generic, they are cheaper than most AIDS drugs and represent a ray of light for poor AIDS ravaged continents like Africa.
Some health experts contend the United States threatens that hope by calling for additional checks and balances when it comes to approving the combination drugs.
United States officials attending the conference have dismissed allegations they are protecting huge pharmaceutical companies threatened by generic manufacturers.
They argue they want internationally accepted standards like those in place for malaria and tuberculosis to avoid drug resistance.
``We know from a decade of clinical experience that if you do not maximally suppress the virus you significantly increase the risk of resistance,'' said Dr. Mark Dybul, Deputy Chief Medical Officer for United States Global AIDS Fund. ``That's why we use three drug combinations, not one or two.''
But trying to set up another review system will slow down attempts to get low-cost drugs to African countries where more than two-thirds of the worlds 40 million AIDS infected live.
The World Health Organization said only 8 percent of those in need receive drugs that in rich countries have turned AIDS from a death sentence into a chronic disease. The UN estimates that about 30 million people have died of AIDS-related causes.
``There are very clear signals that the U.S. government does not support ... the use of fixed-dose combinations'' made by foreign generics manufacturers, Ellen 't Hoen of the group's Campaign for Access to Essential Medicines said last week.
``We are very worried that these arguments about the safety of the medicines ... will lead to loss of confidence in the products'' made by generics manufacturers and recommended by the WHO, she said.
In 2003 the WHO created strict guidelines on appropriate therapy for HIV in resource-limited countries.
Several combination therapies that have been pre-qualified under these standards including Triomune and Triviro -- generic medications manufactured in India that combine in a single pill the recommended regimen of stavudine, lamivudine and nevirapine.
According to Medecins Sans Frontieres, combination drugs cost about US$270 a year for 2 pills a day as compared to other drugs costing about US$562 a year for 6 pills a day.
``WHO has made enormous headway in verifying the quality of generic AIDS drugs that are the only hope for millions of low-income people with AIDS,'' Joanne Csete, director of the HIV/AIDS Program at Human Rights Watch said last week. ``But to protect brand-name pharmaceutical interests, the United States may dash that hope.''
Generic manufacturers have also come out against the U.S.
``This is a political meeting disguised as a scientific meeting. The organizers purpose was to undermine the World Health Organization prequalification process,'' said William Haddad chairman of Brogenerics.
Rep. Henry Waxman said establishing a parallel approval process to the WHO would make no sense. ``Such a process could set up conflicting international standards, confusing countries and donors,'' he said.
Experts suggest if additional standards need to be put in place, it be included in current WHO processes urgently.
``Our association ... is predicated on an overriding interest to ensure that there are no unnecessary regulatory hurdles to the rapid approval and registration of Quality Fixed Dosed Combination(FDC's) in countries,'' Julian Fleet, Senior Adviser for UNAIDS said.
``By providing a set of principles which can be considered by drug regulatory agencies, and also of use to manufacturers, these agencies hopefully will be better able to assess FDC applications in a fast track mode.''
Conference hosts Botswana are the only African country to roll out AIDS drugs on a national scale. Despite cost concerns, no generic drugs are being dispensed.
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