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AFRICA: Generics challenge brand-name anti-AIDS drugs
IRIN News
March 30, 2004

http://www.irinnews.org/report.asp?ReportID=40331

GABORONE - US officials attending a major conference on anti-AIDS drugs in Botswana this week have dismissed allegations that they want to use the meeting to question the quality and safety of more affordable generic fixed-dose combinations (FDCs) of antiretrovirals.

"We want to see use of internationally accepted scientific principles that will be used in evaluation of Fixed Dose Combination drugs for HIV, tuberculosis and malaria. The concern is the risk of resistance, because good drugs are not good enough with this disease," said Dr Mark Dybul, head of the US government's President's Programme for AIDS Relief (PEPFAR).

"We know from a decade of clinical experience that if you do not maximally suppress the virus, you significantly increase the risk of resistance. That is why we use three drug combinations, not one or two," Dybul added.

FDCs of antiretrovirals contain several AIDS drugs in one tablet, and are widely regarded as being a key to scaling up AIDS treatment in developing countries. They are recommended in the World Health Organisation's (WHO) treatment guidelines, and are at the the heart of WHO's "3 by 5" initiative to have three million people on treatment by 2005.

Because patients need to take fewer tablets, FDCs are easier to use than single dose drugs and make adherence simpler. They are generally much more affordable than brand-name regimens, which can involve taking as many as six pills a day. Managing drug storage and distribution is also more straightforward when there is a smaller range of products to supply, AIDS activist point out.

Activists are concerned that because FDCs have not been approved by the US Food and Drug Administration, they would not be procured under the US government's multi-million dollar PEPFAR programme for developing countries.

A statement on the website of the US Department of Health and Human Services, one of the conference sponsors, noted that while the advantages of FDC generics were generally accepted, "currently, there are no uniform principles, guidelines, or international standards addressing the development of FDCs and their potential benefits or disadvantages in treating [HIV, tuberculosis and malaria]".

It added that "there will be cases where individual drugs must be utilised for certain patients".

Anti-AIDS groups alleged that the US government was using the two-day conference, titled "Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical Issues related to Safety, Quality, and Effectiveness", to undermine the case for generics. [http://www.cptech.org/ip/health/aids/fdc/ ]

"The drugs in question meet the stringent standards of the WHO technical review for generic drugs, but have not been approved by the US Food and Drug Administration. The United States, under pressure from pharmaceutical companies selling the brand-name equivalents, claims instead that 'There are no uniform principles, guidelines or international standards addressing the development' of generic drugs — an assertion that calls into question the WHO's widely accepted review process," Human Rights Watch said in a statement.

Generics drug manufacturer, William Haddad, described the Botswana conference as a "political meeting disguised as a scientific meeting".

"The second issue is that they want to add a new level of approval, so that United States brand name companies can sell their products, and generic companies cannot use United States money [to produce drugs for developing countries]," he added.

"Due to lower prices of FDCs, we can treat up to four times more people than we would be able to treat with non-FDC/branded drugs," said Jacqueline Patterson, HIV/AIDS programme manager for Interchurch Medical Assistance, a faith-based health development agency.

"What will happen at the end of the 5-year term of the PEPFAR initiative after we've all changed our protocols and practices to comply with regulations excluding FDCs and requiring high-priced regimens and then resources are withdrawn?" she asked.

In 2003, WHO convened an expert panel to make recommendations about appropriate therapy for HIV in resource-limited countries. Several HIV combination therapies were pre-qualified under the review process, including Triomune and Triviro, generic medications manufactured in India, which combine in a single pill the recommended regimen of Stavudine, Lamivudine and Nevaripine.

Some delegates at the Botswana gathering suggested that if health experts believed additional standards for HIV drugs were necessary, those standards should be quickly built into the existing WHO process.

"Our association with this conference 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 combinations in countries," said Julian Fleet, a senior advisor at UNAIDS.

When the conference was convened, Fleet noted, it had been agreed that the norms and standards to be developed would not be an alternative to the pre-qualification process. UNAIDS, along with WHO and the Southern African Development Community, also sponsored the gathering.

Botswana, with one of the highest HIV-prevalence rates in the world, was the first country in Africa to roll out a national antiretroviral treatment programme. The initiative uses brand-name drugs and is backed by the pharmeceutical company Merck and the Belinda and Melinda Gates Foundation.

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