August 16, 2004
by Jeremiah Norris
The United States' policy on global HIV/Aids is far more principled and beneficial than its critics suggest. I attended the fifteenth international conference on HIV/Aids in Bangkok in July 2004, but fail see how Bill Bowtell in his article "HIV/Aids: global policy after Bangkok" (OpenDemocracy.net, July 29, 2004) was able to determine that United States policy there was motivated by political and corporate self-interest.
Indeed, the speakers representing the U.S. government were drowned out by protestors, and the CEO of a pharmaceutical company was stopped from making his presentation altogether. This made it difficult for objective information to be shared with participants, and all the more difficult now for Bowtell to describe accurately "the ideologically-driven HIV/Aids policies pursued by the United States administration."
Moreover, the U.S. delegation did not arrive in Bangkok to proclaim its commitment to spend $15 billion on Aids. That commitment had been made by President Bush in his State of the Union speech in January 2003, and then reaffirmed in the name of the American people by the U.S. Congress in January 2004. The problems faced in the course of attempting to implement this pledge are instructive.
After the president's announcement, a director of the U.S. National Institutes of Health was quoted in a Reuters dispatch: "we will buy fixed dose combination antiretroviral (ARVs) generics from India."
But there was a technical difficulty. When the World Health Organization (WHO) "prequalified" this ARV, it inserted a disclaimer: "inclusion in this list does not constitute an endorsement, or warranty of the fitness, of any product for a particular purpose, including in regard to its safety and/or efficacy in the treatment of HIV/AIDS."
On March 30, 2004, the WHO offered an explanation for its disclaimer, saying: "safety and efficacy are the responsibility of the manufacturer." On May 17, the U.S. Food and Drug Administration (FDA) announced a fast-track process for foreign companies to obtain FDA approval for their ARVs, thus permitting them to be purchased with aid funds. The FDA offered to waive application fees, and to move foreign companies to the head of the queue - ahead of American companies seeking FDA approvals.
Since the American drug companies manufacture no generic ARVs, this leaves the field entirely open to Indian companies: it is the only cartel prequalified by the WHO to sell copy drugs to United Nations agencies.
If, as Bill Bowtell believes, America's funding policy towards the global HIV/Aids epidemic is guided by "the political and financial power of core elements of the Bush administration's domestic support," this outsourcing of jobs and billions in foreign aid monies to India hardly qualifies as a confirmation of that policy.
To date, no Indian company has availed itself of the FDA's offer. If the prequalified drugs are everything the WHO has claimed them to be, then there must be a reason why their producers haven't applied.
On May 27, 2004, the WHO formally de-listed two ARVs from an Indian company, Cipla, that had been prequalified. The reasons: the outcome of an inspection in which compliance with good clinical practices and good laboratory practices was assessed, as well as a re-examination of raw data from bioequivalence studies. These factors demonstrated that the drugs were not being manufactured to international standards.
After the de-listing, the WHO's only action was to alert other UN agencies. The Indian company did not issue a recall of drugs that had been used with poor patients in Africa, nor did it attempt to conduct any post-marketing surveys to determine if there had been any adverse effects among those taking these substandard drugs.
The WHO is unable to enforce responsible corporate behavior. The reason: Indian companies are not required by law to demonstrate bioequivalence as long as drugs are destined for export. The WHO failed to alert procurement agencies of this fact.
Bowtell contends that the Indian drugs are generic products. But they are copy drugs, or knockoffs. They are produced against no recognized standards which would make them acceptable to patients in the European Union, the United States, Canada, Australia, or Japan. The WHO, when prequalifying them, never used the term "generic." It simply said that they were "HIV-related medicines [that] have been found acceptable in principle." The WHO didn't offer a definition for "acceptable," or for the "principle" that underlies it.
The regulatory authority in India, the Drugs Controller General, when issuing a license for production on July 26, 2001 didn't refer to the drugs as "generics" either. The regulatory authority used the term "formulation." Of the twelve conditions listed for use, number ten read: "no reference in the advertisement or medical literature shall be made that the Government has approved the drug."
The WHO is a voluntary membership organization. It isn't immediately obvious how one of its sovereign members, India, can have its legal and regulatory authority on drugs peremptorily subordinated. If drugs are not approved by the Indian government, under what authority can the WHO approve them for use in other member countries in the absence of their informed consent, as guaranteed by the Universal Declaration on Human Rights?
The Global Fund to fight Aids, the Clinton Foundation, the World Bank, WHO, Unicef, the Vatican, the Pan American Health Organization - all support copy ARV drugs from India. Yet, none of them can present any scientific justification for the use of lesser requirements being promoted by the WHO. The U.S. government is the only entity willing to stand firm on the principle of no double standards for the poor. If a drug isn't good enough for use in Kansas, then it isn't good enough in Kenya, either.
The WHO's withdrawal of three generic Aids drugs manufactured by another Indian company, Ranbaxy, from its list of approved medicines because of safety concerns - only days after the company declared that it would apply for approval by the FDA - is evidence of the need for a single standard that places the needs of the patient, rich or poor, first.
In any case, Bill Bowtell fails to recognize those countries that are exemplars in the field of Aids treatment: Brazil, Botswana, Uganda, and South Africa. Here Aids patients are being treated - not because they are poor, but because they are sick. Here, because the international health community is absolutely new to chronic care treatment and is on an uphill struggle to understand its rather uncompromising dictates, the age-old dictum is applied: first do no harm.
Let us find merit in those who are doing something about this calamity. Start with some uncomfortable facts. Has the Australian drug regulatory authority approved use of Indian ARV products for its Aids patients, or offered to fast-track Indian companies for the Australian market? And why has the Indian government, a global nuclear power, representative of the largest Aids population in the world, refused to buy ARVs from its own producers in any significant amount relevant to the incidence rate?
Of the 192 members of the WHO, why is the United States the only one to believe that if a toxic drug is unacceptable for use among its own people, then it is also unacceptable and misleading to use it with poor people throughout the world?
This article appeared on August 5, 2004 on OpenDemocracy.net in response to a July 29, 2004 article by Bill Bowtell titled "HIV/Aids: global policy after Bangkok."
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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