Open letter to Dr Margaret Chan, DG of the WHO regarding safety issues with HIV/AIDS treatment in Thailand

May 17, 2007

Dr. Margaret Chan
Director-General
World Health Organization
Avenue Appia 20
CH - 1211 Geneva 27
Switzerland

Dear Dr. Chan:

I am writing to encourage you to assess important quality and safety issues pertaining to HIV/AIDS treatment in Thailand. Thai patients deserve to be informed of the health consequences inherent in current treatment regimens, especially through the use of an antiretroviral drug called ‘GPO-Vir’. The World Health Organization has taken a principled stand on its use. Yet, GPO-Vir continues to be distributed to over 100,000 AIDS patients in Thailand, Burma, and Cambodia (many of whom live in poverty) in spite of published data on the number of patients that have become drug resistant from this therapy.

There can be no doubt that through the provisions of TRIPS, Thailand is authorized to issue a compulsory license (CL) for drugs. What is at issue in the current debate, however, is a matter of concern to all those who support Thailand’s right to this provision but don’t wish to see it subordinated to a pretext that masks a much more significant public health issue.

According to the Ministry of Foreign Affairs, the stated purpose of the current CL is that “the price of certain life-saving drugs precludes many people in need from getting treatment.” UNAIDS reports that the country’s national HIV prevalence fell to 1.4% at the end of 2005, down from 1.8% in 2003 and more than 2% a decade earlier. Those are significant declines—in the absence of any CL. If higher prices were a factor in access to ARV medicines, improvements of this nature would have been most difficult.

The Global Fund for HIV/AIDS, TB and Malaria is currently providing $163 million in grant assistance to Thailand’s public health sector. Other donors, such as USAID, the World Bank, the Asian Development Bank, the EU, and WHO and UNICEF are also providing funds and technical assistance. Since grant assistance is increasing, there must be a reason other than price why those in need are not receiving it.

This would indicate that something else is prompting the need for a CL: the onset of drug resistance due to the use of a therapy which stringent regulatory authorities would label as an ‘investigative’ drug. When drug resistance sets in, the price of an ARV pales in comparison to the ongoing medical care costs for patients’ care.

The U. S. Centers for Disease Control published a report on findings presented by Thai scientists during the 2005 National AIDS Seminar in Bangkok. They found that resistance to GPO-Vir from the government owned production facility had accelerated drug resistance among patients. They had to be switched to a second line therapy costing $239 per patient per month from the GPO-Vir which had been costing $24 per month. The increased price is for the ARV alone, rather than the substantial add-on costs for medical care.

In 2003, The Global Fund for HIV/AIDS provided a grant of $133 million to the GPO in order to further test and procure GPO-Vir. GPO itself was to become WHO-compliant on good manufacturing practices in two years time, allowing GPO-Vir to be listed in the Prequalification Program. In August 2006, the Fund withdrew the remainder of monies because the GPO had failed to comply.

To the WHO’s great credit, it did not give in to pressures from Thai officials for the prequalification of this drug. The WHO had previously stated that it should not be sold outside of Thailand. Recently the WHO’s coordinator for the office of quality assurance and safety Dr. Lembit Rago, responded to the GPO’s claim that its ARV was bioequivalent by saying: “well, why should we believe you when there are no studies to prove it.” He publicly commented: “drugs that are not WHO pre-qualified may not directly kill people, but they could foster resistance to AIDS drugs.”

When your predecessor, Dr. J.W. Lee, launched WHO’s ‘3 by 5’ program in December 2003, he preceded it with a compelling article in The Lancet. He fixed the program’s core values on those found in the WHO Constitution of 1946, stating that effective public health action “needs an ethical position as well as technical skills.”

WHO’s coordinator of quality assurance and safety has taken this ethical position on GPO-Vir, and is upholding the rigorous standards of evidence-based medicine. If it is as safe and efficacious as the Thai military government avers, then let it be submitted to the U. S. FDA for Fast Track approval as a true generic. This would permit it to be listed on the WHO’s prequalification program, making it eligible for purchase with U. S. foreign aid funds. Several Indian and South African firms have now used this process and 70% of all ARV therapies among PEPFAR patients are sourced from either of these two countries.

On behalf of the 100,000+ unsuspecting patients now taking the investigative GPO-Vir, I urge you to consider two requests on their behalf: 1) use the moral force of WHO and petition the Thai military government to permit patients access to Informed Consent; 2) that WHO offer to sponsor a laboratory assessment of GPO-Vir in an independent facility to prove that it is as safe and efficacious as GPO claims.

WHO is the one international health institution that can place patients ahead of politics and science ahead of advocacy. Thank you.

Sincerely,

Jeremiah Norris
Director
Center for Science in Public Policy
Hudson Institute