This year’s World AIDS Day is particularly timely, arriving a day after World Health Organization recommends a “phase out” of one of its main ARV drugs: Stavudine.
The WHO promotes the public health approach to global AIDS: treat as many as possible, as quickly as possible, as cheaply as possible. In fact, all UN agencies and many NGOs followed WHO's lead and promoted a public health approach as well. In the public health approach, the interventions are designed to be quick, inexpensive, and cover as many people as possible--as in epidemics for infectious and parasitic diseases. On the other hand, in a clinical approach, medical records are the standard method for recording a patient's response to a therapy.
Now, some 4 million patients are under Antiretroviral (ARV) treatment, yet neither WHO nor any other UN agency has any patients' outcome data of a clinical nature to show for the billions expended--until yesterday. On November 30, the WHO's press release recommended that "countries phase out the use of Stavudine, or 4dt, because of its long term, irreversible side-effects." Stavudine is one of the components of the triple dose combination ARV from India identified as the "backbone" of WHO's '3 by 5' program, launched in December 2003. Stavudine, in single or combination forms, is also one of the most widely used ARVs in Africa.
The triple dose combination ARV was licensed by the Drugs Controller General (India) as a 'formulation' on 26 July, 2001, with several conditions for its use. Among them:
1. "Warning": To be sold by retail as the prescription of a Registered Medical Practitioner only";
2. No reference in the advertisement or medical literature is made that the government has approved the drug.
WHO subordinated both conditions: the first by recommending that tens of thousands of community health workers (not registered medical practitioners) be trained to deliver ARVs and the second by lending its considerable institutional legitimacy to ARV formulations from India which hadn't been approved by any stringent regulatory authority.
Yesterday, the WHO recommended a phase out of this drug due to its long term, irreversible side-effects. If a clinical approach had been used in AIDS treatment, then we would know that patients were having adverse reactions to Stavudine because the medical records would reveal the progress of treatment or lack thereof. Clinicians would then change the therapy and monitor patients to see how they were responding.
To make matters worse, while the WHO has recommended the phase-out of Stavudine, it has not suggested a drug re-call, a standard practice of R&D companies in Japan, the EU, Australia, and the US. With a considerable pipe-line of Stavudine in process, how many more patients must suffer "irreversible side effects" in the absence of a drug re-call?
What is the cost for medical treatment of those affected with "irreversible side-effects" from its use? Did WHO recommend, according to the UN's Universal Declaration on Human Rights, that 'patient consent forms' be secured before Stavudine was administered? Given Stavudine's extensive use in Africa, it is likely that the long term medical care costs for these patients will be larger than the ARV treatment costs for the remainder of patients that were fortunate enough not to have followed WHO's original recommendation of December 2003.
How will AIDS treatment be sustained in the face of such irresponsible treatment protocols?
Stavudine should be the wake-up call for all agencies involved in the treatment of global AIDS. The best thing that the Global Fund can do to improve treatment of AIDS patients is to abandon the public health approach and adopt a clinical health approach. In the short-run, it may be more expensive, but as Stavudine has shown, in the long run it will be greatly less expensive.
Center for Science in Public Policy