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August 13, 2004
WHO director and senior leadership must step down after recent drug scandal
Changes are needed at the WHO after HIV-debacle
Last week’s decision by the World Health Organization to remove three Indian-made generic AIDS drugs from list of approved medicines underscores the need for new and responsible leadership at the helm of what should be the world’s preeminent health agency.
After endorsing these drugs for use in the developing world 3 years ago, the WHO publicly acknowledged on August 4 that its could no longer vouch for the safety of these products - produced by Ranbaxy - or be certain that they were biologically similar to their patented equivalents. This announcement follows another “delisting� of generic AIDS drugs (also by an Indian firm, Cipla) by the WHO just two months ago - dropping the drugs on May 27.
The removals come at a time when the UN-agency has endured harsh criticism for its embattled ‘Roll Back Malaria’ initiative, which experts last spring proved to have caused malaria deaths to actually increase since 1998 by insisting upon cheap drugs - resulting in drug resistance.
Finally, WHO, according to various media accounts, unlikely to meet the goals and expectations set forth in its once vaunted AIDS 3x5 initiative, is facing accusations of “Enron-like� figures after having recently acknowledged that many key objectives in the first 6 months have not been met.
"I am outraged that this can occur in what should be the world’s leading health organization. Bad decisions, missed deadlines and bogus AIDS drugs should not be on their track record – not ever and certainly not for the past 8 months. Africans and the poor should not be treated with worse medicines" says Eudoxa founder and director, Waldemar Ingdahl.
Transparent analysis of all drugs approved under the WHO’s Pre-Qualification Project to ensure they meet safety and efficacy standards similar to regulatory regimes such as the European Agency for the Evaluation of Medical Products (EMEA) and the United States Food and Drug Administration (FDA).
"We need new leadership and better accountability. A pattern of bad decisions has characterized the WHO under Dr. Jong-Wook Lee and he should tender his resignation at once." continues Ingdahl.
While the WHO has – to its credit – de-listed these dangerous drugs it has yet to provide any direction to patients regarding alternative therapeutic treatment.
Specifically, we call upon the WHO to immediately:
• Tender resignations of Dr. Lee Jong-wook, Director-General; Dr. Jack C. Chow, Assistant Director-General, HIV/AIDS, TB and Malaria; Dr. Jim Kim, Director, Department on HIV/AIDS and Dr. Hans V. Hogerzeil, Policy, Access and Rational Use Essential Drugs and Medicines Policy.
• Transparent analysis of all drugs approved under the WHO’s Pre-Qualification Project to ensure they meet safety and efficacy standards similar to regulatory regimes such as the European Agency for the Evaluation of Medical Products (EMEA) and the United States Food and Drug Administration (FDA).
• Notification by the WHO to nations, world government institutions, non-governmental organizations and most importantly AIDS patients that drugs made by Ranbaxy and Cipla have been de-listed.
• Announcement and follow through by the WHO to conduct evaluations of patients to determine if these unsuitable AIDS drugs have promoted HIV resistance.
• Explanation by WHO officials on why 3 years after being approved under the pre-qualification project these AIDS medicines were just now found to be non-compliant with international standards of good clinical practices?
The Eudoxa think tank is situated in Stockholm, Sweden. Their focus is on discussing the effects of emerging technologies and scientific progress on society, in order to promote consumer choice. Eudoxa has published books and reports in Swedish, Danish and English. They recently published a report on how emergent technologies are changing health care.
For further information, please contact Director Waldemar Ingdahl. Telephone +46 8 83 87 73, e-mail waldemar.ingdahl@eudoxa.se
Posted by Waldemar at August 13, 2004 12:22 PM