The World Health Organization’s process for approving generic HIV drugs for use in developing countries is under intense criticism from a gay member of President Bush’s AIDS advisory panel, after 18 already-approved drugs were removed from the WHO pre-qualified list since May due to inadequate bioequivalence data.

Abner Mason, a gay Republican member of the Presidential Advisory Council on HIV/AIDS, said the removal of those drugs from the WHO list of approved medicines validates a resolution passed by PACHA in March. The measure stipulated that generic drugs purchased with American tax dollars must be approved by the Food & Drug Administration or meet a “standard of comparable scientific rigor.”

The resolution, which was drafted by Mason and approved unanimously by the 35-member advisory council, was intended to ensure that drugs purchased by the United States for use in other countries meet the same safety standards as drugs used by Americans, Mason said.

“What [the removal of the drugs] says is that we were certainly right to be cautious,” Mason said. It was “a terrible failure of oversight” by WHO to allow the drugs to be approved and used by patients in the first place, he said.

But some AIDS activists, who have questioned Mason’s close ties to the pharmaceutical industry, say the 18 drugs were de-listed because of “paperwork” glitches involving contractors who were hired to conduct bioequivalence tests to verify the data generic drug manufacturers presented to WHO.

The decision to remove the drugs from the approved medicines list actually highlights the vigilance and reliability of the WHO approval process, said Paul Davis, domestic policy director for Health GAP, an AIDS advocacy group that focuses on increasing global access to life-saving medicines.

“The drugs that were de-listed have not been shown to be of substandard quality [compared to their brand-name counterparts],” Davis said. “Even though the drugs actually work, WHO is stringent enough to de-list these products, so it sounds like evidence the process is working.”

The first two drugs that were yanked off the WHO list in May — generic versions of AZT and 3TC, both manufactured by India-based Cipla Ltd. — were reinstated Nov. 30 after new tests and inspections revealed that the generic drugs had the same bioequivalence as their brand-name versions, said Lembit Rago, WHO coordinator of Quality, Safety & Efficacy of Medicines.

Conflict of interest?
Clint Trout, associate director of federal and international policy at the Los Angeles-based AIDS Healthcare Foundation, described Mason’s position as being “well paid for,” echoing a charge by AIDS activists that Mason’s policy recommendations as a member of PACHA are clouded by the funds his Los Angeles-based AIDS Responsibility Project allegedly receives from brand-name pharmaceutical companies.

Mason did not respond by press time to inquires about which companies provide funds to the AIDS Responsibility Project.

He was cleared this summer of an ethics complaint filed by an AIDS activist in May in response to the resolution Mason drafted recommending U.S. tax dollars not be spent on drugs not approved by the FDA or a comparable agency.

AIDS activists charge that FDA approval of generic drugs is unnecessary because the drugs are already approved by WHO, and intended to expand the “slush fund” for big-name pharmaceutical companies.

The ethics complaint against Mason was sent to PACHA’s then co-chair, Tom Coburn, on May 9, and Coburn forwarded the letter to the Inspector General’s Office of the Department of Health.

The Inspector General’s Office found “nothing criminally actionable” in the complaint against Mason and dismissed the complaint.

But after that, PACHA Executive Director Joseph Grogan talked with Mason to let him know “that doesn’t mean there aren’t appearance problems,” Grogan said this week.

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