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| Abner Mason, a member of the Presidential Advisory Council on
HIV/AIDS, said the recommendation that only drugs approved by the FDA should be
purchased with U.S. funds was validated by a string of generic HIV drugs being
removed from the World Health Organization’s list of approved medicines. |
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HOME > NEWS > NATIONAL NEWS
By: RYAN LEE
COMMENTS |
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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
the Bush Administration, after 18 already-approved drugs were removed from the
WHO prequalified list since May over 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 U.S. 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
U.S. 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 continue to discount Mason as “a lapdog
of 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.
Bioequivalence trials use healthy patients to find out if the concentration
of a generic drug in the blood of a patient is equivalent to that of the original
product, said Rago, who added that WHO dealt with the de-listing controversy
in an “extremely transparent way.”
“This has been short-term pain with much more long-term gain because
this is quite a rigorous process we are using now in terms of assessing bioequivalence,”
Rago said during a telephone interview from his Switzerland office last week.
When announcing the de-listing of the generic HIV medications, the WHO said
that “in principle” patients should cease using the de-listed medications,
but added that “the risk of withholding treatment is higher than that
of providing medicines whose bioequivalence is not proven, but which have demonstrated
quality and safety.”
Established in 2001, the WHO Prequalification Project created a list of vital
HIV medications for use in developing countries that met WHO safety standards.
AIDS activists credit the prequalification process with expediting the delivery
of life-saving drugs to those most in need, and helping drive the cost of HIV
medications down by giving generic drugs the WHO stamp of approval.
“Certainly thousands of people would have died had [the WHO] not made
these drugs available,” said Rachel Cohen, U.S. director of Doctors Without
Borders’ Campaign for Access to Essential Medicines.
A drug is added to the WHO prequalified list after the agency inspects the
sites where the it is manufactured and evaluates the drug’s quality based
on data provided to WHO by pharmaceutical companies.
Companies are also required to submit data from independent contractors verifying
their bioequivalence results. Prior to May 2004, WHO reviewed the data from
these contractors, but did not inspect the sites at which the trials were conducted,
according to WHO’s Rago.
Less than 10 percent of European countries used to require inspections of the
contractors conducting bioequivalence studies, which is why WHO did not originally
make these ...
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