E-drug: BMJ: WHO pulls three more AIDS drugs from list
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[Copied as fair use. KM]
BMJ 2004;329:368 (14 August)
News extra
WHO pulls three more AIDS drugs from list
Geneva Fiona Fleck
In a major blow to efforts to get lifesaving AIDS treatment to millions
of people in the world's poorest countries, the World Health
Organization has withdrawn three more generic drugs from its original
list of seven approved AIDS medicines.
The move came after laboratory tests failed to prove these three drugs
have the same chemical make up (or bioequivalence), as their patented
equivalents. Two other generic AIDS drugs were removed from the list in
June for the same reason.
The lack of bioequivalence means that these generic copies may not be as
effective as the original patented equivalents.
WHO requires proof of bioequivalence for products that it recommends for
serious conditions such as AIDS, malaria, and tuberculosis.
Officials at WHO said that more stringent checks may now have to be
introduced before such products are recommended in future.
Peter Graaff from WHO's AIDS medicines and diagnostics service, said
that WHO was advising countries to suspend use of the drugs that had
been removed from the "approved" list, but if they have no alternative,
to weigh up continued use against the risks of interrupting treatment.
Mr Graaff noted that the drugs that had been removed from the list
fulfilled all other requirements on quality, specifications for active
ingredients, impurity profile, and manufacturing.
He warned that despite their suspension pending further laboratory
tests, switching to other products that have not been registered in a
country with a strict regulatory system could be more risky.
"Although we are not 100% sure yet whether these drugs are
bioequivalent, at least we know they are of good quality and safe," Mr
Graaff said.
Some generic AIDS drugs on the market have not passed WHO compliance
tests, but WHO officials say they cannot publish a list of them for
confidentiality reasons.
Procurement of cheap copies of patented drugs is central to global
efforts to scale up treatment for millions of AIDS patients in
developing countries who cannot afford antiretroviral drugs, which
stabilise but cannot cure their chronic disease.
The removal of five of seven WHO recommended AIDS drugs is set to hamper
these efforts and fuel highly vocal criticism by drug companies and
their advocates that generic copies of their patented products are
substandard.
Andre Zyl, a WHO pharmaceuticals expert, said that non-compliance in
some aspect of generics pharmaceuticals production was not unique to
generics, noting that problems have emerged with patented AIDS drugs in
the past after they were licensed.
The three latest drugs to be removed from WHO's approved list are
products of the Indian generics company Ranbaxy.
One is a "two in one" pill combining 150 mg lamivudine and 300 mg
zidovudine. The other two are three in one pills, one combining 150 mg
lamivudine, 30 mg stavudine, and 200 mg nevirapine, and the other
combining 150 mg lamivudine, 40 mg stavudine, and 200 mg nevirapine.
The two AIDS drugs remaining on WHO's approved list are a two in one
pill combining zidovudine and lamivudine and a three in one pill
combining lamivudine, stavudine, and nevirapine. The three in one pill
has been checked and found to fulfil bioequivalence. The two in one pill
is undergoing checks but it has not been suspended.
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