Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
San Francisco Chronicle - December 1, 2004
Abner Mason
Such a somber audit may be long overdue. After tests showed flaws in its AIDS drugs, Indian generic drug maker Ranbaxy issued a global recall -- unfortunately, it came three years after these dubious drugs were originally "approved" for use by the U.N. health agency, the World Health Organization. For three years, the suspect medicines have been used by tens of thousands of Africans. Relief groups like Doctors Without Borders and the Salvation Army have spearheaded efforts to get these generics into the developing world. They may now face liability claims for distributing these insufficiently tested knockoffs.
The Indian generic drugs have been buoyed by big-name political endorsements -- Rep. Henry Waxman, D-Los Angeles, Sens. Ted Kennedy, D-Mass., and John McCain, R-Ariz., in addition to the Clinton Foundation, have all given their "approval" even in the absence of adequate and rigorous testing from regulatory agencies. Seeking to drive a wedge between the Bush administration -- an advocate of using its $15 billion AIDS relief war chest to purchase only tested AIDS drugs -- politicians and activists have exhausted considerable political capital to sell the public and media on the promise of Indian generics.
Cleaning up this mess is a tall task. Last summer, AMFAR raised eyebrows with its report warning that the bevy of unproven Indian generics in the developing world could lead to "drug resistance, eradicating years of progress. " Despite concerns raised by this report, Daniel Berman of Doctors Without Borders recently told the Washington Post: "We are not worried about the safety of our patients. We are confident in the drugs we are using."
The WHO is still recommending that patients already taking Ranbaxy drugs continue with their regimens. The all-too-hasty rush toward untested Indian generics may end up costing lives. And the recklessness of the politicians and activists who have touted them has been dangerous. "Standards and guidelines are important ... I just don't want people to wait for a road map. Be bold and willing to take risks," said Doctors Without Borders official, Rachel Cohen, reacting to the AMFAR report at the Bangkok AIDS conference this summer.
We may have taken one risk too many.
Abner Mason is founder and executive director of AIDS Responsibility Project (www.aidsresponsibility.org).
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