Allen Myers, Phnom Penh
The Cambodian government is under pressure to allow a controversial trial of the anti-HIV drug tenofovir. A planned trial of the drug was banned by Prime Minister Hun Sen last August after vocal protests by sex workers, whom researchers hoped to involve in the tests.
Tenofovir, marketed under the trade name Viread, is currently approved for use in combination with other drugs to treat people living with AIDS. Its manufacturer, a US corporation called Gilead Sciences, wants to test a new use for the drug. It hopes that a daily oral dose of tenofovir can prevent HIV-negative people from getting infected with the virus.
Viread has been extremely important for Gilead, converting if from a loss-making company into a profitable one.
The Bill and Melinda Gates Foundation and the US National Institutes of Health (a government body) have provided funding to conduct trials of the drug, mostly on sex workers in Africa and Asia. In Cambodia, the trial was to be conducted jointly by the University of California at San Francisco, Australia's University of New South Wales and the Cambodian National Center for HIV, AIDS, Dermatology and Sexually Transmitted Diseases (NCHADS), with funding administered by the US organisation Family Health International (FHI).
Objections
However, Phnom Penh sex workers, organised in the Women's Network for Unity (WNU), strongly objected to what they call unethical aspects of the proposed trial, including insufficient guarantees of long-term medical care for trial participants who might develop side effects.
Reported side effects in HIV-positive people using tenofovir include damage to the liver, kidneys and pancreas, and loss of bone minerals, which may lead to osteoporosis. There have been no tests of what side effects might occur in HIV-negative people.
The WNU also objected because there had been no consultation with sex workers, but only a show of consultation with several non-government organisations that claimed to speak on their behalf. They reported that Cambodians employed by the researchers to recruit trial participants were telling sex workers that there were no side effects from tenofovir and were pretending to represent an NGO that has assisted the WNU.
The WNU has also pointed out that if participants believe the drug makes them more resistant to HIV infection, they may be less likely to use condoms, thereby increasing their risk of HIV infection. The government of the African country of Cameroon suspended a tenofovir trial in early February, after complaints by Cameroon human rights activists and ACT UP-Paris concerning inadequate counselling and protection of trial participants.
In the Cameroon trial, which has since been resumed after visits from FHI, trial participants were not offered treatment if they became infected with HIV.
WNU pointed out that even if tenofovir proves safe and effective, neither they nor other Cambodians are likely to benefit, because it would be too expensive for them to purchase even at foreshadowed discount prices for poor countries.
After a public campaign conducted by the WNU, including a protest at the international AIDS conference in Bangkok in July, Hun Sen publicly declared that medical experiments should not be conducted on Cambodians.
While that put a stop to open preparations for a tenofovir trial, those backing it swung into lobbying mode, under the guise of investigating "what had gone wrong" so that similar problems would not arise with other trials "in the future". NCHADS and Cambodian NGO "partners" of FHI are urging sex workers to drop their objections, and there have been a number of visits from would-be researchers, including Professor John Kaldor from the faculty of medicine at the University of New South Wales.
On March 4, WNU members wrote to Hun Sen, urging him to maintain his position.
Misleading promotion
It is not widely known in Cambodia that in March 2002, the US Food and Drug Administration's Department of Health and Human Services wrote officially to Gilead, saying that the company's promotion of Viread at a science conference held in Chicago the previous December violated the US Food, Drug, and Cosmetic Act.
The FDA said a Gilead representative at the conference made "false and misleading statements" about the risks associated with Viread, including the statements that it had "no toxicities", was "extremely safe" and was "extremely well tolerated". Other statements by Gilead representatives "misleadingly suggest[ed] that the drug is safer than has been demonstrated". Another representative made "false or misleading" statements about the effectiveness of Viread, including calling it a "miracle drug".
Gilead promised to mend its ways, but didn't. According to a more severe "warning letter" sent to the company on July 29, 2003, a Gilead representative continued these violations at a conference in Miami held March 31-April 2, 2003. The salesperson had even tried to discredit the warning on the drug's packaging. The FDA found this "particularly concerning given the serious risks associated with the drug".
One of the things which the FDA attacked was Gilead's failure "to emphasize that patients take Viread as part of an antiretroviral combination regimen because monotherapy can lead to rapid development of a resistant virus".
Some supporters of the trial have been saying that an advantage of tenofovir is the low incidence of it causing resistance to develop. This was repeated in an NCHADS presentation to sex workers, for example. But as the FDA warned Gilead, there is no evidence of low resistance when Viread is used alone, as is proposed for the trial.
The misrepresentations attacked by the FDA are cited in a class-action suit brought against Gilead in November 2003 by investors who claim they were defrauded. They charge that company insiders exaggerated Viread's prospects and its actual sales in order to sell some 300,000 company shares at inflated prices. The suit is still in the courts.
From 91×ÔÅÄÂÛ̳ Weekly, March 23, 2005.
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