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CAMEROON: Clinical trial of anti-HIV drug on sex workers in question

The government of Cameroon has said it may stop the clinical trial of an anti-AIDS drug being tested on 400 sex workers in the port city of Douala following allegations that the women are receiving inadequate counselling and medical care.

The drug in question is Tenofovir, an antiretroviral (ARV) drug manufactured by the US pharmaceutical company Gilead, which has been sold under the brand name Viread for the past three years.

Now the drug is being tested as a possible prophylactic to prevent people becoming infected with the HI virus.

However, AIDS activists in Cameroon and France have alleged that the women volunteers taking part in the clinical trial in Douala have not been sufficiently informed of the risks involved.

Worse still, they have accused Gilead and its agents who are conducting the clinical trial in Cameroon, of failing to guarantee free healthcare to the sex workers if they become infected during the course of the trial.

These critics say the women would be treated very differently if the same trial was being conducted in Europe or the United States.

The controversy has been aired on French television and AIDS activists recently staged a protest outside the Cameroonian embassy in Paris.

The Cameroonian government finally waded into the debate this week when Health Minister Urbain Olanguena Awono warned that he would put a stop to the clinical trial of Tenofovir if the criticisms of it were substantiated.

"This is a very important study because it aims to find out whether a drug that has already proved effective for treatment can also be used to prevent HIV infection," he told the Yaounde newspaper Le Messager in an interview on Monday.

"But obviously, if we find shortcomings on the ground that it fails to meet ethical standards we will be obliged to stop the trial immediately," he added.

The clinical trial in Cameroon was launched in September 2004 with 400 sex workers who were free of infection from the virus. Half of them were given a daily pill of Tenofovir, the other half a placebo.

Similar trials are being conducted on sex-workers in Cameroon, Ghana and Nigeria, and on homosexual men in the United States, with the support of a US $6.5 million grant from the Bill and Melinda Gates Foundation.

However, Gilead was forced to scrap the planned trial of Tenofovir on sex workers in Cambodia last year following a similar row over ethics.

The Health Ministry said this week it had launched an audit to check whether the clinical trial was being carried out in accordance with the procedures set out by the experimental protocol.

"The conclusions of the mission will determine whether the authorities decide to pursue or to interrupt the trial," the ministry said in a statement.

Cameroon's Reseau Ethique Droit et Sida (REDS) - a network for ethics, rights and HIV/AIDS, and a French association of AIDS activists called Act Up-Paris, have both demanded that the tests on Tenofovir in Cameroon be suspended.

They argue that internationally accepted ethical standards in biomedical research are being breached in the West African nation.

"The trial is indeed promising, but we are opposed to the way in which it is being conducted in developing nations," Fabrice Pilorge, the coordinator of Act Up’s treatment and research committee, told PlusNews.

"There needs to be more counselling on safe sex and the organisers must make sure the volunteers are given free therapeutic and psycho-social treatment," he added. "These minimum standards are respected in all developed nations," Pilorge stressed.

The clinical trials of Tenofovir as a protection against HIV infection are being conducted by the US organisation Family Health International (FHI).

If they show the drug to be safe and effective as a prophylactic, California-based Gilead has pledged to provide the drug at cost to resource-poor nations.


In Cameroon, participants in the clinical trial are offered free medical and gynaecological tests as well as free monthly HIV and pregnancy tests.

FHI has no office in Cameroon, so the trials in Douala are being conducted on its behalf by a local HIV/AIDS prevention group called the Care and Health Programme (CHP).

FHI said monthly sex workers taking part in the experiment received health care costing about US $50-60 per month.

They also received a transport allowance of about $5 per month to help them attend the clinical trial's medical centre regularly. This payment is roughly equivalent to their earnings from having sex with two clients.

"Those who experience medical problems directly related to their participation in the trial will receive medical services for those problems free of charge," FHI said in a document sent to PlusNews.

But the president of REDS, Calice Talom, said this was not true. "These researchers are just cowboys," he said in an interview broadcast earlier this month by the French television network France 2.

"People are being plain manipulated with false promises of free medical examinations," he added.

Three doctors and a nurse staff a medical centre that was built specifically to conduct the clinical trial in Douala.

Most of the 400 sex workers who regularly visit for consultations and to collect a supply of free condoms are illiterate. They speak limited French and even less English. However, counselling at the clinic is only delivered in English.

The sex workers are given 96 male condoms a month and may ask for more at any time. "There’s an obvious conflict of interest between enforcing prevention measures and carrying out the clinical trial of a drug that could help prevent HIV infection," Act Up's Pilorge said.

"The trial will only be a success if the women are exposed and become infected."

The volunteers, all of whom are at high risk of HIV infection, were recruited between July and December 2004.


But some AIDS activists fear they may be taking greater risks than previously because they feel protected by the drug.

"A friend who agreed to take part told me she was vaccinated now and couldn't catch AIDS", a young sex worker in Douala told France 2 TV.

The Swiss branch of the medical aid group Médecins sans frontières (MSF) told PlusNews that an MSF health centre in Douala was currently caring for women involved in the Tenofovir experiment.

"These girls turned up at our centre because the laboratory has no plans to take charge of their health-care during the study," Aymeric Peguillan, the spokesman of MSF-Switzerland in Geneva told PlusNews.

The head of the MSF medical centre in Douala, Laurence Gaubert, told France 2 that the medical relief agency had requested that HIV-positive sex workers involved in the Tenofovir test be referred to the centre after realising there was no provision for free care in the protocol agreement governing the clinical trial.

This was denied by the Tenofovir study coordinator in Douala, Doctor Anderson Sama Do.

"We take care of all volunteers who've become infected with HIV since taking part in the clinical trial," he told PlusNews. "We respect the rules, the protocol agreement was drawn up and approved by our national ethics committee."

Although Cameroon set up a national ethics committee as far back as 1987, critics say it lacks the means to enforce its standards.

Do said three women had been infected since the start of the trial in September last year. "We have approved centres where we refer people, and the project and FHI take care of all the expenses," he said.

But in the letter of consent that has to be signed by all sex workers taking part in the trial, FHI states: "In case of infection ... we will not procure treatment against AIDS. We will be able to direct you to clinics where you will have to pay."

A copy of this document was shown to PlusNews.

Despite a big drop in the price of ARVs in Cameroon last October from $34 a month to $8, the treatment remains extremely expensive in a country where half the population lives on less than $2 a day.

Jean-François Delfraissy, who heads AIDS trials worldwide for the French AIDS Research Agency (ANRS), said his organisation used the same ethical charter for poor countries as for rich ones. This clearly pledges free lifelong medical care for anyone infected with HIV, as well as their family, he stressed.

Cameroon is popular with scientists as a testing ground for anti-AIDS drugs because every known sub-type of the HIV virus is found in the country.

However, not all clinical trials conducted there have been approved by the local health authorities. According to REDS, about 50 clinical trials on potential new HIV/AIDS drugs are carried out illegally in Cameroon each year.

Theme (s): Care/Treatment - PlusNews,

[This report does not necessarily reflect the views of the United Nations]

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