Bangkok AIDS Conference
The protesters, led by the AIDS activist group ACT UP, accused the
researchers of purposely providing insufficient prevention education to
Tue, Aug. 03, 2004
Cambodia Prime Minister Opposes Testing Anti-HIV Drug
by KER MUNTHIT, Associated Press
PHNOM PENH, Cambodia - Prime Minister Hun Sen said Tuesday he opposes the testing of drugs on Cambodians, a position that could derail a planned trial for an anti-AIDS medicine here.
His remarks seemed directed at a test, partially funded by the Bill and Melinda Gates Foundation, of the drug Tenofovir DF by the California-based biotech company Gilead Sciences Inc.
"Please, don't use Cambodians for (any drug) trial," Hun Sen said at a groundbreaking ceremony for a hospital, noting that his country had been selected to test AIDS medication. "If a trial is needed, please do it on animals, and don't use Cambodians."
Hun Sen did not single out any project, but his remarks come amid a controversy on the ethics of testing Tenofovir, called Viread DF by Gilead Sciences Inc., in Cambodia.
The study, which seeks to recruit almost 1,000 sex workers, is being conducted by researchers from the University of California San Francisco with funding from the U.S. National Institutes of Health, and the University of New South Wales.
Half those volunteers in the Cambodia experiment will be given Viread, and the others will take a placebo. A year later, researchers will compare the two groups to determine if significantly fewer volunteers taking Viread were infected with HIV than those receiving the dummy pill.
Members of a local sex workers' rights group, Women Network for Unity, said in March they would refuse to participate, citing a lack of insurance against potential side effects.
Activists at last month's International AIDS conference in Bangkok also protested the test, saying the prospective participants were being exploited.
The protesters, led by the AIDS activist group Act Up, accused the researchers of purposely providing insufficient prevention education to the volunteers because it needs infection data to analyze Viread's potential to protect against the virus.
The protesters also demanded that the company take care of the lifetime medical needs of any volunteers who contract AIDS during the experiment - partially funded by the Bill and Melinda Gates Foundation.
The study was approved by the ethics council of Cambodia's Health Ministry last year, but has not yet formally started, said Khol Vohith, a research officer at Cambodia's National Center for HIV/AIDS, Dermatology and Sexually Transmitted Diseases.
Saphonn Vonthanak, a chief of the center's research unit, said he heard about Hun Sen's remarks but was unable to comment on them or say if the Cambodian leader was referring to the Viread study. He said the center would seek clarification.
Cambodia's current HIV infection rate is 2.6 percent among people of 15-49 age group, the highest in Southeast Asia.
Women Network for Unity welcomed Hun Sen's remarks, saying he was "defending the interests of the Cambodian people."
"I'm very glad with what the prime minister has said. I wish for the study to fail, and I will get our girls together to celebrate when it actually fails," said Sou Sotheavy, one of the group's leaders.
Faced with an epidemic that is continually growing, the importance and urgency of effective, global and diversified prevention is one of the fundamental issues involved, on the same level as treatment access for all.
a nucleotide in prévention
from ACT UP/Paris
In this context of prevention, where only the condom has proved its efficacy, it is essential, given the lack of short-term prospects for the discovery of a preventive vaccine and a relaxing of preventive practices, to develop research on effective products that are also well tolerated, easy to use and inexpensive. In this area, there are several leads and trials have already been initiated... Microbicides raised great hopes but their results remain inadequate, to the point that their use, especially in countries of the South raises serious ethical questions. As for vaccines, their production remains problematic and complex.
Since the end of the 1990s, laboratories have had anti-HIV molecules. Animal trials show that they could prevent transmission of the virus and encourage researchers to set up human trials.
placebo versus tenofovir a trial to make you sick
This is the case of Gilead Sciences Inc. with its nucleotide analog tenofovir DF, for which in vitro and animal trial results are promising. An in vivo trial is being prepared and is planned to include 1200 seronegative prostitutes in three countries (Cameroon, Nigeria and Ghana). Half of the subjects will receive tenofovir (one pill a day), and the other half will be given a placebo with the same appearance as tenofovir but lacking the active substance. At the end of the 12- month trial period, a comparison will be made of the number of prostitutes having become seropositive in each of the two groups, in order to determine whether tenofovir is effective in preventing HIV infection. Based on the preliminary results of in vivo animal trials, there is already a parallel market in the United States for tenofovir used in prevention.
The Bill and Belinda Gates (BBG) Foundation offered a grant of 6.5 million dollars to Family Health International (FHI) to launch this clinical research project. For its part, Gilead will supply the product and placebo free of charge. A preventive trial of the same type obtained a subsidy of 3.5 million dollars from the Center for Disease Control (CDC) to test tenofovir in the gay communities of San Francisco and Atlanta.
the end justifies the means?
The trial conducted by FHI in Cameroon, Nigeria and Ghana, financed by BBG with the logistic support of Gilead does not seem to us to provide a satisfactory response to all our questions. Provision for psychosocial support and the means implemented to promote condom use are clearly insufficient, even ridiculous: only 5 counselors and one doctor for 400 prostitutes, no access to the female condom, despite it being much easier for the prostitutes to use in negotiating with their clients. However, scientifically speaking, cases of contamination are needed for the trial results to be interesting.
If all precautions were taken with regard to prevention and supervision, it is certain that the trial would have to recruit a much larger study population so that a difference in contamination rates between the placebo and tenofovir groups would be statistically significant. From the viewpoint of this same concern for peoples safety, the human benefit/ scientific benefit conflict is extreme: is it not possible to test this product on a less vulnerable population than prostitutes who suffer the combined disadvantages of living in a country where access to healthcare and treatment is limited, even non-existent, and practicing a risky profession, all of which is compounded by the poverty of Cameroon and the other countries involved in the trial?
The heart of the dossier is not so much an ethical/scientific conflict, as an n ethical/economic duel. In this sense also, if recruitment for the trial did not target a population already forced to take risks, it would be necessary to considerably increase the number of participants and consequently the cost of the trial... By holding this trial in Africa, Gilead and the BBG Foundation know that they will find a population that is vulnerable both materially and in terms of practices, women willing to let them carry out a trial at minimal cost. It is then, really a question of money and therefore, of the value of life. For Gilead and the BBG Foundation, the life of an African has less value than that of a Westerner.
when hypocrisy rhyme with economy
The tenofovir DF trial expects to provide follow-up and access to treatment for sexually transmitted diseases (STD). This plan may appear generous. In fact, it is nothing more than a means of building the prostitutes loyalty and minimizing the risks of their dropping out. Moreover, it so happens that follow-up tests are required for the scientific validation of the trial. Setting the amount allowed for expenses at 2,750 Fcfa shows an extraordinary level of cynicism. In fact, a rapid calculation shows us that this amount was figured to cover transportation expenses on the one hand (500 F for the taxi) and the prostitutes lost income on the other hand (2,150 F for two tricks, minimal fee in Douala).
What will happen to prostitutes who are found to HIV-positive during pre-enrolment testing? We dont know, but we can imagine. In Cameroon, the promoter plans to refer women who become HIV-positive during the trial to the system of access to care and treatments set up in this country by NGOs and the government. While it is true that in Cameroon, treatment access is less difficult than in other African countries, it remains uncertain. It is estimated that one million people are infected with HIV, i.e. a prevalence of 15% (according to all of our interlocutors, this figure is an underestimate), and that 40,000 people are in urgent need of antiretrovirals (currently only 10, 000 are under treatment). It is therefore particularly shameful that Gilead; which is donating the tenofovir and placebo for the trial has not also arranged to provide free antiretrovirals to participants who need them.
the cost of rumour
If, because of the unethical nature of this trial, a lead for finding a molecule capable of preventing HIV transmission is abandoned, Gilead and the BBG Foundation will be responsible for having destroyed this chance. If the information diffused when the trial is launched is not more transparent, the implications for prevention are likely to become apparent in the form of other victims. Notably those who will become contaminated while taking tenofovir as a preventive agent on the basis of rumors. For all these reasons; we ask that the trial stop immediately, that the people already selected and found to be seropositive or who have become so since June 15 (start date of the trial in Cameroon) be offered comprehensive health care with medical follow-up, treatments for opportunistic infections and antiretrovirals if necessary. In the future; the design of this type of trial must be discussed with the patient associations in the host country. We hold Gilead and the BBG Foundation responsible for the lives of the women included in the trial.
BANGKOK BLOG -- Disruption defines global AIDS meet
Bar girls educate delegates about their profession.
AlertNet Deputy Editor Tim Large is at the 15th International AIDS conference in Bangkok. Here are tidbits from his notebook on the second working day of the worlds biggest AIDS powwow.
Tuesday, July 13, 2004 AlertNet from Reuters (excerpt)
Attendees at an academic symposium on the science of new antiretroviral therapies are astonished to see prostitutes from around the world suddenly clamber onto the stage, waving Gilead prefers us HIV+ placards and chanting Stop the trial now! Stop the trial now!
The disruption is the work of the Asian Pacific Network of Sex Workers (APNSW) and activists from a group called Act Up. Theyre angry at drug maker Gilead, a sponsor of the symposium, for trials of a new preventative AIDS drug known as Tenofovil.
Turns out the company is conducting in vivo trials on sex workers in Cameroon, Ghana, Nigeria and Cambodia. All the prostitutes start off HIV-negative. Half get the drug and half get a placebo. By comparing the two groups at the end of the trial, you can see how effective the drug is as a prophylactic.
According to the APNSW and Act Up, the prostitutes are paid just $3 for each monthly visit they make as part of the trials. The protesters say the women get little effective education in the proper use of condoms and less encouragement to actually use them. Those who do become HIV-positive are then pretty much on their own.
They have gone to a high-risk, disempowered, disenfranchised, poor group of women to do a trial of their drug without any sensitivity to their needs or how to work with people with AIDS, says Act Up spokesman Mark Milano. Were saying they should stop this trial, rethink it, and open it again in a more ethical fashion.
Prostitutes protest AIDS-drug test
Bay Area company hit with charges of exploitation
Sabin Russell, San Francisco Chronicle Medical Writer
Wednesday, July 14, 2004
Bangkok -- On the podium in the Grand Ballroom at the 15th International AIDS Conference, Johns Hopkins University infectious-disease researcher Dr. Joel Gallant suddenly found himself surrounded Tuesday by angry, chanting Cambodian prostitutes.
Gallant was presiding over a seminar on antiviral drugs, and the protesters were demanding a halt to a planned trial designed to determine whether a proven AIDS drug might have a second use -- blocking infection with HIV as effectively as a vaccine.
About 30 protesters, who took over the stage for 15 minutes, held signs declaring the maker of the drug, Gilead Sciences of Foster City, "uses sex workers for free."
For Gilead, a little-known company, the disruption was another sign that it had hit the big time in the politically charged world of AIDS medicine, an inevitable outcome of its enormous success in bringing to market one of the safest and most effective antiviral drugs for patients with HIV.
"The fact that part of our pharmaceutical company makes a living in HIV -- that alone draws attention. As these things go, you can't win," said Norbert Bishofberger, Gilead's executive vice president for research and development.
The protesters, led by ACT UP Paris, were demanding that Gilead, sponsor of the disrupted seminar, provide lifetime health care for any participant in the study who became HIV-positive -- a price they felt the company should pay for allegedly endangering the lives of the young women who enrolled in the experiment.
Dr. James Rooney, the company's vice president for clinical affairs, said the study, which will involve the use of a placebo, was designed to comply with strict ethical guidelines. A community advisory board, he noted, calls the experiment "the hope of women.''
At a conference that is virtually guaranteed to be short on major scientific breakthroughs, Gilead's drug tenofovir, or Viread, is grabbing the spotlight. In the two years since it came on the market, it has reshaped the prescribing patterns of AIDS doctors -- and has added a new wrinkle in the debate over bringing low-cost drugs to the developing world.
"For us, tenofovir is an incredibly important drug,'' said Rachel Cohen of the French medical organization Doctors Without Borders. Because of its safety and relatively low cost, it is a prime candidate to serve as a second line of defense for patients in poor countries who fail to respond to less expensive "first line" therapies.
Although Gilead has offered to sell tenofovir for its stated cost of 80 cents a pill to 68 poor countries, Cohen said the price is not nearly low enough to ease the problem of treating millions of AIDS patients. Doctors Without Borders would like to see prices closer to 30 cents a day.
Cohen expressed skepticism that Gilead could make good on its offer. He noted that the company hasn't obtained government approval to market the drug in many of the poorest countries. "If it is not registered, then the offer of 80 cents is a virtual one,'' she said.
It was an entirely different issue, however, that brought out the protesters from ACT UP. Scientists have been eager to test tenofovir as a potential chemical shield against HIV after studies showed it worked 100 percent of the time on monkeys. Those tests used an intravenous form of the drug, however, and protected the animals against the simian immunodeficieny virus, a cousin of the AIDS virus that can kill macaques.
According to Rooney, 900 HIV-negative "beer girls,'' who work the bars in Phnom Penh, are being recruited for a study in which some will be given tenofovir and others, a placebo. After a year, the women will be tested to see whether there are fewer HIV cases among those who got the drug.
The study is in fact being conducted not by Gilead but by researchers at UCSF, funded by the federal Centers for Disease Control and Prevention. The CDC is sponsoring similar tests in Atlanta, and the Bill and Melinda Gates Foundation is underwriting pre-exposure prophylaxis trials in Africa. Gilead's role is to provide the drugs for free.
All the women will be counseled to use condoms and will be supplied with them following rules used in vaccine trials.
But in the view of Tuesday's vocal critics, the study offers only cursory safer sex counseling. Protesters called the test unethical and demanded that it be halted. The Cambodian prostitutes contend that the study won't work unless some of them become infected, leaving them pawns in a corporate drug development scheme. "Gilead Prefers Us HIV +" read one sex worker's placard.
The bottom line for protesters, however, was a bid to require Gilead to provide health care to any study participants who become ill.
Although Gilead itself is a relatively young company and new to the world of angry AIDS protests, it has a powerful board of directors familiar with corporate power and controversy. Among its members: former Secretary of State George Shultz, former Intel chairman Gordon Moore and Stanford Nobel laureate Dr. Paul Berg. And chairing Gilead's board, from 1997 until 2001, was none other than current secretary of defense, Donald Rumsfeld.
Tenofovir, a variant of AIDS drugs that block a key enzyme in HIV called reverse transcriptase, was acquired by Gilead from a Czech chemist, Antonin Holy, and cobbled into a once-a-day pill approved for marketing by the Food and Drug Administration in October 2001 -- an event vastly overshadowed by the terrorist attacks only weeks before.
Just before the opening of this year's AIDS conference, the Journal of the American Medical Association published results of a three-year study comparing tenofovir to stavudine, or D4T, one of the most widely prescribed AIDS drugs. The study was led by Johns Hopkins' Gallant and showed that the Gilead drug was just as effective as D4T but caused only a fraction of the side effects, such as the disfiguring shifting of fat from the face and limbs to the belly.
Doctors have already been aware of the relative safety of tenofovir, and it has quietly become the most widely prescribed AIDS drug in the United States, according to NDC, a market tracking firm. Gilead's sales of Viread during the first quarter ended in March were $193 million.
Viread is not Gilead's only AIDS drug. A companion medication called emtricitabine, or Emtriva, also has been approved for marketing, and Gilead is in exploratory talks with Bristol-Myers Squibb to develop a single pill that would combine three AIDS drugs into a single, once-a-day pill.
That could once again alter the dynamics of drug sales to the developing world, as it would offer a more expensive, but arguably safer, "fixed dose combination" pill than that being made for Third World patients for as low as 40 cents a day.
Such a pill, from a politically well-connected company such as Gilead, might also find favor with the President's Emergency Program for AIDS Relief, the Bush administration's $15 billion overseas AIDS initiative, which has not, to date, accepted any generic medicines.
Gilead Excludes Latin America and the Caribbean from Price Reductions for Viread
By Eugene Schiff*
Gilead seems to be very strongly promoting their Viread (tenofavir) treatment, and advertising their commitment to "increasing access to this once daily HIV medicine for people living with HIV in developing countries though the Gilead Access Program." The program is available to 68 countries world wide. However, the company has completely left out any price reductions for Latin American and Caribbean nations.
A leaflet and the website:
mention that "because of its ease of use, Viread may be a particularly suitable option in resource limited settings," adding that "...Viread has been shown to suppress resistance to commonly prescribed anti-HIV drugs." Viread is taken as a single tablet once a day.
The program claims to provide
-Sale of the drug at no profit in 68 developing countries,
-Simplified direct purchasing, without intermediary suppliers
-Information and guidance about access to Viread
-Clinical Research to improve HIV treatment strategies in developing countries
However, besides Haiti, NO country in Latin American or the Caribbean country is listed as eligible for this program (only Argentina is mentioned separately as a country where Viread is marketed). All of Africa, selected countries from Southeast Asia and the Pacific Islands (Vauatu, Tuvalu, Kiribati, Solomon Islands and others) are listed as eligible.
It seems noteworthy and puzzing that Gilead skips over this entire region, which might warrant a timely and coherent public response/statement by UNAIDS or PAHO, as PLWHA, physicians, National AIDS Program Directors, activists and others who attended the recent International AIDS Conference in Bangkok were inundated with marketing, press releases, and presentations of scientific studies promoting the use of tenofavir and will likely be returning with this information to their respective countries in the region. Gilead also placed its name and logo prominently across the hundreds of buses transporting delegates from the conference site to their hotels in Bangkok.
The price for Viread through the Access Program is $39 per month, roughly 10 percent of the U.S. wholesale price of $360 per month, according to Bob Huff of Gay Men's Health Crisis in New York. But Latin American and Caribbean nations must still pay the $360 per month price (or more after distribution and shipping costs), an unaffordable price in most countries in the region.
As scaling up treatment occurs throughout the region, it seems essential to avoid further confusion regarding the introduction, need or appropriateness (or not) of these second line and newer drugs options in Latin America and the Caribbean. Unfortunately, another major problem seems to be that testing for drug resistance remains very difficult in most of the region. Even so, one can easily foresee concerns about a black market developing and desperately impoverished patients reselling their medicines to others where high price differentials exist say, between Haiti and the Dominican Republic, or even Haiti and Miami. It therefore seems even more essential now that UNAIDS plays a leading role in responding to gaps in the "Gilead Access Program" and in establishing better guidelines and standards for pricing and distributing drug and diagnostics, generic and original, in order to ensure access to high quality health care and treatment for people living with AIDS in the Latin America and the Caribbean.
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