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HIV Vaccine Testers Recruit Vancouver Women

Ethical concerns raised by DES advocates.

Danielle Egan 8 Dec 2005TheTyee.ca

Danielle Egan is contributing editor on The Tyee.

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Dozens of HIV preventative vaccine trials are in the works around the globe. That sounds promising. But clinical trials conducted for almost 20 years have failed to find an effective vaccine, while succeeding in raising some serious ethical controversies.

Now, women in Vancouver's Downtown Eastside are being asked to participate in HIV vaccine trials by Merck/Frosst, a pharmaceutical giant.

And some women's advocates are taking a cautionary stance against such trials, even if doing so costs them money and other resources.

Rumours that the pharmacorp has been offering financial and resource incentives to some centres had recently been circulating among women's groups in Vancouver. These rumours were confirmed during a forum on the topic of AIDS prevention vaccines at Sunday's Montreal Massacre Memorial sponsored by Vancouver Rape Relief and Women's Shelter.

Representatives of both the Downtown Eastside Women's Shelter and Women's Information and Safe House (WISH) said that they had been approached by representatives of Merck/Frosst along with Dr. Mark Tyndall, program director of Epidemiology for BC Centre for Excellence in HIV/AIDS, a UBC, St. Paul's Hospital affiliated group which receives funding from Merck.

"We were asked to be involved in trials already underway in other places," said Cynthia Low of the Downtown Eastside Women's Centre. "They said that they were open to negotiating funding with women's shelters and said, 'We can help you get what you need.' I asked Mark [Tyndall] 'Would you let your daughter take this vaccine?' He said, 'Well, she's not high-risk.' We quickly decided this is not an area we're interested in and suspended discussions."

A spokesperson for the Canadian HIV Trials Network and the BC Centre for Excellence in HIV/AIDS confirmed that recruiting is going on.

Concerns and consent

Kate Gibson of WISH, a safe house for sex workers, said she also met with Tyndall and Merck representatives. A few individual women sex workers also attended the meeting.

"I said there had to be other supports in place before we do anything like this, since our clients aren't in a position to give informed consent," says Gibson, noting that most of her clients lack decent housing, a stable income or safe working conditions.

"The sex workers didn't necessarily agree and said they could make informed consent," said Gibson who is particularly worried that sex workers being offered financial support will themselves recruit other sex workers.

"This is a very dangerous situation," said Lee Lakeman of Vancouver Rape Relief and Women's Shelter. "We're being starved out of core services so we're all vulnerable to this type of recruitment, but it's particularly worrying if individual women are being offered deals."

Among the advocates' concerns:

Some HIV vaccine trials have found that sexual risk-taking increases among participants, some of whom may be taking a placebo that offers no protection.

Experimental vaccines that don't work as intended could backfire by suppressing the body's immune system, causing increased risk of contracting AIDS during the subject's lifespan, as well as potentially accelerating the virus's course and causing earlier death.

There is also the fear that the virus used in the vaccine to rally the immune system against HIV could instead prove too powerful or even mutate, causing the subject to become seriously ill.

At the Montreal Massacre Memorial session, Caryn Duncan of Vancouver Women's Health Collective voiced concern about "the destructive role the pharmaceutical industry already plays in women's health issues."

Many attendees were concerned their already marginalized clients, particularly sex workers, injection drug users and First Nations women in the Downtown Eastside, could be exploited and "guinea-pigged" with these trials.

'Human volunteers'

AIDS prevention vaccine trials have been officially in the works since 1987, enrolling more than 10,000 "human volunteers" in about 60 clinical trials involving 30 different vaccines according to the Canadian HIV/AIDS Legal Network.

With the goal of targeting people at a high-risk for contracting HIV, the studies have largely focused on men who have sex with men.

But today, about half of HIV cases in developing countries are women. In Canada, one in four HIV cases are women, a steep rise over the past decade. Aboriginal women in Canada are contracting HIV at double the rate of aboriginal men. In BC, the rate of men newly infected with the virus has been holding relatively unchanged while growing fast among women. There was a 47 percent rate increase in girls age 15 to 19, for example, between 2003 and 2004. A quarter of all sex workers in the Downtown Eastside are HIV positive.

Women are at a greater risk of contracting HIV since there are higher levels of the virus in semen than in vaginal fluids and women's genitals are more fragile to tearing and thus infection. Women with AIDS also have a lower survival rate than men, though scientists are unsure whether that's due to biology or socio-economic factors such as poverty, domestic abuse and sexual assault.

Vaccine 'five years' away

With over 40 million people in the world currently infected with HIV and five million new cases in 2005, finding effective ways to curb this epidemic and help those with HIV and AIDS live longer, healthier lives is an urgent mission.

This year, the Canadian government poured $15 million into researching an AIDS vaccine. Many of the government medical research groups, big pharmacorps and non-profits who are involved are now looking to recruit more women into their studies, as well as children of HIV-positive mothers.

A variety of different vaccines are currently in the works, designed to kickoff an immunity response if a person is infected with HIV. Most of the vaccines are made with either "naked DNA" HIV genes or HIV DNA combined with "delivery" viruses like the common cold to induce t-cell immune responses in the body.

Rafick-Pierre Sékaly, the Scientific Director of CANVAC, a vaccine research group, recently stated that there's a good chance an AIDS vaccine will be ready within five years.

If so, it will mean overcoming setbacks and controversies beleaguering prevention vaccine trials to date.

Proving 'efficacy'

One concern of critics so far: It's not uncommon for participants to test positive for the virus during clinical trials, even though they don't actually have HIV.

Another: Some virologists have warned that experimental HIV vaccines so far have not only proven ineffective, but may alter the immune system in harmful ways difficult to predict and track later in the subjects' lives.

Scientists have also expressed concern that DNA-based vaccines can also cause "recombination hotspots" that might generate new pathogens in the body or allow genes associated with cancer, herpes and tuberculosis to alter human chromosomes, triggering disease.

The biggest hurdle for AIDS prevention vaccines is proving efficacy, which is done during Phase III trials. Phase I and II trials recruit smaller groups to look at dosages and side effects. Phase III trials involve thousands of participants and attempt to gauge whether the drug works. But since there are different subtypes of the virus and it can mutate rapidly, efficacy rates are difficult to gauge. Proving efficacy also raises certain ethical paradoxes. Effectiveness can only be fully illustrated if vaccinated individuals come in contact with HIV+ individuals and then either become HIV+ or not and these individuals would have to be monitored their entire lives.

'Disappointing'

The first-ever Phase III efficacy trials failed miserably, according to data released in 2003. The AIDSVAX vaccine trials made by US company VacGen involved over 5,400 volunteers. Most of them were "men who have sex with men" in Canada, the US, the Netherlands and Thailand, recruited from "communities at high risk for HIV infection." Over the course of three years, two thirds were given AIDSVAX and the rest got a placebo; all received risk counseling.

The Canadian study involved 291 men, 105 of whom lived in Vancouver. Their median age was 37, nine out of ten were caucasian and most had a college education. The researchers concluded that "our results clearly demonstrate elevated and worrisome rates of HIV infection" among study participants. Nineteen Canadian participants, including 10 from Vancouver, became HIV-positive during the study.

Three hundred women participants were included in the overall AIDSVAX global study. Those on the vaccine contracted HIV at virtually the same rate as those on the placebo.

The results were called "disappointing" by the AIDS Vaccine Advocacy Coalition (AVAC), a group sponsored by corporations and non-profits.

In a report called "Getting The Global House in Order," AVAC states that regardless of the dismal AIDSVAX outcomes, "these studies have demonstrated that large-scale efficacy trials can be done -- and should be done -- in developing, as well as industrialized countries." The report mentions current vaccine trials of approximately 16,000 Thai citizens "largely financed by the US government" and various pharmaceutical company DNA vaccine trials including ones developed by the US government's Vaccine Research Center.

The authors acknowledge that it's often difficult to recruit participants, particularly women and injection drug users.

The report also cites the "social risk" of clinical trails. "Will participation in a vaccine trial, for instance, stigmatize trial participants? For women in particular -- who have little power in many traditional cultures -- participation could mean ostracism from the family, loss of financial support and even physical abuse."

Regardless, the AVAC report urges accelerated vaccine testing, even on adolescents, particularly in sub-Saharan Africa, where approximately ten million of the areas thirty million HIV-positive citizens are between 15 and 24-years-old; two-thirds are female.

AVAC goes on to state that, "Although international guidelines call for the protection of children from abuse in medical research, the guidelines are equally insistent that children should not be excluded from research that could benefit them."

Primary needs

Critics point to the millions of government and drug company dollars flowing into such global vaccine trials and ask: Wouldn't access to primary human resources like water, food, safe shelter and basic health be of much greater benefit to future generations than vaccines that have yet to show benefit in adult populations? In the fight against AIDS, a particular challenge facing resource-poor countries is lack of access to everything from condoms to risk counseling to HIV drugs, as well as bans on developing cheaper generic drugs.

At Sunday's Montreal Massacre Memorial forum in Vancouver, women discussed the need in the city's poorest pockets for basic human necessities and effective social HIV prevention strategies. "Right now we're just dealing with keeping people alive in the cold weather," said Low of the Downtown Eastside Women's Centre.

The website of the Canadian branch of the global HIV Vaccine Trials Network shows no mention of an HIV vaccine trial in Vancouver. But it does list a Merck sponsored "safety and efficacy" trial with an "investigational vaccine" using a "HIV genetic insert" at the Maple Leaf Medical Clinic in Toronto.

The ongoing Merck trials are said to currently be recruiting approximately "1,500 male and female volunteers aged 18 to 45 of diverse racial groups who are at high risk for contracting HIV." The specific vaccine is called the "MRKAd5 HIV-1 gag/pol/nef, or trivalent, vaccine" which uses a "non-reproducing common cold virus to deliver three synthetically produced HIV genes into the cells."

Merk's Canadian media representative directed questions by The Tyee to their US public relations department which did not return a phone call.

Marianne Harris of the Canadian HIV Trials Network and the BC Centre for Excellence in HIV/AIDS confirmed to The Tyee that they are collaborating with Merck/Frosst on local recruiting for subjects for a vaccine study. "We're going through the ethical review process and informed consent at this point," she said via phone, adding the Vancouver trial "will specifically focus on women."

"Mark [Tyndall] has been setting up contacts, figuring out where clients will be seen. If there's no support from the community, there's no need to proceed," said Harris.

Vancouver writer Danielle Egan is a regular contributor to The Tyee.  [Tyee]

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