Press Release

AIDS Vaccine Advocacy Coalition Issues Report on Tenofovir Prevention Trials: Calls for coordinated response to ensure trials continue

 NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today released a report on issues surrounding clinical testing of the antiretroviral drug tenofovir as pre-exposure prophylaxis (PREP) – a possible once-a-day pill for prevention of HIV.

Legitimate ethical concerns raised by some advocates have led to cancellations and delays in some of the PREP trials. The AVAC report, “Will a Pill a Day Prevent HIV? Anticipating the Results of the Tenofovir “PREP” Trials,” examines the issues surrounding the tenofovir trials and makes recommendations for ensuring that trials are carried out ethically and that provisions are made for dealing with the results of the trials when they are available. The report also calls for more concerted coordination and advance planning to accelerate evaluation, licensing and access to PREP.

“The concerns raised about the trials are serious, and there is a need for thorough and unbiased investigation,” said Mitchell Warren, AVAC Executive Director. “But all of the concerns raised are solvable. AVAC calls on researchers, communities and advocates to work together to ensure that ethical concerns are addressed, solutions are found, and the trials go forward.”

The AVAC report calls for a coordinated effort from the World Health Organization, UNAIDS, the trial sponsors and other organizations to ensure that research and trials are coordinated and progress in an accelerated fashion, and that additional research is carried out in an expedited fashion, to ensure that we will know as soon as possible if tenofovir is a safe and effective biomedical prevention intervention.

Warren added, “We need as many HIV prevention tools as possible, so research on vaccines, microbicides and other potential interventions must also be accelerated whether or not tenofovir proves appropriate for PREP.” “AVAC remains committed to our mission of accelerating development of an AIDS vaccine, but we are also committed to working in partnership with other advocates and researchers to advance ethical prevention research and ensure that the benefits are shared globally.”

The report is available online at www.avac.org and in print on request from [email protected].

About AVAC
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of vaccines against HIV/AIDS.

This special report and AVAC’s continuous policy analysis, advocacy, education and outreach work are made possible by the dedicated labor of AVAC advocates and support from the Bill & Melinda Gates Foundation, Broadway Cares/Equity Fights AIDS, the Ford Foundation, the International AIDS Vaccine Initiative, the Overbrook Foundation, Until There’s a Cure Foundation, the WHO-UNAIDS HIV Vaccine Initiative, and many generous individuals who have become AVAC Members. AVAC is an IRS-certified 501(c)3 tax exempt organization, and donations are tax deductible.

Press Release

A public statement from the Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition on the impact of stopping Tenofovir trials in Cambodia and Cameroon

Recently clinical trials have been launched in Africa, Asia and the United States to explore the potential use of oral Tenofovir as a “once a day” pill to prevent HIV in uninfected individuals – an intervention known as pre-exposure prophylaxis (PREP). Yet concerns from a few activists opposed to these efforts have resulted in government decisions to halt the trials in Cambodia and Cameroon.

The decisions to halt the trials have generated a firestorm of controversy in the HIV/AIDS treatment, prevention, advocacy, and research communities. In both countries, the public allegations criticizing the trials were not completely evidence-based, and the media’s coverage was highly provocative. As a result, government decisions to stop the trials may have been premature.

Left unchecked, these forces threaten to undermine future trials. The cost is paid in people’s lives – the lives of those who might benefit from new technologies or treatments. This is not to say that unethical research should proceed. But derailing trials without high levels of evidence to support the claim that they are unethical, is a costly practice.

The Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition (AVAC) are international networks of advocates who have worked to forge meaningful collaborations between researchers, communities and activists. Both organizations are committed to ensuring that as science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. Good prevention research must be accelerated, must be ethical, must involve communities and must result in products accessible and acceptable to the people who need them most.
We are convinced that the concerns raised by those who oppose the trials are solvable and need not have resulted in stopping trials. Issues can and should be addressed by researchers and sponsors working collaboratively with local communities and governments. Controversy over the ethics of research is an opportunity to engage communities in partnership. As Gregg Gonsalves of Gay Men’s Health Crisis recently noted, shutting down an HIV prevention study “is not a victory – it is a defeat. A victory would have been to be able to craft a solution to fix the local study.”

In this spirit, the Global Campaign and AVAC are planning to generate various materials that accurately reflect current events, assist all stakeholders with working though these issues and provide specific recommendations to accelerate ethical development of new technologies. Among the materials we will produce are:
�    A fact-sheet designed to correct some of the common misperceptions and errors of fact that have been made in the course of public discussion of these trials. This fact sheet will be available on our websites (http://www.global-campaign.org/ and http://www.avac.org/) in the next few weeks.
�    A background document that attempts to articulate the basics about Tenofovir, the current PREP studies and the various issues involved will be available in early March.
�    Two on-the-ground case studies to document what actually happened in Cambodia and Cameroon from each sector’s perspective, to identify lessons learned that could help prevent similar situations in the future. This project is already underway, and we hope to have these materials available in the coming three months.

The following key principles are pivotal:
1.    The HIV pandemic creates an incredibly urgent demand for additional safe and effective tools with which to treat HIV infection and stop transmission. This can only be achieved by responsible, credible scientific studies.
2.    Research to create these tools must be done in a way that protects the rights of vulnerable populations and contributes to overcoming the global imbalance in access to health care resources.
3.    Communities affected by research must be actively involved in its conceptualization and implementation.
4.    The rights of trial participants should be respected and participants should be admired for their contribution to helping others.
5.    Researchers and funding agencies must be held accountable for their studies, and advocates must demand that problems be resolved.
6.    AVAC and the Global Campaign are dedicated to developing effective collaborations among a broad range of civil society actors, researchers and sponsors.
We cannot combat AIDS effectively without research and development of new technologies. Without clinical trials, we cannot know what does and does not work – or how different drugs and interventions work in various populations and settings. This means wrestling, collectively and collaboratively, with the complexities of designing trials that are simultaneously ethical and scientifically rigorous. Simply objecting to existing trial designs and shutting down trials is not a solution. We must, instead, proceed with the much harder job of shaping a research standard we can support and then demanding that trials be designed and adequately funded to meet that standard.

For more information:
�    AIDS Vaccine Advocacy Coalition (AVAC): Mitchell Warren, Executive Director, [email protected], +1 (212) 367-1084, http://www.avac.org/

�    Global Campaign for Microbicides: Lori Heise, Executive Director, [email protected], +1 (202) 822-0033, http://www.global-campaign.org/

2003 AVAC Report: 4 Years and Counting: How do you Fight a Disease of Mass Destruction?

When America became frightened by the bio-terror threat, Congress and the Administration moved swiftly to put funding and incentives in place. That same kind of decisive action is needed to accelerate research and ensure an AIDS vaccine is available to all who need it. This Report looks at the bioterror model, and provides the results of our new industry survey.

2002 AVAC Report: 5 Years and Counting: Science, Urgency and Courage

Five years away from the date former President Bill Clinton set as a goal for finding an AIDS vaccine, there are more candidate vaccine products in development than ever before. No one knows if any of the current experimental vaccines will work. No one even knows what immune response a vaccine needs to elicit to prevent HIV disease. The only way to obtain answers is to ask tens of thousands of altruistic and courageous participants to participate in dozens of trials. The only way to obtain answers is to invest hundreds of millions of dollars to fund these trials.

2001 AVAC Report: 6 Years and Counting: Can a Shifting Landscape Accelerate an AIDS Vaccine?

In 1996, AVAC was the first organization to demand that development of an AIDS vaccine become a national goal. President Clinton set that goal in May 1997, calling for a successful vaccine by 2007. We are now six years away from the goal and counting. None of the challenges are insurmountable. The optimism that characterizes HIV vaccine research today should drive policy makers and researchers to grapple effectively with the issues that remain. An HIV vaccine is possible. The question is how soon we find it, and who gets it when we do.

2000 AVAC Report: 7 Years and Counting: How Can We Overcome Obstacles to an AIDS Vaccine?

The last year was one of great activity across US agencies and throughout the world. This Report documents the steadily increasing activity in the quest for a vaccine against HIV. We have also identified several actions necessary to accelerate development of HIV vaccines, and we outline all of this in the AVAC Report for 2000.

1999 AVAC Report: 8 Years and Counting: What Will Speed the Development of an AIDS Vaccine?

This Report urges government, industry, and community to dedicate themselves to the development of a safe and effective HIV vaccine. If the goal for 2007 cannot be achieved, then we need to know what will be accomplished over the next eight years toward a vaccine that could bring the HIV pandemic under control. With 16,000 new HIV infections each day, the world can afford no delay. This Report describes what each of these sectors has accomplished during the past year and outlines what each can do to speed the search for a preventive vaccine.

1998 AVAC Report: 9 Years and Counting: Will We Have an HIV Vaccine by 2007?

This report surveys the public- and private-sector efforts on HIV vaccine research and development in the past year, with a focus on the US government agencies and pharmaceutical companies that are most likely to make a difference. It finds that, despite an impressive array of dedicated researchers and increasing funding for HIV vaccines, the world will fall short of President Clinton’s deadline. US government research efforts are not focused on results, leaders err on the side of caution rather than on moving forward, responsibility is diffuse, and the nation has stood silent as pharmaceutical companies, including the world’s largest vaccine producer, make little or no investment in one of the greatest public health challenges of our century. AVAC addresses these obstacles and recommends an agenda for action in this report.