02 March 2010-(Global Campaign for Microbicides of support for MDP301 Trial Global Camapign for Microbicides)- The recent attention to microbicides clinical testing in Zambia prompted us to confirm our commitment to the HIV-prevention research and development field and to encourage others to join us in supporting next-generation products in the pipeline.

Since 1998 the Global Campaign for Microbicides has worked with advocates, researchers, donors, policymakers, and others to advance efforts to help the world's most vulnerable people protect themselves from HIV infection.  We aim to mobilize and sustain political support for HIV-prevention technologies, promote civil society involvement in the field, and enable clinical trials, which are essential to bringing effective products to the people who need them.

While there was much hope around the early generations of microbicide candidates, we shared your disappointment and frustration when none proved effective in large-scale testing.  But, as the pandemic continues to affect the people with the fewest resources, we must continue efforts to advance HIV-prevention options and make them accessible to those who most need them.  We must persevere.  It is essential that the progress made and lessons learned compel this field forward until prevention methods are in the hands of those who want them.

The announcement of the finding that PRO 2000 is safe but not effective was a disappointment to all of us in the HIV-prevention field.  But that is just one of a number of trials taking place, and we now strengthen our focus on those other activities.  For example, in Zambia alone there is ongoing efficacy, safety and behavioural research related to orally- and topically-delivered HIV-prevention products.  We must work to advance those efforts. 

Research and development essential in addressing the pandemic

Most of the products being developed and tested contain anti-retrovirals, and many scientists believe they will offer a more potent prevention method than the earlier generation of microbicide candidates.  GCM supports the development of both ARV-based and non-ARV-based formulations-and a range of delivery vehicles-as there is no one product that will meet the needs of everyone.

While it seems obvious to us, others may need to be reminded of the importance of research and clinical trials in making needed products available.  Medical breakthroughs and life-saving products come to us through a rigorous testing process that starts in the laboratories then, if promising, moves to clinical trials.  Those studies are carefully designed and approved by regulatory authorities to protect volunteers' health.  Scientists are hopeful that products that appeared to be effective in laboratories and in small trials with people will be effective in larger trials.  But the reality is that many more products are found to not work as compared to those that are effective and make it into people's homes.  What the field of microbicides has been experiencing is not unusual...it's simply part of the trials and tribulations of developing and bringing a product to market.

In this case, though, people's lives are at stake, and there is a particular urgency.

Efforts to reduce the misunderstanding

The December announcement about the MDP 301 trial of microbicide candidate PRO 2000 resulted in a great deal of attention and some speculation. While much of the media coverage was responsible and accurate, some misinterpretation of the results took place, especially in Zambia. We want to assure you that GCM is working with colleagues in Zambia and other countries to address misconceptions about the MDP 301 trial and about clinical research for HIV prevention.

We also want to offer you our support as you work to build a better understanding of the research process and to advocate for continuing research on the next generation of HIV-prevention technologies.

How is GCM addressing the confusion in Zambia?

* GCM participated in a Zambian Ministry of Health meeting to discuss the issues and the way forward with a range of stakeholders in Zambia.
* We continue to reach out to many concerned colleagues through our network of local and international advocates, trialists, product developers, journalists, government policymakers, and others, to offer assistance to their education and advocacy efforts.

* We have engaged researchers to help clarify information about HIV prevention research and to answer people's questions about the trial and the product.
* GCM has offered to speak to the press on behalf of the advocacy and development communities.
* We continue regular monitoring of the media and blogsphere so that we can help respond to erroneous information.
* GCM has developed materials to explain the microbicides field and the MDP 301 trial, which are available on our website at www.global-campaign.org/download.htm.
* Simple fact sheets describing clinical testing are available at www.global-campaign.org/clientfiles/FS-R&D[E].doc.

What can you do?
* Continue your efforts to keep HIV-prevention on the agenda and to educate people about the need for new products to slow the spread of the disease.
* Contact GCM to show your support and share news about what you are doing and how you are making a difference.
* Visit the GCM at www.global-campaign.org and feel free to ask for help as you are developing communications about HIV-prevention research.

Many of the women who participated in the MDP 301 trial said they did so because they had lost loved ones to AIDS and wanted to help prevent the spread of HIV. For their sake, and for millions of others, we must work together to continue-and redouble-our efforts to advance HIV-prevention options.

For more information on the MDP301 trial results, please visit http://www.global-campaign.org/MDP301.htm.

Thank you,

Global Campaign for Microbicides  

---------
Stay Connected - Speak your world!

A posting from AF-AIDS (af-aids@eforums.healthdev.org)