Lessons Learned from PrEP Trial Cancellations

Between August 2004 and February 2005, the HIV prevention world was rocked by the suspension and cancellation of two pre-exposure prophylaxis (PrEP) trials in Cambodia and Cameroon. To the considerable surprise of researchers, advocates and donors, these HIV prevention trials became embroiled in escalating controversies and sparked protests by activists speaking on behalf of the communities where trial participants were being recruited. The activists not only raised questions about how the research was being conducted, but also challenged the fundamental ethics and underlying motives of the research.

Just this week, my colleagues at the Global Campaign for Microbicides released two in-depth case studies relating the events that led to these trial cancellations and extracting the lessons they provide for current and future research:

• Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site by Elizabeth McGrory, Andrea Irvin and Lori Heise
• Preventing Prevention Trial Failures: A Case Study and Lessons for Future Trials from the 2004 Tenofovir Trial in Cambodia by Anna Forbes and Sanushka Muldaliar

Acknowledging that no single version of the events constitutes the “real story”, the case studies are built from extensive interviews with researchers, policymakers and other government officials, donors, NGO staff, and advocates to reconstruct often incompatible accounts of what eventually led to government intervention that halted the research. The case studies capture the political context and backdrop against which the controversies arose and the underlying and unaddressed conflicts that led to the costly collapse of two Phase 3 trials.

These reports are important and exciting reading for anyone interested in sound science, human rights, gender equality and communication across enormous cultural, social, and economic disparities. The HIV prevention field has made substantial progress since 2005 in forging mechanisms to be transparent and build trust between trial communities and researchers. Still, much remains to be done and the potential for conflict remains.

As the first PrEP trials move toward completion this year, these case studies offer a timely look at what we have learned and what pressing challenges remain unaddressed.

The two case studies are available on-line at http://www.global-campaign.org/.


UPDATE: Dr. Free-Ride over at the blog Adventures in Ethics and Science is going to be hosting a virtual journal club on these two case-studies. Join in the fun here.

Bone Marrow Transplant Cured AIDS?

BBC News reports that a patient suffering from AIDS and leukemia shows no signs of AIDS infection after receiving a bone marrow transplant from an AIDS-resistant donor.

He had been infected with the human immunodeficiency virus, that causes Aids, for more than a decade and also had leukaemia.

The clinic said since the transplant was carried out 20 months ago, tests on the patient's bone marrow, blood and other organ tissues have all been clear.

In a statement, Professor Rodolf Tauber from the Charite clinic said: "This is an interesting case for research.

"But to promise to millions of people infected with HIV that there is hope of a cure would not be right."

Like many of you, I am skeptical about the long-term efficacy of this treatment and am concerned about the social justice challenges presented should this be determined to be a cure. But this story is valuable for the new direction it offers to medical research; while many researchers focus on preventing the virus from propagating, introducing genetics and possibly retroviruses opens up more possibilities. By pursuing all available angles of this crisis, we increase our chances of finding that elusive cure to this global epidemic.

A little Cuervo...

A little Cuervo...

A little Cuervo Can Be Good for You

By Michael Leshinski

A little Cuervo in your life can actually help your liver instead of destroying it. No, I am not talking about the popular tequila maker, but rather about a molecular biologist who shares the same name. As reported by Wired magazine, Dr. Ana Cuervo is working on research that could possibly provide healthier livers to booze hounds in the future. Cuervo and her fellow researchers at Albert Einstein College of Medicine have been working with mice through genetic engineering. The altered mice are usually elderly, in mouse years, but have been altered so that their liver works as effectively as young mice (6 months old). The study focused on a protein found in the liver as well as other parts of the body. The protein collects cellular by-products, mainly appearing as damaged proteins, or garbage as they put it.

The group employs simple logic to back the research. If you take out the garbage properly, then the rest of the cell should work just fine. And it has been so far for these little furry test subjects. Besides the possibility for a healthier liver, the research could be breakthrough for Alzheimer’s disease, a disease also associated with the buildup of cellular by-products. But don’t start celebrating with the Cuervo shots just yet. The research being done is still in very early stages and the possible transformation into human medication has not even yet been thought discussed. Whether you’re a fan of consequence free alcohol consumption or someone who really cares about the advancement of research in these important issues, news can be welcomed by all.

Albany Medical Center Prize Awarded to Two Female Biomedical Researchers

For the first time since its inception, the Albany Medical Center Prize, (the largest prize for medicine in the United States, and second world-wide only to the Nobel), was awarded to two women.

Dr. Joan Steitz of Yale University does research that has improved the lives of people suffering from a variety of auto-immune diseases, while Dr. Elizabeth Blackburn of UCSF discovered the enzyme telomerase, which repair telomeres on chromosomes (and many believe may be linked to aging).

The women will share the $500,000 prize.