From Tuskegee to Transparency: An Evolution in the Ethics and Accountability of Clinical Trials Involving Human Subjects

via RH Reality Check, by Anna Forbes and Kate Ryan

People who participate in clinical trials take the enormous step of volunteering to test a product that may be useful and, sometimes, life-saving if it turns out to be effective. They play an irreplaceable role in research to prevent, treat, and sometimes cure illness – as well as to find other ways to improve people’s health and lives.

Trial participants make a profoundly personal contribution and accept potential medical, social, and personal risks on behalf of others. An ethical trial is one that eliminates or minimizes participants’ risks as much as possible, invests in making sure that participants understand clearly what they are volunteering for, and protects their rights at every step.

For example, without clinical trials, we would not have seen recent advances in antiretroviral drugs to treat HIV, long-acting contraceptive choices that allow women greater control over their use, or microbicides that may be able to protect women from HIV.

The United States government has rules to protect people who participate in federally-funded biomedical and behavioral research. The rules vary depending on which agency is supporting the research, but they all share a starting point known as the Common Rule, a set of regulations for all federally-funded research involving human participants, whether it is conducted inside or outside the U.S.

But those rules have not always been in place, and there are some shameful chapters in the history of medical research supported by the United States that include violations of the most basic standards of ethical behavior. This history has left some people deeply suspicious of clinical trials and the motives of those who conduct them. Many explain their suspicion with one word: “Tuskegee.”

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via the Treatment Action Campaign (TAC), by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications.

Our recommendations

1.The WHO must release its guidelines on serodiscordant couples.
2.People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3.HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4.For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5.Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6.In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7.The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8.Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Fauci - AIDS: Let Science Inform Policy

via Science, by Anthony S. Fauci

Thirty years have passed since the first cases of acquired immune deficiency syndrome (AIDS) were reported by the U.S. Centers for Disease Control and Prevention. How does this anniversary compare to the 20th or the 10th? The differences are considerable, because we now have an unprecedented opportunity, based on solid scientific data, to control and ultimately end the AIDS pandemic.

More than 60 million people have been infected with human immunodeficiency virus (HIV) worldwide. More than 30 million have died, and 34 million are currently living with HIV infection. In 2009, the most recent year for which data are available, 2.6 million people became newly infected. The burden of HIV/AIDS is overwhelmingly felt in resource-poor countries, especially in sub-Saharan Africa, which are least equipped to deal with the disease. Although the toll is staggering, the scientific progress in HIV/AIDS research over 30 years has been extraordinary, particularly in the development of antiretroviral therapy (ART), which has proven to be life-saving to many millions.

For decades, the idea of ending or even controlling the pandemic was a distant aspiration because we lacked sufficient evidence-based tools to convert the hope to reality. At this 30th anniversary, the situation has dramatically changed: We finally have scientifically validated prevention modalities that clearly work, suggesting that ending the pandemic is feasible. Older, proven prevention tools include the proper use of condoms, needle exchange programs for injection drug users, and antiretroviral treatment of HIV-infected pregnant women to prevent transmission of the virus to their newborn infants. Building on this foundation, recent HIV prevention research also has provided strong scientific evidence that adult male circumcision is highly effective in preventing infection in heterosexual men, that an antiretroviral-based topical gel prevents infection in heterosexual women, and that pre-exposure prophylaxis with ART in men who have sex with men is effective at preventing infection. And in May 2011, a randomized controlled clinical trial demonstrated that early initiation of ART by the infected partner in heterosexual couples, where one partner is HIV-infected and the other not, is highly effective in decreasing transmission of HIV to the uninfected partner.

The fact that treatment of HIV-infected adults is also prevention gives us the wherewithal, even in the absence of an effective vaccine, to begin to control and ultimately end the AIDS pandemic. Of course, the development of an AIDS vaccine would be the ultimate game-changer, and efforts toward this goal are intense. However, the existing armamentarium of scientifically proven interventions immediately offers an unprecedented opportunity to make major gains in the fight against HIV/AIDS. Global implementation of HIV interventions, including scale-up of the delivery of ART, must be accelerated, and this will be costly. Certainly, there are many competing priorities for scarce resources in the global health arena, such as other infectious diseases, maternal and child health, and tobacco control. But if one accepts the tenet that science should inform policy, then the scientific data are speaking loud and clear. Global policy-makers must seriously consider these new data in their priority-setting and decision-making.

Last month, world leaders at the United Nations General Assembly Meeting on AIDS called for providing ART for 15 million people in low- and middle-income countries by 2015, an increase from the 6.6 million currently receiving therapy, plus additional efforts toward universal access to HIV prevention, treatment, and care. An estimated $22 billion to $23 billion annually will be needed by 2015; current spending is approximately $16 billion. Such targeted investments could prevent 12 million infections and 7.4 million AIDS-related deaths by 2020. For the first time in the history of HIV/AIDS, controlling and ending the pandemic are feasible; however, a truly global commitment, including investments by those rich and middle-income countries whose contributions have thus far been limited, is essential. Major investments in implementation now will save even greater expenditures in the future; and in the meantime, countless lives can be saved.

Source.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Bloomberg Editorial: Treatment has Grown, Prevention Has Languished

via Bloomberg

AIDS has been with us, officially, for 30 years, since the U.S. Centers for Disease Control and Prevention reported the first cases. This unhappy anniversary is perhaps as good a time as any to spell out why the global response to AIDS is in need of serious adjustment.

Annual spending on AIDS worldwide has risen to $15.9 billion. The bulk of this money goes to the treatment and care of indigent people who are HIV-positive. Without question, the investment in anti-retroviral therapy, or ART, has saved lives. Today, the treatment is provided to about 36 percent of those in the developing world who qualify for it under World Health Organization guidelines.

United Nations member states have pledged to raise that to almost 100 percent. Universal treatment has become the principal mission of many AIDS organizations around the world; governments and philanthropies have followed their lead.

The idea of treating everyone who has the human immunodeficiency virus, regardless of ability to pay, is laudable. The problem is, the laudable runs the risk of crowding out both the practical and the doable. As programs for treatment have grown, those focused on prevention have languished or gotten short-shrift.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

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