Open Letter Urges That PrEP Debate Should be Based on “Facts not Misinformation”

“Ad campaigns that misinform communities at risk for HIV will not help end this epidemic.  We call on everyone to get the facts about PrEP, seek information, and express opinions, but to do so based on real information…”

Earlier this month, a number of US newspapers ran coverage of an open letter, signed by more than 100 “openly HIV-positive gay and bisexual men from across the United States”, calling for an open discussion of the challenges and opportunities presented by pre-exposure prophylaxis (PrEP) for HIV prevention.

The letter was written partly in response to an ongoing paid ad campaign by the AIDS Healthcare Foundation (AHF) that many advocates feel “misrepresents” facts about important PrEP research. Among other things, the campaign expresses concern that PrEP could possibly lead to decreased condom use and an increased risk among gay men because it gives a “false sense of protection”. As a note supporting the open letter posted on IRMA (International Rectal Microbicide Advocates) puts it, “We reject those false assertions and want a full and factual discussion of the pros and cons of PrEP in our community...and make clear our belief that we are entitled to respect, accurate information and new HIV prevention tools.”

“Giving gay men more information about their health only empowers them to make informed decisions. The fear that gay men will take PrEP, forego condoms and become out of control disease spreaders, harkens to the days when men feared women would become crazed nymphomaniacs thanks to the new birth control pill,” says an article about AHF's campaign on FrontiersLA.com, a “breaking gay news” site. You can read more about the AHF campaign on the Mapping Pathways blog post: To PrEP or not to PrEP?

In response to the campaign by the AHF, the open letter states: “PrEP raises many important questions that should be discussed and debated. We are disappointed, however, that an organization that runs HIV clinics, the AIDS Healthcare Foundation (AHF), has chosen to spend tens of thousands of dollars on ads that use simplistic and often misleading arguments to condemn PrEP before the FDA and the HIV community have had a chance to fully review and debate the study data.”

The letter then goes on to urge the AHF to put a stop to its campaign: “Ad campaigns that misinform communities at risk for HIV will not help end this epidemic.  We call on everyone to get the facts about PrEP, seek information, and express opinions, but to do so based on real information, not fear of the scientific process or prejudice against gay/bi men. To that end, we call on AHF to end their expensive and misleading ad campaign, and to work together with us to promote an informed public discussion of HIV prevention that can help reduce HIV risk and save lives.”

One signee who was quoted in an article published in the Sacramento Bee explained his reasons for signing the letter, “As an HIV positive gay man I signed this letter because I learned from experience we need all credible options to stop this epidemic. I owe my life to the fact that advocates and activists have pushed hard for decades to make effective AIDS drugs available to HIV-positive people," said Kali Lindsey.  "Now we know that AIDS drugs can also play an important role in the health and well-being of HIV-negative gay men, how could we not move forward to reap the benefits of this research. It is not an option to ignore these findings."


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

MTN Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women

via Microbicide Trials Network

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada®, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.

Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)’s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet – an approach called oral pre-exposure prophylaxis, or PrEP – and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.

Read the rest.


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Mapping Pathways India: What We’re Hearing so Far

“Individuals should have a right to choose how they want to protect themselves, and different tools for prevention should be made available.” ~ Indian Activist

“Oral prevention is an irresponsible approach that would hurt overall prevention efforts.” ~ Indian PhD and Consultant

An important part of our project is to really learn what people think and feel about PrEP, not just through academic streams and studies but also through everyday wisdom and experience. What do the people who work daily with treatment and prevention and/or have first-hand experience of living with HIV think? What are their concerns? What information do they need about PrEP? Do they feel it can be a useful prevention tool in their country? Would they use it or prescribe it?

The Mapping Pathways online survey and in-depth stakeholder interviews are important ways for us to gain knowledge on these questions. Both are well underway, and already we’re hearing some interesting observations and ideas. Of course, this data is still preliminary but we thought we’d share some snapshots of what we’re hearing from Indian doctors, policymakers, and activists on the ground.

Some of the overall concerns about PrEP that we’re finding in India as well as the other countries are questions about how these strategies will be rolled out and made accessible and affordable. There is also worry that other preventions strategies such a condom promotion will be neglected and unintended consequences, like an increase in risky behavior, might occur. Many of the individuals we’re speaking with want to see more evidence on these strategies, and there are huge concerns about resistance to ARVs and their safety.

One Indian respondent said, “At the moment not even all the HIV infected people needing ARV's are receiving it and adding more numbers to these will only strain the healthcare system in the country more.” Another observed, “PrEP seems to negate moral changes that need to be made within society which is the only ultimate ‘cure.’”

When some of the respondents were asked what types of information they’d like Mapping Pathways to provide to help them when considering PrEP as a strategy for their country, there was real curiosity about finding out how acceptable the strategy is for people living with or at risk for HIV; data on the real cost and cost effectiveness, and more information on clinical trial results; and how to translate all this knowledge into behavior changes.

Other comments and observations so far include:

“It is an assumption that MSM and sex workers are at high risk of getting HIV/AIDS, but women in monogamous relationships are also at high risk.  Nobody can be excluded completely from being at risk.” – Indian politician and policy maker

“It is important to invest in a range of prevention efforts, not simply switching focus from one to another.  Individuals should have a right to choose how they want to protect themselves, and different tools for prevention should be made available.” – Indian activist and HIV consultant

“Global funding for HIV is shrinking, and if a person starts ARVs there is a cost to keeping them on ARVs.” – Indian PhD and consultant

“Oral prevention is an irresponsible approach that would hurt overall prevention efforts.  The HIV epidemic has forced the promotion for overall safe behavior, especially condom promotion and family planning.  These are integral not just for HIV prevention, but for general public health in India.”– Indian PhD and consultant

“From a women’s perspective any prevention tool that gives an individual control over preventing infection is important ...PrEP is a way for a person to take responsibility for their own health.” – Indian activist and HIV consultant

“There is an economic impact that the government needs to acknowledge.  Appropriate funding needs to be allocated to secondary care.” – Indian doctor

For some more insights on Indian reactions toward PrEP and HIV prevention, read our blog posts Notes from India: Concerns and Challenges Around PrEP and A Modern Day HIV Love Story.

We also encourage all Indian citizens who are interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!
 
Take the survey now.

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New data backs early HIV treatment cost-effectiveness

via PlusNews

Modelling has demonstrated the benefits and now data has provided the proof as researchers in Haiti have found that earlier HIV treatment is cost-effective, reducing the risk of death by 75 percent among HIV patients for just US$6.25 more a month.

In 2009, researchers released the results of a then unpublished Haitian clinical trial. Conducted among 800 HIV patients, the study showed that those who received antiretrovirals (ARVs) when their immune systems were stronger - at higher CD4 counts of 200 to 350 - were less likely to die than their peers who waited until their CD4 counts fell to 200.

About five months later, the World Health Organization (WHO) issued new HIV treatment guidelines that advised countries to start HIV patients on treatment at a new higher CD4 count of 350 instead of 200.

Now those researchers have released the world's first and possibly only cost-effectiveness study on earlier HIV treatment tied to a randomized clinical trial. Published in the September 2011 edition of the medical journal, PLoS Medicine, the study is based on data from the original Haitian study that allowed researchers to calculate costs associated with the first three years of earlier treatment - including everything from drug and family caregiver costs to subsidies for patient transport to and from the clinic.

Bruce Schackman, associate professor of public health at the US Weill Cornell Medical College and a co-author of the study, said this was probably the first and last research of its kind. Given the overwhelming evidence for early treatment, duplicating the study now would be unethical, he said.

Read the rest.


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Experts say HIV programs should target unorganized labor in India

via The Hindu

HIV prevention programmes need to reach out to the vast, unorganised labour class, according to experts at a workshop here on Tuesday.

Though the corporate sector has responded to the magnitude of HIV/AIDS — an estimated 90 per cent of HIV infections being reported are in the productive 15-49 year age group — through various measures, the sector needs to closely partner with the government in extending programmes to the unorganised labour segment, participants at the event hosted by the Confederation of Indian Industry (CII) said.

Addressing the meet on ‘HIV/AIDS: Partnerships in Prevention, Treatment, Care and Support', V. Palanikumar, Project Director and Member Secretary Tamil Nadu State AIDS Controls Society (TANSACS), said studies had shown that the informal/unorganised sector, which was significantly at higher infection risk than the general population, was also the most difficult segment to reach.

Of the 400 million members of the workforce in India, only 7 per cent are in the organised sector, leaving 93 per cent in the unorganised and migrant sectors.

Read the rest.


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First Official Mapping Pathways Presentation a Success: Canada keen to adapt project

“It’s not about telling people to go down any one pathway; it’s about providing an array of pathways that are illuminated with a little more analysis with which to shape informed policies and programs.”

Earlier this year, Jim Pickett of the AIDS Foundation of Chicago, a Mapping Pathways partner organization, was asked how he and his colleagues would measure success for this initiative. His response was prompt, explaining that the project would be successful if the knowledge and wisdom it brings together is able to provide tools that are usable for the various stakeholders. “So, for example, if here in Chicago I can take these findings to the Chicago Department of Public Health and it can help inform their community planning process around the prioritization of prevention and care dollars. Or, in India you could take the results of our outputs to the Minister of Health in Delhi and say, ‘Here is something to help us help you think about and plan how you’re going to allocate resources or roll out potential programs…or not.’ Maybe a jurisdiction will decide it will not focus on PrEP, and instead will focus on getting more people tested and treated and on doing a better job on getting people condoms. Basically, we want to help create a package of tools that people can then use to actually influence policy and do good programming in their particular context. At the end of the day, and this is the big picture, we want to avert HIV infections. We want less people to become infected and we want more people who are infected to be linked to appropriate care and treatment. And if our project can, in some small way, help create policies and programs that prevent more infections and get more people into care and treatments that are sustainable and appropriate, then I think we are successful.” (Read more of Jim’s wonderful conversation at the Mapping Pathways blog post “Success! Now What?”)

Recently, at a national stakeholder consultation in Ottawa Canada (see footnote), part of this vision for the Mapping Pathways project came true. Pickett was invited to introduce the project and share some preliminary data to a group of 30-40 key stakeholders from the Canadian government, AIDS service organizations, and others interested in new prevention technologies. This was the first official Mapping Pathways presentation since the project began earlier this year. The consultation was designed to get Canada to think how the country will deal with and incorporate the increasing number of prevention tools and strategies that are already available or will become available soon – PrEP, TLC+, and microbicides (read more about these strategies here and the various prevention trials here).

 “Canada has been following new prevention technologies for a long time,” said Pickett. “So now they are watching the science (and what at incredible year of science it’s been!), and there are things that are actionable; expanding treatment is actionable now. PrEP could be considered actionable now. So at this consultation, these folks were asking, ‘What should we do?’, ‘How do we figure this out?’, ‘What tools will we need?’, ‘How is it going to look?’, ‘How do national bodies fit into this strategy?’”

“Just asking these questions is so challenging,” said Pickett. “And Mapping Pathways is in no way saying any country should do something or not. We’re just asking questions, looking at the data, and then presenting what we find in a useful and usable way.” As Pickett put it at the beginning of this project, “It’s not about telling people to go down any one pathway; it’s about providing an array of pathways that are illuminated with a little more analysis with which to shape informed policies and programs.”

While data from the Mapping Pathways project is still being collected and synthesized, Pickett was able to present snapshots from South Africa, the US, and India; including interesting quotes from stakeholders; and general, country-specific perceptions and trends emerging from the surveys and in-depth stakeholder interviews. 

Much to Pickett’s delight, the presentation was enthusiastically received, with the Canadian stakeholders keen to go ahead and create a Canadian version of the Mapping Pathways project. “We haven’t even synthesized the data completely as yet and people are already interested in it and how they can make the project their own!”

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team.

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[1]  Canada Institute of Health Research Meeting, September 16, 2011

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Mobile testing units show success in linking people to HIV care and treatment

via aidsmap, by Carole Leach-Lemens

Linkage to facility-based HIV care from a mobile testing unit is feasible, South African researchers report in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

In a stratified random sample of 192 newly diagnosed individuals who had received CD4 test results, linkage to care was best among those who were ART eligible, Darshini Govindasamy and colleagues found.

The lower the CD4 cell count the greater the linkage to care: all of those with CD4 counts at or under 200 cells/mm3, two-thirds of those with CD4 counts of 201-350 cells/mm3 and a third of those with CD4 counts over 350 cells/mm3 linked to care.

An estimated two million people died as a result of HIV/AIDS in sub-Saharan Africa in 2008. South Africa now has the largest ART programme in the world, yet half of those in need of treatment do not get it. And a large number of those who do present for care, present late with low CD4 cell counts increasing their risk of early death.

In South Africa traditional HIV counselling and testing (HCT) sites at stationary facilities have increased and consequently so have the numbers tested. Yet this has not resulted in increased numbers on treatment and in care.

Transport costs, being male and having a low CD4 cell count have been well documented as the primary barriers of non-linkage to care.

Successful early diagnosis of HIV has to be accompanied by strategies that assure timely linkage to care and treatment so improving health outcomes.

Mobile testing units offer several advantages: people are often tested at an earlier stage of HIV; it is easier for hard-to-reach and high-risk populations to test; and they are cost-effective. However, maintaining on-going HIV care may prove difficult, requiring referral to stationery facilities.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Kashmir Gets a Grip on AIDS

via IPS News, by Sana Altaf

When the sole Community Care Centre in Jammu and Kashmir providing medical and psychosocial services to people living with HIV/AIDS (PLWHA) closed down for lack of patients it was a sure sign that the north Indian state had beaten back dire forecasts.

"There were few people coming in and fewer new cases," Dr. M. A. Wani, former director of the Jammu and Kashmir AIDS Prevention and Control Society (JKAPCS), told IPS, explaining the closure six months ago.

The latest sentinel survey conducted by the JKAPCS in 2010 shows an HIV prevalence of 0.03 percent - down from the 1.2 percent in the survey conducted in 2009.

According to official statistics, of the 4,846 test samples taken in the year 2008 only three persons were found to be HIV positive, and of the 4,840 samples tested in 2009 not one was found positive.

Such figures contrast sharply with grim projections made by the National Aids Control Organisation (NACO) in 2002-2003 that some 40,000 people would be infected with HIV within two years in Jammu and Kashmir and that 20,000 people would die of AIDS by 2015.

Since 1997, only 193 new patients have tested positive for HIV, most of them urban males in the 15 – 45 age group. There are now 2,787 PLWHA, including 800 women and 176 children, in this state with a population of 12.5 million people.

NACO figures released in June say there are 683 people on anti-retroviral therapy (ART) in Jammu and Kashmir where the total number of people recorded as ever getting full-blown AIDS stands at 1,123 - out of which 203 have died.

The low and declining rates have not made life easier for PLHWA, because of the strong social stigma attached to the disease and difficulties in accessing anti-retroviral drugs.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

An end to AIDS is within our reach

via The Washington Post, by Desmond Tutu

A study published in the New England Journal of Medicine last month has demonstrated that antiretroviral treatment can prevent the spread of HIV, in addition to saving those infected from sickness and death.

Armed with this new data, President Obama should lead the world in a massive effort to expand access to treatment and rid humanity of AIDS — the most devastating disease of our time.

But just as the end of AIDS has finally come within reach, we are witnessing an unprecedented drop in financial and political support for the cause.

The Joint United Nations Programme on HIV/AIDS and the Kaiser Family Foundation reported in August that donor funding for HIV/AIDS leveled in 2009 and then declined — 10 percent — in 2010 for the first time ever. The United States, which accounts for more than half of global contributions to fight the disease, disbursed $700 million less in 2010 than in 2009. And projected U.S. funding in 2011 is roughly $28 million less than in 2010.

This is a great shame, as millions of people receiving treatment worldwide depend on these funds to stay alive.

Our support should be increasing. AIDS remains the leading cause of orphanhood and of death among women of reproductive age. It is a major driver of opportunistic infections — particularly tuberculosis — and keeps tens of millions of Africans mired in poverty.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

National Institutes of Health (NIH) Launches $140M Project to Predict Drug Toxicity

via Science Magazine, by Jocelyn Kaiser

National Institutes of Health (NIH) Director Francis Collins's controversial plan to launch a new center for translational biomedical research got a boost today in a White House announcement on science initiatives. NIH also rolled out an early project for the planned center, promising up to $140 million over 5 years to develop a chip for predicting drug toxicity.

The drug chip will be developed in a partnership to include NIH, the Food and Drug Administration (FDA), and DARPA--the Defense Advanced Research Projects Agency--which is known for funding risky research. Collins says the first-ever collaboration of this kind will try to combine human cell types, such as liver and kidney cells, that can represent physiological systems and "talk to each other" on a chip that will be used to predict whether a drug will be safe. Researchers will try to grow cells in three dimensions rather than as a flat layer because that's a better way to model how a drug will act in human tissues. The project "is really ambitious," Collins says.

DARPA this week began soliciting proposals for its piece, which will focus on engineering. NIH's half of the funding, which may involve both intramural and extramural researchers, will come from the director's Common Fund.

The drug chip will be a project of the National Center for Advancing Translational Sciences (NCATS), which got a mention when President Barack Obama signed a new patent bill. The White house also touted a new low-cost licensing agreement to help startup companies license inventions from NIH and FDA intramural research.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Obama Pushes More Competition on Biologic Drugs

via The New York Times, by Andrew Pollack

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology.

Tucked into the president’s deficit reduction plan released on Monday was a proposal to reduce the market exclusivity offered to brand-name biologic drugs to seven years, down from the 12 incorporated in the 2010 federal health care legislation.

That would allow so-called generic versions of such drugs to reach the market sooner, saving an estimated $3.5 billion in federal health spending over 10 years, or a little over one-tenth of 1 percent of the $3 trillion the president’s deficit reduction plan is supposed to save in a decade.

Biologic drugs are proteins made in living cells, like Avastin and Herceptin for cancer and Enbrel and Humira for rheumatoid arthritis. Such drugs can cost tens of thousands of dollars a year and are not subject to the same rapid onset of generic competition as drugs made in chemical factories, like Lipitor and Prozac.
The issue was a thorny one during the debate in Congress over the health care legislation.

The biotechnology industry argued it needed 12 years of freedom from lower priced competition to recoup research and development costs. Any less, it argued, would retard innovation. The generic industry, as well as many insurers and employers who pay health care bills, said a much shorter period would suffice.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Using HIV medication to treat other ailments

via The Bay Citizen, by Scott James

Thirty years into the AIDS epidemic, the antiretroviral drugs that have provided lifesaving treatment for many of those infected with H.I.V. — 1.1 million in the United States today — are now being used or considered for treating other ailments.

When medications have proved safe and effective for most patients, it is standard practice for pharmaceutical companies to see if the drugs have other applications. But with H.I.V. drugs, the practice has been unusually contentious, fostering debates about questionable science, safety and profiteering, and concerns that thousands of Americans infected with H.I.V. cannot get the medications.

At the center of this controversy is Gilead Sciences, a pharmaceutical company based in Foster City. Gilead is the nation’s largest producer of H.I.V. medications (including Viread, Truvada, and Atripla), accounting for nearly half the United States market for them. The drugs produce $3.5 billion in annual revenues, with profit margins reportedly twice the industry average.

Read the rest.


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2012 International Microbicides Conference (M2012) in Sydney, Australia

The next International Microbicides Conference will be held in Sydney, Australia from April 15-18th, 2012!

Registration
Registration is not yet open, but to submit an expression of interest, please click here. By submitting this, you will be contacted as soon as official registration opens!

Abstract Submission
The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Please click here to view the abstract submission guidelines.  Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011. Click here for more information and details about uploading your abstract.

Scholarships
Scholarships are available to attend the 2012 International Microbicides Conference (M2012) in Sydney, Australia.

Scholarships will be offered in four categories that have distinct criteria:
1. Research
2. Community
3. Government Official/Public Health Policy
4. Media (Further details to come - Media scholarships will open 23 September)

Scholarship applications are due 5:00 pm AEST on Thursday 17 November 2011.  Click here for more details about scholarships and to apply.

For any other information about M2012 please go to microbicides2012.org.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

'Less education' associated with PrEP and PEP use

via aidsmap, by Gus Cairns

A survey (Mansergh) of 454 HIV-negative gay men in four US cities (New York, Los Angeles, Chicago and San Francisco) has found that men with lower educational attainment (high school only) were more likely to use antiretrovirals informally for HIV prevention, either as pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), than men who had had further education.

In a parallel survey of 557 HIV-positive gay men, men with lower educational attainment were, similarly, more likely to share their antiretroviral pills with HIV-negative partners to use as PrEP or PEP.

Taken together, 22% of the men in the two surveys were under 30, 35% in their 30s and 43% 40 or over. A third were black, 38% white and the rest Hispanic or of other ethnicity.

Roughly a third each of the sample had education only to high school level, to some college qualification, or to a university degree.

The survey asked both groups if they had used PrEP or PEP or, in the case of the HIV-positive men, provided it to others, in the last six months.

Informal use of PrEP or PEP was still comparatively uncommon; only a few per cent of those surveyed overall had used ARVs as prevention or provided them in the previous six mnoths.

However men with high-school-only education were two to six times more likely to report using one of these strategies.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Disappointing results from two peer education projects in southern Africa

via aidsmap, by Roger Pebody

Two large HIV prevention programmes that recruited people to educate their friends and classmates have both failed to make an impact on sexual behaviour, researchers report in two separate articles published online ahead of print in AIDS and Behavior.

A peer education programme for 15 and 16 year old school students in South Africa did not have any effect on students’ age of sexual debut or their use of condoms. In Zimbabwe, a programme which trained male customers of beer halls to act as peer educators with their friends did not have an effect on how often men used condoms or how many sexual partners they had.

Whereas there are signs that there were problems with the implementation of the schools programme, the beer hall intervention appears to have been well-delivered. Nonetheless the programme seems to have been unable to make an impact in a context of deep-rooted social problems and tensions.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Harvard School of Public Health to study "unique combination of HIV prevention strategies" in Botswana

via The Financial

A new four-year, $20 million grant from the U.S. Centers for Disease Control and Prevention (CDC) will enable Harvard School of Public Health (HSPH) researchers to evaluate the impact and cost-effectiveness of a unique combination of HIV prevention strategies in Botswana. The CDC grant is part of a U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) initiative that commits $45 million to examine the effectiveness of combination approaches to HIV prevention over four years. The largest evaluation of its kind, the research initiative is poised to help partner countries strengthen their efforts to prevent new HIV infections and save lives.

Principal investigator Max Essex, professor of health sciences and chair of the Harvard School of Public Health AIDS Initiative, and co-principal investigator Victor De Gruttola, professor of biostatistics and chair of the Department of Biostatistics at HSPH, predict that their prevention strategies can reduce HIV infection by at least 50 percent.

Read the rest.
 

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Clues emerge to explain first successful HIV vaccine trial

via Nature News, by Ewen Callaway

After decades of dashed hopes, AIDS vaccine developers are allowing themselves some cautious optimism. At a conference this week in Bangkok, Thailand, scientists reported molecular clues that help to explain the first-ever success of an HIV vaccine trial in humans (see 'Vaccine protects against HIV virus'). The results could point the way forward for designing future vaccines.

"You might say this is the most successful experiment we've had so far," says Adriano Boasso, an immunologist at Imperial College London.

The study analyzed clinical samples from a previous HIV vaccine trial of more than 16,000 people that has been dubbed the 'Thai trial' but is officially called RV144. In 2009, scientists leading that trial reported that, after three years, people who received the vaccine were about 30 percent less likely to contract HIV than those who got a placebo.

The modest results marked the first successful human trial of an AIDS vaccine, two years after the high-profile failure of a vaccine produced by the pharmaceutical company Merck. But Thai trial results also left many researchers scratching their heads.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

HIV Prevention Trials Network (HPTN) Awarded $37 Million for New PopART Trial

via HIV Prevention Trials Network

HPTN 071
The PopART Study

The HIV Prevention Trials Network (HPTN) is delighted to announce a new study, PopART, (HPTN 071), which will examine the impact of a combination prevention strategy, including early antiretroviral therapy (ART), on population level HIV incidence in Zambia and South Africa. Partners for this study include the London School of Hygiene and Tropical Medicine, Imperial College, London, the Zambia AIDS Related Tuberculosis Project (ZAMBART), and the Desmond Tutu TB Centre (DTTC).

HPTN 071 is a natural extension of HPTN’s robust HIV prevention research and will build upon the network’s groundbreaking studies. The primary objective of HPTN 071 is to evaluate a prevention package utilizing a combination of interventions includ-ing voluntary testing, counseling and antiretroviral therapy (ART). The study is in line with the goals of the U.S. President’s Emer-gency Plan for AIDS Relief (PEPFAR) which aims to “expand its emphasis on HIV prevention, and matching interventions and investments with epidemiological trends and needs in order to improve impact.”

Read the rest. 


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

2012 International Microbicides Conference Scholarship and Abstract Opportunity!

via International Microbicides Conference Secretariat

Do you need funding to attend M2012?

The M2012 organisers are pleased to announce that scholarships are available to attend the conference in Sydney, Australia. Scholarships will be offered in four categories that each have distinct criteria:

1. Research

2. Community

3. Government Official/ Public Health Policy

4. Media

Click here to find out how to apply for the scholarship.  

For more information please visit the conference website: http://www.microbicides2012.org/.

Do you want to submit an Abstract to the Conference?
The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Please click here to view the abstract submission guidelines. See below to upload your submission.

DEADLINE FOR ABSTRACT SUBMISSION
Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011.

GUIDELINES FOR SUBMISSION
Abstracts should be submitted via the online submission form. You should first log into your account on the M2012 Delegate Portal to submit an abstract. The delegate portal will be available this week.

If you are a new user please click the 'CREATE A NEW ACCOUNT LINK' at the bottom of the log in page.
If you previously created an account, but forgot your user ID and / or password, please select the link 'FORGOT PASSWORD' on the log in page.

Applicants should complete name, address and other details on the online form, and then upload the abstract as a WORD document. You can exit at any time and log back in to edit your submission prior to the deadline. Please carefully review the abstract prior to its submission. Please do not enter multiple submissions of the same abstract with incremental changes.
Step-by-step instructions are incorporated into the online abstract submission form; however, if you require assistance, or have any questions or concerns about the abstract program or submission process, please contact us. Please send an e-mail to the conference organisers at info@microbicides2012.org

Please click here to upload your abtsract through the delegate portal.

NOTIFICATION AND CORRESPONDENCE
Upon submission of your abstract via the online form, you will receive an acknowledgement within approximately 5 working days at the e-mail address you provide. Please retain this information for your records as verification of receipt. If you do not receive an acknowledgement within approximately 5 working days after submission of your abstract, please contact us. Please send an e-mail to the conference organisers at info@microbicides2012.org
Abstract dispositions will be e-mailed to the submitter of the abstract after 16 January 2012.  It is the responsibility of the primary author to inform co-authors about an abstract's disposition.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Male Circumcision and HIV Prevention

via Daily Monitor, by Moses Karugaba

In 2005, a randomised controlled trial conducted among uncircumcised men of 18-24 years in South Africa showed that male circumcision reduced the risk of acquiring HIV infection by 60 per cent. Two further studies conducted in Uganda and Kenya showed similar results. These three studies provide new, compelling evidence that male circumcision offers significant protection against acquiring HIV infection. These findings confirm those from previous observational studies and that of a meta-analysis of 28 published studies conducted in 2000.

What is Safe Male Circumcision (SMC)? Male circumcision involves the surgical removal of the foreskin, the tissue covering the head of the penis. In adult men, a four to six weeks period is required for the wound to heal fully compared to the one-week period when circumcision is performed for babies.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

The Inevitability of Antibiotic Resistance

via The Atlantic, by Megan Mcardle

On Christmas Eve 1947, George Orwell was admitted to a Scottish hospital with a case of galloping consumption. Orwell had first been diagnosed with tuberculosis almost 10 years earlier, but nonetheless, in what a biographer called “one of the many ill-judged decisions in a life littered with misjudgements,” he had recently moved to a remote and primitive Scottish cottage, where he began work on Nineteen Eighty-Four. There, he developed the night sweats, fever, and weight loss that are hallmarks of active TB. By the time he was admitted to the hospital, Mycobacterium tuberculosis had husked nearly 30 pounds off his already slender frame.

When I was younger and more romantic, I imagined that tuberculosis made you a good writer. After all, so many great ones, from Keats to Chekhov to all three Brontës, seemed to have died of it. Indeed, in 19th-century Europe, the “White Plague” may have caused as many as a quarter of all deaths. Though that proportion had fallen by Orwell’s time, writers from Camus to Bukowski were still contracting tuberculosis, as were millions of their less famous countrymen. Only antibiotics finally conquered the disease.

Victory arrived just barely too late for Orwell. His friends actually managed to obtain a supply of streptomycin, the brand-new anti-TB drug, from America, but it caused such a violent reaction that every morning when he woke, blood from the ulcers in his mouth had glued his lips shut. It had to be soaked off before he could speak. After several weeks, his doctors had to give up. A less powerful new drug called PAS, which he tried in 1949, didn’t make him so sick, but apparently didn’t much bother the tuberculosis bacilli, either. In January of 1950, an artery burst in his lungs, and at the age of 46, George Orwell drowned in his own blood.

It seems a medieval end for a very modern man. But we are not as far from TB as we like to think. It remains endemic in the developing world and is coming back in richer countries, thanks to travel and immigration, but also to a phenomenon that Alexander Fleming, the discoverer of penicillin, warned of in the 1940s: antibiotic resistance.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

TLC+ Strategies in 4 US Cities: San Francisco, Los Angeles, Birmingham, and Washington D.C.

via Project Inform, by Mark R. Vogel

Despite significant advances in the treatment and prevention of HIV, the number of new HIV infections in the United States holds steady at about 50,000.1 Furthermore, 21% of individuals infected with HIV in the United States are not aware of their status, and an estimated 33% of those who know that they are HIV-positive are not engaged in care and treatment for their disease.2 Another 38% of newly diagnosed individuals test positive for HIV so late that they receive an AIDS diagnosis at the same time as, or within a year of testing positive.3 Clearly, novel prevention strategies, ways to engage individuals in care sooner after infection, and methods to maintain them in care and treatment needed.

One such strategy is the Test, Link to Care, Plus Treat (TLC-Plus) approach. TLC-Plus addresses several aspects of the healthcare system that can be improved to help those with HIV live longer and healthier lives while also reducing transmission of the virus to others. The National HIV/AIDS Strategy places testing, linkage to care, treatment and support services at the center of efforts to improve the health outcomes of HIV-positive individuals and to prevent new infections.4

This paper examines successful components of TLC-Plus programs in four jurisdictions and specific strategies used to achieve desired health outcomes, as described by public health officials in each. It is our hope that these strategies may be used to inform the development of TLC-Plus programs across the country. Consideration is also given to funding and to the role of electronic medical records, in Louisiana, in assisting patients who have fallen out of (or never entered into) care.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.] 

Tricky Terminology in HIV Prevention – Part 2: “Microbicides” and “Oral PrEP”

“I think elegance must take second seat to being clear and helping people absorb vast amounts of new information.”

We recently blogged about the terms “abstinence” and “being faithful” – words that have caused a great deal of controversy in the HIV prevention arena. In this post, we discuss another instance of tricky terminology – the need to maintain the distinction between “oral PrEP” and “microbicides,” a difference that is extremely important in the context of the rapidly changing face of HIV prevention.

Lori Heise of the London School of Hygiene and Tropical Medicine has some thoughts on this matter. “In the next few years, as policymakers, providers, and potential users are trying to get their minds around all this new research and the expanding array of prevention options” she says, “it is absolutely essential that we stick to the language of ‘oral PrEP’ and ‘microbicides’ (for instance: ‘oral tenofovir’ or ‘tenofovir gel’).”

There has been a move within scientific circles to shift the language toward PrEP and ARVs, just making distinctions between mode of delivery (topical, oral, systemic), and there are supporters of this formulation. “However, as we shift from clinical trials into introduction and use,” she says, “we need every means at our disposal to help people make appropriate distinctions among methods.”(See this Mapping Pathways blog post for a snapshot of the various ways in which antiretrovirals can be used to prevent new HIV infections.)

Clear and accurate terminology help policymakers, advocates, and other stakeholders engage in rational discussions about which methods might best suit the needs of different individuals at different moments in time and with which types of partners or sexual settings. Substituting words or using umbrella terms tends to cloud clarity and cause confusion. “Over the last several months, I have sat through a number of presentations that combine information about oral PrEP and microbicides, but use the language of PrEP to describe both.” Lori recounts. “Even among groups of experts, I have noticed people getting confused – misapplying data, conclusions, or assumptions that mostly apply to microbicides or to oral PrEP, to both.There is a tendency to talk about PrEP and topical PrEP – but people don't register the ‘topical’ and so important nuances are lost.”

Indeed, these different products have critical distinctions to keep in mind. For instance, oral PrEP may potentially protect a wider range of users than microbicides, such as in the case of injection drug users (IDUs) whose primary risk of HIV infection is from tainted syringes, not unprotected sexual intercourse (though we are still waiting on data on the efficacy of PrEP among IDUs. Then, the license to develop tenofovir gel as a microbicide is held by the public sector, while the licenses for oral tenofovir and Truvada – both of which are already available for treatment – are controlled by Gilead. This dual-use issue where ARVs taken orally can be used for either treatment or prevention doesn't exist for any microbicide.

“These distinctions are important, and I think we need to use terminology that helps people keep them in the forefront of their minds – at least for the next few years, as we broaden the circle of discussion to add groups that as yet know very little about PrEP or microbicides....In this case,” says Lori, “I think elegance must take second seat to being clear and helping people absorb vast amounts of new information.”


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Fighting AIDS: At the Tipping Point

via The Huffington Post, by Ambassadors Eric Goosby, MD and Mark R. Dybul

Starting in 2005, a series of randomized clinical trials demonstrated that medical male circumcision significantly reduces a man's risk of acquiring HIV. A recent follow-on study suggests the reduction in risk may be as much as 68% and the protective effect is increasing over time. The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is sponsoring large programs in countries where rates of HIV prevalence are high and levels of circumcision are low to bring this inexpensive and life-saving intervention to millions of men.

In May, a National Institutes of Health (NIH) randomized control trial documented for the first time that treatment also works as an extraordinarily successful tool for prevention. Initiation of antiretroviral treatment (ART) by HIV-positive individuals substantially protected their HIV-negative sexual partners from acquiring HIV. Treatment lowers the viral load of HIV in a person with the virus, greatly reducing the risk of sexual transmission to a partner. ART produced an astonishing 96 percent reduction in risk of HIV transmission, on par with a vaccine.

Earlier this summer, two other studies confirmed an initial proof-of-concept trial demonstrating the effectiveness of antiretroviral medication for pre-exposure prophylaxis (PrEP) among couples. Individuals taking a daily tenofovir or tenofovir/emtricitabine combination experienced infection rates as much as 73% lower than those on a placebo, advancing potential options for prevention among couples where one partner is infected with HIV and the other is not.

Finally, last summer, the CAPRISA study of tenofovir gel microbicide -- funded by PEPFAR through USAID -- found that those using the gel with the active ingredient had an average of 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug in a microbicide preparation can reduce the risk of HIV in women.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Medicines Control Council Delays HIV Drug Trials in South Africa

via allAfrica.com, by Marian Shinn of the Democratic Alliance

For the past year two applications for field trials have been awaiting approval by the MCC. One is from the Centre for the Aids Programme of Research in South Africa (CAPRISA) for the second field trial of its world-acclaimed antiretroviral vaginal gel.

The second is from the University of the Western Cape-based International Centre for Innovation Partnerships for a field trial of a drug that could delay the onset of AIDS in HIV positive people. This drug is a breakthrough in the use of active extracts from the Sutherlandia indigenous plant.

Both these drug developments are funded, in part, by the Department of Science and Technology (DST).

A year ago CAPRISA's Tenofovir gel received world-wide scientific recognition based on the results of the successful pioneering field trial held in KwaZulu-Natal. In November 2010 the developers of this microbicide gel applied to the MCC for permission to launch a second field trial that would include women attending family planning clinics in KwaZulu-Natal.

Many of these women took part in the first trial and, since that first ended in March 2010, have been prevented from continuing to use the preventative gel because CAPRISA cannot obtain permission to start its new trial, for which about R28 million in funding from UNAids and the DST has been secured.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

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

via Treatment Action Campaign, 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.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Analysis: Legal case in India threatens HIV drug access for poorest

via The Bureau of Investigative Journalism, by Melanie Newman

A technical case going through the Supreme Court in India is being carefully watched by aid agencies and other human rights organisations, who claim it could have severe consequences for the supply of lifesaving drugs to the developing world.

More than 90% of drugs used to treat children with AIDS in Africa come from Indian generic manufacturers, according to the medical NGO Medicins Sans Frontieres. And if the Swiss pharmaceutical giant Novartis wins a case it has brought against the Indian government, MSF fears that supply could dry up.

Novartis is seeking patent protection for its leukaemia drug Glivec, whose patent has expired in India. It is challenging India’s interpretation of a section of the nation’s patent law — Section 3(d) — which prevents ‘evergreening’.

Evergreening is a common method used by drug companies to extend the life of their patents. They make slight alterations to the basis molecule every few years and apply for fresh patents for the amended versions, which then prevents generic copies of the drugs being made.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

How Much Would it Cost to End AIDS?

via Bloomberg, by Simeon Bennet

Michel Kazatchkine and Eric Goosby may be able to halt the spread of HIV. They just need the money.

The two men control the funds that buy drugs for most of the world’s AIDS patients. Studies in July provided the strongest evidence yet that medicines used since 1994 to treat HIV can almost eliminate the chance an infected person will pass the virus to a sex partner. Given to healthy people, the treatments can also protect against infection, offering the potential to end a pandemic that has killed 30 million people in 30 years.

Governments are now planning projects to assess whether those findings can be replicated in the real world, and what that might cost. Getting the drugs just to those patients who should be treated under existing guidelines would cost another $6 billion a year, according to the United Nations. Treating all those infected, in some of the world’s poorest countries, would cost tens of billions more.

Finding more money will be difficult with economic growth stalling and nations including the U.S., the biggest donor to the AIDS fight worldwide, trying to curtail overall spending to rein in debt. Funding for AIDS in poorer nations fell 10 percent to $6.9 billion in 2010 from 2009 levels, according to the UN.

“We may well be able to overcome AIDS,” Kazatchkine, the director of the Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria, said in an interview. Still, “the gap between what the science is telling us we can achieve and what we would be able to achieve is at risk of increasing.”

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Cost-effectiveness of PrEP

via Nature Medicine, by Roxanne Khamsi

Clinical trial data are starting to pour in demonstrating that the HIV prevention strategy known as 'pre-exposure prophylaxis' is an effective way of keeping people at high risk of infection disease free. In July, researchers reported at the International AIDS Society Conference in Rome that taking an antiretroviral drug called Truvada offered a 73% protection rate for heterosexual couples in East Africa in which only one person had HIV. At the same meeting, the US Centers for Disease Control and Prevention also announced trial results demonstrating a 63% reduction in transmission among young adults in Botswana taking the pill.

Buoyed by these and similar findings reported last year among men who have sex with men, health policy experts and economists are now debating how best to roll out the strategy to those who might benefit most. Preliminary analyses, experts say, indicate that PrEP should be a cost-effective tool to address the HIV epidemic until more testing and treatment for the disease becomes available.

Last year, even before PrEP was known to be effective for heterosexuals, a team led by Carel Pretorius of the Futures Institute, a global health think tank based in Glastonbury, Connecticut, published a mathematical model assessing the resources needed to apply it. The analysis concluded that administering PrEP to young South African women could—in an optimistic scenario—prevent up to a quarter of all new cases of HIV in the targeted high-risk age group at a cost of as little as $12,500 per each averted infection. The model asserts that this constitutes a worthwhile investment, as long as the reach of antiretroviral treatment for HIV-positive individuals remains low in the country (PLoS ONE 5, e13646, 2010).

In a similar vein but using a different cost metric, Rochelle Walensky, from Harvard Medical School in Boston has unpublished evidence showing that each year of life saved due to PrEP among a comparable South African cohort should cost just $3,600 when taking into account all downstream survival benefits and costs. That price would be considered by the World Health Organization to be “very cost-effective” since it falls well below the country's average annual per capita gross domestic product.

“There were so many people who expected us to say, 'Prove it's cost saving,'” says Walensky. “I thought that was a tall order, but I thought it would likely be cost effective.”

In certain settings, PrEP can cost around $250 per year for a full dose of daily pills and the associated HIV testing and laboratory monitoring. That may sound cheap, but, given shrinking global health budgets around the world, researchers worry about whether the pills will find their way to those who need them most. “Things can be cost effective and even cost saving, but you've still got to find a big lump of cash,” says Timothy Hallett, who studies resource allocation for HIV at Imperial College London.

Even with adequate funding, however, experts emphasize the moral imperative to assure access to medications for people known to carry the virus before giving limited drug supplies to those not yet infected. “I don't see how we could treat uninfected people without first treating infected people,” says Arleen Leibowitz, a health economist at the University of California–Los Angeles.

But, outside the developing world, Leibowitz thinks that those willing to pay out of pocket for the drugs should have that option. “I would not deny PrEP to anyone who would be able to pay for it,” she says. “If you want to do this with your money, that's perfectly legitimate.”

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]