Late last year, Gilead Sciences, Inc. -- whose HIV treatment and prevention blockbuster pill Truvada (tenofovir/FTC) accounted for about 10% of the drugmaker's $30 billion in sales in 2016 -- announced it was launching The COMPASS Initiative, a 10-year, $100 million commitment to supporting organizations fighting the HIV epidemic in the hard-hit, underfunded American South.
The drugmaker said that it would partner with three regional coordinating centers -- Emory University Rollins School of Public Health in Atlanta, the University of Houston Graduate College of Social Work, and the Southern AIDS Coalition, headquartered in Birmingham, Alabama -- to identify and provide funding to local organizations battling the epidemic, with a special focus on issues surrounding HIV, including mental health, trauma, and stigma.
AIDS activists and researchers in the region, which has especially high rates of both new HIV diagnoses and HIV-related deaths, especially among African-American gay and bisexual men, hailed the announcement. Nicholas Carlisle, J.D., executive director of the Southern AIDS Coalition, said that the money was needed not only to make up funding shortfalls in the South -- where only four southern states have expanded their Medicaid program under Obamacare, compared with 33 states nationwide -- but to better document outcomes of various programs in the region.
"Organizations do good work," he said, "but they don't think about the evaluation component. We need data to take to the Centers for Disease Control [and Prevention (CDC)] and say, 'These things work and you should be funding them in the future.' Right now, we have slim data for work we are doing against HIV stigma, so it's a chicken-and-egg scenario. It's hard to convince even a progressive CDC to pilot things they don't know are effective."
Carlisle pointed to such programs as The LEAD Academy, which trains people living with or affected by HIV/AIDS to talk about the epidemic in their communities and with local and state lawmakers, and The Unity Workshop, a one-day intervention with scripted conversations that aims to get women and gay and bisexual men of color -- the groups in the South most at risk for HIV -- to talk about HIV stigma.
Related: Why the U.S. South Still Has Such High HIV Rates
And, according to Gilead's Douglas Brooks, M.S.W., formerly director of the Office of National AIDS Policy under President Barack Obama, COMPASS will let HIV researchers and advocates on the ground do the decision-making about how to spend its money. The program, he says, started when a Gilead team visited HIV providers, patients, and advocates in the South last spring.
"We heard themes," he said. "Stigma was rampant, and there was a real need for support around mental health, trauma, and well-being and for the organizations to get support for their amazing work." That, he said, could include everything from grant writers to capturing data to learning new interventions, such as how to start a pre-exposure prophylaxis (PrEP) program.
"We'll stay as close to this as we are able, and we'll hire a staff person for it, but we're not going to be managing this directly," Brooks said, adding that even prior to announcing COMPASS, Gilead was already the largest private HIV funder in the South, according to Funders Concerned About AIDS.
There, as elsewhere in the U.S., in recent years the company has poured millions into programs that connect communities (especially of gay men) to PrEP, for which only Gilead's Truvada is currently available.
According to Carlisle, COMPASS will solicit and review funding requests throughout the southern region in 2018, then start giving out money in 2019. "Gilead has been great," he said, "in recognizing that they need to let us people on the ground decide" how to use the money.
But even if Gilead gives its beneficiaries near-total autonomy, such initiatives -- in which private-sector entities with vested interests fund large public-health efforts lacking sufficient federal or state support -- raise concerning questions.
Perhaps the biggest is whether Gilead's effort -- like countless other such efforts on the part of Big Pharma -- is meant to take the heat off its notoriously high drug prices. In recent years, Gilead has earned outrage for pricing its hepatitis C "miracle cure" drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) at roughly $1,000 per pill, or more than $80,000 for a three-month course of treatment. The price tags, which the U.S. government has no power to regulate, have forced many state Medicaid programs to deny or delay treatment to many who need it.
Then there is Truvada itself. Sticker-priced at about $1,500 for a month's supply, the drug is not as expensive as Gilead's hepatitis C drugs, but it has been reaping increasing profits since 2004, especially since the U.S. Food and Drug Administration approved it in 2012 for HIV prevention, as well as treatment. The drug's price has risen dramatically faster than inflation.
True, Gilead has picked up the tab for its hepatitis C drugs and for Truvada for some patients who could not access them any other way.
However, such giveaway programs, which many drugmakers offer, don't undo arbitrarily high sticker prices that put tremendous strain on public and private health plans and make U.S. health care the costliest in the world, by far.
"These philanthropic initiatives [like Gilead's in the South] stem from the fact that these companies are making money hand over fist due to drug pricing being so exorbitant in the first place," says Tim Horn, deputy executive director of HIV and hepatitis C programs at Treatment Action Group, a think tank that receives Gilead funding.
"You tell them that their prices are too high, and they say that it allows them to fund these programs to remove structural barriers to care," says Horn. "But too-high drug prices are a barrier in the first place. So, it's an endless loop."
Says Philip Chan, M.D. a Brown University HIV researcher who also heads a large sexually transmitted infection clinic in Providence, Rhode Island, "I worry about Gilead's motivation for doing this. I don't think it's out of goodwill. It's clear from how they handled their hep C drugs that it's all about making money for them. And I worry that it leads to bias among some in the medical community in terms of being beholden to drug companies and prescribing their drugs."
Chan said he started a PrEP program in 2013 with a Gilead grant but has decided since then to take no pharma money for his programs. "I think PrEP is amazing, but there's a huge conflict of interest when the maker of the PrEP drug is giving you money to prescribe it. Hopefully, other PrEP options will be approved at some point, but if Gilead is already so ingrained in the [provider] infrastructure, you're creating an unbalanced playing field."
Letting States off the Hook?
To be clear, COMPASS will focus on interventions related to HIV stigma, trauma, and well-being -- not on providing PrEP per se. "Private money allows people to create and tailor programs you'd never be able to do through public channels," notes Gilead's Brooks.
Yet, that raises the question of whether state governments are being let off the hook for public-health responsibilities. "We need states to step up," says Horn. Not only have most southern states not expanded Medicaid, he notes, but many of them also still have outdated and unfair HIV criminalization laws and poor or no options for supportive housing or safe injection-drug use (to prevent HIV and hepatitis C infections, as well as overdoses).
"There's a whole lot of structural issues that need to be addressed on the state level," says Horn. "In a lot of HIV/AIDS organizations in the South, there isn't a robust advocacy and policy presence" like there is in such states as New York and California. "They're funded primarily through the CDC and the Ryan White CARE Act, but their focus is on HIV testing and linkage to care" -- not, says Horn, the deeper underlying issues driving the epidemic in the South.
All of which, you might say, proves the argument that the South needs the kind of support that, barring a miraculous political shift toward progressivism in the region, it can only obtain through private entities such as Gilead. "Private-public health alliances are challenging," says Sharon McDonnell, M.D., M.P.H., a public health and epidemiology expert currently retired from Dartmouth University, "but they can build collaborations that produce better outcomes than would be possible otherwise."
This is true particularly around data collection, she says. "Nobody is ever funded to do that well. It's overlooked. I worked for the CDC and the World Health Organization, so I'm a big believer in public programs. On the other hand, the private sector is more nimble. Capitalism can be very cruel, but it can also quickly rush in and do something that needs to be done."
What's more, says Horn, COMPASS is far from the first time Big Pharma has stepped into the realm of HIV public health -- either in the U.S. or globally. "A lot of HIV drugmakers have long supported community-based programs. And it's good to see Gilead funding a program in the country's most heavily impacted region."
But Chan urges caution. "When I was supported by Gilead," he says, "I felt like I was more likely to do things for them, to listen to them, and give them my advice and go out of my way for them. And I don't think that is being objective."