Patrick O’Connell, a venerable AIDS activist who sought to smash stigma with awareness campaigns such as the iconic red ribbon, has died.
O’Connell passed away aged 67 of AIDS-related causes, his brother Barry confirmed to The New York Times.
Living with HIV for 40 years, he spent much of his life fronting campaigns to better educate the public about what it means to live with HIV/AIDS.
The son of a wire lather and secretary, O’Connell was born 12 April, 1953, in post-war New York City.
For much of the 1980s, O’Conell’s life was filled with rented black funeral suits and friends fearful of what was then a dooming diagnosis. By the end of the decade, AIDS had become the leading cause of death for men aged between 25 and 44.
In 1991, O’Connell formed Visual AIDS, a collective of artists and advocates who used a borrowed art gallery space to design exhibitions that forced the public to reckon that the disease.
We had no choice,” he said in a 2003 interview with the BBC. “We had to do something with our professional lives.
“The East Village art scene felt like it was disappearing overnight because of AIDS. All our colleagues around the country were dying.”
No wonder. The White House was, at the time, almost indifferent to the virus’ rampage across the US and treated it more as a punchline than a public health emergency.
That’s when O’Connell had an idea: a small way to encourage the world to reckon with the disease that was destroying so much of the LGBT+ community – a red ribbon.
That same year he launched the Ribbon Project and with it, an unwavering and defiant symbol of AIDS activism.
To O’Connell, the colour red was as rousing as it was morose. It symbolised, he told the BBC, blood. It is “the colour of passion” and is “vibrant and attention-getting”.
The yellow ribbons from the Gulf War were still all around,” he told The New York Timesin 1992. “We noticed that they could mean anything from ‘I care about young people who have gone overseas’ to ‘I support Bush.’
“We wanted that kind of leeway, too, something that could mean ‘I hate this government’ or just ‘I care about people with AIDS’.”
In the two weeks before the 1991 Tony Awards, the 15 artists involved in Visual AIDS oversaw the making of thousands of grosgrain ribbons which were delivered to the Minskoff Theatre.
Soon enough, whether it be pinned on a dress worn by Elizabeth Taylor or printed on United States Postal Service-issued stamps, the red ribbon was everywhere.
O’Connell’s death comes after that of Larry Kramer, the ACT UP agitator who fought against policy-makers to take the disease seriously, and Nita Pippins, who was something of a mother figure to countless AIDS patients.
“It is hard to be prideful of something that was generated by such frustration and sorrow,” O’Connell reflected of his decades-long work in AIDS activism to the BBC.
“I would give anything, I would give back all this attention if I hadn’t lived through these decades of AIDS.
“All the people who died so young, these talented people. Now I know only one person alive from my 20s.”
HIV-positive Americans are at a high risk for intimate partner violence, with one in four (26.3 per cent) having experienced it at least once, new data has shown.
The findings from the Centers for Disease Control and Prevention (CDC), published in the American Journal of Preventive Medicine, used data from the Medical Monitoring Project, “a surveillance system designed to learn more about the experiences and needs of people who are living with HIV”.
The study showed that not only are HIV-positive people in the US at higher risk of physical abuse at the hands of their intimate partners, but that “intimate partner violence is associated with adverse health consequences among people with diagnosed HIV”.
It also showed that 4.4 per cent had experienced intimate partner violence within the last 12 months.
Researchers from the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention and the National Center for Injury Prevention and Control found that people with HIV who had recently suffered intimate partner violence were “more likely to engage in behaviours associated with elevated HIV transmission risk”, like intravenous drug use or high-risk sex, and “have unmet needs for supportive services”.
They were also “less likely to be engaged in routine HIV care but were more likely to seek emergency care services and have poor HIV clinical outcomes”.
The lifetime prevalence of intimate partner violence among people with HIV varied depending on gender and sexual orientation. The highest risk group was HIV-positive bisexual women, of whom more than half had experienced physical abuse from a partner.
Those who had been homeless within the past 12 months were also at a higher risk (37.6 per cent) than those who had not (25.2 per cent).
Researchers said it was “important” that HIV-positive Americans are screened for intimate partner violence at initial HIV tests, as well as during routine appointments.
This, they said, “may help address issues of missed medical visits, poor [antiretroviral treatment] adherence, and difficulty attaining and maintaining viral suppression”.
They added: “When intimate partner violence is identified, supportive services should be offered.
“With these additional supportive services, the safety and health of people with HIV may be improved.”
President Biden, unveiling on Friday his initial budget request to Congress in the first year of his administration, called for ramping up funds to beat the HIV/AIDS epidemic in the United States, signaling he’d continue the PrEP-centric initiative that began in the previous administration.
In the preliminary budget request for fiscal year 2022, known in Washington parlance as the “skinny budget” in anticipation of broader request at a later time, Biden seeks an increase of $267 million for Ending the HIV Epidemic, building on the more than $400 million Congress has appropriated for the program since 2019.
As it was launched in the Trump administration, the initiative sought a 90 percent decrease in new incidents of HIV infections across the United States by 2030, although Biden campaigned on beating that goal by five years and ending the domestic HIV epidemic by 2025.
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, hailed in a statement the proposed increased funds for the initiative, but said it falls short of the amount advocates in the fight against HIV/AIDS were seeking.
“While it falls short of what the community has requested, if this funding is realized it will continue the momentum already created and make further progress in ending HIV in the U.S. Efforts to end HIV will help eradicate an infectious disease that we have been battling for the last 40 years and help correct racial and health inequities in our nation,” Schmid said.
Counterintuitively, Trump had sought more funds to beat HIV/AIDS in his final year in office than Biden has in his first year in office. Last year, President Trump’s budget called for an increase of $412 million for the second year of the initiative for a total of $716 million while Congress settled on an increase of approximately $137 million.
Biden seeks increased funds for HIV/AIDS at a time when advocates in the fight against HIV were at a crossroads at the start of a new administration. Questions had persisted about whether or not the Biden administration would continue the initiative, which was the brainchild of health officials in the Trump administration.
Virginia Gov. Ralph Northam on Thursday signed a bill that decriminalizes HIV transmission, but advocates continue to call for the removal of a felony penalty left in place.
“Although we see this as a victory, we acknowledge the call of people living with HIV in Virginia to continue to fight to change the criminal penalty level of the modernized law from a felony to a misdemeanor level,” said Cedric Pulliam, co-founder of the ECHO VA Coalition, in a press release. “And we accept that fight and will continue efforts until this has been successfully accomplished.”
Senate Bill 1138, sponsored by Sens. Mamie Locke (D-Hampton) and Jennifer McClellan (D-Richmond), removes HIV from a list of “infectious biological substances” under the infected sexual battery section of the state code.
Supporters say this change will reduce stigma and other challenges faced by Virginians who are HIV positive and modernizes Virginia Code in accordance with current understanding about the disease and current guidance from the Centers for Disease Control and Prevention.
As the bill advanced through the General Assembly, the Virginia Senate lowered the penalty for HIV sexual transmission from a felony to a misdemeanor. The House of Delegates, and now the governor, kept the felony punishment in place.
Equality Virginia and HIV advocacy groups ECHO-VA, Positive Women’s Network-USA, and the Sero Project on Thursday stated in a press release that they approved of Northam’s signing the decriminalization bill into law, but they were disappointed the felony penalty was not removed.
“We’re thankful for the many advocates who shared their lived experiences and pushed for changes to Virginia’s HIV laws,” said Equality Virginia Executive Director Vee Lamneck in the released statement, which included a report Northam commissioned that found Black Virginians were almost seven times as likely to be living with HIV in 2015 than white Virginians.
“This new law is an important step towards reducing stigma and breaking down barriers to HIV care and prevention,” Lamneck said. “Moving forward, Equality Virginia remains committed and determined to educate and advocate for removing the felony penalty.”
With the inauguration of President Joe Biden, I hope we may now see the kind of leadership on LGBTQ issues we need. As a gay African-American man living with HIV, I have lived through two pandemics. Under both HIV/AIDS and COVID-19, LGBTQ people have had to shoulder the burden of discrimination while fighting to survive. I hope that 2021 is the year that changes.
I was diagnosed with HIV in 1984, in the early years of the epidemic. I lost many friends in the years that followed. So many of us in that time never expected to live a full life ourselves. After watching our friends die, it became hard to imagine that we’d ever make it to our 40th birthday — let alone retirement. The discrimination we experienced and the looming threat of the virus made it difficult to build careers and save for the golden years we never thought we’d see. I’ve lost jobs due to discrimination myself, and the stress of it nearly killed me. That’s why today, I help advocate for LGBTQ elders and folks on social security.
I have seen every stage of the HIV/AIDS crisis, from the pandemic, to its aftermath, to the present day. I know how much work it takes to survive and thrive in the face of this virus. As the administrator of a group home for folks recovering from HIV-related hospital stays, a member of the local HIV Planning Council, and a care outreach specialist for a community clinic, I’ve seen the kind of discrimination people still face. I once worked with a pregnant woman who was turned away from a local hospital for being HIV-positive. Because our clinic existed, she got the care she needed and her baby was born healthy.
In recent years, advances in prevention and access to testing and treatment have led to encouraging declines in new diagnoses. But stigma and anti-LGBTQ bias continue to have consequential effects on testing decisions. Time and again, I have spoken with clients who choose to hide their condition or status to avoid ostracization and discrimination. According to a recent research report by the Williams Institute at the University of California, Los Angeles, 44 percent of Black LGBTQ adults have either never been tested, tested when they felt at risk, or once every two years or less. It’s an alarming statistic that falls far too short from CDC recommendation for testing frequency for HIV, which is at least once a year or more frequently.
Despite these challenges, it’s possible to live a full and healthy life with HIV/AIDS. As Americans, we should be able to participate in all aspects of daily life with dignity and respect, and without fear of discrimination. If we wholeheartedly want to end the HIV epidemic in the United States, we must seize the moral high ground and ensure LGBTQ Americans are provided with equal rights, better access to care, and increased secure housing. Federal nondiscrimination legislation will help us get there.
Although it’s important to celebrate how far we’ve come, right now, 50 percent of LGBTQ people live in the 29 states that lack comprehensive statewide laws explicitly prohibiting discrimination against LGBTQ people, including here in my home state of Georgia. And in the midst of a pandemic and the accompanying economic crisis, it’s inhumane that millions of us can still be denied housing or medical care just because of who we are or who we love. Situations like these enable the spread of HIV.
Our nation is going through a profound change, but our values of treating others as we would want to be treated remains the same. The Equality Act would ensure that all LGBTQ Americans can live, work, and access public spaces and medical care free from discrimination, no matter what state we call home. It’s the right thing to do — which is why this type of legislation has broad and deep support across lines of political party, demographics, and geography. Public support is at an all-time high, with 83 percent of Americans saying they favor LGBTQ nondiscrimination protections, including 68 percent of Republicans and a majority in every state in the country.
After all, equality is not a Democratic or Republican value, it’s an American value. It’s also the smart thing to do as we work to end the HIV epidemic in America.
Nathan Townsend is a 66-year-old Black gay man living and thriving with HIV for 36 years. He devotes his time and efforts helping to promote health equity and equal access to care for his community.
Virginia lawmakers have approved legislation modernizing laws around HIV exposure.
Passed after two versions of the bill were reconciled, the legislationwould repeal the felony criminal ban on blood, tissue or organ donation by people with HIV and other sexually transmitted infections; make HIV-testing for people convicted of certain crimes, including prostitution and drug charges, optional rather than mandatory; and strike down a statute making failure to disclose HIV-positive status before sex a Class 1 misdemeanor punishable by up to 12 months jail time.
Intentional transmission of HIV, or “infected sexual battery,” would remain a felony in Virginia, rather than a misdemeanor, as proponents had hoped, but the new legislation would require proof of actual infection, rather than just exposure.
The bill now heads to Gov. Ralph Northam, a Democrat, who has until March 31 to sign the measure into law. While Northam has not specifically said he would sign the bill, he has previously signed pro-LGBTQ bills, including one requiring schools to create policies related to the treatment of trans students and a ban on so-called conversion therapy.
Virginia state Sen. Jennifer McClellan, a Democrat, who introduced the bill with fellow Democrat and state Sen. Mamie Locke, said HIV criminalization laws are an ineffective public health tool that disproportionately affect the LGBTQ community and people of color.
“They target and stigmatize people who are HIV positive, even though being HIV positive is itself not a threat to public safety.” McClellan told NBC News. “It makes people less likely to disclose or get tested.”
There’s also the question of determining someone’s intention to expose a partner.
“It’s so hard to prove,” McClellan said. “There have been instances where you’ve had a bad breakup and someone will swear out a warrant, saying ‘You tried to infect me,’ or use it as a threat.”
In the intervening decades, understanding and treatment of HIV have grown exponentially. But leading health organizations, including the American Medical Association, the World Health Organization and the CDC itself, say the laws have not caught up with advances in science.
According to the CDC, many HIV laws criminalize behavior that cannot transmit the virus — including spitting or biting — and can be applied whether or not there is actual transmission. They also don’t account for advances in HIV medication, which can keep an individual’s viral load undetectable, presenting zero risk of transmission.
Before Saturday, only six states had modernized their criminalization laws since 2014: California, Colorado, Iowa, Michigan, North Carolina and Washington, according to the advocacy group Equality Virginia. Just one, Texas, has repealed its laws.
While Virginia’s law has rarely been enforced, between 2019 and 2020 three people in the state were convicted of felony infected sexual battery and misdemeanor sexual battery, according to the Roanoke Times.
McClellan’s bill, which made infected sexual battery a misdemeanor, passed the Senate 21-17 earlier this month. But a version keeping the felony charge intact cleared the House of Delegates 56-44 Friday. In negotiations to reconcile the two bills, the House version prevailed.
Some lawmakers were concerned the language in McClellan’s bill would allow someone to intentionally transmit HIV without fear of prosecution.
“I find it stunning that we would want to eliminate the felony for what is potentially fatal, deadly conduct,” state Sen. Mark D. Obenshain, a Republican, told The Washington Post.
McClellan argues there are other laws about intentionally infecting someone with a disease, including those prohibiting “malicious wounding.” “There’s no reason to specifically single out people with HIV,” she said.
Cedric Pulliam, co-founder of Ending Criminalization of HIV and Overincarceration in Virginia, or ECHO VA, said the group will continue to work with advocates and legislators to change the law, “whether it’s this year or the next.”
“When you’re a felon, it messes up your career, your housing, your education — your entire mental state,” said Pulliam, a public health expert at the CDC. “We want to focus on the rehabilitative things we can do rather than punish people.”Last session ECHO VA didn’t back a less comprehensive version of the bill, because it “didn’t push the needle far enough,” co-founder Deidre Johnson told NBC News. She wasn’t sure McClellan’s bill, which included repeals of the donation ban and mandatory testing, would succeed. “We knew we wouldn’t get everything but we were shocked we got what we did,” she said.
Just last week, a bill banning the use of the so-called panic defense, used to mitigate violent crimes against LGBTQ people, passed with clear majorities in both houses.
“We’ve made generational change in less than two years,” McClellan said. “I think the public was there, I think there were even Republicans that were there. But the GOP leadership wouldn’t let [LGBTQ rights legislation] out of committee.”
The bill’s passage helps to cement Virginia as a leader on LGBTQ rights. On Tuesday, the Congressional HIV/AIDS Caucus reintroduced the REPEAL Act, which provides incentives to states that reform their HIV exposure laws.
Sponsored by Reps Barbara Lee, D-Calif., and Jenniffer González Colón, R-Puerto Rico, the bill also directs the Health and Human Services and Justice departments to review policies that criminalize people living with HIV.
“We cannot achieve our shared goal of an AIDS-free generation while these laws are on the books,” Lee said in a statement. “It is past time that we repeal these harmful and discriminatory laws and instead focus our efforts on promoting public health equity and public awareness.”
President Joe Biden has indicated he supports the REPEAL Act on his policy site, saying HIV exposure laws have no basis in science and “perpetuate discrimination and stigma towards people with HIV/AIDS.”
A study that could one day lead to a potential HIV vaccine has shown promising results, scientists have said.
Researchers from the International AIDS Vaccine Initiative (IAVI) and Scripps Research say that a phase-one trial has shown “proof in principle” for a new type of vaccine that could be used against the virus.
An effective vaccine to prevent HIV infection has proved elusive for nearly four decades, not least because the virus constantly evolves into different strains to evade the immune system.
However, the trial found success in “stimulating production of rare immune cells needed to start the process of generating antibodies” that could neutralise diverse strains of HIV.
The trial succeeded in generating cell production in 97 per cent of participants, though researchers stressed it is only a first step.
Professor William Schief, executive director of vaccine design at IAVI’s Neutralizing Antibody Center, said in a release: “This study demonstrates proof of principle for a new vaccine concept for HIV, a concept that could be applied to other pathogens, as well.
“With our many collaborators on the study team, we showed that vaccines can be designed to stimulate rare immune cells with specific properties, and this targeted stimulation can be very efficient in humans.
“We believe this approach will be key to making an HIV vaccine and possibly important for making vaccines against other pathogens.”
The researchers are now partnering with biotechnology company Moderna to develop and test an mRNA-based vaccine – the same radical approach employed in the creation of coronavirus vaccines.
U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus.
Thursday’s approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals.
“That will enhance quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV infected.”
Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.
The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva.
The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well tolerated.
ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things.
Studies found that patients greatly preferred the shots.
“Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a commentaryaccompanying one study of the drug in the New England Journal of Medicine.
Deeks said long-acting shots also give hope of reaching groups that have a hard time sticking to treatment, including people with mental illness or substance abuse problems.
“There’s a great unmet need” that the shots may fill, he said.
Separately, ViiV plans to seek approval for cabotegravir for HIV prevention. Two recent studies found that cabotegravir shots every two months were better than daily Truvada pills for keeping uninfected people from catching the virus from an infected sex partner.
When Jeff Taylor, a longtime AIDS advocate and survivor, learned about clinical trials for the new Covid-19 vaccine in his hometown, Palm Springs, California, he leapt at the opportunity to participate.
“I always want to be the first person to try something,” he said.
But Taylor’s enthusiasm was short-lived. As soon as he told a recruiter over the phone that he was HIV-positive, Taylor was informed that he was ineligible to join.
“I argued with him, but he said: ‘I don’t make the rules. This is what our sponsor told us to do,'” Taylor, 58, said.
Taylor understood, in a sense, why they were rejecting him. As head of the HIV + Aging Research Project-Palm Springs, he had read plenty of studies that excluded people who were immunocompromised or on immune-modularity drugs.
“It’s something that happens all time,” Taylor said.
A study published this year in the Journal of Clinical Oncology found that 73 percent of over 1,090 analyzed cancer immunotherapy trials specifically excluded patients with HIV.
Not including a sample for the estimated 1.2 million HIV-positive people in the U.S. in the most significant vaccine trial in a generation seemed to him unwise. On July 18, Taylor notified a private listserv for HIV activists and researchers called IBT-Cure. Shortly thereafter, he got a response from Lynda Dee, executive director of AIDS Action Baltimore, another heavyweight in the HIV advocacy world who has been agitating for an AIDS vaccine since the 1980s.
“Vaccine protocols change, and there are usually 20 iterations before they actually get sent to the FDA for approval,” she said. “Someone must have stuck [the HIV exclusion] in there.”
She speculated that researchers didn’t want to include a population that they thought could compromise their results.
“Somebody must have thought: ‘Well, this is about immune systems. I don’t want to confound the data by including someone with HIV,’” she said. “They had no idea what something like that looks like and what hell they were going to get from people like us.”
Written with a palpable urgency and more than a whiff of anger, the letter, which the activists also posted to Change.org, said the agency was shooting itself in the foot by excluding HIV-positive people from Covid-19 vaccine trials. Black and Latino residents of the U.S. had been disproportionately affected by both HIV/AIDS and Covid-19, the letter said, and now both communities were the most likely to express skepticism about the coronavirus vaccine.
The activists also pointed out that people with HIV who were responding well to antiretroviral therapy weren’t considered so “immunodeficient” that they were barred from getting other vaccines. (The Centers for Disease Control and Prevention doesn’t recommend certain live vaccines for people with HIV whose CD4 white blood cell count is below 200.)
Dee said she also reached out to her contacts in the U.S. government, including Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases. She said Dieffenbach was able to quickly begin discussions with Moderna, because the drugmaker was using government-run clinical trial networks to test its vaccine. (Pfizer didn’t rely on funding from the U.S. government’s Operation Warp Speed.)
Dieffenbach did not respond to a request for comment.
On Aug. 5, about eight days after Dee posted the letter on Change.org, Moderna changed course and announced plans to drop its exclusions. Moderna recruited 176 people living with HIV out of 30,000 participants, according to data on the FDA’s website. Of those with HIV, one who received the placebo and none who received the vaccine developed Covid-19, according to the data.https://platform.twitter.com/embed/index.html?creatorScreenName=NBCNews&dnt=false&embedId=twitter-widget-0&frame=false&hideCard=false&hideThread=false&id=1291056643464192001&lang=en&origin=https%3A%2F%2Fwww.nbcnews.com%2Ffeature%2Fnbc-out%2Finside-fight-include-hiv-positive-people-covid-19-vaccine-trials-n1252458&siteScreenName=NBCNews&theme=light&widgetsVersion=ed20a2b%3A1601588405575&width=550px
Pfizer made a similar announcement a day later and ended up enrolling a relatively small number of HIV-positive people — 120 out of 43,000 participants — in the last phase of its trials, according to information on the FDA’s website. An efficacy rate for the HIV-positive participants in Pfizer’s vaccine is not yet available.
The CDC’s website says people with HIV “may receive the vaccine” but notes that the safety data specific to this population “is not yet available.” The agency adds that people with weakened immune systems “should also be aware of the potential for reduced immune responses to the vaccine, as well as the need to continue following all current guidance to protect themselves against COVID-19.”
Even though Dee was able to exert pressure on much of the hulking bureaucracy that decides who gets injected first, she still laments that it took so long for the vaccine makers to change their rules.
“We got ’em in,” she said, “but my God, what a mistake,” she said of the initial exclusion of those with HIV.
Neither Pfizer nor Moderna responded to multiple requests for comment.
Dr. Larry Corey, a virologist who was chosen by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, to run vaccine testing operations for Operation Warp Speed, said the pressure on Pfizer and Moderna has been immense, “similar to playing Wimbledon Center Court.”
“I think there were an overwhelming number of priorities and things to do, and it just fell off the radar,” he said.
Corey said there was never “any worry” in the advocacy world that people successfully managing their HIV infections on antiretroviral therapy would have bad responses to the Covid-19 vaccine. Other experts at the Joint U.N. Program on HIV/AIDS, the British HIV Association and Aidsmap have also said the Covid-19 vaccine should be considered safe and effective for people with HIV.
Now, Dee and others are working to amend CDC guidelines and prioritize HIV-positive people for vaccination after the elderly and essential workers, as Germany has done. Some data have emergedthat suggest that people living with HIV are also at an increased risk of severe Covid-19 (although more research is needed), and nearly half of Americans who are HIV-positive are over age 50 and thus more likely to live with co-existing conditions that can complicate the course of the illness, like diabetes or cardiovascular disease.
Dee, who watched all of her friends die of AIDS in the ’80s, said she’s ready for this next fight.
“I’m a pushy old broad, and I’ve been doing this for 33 years,” she said. “People know me, they trust me, and they’re often a little afraid of me because I’m this East Coast battle-ax, and I say what I think.”
A new pilot study funded by the Food and Drug Administration could be the first step toward lifting restrictions on blood donations by gay and bisexual men.
The program, called Assessing Donor Variability and New Concepts in Eligibility (Advance), has been launched by three of the nation’s largest blood centers — the American Red Cross, Vitalant and OneBlood.
Approximately 2,000 men who have sex with men (MSM) will be recruited at community health centers in San Francisco; Los Angeles; Memphis, Tennessee; Atlanta; Orlando, Florida; Miami; Washington, D.C.; and Baton Rouge, Louisiana. Participants must be 18 to 30, have had at least one male sex partner in the last three months and be willing to donate blood. The results could ultimately determine whether the FDA changes its blood-donor history questionnaire, asked of all potential donors to assess risk factors for infection by transfusion-transmissible diseases such as HIV and Hepatitis B.
“If the scientific evidence supports the use of the different questions, it could mean men who have sex with men who present to donate would be assessed based upon their own individual risk for HIV infection and not according to when their last sexual contact with another man occurred,” a statement on the Advance website reads.
Restrictions on certain blood donors date to the early 1980s, during the height of the AIDS epidemic in the United States, when the FDA instituted a lifetime ban on any man who had had sex with another man since 1977. That rule, intended to keep HIV out of the blood supply, was replaced in 2015 with a year-long abstinence requirement.
After the 2016 Pulse nightclub massacre in Orlando, more than 100 members of Congress — including Sens. Tammy Baldwin, D-Wis., Elizabeth Warren, D-Mass., and Bernie Sanders, I-Vt. — signed letters urging then-FDA Commissioner Dr. Robert Califf to eliminate the deferral policy.
“We can’t say some people can give blood, other people can’t based on their sexual orientation,” then-Rep. Alan Grayson, D-Fla., who represented Orlando at the time, told reporters, according to The Washington Blade.
Gay, bisexual and other men who have sex with men are the group most affected by HIV in the U.S., according to the CDC: In 2018, they accounted for 69 percent of the nearly 38,000 new HIV diagnoses across the country.
In April, as coronavirus lockdowns caused donations to plummet, the FDA quickly lowered the eligibility requirement for MSM to just three months.
The pandemic’s impact on available blood was swift and severe: By mid-March, the American Red Cross had canceled some 2,700 blood drives, resulting in 86,000 fewer donations. In April, donations at the New York Blood Center were down from an average of 9,500 a month to fewer than 2,000, according to New York state Sen. Brad Hoylman, who is gay and was initially rejected as a donor despite meeting the new criteria. “A regular month they host about 600 blood drives,” Hoylman told NBC News in May. “Last week, they hosted two.”
The three-month deferral also affects women who have sex with MSM, sex workers, injection drug users and those with recent tattoos or piercings.
In an April letter to the FDA, two New York Democrats, Rep. Carolyn B. Maloney, chair of the Committee on Oversight and Reform, and committee member Rep. Alexandria Ocasio-Cortez, called the change “a good first step” but urged the agency to move toward assessing potential donors by individual risk.
“A policy that fails to do this perpetuates stigma and falls short of ensuring that every person who can safely donate blood in the United States has the opportunity to do so,” they said.
The Red Cross, which had encouraged the FDA to adopt the three-month deferral model, also called it “a scientifically based interim step” toward abolishing restrictions altogether.
“Blood donation eligibility should not be determined by methods that are based upon sexual orientation,” the relief organization said.
“Italy, Spain and other nations modernized their donor policies years ago, before the U.S. even ended its lifetime ban,” he told NBC News.
More than a dozen nations — including Argentina, Brazil, Mexico and Colombia — have adopted a risk-based questionnaire in place of a blanket policy based on sexual orientation. Earlier this month, the U.K. became the latest.
Franzone said he’s confident the Advance study will bear out what advocates like him have been saying all along: “Individual, risk-based assessment is safer for recipients of lifesaving blood.”
Jason Cianciotto, senior managing director of institutional development and strategy at New York’s Gay Men’s Health Crisis, said it’s exciting to reach this point after more than a decade of advocating for policy change.
He did have concerns about the Advance study, though, saying 2,000 individuals “is not a representative sample,” especially as no health centers in Chicago, New York, Boston or other Northeastern cities are involved.
He speculated that the pilot study, like the three-month deferral, was spurred by the pandemic.
“When we’ve lobbied the FDA in the past, their statements showed they didn’t really see an imperative” to change the current policy, Cianciotto told NBC News. “Even though we explained the ban contributed to stigma against people with HIV.”
But when advocates had mentioned gay and bisexual donors could help alleviate blood shortages, Cianciotto said, the FDA has always claimed it didn’t really have any. “Of course, no one could have predicted a nationwide shortage of blood and blood products caused by a pandemic,” he added.
That the program has started under the Trump administration, which has been accused of rolling back LGBTQ rights, increases the likelihood that it was being driven by necessity, he said.
An FDA spokesperson told NBC News that the agency “remains committed to considering alternatives to time-based deferral by generating the scientific evidence that is intended to support an individual risk-assessment-based blood donor questionnaire.”
The spokesperson indicated there is no announced timeline for the study’s completion, although ABC News reported that researchers aim to present their findings by late 2021.
Cianciotto said he hopes the program is completed and implemented before the next election.
“In a Biden administration, we’ll have an advocate like we had in the Obama administration — in fact, one who actually was in the Obama administration,” he said. “But we can’t risk this becoming a campaign issue.”