I was diagnosed with HIV just shy of my 30th birthday. That day, everything changed. I was apprehensive about my prognosis, my treatment plan, and my ability to live a normal life.
Fortunately, medical advances have turned HIV from a certain death sentence into a manageable condition. Still, like all Americans who depend on complex medications to stay healthy, I worry about high drug prices, and this concern has only intensified amid the COVID-19 pandemic. Especially since some of the proposed “solutions” to high drug prices would put patients’ health at risk.
Just recently, the Trump administration announced that it would allow states to import prescription medications from Canada with the aim of saving money for consumers. Doing so, though, could expose millions of Americans to counterfeit drugs, while achieving little in the way of savings.
I’ve seen firsthand how importation schemes can put patients at risk.
Shortly after learning I was HIV-positive, I ordered my anti-retroviral drugs from an online Canadian pharmacy. For two months, I received medications via mail without ever wondering where they were sourced or whether they contained the active ingredients I needed to keep me alive.
Then my doctor intervened. She told me that drugs purchased through online storefronts are often adulterated or counterfeit—in fact, the global trade in fake medicines is a $30 billion-a-year business. Unknowingly, I had been rolling the dice with my health.
There are two types of counterfeit drugs. The first contains potentially deadly substances— everything from arsenic to antifreeze. The second contains few, if any, active ingredients. Though pills in the latter category don’t contain actual poisons, they can be deadly. Anti-retroviral drugs have to be taken exactly as prescribed; missing even a few doses can allow the virus to reemerge.
There is no mechanism in place to regulate the quality of drugs imported by American patients. A senior official at Health Canada explicitly told the U.S. surgeon general that her agency “does not assure that products being sold to U.S. citizens are safe, effective, and of high quality.” The FDA, meanwhile, plainly states that it “cannot ensure the safety and effectiveness of drugs that it has not approved.”
Moreover, drugs purportedly from Canada could come from anywhere. A 2017 study by the National Association of Boards of Pharmacy found that three quarters of online pharmacies claiming to sell Canadian drugs actually sourced their products from places like India, Singapore, and Hong Kong, all major suppliers of counterfeits. Back in 2005, the FDA reported that only 15 percent of imported drugs marketed as Canadian actually originated in Canada. The other 85 percent came from “27 countries around the globe,” meaning that many likely didn’t go through rigorous quality control.
It’s relatively easy to get hoodwinked by online pharmacies that promise quality drugs at bargain prices. CanadaDrugs.com, for instance, started out in 2001 as a seemingly reputable online pharmacy. But soon it turned to distributors outside of Canada to secure medicines. In 2018, a U.S. court prosecuted and fined the company for selling fake cancer drugs to American doctors.
Counterfeiters have shown they are willing to prey on people living with all kinds of diseases, including HIV. In 2011, a British regulatory agency discovered that two fake HIV medications had infiltrated the market and were circulating among patients.
Opening the door to drug imports would allow that kind of thing to happen here, putting us all at risk. And it’s not even certain that legalizing importation would cut costs. The FDA acknowledges that it is “unable to estimate the cost savings” from President Trump’s new plan. Former FDA Commissioner Scott Gottlieb wrote that “when importation of foreign drugs is done under a regulated scheme, it really wouldn’t save money.”
Right now, Americans are anxious enough about our health. Let’s not add drug imports to our list of things to worry about.
Brandon M. Macsata has been living with HIV since 2002, and serves as CEO of the ADAP Advocacy Association, an organization that promotes the AIDS Drug Assistance Program and works to improve access to care.
When Dr. Anthony Fauci, one of the most visible members of the White House Coronavirus Task Force, learned about the impact the virus could have on patients with underlying medical conditions, among his concerns was the health of a man he had grown to love and admire while battling a prior public health crisis.
“As soon as Covid-19 came, I immediately thought about my dear friend Larry,” Fauci, 79, said of the longtime AIDS activist and gay rights titan Larry Kramer.
When the coronavirus swept through New York City earlier this year, Kramer, who resided in Manhattan, was 84, HIV-positive and the recipient of a liver transplant. If he were to contract the novel virus, his odds of suffering a severe case of Covid-19 would have been high. But while the outbreak gave the two old friends reason to reflect on the early days of the AIDS epidemic — where they were both on the front lines — and discuss the current global health crisis, it was not Covid-19 that claimed the life of the outspoken activist in May, but pneumonia.
In the months following Kramer’s death, Fauci recalled some of their final conversations and the legacy of a man with whom he had a “complicated relationship,” though “at its foundation there was a great deal of affection.”
Kramer — who in 1982 co-founded the Gay Men’s Health Crisis, once the largest supplier of resources to AIDS patients across the country, and then in 1987 founded the grassroots activist group AIDS Coalition to Unleash Power (ACT UP) — never turned down a fight against federal officials tasked with overseeing public health policy. One of these officials was Fauci, who in 1984, as the AIDS crisis rose to prominence, became the director of the National Institute of Allergy and Infectious Diseases, a position he still holds today.
Kramer would regularly lambaste Fauci during the early years of the AIDS crisis in public statements, saying he was too inexperienced to lead the national institute. He also accused Fauci of ignoring the outbreak, similar to how former President Ronald Reagan had done so throughout much of his first term in office, when he refused to even acknowledge the existence of the then-novel virus.
In a 1988 open letter that called Fauci a “murderer,” Kramer wrote: “Your refusal to hear the screams of AIDS activists early in the crisis resulted in the deaths of thousands of queers.”
But many AIDS activists would later hail Fauci as a powerful mediator between them and the international scientific community. He has been credited by both advocates and scientists alike with increasing the amount of patients with access to experimental treatments for HIV and AIDS by amending the way the government conducts clinical drug trials.
“One important legacy from the HIV epidemic is how the FDA, clinical research and science were transformed by the urgency and activism of groups like ACT UP,” said Dr. Adrienne Shapiro, an infectious disease specialist at the University of Washington who is part of a national study exploring the impact Covid-19 has on those living with HIV.
Shapiro said much of the research she is now conducting would not have been possible without AIDS activists like Kramer and the initiatives led by Fauci throughout his career.
“Here we are leveraging this incredibly well-characterized, well-resourced cohort study that has been set up for 15 years, with people who have been followed for years and years, to ask questions about Covid. Data collection processes were already in place,” she said. “We didn’t have to reinvent the wheel.”
In both public health crises, Fauci has worked under presidents who were slower than he was to sound the alarm about the viral outbreaks. Whereas Reagan was accused of outright ignoring the AIDS crisis, President Donald Trump has been accused of “downplaying” the coronavirus pandemic so as not to cause widespread concern.
While Kramer was one of Fauci’s loudest critics during the early days of the AIDS crisis, Fauci said the late activist was one of his strongest defenders during the early days of the Covid-19 outbreak.
“He became kind of protective,” Fauci said, recalling that Kramer was livid when he heard the immunologist faced death threats and incendiary attacks over his calls for Americans to wear masks and follow social distancing measures during the initial months of the coronavirus pandemic.
“Larry wrote me this email, and he was really indignant,” Fauci said. “He would say, ‘These a——- are not treating you very well.’”
Fauci said there was a notable irony in their final conversations.
“Here was a guy who would not hesitate for a moment to criticize me,” he said, “but he didn’t want anybody else unjustifiably criticizing me.”
He recalled how Kramer would send him notes complaining about how his response to the pandemic was being criticized by some in the media.
“You’re killing yourself during this outbreak,” Kramer wrote, according to Fauci. “What a bunch of jerks.”
When the two discussed the pandemic on the phone, Fauci said it felt as if Kramer “really was like my old friend being protective of me.”
But the leading immunologist’s reputation was the last thing on his mind when he spoke to his once-toughest critic after learning what the pandemic was capable of inflicting on those with pre-existing health conditions.
“I have always been very concerned about Larry,” Fauci said, adding that he called Kramer as Covid-19 cases began to soar in the U.S., to ensure his safety: “I got on the phone with him, and I said, ‘Larry, you’re not going to like this, but here’s what you’ve got that’s a problem: You’re 80-something-years old, you have HIV and you have a liver transplant.”
Like millions of other Americans, Fauci was trapped in a battle of words, trying to convince his friend to focus on what he felt was the biggest issue at hand.
“I told him, ‘I know you like to be up and about, but you’ve really got to hunker down until this thing blows over,’” he remembered telling him. “I joked about it. You know, I’m not so young myself. I said, ‘We old guys, Larry, us old has-beens, we’ve got to take care of ourselves.’”
Now, four months after Kramer’s passing, Fauci said the activist’s legacy and indefatigable tenacity live on. Whether it’s the coronavirus or another novel virus that sweeps the nation, the country’s top doctor said he will always be guided by the spirit — and the unending criticism — of his “dear friend.”
Timothy Ray Brown, who made history as “the Berlin patient,” the first person known to be cured of HIV infection, has died. He was 54. Brown died Tuesday at his home in Palm Springs, California, according to a social media post by his partner, Tim Hoeffgen.
The cause was a return of the cancer that originally prompted the unusual bone marrow and stem cell transplants Brown received in 2007 and 2008, which for years seemed to have eliminated both his leukemia and HIV, the virus that causes AIDS.
“Timothy symbolized that it is possible, under special circumstances,” to rid a patient of HIV — something that many scientists had doubted could be done, said Dr. Gero Huetter, the Berlin physician who led Brown’s historic treatment.
One other man is believed to have been cured of HIV after undergoing to same transplants in 2016.
A Navy veteran is suing the US government after doctors allegedly forgot to tell him he tested positive for HIV in the 1990s.
The South Carolina man says he was unaware he was living with HIV for more than two decades after government health workers failed to inform him of his test results.Read More
A federal lawsuit explains how he was tested in November 1995 at a Department of Veterans Affairs (VA) medical centre in Columbia, South Carolina as part of routine lab work.
The veteran, named only as John Doe in the filing, was under the care of the department after being involved in a 1976 shipwreck which left him with post-traumatic stress disorder (PTSD).
However, “in clear contravention of the standard of care, Mr Doe was not informed of the positive HIV test until decades later”, the lawsuit states.ADVERTISING
In fact, it wasn’t until 2018 that the veteran says he was made aware of his status.
In 2014, a nurse practitioner at the Columbia facility had noted the 1995 test results in a memo. Mr Doe still wasn’t informed, the suit states.
He saw another VA doctor in 2015 who asked if he knew who his infectious disease doctor was. When he replied that he didn’t have one, the doctor reportedly asked the veteran if he knew whether he was living with HIV. Even still, the suit states, Mr Doe wasn’t made aware of his positive status.
Finally, in September 2018, the veteran visited an emergency room not affiliated with the department. It was here that he says he was diagnosed with HIV and AIDS, and immediately began treatment.
According to the suit, the veteran had by this time developed a number of related illnesses including an infection of his brain tissue.
“[He] needlessly suffered for decades with co-existing conditions common in HIV infected persons, including lymphadenopathy, neurotoxoplasmosis, muscle aches and joint pain,” the lawsuit says.
“Had defendants acted within the standard of care, Mr Doe would not have suffered the losses he has suffered, and will continue to suffer in the future, and more likely than not, he would not have developed AIDS.”
The veteran’s lawyer Chad McGowan said he is responding to antiretroviral therapy, but has “had essentially 25 years of wear and tear for having no treatment”.
“He feels extremely guilty about the girlfriends he’s had over the last 25 years because he didn’t know.”
The Department of Veteran Affairs told the Associated Press it “does not typically comment on pending litigation”.
According to the Terrence Higgins Trust, a person who is diagnosed and starts treatment early can expect to live as long as person without HIV.
Once the treatment has lowered the levels of the virus in a person’s blood – their viral load – they are unable to pass on HIV and the virus is no longer able to damage their immune system. This is known as being undetectable (meaning tests can no longer detect HIV in a person’s blood). Undetectable equals untransmittable.
A man in Perth, Australia, has been jailed for five years after he failed to disclose that he was living with HIV to four sexual partners – all of whom later tested positive for the virus.
The 30-year-old, who has not been named to protect the identities of his victims, told the four men that he did not have HIV before having condomless sex with them, the West Australian reports.
A court heard that the accused had actually been diagnosed with HIV in 2012.
In 2013, he told a man that he did not have HIV before having condomless sex with him. His sexual partner was later diagnosed with the virus.
In 2014, he told another man through the dating app Squirt that he did not have HIV. A year later, the two met and had condomless sex. Just weeks later, his sexual partner became ill, and he tested positive for HIV four months later.
In 2012 the accused embarked on a long-term relationship, and told his boyfriend that he did not have HIV. They started having condomless sex in 2014, but his boyfriend’s suspicions were aroused in 2015 when he found antiretroviral medication.
The boyfriend went for a HIV test and discovered that he too had the virus. They separated a year later.
Following that incident, the accused met up with a man through Tinder and had condomless sex with him after claiming that he did not have HIV. That man also tested positive.
Man who lied about HIV status ‘extraordinarily selfish’.
The offender was arrested in January 2018 and charged with unlawfully engaging in an act that was likely to endanger his victims’ life, health or safety.
In his sentencing, district court Judge Troy Sweeney said the man had been “reckless” by failing to disclose his HIV status to the four men.
Puerto Rico Resident Commissioner Jenniffer González Colón and former U.S. Rep. Ileana Ros-Lehtinen (R-Fla.) on Monday stressed the fight against HIV/AIDS remains a bipartisan issue.
“This is a health issue,” said González during a Zoom call that AIDS United organized. “This is not about a certain group of the community. This is not about a specific gender. This is about health care. This is about health.”
González is a Republican non-voting member of the U.S. House of Representatives who is a member of Puerto Rico’s pro-statehood New Progressive Party. California Congresswoman Barbara Lee, who chairs the Congressional HIV/AIDS Caucus, late last year named González co-chair of the group.
González on Monday said more than 40,000 people in Puerto Rico live with HIV. She also noted she and Lee in March introduced a bill that would repeal laws that criminalize people with HIV/AIDS and discriminate against them.
“This is something that goes across party lines,” she said. “This is something that affects everybody … we should be doing something about it.”
Ros-Lehtinen, who was born in Cuba, in 1989 became the first Latina woman elected to Congress. She represented portions of South Florida in the House until her retirement in 2019.
Ros-Lehtinen co-chaired the Congressional HIV/AIDS Caucus until Lee named González as her successor.
“Jenniffer understands the issue,” said Ros-Lehtinen on the call, referring to González.
Ros-Lehtinen acknowledged the HIV/AIDS pandemic has “heavily impacted” South Florida.
González herself announced hours after she participated in the AIDS United call that she had tested positive for coronavirus.
Ros-Lehtinen noted she and Lee had vastly different positions on a variety of issues, but “on this subject and on many other subjects, there are no party labels.”
“You have the disease, there’s no discrimination,” said Ros-Lehtinen.
“I believe in equality,” she said. “I’m living in Puerto Rico where 3.2 million Americans are disenfranchised. They cannot vote for president. They cannot vote for their senators. They don’t have equal representation in Congress. I can’t be selecting how equality is going to be defined or what issues are equal or what not.”
“Equality is equality,” added González. “Health care is equality and in that sense I should be representing my island and all the people, including the people with HIV.”
The AIDS United call coincided with the first day of the Republican National Convention.
President Trump in his 2019 State of the Union address vowed to end the HIV/AIDS epidemic within a decade. Advocates with whom the Blade spoke at the time expressed skepticism and noted, among other things, Trump in 2017 abruptly fired all members of the Presidential Advisory Council on HIV/AIDS without explanation.
The Trump administration’s record on LGBTQ rights issues has been sharply criticized. Outgoing Puerto Rico Gov. Wanda Vázquez Garced, who is a member of González’s party, has also faced intense criticism from activists in the U.S. commonwealth and elsewhere over her administration’s LGBTQ rights record.
Ros-Lehtinen on the call noted former Vice President Biden, like Trump, has also pledged to end the HIV epidemic.
“This is a human issue,” said Ros-Lehtinen. “It’s not a Republican problem or a Democratic problem. We’ve got to come together to solve it.”
AIDS United President Jesse Milan, Jr., who has lived with HIV for 38 years, agreed.
“Ending this epidemic is clearly a bipartisan issue,” he said.
HIV/AIDS service providers in Florida say the coronavirus pandemic has further exacerbated health care and economic disparities that many of their clients face.
Tatiana Williams is the co-founder and executive director of Transinclusive Group, a Fort Lauderdale-based organization that serves transgender people in South Florida. Williams is also the co-chair of South Florida FLUX, which advises AIDS Healthcare Foundation on trans-specific issues.
Williams on Aug. 11 told the Washington Blade during a telephone interview from Fort Lauderdale the pandemic “just really highlighted some of the challenges that are happening within the transgender community.”
“A lot of our clients were already dealing with unemployment, dealing with a lack of access to health care, dealing with a lot of these issues,” she said.
Williams said her organization’s Transinclusive Emergency Crisis Fund has been able to provide clients emergency housing and a host of other services that include help paying utility bills and medications.
“You had a lot of our clients working in these nightclubs that were closed down, so a lot of them immediately went into a position of survival mode and not having access to a lot of things,” she said. “With COVID, it just turned their lives upside down.”
Williams said problems with Florida’s unemployment system delayed payments to many Transinclusive Group clients who lost their jobs because of the pandemic. Williams told the Blade they “were behind” once they began to receive unemployment checks, and this delay created “gaps” in their medications.
“A lot of health care providers weren’t working at full capacity,” she said. “A lot of them weren’t even returning calls, so a lot of the clients, especially HIV-positive clients, hadn’t received care, so we had to go into the telemedicine mode and we were linking people back to care.”
Other HIV/AIDS service organizations in Florida have made similar adjustments in response to the pandemic.
Arianna Lint is a Peruvian woman with HIV who founded Arianna’s Center, a Wilton Manors-based organization that serves trans women with HIV.
She told the Blade on Aug. 3 during an interview at her office the pandemic has made her organization’s work “more difficult because we have (had) to invest more time” with teaching clients how to use technology to access health care. Lint said Arianna’s Center has also had to visit clients at their homes.
Stephen Fallon, co-founder and director of Latino Salud, another Wilton Manors-based organization that serves LGBTQ Latinos with HIV, during a July 23 Zoom call with other HIV/AIDS service providers that AIDS Healthcare Foundation organized said the majority of health care providers in his area remained open “to some extent” during the lockdown imposed when the pandemic began. Fallon said testing agencies were closed during this period.
“We were getting deluged with all the folks who needed testing services who couldn’t go anywhere,” he said.
Scott Pridgen is executive director of AH Monroe, an organization that serves people with HIV/AIDS in the Florida Keys.
AH Monroe has offices in Key West, Marathon, Tavernier and Key Largo.
Pridgen on Aug. 12 told the Blade during a telephone interview from Key West the pandemic has forced his organization to operate its offices virtually, “which is new because a lot of our case management, especially our older population that is living with HIV have other co-morbidities that require more of a physical, hands-on type of care versus doing it virtually.”
“We’ve had to take that into consideration,” said Pridgen.
The pandemic began during the height of the Keys’ tourism season, which Pridgen said is “when people make their money to carry them through during the slow season.”
Pridgen told the Blade that AH Monroe has been able to provide short-term mortgage, rent and utility assistance through grants from the CARES Act, the Housing Opportunities for Persons with AIDS (HOPWA) program and the U.S. Department of Housing and Urban Development’s Office of HIV Housing.
“The biggest need due to COVID-19 in Monroe County is housing, paying rent for someone or mortgages,” said Pridgen.
Pridgen added Keys residents “who’ve never asked for anything, ever, ever, (are) in line at the food bank or you’re handing them a bag of groceries.”
AIDS Healthcare Foundation Regional Director Dawn Averill is based in Pensacola, but works throughout Florida and the Deep South. Averill on the July 23 Zoom call echoed Pridgen’s observations about the pandemic’s impact.
“We’re actually seeing a lot of fear,” said Averill, referring to people with HIV/AIDS. “They’re fearful to go to the grocery store. They’re fearful to come to the office, to get their blood drawn, to see their families.”
Averill also noted “significant health disparities” in rural and urban areas that factor into health outcomes for people with HIV/AIDS.
State Rep. Carlos Guillermo Smith, who represents portions of Orlando in the Florida House of Representatives, on Aug. 14 noted to the Blade during a telephone interview that HIV rates in Florida are higher among trans people, people of color, undocumented immigrants and other vulnerable groups. Smith said efforts to curb the coronavirus’ spread have had a disproportionate impact on these populations.
“Quarantines and other COVID-related restrictions are also pushing people with HIV who are already vulnerable into isolation away from friends, chosen family,” he added.
South Florida remains state’s coronavirus epicenter
The Florida Department of Health on Tuesday said there have been 579,932 confirmed coronavirus cases in the state. Statistics also indicate the pandemic has killed 9,758 people in Florida.
Miami-Dade and Broward Counties remain the pandemic’s epicenter in Florida, with 25 and 12 percent of the state’s total cases respectively. Statistics indicate the coronavirus has killed 2,126 people in Miami-Dade County and 1,025 people in Broward County.
The Florida Department of Health reported 15,300 new coronavirus cases on July 12, compared to 3,838 new cases on Monday. A press release notes the rate of positive tests in the state on Tuesday were below 10 percent for the sixth consecutive days.
Republican Gov. Ron DeSantis nevertheless continues to face widespread criticism over his response to the coronavirus. Many of the HIV/AIDS service providers with whom the Blade spoke noted he has not imposed a statewide mask order and moved too quickly to reopen Florida.
“He’s shown time and time again that he is a politician over everything,” Equality Florida HIV Advocacy Coordinator Alejandro Acosta told the Blade on Aug. 14 during a telephone interview from Wilton Manors. “He makes health care decisions based on his politics and his personal beliefs and that is not conductive for a good public health outcome.”
Smith, who is also Equality Florida’s Central Florida Outreach Coordinator, told the Blade he welcomed DeSantis’ decision in March to lock down nursing homes and other long-term care facilities in order to curb the pandemic’s spread. Smith was nevertheless critical of the governor’s overall response.
“We’re the world’s epicenter of the pandemic and we still don’t even have a statewide mask order, which costs us nothing,” Smith told the Blade.
Smith also expressed concern over the Department of Health’s decision to reassign employees who worked on HIV and STI-related issues to fight the coronavirus.
The Department of Health on Tuesday declined to make anyone available to the Blade for an interview about efforts to protect vulnerable Floridians with HIV/AIDS during the pandemic.
“COVID-19 requires an unprecedented response at both the state and local level,” said the Department of Health in an email.
The Department of Health has yet to respond to a follow-up email about Smith’s concerns.
“We have an HIV workforce in Florida,” Smith told the Blade. “As a direct result of COVID-19, we’re just kind of seeing this trend of diversion of scientific and public attention away from HIV in Florida. That’s what has me concerned.”
“We could come out of the other end of this pandemic and realize that we have another public health crisis on our hands,” he added. “It’s a recipe for disaster if we don’t focus and if we don’t veer course when it comes to staying committed to HIV prevention.”
American Gene Technologies, a Rockville, Md.-based gene and cell therapy company, announced on Aug. 11 that it has received approval from the U.S. Food and Drug Administration to begin its first human clinical trial for a unique cell altering treatment that it believes will enable the immune system of people who are HIV positive to permanently eliminate HIV from their body.
“AGT developed a new treatment to repair immune system damage done by HIV and allow natural responses to control the virus,” the company says in a statement announcing the approval for its clinical trial. “From its research, AGT believes a cure is attainable and is now taking the significant step of testing in humans.”
The statement says AGT is conducting its Phase 1 clinical trials at sites in the Baltimore-D.C. area. It says the Washington Health Institute in Northeast D.C., Georgetown University, and the University of Maryland’s Institute of Human Virology in Baltimore will be the three sites for the trials.
According to the statement, the Phase 1 trial will investigate the safety and efficacy of a product the company calls AGT 103-T, “a genetically modified cell product made from a person’s own cells.” It says the product and treatment should work to remove HIV infected cells from the body and “decrease or eliminate the need for lifelong antiretroviral treatment.”
In an online virtual news conference held on Aug. 12, AGT Chief Executive Officer Jeff Galvin explained that the clinical trial involves a multi-step process of extracting blood from an HIV-positive person whose HIV is fully under control through anti-retroviral medication and immediately subjecting the blood to a process of Leukapheresis, which separates a type of white blood cells known as T-cells.
Galvin said the T-cell samples extracted through that process will be sent to a lab, where they will be genetically altered in a process developed by AGT. He said AGT believes the genetically altered T-cells will make them resistant to HIV infection and enable them to do what HIV has prevented human T-cells from doing during the course of the 40-year plus HIV epidemic – to neutralize the virus and prevent it from harming the human body.
Once the gene altering process is completed and an initial waiting period is used to allow the altered cells to multiply in the lab, the cells will be “reinfused” into the body of the person participating in the trial and from whom the original collection of T-cells was obtained, Galvin said.
AGT has said in earlier statements that individuals participating in the clinical trial will initially continue to take their regularly prescribed anti-retroviral medication while testing of their blood continues to determine whether the newly infused T-cells are killing or neutralizing HIV to a degree that will no longer make the anti-HIV medication necessary.
C. David Pauza, AGT’s chief science officer and the company’s lead researcher in the development of the genetically altered, HIV resistant T-cells, stated at the news conference that under FDA protocol, the process must be shown to be safe and not have significant side effects on the first person to undergo the procedure before the procedure is performed on the second person to participate in the clinical trial.
Pauza said he, Galvin and the AGT team consider the FDA’s approval of the clinical trial an important development brought about by years of research and laboratory testing.
“This is momentous news that we have FDA approval to launch Phase 1 and conduct our first human trials,” he said in a statement. “We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines,” he said.
“Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective,” Pauza said.
Galvin told the news conference that the current cost for the complete process of extracting cells from an HIV infected person, genetically altering the cells, and reinfusing the HIV resistant T-cells back into the person’s body is about $200,000. But he said he’s optimistic that the cost of the procedure will go down dramatically as it is used more frequently in coming years. Among other things, he said that the extraction of the T-cells and the genetic alternation process can be done through machines in an automated process that can lower costs.
FDA spokesperson Monique Richards told the Washington Blade the FDA is prohibited by law and regulation from commenting on or acknowledging the existence of an “investigational new drug” application, known as an IND, or whether a clinical trial is taking place.
“The FDA supports the safe clinical development of these products and we are committed to continuing to work collaboratively with industry and the medical and scientific communities to provide the information and guidance needed to help foster the advancement of these promising therapies,” Richards said in an email on Friday.
Dr. Anthony Fauci on Friday said it remains unclear whether people with HIV are more vulnerable to the coronavirus.
“The story is not yet completely out in individuals with HIV,” he said during a panel that took place on the final day of the 2020 International AIDS Conference. “Those with HIV that’s not controlled in the sense of controlled viremia as opposed to those with good control. That knowledge store is still evolving.”
Fauci in his presentation also said there is a “significant issue” in the U.S. “with a disproportionate disparity or serious illness among our minority population” with Black people, Latinos and Native Americans most impacted. Dr. Deborah Birx, the coordinator of the White House’s coronavirus task force, echoed Fauci in her own remarks during the panel.
“This is like HIV and that there are specific vulnerable groups, either by race, ethnicity or their relationship in poverty,” she said.
Both Birx and Fauci said hypertension, diabetes and obesity are among the underlying health issues that make people more vulnerable to coronavirus.
Dr. Sarah Henn, chief medical officer at Whitman-Walker Health in D.C., told the Washington Blade in March that older people with underlying medical conditions and those who have chronic illnesses are most vulnerable to the pandemic. Immigration Equality and other advocacy groups have also said U.S. Immigration and Customs Enforcement detainees with HIV are also at risk.
“When I think of people who are at increased risk or high risk for coronavirus I think of people who are significantly immunosuppressed,” Henn told the Blade. “I think of people who are going through cancer chemotherapy, people who are immunosuppressed with medications with a history of organ transplants, and people with a very low CD4 count and uncontrolled HIV and AIDS.”
Fauci: U.S. in midst of ‘very serious problem’
The International AIDS Conference was to have taken place this week in San Francisco and Oakland, Calif., but it happened virtually because of the coronavirus pandemic.
Johns Hopkins University of Medicine’s Coronavirus Resource Center notes there are more than 3.2 million confirmed coronavirus cases in the U.S. Their statistics also indicate the pandemic has killed 134,729 people in this country.
The New York Times reported there were 68,241 new coronavirus cases reported in the U.S. on Friday.
Birx noted four states — Arizona, California, Florida and Texas — account for 50 percent of new coronavirus cases in the country. She also said positive test rates in Houston and Phoenix are higher than 20 percent.
“In the United States we have increased number of cases over the … particularly past three weeks,” said Birx. “We have not seen this result in increased mortality but that is expected as the disease continues to spread in some of our large metro areas where co-morbidities exist.”
Fauci also said upwards of 45 percent of people with confirmed coronavirus cases are asymptomatic.
“There is transmission by asymptomatic and pre-symptomatic individuals to unaffected individuals, which clearly complicates greatly attempts at contract tracing and isolation,” he said.
The Trump administration’s response to the pandemic has been widely criticized, but Birx stressed the U.S. has “worked hard to expand testing.” Birx also said efforts to combat the virus in this country remain largely focused on the state and local level.
Florida Gov. Ron DeSantis, a Republican who is a close Trump ally, is among the governors who continue to face sharp criticism over their response to the pandemic.
“The United States is a state-by-state, county-by-county and that’s the way we’ve made our response, very much looking at a very granular level and then working with the governors and the mayors to have a very specific and tailored response for each of these areas,” said Birx.
Fauci, like Birx, acknowledged the pandemic is far from under control in the U.S.
“My own country, the United States … is in the middle right now, even as we speak, of a very serious problem,” said Fauci.