A representative of at least 15 D.C. pharmacies dispensing prescription drugs for low income people with HIV and AIDS and the director of the city’s Department of Health gave conflicting views this week on whether patients’ ability to refill their prescriptions for life-saving AIDS drugs will be disrupted beginning July 1.
A decision by DOH to terminate its contract with the local pharmacy chain Care Pharmacies that has administered the city’s AIDS Drug Assistance Program, or ADAP, was expected to prompt an as yet undetermined number of pharmacies to discontinue serving ADAP patients, potentially preventing the patients from obtaining the drugs when their current prescriptions run out, according to pharmacist Michael Kim, owner of Grubbs Pharmacy.
“This is going to be an absolute disaster,” said pharmacist Tamara Foreman, a member of the D.C. Board of Pharmacies, an independent entity that advises the city on pharmacy related matters.
“The patients are not being notified,” said Foreman, who also serves on the board of a non-profit organization that advocates on behalf of pharmacy patients. “They are being told to anticipate a gap in service, but they’re not being told where to go if their pharmacy stops filling their prescription.”
Dr. Mohammad Akhter, director of the DOH, and Dr. Gregory Pappas, director of DOH’s HIV/AIDS, Hepatitis, Sexually Transmitted Disease, and Tuberculosis Administration (HAHSTA), strongly dispute that assessment. Both told the Blade that no ADAP patients will be adversely impacted by the pharmacy related changes DOH is putting in place.
“We are providing the patients with a 60-day supply of drugs during the transition period,” Akhter told the Blade on Wednesday at a news conference on the release of the city’s 2011 Annual Report on its efforts to combat HIV/AIDS.
“I can tell you that no patients will be harmed in any way,” said Akhter.
He said DOH recently decided to postpone for one month the implementation of the revamped ADAP pharmacy program.
But he and Pappas declined to disclose how many pharmacies involved in the existing ADAP program operated by Care Pharmacies and how many others have opted to join the revised program to be operated directly by DOH.
Some AIDS activists, including Patricia Hawkins, a former Whitman-Walker Health official and member of the D.C.-area HIV Planning Council, have expressed concern that patients’ ability to refill their ADAP prescriptions could be jeopardized if too few pharmacies agree to be part of the new DOH pharmacy network.
Kim said Grubbs planned to stop serving ADAP patients beginning July 1, when the new city-administered program was originally scheduled to go into effect. Kim couldn’t be immediately reached to determine whether Grubbs would continue filling ADAP prescriptions for another month following DOH’s decision to postpone the new program.
Kim indicated in an earlier interview that DOH might postpone implementation of the new program, but said DOH had not informed Care Pharmacies that it planned to do so.
He and others familiar with the ADAP program said they were told by the city that a list of the participating pharmacies in the new program would be released on June 15.
The city didn’t release such a list on that date, prompting pharmacists and activists to fear that too few pharmacies would join the new system to adequately serve ADAP patients in need of prescriptions.
Kim said Grubbs, which is believed to have processed the largest number of ADAP prescriptions in D.C. over the past decade, isn’t signing up for the city’s revamped program because the DOH has cut in half its reimbursement payment for ADAP drug prescriptions and plans to keep the lower payment in place for the next five years.
He said the lower payment makes it too costly for Grubb and other pharmacies to process ADAP prescriptions. He acknowledged that Care Pharmacies currently collects the reimbursement for the prescriptions from the city, takes a cut to cover its own administrative costs and disburses the remaining amount of about $7 per prescription to the other pharmacies in the current program. The city was expected to dispense the reimbursement directly to each pharmacy under the new system.
ADAP, a joint federal-state program, was created under the Ryan White AIDS Care Act in the early 1990s as a means of providing life-saving AIDS drugs to low-income patients as well as symptom-free people with HIV who don’t have private health insurance coverage and can’t afford to pay for the drugs.
Many of the HIV medications, such as anti-retroviral drugs, cost between $1,000 to as much as $2,000 for a one-month prescription, AIDS advocacy groups familiar with ADAP have said.
A staffer with the city’s AIDS administration, who isn’t authorized to speak to the media, said DOH chose to set up its own network of local pharmacies to process ADAP drug prescriptions rather than renew Care Pharmacies’ contract to “expand the options” for patients.
The staffer said DOH wanted to bring in more pharmacies and different types of pharmacies, including those providing mail order services, into the ADAP network beyond the 24 that have been participating under the Care Pharmacies network.
Kim, who serves on the Care Pharmacies board of directors, said that in addition to about 24 pharmacies that are part of the Care Pharmacies franchise, several unaffiliated pharmacies were part of Care’s ADAP network. Among them was Whitman-Walker Health, the city’s largest private AIDS services provider, which has its own in-house pharmacy. Others included the AIDS Healthcare Foundation, a worldwide AIDS care provider that has an in-house pharmacy in its D.C. office; and Safeway supermarket stores, which also have in-house pharmacies.
Foreman said the non-profit group CMS Health Initiative, with which she is affiliated, has provided quality control training and supervision under a city contract to ensure that D.C. pharmacies dispensing ADAP drugs meet the city’s requirements under the ADAP program operated by Care Pharmacies.
She said that in order to be approved by the city to dispense ADAP drugs, a pharmacy is required to provide patient counseling and a series of other patient-related services, including checks to make sure patients remain compliant with their drug regimen and don’t drop out of the program, placing their health at risk. She said all pharmacies in the program must provide free delivery service to patients.
Foreman and Kim also noted that under rules established by the D.C. DOH, pharmacies participating in the city’s ADAP program are reimbursed under a drug “replenishment” system. The system, which saved money for the city, requires the pharmacies to pay wholesale pharmaceutical supplies the first month’s prescription for all new patients. The city then replenishes the pharmacies with supplies of drugs for all subsequent prescriptions.
Kim said the system requires a pharmacy to pay out of pocket for the first prescription, which could come to between $1,000 and $2,000. He said he now fears that the expected fewer number of pharmacies that join the city’s in-house network will be hit by dozens of patients dropped from the pharmacies like Grubb’s, that choose not to join the new network.
“They could be facing an initial payment of $40,000 in a single month,” Kim said. “Many of them just can’t absorb that. They are small, independent pharmacies.”
One city government source, speaking on condition of anonymity, said Care Pharmacy and its representatives were exaggerating the potential harm the changes will have on patients because the city has ended what the source called a “sweetheart deal” for Care Pharmacies.
Kim disputes claims by sources from the DOH that the new city-operated network will include improved services and options over and above the Care Pharmacies contract.
“Basically, in my opinion, it’s all about money,” he said. “They feel that they are paying too much for the ADAP program. If you look at their program, they just took the current program that’s being run by Care Pharmacies and then they put it out and stamped it with their name and they cut the reimbursement in half. And that’s it,” he said.
“So if they say they’ve improved the program somewhat that’s a flat out lie because they haven’t done anything to the program except cut the reimbursement in half.
He said the current per-prescription reimbursement to Care Pharmacies is $20.50. DOH has invited pharmacies to apply to be accepted into the new program for a reimbursement of $10.50, he said.
“I can tell you that $10.50 was the rate that was given to us about 10 years ago,” Kim said. “It just doesn’t cover the costs.”
Whitman-Walker and AIDS Healthcare Foundation are among the local pharmacy providers that have signed up to be part of the new city ADAP network, representatives of the two organizations said.
Jerame Zelner, regional director of AIDS Healthcare Foundation’s pharmacies, said AHF is “very concerned” that many ADAP patients in D.C. will be unable to refill their prescriptions if a large number of local pharmacies that once participated in the program don’t join the new city network.
“We are taking steps to step in and help,” he said, noting that AHF, with a multi-million dollar budget, has the financial cushion to absorb the cost of a first month’s supply of drugs that other smaller pharmacies may not have.
AIDS Healthcare Foundation’s offices and pharmacy are located at 2141 K St., N.W., Suite 606. Zelner said that AHA, like all pharmacies participating in the current and soon-to-be started ADAP pharmacy network, provides fill delivery services for prescription drugs.
Hawkins of the HIV Planning Council said the Council is also concerned about patients not being able to fill prescriptions during the transition into the new program.
“No one from the city has told us how many pharmacies are dropping out and how many will be joining the new system,” she said. She said the Planning Council would be taking up the issue at an executive committee meeting on June 21.
Don Blanchon, Whitman-Walker’s executive director, said he doesn’t believe patients will suffer under the new system and said Whitman-Walker looks forward to its participation in the new program.
According to Blanchon, a decision during the past few years by the city to transfer many of its ADAP patients to the city’s Medicaid program has significantly decreased the number of remaining ADAP patients.
“There are currently around 500 ADAP patients and Whitman-Walker has 400 of them,” he said.
He said he doesn’t think city pharmacies should have a problem dispensing prescription drugs to the remaining 100.
Should we vacation in homophobic countries?
Secret gay bar in St. Petersburg seemed unfathomable
ST. PETERSBURG, Russia — The tiny rainbow light projecting onto the corner baseboard of the bar and tipsy people constantly belting out Mariah Carey karaoke songs clued me in. There was something unique happening here. It wasn’t until a gentleman with glittered cheeks approached me to say how fabulous my dress was that I suddenly clocked it. I’d unknowingly ended up in a gay bar in the middle of Saint Petersburg, Russia.
A flood of overwhelming joy first took over. Before coming to Russia on vacation, I knew all too well the discrimination and fear LGBTQ Russians lived in. A gay bar in Russia, even a secret one like this, seemed unfathomable, so being where people could unapologetically be out and proud — even if it was only in the compounds of these four walls — was emotionally profound.
But within seconds, dread took over. Were we all safe? If you didn’t know what to look out for, you’d assume this was just like every other neighboring non-gay bar — it wasn’t hidden or anything. I wondered what was stopping a homophobe, if they found out, from vandalizing the bar or doing something much worse.
After all, Russia approved a legislation in 2013 prohibiting the distribution of information about LGBTQ matters and relationships to minors. The legislation, known as the “gay propaganda law,” specifies that any act or event that authorities believe promotes homosexuality to individuals under the age of 18 is a punishable felony. According to a 2018 report by the international rights organization Human Rights Watch, anti-LGBTQ violence in the country spiked after it passed. The bill perpetuates the state’s discriminatory ideology that LGBTQ individuals are a “danger” to traditional Russian family values.
A recent poll indicated that roughly one-fifth of Russians want to “eliminate” gay and lesbian individuals from society. In a poll conducted by the Russian LGBT Network — a Russian queer advocacy group — 56 percent of LGBTQ respondents said they had been subjected to psychological abuse, and disturbing reports of state-sanctioned detention and torture of gay and bisexual men in Chechnya, a semi-autonomous Russian region, have surfaced in recent years.
Considering this, it was no surprise that most of my gay friends refused to come on vacation with me to Russia. In our everyday, gay people don’t march around with a gay Pride flag so homophobic Russians would probably never be able to tell which tourists are gay. However, many LGBTQ people will never travel to Russia or any other homophobic country for one logical reason: Fear.
Unfortunately, many exotic locations abroad are dangerous territory for the LGBTQ community to be in. Physical safety isn’t guaranteed in countries like Nigeria, Iran, Brunei and Saudi Arabia where same-sex relationships are punishable by the death penalty. Not to mention the numerous transgender people who’ve been detained and refused entry to similar countries — even when it’s only been a layover! However, an alternative reason why someone may refuse to vacation in a homophobic country is having a conscience.
When you pay for accommodation, nights out and sightseeing tours, your money doesn’t just reach the hotel staff and waiters pockets — you’re also financially supporting that country’s government. Money talks so not giving homophobic countries tourism puts pressure on them. Ethically, why would anybody ever want to support a country through tourism that treats their LGBTQ community like dirt? Homophobia shouldn’t be shrugged off simply as a local “culture.”
Other LGBTQ people firmly embrace the right to go anywhere they choose, and that choosing to go gives them power. Homophobic countries still have closeted LGBTQ folks living there running underground gay spaces and groups. Is turning our back on the wonderful people and beautiful culture of a new place turning our back on their gay community too? There are countries where gay marriage is legal and trans rights are progressive, but abortion laws remain backwards. Do we boycott these countries too? And, how do we collectively define what a homophobic country is? Is legalizing gay marriage a requisite? Gay marriage is still illegal in Thailand when it is one of the most gay and trans-friendly countries in the world.
Increasingly the line of what is “right” and “wrong” erases all grey areas. Morality and activism — particularly when politics is involved — is never straightforward. The biggest surprise about Russia was how my own stereotypes I’d picked up from the media weren’t always true. Saint Petersburg in Russia is far more liberal and gay-friendly compared to rural Russia but the fact still stands that my bisexual friend and I actively chose to go to a homophobic country for pleasure. In an ideal world, anybody of any sexual orientation or gender identity would be able to vacation wherever they want but that’s sadly not reality. In the meantime, the wanderlust LGBTQ community will go on gay cruises that guarantee safe refuge or put civil rights and ideological differences aside to experience the world’s natural wonders and incredible cultures.
Ash Potter is a writer and radio host.
FDA approves injectable PrEP to reduce the risk of sexual HIV infection
Manufactured as Apretude, it will be available to at-risk adults & adolescents who weigh at least 77 pounds & have tested negative for HIV
SILVER SPRING, Md. – The U.S. Food and Drug Administration announced Monday that the agency had approved the first injectable treatment for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.
Manufactured under the name Apretude, it will be available to at-risk adults and adolescents who weigh at least 77 pounds and have tested negative for HIV immediately beforehand the agency said in a press release.
By granting its approval, the FDA opens up the option for patients to receive the injectable drug instead of a daily HIV prevention oral medication, such as Truvada.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015.
However, there remains significant room for improvement. PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication.
Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.
The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP.
Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.
Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.
Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.
In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally.
The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.
Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.
Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen.
The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.
FDA slow in responding to calls for end to ban on MSM tissue donors
‘Scientific evidence does not support these restrictions’
As of early this week, the U.S. Food and Drug Administration had yet to respond to a Nov. 29 joint letter by 52 members of the U.S. House and U.S. Senate calling on the FDA to end its policy of restricting the donation of human tissues such as corneas, heart valves, skin, and other tissue by men who have sex with men, or MSM.
The letter is addressed to Acting FDA Commissioner Janet Woodcock and Department of Health and Human Services Secretary Xavier Becerra. The FDA is an agency within the HHS.
The letter says the FDA’s restrictions on MSM tissue donation date back to a 1994 U.S. Public Health Service “guidance” related to the possible transmission of HIV, which stated that any man “who has had sex with another man in the preceding five years” should be disqualified from tissue donation.
“We also call your attention to the broad consensus within the medical community indicating that the current scientific evidence does not support these restrictions,” the letter states. “We have welcomed the FDA’s recent steps in the right direction to address its discriminatory MSM blood donation policies and urge you to take similar actions to revise the agency’s tissue donation criteria to align with current science so as not to unfairly stigmatize gay and bisexual men.”
The letter adds, “In fact, a recent study in the medical journal JAMA Ophthalmology estimated that between 1,558 and 3,217 corneal donations are turned away annually from otherwise eligible donors who are disqualified because of their sexual orientation, an unacceptable figure given widespread shortages of transplantable corneas.”
The letter continues, saying, “FDA policy should be derived from the best available science, not historic bias and prejudice. As with blood donation, we believe that any deferral policies should be based on individualized risk assessment rather than a categorical, time-based deferral that perpetuates stigma.”
U.S. Sen. Tammy Baldwin (D-Wisc.), the nation’s only out lesbian U.S. senator, and U.S. Rep. Joe Neguse (D-Colo.) are the two lead signers of the letter. All 52 signers of the letter are Democrats.
Among the others who signed their names to the FDA letter are four of the nine openly gay or lesbian members of the U.S. House. They include Reps. David Cicilline (D-R.I.), Richie Torres (D-N.Y.), Mondaire Jones (D-N.Y.), and Mark Takano (D-Calif.).
Also signing the letter are D.C. Congressional Del. Eleanor Holmes Norton (D-D.C.), and Rep. Jamie Raskin (D-Md.).
In response to a Dec. 21 email inquiry from the Washington Blade, FDA Press Officer Abigail Capobianco sent the Blade a one-sentence statement saying, “The FDA will respond to the letter directly.”
The statement didn’t say to whom the FDA would respond or when it would issue its response.
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