Gay and bisexual men at high risk for mpox infection should get vaccinated for the virus even after the current outbreak ends, government health advisers said Wednesday.
The committee’s recommendation now goes to the director to the Centers for Disease Control and Prevention and — if she signs off on it — is sent out as guidance to U.S. doctors.
More than 30,000 U.S. mpox cases were reported last year. The number dropped dramatically this year, to about 800. But because the virus doesn’t naturally circulate in the U.S., any single case counts as an outbreak, according to the CDC.
Mpox, formerly known as monkeypox, is caused by a virus that’s in the same family as the one that causes smallpox. It is endemic in parts of Africa, where people have been infected through bites from rodents or small animals.
The virus was not known to spread easily among people, but cases exploded in Europe and the U.S. in the spring and summer of 2022, mostly among men who have sex with men. Deaths were rare, but many people suffered painful skin lesions for weeks.
A two-dose vaccine, Jynneos, became a primary weapon in the U.S. It’s recommended primarily for men who have sex with men who have more than one sex partner, who have recently had a sexually transmitted disease, or who are at higher risk for infections through sexual contact for other reasons.
About 500,000 people in the U.S. have gotten the recommended two doses of the vaccine, about a quarter of the 2 million who are eligible, CDC officials said.
The new recommendation may serve to remind people the virus is still out there, and that people can be infected during international travel, CDC officials said.
The daily average of new U.S. cases is one to four per day, though some people likely aren’t being diagnosed, CDC officials said. Two deaths were reported in September, bringing the total to 54 in the U.S. since mpox hit last year.
San Francisco had more than 800 cases last year, but the count dropped to an average of only one per month in the first half this of year. The number of cases rose to seven in August, 20 last month and at least 10 so far this month.
“Things are much better than they were last summer,” said Dr. Stephanie Cohen, who oversees STD prevention work at San Francisco’s health department. “But there are (still) many more cases than there should be.”
Throughout the late 80s, 90s, and early 2000s, Americans became obsessed with anabolic steroid doping – i.e., hormonally altering one’s body to win sports competitions. In 1988, American Olympic sprinter Ben Johnson lost his gold medal from the Seoul Olympics due to doping with anabolic steroids. This was considered a national embarrassment, and after a series of hearings, the Anabolic Steroids Control Act of 1990 was passed as part of the Crime Control Act.
Twenty-seven steroids, including testosterone, were classified as Schedule III drugs and subject to imprisonment and fines for possession and distribution. Then-senator Joe Biden was invested in this issue, saying at the time, “I think you are going to see, over the next several years, some real backlash from the public about sports in America… There is a feeling of resentment that is growing, and I do not know how it will manifest itself.”
Unfortunately, moral panic over steroids has always had the criminalization of transmasculine people as collateral damage. Prior to 1990, FTM Newsletter was known to suggest getting around pricey American testosterone by trafficking it across the border. One September 1989 ad read, “Vacationing in Mexico? One of our members asked us to inform any FTM’s visiting Tijuana, Mexico, that he was able to purchase Depo-Testosterone in a 10 ml vial over the counter for $18.”
In contrast, the September 1990 issue of FTM Newsletter informed its readers that they would have to ask their doctors to lie on their prescriptions if they wanted to have a stockpile of extra testosterone in their home – a useful thing to have in the case of shortages or rejections from transphobic pharmacists. These rejections are all too common because many states require people to show their photo identification (potentially revealing one’s dead name and legal sex) and log their prescription in prescription drug monitoring programs (often under one’s dead name) for them to be able to access testosterone.
The criminalization of simple possession and the risk of being accused of encouraging drug trafficking across borders has chilled discussion of trying to get hormones abroad or on the gray market. Do-it-yourself transition communities today, which allow discussions of gray market estrogen, ban discussions of how one might acquire testosterone. The fear of prosecution is not unfounded; transmasculine folks have reported being arrested for possession of testosterone they acquired legally. If law enforcement were to decide that a transmasculine person was possessing testosterone illegally, their first offense could land them up to a year in prison and a $1000 fine.
One would hope that the passage of the Anabolic Steroids Control Act of 1990 would satisfy politicians and a populace obsessed with steroids, but one would be wrong. Between 1998 and 2006, American politicians and NGOs purposefully engineered a second anabolic steroid moral panic. The anti-steroid propaganda many millennials probably experienced as children has roots in a Salt Lake City, Utah Olympic bribery scandal and the way cisgender men in power tried to save face in the aftermath.
The Winter Olympic bid scandal
In 1998, it was revealed that the president and vice president of the Salt Lake City bid committee had allegedly paid a total of over $1 million in cash and gifts to bribe over a dozen International Olympics Committee (IOC) officials in the hopes that their city could host the 2002 Winter Olympics. The president and vice president (who were indicted in 2002 but acquitted in 2003) allegedly also pocketed $130,000 in bribes from the hospitality company Jet Set Sports. Three other Americans were indicted for fraud, and one became a fugitive of the law. Shortly after, the news broke that similar bribery and fraud may have taken place when bidding for the Atlanta, Georgia; Nagano, Japan; and Sydney, Australia games.
It came as no surprise to journalists at the time that the IOC would wish to rebrand itself as an upstanding organization leading the charge against corruption in sports. The IOC looked to the United States for suggestions on how to clean up its image. The Office of National Drug Control Policy (ONDCP) recommended that it create an Olympic anti-drug agency and stated that the US was open to committing $1 million for research into new anti-drug tests.
In February 1999, the IOC unveiled the World Anti-Doping Agency (WADA), which sought to curb the use of performance-enhancing drugs. WADA received $25 million from the IOC to level up its bureaucracy, with hopes that this would eventually be subsidized by governments – though, as Scientific American noted at the time, WADA was “unwilling to put its full support behind experimental tests that might not withstand legal challenge in the Court of Arbitration.”
In 2000, President Bill Clinton created the White House Task Force on Drug Use in Sports, emphasizing that it came from concern for “the health and safety of America’s athletes, in particular our Nation’s young people” and “the integrity of honest athletic competition.” He cited the 1999 Monitoring the Future Study and claimed that it found that “steroid use among young people rose roughly 50 percent among both sexes and across all age groups.” This was a lie. For all young people, the number jumped from 1.4% to 1.9% between 1998 and 1999. But it sounded true enough to give the task force legitimacy.
Shortly after, the US Olympic Committee launched the US Anti-Doping Agency (USADA). USADA launched playclean.org as a hub for propaganda and began producing anti-doping commercials, print ads, and handbooks for coaches that conflated anabolic steroid use with the use of addictive drugs. In 2000, the White House Task Force on Drug Use in Sports met for the first time in Salt Lake City, accompanied by Mitt Romney (then-President of the Salt Lake City organizing committee), Mike Leavitt (then-Governor of Utah), and many other government and NGO representatives and athletes.
Experts who attended the meeting expressed the desire to push the federal government to close loopholes on steroid precursors and prosecute steroid possession and sale more harshly. Both the White House Task Force on Drug Use in Sports and the USADA fixated on how youth might admire athletes who use anabolic steroids and how they might access steroids on the internet.
As usual, this stigmatization came at a cost for transmasculine people. In the Fall 2002 issue of FTM Newsletter, trans man Marcus de María Arana wrote an article called The High Price of Manhood in which he described medical neglect at the UCSF ER that caused him to experience septic shock and lose 25% of his femur after a botched testosterone injection. According to Arana, “[T]he prevailing attitude was that I brought this upon myself by messing around with steroids… I got the vibe from some providers that I had gotten what I deserved for messing with nature.”
The aftermath
In 2004, Utah Republican congressman Orin Hatch and then-Senator Joe Biden cosponsored the Anabolic Steroid Control Act of 2004, which was framed as a way to stop health food stores from selling shady products, to demand an investigation into whether stronger sentencing was necessary, and to award grants to organizations that would distribute anti-steroid propaganda. Considering that Hatch was the architect of a 1994 law that allows supplement companies to avoid federal regulation (which has resulted in deaths), it’s tough to believe that Hatch was more invested in consumer safety than the reputation of the state of Utah. Biden expressed nationalistic concerns at a hearing in March 2004, saying, “There’s something simply un-American about this. This is about values, about culture, it’s about who we define ourselves to be.”
According to Hooton, “When I put three words into the Google search engine: ‘buy, steroids, online,’ over three hundred thousand sites popped up. Senators, all our kids need are a credit card number or a money order to have hardcore prescription anabolic steroids shipped right to their doorstep.”
Joe Biden claimed that half of all children believed that their favorite sports stars used steroids and called it “a devastating idea.” The Anabolic Steroid Control Act of 2004 was passed, and by 2006, sentencing guidelines for steroid possession and distribution became much more severe.
Meanwhile, Joe Biden’s political stock has risen, thanks largely to his reputation as a bipartisan negotiator of bills like the Anabolic Steroids Control Act of 2004.
Biden is sitting President of the United States at a time in which transmaculine folks’ increased visibility has prompted fearmongering books such as Abigail Shrier’s Irreversible Damage: The Transgender Craze Seducing our Daughtersand legislation restricting transition of all kinds. Transmasculine folks are now in the curious position of hoping that recent calls from Senators Ed Markey (D-MA) and Elizabeth Warren (D-MA) to deschedule testosterone will not be ignored by the very man who put those laws in place.
While Biden has made statements nominally supporting transgender folks, they have not extended to removing one of the biggest legal hurdles to transmasculine folks living lives free of fear and harassment, nor have they even acknowledged his own culpability in the situation.
For now, and seemingly for the first time, Biden has chosen to have no opinion on testosterone.
The Food and Drug Administration’s first-ever approval of an at-home test for chlamydia and gonorrhea could help drive earlier detection and treatment of these sexually transmitted infections amid a ballooning epidemic in the U.S. But some sexual health advocates worry that the FDA’s proposal to begin stepping up regulation of over-the-counter self-testing of STIs could backfire.
The need for new tools to combat these infections is dire.
Diagnoses of gonorrhea, chlamydia and syphilis have soared in the past two decades. Public health experts argue that this is at least partially driven by woeful long-term flat funding of the Centers for Disease Control and Prevention’s budget to fight the spread of STIs during this period.
Some public health officials and advocates expect that greater FDA oversight will help legitimize home STI testing, making it easier to get insurance coverage and actually expanding its use.
Other home tests for these three bacterial STIs are already available over the counter. But the FDA, which has not previously sought to enforce regulation or require that their manufacturers apply for formal approval, cannot vouch for their accuracy.
A consortium of LGBTQ sexual health advocates has objected to a recent FDA policy proposal that, if enacted, would require the companies already offering at-home medical tests, including for STIs, obtain regulatory approval. A central worry is that the expense of meeting the FDA’s demands could drive some companies out of the STI self-testing market and otherwise drive up the cost of the tests.
There are also concerns that the newly approved test does not cover syphilis and is not well suited to address gay and bisexual men’s needs.
The test kit, called Simple 2, does not screen for syphilis, which typically requires at least a finger-prick blood sample. There were at least 177,000 syphilis cases in 2021, a 74% increase since 2017, according to the CDC. Most concerningly, CDC data shows that rates of syphilis in newborns, which can be fatal, rose more than tenfold in the past decade.
Dr. Boghuma Titanji, an infectious disease specialist at Emory University, said that the inconvenience of having to go into a clinic was a major barrier to getting at-risk people tested for STIs.
“Just remove that requirement, that will make the access better for a lot of patients,” she said.
Dr. Leandro Mena, director of the Division of STD Prevention at the Centers for Disease Control and Prevention, believes the new at-home test’s approval will indeed increase testing for gonorrhea and chlamydia.
Self-testing, he said, provides “a tremendous opportunity to empower people to control when, where and how they get tested, and how they learn about their test result, so they can get appropriate treatment for these STIs.”
Chlamydia and gonorrhea are the most common STIs in the U.S., diagnosed in 1.6 million and 710,000 people respectively in 2021, according to the CDC. They can often be asymptomatic and are easily cured with antibiotics. However, if left untreated, the infections can lead to infertility and can be especially harmful to women, leading, for example, to pelvic inflammatory disease. They spread disproportionately among adolescents and young adults, gay and bi men, and people of color.
Will FDA oversight help or hinder the STI fight?
On Nov. 15, the FDA granted marketing authorization for adults to use the over-the-counter Simple 2 Test for gonorrhea and chlamydia, from the home-testing company LetsGetChecked. The test kit, currently sold for $99 through the company’s website, can be activated online, where the consumer fills out a health questionnaire before shipping in samples to a laboratory.
If the results are positive, the company would then put the individual in contact with a physician.
Previously, HIV was the only other sexually transmitted infection to have an FDA-approved at-home test.
Other at-home STI tests are available through telemedicine companies and major pharmacy chains. However, these tests exist in a legal gray zone. Because they’re based on samples that are not taken in a lab, they don’t qualify for an exemption from requiring FDA approval that the agency grants to so-calledlaboratory-developed tests.
The FDA has generally not sought to exert control over home-based tests. However, on Sept. 29, the agency opened a two-month public comment period on a proposed new plan to require companies offering medical self-testing kits for any purpose to seek formal marketing authorization for their products. The FDA’s move followed reports of faulty self-tests that led to undertreatment or improper treatment for heart disease and cancer.
The goal, according to the FDA, is to “ensure the safety and effectiveness of these tests.”
In response, a group that includes sexual health advocates and owners of gay dating apps that provide free at-home HIV and STI testing, began circulating a petition that calls for the FDA to exempt such public health programs from the proposed new demands. Gaining approval for existing STI tests, the petition states, would involve a “time-consuming and expensive process.”
“Many public health leaders are concerned that new FDA regulations will create additional barriers to public health testing,” said Jen Hecht, director of the consortium Building Healthy Online Communities.
Dr. Matthew Golden, who leads the HIV and STI control program at Seattle’s public health department, said that the FDA is playing catch-up in an effort to enforce regulation of an industry that has grown fast since Covid.
“At some level, the horse has left the barn,” said Golden, noting that self-testing kits have been widely used for years. However, he said that for “some of those tests, how well they perform is not well known. So cleaning this up makes sense.”
A source familiar with FDA policies and practices told NBC News that if the agency decides to demand that self-testing companies obtain regulatory approval, it would not likely interrupt the availability of existing medical self-tests during the application process.
That said, it is likely that once a critical mass of self-testing companies obtained or otherwise sought approval, the agency would go after any laggards.
Gay men’s needs are left out — for now
The Simple 2 Test is effectively geared only toward STI exposures from vaginal intercourse.
The kit can process a urine sample and a swab of the vaginal area. Chlamydia and gonorrhea infections, however, can be localized in the throat, urogenital area or rectum. A urine sample can detect urogenital infections in men and women. For people who may have otherwise been exposed through oral or anal sex, oral and rectal swabs would also be needed.
David Harvey, executive director of the National Coalition of STD Directors, said that public health experts “expect and need” the FDA ultimately to approve at-home tests for syphilis and for oral and rectal gonorrhea and chlamydia infections, “so we’re also reaching others who are at high risk, including gay men.”
The CDC’s Mena said he hoped that the agency and the FDA will confer with LetsGetChecked or other testing companies about pushing for additional approvals.
The FDA’s authorization for the Simple 2 Test was based on data indicating that consumers could successfully use the home tests, understand the results and then take any necessary subsequent action.
It’s unclear whether the test will be available outside LetsGetChecked website or whether $99 kit will be covered by insurance. The company didn’t respond to requests for comment.
Tristan Schukraft, CEO of MISTR, a telehealth company that provides the PrEP HIV prevention pill, is supportive of greater FDA oversight of home tests, but expressed concern that tighter regulation could increase the cost of testing.
“Labs are going to be required to spend additional money and resources on studies, quality systems, reagents and software systems,” Schukraft said.
In addition, MISTR requires that PrEP recipients undergo testing every three months for chlamydia, gonorrhea and syphilis. At least 85% of MISTR customers on PrEP opt for at-home testing. The company advises people who test positive — about 13.5% of the kits detect at least one STI — to seek medical care and provides assistance in connecting people to care for those who need it.
Schukraft suggested that greater regulation could lead companies to pull such tests from the market.
If so, he said, “the FDA would be doing harm to public health.”
n the wake of numerous discussions, panels, and speeches at PFLAG’s National Convention in Arlington, VA. last month, a notable conversation took place to illuminate the shadows cast by disinformation on trans healthcare.
The ambiance within the Crystal Ballroom at DoubleTree Crystal City was anything but cold as attendees gathered for a crucial dialogue on trans healthcare. The session, “Courageous Love in Trans Healthcare,” moderated by writer and activist Charlotte Clymer, featured a panel of health experts, including Admiral Rachel L. Levine, the assistant secretary for health in the U.S. Department of Health and Human Services, and Dr. Jesse M. Ehrenfeld, the president of the American Medical Association. The focus was clear — to dismantle the towering wall of disinformation encircling trans healthcare and foster a narrative grounded in facts and empathy.
Levine, who is trans, wasted no time in addressing one of the frequently misunderstood aspects of trans healthcare — the use of puberty blockers.
She explained, “Puberty blockers have been used for a long time. They’re used for a condition called precocious puberty or early puberty, and there was a protocol developed first in the Netherlands probably 15 to 20 years ago, where transgender children could get blockers as they continue to be with their family and to work with their therapists and their physician.” Her words emphasized the long-standing medical practice and the familial and medical support integral to the protocol.
Ehrenfeld, an out gay man whose husband and four-year-old son were also in attendance, brought to light a grave concern — a lawsuit challenging the abortion drug mifepristone that threatens to unravel the FDA’s approval process for certain medications, including puberty blockers.
He stressed, “…if this is going to go to the Supreme Court [and] if the Supreme Court decides that the FDA regulatory process for how we approve drugs and medications and biologics in this country doesn’t work or isn’t appropriate, it will cause chaos because there is a whole list of other medications, puberty blockers included, that will suddenly be challenged.” He outlined this could spawn a cascade of challenges against numerous medications, fuelled by disinformation and devoid of scientific basis.
The conversation also touched upon false narratives emerging from certain European countries re-evaluating gender-affirming care for youth.
Ehrenfeld clarified, “We evaluate our policies all the time because we want to make sure that whatever the science and evidence it is, we’re holding it up… based on what we have today, we have a clear policy that makes sense.”
He underscored the unwavering commitment to evidence-based policies amidst a swirl of misinformation.
Engaging the community emerged as a pivotal theme.
“We know that public perceptions change when you know someone who’s in the community… we can only help educate those in the community if we’re out there having those conversations,” Levine said.
Her call to action resonated as a reminder of the power of personal interactions in altering misconceptions.
According to a survey by The 19thThe 19th, 67 percent of those who know someone who is transgender support gender-affirming care for adults, while 48 percent support it for minors. However, 48 percent support gender-affirming care for those who don’t know transgender people personally, and 33 percent support it for them. For those who identify as LGBTQ+, 84 percent favor gender-affirming care for adults, and 70 percent favor it for minors.
Furthermore, the panel delved into the imperative of medical education and fostering diversity within healthcare. They advocated for an environment where all individuals, irrespective of their gender identity, are welcomed and respected.
“Diversity brings in all sorts of different experiences and different cultures and different perceptions, and it enhances any organization,” Levine said.
As the dialogue neared its conclusion, the unwavering resolve to challenge disinformation and advocate for an inclusive, evidence-based approach to trans healthcare was evident. Levine and Ehrenfeld’s potent blend of facts, empathy, and advocacy painted a hopeful picture of the road ahead.
This enlightening Saturday afternoon conversation was vital to PFLAG’s National Convention from Thursday to Sunday. On Friday, First Lady Jill Biden spoke in support of the families and friends of LGBTQ+ individuals for their unwavering advocacy for marginalized communities. Following Biden’s address, MSNBC’s Ali Velshi took the helm, moderating a panel discussion concerning book bans, sharing the stage with the president of the American Library Association, among other panelists.
Gay, lesbian, and bisexual young people are more likely to use alcohol, e-cigarettes, cannabis, and tobacco than their heterosexual peers, a new study has found. Researchers say that stress from sexual orientation-based discrimination is to blame.
The study — published this autumn in the American Medical Association’s open-access medical journal, JAMA Network Open — looked at data on the habits of 28,291 middle and high school students taken from the Centers for Disease Control and Prevention’s (CDC) 2022 National Youth Tobacco Survey.
About 4.5% of student respondents self-identified as gay or lesbian, and 11.8% self-identified as bisexual. These percentages represent about 4,611 of the respondents.
Researchers found that 29.3% of non-heterosexual youths had used alcohol in the last 30 days, compared to 21.6% of heterosexual youth. About 25.6% of non-hetero youth self-reported cannabis use over the last 30 days, compared to 14% of heterosexual youth. Approximately 26.2% of non-hetero youth self-reported e-cigarette use, compared to 16.4% of hetero youth. Lastly, 9.1% of non-hetero youth self-reported cannabis use over the last 30 days, compared to 4.6% of heterosexual youth
Researchers found that bisexual youths were especially more likely to have vaped cannabis oil and e-cigarettes than their gay and heterosexual counterparts.
“It is well-documented that minority stress (eg, stress from sexual orientation-based discrimination) is associated with youth substance use, which may be consistent with vaping cannabis,” the study’s authors wrote. “Preliminary evidence from this study may inform future prevention strategies directed at reducing substance use disparities among sexual minority youth.”
The study’s findings reflect similar findings from past studies. A 2018 surveyfrom the Ohio Department of Health showed that LGBTQ+ teens were more likely to have vaped or smoked in the last 30 days compared to their straight counterparts.
A 2017 CDC study found that LGBTQ+ people were twice as likely to smoke than straight and cisgender people. Another study from the same year found that queer youth were more likely to smoke than straight and cis youth. One studyfound that LGBTQ+ people spend about $7.9 billion on cigarettes each year.
A new antibiotic has proven as effective as the last remaining recommended treatment for gonorrhea, helping to assuage mounting fears among public health experts about the emergence of drug-resistant strains of the sexually transmitted infection.
Gonorrhea is the second most common STI in the U.S. and has developed resistance to all antibiotics used to treat it, except for the recommended combined therapy of an injection of the antibiotic ceftriaxone with one dose of azithromycin pills. In recent years, ominous reports have suggested that this antibiotic arsenal might not maintain its robust effectiveness against the fast-evolving pathogen for much longer.
On Wednesday, results from a late-stage clinical trial of a new antibiotic called zoliflodacin showed the drug cured so-called uncomplicated gonorrhea infections as effectively as ceftriaxone and azithromycin. The drug was developed by the Global Antibiotic Research & Development Partnership, a Swiss nonprofit, and the U.S.-based Innoviva Specialty Therapeutics.
“Zoliflodacin gives us a new tool in the treatment of gonorrhea, and if used wisely, a barrier against the further spread of resistant infections,” said Dr. Jeffrey Klausner, an infectious disease expert at the Keck School of Medicine of USC, who was not involved in the trial.
The antibiotic, which would be the first new gonorrhea treatment approved in decades, could make it to market by 2025.
The World Health Organization estimates that globally there are more than 82 million new gonorrhea cases every year. In the U.S., in the wake of decades of cuts to state and local public health departments, STIs have soared to record heights. In 2021, there were 710,151 diagnosed cases of gonorrhea, a 28% increase since 2017, according to the Centers for Disease Control and Prevention.
Gonorrhea spreads through sexual contact and can separately infect the genitals, rectum and throat.
The STI is especially common among adolescents and young adults and occurs disproportionately among gay and bisexual men, the CDC reports. Left untreated, gonorrhea poses a risk of infertility and can prove especially damaging to women, leading to pelvic inflammatory disease and ectopic pregnancy. The infection can also raise the risk of HIV transmission.
In recent years, global health authorities have issued increasingly urgentwarnings that gonorrhea has been acquiring resistance to ceftriaxone and azithromycin, with cases of highly drug-resistant gonorrhea reported in multiple nations.
In January, the Massachusetts Department of Public Health reported the first two U.S. cases of gonorrhea that had resistance or reduced response to five classes of antibiotics. Ceftriaxone did cure those cases, but public health officials said they served as a harbinger for the emergence of strains that could evade the antibiotic.
Without a new antibiotic weapon, curing highly drug-resistant strains of gonorrhea could require intensive treatment with multiple antibiotics, according to Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases. This so-called kitchen-sink approach, she said, would strain medical resources and raise the risk of driving the emergence of further microbial drug resistance to those other antibiotics.
The ultimate fear is that eventually, gonorrhea could prove wholly untreatable, in at least some people.
According to an Innoviva representative, the company aims to file for approval of the antibiotic with the Food and Drug Administration “as quickly as practicably possible.” Innoviva expects an expedited review, meaning the FDA would take about six months to issue a decision.
Zoliflodacin belongs to a new class of antibiotics, and attacks gonorrhea in a novel way. In previous laboratory studies, zoliflodacin proved effective at neutralizing gonorrhea strains that were highly resistant to ceftriaxone and azithromycin and strains that had resistance to other antibiotics as well.
A downside of zoliflodacin is that a previous, phase two clinical trial published in 2018 found that it was not as efficacious at treating gonorrhea infections in the throat as in the genital or rectal areas. However, Marrazzo, who was a co-author on that study, said that this disparity is common among gonorrhea treatments.
“Gonorrhea in the throat is probably going to be a major Achilles heel in our battle to control gonorrhea going forward,” Marrazzo said.
But according to Dr. Margaret Koziel, chief medical officer of Innoviva, the new zoliflodacin trial showed “encouraging” results in the small number of participants with rectal or throat infections.
The company “will certainly engage the FDA about whether the label indication might be for urogenital disease or for all uncomplicated gonorrhea,” Koziel said.
According to Dr. Manica Balasegaram, executive director of Global Antibiotic Research & Development Partnership — Innoviva’s partner in the trial — zoliflodacin holds promise in retaining potency against gonorrhea for a longer period than previous treatments for the infection, because it was developed solely as a treatment for that STI. Ceftriaxone and azithromycin are each used to combat numerous other infections;and the more they are used, the more opportunity gonorrhea has to develop resistance to them.
“This new drug is also given orally instead of an intramuscular injection with ceftriaxone; this is an advantage,” said Dr. Jean-Michel Molina, who studies STI prevention at the University of Paris and was not involved in the clinical trial.
Molina is the head of one of the multiple clinical trials currently running of a meningitis B vaccine as prevention for gonorrhea. He said he expects to present final results of his trial at a scientific meeting in 2024.
The new zoliflodacin study enrolled 930 men, women and adolescents, including people with HIV, with uncomplicated gonorrhea at 16 trial sites in five nations, including Belgium, the Netherlands, South Africa, Thailand and the U.S. Participants were randomized to receive a single oral dose of zoliflodacin or a ceftriaxone injection plus oral azithromycin.
The WHO has called the emergence of drug-resistant pathogens one of the top 10 global public health threats facing humanity and has identified gonorrhea in particular as a priority pathogen.
The zoliflodacin trial is the first to address such a priority pathogen that was marshalled by a nonprofit organization. Established in 2016 by the WHO to help shepherd new antibiotics to market, efforts by the Global Antibiotic Research & Development Partnership’ represent a promising new front in the vital effort to spur research and development of new antibiotics. Offering only thin profit margins, antibiotics do not tend to attract investment by pharmaceutical companies.
“Treating gonorrhea, it’s not going to be your next Ozempic,” said Marrazzo.
The National Center for Lesbian Rights is opening Transgender Awareness Weekwith the launch of #HealthcareIsCaring, a campaign aimed at transforming the narrative surrounding trans youth’s access to health care and empowering parents to support their trans children.
It comes at a time when gender-affirming care for young trans people is being banned in conservative states across the nation — 22 states at last count — and the provision of such care is sometimes being criminalized or being defined as child abuse. There has also been an effort by Republicans in Congress to ban such care nationwide.
NCLR seeks to tell what gender-affirming care and supportive parents mean for trans youth. The campaign includes a short film featuring trans young people their parents — Cameron and his mother, Myriam, from Texas; Allie and her father, Sean, from New York; and Luke and his mother, Jen, from Illinois. The film was created in collaboration with Emmy-nominated director Zen Pace and the Windy Films production agency.
“The families in our campaign, like so many other families with transgenderchildren, are proof that helping transgender youth get medically needed care can enable them to lead happy and successful lives,” NCLR Legal Director Shannon Minter said in a press release. “Still, many legislators continue to push harmful policies that prevent these young people from getting the health care they need and deserve. We’re working to take action against these bills and show the politicians behind them that transgender youth and their families are not alone.”
NCLR has successfully challenged state bans on medical care for transgender adolescents in Alabama, Florida, and Kentucky. This month, NCLR filed a petitionasking the U..S. Supreme Court to review the Sixth Circuit Court of Appeals’ decision in Doe v. Commonwealth of Kentucky reversing the victory in the Kentucky challenge. If the Supreme Court takes the case, it will be the first case involving transgender youth ever heard by the high court.
The campaign was created by public relations company Edelman and its Out Front LGBTQ+ task force. Edelman recently conducted a survey in which 74 percent of respondents said they believe parents want what’s best for their children when it comes to medical care.
“This campaign is proof of two things: the magic that happens when you bring people of every discipline together to drive meaningful change, and that having access to trans healthcare isn’t just critical to helping youth survive, but to thrive as well,” said Jordan Atlas, Edelman’s U.S. chief creative officer.
Of the film, Pace said, “This film is special to me because not only does it touch my community, but it helps put forward a much more accurate story of these families that simply doesn’t exist out there. It gives space to these parents; it’s a gift from their children.”
NCLR also has an open letter for the public to sign in support of health care for trans youth, and it offers a variety of resources explaining gender-affirming care..
The American Civil Liberties Union has asked the Supreme Court to block a Tennessee law banning gender-affirming care for minors.
On Wednesday, the ACLU, along with the ACLU of Tennessee and Lambda Legal, petitioned the court to review a Sixth Circuit Court of Appeals ruling allowing the state’s anti-trans law to go into effect. As The Hill notes, if the court accepts the case, it would be the first time the Supreme Court hears a case involving gender-affirming care.
Tennessee Republicans passed the state’s S.B. 1 in February, and it was signed into law by Gov. Bill Lee (R) in early March. In addition to banning Tennessee doctors from providing gender-affirming care, including puberty blockers and hormone therapy, to anyone under the age of 18, it also requires trans young people who are already receiving gender-affirming care to end their treatment by March 31, 2024, effectively forcing them to detransition.
Every major medical organization in the U.S. has recognized that gender-affirming healthcare — which can include puberty blockers and hormone therapy — is evidence-based, safe, effective, and can be medically necessary to treat gender dysphoria in young people.
In April, the ACLU and Lambda Legal filed a lawsuit in a federal court in Nashville on behalf of three families with transgender children and a Memphis doctor who provides gender-affirming care to block the law, arguing that that S.B. 1 unlawfully discriminates against transgender people based on their sex in violation of the Constitution’s Equal Protection Clause. A district court judge blocked the law from going into effect in June, but in July, the Sixth Circuit voted 2–1 to allow S.B. 1 to go into effect while the court challenged proceeded. Similarly, the Sixth Circuit ruled in August that Kentucky could enforce its own law banning gender-affirming care for minors.
Legal challenges brought by the ACLU of Kentucky and Tennessee, along with other organizations, in both cases were consolidated in July for consideration at the Sixth Circuit, which hears appeals from both states. In September, the court again voted 2–1 to uphold both laws.
In Wednesday’s legal filing, attorneys for the ACLU and Lambda Legal wrote that conflicting court decisions around laws banning gender-affirming care for minors are “creating chaos across the country for adolescents, families, and doctors.”
In addition to the Sixth Circuit decision regarding the Tennessee and Kentucky laws, the Eleventh Circuit Court of Appeals lifted an injunction against Alabama’s gender-affirming care ban in August. Meanwhile, similar laws in Florida, Montana, and Indiana have been blocked, and Arkansas’s ban was struck downin June.
“Neither the wave of state bans on gender-affirming medication nor the lawsuits challenging them are likely to abate in the near future,” the ACLU’s petition states. “Given the division among the courts of appeals on the appropriate level of scrutiny in these and related cases, any delay in this Court’s review only risks subjecting transgender adolescents, their parents, and their doctors to a patchwork of inconsistent laws and legal standards that obstruct their medical care.”
As The Hill notes, while the Supreme Court has not yet taken up a case involving bans on gender-affirming healthcare, conservative Justices Samuel Alito and Clarence Thomas appear eager to address transgender rights. According to HuffPost, both the Sixth Circuit’s decision in the Tennessee and Kentucky case and the Eleventh Circuit’s decision in upholding Alabama’s law cited the Supreme Court’s reasoning that the federal right to abortion is not “deeply root” in the “history and tradition” of the U.S. in its 2022 decision overturning Roe v. Wade.
Queer teens are twice as likely to experience binge eating disorders compared to their straight peers, a new study has found.
Binge-eating disorder (BED) is, according to the study, the most common type of eating disorder in the US, affecting up to 16.6 million Americans.
The disorder can act as a precursor for serious physical and mental health problems like cardiovascular disease, type 2 diabetes, high blood pressure or cholesterol, arthritis, depression, or anxiety, if not treated.
Binge-eating disorder (BED) is, according to the study, the most common type of eating disorder in the US, affecting up to 16.6 million Americans. (Getty Images)
Based on data from the Adolescent Brain Cognitive Development Study, a large-scale 2020 study that recorded 10,000 adolescents aged 10-14, researchers were able to determine that teens from low-income households, teens of Native American descent, and teens who identify as queer were most likely to be associated with BED.
The study from the University of California at San Francisco points to stressors like bullying, discrimination, and internalised homophobia as the cause of heightened disordered eating and lowered self-esteem among gay, lesbian, and bisexual teens.
Lead study author Dr Jason Nagata writes: “Adolescents who identify as gay and bisexual face external and internal stressors, such as stigma, bullying, discrimination, and internalized homophobia, which all compound to an increased risk for disordered eating.
“This study found that adolescent males who identified as gay or bisexual had 12.5 times the odds of binge eating compared to their heterosexual counterparts.
“Similarly, adolescent girls who identified as lesbian or bisexual had twice the odds of binge eating and purging compared to their heterosexual counterparts.
“Given the emerging research that supports this association, future studies should explore the prevention, early identification, and management strategies of binge-eating behaviors for gay or bisexual adolescents.”
Stressors like bullying, discrimination, and internalised homophobia as the cause of heightened disordered eating. (Getty Images)
He continues: “Binge eating can result in psychological effects like depression and anxiety, and long-term physical health problems, including diabetes and heart disease.
“Given the higher risk of eating disorders in LGBTQ+ youth, it is important that health care providers foster a welcoming environment to youth of all sexual orientations and genders.”
The study also determined that, although disordered eating behaviours are often thought to primarily affect women and girls, data proves that male adolescents are more likely to display binge eating behaviours than their female counterparts.
“In male adults and adolescents, body dissatisfaction is often tied to a drive for muscularity and larger size as opposed to thinness,” the study reads.
“Over half of young men who report weight gain and bulking goals report eating more to achieve this goal, which leads to the consumption of larger volumes of food.”
It adds that men are more likely than their female counterparts to engage in “cheat meals” the practice of briefly indulging in prohibited foods before returning to a strict diet.
Cheat meals, the study says, are linked to over-eating, loss of control while eating, and binge-eating behaviours.
It determines: “The findings from our analysis further illustrate the prevalence of binge-eating behaviors in adolescent males and serve as a call for more studies focusing on eating disorders in this population, particularly on the relationship between muscularity-oriented eating goals and binge eating.”
Dr Nagata concluded that any teenagers experiencing eating disorder symptoms should immediately “seek professional help.”
“Eating disorders are best supported by an interdisciplinary team, including a mental health, medical, and nutrition provider.”
The Centers for Disease Control and Prevention along with the World Health Organization are raising red flags for the second time this year as cases multiply of a “super strain” of drug-resistant gonorrhea globally, but particularly among men who have sex with men.
This strain of gonorrhea has been previously seen in Asia-Pacific countries and in the U.K., but not in the U.S. A genetic marker common to two Massachusetts residents and previously seen in a case in Nevada, retained sensitivity to at least one class of antibiotics. Overall, these cases are an important reminder that strains of gonorrhea in the U.S. are becoming less responsive to a limited arsenal of antibiotics.
Gonorrhea is a STI with most people affected between ages 15-49 years. Antimicrobial resistance in gonorrhea has increased rapidly in recent years and has reduced the options for treatment.
Last February, cases of XDR, or “extensively drug resistant,” gonorrhea, are on the rise in the U.S., the CDC said.
Gonococcal infections have critical implications to reproductive, maternal and newborn health including:
a five-fold increase of HIV transmission
infertility, with its cultural and social implications
inflammation, leading to acute and chronic lower abdominal pain in women
ectopic pregnancy and maternal death
first trimester abortion
severe neonatal eye infections that may lead to blindness.
This past January, Fortune reported the U.S. is experiencing “a rising epidemic of sexually transmitted disease,” Dr. Georges Benjamin, executive director of the American Public Health Association, said with some experts referring to the issue as a “hidden epidemic.”
Cases of gonorrhea — an STI that often shows no signs, but can lead to genital discharge, burning during urination, sores, and rashes, among other symptoms — rose by 131 percent nationally between 2009 and 2021, according to public health officials. While rates of STI transmission in the U.S. fell during the early months of the pandemic, they surged later in the year, with cases of gonorrhea and syphilis eventually surpassing 2019 levels, according to the CDC.
