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FDA oks adverts for first condom specifically designed for anal intercourse

FDA authorized One Male Condom also aa a contraceptive to reduce risk of pregnancy and the transmission of STIs during vaginal intercourse

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Courtesy of Global Protection Corp.

WASHINGTON – Boston, Massachusetts-based Global Protection Corporation, a world leader in manufacturing and distributing sexual health products, condom manufacturing, lubricant manufacturing and much more was granted permission by the U.S. Food and Drug Administration, (FDA), to market its condoms designed for anal intercourse.

On Wednesday, the FDA authorized the marketing of the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.

Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse. Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission. Consistent and correct condom use has the potential to significantly help decrease the risk of STIs. While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention. It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

“Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster,” she added.

The One Male Condom is a natural rubber latex sheath that covers the penis. It has three different versions: standard, thin and fitted. The fitted condoms, available in 54 different sizes, incorporate a paper template to aid in finding the best condom size for each user. When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant.

The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. All participants were between 18 through 54 years old.  

The study found that the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse with the One Male Condom. Condom failure rate was defined as the number of slippage, breakage or both slippage and breakage events that occurred over the total number of sex acts performed.

For the One Male Condom, the overall percentage of adverse events was 1.92%. Adverse events reported during the clinical trial included symptomatic STI or recent STI diagnosis (0.64%), condom or lubricant-related discomfort (0.85%), partner discomfort with lubricant (0.21%) and partner urinary tract infection (0.21%).

The symptomatic STI or recent STI diagnoses observed in the study were self-reported and may be the result of subjects having intercourse without a condom or may have preceded use of the One Male Condom, as STIs were not measured at baseline.

The FDA reviewed the One Male Condom through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing.

When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted the marketing authorization to Global Protection Corp.

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AHF urges community outreach & education around monkeypox

“Our hope is this [monkeypox outbreak] is a passing issue, not something that’s ultimately a great cause for alarm and concern”

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Dr. Carl Millner (Screenshot/Press briefing June 20, 2022 AHF)

LOS ANGELES – During a press conference Monday, representatives from the AIDS Healthcare Foundation (AHF) urged public health officials and other healthcare stakeholders to ramp up educational and outreach efforts to slow the current rates of the monkeypox virus transmission.

“Our hope is this [monkeypox outbreak] is a passing issue, not something that’s ultimately a great cause for alarm and concern,” AHF President Michael Weinstein said. “But it’s better [to be] safe than sorry.”

Weinstein, joined by the organization’s Interim National Director of Infectious Diseases, Dr. Stuart Burstin, and its West Coast Regional Director of Internal Medicine, Dr. Carl Millner, stressed the importance of minimizing community spread through measures that can reduce the likelihood of exposure to monkeypox.

These measures, they said, include avoiding skin-to-skin contact with individuals who are known to have an active infection or who were previously infected but may still carry a risk of transmitting the virus. 

Weinstein and Burstin both pointed to public health experts’ calls for patients who are recovering from monkeypox to use condoms during all sexual activity for at least 12 weeks, pursuant to guidelines from the World Health Organization’s (WHO) that were last updated June 17.

As the virus can also be spread by exposure to bedding and clothing that has been contaminated by infected persons, contact with these items should also be avoided wherever possible, Burstin said. 

“We can reduce [the risk of transmission] by behavioral means,” Burstin said. “What we have to do is to educate people so that the risk remains low to zero,” he said. “If that fails, there’s vaccination and therapy.”

Infections are currently concentrated in Europe: the U.K. has reported 524 cases, and Spain, Germany, Portugal, and France have reported 313,303, 241, and 183 cases respectively. Many of the infections in Europe and the Americas can be traced back to LGBTQ+ events where men gathered — specifically a LGBTQ+ fetish festival in Belgium and a gay pride event in the Canary Islands. 

No deaths have been reported, and most monkeypox cases are mild — symptoms include rashes, initial flu-like symptoms, and lesions or sores.

Men, particularly gay men, and men who have sex with men (MSM), have been disproportionately represented in the clusters of cases documented.

The Centers for Disease Control and Prevention (CDC) reports there have been 113 confirmed cases in the U.S., of which 24 have been reported in California. Burstin said that figure is probably far lower than the number of actual cases, as the significant overlap in symptoms caused by monkeypox with those caused by other illnesses, including COVID-19, raises the likelihood of underreporting and misdiagnoses. 

Millner said it can even be easy to miss the prototypical rash that develops with monkeypox infections, which he described as a lesion or multiple lesions that usually appear on the hands, mouth, feet and genitals. These are often, and reasonably, misidentified as pimples, infected hair follicles, or – especially when located on or near the genitals – blisters caused by sexually transmitted diseases like herpes or syphilis. 

Screenshot of infected patient via AHF press conference

Burstin said that while monkeypox can, in rare cases, cause serious and even life-threatening symptoms, the disease has a low case fatality rate, around one percent. Plus, he said, the possibility that future variants may be deadlier or more contagious appears to be slim, given what epidemiologists have learned about the widely studied and now eradicated but closely related smallpox virus.  

There are vaccinations and treatments available for monkeypox, Burstin said, which are reserved for cases of serious illness and for populations deemed high-risk, which include pregnant women, young children, the elderly and the immunocompromised. 

Instead of mass vaccination campaigns, public health experts say immunizations should be administered based on assessments of patients’ risk of becoming seriously ill. For those deemed eligible, if given within the first four days after contracting the virus, vaccines can reduce the number and severity of symptoms, Burstin said.

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Monkeypox cases rise amid calls for equitable treatment & vaccine equity

2,166 cases of monkeypox have been recorded globally, spanning 37 countries, including places where it is not usually seen

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Dr. Tedros Adhanom Ghebreyesus, Director-general of the World Health Organization gives briefing on Monkeypox June 16, 2022 (Screenshot/YouTube)

WASHINGTON – As of June 16th, 2,166 cases of monkeypox have been recorded globally, spanning 37 countries, including places where it is not usually seen. The United States currently has 100 recorded cases of monkeypox — California, New York, and Illinois are hot spots with 21, 17, and 13 cases respectively. 

Infections are currently concentrated in Europe: the U.K. has reported 524 cases, and Spain, Germany, Portugal, and France have reported 313,303, 241, and 183 cases respectively. Many of the infections in Europe and the Americas can be traced back to LGBTQ+ events where men gathered — specifically a LGBTQ+ fetish festival in Belgium and a gay pride event in the Canary Islands. 

No deaths have been reported, and most monkeypox cases are mild — symptoms include rashes, initial flu-like symptoms, and lesions or sores.

According to the CDC’s latest report, most of the reported cases have occurred in men who have sex with men, but monkeypox can be transmitted to anyone who has had close skin-to-skin contact with an infected person.

Although cases are currently concentrated in gay and bisexual men, Kyle Knight, senior LGBT and health researcher at Human Rights Watch, stressed the importance of managing the outbreak without stigmatizing gay men — or deepening the divide between wealthy and poor countries. 

“Whether it’s lessons drawn from HIV, Covid-19, or other public health issues, it is essential to place human rights at the center of the response to infectious disease outbreaks,” Knight said, in a statement.

In an email to the Blade, Dr. Sarah Henn, Chief Health Officer for Whitman-Walker Health, reiterated the need to spread awareness of monkeypox within the LGBTQ+ community while simultaneously eradicating stigma.

“When dealing with an outbreak of any infection it is important to recognize risk factors for infection and specific communities where the infection is being seen. This must be done without stigmatizing those affected. This is the delicate balance that public health authorities are currently trying to walk with the outbreak of monkeypox. There is nothing intrinsic to the monkeypox virus that makes it a sexually transmitted infection, but it is transmitted by close skin to skin contact with the pox lesions, which obviously sexual intimacy involves,” she said. 

“People in the queer community need to know what to look for and understand what the potential risks are to their own health. We want to empower the community to help control the outbreak and protect themselves from possible infection without creating stigma or unnecessary fear.”

In addition to its prevalence among gay and bisexual men, monkeypox has a history of unequal treatment options in poorer countries. While some wealthy countries have stockpiles of the smallpox vaccine leftover from when the disease was eradicated in the 1980s, the vaccine — which is effective against monkeypox — is currently unavailable on the entire continent of Africa, where monkeypox is an endemic disease.

Dr. Matshidiso Moeti, World Health Organization, (WHO) regional director for Africa, advocated for a unified global approach that includes vaccine equity.

“We must avoid having two different responses to monkeypox – one for Western countries which are only now experiencing significant transmission and another for Africa,” Moeti said. “We must work together and have joined-up global actions which include Africa’s experience, expertise and needs.”

In countries such as the U.S. and Canada, “ring vaccinations” are being used to prevent outbreaks, in which close contacts of infected people are given a smallpox vaccine within four days of exposure. This approach prevents serious infection and reduces the risk of further spread, but in places where smallpox vaccines are not readily available, it is not an option.

In Chicago, where the state of Illinois’s monkeypox cases are concentrated, officials are also focusing on providing information about prevention and safer sex to gay and bisexual men. With the San Francisco and New York Prides happening next weekend — the country’s two largest — the future of monkeypox outbreaks in the U.S. appears uncertain.

Guidance from the Chicago Department of Public Health encourages people attending “festivals or other summer events” to be mindful of skin-to-skin contact, get tested for monkeypox if exposed, and monitor for symptoms after exposure. Additionally, the CDPH has printed cards with links to the CDC health tips for gay and bisexual men, for organizers to hand out at events.

In Washington D.C., the outbreak is currently smaller — four cases to Chicago’s seven — but officials are still taking preventative measures to diagnose and treat the illness. 

“As of today, 4 cases of monkeypox have been diagnosed within the District of Columbia,” Dr. Henn said. “We are working closely with DC Health to screen people for monkeypox who are presenting with rashes that could possibly represent infection and have been coordinating with the city around vaccination of those who have been exposed to a diagnosed case.”

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Monkeypox outbreak, CDC asks for reaction guided by science, not stigma

CDC says cases have been identified in Massachusetts, Florida, Utah, Washington, California, Virginia and New York

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Dr. Rochelle Walensky, Director, CDC (Screenshot/YouTube)

ATLANTA – During a press briefing Thursday, Dr. Rochelle Walensky, Director of the US Centers for Diseases Control and Prevention confirmed that there are now seven states reporting active cases of infection of the Monkeypox virus.

Walensky told reporters that cases have been identified in Massachusetts, Florida, Utah, Washington, California, Virginia and New York. She added that all of the reported cases so far have been gay or bisexual men.

Samples from the nine identified cases were sent to the CDC for additional confirmatory testing and genomic investigation, she noted, and there are efforts to learn how each individual contracted the virus.

The CDC Director then called for an approach “guided by science, not by stigma.”

“This is a community that has the strength and has demonstrated the ability to address challenges to their health by focusing on compassion and science,” Walensky said in a reference to the AIDS pandemic.

“While some groups may have a greater chance of exposure right now, infectious diseases do not care about state or international borders. They’re not contained within social networks and the risk of exposure is not limited to any one particular group,” she cautioned.

Walensky implored people “to approach this outbreak without stigma and without discrimination.”

Health officials on both sides of the Atlantic are cautioning gay and bisexual men to be cautious as numbers of infections of the non-lethal monkeypox continue to climb. The outbreak according to the World Health Organization can be traced to sexual activity stemming from LGBTQ+ events, one in the Spanish in the Canary Islands and the other in Belgium.

The United Nations’ AIDS agency (UNAID) in a press release Monday decried the semingly homophobic news coverage of the recent outbreaks of monkeypox in Europe and the United States.

“Lessons from the AIDS response show that stigma and blame directed at certain groups of people can rapidly undermine outbreak response,” UNAIDS said.

Monkeypox is not usually fatal but often manifests itself through fever, muscle aches, swollen lymph nodes, chills, exhaustion and a chickenpox-like rash on the hands and face.

The virus can be transmitted through contact with skin lesions or droplets of bodily fluid from an infected person. Most people recover from the disease within several weeks without requiring hospitalization. Vaccines against smallpox, a related disease, are also effective in preventing monkeypox and some antiviral drugs are being developed.

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