On June 21, the U.S. Food and Drug Administration (FDA) approved Vyleesi, a libido drug being hailed as the new “female Viagra.” On its surface, the move seems like a win for women’s sexual health—but it has reignited a debate over the role drugs should play in complicated issues like desire.
Vyleesi, which is made by AMAG Pharmaceuticals and known scientifically as bremelanotide, is the second drug approved by the FDA to treat hypoactive sexual desire disorder (HSDD), a condition that involves low sexual desire, and resulting distress or interpersonal issues, in premenopausal women. The first such medication, Addyi (flibanserin), was approved in 2015, but has so far proved disappointing in both sales and results; the FDA has continued to warn patients about safety concerns associated with the drug, thought it did relax some labeling restrictions this year.
Whereas Addyi is an oral medication that must be taken daily, Vyleesi is an injection that women self-administer to their thigh or abdomen at least 45 minutes before sexual activity. But like Addyi before it, Vyleesi’s approval has caused some experts to argue that female desire has been over-medicalized, and that drugs aren’t the best way to boost it at all.
“Desire is a complex issue that, as the science has shown, is not something that is an easy fix,” says Dr. Anne Katz, a Canada-based sexuality counselor who has written about drugs and female desire. “Addyi is a failure. I suspect this one will be too.”
The data the FDA used in its decision don’t sound especially compelling. In a pair of 24-week trials involving some 1,200 women with HSDD, about a quarter of women taking the drug reported a noticeable increase in sexual desire, compared to 17% of those taking a placebo. About 35% reported a drop in psychological distress related to their lagging desire, compared to 31% taking a placebo. Some experts feel these modest results point to the fact that female desire, which is intricately related to life circumstances, stress, relationship issues and other factors, can’t be boosted with drugs alone.
Kim Wallen, a professor of psychology and behavioral neuroendocrinology at Emory University who has studied female desire, argues that some women struggling with low interest in sex may have little inward motivation to use an injection like Vyleesi. While there are certainly women with HSDD who want a treatment, Wallen says he fears that others will feel “pressured to take the drug to engage in sex,” just to please a partner or meet societal expectations.
Not all experts feel this way, though. “The argument that this is not a biological issue, this is a lifestyle issue, is completely misguided,” says Dr. Leah Millheiser, the director of the Female Sexual Medicine Program at Stanford Health Care. Millheiser says her research on HSDD shows that women with the condition experience changes in brain activity independent of lifestyle factors, so both must be addressed. That said, there’s some debate around HSDD. Wallen, for one, says he doesn’t feel the data on HSDD are compelling enough to make that argument.
Millheiser acknowledges that Vyleesi’s effects aren’t huge, but she says even a small improvement can matter for patients.
“Is that small increase enough? The answer is absolutely, if the woman is acting on it and it’s improving her life and well-being,” Millheiser says. “I hope that the naysaying doesn’t scare women away from addressing this very important issue.” She also notes that female sexuality can’t be measured the way male desire is. Viagra either helps a man get an erection or it doesn’t; female libido drugs, she says, may have subtler results that might get lost in a clinical trial.
In a statement provided to TIME, a representative for AMAG emphasized the scientific rigor of the company’s studies, as well as the efficacy of its product. “In some recent news coverage of Vyleesi there has been a misperception around the meaningfulness of the improvements patients experienced with the drug,” the statement says. “Given the nature of the scale, even small improvements can have a significant impact on the patient’s experience. To put it into context, the effect size that we saw…[was] consistent with what has been seen with a number of anti-depressant and anti-anxiety drugs.”
The FDA has drawn criticism over Vyleesi’s approval, since it did not convene an expert panel to analyze the drug and moved forward without long-term safety data, the Washington Post reports. (AMAG says the 24-week trials had a voluntary, yearlong extension period to assess safety.) The FDA admitted in a statement that it isn’t totally sure how Vyleesi works, and recommended that women use the therapy no more than once per day and eight times per month. The agency also warned that it’s associated with side effects including nausea, vomiting, injection site pain and headaches, and is not recommended for those with blood pressure or cardiovascular issues.
Dr. Aaron Kesselheim, a professor at Harvard Medical School who has studied FDA approval processes, says the lack of an expert panel and long-term data aren’t major red flags, at least within the context of the existing drug approval system. Advisory panels are convened for only a quarter to a third of drug approvals, he says, and about two-thirds of drugs are approved based on studies lasting six months or shorter. So at the very least, Kesselheim says, Vyleesi isn’t unique in those respects—but that doesn’t necessarily mean it’s a good drug.
“I think the most important thing is how the drug works and what sort of efficacy is demonstrated in the clinical trials,” Kesselheim says. “It doesn’t look like there was a substantial amount of efficacy identified in the trials.”
Wallen agrees that the efficacy data aren’t terribly impressive, and says he likely wouldn’t recommend that the average woman struggling with libido issues use Vyleesi, at least until there’s a more robust understanding of issues that hinder female sexuality.
“I’m glad people are asking the question,” Wallen says. “I just wish they were asking it in a much broader context.”
Shares of Palatin Technologies (PTN - Get Report) on Monday jumped and then pulled back after the biopharma was cleared by the U.S. Food and Drug Administration to market a drug to treat weakened sexual desire in women. Palatin shares closed down 9.7% at $1.21. They traded as high as $1.78 on Monday. The FDA cleared Vyleesi, a treatment for premenopausal women with acquired generalized hypoactive sexual desire disorder, Palatin said. Palatin has licensed the drug to Amag Pharmaceuticals (AMAG - Get Report) , the Waltham, Mass., drugmaker. Amag shares on Monday were down 2.8% at $8.72 on the Nasdaq Stock Market. The FDA move regarding Vyleesi, generically bremelanotide, prompts a $60 million payment to Palatin from Amag. Palatin, Cranbury, N.J., said it also was in line for as much as $300 million of payments from Amag based on sales. And their deal gives Palatin royalties based on sales. The company said in a statement that it does not know the drug's exact mechanism of action, but "Vyleesi is believed to bind to melanocortin receptors in the central nervous system that are thought to be associated with sexual function." About 6 million women suffer from the disorder, Palatin said. Women with uncontrolled high blood pressure and those with cardiovascular disease should not take the drug, Amag said in a statement. A woman expecting a sexual encounter will inject herself with the drug via a pen. Amag should have the drug available in specialty pharmacies in September, Palatin said.continue reading
On Friday, the Food and Drug Administration (FDA) approved the injectable drug Vyleesi to treat women with hypoactive sexual desire disorder. The prescription drug, which will hit the consumer market in September, aims to boost affected women’s libidos by activating the brain’s receptors that play a role in feeling sexual desire.
“As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction,” Dr. Hylton V. Joffe, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said in an FDA press release.
Vyleesi is the second drug the FDA has approved for hypoactive sexual desire disorder in women. In 2015, the FDA approved Addyi for hypoactive sexual desire disorder as well. While Addyi is a pill meant to be taken daily, Vyleesi users are supposed to inject the drug at least 45 minutes before having sex.
Both Vyleesi and Addyi are for women who have not yet gone through menopause and work through a similar mechanism. Their side effects can include nausea, vomiting, and dizziness, and they have also been shown to increase a users’ blood pressure.
According to The Society for Women’s Health Research, hypoactive sexual desire disorder affects an estimated 1 in 10 women.
The condition can be diagnosed when a woman’s lack of sexual desire is so distressing to her that it interferes with her relationships and personal life. Distress is an important factor in diagnosing hypoactive sexual desire disorder, since some people with low libidos might not feel distress or experience relationship problems, according to the American Sexual Health Association (ASHA) website.
“[To diagnose it] we would ask about the past and if the level [of sexual desire] you’re experiencing now is different from the past,” Rachel Wright, a relationship therapist and cofounder of the Wright Wellness Center, told INSIDER. “Then, we would ask if you’re bothered by [the new lower sex drive]. It’s very subjective compared to other diagnoses, like a panic attack.”
Hypoactive sexual desire disorder – which can also affect men, though this medication is for women only – has many potential causes. It may be a byproduct of libido-reducing medication or another illness, but it could also be the result of being in an unhealthy relationship or poor communication, according to Wright.
“Women’s sexual desire is so complex, not even the best scientist will understand fully what’s happening with low libido. It can be a symptom of so many things, just like fatigue,” Wright said.
Addyi and Vyleesi have both been called “female Viagra” because of their uses, but Wright said this moniker is misleading since hypoactive sexual desire disorder is a complicated condition rooted in the brain rather than a mechanical issue. “Viagra is about treating an in-the-moment issue and an operational functional thing, whereas Vylessi is actually about overall desire, not in-the-moment performance,” Wright said. “It’s a symptom of a larger issue.”
Since identifying the cause of low sexual desire can be so complicated, prescribing a drug like Vyleesi may be nothing more than a Band-Aid for a bigger relationship-related problem that takes a lot of work, not an injection, to deal with effectively. “If somebody can take a pill versus doing that hard work of therapy or talking about what’s going on, people will do that,” Wright said. “This feels a little like a slippery slope, especially if someone is in an unhealthy relationship and responding to that by not being interested in sex.”
In that case, Wright recommends talking to your partner about why you’re not interested in sex like you used to be. It can be awkward at first since societal messages can make women feel shameful about sexual health problems, but doing so could lead to a discussion that better prioritises your sexual needs in the long run.
Wright said the majority of her patients who experience low libido feel that way because of an underlying issue like childhood sexual trauma or resentment toward their partners. Discussing how you feel in a scenario like this may serve you better than a drug.
National HIV Testing Day — on June 27 — is a day to encourage people to get tested to know their health status. This year's annual observance is going with the theme "Doing It My Way."
Under this theme, officials want people to know they can get tested at clinics, using at-home tests, and by seeing your personal health care provider.
About 1.1 million people in the United States have HIV, and one in seven people with HIV in the U.S. don't know they have it. According to the Indiana State Department of Health, there were 419 new cases of HIV in Indiana reported in 2018, and approximately 6,357 people currently living with HIV.
The Centers for Disease Control and Prevention recommends that everyone between the ages of 13 and 64 gets tested for HIV at least once, as part of their health care routine. Those at high risk are recommended to be tested at least once a year.
HIV testing is done through a finger prick blood sample, with results ready as soon as 20 minutes after.
The Damien Center will be offering free and confidential HIV and STI testing on Thursday in Indianapolis from 8:30 a.m. to 5 p.m. at 26 North Arsenal Avenue.
The Indianapolis Urban League will have a mobile unit traveling for HIV Testing Pop-Up's throughout Marion County on Thursday, as well.
Step Up Inc. is also set to offer free HIV testing on Thursday at two locations. One at their office at 850 North Meridian Street from 19 a.m. to 2 p.m., and the second at Club-Indy at 620 North Capitol Avenue from 7 p.m. to 10 p.m.
Free screenings will be offered at IU Health's LifeCare unit from 8 a.m. to 4 p.m. in the Methodist MedTower located at 1633 North Capitol Avenue.
The Hendricks County Health Department will also be hosting a free HIV testing clinic on Thursday. The Public Health Nursing Division will be hosting the clinic from 8:30 a.m. to 11:30 a.m. and 1:30 p.m. to 3:30 p.m. for residents 14-years-old or older.
“The most common way HIV is transmitted in Indiana is through sexual contact between an infected partner and a noninfected partner, followed by intravenous drug use,” Teresa Krupka, Infectious Disease Nurse at HCHD, said. “Babies born to HIV positive mothers are also at risk of contracting the virus.”
The Boone County Health Department will be offering free HIV screenings in Lebanon from 9 a.m. to 4 p.m. at 116 West Washington.
Testing at the LGBTQ+ Cultural Center on the Indiana University Bloomington campus from 10 a.m. to 2 p.m. at 705 East 7th Street.
Multiple Walgreen Stores
Walgreens is participating nationally by offering confidential HIV testing, counselors and more.
Here is a list of participating Walgreens locations in Central Indiana:
Andreson: 3736 South Scatterfield Road
Muncie: 400 East Memorial Drive
Lafayette: 1801 South Street
Indianapolis: 3003 Kessler Blvd North Drive and 1530 North Meridian Street
All Walgreen testing clinics will be open from 10 a.m. to 7 p.m. on Thursday.
Thursday marks National HIV Testing Day, the annual event that encourages people to get tested or treated for the human immunodeficiency virus.
According to the U.S. Centers for Disease Control and Prevention, this year’s theme is “Doing It My Way,” which focuses on encouraging folks to get tested in the way that best suits them. This could be at your physician’s office, a testing site or clinic or even via an at-home testing kit.
An estimated 1.1 million people in the United States have HIV and, incredibly, one in seven of them don’t even know it, says the CDC, which explains that HIV weakens a person’s immune system by destroying important cells that fight disease and infection. There is no effective cure, but the virus can be controlled with proper medical care.
In Pennsylvania, the latest statistics out of the Department of Health, hold that about 36,000 state residents are living with HIV. In 2017, the state saw less than 1,000 new cases of HIV, the health department said.
In the Philadelphia area, nearly 50 places offer free or low-cost testing. Find the one closest to you here using the CDC’s Get Tested map.
In Allentown, the Morning Call reports there will be “free and confidential” HIV testing at 245 N. 6th St., on June 27 between 9 and 11 a.m.
In York, HIV testing and counseling will be available at three health care locations on Thursday, according to city officials.
Current CDC guidelines hold that everyone between the ages 13 and 64 should be tested for HIV at least once, while those at high risk should get tested at least once a year. Some individuals — like sexually active gay and bi-sexual men — might benefit from multiple testings throughout the year.
Are you aware of your HIV status? Have you ever been tested? If not, this week might be the perfect time to do so. Thursday marks national HIV testing day nationwide. It's one day that everyone joins together for the same common cause, finding out their HIV status. The testing is completely free and will be taking place in Marianna on Wednesday from 10-2p.m. at Three Rivers apartments. On Thursday, the staff will be at the Basic NWFL office located at 432 Magnolia Avenue from 8 a.m. to 8 p.m. Staff said they want people to be able to have a happy healthy life and encourage everyone to get tested. "Please, get tested. It's not just for National HIV testing day, but anytime that works for you that's convenient. It's important to know your status," said Basic NWFL President/CEO, Valerie Mincey. The test is a simple finger prick with results returned in 20 minutes. Basic of NWFL is located in downtown Panama City, and they actually do free HIV testing year round. You can either walk into their office or make an appointment.continue reading
Its summer and that means vacation time. Are you one of those who leaves vacation days on the table or do you take them all? Researchers from Syracuse University found that people who used their vacation time over the course of a year had a lower number of risk factors for cardiovascular disease. People generally feel more rejuvenated after getting away. However, a 2018 report by the U.S. Travel Association showed that about 50% of American employees do not use all of the vacation days. Medical evidence now shows that taking a vacation may significantly reduce the risk of metabolic syndrome and symptoms. To be clear, the syndrome is not a specific condition but it groups together a set of risk factors that have been linked to a higher chance of developing cardiovascular disease and heart and type two diabetes. These risk factors include high blood pressure, high blood sugar, body fat around the waist, and high cholesterol. According to the American Heart Association a doctor will often consider metabolic syndrome if a person has at least three of the following five symptoms / risk factors. Researchers from Syracuse University studied a group of sixty three full- time healthy workers. These adults were eligible for paid vacation over the course of one year. These participants took approximately five vacations and used about two weeks of their paid vacation days. The research that was recently published in the Journal Psychology and Health found that people who went on vacations more frequently in the past 12 months have a 24% lower risk for metabolic syndrome and a lesser number of metabolic symptoms. Meaning In other words, they had less risk for cardiovascular disease. According to the study this is an important finding because the metabolic risk factors are modifiable, they can change. For example if someone is doing more vacationing, they can decrease their risk for cardiovascular disease by reducing these symptoms. Bryce Hruska, an assistant professor of public health at Syracuse University's Falk College of Sport and Human Dynamics and an author of the study says they are still learning what it is about vacations that make them beneficial for heart health, but at this point, what they do know that it is important for people to use the vacation time that is available to them. In light of this, researchers say the next step would be to determine if there is another way to get these health benefits. It is important to point out that taking a vacation can be expensive and sometimes people may not have the budget or time. According to The study authors , this research represents the first empirical comparison of home and away vacations and their relationship to physical health outcomes. For many people getting away may mean un-plugging from the internet and social media, putting down the phone and instead spend some time in nature or doing things we enjoy. Some other ways you can make your weekend or day off stress free or feel like a vacation get -away , could include being a tourist in your own town , trying a new restaurant or park, going for a long walk or bike ride, create a spa-like environment in your own bedroom. The study stated that the US is the only industrial nation that does not guarantee paid vacation time to its workers. If circumstances are preventing you from taking an extended amount of time away , this research shows a few long weekends here and there may be the remedy.continue reading
1. Manage anxiety
Having high levels of anxiety is a common barrier to sexual functioning and libido for both males and females. This may be anxiety due to life stress or specific sex-related anxiety.People with an intense work schedule, caring responsibilities, or other life stresses may feel fatigued and, as a result, have a low sexual desire.Anxiety and stress can also make it more difficult for someone to get or maintain an erection, which can put a person off having sex. A 2017 review of erectile dysfunction in young men has suggested that depression and anxiety can result in a reduced libido and increased sexual dysfunction.
2. Improve relationship quality
Many people experience a lull in sexual desire and frequency at certain points in a relationship. This may occur after being with someone for a long time, or if a person perceives that things are not going well in their intimate relationships.
3. Focus on foreplay
Having better sexual experiences may increase a person's desire for sex, thereby boosting their libido. In many cases, people can enhance their sexual experiences by spending more time on touching, kissing, using sex toys, and performing oral sex. Some people call these actions outercourse.
4. Get good-quality sleep
Getting good sleep can improve a person's overall mood and energy levels, and some research also links sleep quality to libido. A small-scale 2015 study in women suggested that getting more sleep the night before increased their sexual desire the next day. Women who reported longer average sleep times reported better genital arousal than those with shorter sleep times.
5. Eat a nutritious diet
Following a nutritious diet can benefit people's sex drive by promoting good circulation and heart health, and by removing specific foods that can decrease libido. Metabolic syndrome and cardiovascular disease can affect physical sexual functioning. Also, polycystic ovarian syndrome can affect hormone levels, which may also disrupt libido. Eating a diet rich in vegetables, low in sugar, and high in lean proteins can help prevent disorders that affect libido.
6. Try herbal remedies
There is little research into how effective herbal remedies are at improving sexual function in males and females, though some people may find them beneficial. A 2015 review study states that there is limited but emerging data that the following herbal remedies may improve sexual function:
People should be wary of using herbal medicines without their doctor's approval. Some herbal medicines can interact with existing medications, and the Unites States Food and Drug Administration (FDA) do not regulate them. For this reason, their quality, purity, and safety remains unclear.
8. Get regular exercise
Getting regular exercise can help libido in many ways. A 2015 study of men undergoing androgen deprivation therapy, which lowers testosterone levels, found that regular exercise helped men cope with issues such as body image concerns, low libido, and relationship changes.
7. Maintain a healthful weight
Some scientists link overweight and obesity to low sex drive, along with other factors related to reduced fertility. This is associated with hormonal factors, such as low testosterone concentrations. Some people who are overweight may also experience psychological effects, such as lower body confidence.
9. Try sex therapy
Sexual desire is complex, with both psychological and physical components. Even when a person has a physical condition that affects libido, such as diabetes, improving the emotional and psychological response to sex can improve libido and sexual functioning. Therapy is an effective strategy for increasing low libido. Individual counseling can help address negative views about sex, self-esteem, and secondary causes of low libido, such as depression and anxiety. Relationship counseling can help some people work through factors affecting their sexual desire.
10. Quit smoking
Smoking cigarettes can have a negative impact on a person's cardiovascular system. Good heart health is important for good sexual functioning. People who smoke cigarettes may find that their energy levels and sex drive increase after they quit.