News Sexual Health

Eight-Hour Erection Case Leads to Complaint Against Men’s Health Clinic

Martha Kempner

The complaint was filed by a local urologist who said he's seen a number of cases of priapism in patients of a Minnesota clinic who end up in the ER.

A complaint has been filed against the Minneapolis Men’s Clinic in Bloomington, Minnesota, on behalf of one of several patients who says the clinic pushed him into buying injectable erectile dysfunction drugs that caused a painful episode of priapism.

The complaint was filed with the Minnesota Attorney General’s Office and the state Board of Medicine by Karl Kemberling, a local urologist who ended up treating the patient for an erection that lasted more than eight hours. (He was unable to reach anyone at the clinic after-hours.) Kemberling says he and his partners have seen a number of cases of priapism in patients of the clinic who end up in the emergency room. He told the Star Tribune, “We … consider their lack of care medical negligence or patient abandonment.”

According to reports, the clinic appears to be pushing injectable treatments over the more widely used oral medications, which are less likely to cause this condition.

Erectile dysfunction (ED) is defined as the inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. In order to be diagnosed with ED, the issue must affect a man’s physical and psychosocial health and have significant impact on his quality of life and that of his partners or family. It is estimated that 20 to 30 percent of men suffer from ED at some point, with 5 to 20 percent of men reporting moderate to severe cases. The likelihood of ED increases as men age.

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ED can have its roots in physical and/or psychological issues. Erections require increased blood flow to the penis, which means that cardiovascular problems such as heart disease, clogged blood vessels, high blood pressure, high cholesterol, diabetes, obesity, and heavy smoking can contribute to trouble getting or maintaining an erection. Other health issues such as Parkinson’s disease and multiple sclerosis can also increase the likelihood. Some prescription medications are known to limit sexual desire and functioning, as can some illicit drugs and even alcohol when used in excess. Other issues more closely associated with sexual function also increase the risk of ED, such as prostate cancer and treatments for prostate cancer, low testosterone levels, and injuries to or surgeries on the pelvic area or spinal cord. Relationship issues and other psychological issues such as depression and anxiety can also affect erectile functioning.

Although the ideal treatment for most men would address both the physical and psychological realms, since the introduction of Viagra in 1988 most doctors and patients turn first to PDE5 inhibitors. By blocking the PDE5 enzyme, the medications help the smooth muscles in the penis relax and increase blood flow to the penis. Other PDE5 inhibitors have been introduced since then, including Tadalfil (sold as Cialis) and Vardenfil (sold as Levitra). The differences between these drugs are mainly in how long they take before they begin to work and how long they last in the body before they stop working.

As with any medication, there are side effects to PDE5 inhibitors. Common side effects include headaches, flushing, indigestion, nasal congestion, and dizziness. About 2 percent of patients experience vision issues that include seeing a blue haze, temporary increased brightness, and even sudden vision loss or partial vision loss. Though all advertisements for these drugs warn of the multi-hour erection, cases of priapism are very rare.

Before 1988, doctors often relied on drugs that were injected into the penis with a fine-gauge needle. The most common of the drugs is alprostadil, which is marketed under the names Caverject Impulse or Edex. Other drugs include papaverine and phentolamine. These can be used in combination and the dose can be tinkered with for each patient. Side effects can include bleeding from the injection, formation of fibrous tissue at the injection site, and prolonged erections. These drugs are still available but are no longer considered first-line treatments.

Yet patients at the Minneapolis Men’s Clinic say they were given the hard sell on this type of treatment, and the long erection appears to be a part of the sales tactic. The clinic’s website says its treatment is unique:

Our pharmacy custom blends your prescription medication so that after you achieve a climax your penis will stay erect for the entire requested amount of time whether it’s 45 minutes, 90 minutes, and hour or more. This allows you to achieve a second climax (the sensation is greater each time) and adequately please your partner.

One man, a 63-year-old retired surgeon, who spoke to the Star Tribune on the condition of anonymity, said that he went to the clinic in response to an ad offering a free trial of ED treatment. After he met with a clinic doctor, he was handed over to a salesman for the treatment who was pushing a one-year supply, for a total cost of $2,800. When he asked if he could start with a smaller supply, the salesman “rolled his eyes” and “acted like that would be difficult.” The first time the man gave himself an injection he ended up with an erection that would not go down. He tried cold baths and Sudafed (a decongestant that contracts blood vessels, which was given to him by the clinic for just this situation), but neither worked. He ended up in the emergency room, after he wasn’t able to get in touch with anyone at the clinic, where doctors inserted a large needle into his penis to extract the blood. He called the treatment excruciating. The retired doctor tried the self-injected ED drugs one more time in a lower dose and wound up in the ER yet again. As he told the Star Tribune, “The stuff worked, it just didn’t unwork.”

According to the Star Tribune, Thomas Lund, a regional medical director at the Bloomington clinic, said the clinic does have a 24-hour emergency hotline with medical staff. “These claims by the local urology clinic are baseless and motivated by an attempt to drive out their competition,” Lund told the newspaper in an email.

The Men’s Clinic is one of a chain of 14 clinics across the country, which was founded by Dr. Kevin Hornsby, who self-published a book on ED and says his clinics offer an alternative to Viagra and other pills. According to the Star Tribune, the Better Business Bureau has received 19 complaints against Men’s Clinics in various states.

Commentary Sexuality

The Middle Ground in the Fight Over ‘Viagra for Women’

Martha Kempner

Some advocates are calling the Food and Drug Administration's historical hesitation to approve a drug that would treat low sex drive in women sexist; others are saying the development of the medication itself is sexist. Who's in the right?

Last week, Sprout Pharmaceutical resubmitted its New Drug Application to the Food and Drug Administration (FDA) for the approval of flibanserin, a medication designed to increase sex drive in women suffering from what has been called hypoactive sexual desire disorder (HSDD). The FDA has rejected the drug twice before, asking for more research on its safety. This has prompted some people—many of whom identify as feminists—to call the agency sexist and to argue that if the medication were for men, it would have been on pharmacy shelves already. Other advocates, however, think drugs like flibanserin should never make it to market at all, because they believe that HSDD was made up by companies trying to profit off of women’s sexual insecurities. So, what is this pill, why are so many people fighting about it, and is there a happy medium here?

Flibanserin, which will likely have a sexier name if or when it is available for sale, was originally developed as an anti-depressant. As such, it works on neurotransmitters in the brain—increasing levels of dopamine and norepinephrine and decreasing levels of serotonin. In trials, this rebalancing of brain chemistry seems to also increase women’s desire for sex. “Cara,” a woman who has become a bit of a spokesperson (albeit one going by a pseudonym) on behalf of the company’s efforts with the FDA, explained to Marie Claire that she and her husband had wonderful sexual chemistry before kids, but that all but disappeared once she became a mother: “That broke [my husband’s] heart. He’d be lying next to me and I could just feel his anger and sadness in the air.” After she joined the drug trial, she says, her libido returned. As she noted, “Flibanserin helped me remember that person I used to be.”

But, like other antidepressants, flibanserin has side effects—most notably nausea and sleepiness—which were reported by 10 percent of the women, some of whom said their drowsiness was intense enough to interfere with their ability to drive. The FDA cited side effects like these as the main reason for rejecting the drug the first time it was up for review in 2010. At the time, a panel of experts unanimously voted against it because they believed the benefits did not outweigh the risks. The drug’s initial developer, Boehringer Ingelheim, then sold the drug to Sprout, which conducted additional efficacy and safety studies before resubmitting an application for approval. This second application was rejected in 2013; after a formal dispute of the decision, the FDA asked the company to provide more data on flibanserin’s interactions with other medications.

One particular concern is how the drug will combine with a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medications increase serotonin in the brain, which is the opposite of what flibanserin does. Interestingly, and perhaps significantly, doctors consider SSRI use to be linked to many women’s low sex drives. The application Sprout filed last week included more information on drug interactions like these.

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Ahead of the filing, Sprout and supporters have been lobbying hard for the drug’s approval and gone so far as to call the FDA’s rejection of the earlier applications sexist. Several prominent women’s rights groups, as well as some lawmakers, have joined with a group of drug companies all working on this issue to create the Even the Score campaign. Those behind the campaign argue that men have 26 drugs to address sexual dysfunction, while women have none; they say, “Treatments for women’s sexual dysfunction seem to be held to a different standard for approval at the FDA, and women suffer the consequences due to lack of access to safe and effective treatments.”

As Coco Jervis of the Women’s Health Network explains in a recent piece for Rewire, however, these arguments don’t hold up to scrutiny very well. First, she points out that men only have 26 drugs if you count every duplicate drug (a brand name and all of its copies)—in reality, men have about six solutions for sexual dysfunction. And while this is six solutions more than women have, this doesn’t mean sexism is at play.

On a biological level, men and women function very differently when it comes to sexual arousal and performance. Viagra—and medication like it—is all about the plumbing. Men who get aroused but fail to get erections take the pill when they want to have sex, and it increases blood flow to the penis. That is far simpler and more direct than a treatment like flibanserin, which is trying to change how women’s brains are wired and must be taken every day. In a statement made last year, the FDA said, “We do not believe there has been any gender bias with regard to our review of this drug.”

Jervis brings up another important point about the “score” that the campaign is trying to even. She notes that it is unfair to directly compare women’s sexual dysfunction—which is a wide-ranging and not well-defined concept—with men’s impotence. She writes:

The word “dysfunction”—medical jargon for anything that doesn’t work the way it should—suggests that there is an acknowledged norm for female sexual function. That norm has never been established. Although male sexuality is more complex than sheer physical arousal, erections are quantifiable events that scientists can measure in objective terms. By contrast, cis women’s sexual response is, by and large, qualitative, and difficult to subject to clinical trials. Furthermore, as we all already know, sexual desire differs over time and between people for a range of reasons largely related to relationships, life situations, past experiences, and individual and social expectations—and “normality” can vary widely from person to person.

In fact, there is not widespread agreement about whether HSDD, the disorder filbaserin is designed to treat, even exists. In an op-ed for the New York Times, sex educator and author Emily Nagoski points out that HSDD was removed from the Diagnostic and Statistical Manual of Mental Disorders in 2013 and replaced with female sexual interest/arousal disorder (FSIAD). The reason, she explains, is that women often follow a different pattern of sexual desire than expected. Rather than experiencing sexual desire as a spontaneous, frequent occurrence, Nagoski says, many women need to be aroused first. Then, she says, desire will follow. Sexual desire, in this case, is reactive. FSIAD is intended to describe women who have neither spontaneous or reactive desire, many of whom, according to Nagoski, can be helped with non-pharmaceutical treatments like therapy.

Which brings us to those sexual health experts who believe the drug would do a disservice to women. Leonore Tiefer, a clinical professor of psychiatry at NYU School of Medicine, has been an outspoken critic of efforts to create drugs to treat women’s sexual health. She told NPR, “The misrepresentation that everybody should be having it—needs to have it, wants to have it, has a problem if they don’t have it—is to change, really, what sexuality is into more of a medical thing.” And, as she added in Marie Claire“The pharmaceutical industry wants people to think that sexual problems are simple medical matters, and it offers drugs as expensive magic fixes.”

Those who take this view would often prefer to see a concentration on the emotional and relationship components of sexuality, which may very well be at the core of women’s lack of sexual desire. They also point out, again, that all women are different and there is no “right” amount of sexual desire to be “fixed” with medication. Adriane Fugh-Berman, who studies drug companies at Georgetown University, told NPR, “There’s really been a move toward medicalizing normal human experience. And while there are certainly some women who have very troublesome symptoms of low libido, it’s not at all clear that medication is a good answer for them.”

Drug companies indeed stand to profit off women—that is an unmistakable consequence of the availability of a “Viagra for women” on the market. But caught in the fight between them and the scholars who think this medicalization of sexuality is the wrong direction for society are the women themselves. And many of them, like Cara, just want to see their sex drive—which is often buried under kids, laundry, and a full-time job—return to what it used to be.

To me, there seems to be a pretty clear middle ground here (though I realize those on each side of the issue will likely disagree). If a drug can help a woman want and enjoy sex again, that is not in of itself a bad thing. It seems almost cruel to deny her pharmaceutical relief on the grounds that she’s a victim of society’s unrealistic expectations about female sexual desire. It’s dismissive to suggest that her feelings on the issue are not at all her own. And it is demeaning to suggest that a woman didn’t notice her lack of sexual desire until drug companies came along with a solution.

Of course, at the same time, the FDA needs to be extremely cautious (as it has been) before approving any drug that is working on something as important and complicated as brain chemistry. And, if it takes a lot longer to get it right and effective than it did for drugs that make men hard, that’s not sexism—that’s just reality. If it does hit the market, health-care providers should help women carefully decide if this is the right choice.

Women deserve sexual desire and pleasure. For some, it will come easily. For others it may take therapy, relationship counseling, or finding a better partner. And, someday, for others it may come in an easy-to-swallow pill. It’s time to stop bickering and slinging accusations and instead let women find their sexual satisfaction through whatever means works best for them.

Commentary Sexual Health

The FDA’s Hesitation to Approve ‘Female Sexual Dysfunction’ Drugs Isn’t About Sexism

Coco Jervis

The pharmaceutical industry launched a campaign in January of this year to persuade the FDA to approve such medications in the name of equality—which overlooks the fact that most of the drugs being considered simply don’t work.

The cultural impact and multibillion-dollar profitability of male-targeted impotence drugs has prompted a rapidly accelerating race to create a similar drug treatment for women. Despite more than a decade of research and millions of dollars spent on development, however, the U.S. Food and Drug Administration (FDA) has yet to approve a single drug treatment for cis women dealing with sexual problems. In response, the pharmaceutical industry launched a campaign in January of this year to persuade the agency to approve such medications in the name of equality—which overlooks the fact that most of the drugs being considered simply don’t work.

This campaign, called Even the Score, hinges on the fact that drugs to treat so-called female sexual dysfunction (FSD)—an umbrella term for a number of disorders, such as hypoactive sexual arousal disorder, female sexual arousal disorder, orgasm disorder, and sexual pain disorder—are disproportionately unavailable when compared to those for erectile dysfunction. Therefore, the campaign’s supporters claim, the FDA is holding drugs meant to treat women’s sexual problems to a higher standard—which, they say, is preventing women from making informed choices about their sexual health. And their tactics are working: Even the Score’s backers don’t just include Sprout Pharmaceuticals, Trimel Pharmaceuticals, and Palatin Technologies, all of which have worked to develop medications for FSD. Its website also lists several prominent women’s rights and reproductive justice groups as supporters, and it has enlisted many legislators in the fight too.

No amount of slick marketing, however, can get around the fact that the drugs currently being proposed for FSD just don’t work. There are many reasons why the proposed drugs may not have been effective in increasing women’s sexual enjoyment; chief among them are the heterogeneity of female sexuality and, of course, research demonstrating that sexual problems are mostly shaped by interpersonal, psychological, and social factors. Nevertheless, pharmaceutical executives will continue to drum up hype over the possibility of a “pink Viagra,” because the potential market is estimated to be over $2 billion a year.

As this push continues, it’s vital to consider how much of the discussion around female sexuality is fact—and how much is fiction.

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Myth: 43 percent of women suffer from female sexual dysfunction.

Fact: Even the Score and others urging the FDA to weaken its standards claim that there is an enormous unmet need for medical treatments for FSD. The claim that 43 percent of women suffer from a sexual dysfunction was first made in 1999 in an article published in the Journal of the American Medical Association. This “43 percent” figure emerged from an analysis of responses by 1,749 women and 1,410 men to a set of questions about their sex lives. Women who reported lack of sexual desire, difficulty in becoming aroused, inability to achieve orgasm, or anxiety about sexual performance within the last two months were labelled as having a sexual dysfunction. The researchers also noted that women were more likely to suffer from sexual dysfunction if they were single, had less education, had physical or mental health problems, had undergone recent social or economic setbacks, or were dissatisfied with their relationship with a sexual partner—all reasons why someone might be less inclined to become aroused that have little to do with physiology. In the years since the report’s publication, scientists have revisited the validity of this study and rightly challenged its problematic conclusions.

Myth: There is a norm of female sexual function.

Fact: The implied parallel between female sexual dysfunction and male impotence is inaccurate and problematic. The word “dysfunction”—medical jargon for anything that doesn’t work the way it should—suggests that there is an acknowledged norm for female sexual function. That norm has never been established. Although male sexuality is more complex than sheer physical arousal, erections are quantifiable events that scientists can measure in objective terms. By contrast, cis women’s sexual response is, by and large, qualitative, and difficult to subject to clinical trials. Furthermore, as we all already know, sexual desire differs over time and between people for a range of reasons largely related to relationships, life situations, past experiences, and individual and social expectations—and “normality” can vary widely from person to person. Without downplaying the significance of any woman’s pain or distress, there can be real danger in defining difference as “dysfunction.”

Myth: Female sexual dysfunction is a defined disease category.

Fact: Without an empirical standard by which we can assess female sexual function, it is extremely difficult, if not impossible, to come up with an effective treatment criteria for FSD—which, again, is an umbrella term for many different disorders. But that hasn’t stopped drug manufacturers from trying. In fact, every time a drug sponsor claims to have a new solution for women’s sexual concerns, the supposed reasons for the dysfunction changes. Over the past 15 years, drugs affecting vaginal blood flow were tested on women who were deemed to be suffering from FSD due to “insufficient vaginal engorgement.” Then, corporations and the media hailed testosterone patches as a magic bullet because FSD allegedly resulted from hormone deficiencies. Most recently, re-purposed antidepressants have gained scientific currency, as women are being told that their low libido is due to a chemical problem in their brains. 

Myth: Drug developers are searching for a solution for women’s sexual concerns.

Fact: The pharmaceutical industry is driven by profit. As such, if a solution is not found at the bottom of a pill bottle, its front-runners are simply not interested. If product development-driven research were happening in a balanced context, with proportionate attention being paid to all the causes of women’s sexual concerns, the focus on only biomedical causes and solutions might not be so damaging. The focus on pharmaceutical rather than emotional solutions has serious limitations, including the fact that they are simply unlikely to be effective. And the way the industry has shaped the FSD discussion threatens to make women’s sexual experience a “performance” issue, much like it has with men’s.

Myth: There are 26 drugs approved for men, and none approved for women.

Fact: On its website, Even the Score continues to inaccurately claim that there are 26 drugs approved for men, and zero for women. This claim perpetuates a miscalculation. It counts each brand-name drug and many of its identical counterparts as unique treatment options, which artificially inflates the number of drugs available for men. In fact, there are six different FDA-approved drugs available for male sexual dysfunction, including erectile dysfunction. Nevertheless, the inflammatory claim of gender bias has garnered press and political attention. 

Myth: The standard for FDA review of male impotence drugs should be the same for FSD drugs.

Fact: Even the Score’s gender equity argument ignores the real safety difference between FSD drugs that are currently being tested and the drugs approved for men: a different indication for use, specifically the dosage and administration. All but one of the drugs approved for men are taken on an as-needed basis, whereas the most recent drug being tested for women is very similar to an antidepressant. Sponsored by Sprout Pharmaceuticals, flibanserin is a central nervous system serotonergic agent with effects on adrenaline and dopamine in the brain; it requires daily, long-term administration. This raises toxicological concerns that make it appropriate for the FDA to subject that type of drug to an elevated safety scrutiny. Substantial adverse events reports and dropout rates in the latest flibanserin trial also need to be taken seriously. Women have answers to the age-old question, “What do women want?” Just ask us: We want and demand products that are rigorously evaluated, safe, effective, and meet our real needs.

Even the Score’s attempts to make this a conversation about gender equality are misleading and dangerous; although the FDA should be held accountable for gender equality, it should not compromise the safety of women’s health by approving a drug that is not effective and not safe. The FDA should continue to balance a serious and respectful incorporation of patient input while maintaining a rigorous, science-based review standard for drugs and devices they approve.