This is a guest contribution for The Economists Open Future initiative, which aims to foster a global conversation on the challenges of the 21st century. More Open Future articles are at Economist.com/openfuture

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The day I knew I should quit my job answering phones at the transgender health-care clinic in California was the day a caller (lets use the name Betty) threatened her in-home caretaker with a knife during the call. As the caretaker begged our clinics nurse to track down Bettys doctor and tell him that Betty was having a psychotic episode, Betty stood between her and the apartments front door with a kitchen knife. Betty had poorly controlled paranoid schizophrenia, and often called the clinic agitated, alternately whispering and screaming about government agents stalking her. Betty was also a trans woman whom most people regarded as male, the sex of her birth.

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The clinic followed the informed-consent protocol: its mission was to provide transgender patients who otherwise lacked access to health care with injections, skin patches and pills of feminising or masculinising hormones without having to pass through a series of requirements and assessmentsknown as gatekeepingthat restricted access in the past.

In medicine broadly, informed-consent refers to the ethical requirement that a clinician administering a treatment communicate to the patient the anticipated risks and benefits, as well as reasonable alternatives to the treatment. Yet for transition medicine in America, informed-consent programmes do not require clinical documentation, beyond patient reports, of the patients gender dysphoria over time (ie, a feeling of mismatch between ones biological sex and gender identity) and readiness for medical interventions.

Gatekeeping horror stories are notorious in the transgender community. In the past it was not unusual for a trans person to be told by doctors and psychologists they would not be referred for hormones because they were not visually appealing as their preferred gender, werent interested in dating the opposite gender, or had unresolved mental-health problems (some of which are predictable responses to experiencing transphobia, such as anxiety and depression).

It was not unusual for a trans person to be told they would not be referred for hormones because they were not visually appealing

Pioneering LGBT health centres across America developed informed-consent protocols for hormone treatment in a well-intentioned effort to imbue the experience of pursuing hormone treatment with dignity for patients. But as informed-consent protocols have become the norm rather than the exception, we may be shunting transgender people in America into a parallel medical systemone in which patients bargain away careful assessment and education for greater autonomy and shortened timelines to access medical treatments.

At my clinic, we were informed-consent true-believers. We didnt badger you with questions; as long as you were 18, even if you had no way to pay the clinics fees, you would get your hormones. You had to sign forms stating that you understood that although hormone-replacement therapy (HRT) benefits many trans people suffering from gender dysphoria, the health risks are largely unknown. Starting hormones could have negative consequences for your mental well-being, social functioning and even the intensity of your gender dysphoria (many people find that their distress about a body part like their breasts will only increase when the effects of testosterone appear, such as facial hair).

Also, people were informed that they were waiving the mental-health screening recommended by the World Professional Association for Transgender Health. Its standard of care recommends that patients seeking HRT be screened for schizotypal disorders, autism-spectrum disorders, personality disorders, dissociative disorders, post-traumatic stress disorders and more.

In the case of Betty, I felt that the clinic where I worked wasnt sufficiently concerned whether her mental disorder created delusions that often controlled her life, or meant she was so cognitively disabled that transition predictably left her more isolated and chronically stressed than before she started HRT. The medical staffs attitude towards Betty and many of the other patients who were receiving hormones while managing (or failing to manage) severe mental illness was a profound lack of interest about whether one affected the other.

We were informed-consent true-believers. We didnt badger you with questions; as long as you were 18, you would get your hormones.

In fact, most of us worked there because we rejected the idea that a strongly felt internal sense of gender could be a symptom of mental illness. That shared, ideological foundation meant it was verboten for the staff to consider whether the HRT might be exacerbating Bettys schizophrenic symptoms or making it harder for her to build the basic social relationships that provide the support and positive feedback that is so necessary for mental health. If the HRT did not actually assist Betty in presenting as a woman or improve her functioningand it seemed to be doing neitherwe considered affirming her identity more important than those conventional measures of the treatments effectiveness.

The most radical and liberatory action we could take was to affirm Bettys identity. If we were the one and only place she visited in her day where she was referred to using her chosen pronouns, we considered it paramount we gave her that experience. This commitment to affirming identity through correct pronouns and easy HRT was our reason for being. But strangely, by fulfilling our commitment to affirming felt identity, we seemed to be off the hook for questioning whether we were doing all we could to avoid harming her.

I quit the clinic in 2014, and in 2016 I spoke to the lawyer of a patient suing that same clinic. This patient also pursued HRT while experiencing intense delusional symptomsit was 2012 and he thought the world was ending. The clinic, affirming as ever, recommended and provided the referral letters for him to have an orchiectomy, a removal of his testicles, which he underwent. When his delusional symptoms eventually abated he detransitioned, coming to an uneasy peace being, and presenting as, male.

I know him because we are both detransitioned people. I was also convinced that I was a trans personas a result of misunderstanding a persistent sense that my body felt unreal, a common dissociative symptom following traumaand received HRT at this same clinic, taking testosterone for nine months. For the past five years Ive been a part of a growing community of detransitioned people who are speaking out about questionable norms and practices in transgender medicine.

The clinic, affirming as ever, provided the referral letters for him to have an orchiectomy, a removal of his testicles

When I first detransitioned, my community consisted of online groups of fewer than 100 women. Five years later the detransition discussion-forum on the popular site Reddit has just hit 7,000 people of both sexes. I know detransitioned people who later discovered they had autism-spectrum disorders, detransitioned people who came to recognise that they were experiencing traumatic dissociation, even detransitioned people who had such severe dissociation that they had multiple alters (ie, multiple identities) while being treated with hormones and surgeries.

Our stories, if taken seriously, could help improve the state of transgender health careparticularly at informed-consent clinics, which are becoming the norm at American colleges, LGBT health centres and recently many Planned Parenthoods. Instead we are ignored, compared to ex-gay Christians or treated as political footballs. (I was particularly disheartened when Ryan Anderson, a fellow at the Heritage Foundation, a conservative think-tank, used my and other detransitioners stories in his book that was critical of LGBT and feminist issues, When Harry Became Sally.)

That is because the burgeoning orthodoxy on the left is that detransition is so rare that only transphobes care about it. If you draw attention to the stories of transition gone wrong, the thinking goes, there will be less public support for transition and for transgender people themselves. For academic researchers and journalists, telling our stories is a fast track to being labelled a transphobe. This has profound consequences for what we know about the medical paths that leads to detransition.

In fact, we have no idea how prevalent detransition is in America. The most widely used estimate, that 2.2% of people who transition later detransition, comes from a study in a completely different place (Sweden) and time (1960-2010), when gatekeeping was much stricter. Moreover, that study defined a detransitioner as someone who had changed their name and gender legally (an arduous process in Sweden at the time) and then had the motivation and money to go through the name change process in reverse, a standard so strict that I wouldnt be counted, and nor would 90% of the detransitioners I know.

If you draw attention to the stories of transition gone wrong, the thinking goes, there will be less public support for transgender people

This passionate but misguided argumentthat detransition is extremely rare, thus any research into it is harmful and motivated by transphobiahas led to outright censorship. In 2017 Bath Spa University in Britain shot down a research proposal that sought simply to collect stories from detransitioners. The same year the Philadelphia Trans Health Conference, a major annual gathering of the transgender health community, abruptly cancelled two previously approved panels that I had helped organise on detransition and alternative methods of managing gender dysphoria, because of the level of heated conversation and controversy. These were just two out of nearly 200 sessions.

As a result, the subject of detransitioners health-care experiences remains virtually untouched by academic researchers. This shows in the clumsy approaches of those few researchers willing to engage the subject. For example, a poster presented this summer at the European Professional Association of Transgender Health conference purported to show a very low rate of detransition and regret (0.47%) at an NHS clinic in London. The poster bounced all over social media, cited as proof that detransition is indeed exceptionally rare.

But that estimate was generated by combing through case files for patients who returned to the clinic to inform staff of their detransition or regret. The thing is, though, detransitioners almost never do this. This is widely known within the communitywhy would you go back to a clinic or to a doctor who, in your view, helped you hurt yourself?

Apart from the few who sue their doctors and therapists, detransitioners tend simply to disappear from a clinics view, despite often having urgent needs for continued medical treatment and therapy. I have heard of only three detransitioners who went back to talk to the clinicians who had assisted them in transitioning. (The experience of one who did just that convinced me that I probably never will.) Nor do they tend to go to other clinics for follow-on care: they simply become invisible.

The majority of the studies supporting the conclusion that medical transition yields positive outcomesand there are manyfollowed patients in highly structured clinical programmes that provided comprehensive assessments. But when I searched last February for programmes that met that careful standard in America, I wasnt able to find one. No one knows whether informed-consent protocols will yield the same success rate, but the stories Ive heard during the past five years make me profoundly sceptical.

In a comprehensive examination of peer-reviewed articles on medical-transition between 1991 and 2017 by researchers art Cornell University, called What We Know, there have been no studies tracking a cohort of patients at an informed-consent clinic over time to investigate the outcomes that their protocol produces. Moreover, there have been no studies on what percentage of clinics in America follow the standard of care recommended by the World Professional Association for Transgender Health versus their own informed-consent protocols.

From the point of view of clinics, they would respond to the criticisms by noting that informed-consent clinics often serve a poor and transient population, which presents challenges to following up with patients. Another difficulty is that transgender medicine is a relatively new field serving a small minority of the population, necessarily limiting funding and opportunities for research. As to whether informed-consent policies have the effect of leading people to medical interventions too soon, they would argue that the people who end up feeling ill-served by the high level of patient autonomy will always be a small minority.

Yet this does not obviate the need for better practices. I dont want informed-consent clinics shuttered. I want them to do the tasks normally associated with medical care. This includes giving patients access to differential diagnosis (distinguishing between conditions that share similar symptoms) and follow-up research so that providers can improve the care they offer.

There is a responsible path between making transgender people jump through hoops and allowing people experiencing psychosis to have their testicles removed

For example, ensuring that low-cost psychology referrals are offered to all patients seeking informed-consent care could increase voluntary participation in comprehensive evaluations. Ensuring that staff are trained to identify patients showing signs of certain severe disorders, and to provide psychological evaluations when appropriate, could help prevent outcomes like Bettys.

Even ensuring that all clinics have counselling referrals on hand would be a step in the right direction. Although I received a prescription for hormones by my second visit, many patients sat on the waiting list for counselling from the same clinics social workers for more than five months and when I requested an outside referral, I was told to google the phone number of a local counselling internship site.

There is a responsible middle path between making transgender people jump through hoops to access needed medical care and allowing people experiencing psychosis and delusions to have their testicles removed. Until gender care providers accept their ethical responsibility to find that path, the American medical system continues to serve this community of people poorlybut this time, this neglect is designed and perpetrated by allies under the banner of transgender rights.

_________________

Carey Callahan is a family therapist and board member of the Gender Care Consumer Advocacy Network, a non-profit group that advocates for the rights and welfare of consumers of gender care services.

More:
Gender identity is hard but jumping to medical solutions is worse - The Economist

Transgender participation in sport has come to the forefront in the last few years at all levels, from youth leagues to the Olympics. And thats led to backlash from many groups and individuals who are supported by and stand up for those who have always maintained an anti-LGBTQ position.

On November 20, Outsports contributor Ken Schultz looked into whats behind a recent poll by Rasmussen, which concluded a majority of Americans oppose transgender inclusion in sports.

What he found were polling methods and loaded questions with terms that slant toward creating results opposing trans inclusion.

In his analysis, Schultz stated: In order to move the debate in that more inclusive direction, we need to educate the public on these kinds of biased euphemisms and anti-trans code words that transphobes use to sway public opinion.

As a sports journalist, a sports fan and as a participating transgender athlete, I couldnt agree more with my Outsports colleague. When you look in the transphobes playbook, you find a number of varied tactics designed to make bigotry look reasonable.

My examination here will look at a recent piece of propaganda making the rounds and the tactics it employs. The poster below was created by an operative for an anti-trans organization.

Willful, deliberate misgendering is a critical piece of this con game. The quote used at the top of this image is an example of the conditioning. Its also the tactic of websites such as Breitbart, The Blaze and RedState, who ruthlessly target transgender female athletes. Consider the example of cyclist Dr. Veronica McKinnon, who is one of the most targeted trans athletes in the world right now, ever since winning her first UCI Masters track cycling championship in 2018. She had barely reached the winners podium when the clickbaiter sites screamed headlines such as Man Pedals Faster at the Womens World Cycling Championships, and Transgender female cyclist place first against biological women

The body copy of their articles stays with this theme. There is consistent use of terms such as biological males and biological females, which is passive-aggressive misgendering. Some sites dont even bother with such backhanded attempts, and neither do the professional political transphobe groups. In the Alliance Defending Freedoms complaint to the Department of Education concerning Connecticut high school athletes Andraya Yearwood and Terry Miller, the 29-page document consistently refers to both girls as boys and biological males.

You will rarely if ever see attacks directed at Patricio Manuel (above), or at Chris Mosier, or any transgender male athletes with this piece of propaganda, or any piece by the anti-trans lobby. This is by design. Transgender male athletes dont sell the narrative that transphobes are trying to sell. This is about more than sport to the anti-lgbtq and anti-human rights lobby. It also shows the misogyny of the people who are behind the curtain. The main message here is transgender women are not women and cisgender women are too inept to compete successfully in sport.

Lies of omission are a centerpiece tactic of the anti-trans crowd. The most used is the matter of regulations. They intensely try to sell the idea that men wake up one morning, say they are a woman and play womens sports. Yet they know that there are extensive rules and regulations that transgender athletes must follow to the letter, like every athlete.

For example, consider the case of Southern Illinois swimmer Natalie Fahey. Below is the NCAA regulation that applies to her case.

A trans female (MTF) student-athlete being treated with testosterone suppression medication for Gender Identity Disorder or gender dysphoria and/or Transsexualism, for the purposes of NCAA competition may continue to compete on a mens team but may not compete on a womens team without changing it to a mixed team status until completing one calendar year of testosterone suppression treatment.

There are also lies of omission in terms of context and backstory. Fahey continued to compete during that interim year on the mens team at SIU. When she met the NCAAs regulations and began competing as a woman, she was entered as an exhibition swimmer and her finishes did not count in the overall team standings at the conference championship meet because of the timing when she became eligible to compete. This is the crucial context that the anti-trans lobby will ignore because it wrecks the narrative they are trying to sell.

One can also look the case of an athlete such as 2019 Division II national 400 meter hurdles champion CeC Telfer, who took a year off from competition while starting hormone replacement therapy and then returned to active competition after fulfilling the NCAA requirements. Again, this is what the other side wont tell you.

At times, the other side will just flat-out lie.

How New Zealand weightlifter Laurel Hubbard is portrayed here is a textbook example. The propaganda here and in other places is that she is a world champion. She has never won a world championship. At the 2017 world weightlifting championships she won two silver medals. The anti-trans crowd relies upon the fact that most readers and/or sports fans will not bother to check the facts for themselves, in part, because the sport is more obscure. Keep that in mind as we consider:

Consider how roller derby athletes are mentioned in this piece above. They are attacking perhaps the most trans-inclusive sport in the world. Noted TERF writer Emma Chesworth recently learned that this is not a good idea, when she wrote an article critical of widespread policies of inclusion in roller derby. Teams and leagues in the US and UK lit up Twitter in a vigorous defense of their sport.

Fact checking would have perhaps saved Chesworth some embarrassment, but thats the rub here. A transphobe counts on the general public to not research the claims for themselves.

Notice also that most of the targets pictured on the anti-trans poster come from sports that are out of the mainstream. This type of propaganda also tends to focus on small college and high school athletes because it is easier to bend a story fewer people actively know about.

The propaganda poster here was built by an operative representing Hand Across The Aisle Women. They characterize themselves as radical feminists, lesbians, Christians and conservatives that are tabling our ideological differences to stand in solidarity against gender identity legislation.

But they are allied with groups including the Heritage Foundation, the Family Research Council, and the Alliance Defending Freedom. These are among most influential anti-womens rights and anti-LGBTQ lobbies in the world. Both the FRC and the ADF are also classified as anti-LGBTQ hate groups by the Southern Poverty Law Center.

Scratch the surface of many of these radical feminists and you are finding greater synergies with groups that have made their name by demonizing feminism for decades, and the media mouthpieces like a Breitbart or the Blaze.

Why does this matter? Because this isnt only about sports, just like the headline-making battles in Houston, Texas and North Carolina were not only about bathrooms, and the anti-LGBTQ lobby does not deny this.

This is one of the few fronts they are fighting in a larger battle that legally and culturally they are losing, and they admit to it. Theyve even admitted that the bathroom hysteria was deliberately built to scare people, even though the stats dont fit the hysteria.

Such is the fulcrum lifting three cases pending in the U.S. Supreme Court right now that could redefine a whole spectrum of human rights issues for all LGBTQ citizens.

The real match here is inclusion versus erasure, and it's a match we transgender Americans cannot afford to lose.

See original here:
Cracking the code of bias against trans athletes - Outsports

TORONTO--(BUSINESS WIRE)--

Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced that the revised commercial partnership agreement with Aytu Bioscience (Aytu) to accelerate the growth of NATESTO in the United States is now closed and fully effective as of December 1, 2019. Both parties have mutually waived the closing conditions of the revised partnership agreement, including the requirement that Acerus complete a raise of a minimum of USD 10 million on or before the end of January 2020, enabling Acerus to launch a U.S.-based specialty sales force, which will promote NATESTO to urologists and endocrinologists. Aytu will continue to book all NATESTO revenue in the United States and they will promote NATESTO to all other specialties including internal medicine and family practice.

To accelerate the launch of Acerus U.S. commercial team, Aytu has agreed to transfer 5 current sales personnel to Acerus as of December 2, 2019. These staff will operate as Acerus employees but they will remain on Aytus payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020. Aytu will deduct the costs of these sales personnel from quarterly payments otherwise owed to Acerus under the revised agreement, with a final accounting to be done once per year. Throughout 2020, Acerus will be building out a complete US-based specialty care sales force and other commercial functions, significantly increasing the number of employees working directly on NATESTO in the United States.

This co-promotion is expected to significantly increase sales force coverage of targeted U.S. prescribers, putting a higher promotional focus on urologists and endocrinologists, while enabling Aytu to focus its promotional efforts in primary care and other specialties.

Acerus is extremely pleased to see our revised partnership with Aytu moving to execution mode as we strongly believe that the performance of NATESTO in the U.S. will benefit from an enhanced commercial focus on urology and endocrinology, said Ed Gudaitis, President and Chief Executive Officer of Acerus. We are happy to welcome the former Aytu staff to the Acerus team. With this revised partnership, Acerus is effectively pivoting its focus of effort to the U.S. NATESTO opportunity. As such, we have implemented a resource reallocation program within our Canadian office that has led to a greater than 50% reduction in headcount so that we can align our SG&A spend appropriately.

On July 29, 2019 the companies agreed to expand their commercial partnership and amend and restate the original 2016 NATESTO exclusive U.S. license agreement. Under the terms of the new agreement, Aytu returns the NDA for NATESTO in the U.S. back to Acerus. Going forward Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. Acerus will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy as part of the companies joint commercialization committee, and will launch a specialist sales force focused on urologists and endocrinologists (Acerus Sales Channel). Aytu will retain its primary care sales force (Aytu Sales Channel) and will continue to book all product net revenue while serving as the exclusive U.S. supplier of NATESTO to wholesalers, pharmacies and other customers that receive a direct shipment. Financial payments will be based upon a tiered level of net revenue, post cost of goods sold (COGS), based on annual sales performance in the respective Acerus and Aytu Sales Channels.

To establish a high performing commercial footprint in the U.S., Acerus has engaged Syneos Health (SYNH), a leading integrated biopharmaceutical solutions organization including the industrys largest Contract Commercial Organization (CCO), to be its commercialization partner. Syneos Health has extensive experience in Mens Health and with NATESTO, and offers an end-to-end model that will enable Acerus to rapidly stand up a U.S. commercial team; to scale across all aspects of commercialization, including medical and regulatory affairs, managed markets, marketing and sales; and will provide greater flexibility and effectiveness in resource deployment.

Story continues

Low testosterone is estimated to affect approximately 39% of men over 45 years old in the U.S.; however, because the condition is underdiagnosed the overall prevalence is uncertain1. While patients have access to other treatment options, NATESTO is unique in that it is administered in seconds via a convenient and simple nasal gel applicator, addressing the risk of testosterone transference associated with other topical products, which carry black box warnings on their product labels.

About NATESTO (Testosterone) Nasal Gel

NATESTO is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. Food and Drug Administration, Health Canada and South Korea Ministry of Food and Drug Safety (MFDS), available in a no-touch dispenser with a metered dose pump. A copy of the NATESTO Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO /default.aspx. For further information, specific to the U.S. product dosing and administration, please visit: http://www.NATESTO .com.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of mens health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.

Acerus shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit http://www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the commercial performance of NATESTO in the United States, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 4, 2019 which is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

1 Mulligan T, Frick MF, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762769

View source version on businesswire.com: https://www.businesswire.com/news/home/20191202005215/en/

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Expanded U.S. NATETSO Partnership Between Acerus Pharmaceuticals and Aytu BioScience Is Now Fully Operational - Yahoo Finance