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Studies: Transgender Hormone Therapy Less Risky Than Birth Control Pills

New research published in Men’s Health Issue of AACC’s Clinical Chemistry journal find transgender hormone therapy Is less risky than birth control pills

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Novel studies published in the Men’s Health Issue of American Association for Clinical Chemistry‘s journal Clinical Chemistry suggest that hormone therapy for transgender people increases the risk of blood clots less than birth control pills and does not increase the risk of cardiovascular disease at all. These preliminary results could help more transgender individuals to access essential hormone therapy by increasing physician comfort with prescribing it.

Obstacles to Therapy

All major medical associations agree that transgender individuals need to be able to express their gender in ways with which they feel comfortable and that this is the most effective treatment for psychological distress caused by incongruence between sex assigned at birth and gender. For many transgender individuals, expressing their gender involves physically changing their body through medical steps such as taking hormone therapy. However, transgender patients often experience difficulty getting hormone therapy prescriptions, to the point that 1 in 4 transgender women have to resort to illegally obtaining cross-sex hormones. Part of this is because existing research on transgender hormone therapy is limited and conflicting, which has led to some physicians denying patients this treatment out of concern that it could significantly increase the risk of health problems such as blood clots and cardiovascular disease.

First Study

A team of researchers led by Dina N. Greene, PhD, of the University of Washington in Seattle has now estimated that in transgender women prescribed estrogen, blood clots only occur at a rate of 2.3 per 1,000 person-years. While this is higher than the estimated incidence rate of blood clots in the general population (1.0-1.8 per 1,000 person-years), it is less than the estimated rate in premenopausal women taking oral contraceptives (3.5 per 1,000 person-years), which means that it is an acceptable level of risk. In order to determine this, Greene’s team performed a systematic review of all studies that have included the incidence rate of blood clots in transgender women receiving estrogen therapy, identifying 12 that were most relevant. The researchers then used meta-analysis to combine the results of these 12 studies and calculate a risk estimate that is based on all available evidence to date.  

“Documenting the risks associated with hormone treatment may allow for prescribers to feel more comfortable with prescribing practices, allowing for better overall management of transgender people,” said Greene. “Our data support the risk of thrombotic events in transgender women taking estrogen therapy being roughly comparable to the risk of thrombotic risks associated with oral contraceptives in premenopausal women. Given the widespread use of oral contraception, this level of risk appears to be broadly accepted.”

Second Study

In a second study, a team of researchers led by Guy G.R. T’Sjoen, MD, PhD, also conducted a systematic review of all studies that have measured risk factors for cardiovascular disease in transgender people taking hormone therapy. The researchers identified 77 relevant studies in this area and found that the majority of them report no increase in cardiovascular disease in either transgender men or women after 10 years of hormone therapy. The studies that did indicate a higher cardiovascular disease risk for transgender women in particular mainly involved patients using ethinyl estradiol, a now obsolete estrogen agent, and are therefore no longer valid.

T’Sjoen’s team does state that their results are not conclusive due to the small sample sizes and relatively short duration of the studies in this area (and Greene’s team included a similar caveat for their work). However, it is important to look at Greene and T’Sjoen’s studies in the context of transgender research as a whole. The field only began to receive National Institutes of Health funding in 2017 and is also lagging due to the fact that transgender patients often aren’t identified in medical databases that provide data for research. In light of this, these studies are significant not only because they suggest that transgender hormone therapy is safe, but also because they underscore the need for longer-term, large scale studies involving this underserved population.

Source: Press release

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Trump Administration Rule Would Undo Health Care Protections For LGBTQ Patients

Supporters of the rule say it would strengthen health care professionals’ freedom of conscience, but opponents say it “empowers bad actors to be bad actors.”

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Photo credit: rawpixel.com / Pexels

This article originally appeared in Kaiser Health News.

A new Trump administration proposal would change the civil rights rules dictating whether providers must care for patients who are transgender or have had an abortion. Supporters of the approach say it protects the freedom of conscience, but opponents say it encourages discrimination.

The sweeping proposal has implications for all Americans, though, because the Department of Health and Human Services seeks to change how far civil rights protections extend and how those protections are enforced.

Roger Severino, the director of the HHS Office for Civil Rights, has been candid about his intentions to overturn an Obama-era rule that prohibited discrimination based on gender identity and termination of a pregnancy. In 2016, while at the conservative Heritage Foundation, he co-authored a paper arguing the restrictions threaten the independence of physicians to follow their religious or moral beliefs.

His office unveiled the proposed rule on May 24, when many people were focused on the start of the long Memorial Day holiday weekend.

The rule is the latest Trump administration proposal to strip protections for transgender Americans, coming the same week another directive was proposed by the Department of Housing and Urban Development that would allow homeless shelters to turn away people based on their gender identity.

The public was given 60 days to comment on the HHS proposal. Here’s a rundown of what you need to know about it.

What would this proposal do?

Fundamentally, the proposed rule would overturn a previous rule that forbids health care providers who receive federal funding from discriminating against patients on the basis of their gender identity or whether they have terminated a pregnancy.

The Trump administration proposal would eliminate those protections, enabling providers to deny these groups care or insurance coverage without having to pay a fine or suffer other federal consequences.

That may mean refusing a transgender patient mental health care or gender-confirming surgery. But it may also mean denying patients care that has nothing to do with gender identity, such as a regular office visit for a bad cold or ongoing treatment for chronic conditions like diabetes.

“What it does, from a very practical point of view, is that it empowers bad actors to be bad actors,” Mara Keisling, executive director of the National Center for Transgender Equality, told reporters.

The proposal would also eliminate protections based on sexual orientation and gender identity from several other health care regulations, like non-discrimination guidelines for the health care insurance marketplaces.

Does it affect only LGBTQ people?

The proposal goes beyond removing protections for the LGBTQ community and those who have had an abortion.

It appears to weaken other protections, such as those based on race or age, by limiting who must abide by the rules. The Trump proposal would scrap the Obama-era rule’s broad definition of which providers can be punished by federal health officials for discrimination, a complicated change critics have said could ease requirements for insurance companies, for instance, as well as the agency itself.

And the proposal erases many of the enforcement procedures outlined in the earlier rule, including its explicit ban on intimidation or retaliation. It also delegates to Severino, as the office’s director, full enforcement authority when it comes to things like opening investigations into complaints lodged under the non-discrimination rule.

Why did HHS decide to change the rule?

The Obama and Trump administrations have different opinions about whether a health care provider should be able to refuse service to patients because they are transgender or have had an abortion.

It all goes back to a section in the Affordable Care Act barring discrimination on the basis of race, color, national origin, age, disability or sex. President Barack Obama’s health officials said it is discrimination to treat someone differently based on gender identity or stereotypes.

It was the first time Americans who are transgender were protected from discrimination in health care.

But President Donald Trump’s health officials said that definition of sex discrimination misinterprets civil rights laws, particularly a religious freedom law used to shield providers who object to performing certain procedures, such as abortions, or treating certain patients because they conflict with their religious convictions.

“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” Severino said in a statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives.”

Much of what the Office for Civil Rights has done under Severino’s leadership is to emphasize and strengthen so-called conscience protections for health care providers, many of which existed well before Trump was sworn in. Last year, Severino unveiled a Conscience and Religious Freedom Division, and his office recently finalized another rule detailing those protections and their enforcement.

The office also said the proposed rule would save about $3.6 billion over five years. Most of that would come from eliminating requirements for providers to post notices about discrimination, as well as other measures that cater to those with disabilities and limited English proficiency.

The rule would also save providers money that might instead be spent handling grievances from those no longer protected.

The office “considers this a benefit of the rule,” said Katie Keith, co-founder of Out2Enroll, an organization that helps the LGBTQ community obtain health insurance. “Organizations will have lower labor costs and lower litigation costs because they will no longer have to process grievances or defend against lawsuits brought by transgender people.”

Why does this matter?

Research shows the LGBTQ community faces greater health challenges and higher rates of illness than other groups, making access to equitable treatment in health care all the more important.

Discrimination, from the misuse of pronouns to denials of care, is “commonplace” for transgender patients, according to a 2011 report by advocacy groups. The report found that 28% of the 6,450 transgender and gender non-conforming people interviewed said they had experienced verbal harassment in a health care setting, while 19% said they had been refused care due to their gender identity.

The report said 28% had postponed seeking medical attention when they were sick or injured because of discrimination.

Critics fear the rule would muddy the waters, giving patients less clarity on what is and is not permissible and how to get help when they have been the victims of discrimination.

Jocelyn Samuels, the Obama administration official who oversaw the implementation of the Obama-era rule, said that for now, even though the Trump administration’s HHS will not pursue complaints against those providers, Americans still have the right to challenge this treatment in court. Multiple courts have said the prohibition on sex discrimination includes gender identity.

“The administration should be in the business of expanding access to health care and health coverage,” Samuels told reporters on a conference call after the rule’s release. “And my fear is that this rule does just the opposite.”

Editor’s note: This story was also published by Vice.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

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World’s First HIV-To-HIV Kidney Transplant With Living Donor Succeeds

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This article originally appeared in Kaiser Health News.

The world’s first kidney transplant from a living HIV-positive donor to another HIV-positive person was successfully performed Monday by doctors at a Johns Hopkins University hospital.

By not having to rely solely on organs from the deceased, doctors may now have a larger number of kidneys available for transplant. Access to HIV-positive organs became possible in 2013, and surgeries have been limited to kidneys and livers.

“It’s important to people who aren’t HIV-positive because every time somebody else gets a transplant and gets an organ and gets off the list, your chances get just a little bit better,” said Dr. Sander Florman, director of the Recanati/Miller Transplantation Institute at Mount Sinai in New York.

Nina Martinez, 35, is the living donor. She donated her kidney to an anonymous recipient after the friend she had hoped to give it to died last fall. Martinez acquired HIV when she was 6 weeks old through a blood transfusion and was diagnosed at age 8.

In a news conference Thursday, Martinez said that even after her friend died, she wanted to carry on in honoring him by donating her kidney and making a statement.

“I wanted to show that people living with HIV were just as healthy. Someone needed that kidney, even if it was a kidney with HIV. I very simply wanted to show that I was just like anybody else,” said Martinez.

Johns Hopkins said that Martinez was being discharged Thursday from the hospital. The anonymous recipient is in stable condition and will likely be discharged in the next couple of days.

Since 1988, doctors have transplanted at least 1,788 kidneys and 507 livers — both HIV-positive and HIV-negative organs — to patients with HIV, according to the United Network for Organ Sharing, a private nonprofit that manages the nation’s organ transplant waiting list. All the HIV-positive organs came from recently deceased people.

Johns Hopkins Medicine was the first to perform the initial HIV-to-HIV transplant from a deceased donor in the U.S. in 2016.

Dr. Dorrey Segev, one of the Johns Hopkins surgeons who performed the organ transplant, said the surgery was no different than any other live donor transplant that he has done because Martinez’s HIV was so well-controlled by antiretroviral medication. He said Johns Hopkins has already been receiving calls from people living with HIV who want to be living organ donors.

“This is not only a celebration of transplantation, but also HIV care,” said Segev during the news conference.

People living with HIV have faced challenges participating in organ transplants as recipients and donors. Organ transplant centers initially hesitated to give these patients organs for fear of inadvertently infecting them with the virus or accelerating the onset of AIDS in the recipient. Physicians thought the medicines given to prevent organ rejection — which suppress the immune system — could allow HIV to attack more of the body’s cells, unchecked.

Yet, some centers assumed the risks and performed these procedures. “There were no rules,” Florman said. “That was the wild west.”

Transplants slowly increased as more evidence proved liver and kidney recipients with HIV survived at rates similar to patients without the virus. But by the 2000s, the medical community and advocates wanted more. Prospective donors with HIV could not donate their organs, as Congress had banned the practice.

The push for change resulted in the HIV Organ Policy Equity Act, known as the HOPE Act, in 2013. This federal law allowed organ transplants between people with HIV in clinical trials. The legislation drastically cuts the waiting time for recipients with HIV who are willing to accept an organ from a person with the virus from years to months, Florman said. Only patients with HIV are allowed to accept these organs.

Kidney and liver transplants began under the HOPE Act three years after the legislation passed. As of March 24, 116 HOPE Act kidney and liver transplants have taken place.

UNOS does not track HIV status information for transplant candidates on its waiting list. But, as of March 8, 221 registrants have indicated they would be willing to accept a kidney or liver from a donor who has HIV.

Under the HOPE Act, recipients and living donors must meet requirements like undetectable levels of HIV, a normal CD4 count — an important type of white blood cell — and no opportunistic infections. Deceased donors are highly scrutinized to make sure they do not have a strain of HIV that is difficult to manage or treat, Florman said.

Researchers are seeking to expand the HOPE Act protocol to other organs. Dr. David Klassen, the chief medical officer for UNOS, said the Johns Hopkins living donor transplant opens up a promising new avenue for both organ recipients and donors living with HIV.

“As we accumulate more safety data, I think it is possible that the HOPE Act could become a standard of care possibly in the next couple of years,” said Klassen. “At some point, I think this will move into the mainstream.”

Some view the legislation not only as an avenue to advance medicine, but also to challenge how people perceive HIV. The ability to donate an organ implies a certain level of health that was once thought impossible in people living with HIV, said Peter Stock, professor of surgery at the University of California-San Francisco and one of the pioneering surgeons in HIV organ transplants.

“It used to be a death sentence,” he said of HIV. “And now we’re transplanting them.”

Dr. Christine Durand, another Johns Hopkins surgeon involved in the organ transplant, encouraged those living with HIV to sign their organ donor cards and contact their local transplant center if they’re interested in living donation.

“I am hoping this leads to a ripple effect,” said Durand. “And many people with HIV will be inspired to sign up as an organ donor as a result.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Victoria Knight and Carmen Heredia Rodriguez contributed to this story.

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Trump Pledges To End HIV Transmission By 2030. Doable, But Daunting.

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This article originally appeared in Kaiser Health News.

Noting that science has “brought a once-distant dream within reach,” President Donald Trump on Tuesday night pledged to eliminate HIV transmission within 10 years.

“We have made incredible strides, incredible,” Trump said in the annual State of the Union address. “Together, we will defeat AIDS in America and beyond.”

It’s a goal long sought by public health advocates. But even given the vital gains made in drug therapies and understanding of the disease over nearly 40 years, it is not an easy undertaking.

“The reason we have an AIDS epidemic is not just for a lack of the medication,” said Dr. Kenneth Mayer, medical research director at the Boston LGBT health center Fenway Institute. “There are a lot of social, structural, individual behavioral factors that may impact why people become infected, may impact if people who are infected engage in care and may impact or affect people who are at high risk of HIV.”

Health and Human Services Secretary Alex Azar, who provided details of the initiative after Trump’s announcement, said the administration will target viral hot spots by providing local groups more resources, using data to track the spread of the disease and creating local task forces to bolster prevention and treatment.

Neither Azar nor other federal officials who briefed reporters offered cost estimates for the program.

Azar said the plan seeks to reduce new infections by 75 percent in the next five years and 90 percent in the next decade.

That goal is predicated on growing use of current medications that suppress the virus to such low levels that it is not transmitted during sexual intercourse. PrEP, a drug combination available to individuals with a negative HIV status but may become infected, can reduce their risk of getting the virus by 97 percent, Azar said.”

“This is not the HIV epidemic of the 1990s,” said Terrance Moore, acting executive director of NASTAD, a nonprofit organization that represents officials who administer HIV and hepatitis programs. “We have the tools to end this epidemic.”

Gay and bisexual men made up two-thirds of the nearly 40,000 new HIV cases in 2017, but one clear signal of that difference in the epidemic today is the geography. The nation’s HIV hotbeds are no longer located just in coastal metropolitan areas. In 2017, more than half of the new cases were diagnosed in Southern states.

HHS said it will focus its efforts on the heart of the epidemic: 48 counties across 19 states; the District of Columbia; San Juan, Puerto Rico; and rural areas in seven states, many of which are in the South.

The new federal initiative would expand PrEP access in community health clinics for low-income patients and quickly refer any new clinic patients with HIV to specialized care.

Medications alone are not the answer. Lawmakers must have the political will to move forward with policies based in science, said Moore. Existing programs do not provide enough infrastructure to achieve this goal, he added.

“You can’t be simultaneously attacking and undermining the needs of these communities, while claiming that you want to support them and end the AIDS epidemic,” said Scott Schoettes, HIV project director for the LGBT advocacy group Lambda Legal.

The Trump administration has pursued policies that may hinder the president’s goal. And efforts in the South face additional challenges, like higher levels of poverty, difficulty providing health care in rural areas and historical racial tension.

“I don’t think that these things are things that we cannot overcome,” said Greg Millett, vice president and director of public policy at the HIV research foundation amfAR. “But I also think that we need to be very clear about what the obstacles are and to start thinking now innovatively about how we’re going to be able to obviate them.”

Here are some of the challenges that experts said the president’s plan could face.

Health Insurance

Insurance coverage plays a crucial role in keeping HIV patients healthy.

Comprehensive insurance helps patients access the expensive medications needed to keep the virus under control and vital tests to check on virus levels and white blood cell counts — key health indicators. HIV patients are also often susceptible to infections because the virus compromises the immune system. And they tend to have higher rates of mental health conditions, which could affect their ability to adhere to HIV medication if left untreated.

The Affordable Care Act opened up coverage for thousands of HIV patients with its guarantee of insurance for people with preexisting conditions, but many Republican officials are still calling for the law’s repeal.

In addition, the ACA’s Medicaid expansion led to a substantial jump in the number of people with AIDS who got that coverage, according to the Kaiser Family Foundation. But many states, especially in the South, have not expanded Medicaid. (Kaiser Health News is an editorially independent program of the foundation.)

A federal judge in Texas in December ruled the ACA unconstitutional in a lawsuit waged by a faction of conservative states and supported by the president.

“If you’re not going to provide it through the Affordable Care Act,” Schoettes said, “then there needs to be something that’s as comprehensive in terms of getting people care.

Housing

Although the federal government provides some housing assistance for people with HIV, it does not fill the need.

Those who are homeless or have unstable housing have lower access to HIV medications and poorer treatment outcomes.

study from the Centers for Disease Control and Prevention found that among individuals living with HIV in certain impoverished urban areas across the country, the lower the household income, the higher the rate of HIV in the area. 

The federal government provides assistance through a program called Housing Opportunities for Persons With AIDS, known as HOPWA. In 2016, HOPWA changed its  funding formula to better allocate its resources to Southern areas hardest hit by HIV.

However, some of these HOPWA programs have waiting lists that can extend years. The nation is also experiencing an affordable housing shortage, which further limits options for low-income individuals living with HIV and their families.

Stigma And Mistrust

Experts continue to cite stigma as a key obstacle for treatment. Twenty-six states have laws that penalize an HIV patient for exposing someone to the virus, including 19 that require people who are aware they are infected to notify sexual partners and 12 that mandate disclosure to needle-sharing partners, according to the CDC.

The problems extend to doctors and medical staff. One study, published in 2016, found widespread stigma against HIV patients among health care staff in Alabama and Mississippi, especially among whites and men.

Gina Brown, a community engagement manager for the Southern AIDS Coalition, in part blames the culture of the South, where religious beliefs often clash with gay culture, for perpetuating these problems. “We are still in Bible Belt country, where religion plays a huge part in how we talk about sex or not talk about sex,” she said.

But federal policies, such as the Trump administration’s ban on transgender men and women serving in the military, also play a role.

Federal officials acknowledged these difficulties and affirmed the program would not discriminate against transgender patients.

In addition, minority communities hard hit by the HIV epidemic harbor lingering distrust toward the medical system due to historical abuses such as the Tuskegee syphilis trials, said Mayer.

Injection Drug Use

The scourge of addiction has killed tens of thousands across the nation, spread hepatitis C and is now leading to spikes in HIV transmission, as drug users share needles. In 2015, Scott County, Ind., sought to combat an HIV outbreak fueled by injected opioid use that infected 215 people. Drug use has also been connected to multiple HIV clusters in Massachusetts and Kentucky.

HHS reported that injection drug users accounted for 1 in 10 new HIV cases in 2016.

Expanding syringe exchange programs across the country could minimize this problem, experts said.

“Unfortunately, in the United States we haven’t done as good a job as other Western countries in making sure that those programs are widely available for those Americans who need them,” said Millett.

The CDC and HHS consider syringe exchange programs effective interventions, but some cities, such as Charleston, W.Va., that implemented the programs have now shut them down because of neighborhood complaints, funding concerns and opposition from citizens who object to providing injection equipment.

Federal funds can be used to support this intervention, but these dollars cannot go directly toward purchasing needles.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Carmen Heredia Rodriguez contributed to this story.

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