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High price for Hep C drug sparks controversy

Treatment can cure disease common in people with HIV

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Carl Schmid, Hep C, drug, Gilead, the AIDS Institute, gay news, Washington Blade

Carl Schmid, deputy director of the AIDS Institute, said Sovaldi is expensive, ā€˜but this is remarkable progress and the cure rate is extremely high.’ (Photo courtesy of Schmid)

The pharmaceutical company Gilead Sciences received praise earlier this month for bringing to market a newly approved drug capable of curing the potentially fatal liver disease Hepatitis C without the serious and debilitating side effects caused by the existing drug used to treat the disease.

Experts say 20 percent of people with HIV are co-infected with Hepatitis C, which over a period of years can lead to death through liver cancer and liver failure. Physicians treating people with HIV, including Whitman-Walker Health’s medical director, Dr. Richard Elion, have called Gilead’s new drug a major breakthrough.

But at least two organizations that advocate for people with HIV and Hepatitis C have denounced Gilead for setting the wholesale price for its new drug Sovaldi at a level they consider exorbitant and which they say could lead to further escalating prices for AIDS drugs.

The AIDS Healthcare Foundation, the nation’s largest private organization providing medical services for people with HIV/AIDS, and the Fair Pricing Coalition, which advocates for affordable prices for prescription drugs for people with serious illnesses, called Gilead’s decision to set a wholesale acquisition cost of $84,000 for a 12-week treatment regimen of Sovaldi unprecedented.

ā€œThere can be no better example of the unbridled greed of the pharmaceutical industry than Gilead’s latest move: pricing its new hepatitis drug at $84,000 per 28-tablet bottle or $1,000 per pill,ā€ said Michael Weinstein, president of AHF.

Lynda Dee, co-chair of Fair Pricing Coalition, called Sovaldi a ā€œvery safe and highly effective drugā€ but noted that it must be used in combination with other drugs to treat different Genotypes, or strains, of Hepatitis C.

She said that although the other drugs – pegylated interferon and ribavirin – are not as expensive as Sovaldi, the price tag for combination therapy with Sovaldi comes to $93,000 and $168,000 for various treatment regimens for a single person living with Hepatitis C.

ā€œGilead has set the bar dangerously high as other companies determine prices for similar Hepatitis C drugs as they enter the market,ā€ Dee said.

In a statement released at the time the U.S. Food and Drug Administration approved Sovaldi for patient use on Dec. 6, Gilead said it had put in place a patient assistance program to ensure that people with Hepatitis C have access to Sovaldi regardless of their ability to pay for it.

The statement said the program provides assistance to ā€œpatients who are uninsured, underinsured or who need financial assistance to pay for the medicine.ā€ The program, called Support Path, will provide Sovaldi ā€œat no charge for eligible patients with no other insurance options,ā€ according to the statement.

While praising Gilead for offering such a program, which is common within the pharmaceutical industry, critics say the high price for Sovaldi would likely prompt other companies to put in place similarly high pricing policies for other promising drugs about to be released for the treatment of both Hepatitis C and HIV/AIDS.

Some Wall Street analysts suggested Gilead’s price for Sovaldi may be justified when taking into consideration the amount it spent to bring such a beneficial drug to market. Bloomberg business news service reported that Gilead, which didn’t invent Sovaldi, paid $11 billion in 2011 to buy Pharmasset, Inc., the company that developed Sovaldi and other Hepatitis C drugs expected to be approved soon.

Bloomberg cited pharmaceutical industry observers who said the Hepatitis C drugs Gilead obtained through this purchase could pull in as much as $20 billion by 2020.

Clinical trials with patients monitored by the Food and Drug Administration demonstrated that Sovaldi had a cure rate of more than 90 percent for patients with the Genotype 2 strain of Hepatitis C following a 12-week regimen with the drug ribavirin. Patients with Genotype 3, another strain of Hepatitis C, had a similarly successful cure rate following a 24-week regimen of Sovaldi and Ribavirin, the trials showed.

For patients with Genotype 1 or 4 of the Hepatitis C infection, the Sovaldi treatment needed to be combined with pegylated alfa interferon, the drug of choice for Hepatitis C before the development of Sovaldi and other new drugs nearing completion of clinical trials, statements by Gilead and the FDA said. Interferon causes serious and debilitating side effects for most patients, forcing some to stop using it before the Hepatitis C virus can be eliminated, according to medical experts.

The good news, according to those monitoring Hepatitis C treatment developments, is that Gilead and other pharmaceutical companies are close to releasing other new drugs capable of effectively curing patients with the Genotype 1 and Genotype 4 strains without the need for Interferon.

ā€œI believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of Hepatitis C,ā€ said Dr. Ira Jacobson, chief of the Division of Gastroenterology at Weill Cornell Medical College in New York City, who served as a principal investigator in the clinical trials of Sovaldi.

Carl Schmid, deputy director of the AIDS Institute, which advocates for people with HIV, said the ability of Sovaldi to actually cure patients with Hepatitis C makes it different from HIV drugs on the market, which keep most patients healthy but cannot cure HIV/AIDS.

ā€œYes, it’s expensive,ā€ he said of Sovaldi. ā€œBut this is remarkable progress and the cure rate is extremely high.ā€

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U.S. Supreme Court

Supreme Court to hear Md. religious freedom case on Tuesday

Advocacy groups to rally outside during Mahmoud v. Taylor oral arguments

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U.S. Supreme Court (Washington Blade photo by Michael Key)

Activists on Tuesday will hold a rally in front of the U.S. Supreme Court as the justices hear oral arguments in a case that will determine whether schools are violating parents’ religious freedom by not letting them opt their children out of learning about LGBTQ-specific topics.

Mahmoud v. Taylor is a case out of Montgomery County about parents who wish to opt their children out of LGBTQ-themed lessons in public schools for religious reasons.Ā 

Montgomery County Public Schools, after initially allowing parents to opt their children out, changed the policy in March 2023.

The plaintiffs — Tamer Mahmoud, Enas Barakat, and other parents — argue ā€œthe storybooks were chosen to disrupt ā€˜cisnormativity’ and ā€˜either/or thinking’ among students.ā€ 

ā€œThe board’s own principals objected that the curriculum was ā€˜not appropriate for the intended age group,’ presented gender ideology as ā€˜fact,’ ā€˜sham[ed]’ students with contrary opinions, and was ā€˜dismissive of religious beliefs,ā€™ā€ according to the petition on the Supreme Court’s website. 

The petition goes further, saying the parents are ā€œnot challenging the curriculum, but arguing that compelling their elementary-age children to participate in instruction contrary to their parents’ religious convictions violated the Free Exercise Clause. Construing Wisconsin v. Yoder, the 4th Circuit found no free-exercise burden because no one was forced ā€˜to change their religious beliefs or conduct.ā€™ā€

The Coalition for Inclusive Schools and Communities, an organization that aims to bring together ā€œadvocates, educators, families, and organizations committed to inclusive, affirming, fact and science-based education,ā€ will participate in the ā€œRally for Inclusive Educationā€ rally outside the Supreme Court alongside Live In Your Truth and the Montgomery County Pride Family.

ā€œInclusive education isn’t just a value — it’s a necessity,ā€ said Phillip Alexander Downie, co-chair of the Coalition for Inclusive Schools and Communities and CEO of Montgomery County Pride Family. ā€œThe right of every child to learn in an environment where they see themselves reflected, affirmed, and respected is under attack. This rally is our moment to protect that right — and ensure future generations inherit classrooms rooted in truth, equity, equality, and justice.ā€

The Coalition for Inclusive Schools and Communities says the rally is a ā€œnonpartisan community gathering rooted in education, advocacy, and solidarity.ā€ 

ā€œThe focus of this event is to uplift the importance of inclusive learning environments, celebrate the power of diversity in our schools, and amplify the voices of those most impacted by exclusionary practices and rhetoric,ā€ it said.

The rally will feature speakers from across the country, including students, educators, civil rights leaders, and authors who will give their own testimonies as to why it is important to have inclusivity in primary education. Trans Maryland, the National Women’s Law Center, MoCoPride Center, and Authors Against Book Bans are among the LGBTQ groups sponsoring the event.

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EXCLUSIVE: Rodrigo Heng-Lehtinen to step down from Advocates for Trans Equality

A4TE formed last year when two transgender rights groups merged

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Rodrigo Heng-Lehtinen (Photo courtesy of Rodrigo Heng-Lehtinen)

Advocates for Trans Equality Executive Director Rodrigo Heng-Lehtinen on Monday announced he will step down on April 30.

The Transgender Legal Defense and Education Fund and the National Center for Transgender Equality formed Advocates for Trans Equality last year when they merged. Heng-Lehtinen was previously NCTE’s executive director.

ā€œNow that we’ve made it through the merger, and A4TE is established as a new, prominent institution fighting hard for trans equality, it’s time for me to take my next step,ā€ said Heng-Lehtinen in a press release that Advocates for Trans Equality sent exclusively to the Washington Blade. ā€œWhen Andy (Hong Marra) and I began envisioning the merger, I committed to seeing it through. I’m proud that now our vision has been realized. A4TE has not just launched, but is fully up and running, delivering results for trans people around the country. With A4TE gaining momentum, I’m now ready to move on to my next chapter.ā€  

Heng-Lehtinen, whose mother is former Florida Congresswoman Ileana Ros-Lehtinen, in the press release stressed he “will be focusing on changing hearts and minds.”

“With my background in persuasion and messaging, it’s where I can make the biggest difference, and what I feel called to return to in this era of anti-trans backlash,” said Heng-Lehtinen. “I will still be fighting shoulder-to-shoulder with everyone (in) the trans movement, simply in a different capacity.”

Marra, who is Advocates for Trans Equality’s CEO, praised Heng-Lehtinen and said the organization’s work will continue.

ā€œWe thank Rodrigo for his years of dedicated leadership and service,ā€ said Marra. ā€œA4TE will continue to deliver on our promise to advocate for the lives of trans people who need us now more than ever. We remain undaunted by our endeavor to ensure trans people and our families are no less than free and equal and treated with dignity and respect.ā€Ā 

Louisiana Trans Advocates Executive Director Peyton Rose Michelle also praised Heng-Lehtinen.

“Rodrigo has been a steady hand and a bright light in this work,” she said. “He’s someone who shows up with integrity, kindness, and a deep commitment to meeting this political moment with courage. I’ve always felt deeply supported and heard by him, which is something I value deeply.ā€

ā€œI fully support him as he steps into this new chapter, and I know his clarity of vision and heart-forward leadership will keep shifting this landscape back toward justice for trans people, and therefore, all people,” added Michelle. 

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U.S. Federal Courts

Federal judge blocks Trump passport executive order

State Department can no longer issue travel documents with ‘X’ gender markers

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(Bigstock photo)

A federal judge on Friday ruled in favor of a group of transgender and nonbinary people who have filed a lawsuit against President Donald Trump’s executive order that bans the State Department from issuing passports with “X” gender markers.

The Associated Press notes U.S. District Judge Julia Kobick in Boston issued a preliminary injunction against the directive. The American Civil Liberties Union, which represents the plaintiffs, in a press release notes Kobick concluded Trump’s executive order “is likely unconstitutional and in violation of the law.”

“The preliminary injunction requires the State Department to allow six transgender and nonbinary people to obtain passports with sex designations consistent with their gender identity while the lawsuit proceeds,” notes the ACLU. “Though today’s court order applies only to six of the plaintiffs in the case, the plaintiffs plan to quickly file a motion asking the court to certify a class of people affected by the State Department policy and to extend the preliminary injunction to that entire class.”

Former Secretary of State Antony Blinken in June 2021 announced the State Department would begin to issue gender-neutral passports and documents for American citizens who were born overseas.

Dana Zzyym, an intersex U.S. Navy veteran who identifies as nonbinary, in 2015 filed a federal lawsuit against the State Department after it denied their application for a passport with an ā€œXā€ gender marker. Zzyym in October 2021 received the first gender-neutral American passport.

The State Department policy took effect on April 11, 2022. Trump signed his executive order shortly after he took office in January.

Germany, Denmark, Finland, and the Netherlands are among the countries that have issued travel advisories for trans and nonbinary people who plan to visit the U.S.

ā€œThis ruling affirms the inherent dignity of our clients, acknowledging the immediate and profound negative impact that the Trump administration’s passport policy would have on their ability to travel for work, school, and family,ā€ said ACLU of Massachusetts Legal Director Jessie Rossman after Kobick issued her ruling.

ā€œBy forcing people to carry documents that directly contradict their identities, the Trump administration is attacking the very foundations of our right to privacy and the freedom to be ourselves,” added Rossman. “We will continue to fight to rescind this unlawful policy for everyone so that no one is placed in this untenable and unsafe position.ā€

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