National
High price for Hep C drug sparks controversy
Treatment can cure disease common in people with HIV
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 Healthās medical director, Dr. Richard Elion, have called Gileadās 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 nationās 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 Gileadās decision to set a wholesale acquisition cost of $84,000 for a 12-week treatment regimen of Sovaldi unprecedented.
āThere can be no better example of the unbridled greed of the pharmaceutical industry than Gileadās 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 āvery 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 ā pegylated interferon and ribavirin ā 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.
āGilead 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 āpatients who are uninsured, underinsured or who need financial assistance to pay for the medicine.ā The program, called Support Path, will provide Sovaldi āat 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 Gileadās 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 didnāt 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.
āI 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.
āYes, itās expensive,ā he said of Sovaldi. āBut this is remarkable progress and the cure rate is extremely high.ā
Federal Government
GLAAD catalogues LGBTQ-inclusive pages on White House and federal agency websites
Trump-Vance administration to take office Monday
GLAAD has identified and catalogued LGBTQ-inclusive content or references to HIV that appear on WhiteHouse.gov and the websites for several federal government agencies, anticipating that these pages might be deleted, archived, or otherwise changed shortly after the incoming administration takes over on Monday.
The organization found a total of 54 links on WhiteHouse.gov and provided the Washington Blade with a non-exhaustive list of the “major pages” on websites for the Departments of Defense (12), Justice (three), State (12), Education (15), Health and Human Services (10), and Labor (14), along with the U.S. Equal Employment Opportunity Commission (10).
The White House web pages compiled by GLAAD range from the transcript of a seven-minute speech delivered by President Joe Biden to mark the opening of the Stonewall National Monument Visitor Center to a readout of a roundtable with leaders in the LGBTQ and gun violence prevention movements and the White House Office of National Drug Control Policy’s 338-page FY2024 budget summary, which contains at least a dozen references to LGBTQ-focused health equity initiatives and programs administered by agencies like the Substance Abuse and Mental Health Services Administration.
Just days after Trump took office in his first term, news outlets reported that LGBTQ related content had disappeared from WhiteHouse.gov and websites for multiple federal agencies.
Chad Griffin, who was then president of the Human Rights Campaign, accused the Trump-Pence administration of “systematically scrubbing the progress made for LGBTQ people from official websites,” raising specific objection to the State Department’s removal of an official apology for the Lavender Scare by the outgoing secretary, John Kerry, in January 2017.
Acknowledging the harm caused by the department’s dismissal of at least 1,000 employees for suspected homosexuality during the 1950s and 60s “set the right tone for the State Department, he said, adding, āIt is outrageous that the new administration would attempt to erase from the record this historic apology for witch hunts that destroyed the lives of innocent Americans.”
In response to an inquiry from NBC News into why LGBTQ content was removed and whether the pages would return, a spokesperson said “As per standard practice, the secretary’s remarks have been archived.” However, NBC noted that “a search of the State Department’s website reveals not much else has changed.”
U.S. Federal Courts
Appeals court hears case challenging Florida’s trans healthcare ban
District court judge concluded the law was discriminatory, unconstitutional
Parties in Doe v. Ladapo, a case challenging Florida’s ban on healthcare for transgender youth and restrictions on the medical interventions available to trans adults, presented oral arguments on Wednesday before the U.S. Court of Appeals for the 11th Circuit in Atlanta.
The case was appealed by defendants representing the Sunshine State following a decision in June 2024 by Judge Robert Hinkle of the U.S. District Court for the Northern District of Florida, who found “the law and rules unconstitutional and unenforceable on equal protection grounds,” according to a press release from the National Center for Lesbian Rights, which is involved in the litigation on behalf of the plaintiffs.
The district court additionally found the Florida healthcare ban unconstitutional on the grounds that it was “motivated by purposeful discrimination against transgender people,” though the ban and restrictions will remain in effect pending a decision by the appellate court.
Joining NCLR in the lawsuit are attorneys from GLAD Law, the Human Rights Campaign, Southern Legal Counsel, and the law firms Lowenstein Sandler and Jenner and Block.
“As a mother who simply wants to protect and love my child for who she is, I pray that the Eleventh Circuit will affirm the district courtās thoughtful and powerful order, restoring access to critical healthcare for all transgender Floridians,” plaintiff Jane Doe said. “No one should have to go through what my family has experienced.ā
“As a transgender adult just trying to live my life and care for my family, it is so demeaning that the state of Florida thinks itās their place to dictate my healthcare decisions,” said plaintiff Lucien Hamel.
“Members of the legislature have referred to the high quality healthcare I have received, which has allowed me to live authentically as myself, as āmutilationā and āan abominationā and have called the providers of this care āevil,ā” Hamel added. “We hope the appellate court sees these rules and laws for what truly are: cruel.ā
āTransgender adults donāt need state officials looking over their shoulders, and families of transgender youth donāt need the government dictating how to raise their children,ā said Shannon Minter, legal director of NCLR. āThe district court heard the evidence and found that these restrictions are based on bias, not science. The court of appeals should affirm that judgment.ā
Noting Hinkle’s conclusion that the ban and restrictions were “motivated by animus, not science or evidence,” Simone Chris, who leads Southern Legal Counsel’s Transgender Rights Initiative, said, āThe state has loudly and proudly enacted bans on transgender people accessing healthcare, using bathrooms, transgender teachers using their pronouns and titles, and a slough of other actions making it nearly impossible for transgender individuals to live in this state.”
Lowenstein Sandler Partner Thomas Redburn said, āThe defendants have offered nothing on appeal that could serve as a valid basis for overturning that finding” by the district court.
āNot only does this dangerous law take away parentsā freedom to make responsible medical decisions for their child, it inserts the government into private health care matters that should be between adults and their providers,” said Jennifer Levi, senior director of transgender and queer rights at GLAD Law.
State Department
LGBTQ rights abroad not discussed during Marco Rubio confirmation hearing
Senate expected to confirm Fla. Republican as next secretary of state
U.S. Sen. Marco Rubio (R-Fla.) on Wednesday did not speak about LGBTQ rights abroad during his confirmation hearing to become the next secretary of state.
The Florida Republican in his opening statement to the Senate Foreign Affairs Committee noted President-elect Donald Trump “returns to office with an unmistakable mandate from the voters.”
“They want a strong America, a strong America engaged in the world, but guided by a clear objective to promote peace abroad and security and prosperity here at home,” said Rubio.
“The direction he has given for the conduct of our foreign policy is clear,” he added. “Every dollar we spend, every program we fund, and every policy we pursue must be justified with the answer to three simple questions: Does it make America safer? Does it make America stronger? Does it make America more prosperous?”
Trump nominated Rubio a week after Vice President Kamala Harris conceded she lost the presidential election.
Rubio in 2022Ā defendedĀ Florida’s āDonāt Say Gayā law that Republican Gov. Ron DeSantis signed. The Florida Republican that year also voted against the Respect for Marriage Act that passed with bipartisan support.
LGBTQ rights a cornerstone of Biden-Harris administration’s foreign policy
President Joe Biden in February 2021Ā signed a memo that committed the U.S. to promoting LGBTQ and intersex rights abroad as part of his administrationās overall foreign policy. A few months later he named Jessica Stern, the former executive director of Outright International, a global advocacy group, as special U.S. envoy for the promotion of LGBTQ and intersex rights abroad.
Ned Price, who was the State Departmentās first openly gay spokesperson, during a May 2021 interview with the Washington Blade noted the decriminalization of consensual same-sex sexual relations was one of the administrationās priorities in its efforts to promote LGBTQ rights abroad.
Trump during his first administration tapped then-U.S. Ambassador to Germany Richard Grenell, who has been tapped as special missions envoy, to lead an initiative that encouraged countries to decriminalize homosexuality. Activists with whom the Blade has previously spoken questioned whether this effort had any tangible results.
Stern in 2022 noted the Biden-Harris administration also supported marriage equality efforts in countries where activists said they were possible through legislation or the judicial process.
Brittney Griner in December 2022 returned to the U.S. after Russia released her in exchange for a convicted arms dealer. The lesbian WNBA star had been serving a nine-year prison sentence in a penal colony after a court earlier that year convicted her on the importation of illegal drugs after Russian customs officials found vape canisters containing cannabis oil in her luggage at Moscowās Sheremetyevo Airport.
The State Department in 2022 began to issue passports with an āXā gender marker.
The Biden-Harris administration in response to the signing of Ugandaās Anti-Homosexuality Act sanctioned officials and removed the country from a program that allows sub-Saharan African countries to trade duty-free the U.S. Harris during a 2023 press conference with then-Ghanaian President Nana Akufo-Addo in Accra, the Ghanaian capital, spoke about LGBTQ rights.
Chantale Wong, the U.S. director of the Asian Development Bank, in 2022 became the first openly lesbian woman ambassador. David Pressman, the outgoing U.S. ambassador to Hungary, and Scott Miller, the outgoing U.S. ambassador to Switzerland and Liechtenstein, are two of the other American ambassadors who Biden nominated that are gay.
Outgoing Secretary of State Antony Blinken in 2021 appointed former U.S. Ambassador to Malta Gina Abercrombie-Winstanley as the State Department’s first chief diversity and inclusion officer.
U.S. Sen. Jim Risch (R-Idaho), who chairs the Senate Foreign Affairs Committee, criticized the State Department’s DEI efforts during Rubio’s confirmation hearing.
“The Biden administration often undercut effective foreign policy by inserting ideological and political requirements into the fabric of personnel decisions and policy execution,” said Risch.
“Rather than making hires or promotions based on merit and effectiveness, the department created new diversity, equity, inclusion, and accessibility (DEIA) requirements that distracted from this mission, undermined morale, and created an unfair and opaque process for promotions and performance evaluations,” he added. “Fealty to progressive politics became the benchmark for success. As we look around the United States that view is diminishing very quickly amongst even large progressive cooperations.”
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