Connect with us

National

High price for Hep C drug sparks controversy

Treatment can cure disease common in people with HIV

Published

on

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, ‘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.

“There 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,” said Michael Weinstein, president of AHF.

Lynda Dee, co-chair of Fair Pricing Coalition, called Sovaldi a “very safe and highly effective drug” 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.

“Gilead has set the bar dangerously high as other companies determine prices for similar Hepatitis C drugs as they enter the market,” 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 “patients who are uninsured, underinsured or who need financial assistance to pay for the medicine.” The program, called Support Path, will provide Sovaldi “at no charge for eligible patients with no other insurance options,” 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.

“I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of Hepatitis C,” 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.

“Yes, it’s expensive,” he said of Sovaldi. “But this is remarkable progress and the cure rate is extremely high.”

Continue Reading
Advertisement
6 Comments

6 Comments

  1. James Driscoll, Ph.D.

    December 24, 2013 at 12:23 am

    If Salk charged a comparable price for his polio vaccine, that disease would have ravaged the globe until its patent expired. Have those who by their silence condone Gilead’s all the traffic will bear pricing of Sovaldi calculated the cost of curing all the estimated 200,000,000 million infected with HCV across the globe? I have, the cost is approximately $17,000,000,000,000, that’s seventeen trillion dollars for those of you who get lost counting the zeros. Seventeen trillion is approximately equal to the US GDP for one year or to the entire federal deficit, and slightly more than twice the GDP of China. Granted Gilead will not make that much, but JP Morgan recently set the target for their stock, symbol GILD, at $100.00/share, for a market cap of $152B compared to $144B and $123B for giant pharmas Merck and GSK. Only 2 years ago GILD’s market cap was only 20B. Most of GILD’s gain is based on one wildly overpriced HCV drug they did not even invent, nearly all of it based on drugs government health systems are expected to provide for impoverished HIV and HCV patients at taxpayer expense (Republican “fiscal conservatives” wake up!). Fortunately, competing drugs are likely to be approved soon. Responsible HIV and HCV advocates should pressure the next company in line, Abbvie whose drug may actually be better than Sovaldi, to price it more responsibly (and grab the market advantage) by knocking $25,000+ off GILD’s exorbitant price.

  2. Connie Trowbridge-Geldreich

    December 26, 2013 at 9:02 am

    My brother is being put into hospice tomorrow, it's also his birthday. He's poor and has been waiting for this medicine for years. Now it's here he's doomed to die. You say this is available to anyone no matter the ability to pay. Can you direct me to someone that will help me?

  3. Connie Trowbridge-Geldreich

    December 26, 2013 at 9:08 am

    He was hoping Obamacare would arrive in time. He now admits voting for Obama was the worst thing he ever did, he's even lost his doctor and his only hope of relief is Hospice. He's being sent to his death. I'm sure a lot of other people needing these drugs will never get them!

  4. Imran Akram

    December 29, 2013 at 6:22 pm

    what is the price for developing countries

  5. Terry Dorcas

    December 30, 2013 at 6:35 pm

  6. Terry Dorcas

    December 30, 2013 at 6:37 pm

    Hi Connie Also go to this site and ask all the questions you like and they are great people. http://hepcfriends.activeboard.com/

Leave a Reply

Your email address will not be published. Required fields are marked *

Utah

VIDEO: Utah deal promoted as national model for LGBTQ rights, religious liberty

Data finds state has 2nd highest support for LGBTQ rights

Published

on

(Screen capture via YouTube)

A new video from the premier LGBTQ group in Utah, challenging the idea LGBTQ rights must be at odds with religious liberty, promotes an agreement reached in the state as a potential model to achieve a long sought-after update to civil rights law at the federal level.

The video, published Friday by Equality Utah, focuses on a 2015 agreement in Utah between the supporters of LGBTQ rights and the Mormon Church to enact a compromise acceptable to both sides. The agreement by those two sides led to an LGBTQ civil rights law in the state, which has Republican control of the state legislature and the governor’s mansion.

Troy Williams, executive director of Equality Utah, says in the video dialogue is key to achieving meaningful success, whether its among the people of Utah, a state legislature or lawmakers in Congress.

“When you are working with LGBT rights in a state like Utah, and you want to advance legal equality, you can’t do it without working with Republicans, with conservative, with people of faith,” Williams says.

Williams, speaking with the Washington Blade over a Zoom call, said the main audience for the video is people on “the center right and the center left” willing to listen to other side when it comes to LGBTQ rights and religious liberty.

“People that have the courage to reach out to each other, and sit down across from each other and say, ‘Hey look, let’s hammer this out,” Williams said. “That’s who my audience is.”

Not only did Utah enact non-discrimination protections for LGBTQ people, but the state under a Republican governor administratively banned widely discredited conversion therapy for youth. When lawmakers proposed legislation that would ban transgender youth from competing in school sports, the proposal was scuttled when Gov. Spencer Cox (whom Williams called a “super Mormon”) said he’d veto it after it came to his desk.

Marina Gomberg, a former board for Equality Utah, is another voice in the video seeking dispel the narrative religious liberty and LGBTQ rights are in conflict.

“in order to protect LGBTQ people, we don have to deny religious liberty, and in order to provide protections for religious liberties, we don’t have to deny LGBTQ people,” Gomberg says. “The idea that we do is a fallacy that Utah has dismantled.”

In July, new polling demonstrated the surprisingly the Utah, despite being a conservative state, has the second highest percentage of state population in support for non-discrimination protections for LGBTQ people. The data Public Religion Research Institute from 77 percent of Utah residents support LGBTQ people, which is just behind New Hampshire at 81 percent.

Tyler Deaton, senior adviser for the pro-LGBTQ American Unity Fund, said the Utah agreement demonstrates the possibility of reaching an agreement at the federal level once “second order” issues are put into perspective.

“The first order question has to be how are we winning the culture,” Deaton said. “Do people even want to pass the bill? And if they do, you then figure out the details.”

The American Unity Fund has helped promote as a path forward for LGBTQ non-discrimination at the federal level the Fairness for For All Act, legislation seeking to reach a middle ground on LGBTQ rights and religious freedom. Polling earlier this year found 57 percent of the American public back a bipartisan solution in Congress to advance LGBTQ civil rights.

Supporters of the Equality Act, the more established vehicle for LGBTQ rights before Congress, say the Fairness for For All Act would give too many carve-out for LGBTQ rights in the name of religious freedom. The Equality Act, however, is all but dead in Congress and has shown no movement in the U.S. Senate.

Skeptics of the Utah law would point out the law doesn’t address public accommodations, one of the more challenging aspects in the fight for LGBTQ rights and one or remaining gaps in civil rights protections for LGBTQ people in the aftermath of the U.S. Supreme Court’s decision last year in Bostock v. Clayton County. As a result, it’s perfectly legal in Utah for a business owner to discriminate against LGBTQ coming as patrons.

Williams, however, shrugged off the idea the lack of public accommodations protections in Utah make the agreement in the state makes it any less of a model, making the case the spirit behind the deal is what matters.

“I think copying and pasting Utah’s law doesn’t work for lots of reasons,” Wililams said. “What’s most important is a model of collaboration because when you are sitting around the table with each other — Democrats and Republicans, LGBTQ people and people of faith — that’s when the transformation happens. That is when the mutual respect is really forged.”

Continue Reading

National

Venezuelan man with AIDS dies in ICE custody

Pablo Sánchez Gotopo passed away at Miss. hospital on Oct. 1

Published

on

Pablo Sanchez Gotopo, who was living with HIV/AIDS, died in U.S. Immigration and Customs Enforcement custody in Mississippi on Oct. 1, 2021. (Courtesy photo)

A Venezuelan man with AIDS died in U.S. Immigration and Customs Enforcement custody on Oct. 1.

An ICE press release notes Pablo Sánchez Gotopo, 40, died at Merit Health River Oaks in Flowood, Miss., which is a suburb of Jackson, the state capital. The press release notes the “preliminary cause of death was from complications with acute respiratory failure, Acquired Immune Deficiency Syndrome (AIDS), pneumonia, acute kidney failure, anemia and COVID-19.”

ICE said U.S. Border Patrol took Sánchez into custody near Del Rio, Texas, on May 17. He arrived at the Adams County Detention Center in Natchez, Miss., four days later.

“Upon arrival to an ICE facility, all detainees are medically screened and administered a COVID-19 test by ICE Health Service Corps (IHSC) personnel,” said ICE in its press release. “Sánchez’s test results came back negative.”

The press release notes Sánchez on July 28 received another COVID-19 test after he “began showing symptoms of COVID-19.” ICE said he tested negative, but Adams County Detention Center personnel transferred him to a Natchez hospital “for additional advanced medical care.”

ICE Enforcement and Removal Operations staff in its New Orleans Field Office, according to the press release, “coordinated with hospital staff to arrange family visitation” after Sánchez’s “health condition deteriorated.” Sánchez was transferred to Merit Health River Oaks on Sept. 25.

“ICE is firmly committed to the health and welfare of all those in its custody and is undertaking a comprehensive agency-wide review of this incident, as it does in all such cases,” says the press release.

Venezuela’s political and economic crises have prompted more than 10,000 people with HIV to leave the country, according to the New York-based Aid for AIDS International.

Activists and health care service providers in Venezuela with whom the Washington Blade has spoken in recent years have said people with HIV/AIDS in the country have died because of a lack of antiretroviral drugs. Andrés Cardona, director of Fundación Ancla, a group in the Colombian city of Medellín that works with migrants and other vulnerable groups, told the Blade last month that many Venezuelans with HIV would have died if they hadn’t come to Colombia.

The Blade has not been able to verify a Venezuelan activist’s claim that Sánchez was gay. It is also not known why Sánchez decided to leave Venezuela and travel to the U.S.

ICE detainee with HIV described Miss. detention center as ‘not safe’

Activists and members of Congress continue to demand ICE release people with HIV/AIDS in their custody amid reports they don’t have adequate access to medications and other necessary medical treatment.

Two trans women with HIV—Victoria Arellano from Mexico and Roxsana Hernández from Honduras—died in ICE custody in 2007 and 2018 respectively. Johana “Joa” Medina Leon, a trans woman with HIV who fled El Salvador, died in 2019, three days after ICE released her from a privately-run detention center.

The Blade in July 2020 interviewed a person with HIV who was in ICE custody at the Adams County Detention Center. The detainee said there was no social distancing at the privately-run facility and personnel were not doing enough to prevent COVID-19 from spreading.

“It’s not safe,” they told the Blade.

The entrance to the Adams County Detention Center in Natchez, Miss. (Washington Blade photo by Michael K. Lavers)

Elisabeth Grant-Gibson, a Natchez resident who supports ICE detainees and their families, on Wednesday told the Blade that she was able to visit the Adams County Detention Center and other ICE facilities in the Miss Lou Region of Mississippi and Louisiana from November 2019 until the suspension of in-person visitation in March 2020 because of the pandemic.

“Medical neglect and refusal of medical care has always been an issue in the detention center at Adams County,” said Grant-Gibson. “After the facilities were closed to public visitation, those problems increased.”

Grant-Gibson told the Blade she “worked with a number of families and received phone calls from a number of detainees, and I was told again and again that detainees were being refused the opportunity to visit the infirmary.”

“When they did visit the infirmary, they were given virtually no treatment for the issues they were presenting with,” said Grant-Gibson.

ICE in its press release that announced Sánchez’s death said fatalities among its detainees, “statistically, are exceedingly rare and occur at a fraction of the national average for the U.S. detained population.” ICE also noted it spends more than $315 million a year “on the spectrum of healthcare services provided to detainees.”

“ICE’s Health Service Corps (IHSC) ensures the provision of necessary medical care services as required by ICE Performance-Based National Detention Standards and based on the medical needs of the detainee,” notes the ICE press release. “Comprehensive medical care is provided from the moment detainees arrive and throughout the entirety of their stay. All ICE detainees receive medical, dental, and mental health intake screening within 12 hours of arriving at each detention facility, a full health assessment within 14 days of entering ICE custody or arrival at a facility, and access to daily sick call and 24-hour emergency care.”

An ICE spokesperson on Wednesday pointed the Blade to its Performance-Based Detention Standards from 2011, which includes policies for the treatment of detainees with HIV/AIDS.

A detainee “may request HIV testing at any time during detention” and ICE detention centers “shall develop a written plan to ensure the highest degree of confidentiality regarding HIV status and medical condition.” The policy also states that “staff training must emphasize the need for confidentiality, and procedures must be in place to limit access to health records to only authorized individuals and only when necessary.”

“The accurate diagnosis and medical management of HIV infection among detainees shall be promoted,” reads the policy. “An HIV diagnosis may be made only by a licensed health care provider, based on a medical history, current clinical evaluation of signs and symptoms and laboratory studies.”

Continue Reading

National

Rachel Levine on becoming four-star admiral: ‘It comes from my desire to serve’

Trans official sworn-in to U.S. Public Health Service

Published

on

For Rachel Levine, the appointment to her new role as a four-star admiral complementing her existing duties as assistant secretary for health is another way for the first openly transgender Senate-confirmed presidential appointee to serve.

“I think that this just really comes from my desire to serve in all capacities,” Levine said in an interview Tuesday with the Washington Blade. “To serve the first day in my field of academic medicine and pediatrics, but then in Pennsylvania and now in the federal government, and it furthers my ability to do that.”

Levine, 63, also recognized the importance of the appointment as a transgender person within the U.S. Public Health Service, for which she was ceremonially sworn in on Tuesday

“I think for the LGBTQ+ community, it is a further sign of progress and our president’s commitment to equity, to inclusion and diversity,” Levine said. “So I think that it is a very important milestone, and I’m pleased to serve.”

As part of her duties, Levine will lead an estimated 6,000 public health service officers serving vulnerable populations, including deployments inside and outside the country for communities beleaguered with the coronavirus, according to the Department of Health & Human Services. The role involves working closely with U.S. Surgeon General Vivek Murphy, whom Levine called her “friend and colleague.”

The U.S. Public Health Service, Levine said, has deployed “many, many times,” including its greatest number ever of deployments to vulnerable populations during the coronavirus pandemic. Among the places the service has deployed, Levine said, was in her home state of Pennsylvania, where she recently served as secretary of health.

Not only is Levine the first openly transgender person to serve in the uniformed health service as a four-star general, but she’s also the first woman to serve in that capacity.

“We have 6,000 dedicated committed public servants really all focused on our nation’s health, and they serve in details to the CDC and the FDA and the NIH, but also clinically with the Indian Health Service, and the federal prison system,” Levine said. “They’re also detailed and deployed throughout the country, and they deployed like never before for COVID-19 as well as the border, as well as dealing with floods and hurricanes and tornadoes.”

Although the Public Health Service is primarily focused on addressing public health disasters within the United States, Levine said it has a record of deployments overseas, including years ago when it was deployed to Africa under the threat of Ebola.

Secretary of Health & Human Services Xavier Becerra had high praise for Levine in a statement upon news of taking on a leadership position in the service.

“This is a proud moment for us at HHS,” Becerra said. “Adm. Levine — a highly accomplished pediatrician who helps drive our agency’s agenda to boost health access and equity and to strengthen behavioral health — is a cherished and critical partner in our work to build a healthier America.”

Levine, however, was careful to draw a distinction between her appointment within the Public Health Service and being a service member within the U.S. armed forces.

“It is not a military branch, it’s not the armed forces: It’s a uniformed force, so it’s different,” Levine said. “For example, the Army, the Navy, our military, there are two other uniformed branches, and that is ours, the United States Public Health Service Commissioned Corps and NOAA.”

The new role, Levine said, would complement her duties as assistant secretary for health. Although not only secretaries of health have been commissioned to take the uniform, Levine said she wanted to undertake that as part of her role in the Biden administration.

The two appointments were not simultaneous, Levine said, because of a general process she undertook, which was completed just this week.

It hasn’t been an easy road for Levine. During her Senate confirmation process, when she was hounded by anti-transgender attacks in conservative media and rude, invasive questioning by Sen. Rand Paul (R-Ky.) on her gender identity.

Levine, however, said she hasn’t encountered any hostility regarding her new role (as of now) and shrugged off any potential attacks in the future and said the move is about her career “to serve and to help people.”

“I’ve continued that for our nation as the assistant secretary for health and this is just a further demonstration of my commitment to service,” Levine said. “I don’t know what others will say, but that’s the genesis of my wanting to serve in the United States Public Health Service Commissioned Corps, and to place on the uniform.”

Levine’s new appointment comes shortly after a group of Democratic senators led by Sen. Chris Murphy (D-Conn.) sent her a letter dated Sept. 30 calling on her and Miriam Delphin-Rittmon, assistant secretary for mental health and substance use, to issue new guidance for hospital or residential care on mental health needs of transgender people.

Asked about the letter, Levine said mental health issues are under the authority of Delphin-Rittmon and the two “will work together and we will respond.”

Specifically, the senators in the letter call on the Behavioral Health Coordinating Council, or BHCC, and experts in the field of adolescent trans care to offer guidance on best practices for inpatient mental health care among these youth.

Asked what the response will look like, Levine said, “We’re going to work on that.”

“We will be looking at what they’re asking for and the requirements, and we’ll talk with them and the stakeholders and we’ll look to issue appropriate guidance,” Levine said.

Continue Reading
Advertisement
Advertisement

Follow Us @washblade

Sign Up for Blade eBlasts

Popular