Connect with us

U.S.

AOC and Sanders Ask for HIV Medicine Patent to be Rejected

Published

on

  • A petition filed by advocacy group PrEP4All Collaboration alleges that biotech company Gilead Sciences suspended the development of a potentially safer HIV prevention drug for five years in 2005 so they could continue to profit from their current monopoly on the market, despite the fact that it was less safe. 
  • Gilead is asking now asking to extend the patent on the new drug while PrEP4All is asking for this patent to be rejected. 
  • Sen. Bernie Sanders and Rep. Alexandria Ocasio-Cortez also wrote a joint letter urging the Trump administration to reject this request, calling the alleged practice a “disgrace.”
  • Gilead has denied these accusations.

Petition Filed Against Gilead

Rep. Alexandria Ocasio-Cortez (D-NY) and Sen. Bernie Sanders (I-VT) are calling on the Trump administration to reject a patent extension request from Gilead Sciences after the company was accused of delaying the development of a safer HIV prevention drug. 

A petition filed by advocacy group PrEP4All Collaboration alleges that when Gilead suspended the development of a newer and potentially safer HIV prevention drug in 2005, it did so in order to maximize its monopoly on profits from its less-safe drug that was already on the market. The petition says they wanted to leave this old drug on the market until its patent expired, and before generic competition came up. The company did not submit the new drug, tenofovir alafenamide, or TAF, to the Food and Drug Administration until 2010. It was approved in 2015. 

According to a report from the Washington Post, Gilead is currently requesting that its patent on TAF be extended for another three years. PrEP4All is asking the Patent and Trademark Office to reject this request because of this allegation. 

TAF is meant to prevent HIV infections via a process called pre-exposure prophylaxis, also known as PrEP. Extending the patent would make sure they had a monopoly on the drug. 

Letter from Sanders and Ocasio-Cortez

PrEP4All’s fight got a new push of support on Monday when Sanders and Ocasio-Cortez gave their support. In a letter to the U.S. Patent and Trademark Office obtained by The Guardian, the leaders condemned Gilead for these accusations. 

“It is an absolute disgrace that in America, a greedy drug company like Gilead can deprive hundreds of thousands of Americans of lifesaving HIV medicine to extract more profit, lie about it, and then have the audacity to ask the US government to award it with a longer monopoly to reap tens of billions more in profits,” Sanders wrote. 

Ocasio-Cortez said this practice “inhibited efforts to end the HIV epidemic.”

Together, the two urged the Trump administration to “not reward Gilead for this immoral behavior.” 

If the Trump administration followed their requests, it would not be the first time they took action against Gilead. In November, the administration sued the company in a patent infringement case. They accused the company of profiting off of taxpayer-funded research without giving taxpayer money back. 

Statements From Those Involved

Ocasio-Cortez and Sanders have not been the only ones to speak out. 

“Gilead has not only intentionally delayed clinical development of a drug to artificially manipulate its eligibility for a patent-term extension, but it has done so despite the apparent harm to patients,” said attorney Christopher Morten, who filed PrEP4All’s petition in a statement to the Washington Post. 

The Post says that the petition cites statements made by the company’s executives in 2011, where some indicated a desire to “avoid cannibalizing sales of the old drug” with the expectation that TAF could maintain the patent longevity of their HIV drug franchise. The petition also says that Gilead stated that clinical trials had indicated that TAF is safer than older drugs. A study funded by them found that restricting patients from the new drug could cause 16,000 deaths over the course of nine years.

Still, the Washington Post said the outcome of PrEP4All’s petition is not set in stone. 

“Odds of success are steep because the patent office will review such third-party petitions only in ‘extraordinary’ circumstances, according to its rules,” their report said. 

“Patient safety is of foremost importance to us, and any implication that Gilead delayed the development of a drug known to be safer than [the older drug] is false,’’ Gilead spokesperson Ryan McKeel said in a statement obtained by the Post.  

See what others were saying: (The Washington Post) (The Guardian) (The Advocate)

U.S.

FDA Authorizes Moderna and J&J COVID Vaccine Boosters, Approves Mix-and-Match Doses

Published

on

The approval will allow at-risk Americans who received Pfizer and Moderna vaccines to get any booster six months after their initial series and all Johnson & Johnson recipients 18 and older to do the same two months after their single-shot dose.


New FDA Authorization

The U.S. Food and Drug Administration (FDA) on Wednesday authorized boosters shots of Moderna and Johnson & Johnson COVID-19 vaccines and approved a mix-and-match strategy that will allow people who got one company’s shot to get a booster from a different maker.

The decision paves the way for millions of more at-risk Americans to get extra protection, and not just certain Pfizer recipients as previously approved by the FDA.

Under the authorization, people who received Moderna or Pfizer can get any one of the three booster shots six months after completing their initial series if they are 65 and older, at high risk of severe COVID, or face increased exposure because of their work.

Meanwhile, all J&J recipients 18 and older can get any of the approved vaccines two months after they received the one-shot jab.

Hazy Recommendations, For Now

Notably, the FDA did not recommend a certain combination of vaccines, nor did the agency say whether or not it would be more effective for people to stick with their original vaccine maker for their booster.

The new authorizations draw on a study from the National Institutes of Health (NIH), which found that there are no safety concerns with mixing boosters and that vaccine combinations were at least as effective in stimulating antibodies as matched vaccines.

In the case of J&J recipients, the NIH found that people actually had a higher boost from mixing either Moderna or Pfizer boosters.

However, some of the scientists who worked on the study said it should not be used to recommend one combination over another because the research was limited.

The Centers for Disease Control and Prevention (CDC), which determines vaccine recommendations, could issue more guidance on when and whether people should switch vaccine makers for their booster shots.

An advisory panel for the agency is meeting Thursday to discuss the new FDA authorizations and recommendations.

Once the panel makes its decision, the CDC director has the final say on the guidelines. If the agency agrees with the FDA’s decisions, the booster shots could be rolled out as soon as this weekend.

See what others are saying: (The New York Times) (NPR) (The Washington Post)

Continue Reading

U.S.

Paris Hilton Urges Lawmakers To Crack Down on Abusive Teen Treatment Facilities

Published

on

The heiress alleges that she was a victim of abuse in these types of centers for two years and wants to ensure that no child suffers through the same experience.


Paris Hilton Details Abuse Within “Troubled Teen Industry”

Socialite and entrepreneur Paris Hilton spoke outside of the U.S. Capitol on Wednesday to support the Accountability for Congregate Care Act, which is set to be introduced in the near future.

Hilton joined Rep. Ro Khanna (D-CA), Rep. Adam Schiff (D-CA), Rep. Rosa DeLauro (D-Conn.), and Sen. Jeff Merkley (D-Ore.) to advocate for the legislation, which aims to create a “bill of rights” for children in treatment and behavioral centers.

The heiress has alleged that she spent two of her teenage years in these types of facilities and was subject to rampant abuse. She is far from alone. 

During a press conference, Hilton said that one night when she was 16, she woke up to two large men in her bedroom forcing her out of her house. She said she screamed for help because she thought she was being kidnapped, but her parents watched as she was taken away to a “troubled teen” program. 

“Like countless other parents of teens, my parents had searched for solutions to my rebellious behavior,” she explained in an op-ed for The Washington Post this week. “Unfortunately, they fell for the misleading marketing of the ‘troubled teen industry’ — therapeutic boarding schools, military-style boot camps, juvenile justice facilities, behavior modification programs and other facilities that generate roughly $50 billion annually in part by pitching ‘tough love’ as the answer to problematic behavior.”

Hilton said she was sent to four different facilities where she was “physically and psychologically abused.” 

“I was strangled, slapped across the face, watched in the shower by male staff, called vulgar names, forced to take medication without a diagnosis, not given a proper education, thrown into solitary confinement in a room covered in scratch marks and smeared in blood and so much more,” she explained during the press conference. 

“At Provo Canyon School in Utah, I was given clothes with a number on the tag. I was no longer me, I was only number 127,” she continued. “I was forced to stay indoors for 11 months straight, no sunlight, no fresh air. These were considered privileges.”

Goals of the  Accountability for Congregate Care Act

Hilton claims that a lack of transparency and accountability has allowed this structure of abuse to thrive for decades. In some cases, she said it has taken children’s lives. Now, she wants Congress and President Joe Biden to act. 

“This bill creates an urgently needed bill of rights to ensure that every child placed into congregate care facilities is provided a safe and humane environment,” Hilton said of the Accountability for Congregate Care Act.

“This bill of rights provides protections that I wasn’t afforded, like access to education, to the outdoors, freedom from abusive treatment, and even the basic right to move and speak freely. If I had these rights and could have exercised them, I would have been saved from over 20 years of trauma and severe PTSD.” 

Foster children, children being treated for mental disorders, and other children in youth programs would be impacted by the bill.

Hilton was one of several survivors and advocates who fought for the legislation on Wednesday. Rep. Khanna thanked them for using their stories to fight for change. 

“No child should be subjected to solitary confinement, forced labor, or any form of institutional abuse,” he wrote. “Thanks to Paris Hilton, my colleagues & the survivors & advocates who joined us today to discuss how we can hold the congregate care industry accountable.”

While only Democratic legislators are currently sponsoring the bill, Hilton called for a bipartisan effort to fight for the rights of children. 

Ensuring that children are safe from institutional abuse isn’t a Republican or Democratic issue,” Hilton said. “It’s a basic human rights issue that requires immediate attention.”

See what others are saying: (The Washington Post) (The Hill) (NBC News)

Continue Reading

U.S.

Surgeons Successfully Test Pig Kidney Transplant on a Human

Published

on

The procedure has been hailed as a major scientific breakthrough that could eventually open the door to a renewable source of desperately needed organs.


Groundbreaking Procedure

Surgeons at the NYU Langone Transplant Institute revealed Tuesday that they temporarily attached a kidney from a genetically modified pig to a human patient and found that it worked normally.

The operation was the first of its kind and could one day lead to a vast supply of organs for those who are in severe need. According to the Associated Press, more than 90,000 people in the U.S. are in line for a kidney transplant. Each day, an average of 12 die while waiting.

With the family’s consent, the groundbreaking procedure was performed on a brain-dead patient who was kept alive on a ventilator.

According to the surgeons, the pig used was genetically engineered to grow an organ that wouldn’t produce a sugar that the human immune system attacks, which would then trigger the body to reject the kidney. 

The organ was connected to blood vessels on the patient’s upper leg, outside the abdomen, and it was observed for over 54 hours, with doctors finding no signs of rejection.

Concerns and Hurdles Ahead

While the procedure was successful, this doesn’t mean it’ll be available to patients anytime soon. Several questions about long-term functionality remain, and it will still have to go through significant medical and regulatory hurdles. 

Details of the procedure haven’t even been peer-reviewed or published in a medical journal yet, though there are plans for this. 

Experts are also considering the ethical implications of this type of animal-to-human transplant. For some, raising pigs to harvest their organs raises concerns about animal welfare and exploitation. Such medical procedures have already earned criticism from People for the Ethical Treatment of Animals, or PETA.

“Pigs aren’t spare parts and should never be used as such just because humans are too self-centered to donate their bodies to patients desperate for organ transplants,” PETA said in a statement, according to The New York Times.

On the other side of the debate are people like Dr. Robert Montgomery, the director of the N.Y.U. Langone Transplant Institute who performed the breakthrough procedure in September.

“I certainly understand the concern and what I would say is that currently about 40% of patients who are waiting for a transplant die before they receive one,” he told BBC.

“We use pigs as a source of food, we use pigs for medicinal uses – for valves, for medication. I think it’s not that different.”

See what others are saying: (CNN)(BBC) (The New York Times)

Continue Reading