FDA approves new type of non-opioid pain medication, 1st of its kind in more than 20 years
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(NEW YORK) — The U.S. Food and Drug Administration (FDA) on Thursday approved a new type of prescription pain medication for adults to treat moderate to severe acute pain.
The drug, called Journavx (suzetrigine) and manufactured by biotech company Vertex Pharmaceuticals, is a non-opioid painkiller, which doesn’t have addictive properties, unlike opioids often used for this type of pain.
This is the first class of non-opioid pain medication approved to treat moderate to severe acute pain approved by the FDA in more than 20 years.
“Today’s approval is an important public health milestone in acute pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
In two clinical trials, tested on adults between ages 18 and 80, Journavx was found to reduce moderate to severe acute pain for adults from baseline by about 50% in 48 hours.
The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group.
Journavx works by inhibiting the NaV1.8 pain signal in the peripheral nervous system. This channel is not expressed in the brain or anywhere else in the central nervous system, therefore the drug does not have addictive properties like opioids, according to Vertex.
Journavx was found to be as similarly effective as hydrocodone, an opioid pain medication, for reducing acute pain, with the added benefit of being a non-opioid and non-addictive drug.
In another clinical trial, the drug was tested in patients with a broader range of surgical and non-surgical acute pain conditions and was found to be safe and effective.
More than 80% of patients in this clinical trial rated Journavx as a good, very good or excellent pain medication when investigating multiple acute pain types.
The new drug “offers a safer option for managing moderate-to-severe acute pain, reducing reliance on opioids,” Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic, who was not involved in the clinical trials, told ABC News. “It offers rapid relief and can be integrated into postoperative pain protocols or acute pain scenarios where immediate relief is critical.”
“By managing acute pain effectively, [Journavx] may help prevent the transition to chronic pain, reducing the need for long-term pain management strategies,” he added.
Derek Crowe, a spokesman for the nonprofit People’s Action Institute, speaks with ABC News. (ABC News)
(NEW YORK) — Fury, anger and resentment toward the health care industry have exploded in the public rhetoric in the wake of UnitedHealthcare CEO Brian Thompson’s killing and one activist said that “volcanic” eruption of emotion has been boiling up for years.
People have been flooding social media posts with statements chastising UHC for its policies, bringing up times they were personally denied coverage or hit with huge bills for services.
In some instances, some users have even praised Thompson’s murder and the shooter, who is still on the lam and not been publicly identified as of Friday evening. UHC’s Facebook post memorializing Thompson was filled with “laughing” emojis and comments chastising the insurer before comments were shut off.
Derrick Crowe, a spokesman for the nonprofit People’s Action Institute, a social advocacy nonprofit that has protested UHC and other health care, told ABC News that he was horrified by Thompson’s shooting and offered his condolences to his loved ones.
However, he noted the anger online has been a long time coming.
“I think the reason that anger was pent up and it came out in such a volcanic way is that corporations have too much power in this country and they’re standing in the way of dealing with two big epidemics,” he told ABC News. “One is the epidemic of gun violence, which we saw an example of in Manhattan, and one is an epidemic of care denials across the country.”
Crowe said more than 250 million health claims are denied annually by health insurance companies. He claimed the UHC “by far leads the clear care denials of people’s claims when they’re seeking health care.”
He cited examples such as patients claiming they were denied coverage for a congenital defect or infant care.
“Many of the folks that we’ve talked to have had personal stories of needing acute health care quickly and have found that this company has been standing in their way,” he said.
When asked by ABC News about the increase in rhetoric against the healthcare industry following the shooting, a UHC spokesperson deferred to its latest statement about Thompson’s killing.
“While our hearts are broken, we have been touched by the huge outpouring of kindness and support in the hours since this horrific crime took place. So many patients, consumers, health care professionals, associations, government officials and other caring people have taken time out of their day to reach out. We are thankful, even as we grieve,” the statement said.
“Our priorities are, first and foremost, supporting Brian’s family; ensuring the safety of our employees; and working with law enforcement to bring the perpetrator to justice. We, at UnitedHealth Group, will continue to be there for those who depend upon us for their health care. We ask that everyone respect the family’s privacy as they mourn the loss of their husband, father, brother and friend,” the statement continued.
In the past, protests have been held against UHC in Minneapolis, where its headquarters are based, including one back in July.
Crowe said that his organization has led many movements to call out the insurance companies for their practices.
“The purpose of that action was to draw attention to the epidemic of claims, denials and care denials across the country, and to bring people who have had their health care directly affected by a care denial by this corporation to the place where the denial is coming from, and to demand that they stop putting profits over people’s lives,” he said.
Crowe reiterated that his group only supports non-violent and peaceful means of protesting the industry and condemned Thompson’s murder. However, he reiterated that the fight against greed in the health insurance industry needs to continue.
“We believe that in keeping with the principles behind the First Amendment, that there are democratic, powerful, nonviolent ways that we can take that private pain and turn it into public power when we bring people together. And we’re going to continue to do that. And we think that’s an essential part of making change in our democracy,” he said.
(NEW YORK) — The Mediterranean diet — which emphasizes fruits, vegetables, lean proteins and whole grains — has once again topped U.S. News and World Report’s annual ranking of best diets.
The publication on Friday named the diet the best overall diet for the eighth year in a row.
The Mediterranean diet scored a 4.8 out of 5 based on an evaluation of several factors, including nutritional completeness, health risks and benefits, long-term sustainability and evidence-based effectiveness, according to U.S. News and World Report.
The diet also scored the top spot in 11 additional categories in the publication’s annual rankings, including easiest-to-follow, gut health, weight loss and mental health.
The DASH (Dietary Approaches to Stop Hypertension), which focuses on whole foods and low sodium, was ranked second on the Best Diets list, followed by the Flexitarian, MIND and Mayo diets. All of the top five diets embrace a plant-forward philosophy, minimizing the intake of red meats, processed foods, inflammatory fats, high-sugar foods and sugar-sweetened beverages, rather than enforcing strict rules or banning entire food groups.
If you’re looking to start the Mediterranean diet, here is what you need to know.
What is the Mediterranean diet?
The Mediterranean diet is not one way of eating but a broad term used to describe the eating habits popularized in the countries bordering the Mediterranean Sea including Italy, Greece, Morocco, Spain and Lebanon.
The way of eating focuses on the quality of foods consumed rather than focusing on a single nutrient or food group, according to U.S. News and World Report.
Nutrition experts say there’s no one diet that will work for everyone. Certain diets may be more beneficial depending on your circumstances, and some may be harmful depending on your health conditions. Anyone considering changes to their diet should consult with their doctor.
What types of foods are eaten on the Mediterranean diet?
Overall, the diet is mostly plant-based and focuses on healthy fats.
Healthy fats emphasized in the Mediterranean diet include extra virgin olive oil, avocados, nuts, salmon and sardines, according to the American Heart Association.
All types of vegetables and fruits are encouraged on the diet, as are non-meat sources of protein like beans and other legumes.
Fish is encouraged at least twice weekly and other animal proteins like poultry, eggs, cheese and yogurt are encouraged in smaller portions. Red meat consumption is should be limited to a few times a month.
The main source of hydration should be water.
Are any foods prohibited?
No, the Mediterranean diet does not totally eliminate any foods or food groups.
However, it is recommended to limit foods such as butter, processed foods like frozen meals and candy, and refined grains and oils. Fruits are encouraged for dessert over sugary sweets.
U.S. News and World Report describes the diet as leaving “little room for the saturated fat, added sugars and sodium that inundate the standard American diet.”
What are the health benefits?
According to U.S. News and World Report, “People who eat a Mediterranean-style diet have longer lifespans, report a higher quality of life and are less likely to suffer from chronic diseases such as cancer and heart disease.”
In a study of over 60,000 people, those who followed the Mediterranean diet more closely had a lower risk of dementia, regardless of genetic risk.
The American Heart Association says the Mediterranean diet can “play a big role” in preventing heart disease and stroke and reducing risk factors like diabetes, high cholesterol and high blood pressure. Consuming virgin olive oil, in particular, may help the body “remove excess cholesterol from arteries and keep blood vessels open,” according to the AHA.
Citing research, the Mayo Clinic touts the Mediterranean diet as a way to help maintain a healthy weight, improve brain health, increase longevity, support a healthy gut and lower the risk of certain cancers.
Dr. Brent Gawey, a member of the ABC News Medical Unit, contributed to this report.
LW, who asked not to show her face, is a 16-year-old transgender teenager challenging Tennessee’s ban on gender-affirming medical treatments that have improved her quality of life. (ABC News)
(WASHINGTON) — Medical treatments for transgender children, endorsed by major American medical associations and safely used for decades, hang in the balance at the U.S. Supreme Court on Wednesday as the Biden administration and three families with transgender teenagers ask the justices to strike down a state law banning some gender-affirming care for kids.
The landmark case — U.S. v. Skrmetti — comes from Tennessee, which is among 26 states that have moved to prohibit administration of puberty-blocking medication and hormone therapy to minors who seek to identify with, or live as, a gender identity inconsistent with his or her sex at birth.
Oral arguments mark the first time the nation’s highest court has openly considered a state law targeting transgender people. It is also the first time an openly transgender litigator, ACLU attorney Chase Strangio, will argue a case in the Supreme Court chamber.
The historic hearing thrusts the justices to the forefront of a cultural debate that has sharply divided the country and tested the limits of science and parental rights.
The outcome of the case could determine access to health care for hundreds of thousands of trans teens and more broadly influence how communities treat transgender people in hospitals, schools and on sports fields.
The government argues that Tennessee’s SB1, which was enacted in March 2023, violates the Constitution’s Equal Protection clause because it discriminates on the basis of sex to decide who can receive otherwise legal medical treatments available to youth.
“Put simply, an adolescent assigned female at birth cannot receive puberty blockers or testosterone to live as a male, but an adolescent assigned male at birth can,” the administration wrote in its brief to the court.
The Tennessee law expressly allows minors who are not transgender to receive gender-affirming treatments to address a “congenital defect, precocious puberty, disease, or physical injury.”
Denying discrimination, the state argues its law is a reasonable regulation of medical treatment based on its purpose, meant to protect children from potential long-term health risks and possible irreversible changes to the body.
The law’s Republican sponsors claim that contradictory scientific evidence and documented regret among some young people who have transitioned both warrant caution in developing standards of care.
The law also cites a “compelling interest in encouraging minors to appreciate their sex, particularly as they undergo puberty” and preventing them from becoming “disdainful of their sex.” The government says the text proves an intent to enforce gender conformity.
Hundreds of Tennessee transgender children were receiving treatments before SB1 was enacted, legislators concluded. It is not known how many suffered alleged harm.
The plaintiffs in the case include 16-year-old LW and her parents Brian and Samantha Williams of Nashville. After several years of successful hormone therapy, LW now has to travel out of state to continue treatments she says have dramatically improved her quality of life.
“I feel normal now,” LW said in an exclusive interview with ABC News last month.
“Our state legislature had made such a big deal out of parents rights during COVID, about masks and vaccines — that that’s for parents to decide these medical decisions for their children,” noted Samantha Williams. “And then, they made this medical decision for our child.”
Nationwide, an estimated 300,000 Americans ages 13 to 17 identify as transgender, according to the Williams Institute at UCLA School of Law. Of those, nearly 100,000 live in states that have banned access to gender-affirming medical treatments for minors.
“It’s a case of enormous significance that presents fundamental questions about the scope of state power to regulate medical care for minors, of the rights of parents to make medical decisions for their children… and the level of scrutiny that courts should apply to laws that discriminate against transgender people in general,” said Deepak Gutpa, a veteran Supreme Court litigator. “This is a major, major constitutional civil rights issue.”
More than 60% of Americans say they oppose law banning certain types of gender-affirming medical treatment for minors, according to Gallup.
Major American medical associations have endorsed the treatments for more than a decade as part of “individually tailored interventions” to support trans kids and affirm their sense of self. Not all transgender children seek medical care to facilitate transition to another sex.
“It needs to be part of a very deliberate process that involves medical specialists, who are expert at doing this, and, again, are following the science,” said Dr. Ben Hoffman, a pediatrician and president of the American Academy of Pediatrics. “It all begins and ends with science. This is not about any sort of agenda.”
Clinical practice guidelines from the American Endocrine Society, based on more than 260 research studies, recommend the use of puberty-delaying medications and waiting until a child reaches adulthood to consider gender-affirming surgery.
The American Academy of Pediatrics says the effects of puberty blockers are not permanent if treatment is discontinued. Many effects of hormone therapy can also be reversed. Long-term risks may include fertility challenges and possible harm to bone density, but the group says those risks require further study.
In contrast to the U.S. medical establishment, several European countries, including the United Kingdom, have reversed course on the use of gender-affirming treatments as a standard-of-care for transgender children, citing insufficient scientific evidence of long-term benefits.
“When you look at the totality of the medical research, to me there is more than enough uncertainty and evidence of bad outcomes for kids who’ve gone through these treatments when they reach the later stages in life,” said Tennessee Senate GOP Leader Jack Johnson.
A federal district court sided with the plaintiffs, temporarily halting enforcement of SB1, but the Sixth Circuit U.S. Court of Appeals reversed. The panel of judges concluded Tennessee had a rational basis for enacting the law.
“Kind of the whole ballgame in the case is the debate about whether there actually is discrimination on the basis of sex,” said Erin Murphy, a Supreme Court litigator and former clerk to Chief Justice John Roberts.
“It’s really not,” Murphy argued. “To say providing testosterone to a biological boy and biological girl is the same thing because testosterone is involved — it’s a different treatment that has different risks.”
David Cole, former legal director of the American Civil Liberties Union, which is representing the Williams family, says the court’s conservative majority will have to confront the legacy of its decision.
“I think there’s no question in 25 years that the court will have recognized that treating people differently because their gender identity is sex discrimination,” Cole said.
“The question is whether the court wants to write a decision will be overturned, you know, in the course of the next 10 years or 15 years,” he said, “or whether it wants to recognize what is going on, which is sex discrimination.”
A decision in the case is expected by the end of June 2025.
