Tag: Medication

Nobel in medicine goes to scientists whose work led to mRNA vaccines against COVID

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STOCKHOLM — Two scientists won the Nobel Prize in medicine on Monday for discoveries that enabled the creation of mRNA vaccines against COVID-19 that were critical in slowing the pandemic and whose technology could be used in the future to develop shots against non-infectious diseases like cancer.

Hungarian-American Katalin Karikó and American Drew Weissman were cited for contributing “to the unprecedented rate of vaccine development during one of the greatest threats to human health,” according to the panel that awarded the prize in Stockholm.

The panel said the pair’s “groundbreaking findings … fundamentally changed our understanding of how mRNA interacts with our immune system.”

Traditionally, making vaccines required growing viruses or pieces of viruses and then purifying them before next steps. T he messenger RNA approach starts with a snippet of genetic code carrying instructions for making proteins. Pick the right virus protein to target, and the body turns into a mini vaccine factory.

But simply injecting lab-grown mRNA into the body triggered a reaction that usually destroyed it. Karikó, a professor at Szeged University in Hungary and an adjunct professor at the University of Pennsylvania, and Weissman, of the University of Pennsylvania, figured out a tiny modification to the building blocks of RNA that made it stealthy enough to slip past immune defenses.

Karikó, 68, is the 13th woman to win the Nobel Prize in medicine. She was a senior vice president at BioNTech, which partnered with Pfizer to make one of the COVID-19 vaccines. Kariko and Weissman, 64, met by chance in the 1990s while photocopying research papers, Kariko told The Associated Press.

Dr. Paul Hunter, a professor of medicine at Britain’s University of East Anglia, described the mRNA vaccines made by BioNTech-Pfizer and Moderna Inc. as a “game changer” in shutting down the coronavirus pandemic, crediting the shots with saving millions of lives.

“We would likely only now be coming out of the depths of COVID without the mRNA vaccines,” Hunter said.

Dr. Bharat Pankhania, an infectious diseases expert at Exeter University, predicted the technology used in the vaccines could be used to refine vaccines for other diseases like Ebola, malaria and dengue, and might also be used to create shots that immunize people against certain types of cancer or auto-immune diseases including lupus.

Peter Maybarduk, at the Washington advocacy group Public Citizen, welcomed the recognition of mRNA vaccines, but said the award should also be deeply embarrassing for Western countries.

“This is a technology that should have been available to all of humanity but it was almost exclusively available only in the richest countries in the world,” he said, adding that much of the funding that led to the development of mRNA technology came from U.S. public funds.

“The future is just so incredible,” Weissman said. “We’ve been thinking for years about everything that we could do with RNA, and now it’s here.”

Karikó said her husband was the first to pick up the early morning call, handing it to her to hear the news. She then watched the announcement to make sure she wasn’t being pranked.

“I was very much surprised. But I am very happy.”

Kariko said she was the one to break the news to Weissman, since she got in touch before the Nobel committee could reach him.

The two have collaborated for decades, with Kariko focusing on the RNA side and Weissman handling the immunology: “We educated each other,” she said.

Before COVID-19, mRNA vaccines were already being tested for other diseases like Zika, influenza and rabies — but the pandemic brought more attention to this approach, Karikó said.

“There was already clinical trials before COVID, but people were not aware,” she said.

Karikó’s family are no strangers to high honors. Her daughter, Susan Francia, is a double Olympic gold medalist in rowing, competing for the United States.

The prize carries a cash award of 11 million Swedish kronor ($1 million) — from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel. The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death.

Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the economics award on Oct. 9.

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This story has been updated to correct that Karikó is a professor at Szeged University, not Sagan’s University.

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Corder reported from The Hague, Netherlands. Associated Press writers Maria Cheng in London, Maddie Burakoff in New York and Lauran Neergaard in Washington contributed to this report.

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Follow all AP stories about the Nobel Prizes at https://apnews.com/hub/nobel-prizes

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October 2, 2023
What to know as fall vaccinations against COVID, flu and RSV get underway

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WASHINGTON — Updated COVID-19 vaccines may be getting a little easier for adults to find but they’re still frustratingly scarce for young children. Health officials said Thursday the kid shots have started shipping — and reminded most everyone to get a fall flu shot too.

About 2 million Americans have gotten the new COVID-19 shot in the two weeks since its approval despite early barriers from insurance companies and other glitches, according to the Department of Health and Human Services.

For the first time, the U.S. has vaccines to fight a trio of viruses that cause fall and winter misery. But health officials worry that shot fatigue and hassles in getting them will leave too many people needlessly unprotected.

“We need to use them,” Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention, said Thursday. “Right now is the right time.”

A flu vaccination and that updated COVID-19 shot are urged for just about everyone, starting with babies as young as 6 months.

Also this year, a vaccine against another scary virus called RSV is recommended for people 60 and older and for certain pregnant women. And for babies, a vaccinelike medicine to guard against that respiratory syncytial virus is expected to arrive next month.

“These vaccines may not be perfect in being able to prevent absolutely every infection with these illnesses, but they turn a wild infection into a milder one,” said Dr. William Schaffner of Vanderbilt University and the National Foundation for Infectious Diseases.

Some things to know:

This year’s vaccine is updated to protect against newer versions of the constantly evolving coronavirus. Already there’s been a late summer jump in infections, hospitalizations and deaths. And so far the new vaccine recipe appears to be a good match to the variants currently circulating.

Protection against COVID-19, whether from vaccination or from an earlier infection, wanes over time — and most Americans haven’t had a vaccine dose in about a year. Everyone 5 and older will need just one shot this fall even if they’ve never had a prior vaccination, while younger children may need additional doses depending on their vaccination and infection history.

The rollout’s start has been messy. This time the government isn’t buying and distributing shots for free. Now drugstores, doctors’ offices and other providers had to place their own orders, and sometimes canceled appointments if supplies didn’t arrive in time. Some people had to wait for their insurance companies to update the billing codes needed to cover them or risk paying out of pocket.

Manufacturers Pfizer and Moderna have shipped millions of doses, and say there’s plenty of supply — and in recent days, more appointments have started opening, at least for people 12 and older. In a Wednesday meeting, insurance companies told HHS Secretary Xavier Becerra they’ve largely resolved the paperwork issues blocking some patients’ vaccinations.

The shots are supposed to be provided free in-network to the insured. For the uninsured or underinsured, CDC has opened what it’s calling a “bridge” program to provide free shots at certain sites.

Adult doses got shipped first, CDC’s Cohen said. Doses for the under-12 set have begun shipping, and “the supply is filling out,” she said.

Drugstore chain CVS said its doses for ages 5 and older began arriving last week, although supplies vary by location, while its MinuteClinic locations anticipate opening appointments for tots as young as 18 months in the coming days.

As for pediatricians, they’ve had to guess how many doses to buy up-front while waiting to learn how much insurance companies would reimburse them for each shot, said Dr. Jesse Hackell of the American Academy of Pediatrics. He said early parent demand is heartening but that pediatricians expect to spend lots of time this fall explaining to hesitant families how important COVID-19 vaccination is even for healthy children.

In Redmond, Washington, Ania Mitros got herself, her husband and her 13-year-old vaccinated pretty easily but despite calls to multiple pharmacies and clinics can’t find anyone to tell her when shots for her 8- and 11-year-old will be available. “There need to be clear expectations,” she said.

Fewer Americans got a flu vaccine last year than before the coronavirus pandemic –- a discouraging gap that CDC hopes to reverse.

People need a flu vaccine every fall because influenza also mutates each year. Like with COVID-19, flu is most dangerous to older adults, the very young and people with weak immune systems, lung, heart or other chronic health problems, or who are pregnant.

There are multiple kinds of flu vaccines, including a nasal spray version for certain younger people. More important, three kinds are specifically recommended for seniors because they do a better job revving up an older adult’s immune system.

Yes, although one in each arm might be more comfortable.

RSV is a cold-like nuisance for most people, and not as well-known as the flu. But RSV packs hospitals every winter and kills several hundred tots and thousands of seniors. The CDC says already, RSV cases are rising in the Southeast.

RSV vaccines from GSK and Pfizer are approved for adults 60 and older.

Drugstores have adequate supplies but some seniors are reporting hurdles such as requirements to get a prescription. That’s because the CDC recommended that seniors talk with their doctors about the new vaccine. Cohen said it was meant just for education about a virus that people may not know much about.

“We want folks to … get access to the vaccine as quickly as possible,” she said.

The FDA also has approved Pfizer’s RSV vaccine to be given late in pregnancy so moms-to-be pass virus-fighting antibodies to their fetuses, offering some protection at birth. The CDC is recommending that pregnancy vaccinations be offered between September and January, when RSV tends to be most common.

There’s no vaccine for children but babies whose mothers didn’t get vaccinated in pregnancy may get an injection of lab-made antibodies to guard against RSV. Called Beyfortus, the one-dose shot from Sanofi and AstraZeneca is different than a vaccine, which teaches the body to make its own infection-fighting antibodies, but is similarly protective. Cohen said it should be available in October.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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September 28, 2023
CVS responds quickly after pharmacists frustrated with their workload miss work

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CVS pharmacists are experiencing a lot of pain on the job these days.

The company found the right prescription on Wednesday to keep its stores open in the Kansas City area and avoid a repeat of last week’s work stoppage. It promised to boost hiring to ease overwhelming workloads that sometimes make it hard to take a bathroom break and may have brought in additional help from other cities.

But it won’t be easy to resolve the bigger problems that have been growing as pharmacists at CVS and other drug stories in the U.S. took on more duties in recent years and are gearing up to deliver this year’s latest flu and COVID-19 vaccines.

“It all relates to not enough dollars going in to hire the appropriate staff to be able to deliver the services,” said Ron Fitzwater, CEO of the Missouri Pharmacy Association.

Pharmacists in at least a dozen Kansas City-area CVS pharmacies did not show up for work last Thursday and Friday and planned to be out again this Wednesday until the company sent its chief pharmacy officer with promises to fill open positions and increasing staffing levels.

It was one of the latest examples nationwide of workers fed up enough to take action. But unlike in the ongoing strikes at the automakers or in Hollywood, the pharmacists weren’t demanding raises or more vacation, but more workers to help them.

CVS spokeswoman Amy Thibault said the company is “focused on addressing the concerns raised by our pharmacists so we can continue to deliver the high-quality care our patients depend on.”

Chief Pharmacy Officer Prem Shah apologized for not addressing concerns sooner in a memo to Kansas City-area staff that was obtained by USA Today. He promised to remain in the city until the problems are addressed and come back regularly to check on the progress.

“We want you, our valued pharmacy teams, to be in a position to succeed. We are working hard to support you and are here to help and create sustainable solutions,” Shah said as he encouraged the pharmacists to continue to share their concerns even anonymously.

It’s unclear why workload concerns that are common industrywide led to a walkout in Kansas City. The pharmacists involved haven’t spoken publicly.

At stores where there is only one pharmacist on duty, the pharmacy has to shut down every time that person leaves the area because a pharmacist must be there to supervise technicians in their work.

The American Pharmacists Association said in a statement that it supports the stand the Kansas City pharmacists took.

“Pharmacists who find themselves in situations where the welfare of others is in question should always pause, evaluate the situation, and take the steps necessary to ensure safe, optimal patient care,” the group said.

CVS Health has about 300,000 employees and runs prescription drug plans through one of the nation’s largest pharmacy benefits managers. Its Aetna insurance arm covers more than 25 million people, and the company has nearly 10,000 drugstores.

The company said last month that operating income at its drugstores fell 17% as reimbursement rates from patient’s insurance providers for drugs remained tight. CVS eliminated about 5,000 jobs, but company officials said none of those involved dealing with customers.

Amanda Applegate with the Kansas Pharmacists Association said pharmacists have always had a lot on their plate.

“When we are not valued as health care professionals, it doesn’t allow the job that needs to be done to be done,” she said. “And that’s keeping you know, patients safe — right drug, right patient, right time, right dose.”

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Associated Press reporter Heather Hollingsworth contributed to this report from Mission, Kan., and Summer Ballentine contributed from Columbia, Mo.

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September 27, 2023
Scottish officials approve UK’s first drug consumption room intended for safer use of illegal drugs

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LONDON — Scottish authorities on Wednesday approved a 2.3 million-pound ($2.8 million) pound drug consumption room, the first government-backed place in the U.K. where users can take illegal drugs such as cocaine and heroin under the supervision of medical staff.

Local officials in the Scottish city of Glasgow on Wednesday approved the facility, which had long been delayed by political disagreements. Authorities hope the pilot project will help tackle drug misuse problems in Scotland, which has the highest drug death figures in Western Europe and saw almost three times the rate of drug poisoning deaths compared to the U.K. average in 2021.

The facility, which will start recruiting staff next year, was first proposed in 2016 following an HIV outbreak in Glasgow among people who injected drugs in public places. It’s backed by the Scottish government, although some lawmakers have raised concerns about the impact on local residents and businesses.

Proponents, including Scotland’s drug and alcohol policy minister Elena Whitham, say evidence from more than 100 similar facilities worldwide, including in Germany and the Netherlands, show they work to save lives and reduce overall costs to health services.

The center will be staffed by trained health care professionals and offer a hygienic environment where people can consume drugs they obtained elsewhere.

Officials say people can’t share drugs with others in the facility, and that health and social workers at the center will offer advice and support on recovery and welfare. They added that the center doesn’t encourage drug use but promotes harm reduction and reduces overdoses.

In a report, Glasgow officials, including health professionals, said there was “overwhelming international evidence” that such facilities reduce the negative impact of drug use in public spaces, in particular the risk of infection and risks to the public from discarded needles.

It said that following the 2016 HIV outbreak, an assessment found there were “approximately 400 to 500 people injecting drugs in public places in Glasgow city centre on a regular basis.”

Official figures for last year showed that 1,051 people died in Scotland because of drug misuse, a decrease compared to recent years but still far higher than the rest of the U.K. and most places in Europe. The city of Glasgow had the worst problem, with 44 such deaths per 100,000 people.

Whitham said Scotland’s government has committed 2.35 million pounds a year from 2024 to fund the pilot facility.

Scotland’s devolved government makes it own policy decisions on matters such as health and education. The U.K.-wide government in London has previously said it does not support such facilities in England and Wales, citing concerns that they condone or encourage drug use.

The Scottish government, which often taken more liberal positions on social issues than the Conservative administration in London, has proposed decriminalizing possession of all drugs for personal use. But that suggestion was blocked by the U.K. government in London, which said it had no plans to soften drug laws.

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September 27, 2023
After US approval, Japan OKs Leqembi, its first Alzheimer’s drug, developed by Eisai and Biogen

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Japan’s health ministry has approved Leqembi, a drug for Alzheimer’s decease that was jointly developed by Japanese and U.S. pharmaceutical companies

ByMARI YAMAGUCHI Associated Press

September 26, 2023, 2:18 AM

TOKYO — Japan’s health ministry has approved Leqembi, a drug for Alzheimer’s disease that was jointly developed by Japanese and U.S. pharmaceutical companies. It’s the first drug for treatment of the disease in a country with a rapidly aging population.

Developed by Japanese drugmaker Eisai Co. and U.S. biotechnology firm Biogen Inc., the drug’s approval in Japan comes two months after it was endorsed by the U.S. Food and Drug Administration.

Leqembi is for patients with mild dementia and other symptoms in the early stages of Alzheimer’s disease, and the first medicine that can modestly slow their cognitive decline.

Prime Minister Fumio Kishida, who announced Japan’s approval of Leqembi on Monday, called it “a breakthrough” and said that the “treatment of dementia has now entered a new era.”

Kishida has pledged to step up support for the growing number of dementia patients and their families and is due to launch a panel this week to discuss measures for a dementia-friendly society.

According to the health ministry, Japan’s number of dementia patients who are 65 years of age or older will rise to 7 million in 2025, from the current 6 million.

The drug, however, does not work for everyone and — as with other Alzheimer’s drugs that target plaques in the brain — can cause dangerous side effects such as brain swelling and bleeding in rare cases.

Eisai said it will conduct a post-marketing special use survey in all patients administered the drug until enough data is collected from unspecified number of patients under Japanese health ministry procedures.

The drug will be partially covered by health insurance and is expected to be ready for clinical use by the end of the year. The price is yet to be decided but is expected to be expensive, Kyodo News agency reported.

Eisai is committed to delivering Leqembi to people who need it and their families “as a new treatment,” said Haruo Naito, the company’s CEO.

“We aim to create impact on issues surrounding dementia in Japanese society,” he said.

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September 25, 2023
Tornado-damaged Pfizer plant in North Carolina restarts production

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A major Pfizer pharmaceutical plant has restarted production, 10 weeks after it was heavily damaged by a tornado

ByThe Associated Press

September 25, 2023, 1:12 PM

ROCKY MOUNT, N.C. — A major Pfizer pharmaceutical plant in North Carolina that makes critical supplies for U.S. hospitals has restarted production about 10 weeks after it was heavily damaged by a tornado, the company announced Monday.

Getting a majority of manufacturing lines at the Rocky Mount facility back up and running is a “proud achievement,” Pfizer said in a statement. Full production across the facility’s three manufacturing sites is expected by the end of the year.

Parts of the massive plant’s roofs were ripped open and pallets of medicine tossed around when the tornado touched down on July 19. But most of the damage was to a storage facility for raw materials, packaging supplies and finished medicines, rather than its medicine production areas, Pfizer said. No employees were hurt.

The plant produces anesthesia and other drugs as well as nearly one-fourth of the sterile injectable medications Pfizer supplies to U.S. hospitals, the company said.

Thirteen medicines were prioritized based on patient need and inventory levels, and are now back in production on the lines that have restarted, Pfizer said. The medicines are expected to ship to distribution centers in the fourth quarter of this year. Although manufacturing has resumed, the company said some medicines may not be back in full supply until next year.

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September 25, 2023
RSV vaccine recommended during pregnancy as a second option to protect newborns

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NEW YORK — U.S. health officials on Friday recommended RSV vaccinations for moms-to-be, a second new option to protect newborns from serious lung infections.

The shots should be given late in pregnancy but only during RSV season, the Centers for Disease Control and Prevention said.

“This is another new tool we can use this fall and winter to help protect lives,” said CDC Director Dr. Mandy Cohen in a statement.

Cohen signed off after a CDC advisory panel backed the vaccine. The only opposition came from a panel member who found the recommendation “incredibly complicated.”

A month ago, the agency recommended another option for infants to guard against severe RSV: lab-made antibodies given to babies younger than 8 months before their first RSV season. A single dose is given to babies by injection after they are born.

Most infants will likely only need protection from one — either the mom’s vaccine or the antibodies — but not both, Cohen said.

There is no head-to-head study that answers which is more effective, and no published research on how safe it is to give both. And they are both expensive, although the cost will be ultimately covered by insurance.

The RSV vaccine, made by Pfizer, should only be given between 32 weeks and 36 weeks of pregnancy. The shot prompts the moms-to-be to develop virus-fighting antibodies that pass through the placenta to the fetus. Protection in newborns likely drops after 6 months of age, so the shot is for use between September and January in most of the U.S., to coincide with the time of year when RSV infections tend to be most common.

A baby born in April, for example, may not have much immunity left from the mother’s vaccination by the time the fall RSV season comes around.

“It really depends on when the due date is as to how impactful this vaccination will be,” said Dr. Grace Lee, chair of the CDC advisory panel.

RSV, or respiratory syncytial virus, is a common cause of coldlike symptoms. A surge last year filled hospitals with wheezing children, but far more U.S. seniors are hospitalized and die from the virus.

Two new vaccines were recently approved for Americans age 60 and older. There isn’t a vaccine for children.

Some CDC panel members who ultimately supported the recommendation expressed reservations. Available data suggests the antibodies are a more cost-effective — and probably longer-lasting — way to prevent severe illness in infants. Several also balked at the $295-a-dose price Pfizer has been charging for the same RSV vaccine for seniors, called Abrysvo.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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September 22, 2023
California sues anti-abortion organizations for unproven treatment

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California Attorney General Rob Bonta has sued an anti-abortion group and a chain of anti-abortion counseling centers, saying the organizations misled women when they offered them unproven treatments to reverse medication abortions

ByOLGA R. RODRIGUEZ Associated Press

September 21, 2023, 3:36 PM

SAN FRANCISCO — California Attorney General Rob Bonta on Thursday sued an anti-abortion group and a chain of anti-abortion counseling centers, saying the organizations misled women when they offered them unproven treatments to reverse medication abortions.

Heartbeat International, a national anti-abortion group, and RealOptions Obria, which has five anti-abortion counseling centers in Northern California, used “fraudulent and misleading claims to advertise a procedure called abortion pill reversal, according to the lawsuit. Abortion pill reversal treatments are unproven, largely experimental and have no scientific backing, Bonta said in the lawsuit.

“Those who are struggling with the complex decision to get an abortion deserve support and trustworthy guidance — not lies and misinformation,” Bonta said.

Heartbeat International and RealOptions’ deceptive advertising of abortion pill reversal treatments violates California’s False Advertising Law and Unfair Competition Law, the lawsuit said. The lawsuit seeks an injunction to block further dissemination of the claims by the defendants, as well as other remedies and penalties available under state law, according to Bonta’s office.

Despite the lack of scientific evidence and lack of certainty about its safety, Heartbeat International and RealOptions falsely and illegally advertise the treatment as a valid and successful option, and do not alert patients to possible side effects, such as the risk of severe bleeding, the lawsuit said.

The companies did not immediately respond to email and phone messages from The Associated Press seeking comment.

RealOptions has “crisis pregnancy centers” in San Jose, Oakland, Redwood City and Union City. The anti-abortion centers’ aim is to dissuade people from getting an abortion.

Medication abortions involve taking two prescription medicines days apart — at home or in a clinic. The method, which involves mifepristone and misoprostol, became the preferred way for ending pregnancy in the country even before the U.S. Supreme Court overturned Roe v. Wade last year.

Advocates of abortion pill reversal treatments claim that if a pregnant person takes high doses of the hormone progesterone within 72 hours of taking the first drug — mifepristone — it will safely and effectively cancel the effects of the mifepristone.

The American College of Obstetricians and Gynecologists says so-called abortion “reversal” procedures are unproven and unethical.

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September 21, 2023
Psychedelic drug MDMA eases PTSD symptoms in a study that paves the way for possible US approval

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The psychedelic drug MDMA can reduce symptoms of post-traumatic stress disorder, researchers reported in a new study published Thursday.

The company sponsoring the research said it plans later this year to seek U.S. approval to market the drug, also known as ecstasy, as a PTSD treatment when combined with talk therapy.

“It’s the first innovation in PTSD treatment in more than two decades. And it’s significant because I think it will also open up other innovation,” said Amy Emerson, CEO of MAPS Public Benefit Corporation, the research sponsor.

Earlier this year, Australia became the first country to allow psychiatrists to prescribe MDMA and psilocybin, the psychoactive ingredient in psychedelic mushrooms. The drugs are gaining wider cultural acceptance in the U.S. in part because of efforts by the nonprofit advocacy group Multidisciplinary Association for Psychedelic Studies.

For the new study, researchers measured symptoms in 104 people with PTSD who were randomly assigned to get either MDMA or a dummy pill during three sessions, one month apart. Both groups received talk therapy.

Common side effects in the MDMA group were muscle tightness, nausea, decreased appetite and sweating. But only one person in the MDMA group dropped out of the study.

After treatment, 86% of the MDMA group improved on a standard PTSD assessment compared to 69% of the placebo group. The assessment measures symptoms such as nightmares, flashbacks and insomnia.

By the study’s end, 72% of people in the MDMA group no longer met the diagnostic criteria for PTSD, compared to about 48% of the placebo group.

“The results that they got are very exciting,” said Barbara Rothbaum, who directs the Emory Healthcare Veterans Program in Atlanta. She was not involved in the research, which was published in the journal Nature Medicine.

PTSD also can be treated with other medications or talk therapy.

“They are very effective, but nothing is 100% effective,” Rothbaum said. “So we absolutely need more options for treatment.”

Before MDMA could be prescribed in the U.S., the Food and Drug Administration would need to approve it and the Drug Enforcement Administration would need to change its classification. MDMA is currently classified as Schedule 1, on par with heroin and deemed to have “no currently accepted medical use and a high potential for abuse.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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September 14, 2023
Popular nasal decongestant doesn’t actually relieve congestion, FDA advisers say

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WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.

The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.

Those original versions of Sudafed and other medicines remain available without a prescription, but they’re less popular and account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled “PE” on packaging — make up the rest.

If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.

In that scenario, the FDA would have to work with drugstores, pharmacists and other health providers to educate consumers about the remaining options for treating congestion, panelists said Tuesday.

The group also told the FDA that studying phenylephrine at higher doses was not an option because it can push blood pressure to potentially dangerous levels.

“I think there’s a safety issue there,” said Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think this is a done deal as far as I’m concerned. It doesn’t work.”

This week’s two-day meeting was prompted by University of Florida researchers who petitioned the FDA to remove most phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.

That was also the recommendation of FDA’s outside experts at the time, who met for a similar meeting on the drug in 2007.

This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn’t show a benefit for the drug.

“I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel. “Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.”

The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week’s meeting, which found numerous flaws in the 1960s and 1970s studies that supported phenylephrine’s original approval. The studies were “extremely small” and used statistical and research techniques no longer accepted by the agency, regulators said.

“The bottom line is that none of the original studies stand up to modern standards of study design or conduct,” said Dr. Peter Starke, the agency’s lead medical reviewer.

Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.

A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have “easy access” to phenylephrine.

Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into approval during a sweeping FDA review begun in 1972. It has been sold in various forms for more than 75 years, predating the agency’s own regulations on drug effectiveness.

“Any time a product has been on the market that long, it’s human nature to make assumptions about what we think we know about the product,” said Dr. Theresa Michele, who leads the FDA’s office of nonprescription drugs.

But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays or drops, and those products are not under review.

There’s unlikely to be any immediate impact from Tuesday’s panel vote, which is not binding.

The group’s negative opinion opens the door for the FDA to pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids. The FDA said removing the products would eliminate “unnecessary costs and delay in care of taking a drug that has no benefit.”

The FDA’s nasal decongestants drug list, or monograph, has not been updated since 1995. The process for changing a monograph has traditionally taken years or decades, requiring multiple rounds of review and public comment. But a 2020 law passed by Congress streamlines the process, which should allow the FDA to accelerate the publication of new standards for nonprescription ingredients.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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This story has been updated to delete an incorrect reference to Allegra containing phenylephrine.

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September 12, 2023
Kroger agrees to pay up to $1.4 billion to settle opioid lawsuits

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One of the nation’s largest grocery chains is the latest company to agree to settle lawsuits over the U.S. opioid crisis.

In a deal announced Friday, the Kroger Co. would pay up to $1.4 billion over 11 years. The amount includes up to $1.2 billion for state and local governments where it operates, $36 million to Native American tribes and about $177 million to cover lawyers’ fees and costs.

Kroger currently has stores in 35 states — virtually everywhere save the Northeast, the northern plains and Hawaii. Thirty-three states would be eligible for money in the deal. The company previously announced settlements with New Mexico and West Virginia.

Over the past eight years, prescription drug manufacturers, wholesalers, consultants and pharmacies have proposed or finalized opioid settlements totaling more than $50 billion, including at least 12 others worth more than $1 billion. The U.S. Supreme Court is set to hear arguments later this year on whether one of the larger settlements, involving OxyContin maker Purdue Pharma, is legal.

Most of the settlement money is to be used to address an overdose epidemic linked to more than 80,000 deaths a year in the U.S. in recent years, with most of the latest deaths connected to illicit synthetic drugs such as fentanyl rather than prescription painkillers.

Still, Jayne Conroy, a lead lawyer for the governments suing the companies, told The Associated Press in an interview Friday that it makes sense for players in the prescription drug industry to have a major role in funding solutions to the crisis.

“It really isn’t a different problem,” she said. “The problem is the massive amount of addiction. That addiction stems from the massive amount of prescription drugs.”

The companies have also agreed to change their business practices regarding powerful prescription painkillers, consenting to restrictions on marketing and using data to catch overprescribing. Conroy said those noneconomic terms for Kroger have not been finalized, but they’ll look like what other companies have agreed to.

Kroger said it intends to finalize its deal in time to make initial payments in December.

The company would not admit wrongdoing or liability as part of the deal, which is called in a statement a milestone in efforts to resolve opioid lawsuits. “Kroger has long served as a leader in combatting opioid abuse and remains committed to patient safety,” the company said.

While most of the biggest players have settled, the opioid litigation is continuing. Cases are being prepared for trial involving the supermarket chains Publix and Albertsons, the latter of which is attempting to merge with Kroger. Pharmacy benefit managers such as Express Scripts and OptumRx also face opioid claims from governments.

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September 8, 2023
See which drugs President Biden is targeting first for Medicare price-lowering talks

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WASHINGTON — The Biden administration is targeting the blood thinner Eliquis, diabetes treatment Jardiance and eight other medications for Medicare’s first-ever drug price negotiations as it seeks to lower medical costs for Americans.

The administration on Tuesday released a list of the 10 drugs for which prices will be negotiated directly with the manufacturer. The move is expected to cut costs for many patients, but it faces litigation from drugmakers and heavy criticism from Republican lawmakers, and it will be years before consumers notice any savings.

The effort is a centerpiece of President Joe Biden’s reelection pitch as the Democrat seeks to show Americans he’s deserving of a second term because of the work he’s doing to lower costs for them while the country is struggling with inflation. But like the drug negotiations, many of Biden’s biggest policy moves take time to roll out, and his challenge is to persuade the public to be patient.

“For many Americans, the cost of one drug is the difference between life and death, dignity and dependence, hope and fear,” Biden said in a statement. “That is why we will continue the fight to lower healthcare costs — and we will not stop until we finish the job.”

Biden plans to deliver a speech on health care costs from the White House later Tuesday. He’ll be joined by Vice President Kamala Harris.

The drugs on the list announced Tuesday accounted for more than $50 billion in Medicare prescription drug costs between June 1, 2022, and May 31, according to the Centers for Medicare and Medicaid Services, or CMS.

That includes more than $16 billion on Eliquis. The drug from Pfizer and Bristol-Myers Squibb treats blood clots in the legs and lungs and reduces the risk of stroke in people with an irregular heartbeat called atrial fibrillation.

Senior administration officials said Tuesday that the 10 drugs selected for negotiation are among the most costly to the Medicare program. They said 8.2 million people with Medicare Part D prescription drug coverage take them.

The diabetes treatments Jardiance from Eli Lilly and Co. and Boehringer Ingelheim and Januvia from Merck made the list. It also included Amgen’s autoimmune disease treatment Enbrel and Entresto from Novartis, which is used to treat heart failure.

Other drugs on the list include AstraZeneca’s diabetes and heart failure treatment Farxiga and three drugs from Johnson & Johnson: the blood thinner Xarelto, the blood cancer treatment Imbruvica and it’s biggest seller, Stelara, an IV treatment for psoriasis and other inflammatory disorders.

The list also includes several versions of Novo Nordisk’s Fiasp, a fast-acting insulin taken around meals.

The Inflation Reduction Act already caps Medicare patient out-of-pocket costs for insulin at $35 a month. An administration official said Tuesday that upper limit will hold but there could be further changes in those costs.

The announcement Tuesday is another significant step toward taming drug pricing under the Inflation Reduction Act, which was signed by Biden last year. The law also calls for a $2,000 annual cap on how much people with Medicare have to pay out of pocket for drugs starting in 2025.

For drugs on the list released Tuesday, the government aims to negotiate the lowest maximum fair price. That could help some patients who have coverage but still face big bills like coinsurance payments when they get a prescription.

About 9% of Medicare beneficiaries age 65 and older said in 2021 that they did not fill a prescription or skipped a drug dose due to cost, according to research by the Commonwealth Fund, which studies health care issues.

Currently, pharmacy benefit managers that run Medicare prescription plans negotiate rebates off a drug’s price. Those rebates sometimes help reduce premiums customers pay for coverage. But they may not directly change what a patient spends at the pharmacy counter.

The new drug price negotiations aim “to basically make drugs more affordable while also still allowing for profits to be made,” said Gretchen Jacobson, who researches Medicare issues at Commonwealth.

The federal government will benefit most from any lowered drug prices, noted Larry Levitt, an executive vice president for health policy at KFF, another non-profit that studies health care. But he said that if Medicare spends less on prescription drugs, then premiums for everyone with its drug coverage also should fall.

Drug companies that refuse to be a part of the new negotiation process will be heavily taxed.

The pharmaceutical industry has been gearing up for months to fight these rules. The lobbying group Pharmaceutical Research and Manufacturers of America said Tuesday that the drug list announcement stemmed from “a rushed process focused on short-term political gain rather than what is best for patients.”

“Many of the medicines selected for price setting already have significant rebates and discounts due to the robust private market negotiation that occurs in the Part D program today,” PhRMA CEO Stephen J. Ubl said in a statement.

PhRMA representatives also have said pharmacy benefit managers can still restrict access to drugs with negotiated prices by moving the drugs to a tier of their formulary — a list of covered drugs — that would require higher out-of-pocket payments. Pharmacy benefit managers also could require patients to try other drugs first or seek approval before a prescription can be covered.

PhRMA and several drugmakers have filed lawsuits over the administration’s plan.

Republican lawmakers also have blasted the Biden administration, saying companies might pull back on introducing new drugs that could be subjected to future haggling. They’ve also questioned whether the government knows enough to suggest prices for drugs.

CMS plans to meet this fall with drugmakers that have a drug on its list, and government officials say they also plan to hold patient-focused listening sessions. By February 2024, the government will make its first offer on a maximum fair price and then give drugmakers time to respond.

Any negotiated prices won’t take hold until 2026.

CMS aims to add 15 more drugs to its negotiation list for 2027 and another 15 for 2028. It then plans to add up to 20 more for each year after that.

___

Murphy reported from Indianapolis.

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August 29, 2023
Biden targets diabetes drug Jardiance, blood thinner Eliquis and 8 others for Medicare price talks

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WASHINGTON — The blood thinner Eliquis and popular diabetes treatments including Jardiance are among the first drugs that will be targeted for price negotiations in an effort to cut Medicare costs.

President Joe Biden’s administration on Tuesday released a list of 10 drugs for which the federal government will take a first-ever step: negotiating drug prices directly with the manufacturer.

The move is expected to cut costs for some patients but faces litigation from the drugmakers and heavy criticism from Republican lawmakers. It’s also a centerpiece of the Democratic president’s reelection pitch as he seeks a second term in office by touting his work to lower costs for Americans at a time when the country has struggled with inflation.

The diabetes treatments Jardiance from Eli Lilly and Co. and Merck’s Januvia made the list, along with Amgen’s autoimmune disease treatment Enbrel. Other drugs include Entresto from Novartis, which is used to treat heart failure.

“For many Americans, the cost of one drug is the difference between life and death, dignity and dependence, hope and fear,” Biden said in a statement. “That is why we will continue the fight to lower healthcare costs — and we will not stop until we finish the job.”

Biden plans to deliver a speech on health care costs from the White House later Tuesday. He’ll be joined by Vice President Kamala Harris.

The drugs on the list announced Tuesday accounted for more than $50 billion in Medicare prescription drug costs between June 1, 2022, and May 31, according to the Centers for Medicare and Medicaid Services, or CMS.

Medicare spent about $10 billion in 2020 on Eliquis, according to AARP research. The drug treats blood clots in the legs and lungs and reduces the risk of stroke in people with an irregular heartbeat called atrial fibrillation.

The announcement is a significant step under the Inflation Reduction Act, which was signed by Biden last year. The law requires the federal government for the first time to start negotiating directly with companies about the prices they charge for some of Medicare’s most expensive drugs.

More than 52 million people who either are 65 or older or have certain severe disabilities or illnesses get prescription drug coverage through Medicare’s Part D program, according to CMS.

About 9% of Medicare beneficiaries age 65 and older said in 2021 that they did not fill a prescription or skipped a drug dose due to cost, according to research by the Commonwealth Fund, which studies health care issues.

The agency aims to negotiate the lowest maximum fair price for drugs on the list released Tuesday. That could help some patients who have coverage but still face big bills like high deductible payments when they get a prescription.

Currently, pharmacy benefit managers that run Medicare prescription plans negotiate rebates off a drug’s price. Those rebates sometimes help reduce premiums customers pay for coverage. But they may not change what a patient spends at the pharmacy counter.

The new drug price negotiations aim “to basically make drugs more affordable while also still allowing for profits to be made,” said Gretchen Jacobson, who researches Medicare issues at Commonwealth.

Drug companies that refuse to be a part of the new negotiation process will be heavily taxed.

The pharmaceutical industry has been gearing up for months to fight these rules. Already, the plan faces several lawsuits, including complaints filed by drugmakers Merck and Bristol-Myers Squibb and a key lobbying group, the Pharmaceutical Research and Manufacturers of America, or PhRMA.

PhRMA said in a federal court complaint filed earlier this year that the act forces drugmakers to agree to a “government-dictated price” under the threat of a heavy tax and gives too much price-setting authority to the U.S. Department of Health and Human Services.

PhRMA representatives also have said pharmacy benefit managers can still restrict access to drugs with negotiated prices by moving the drugs to a tier of their formulary — a list of covered drugs — that would require higher out-of-pocket payments. Pharmacy benefit managers also could require patients to try other drugs first or seek approval before a prescription can be covered.

Republican lawmakers also have blasted the Biden administration for its plan, saying companies might pull back on introducing new drugs that could be subjected to future haggling. They’ve also questioned whether the government knows enough to suggest prices for drugs.

CMS will start its negotiations on drugs for which it spends the most money. The drugs also must be ones that don’t have generic competitors and are approved by the Food and Drug Administration.

CMS plans to meet this fall with drugmakers that have a drug on its list, and government officials say they also plan to hold patient-focused listening sessions. By February 2024, the government will make its first offer on a maximum fair price and then give drugmakers time to respond.

Any negotiated prices won’t take hold until 2026. More drugs could be added to the program in the coming years.

___

Murphy reported from Indianapolis.

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August 29, 2023
Teva to pay $225M to settle cholesterol drug price-fixing charges

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The generic drug maker Teva Pharmaceuticals agreed Monday to pay $225 million to settle price-fixing charges related to sales of a widely used cholesterol-lowering drug

FILE – An Israeli flag flies outside a Teva Pharmaceutical Industries building on Dec. 14, 2017, in Neot Hovav, Israel. The generic drug maker Teva Pharmaceuticals agreed Monday, Aug. 21, 2023, to pay $225 million to settle price-fixing charges related to sales of a major cholesterol-lowering drug. The U.S. Department of Justice said the agreement also requires Teva to divest its business making and selling the drug, pravastatin, a generic version of the brand-name medicine Pravachol. (AP Photo/Tsafrir Abayov, File)

The Associated Press

WASHINGTON — The generic drug maker Teva Pharmaceuticals agreed Monday to pay $225 million to settle price-fixing charges related to sales of a major cholesterol-lowering drug. The U.S. Department of Justice said the agreement also requires Teva to divest its business making and selling the drug, pravastatin, a generic version of the brand-name medicine Pravachol.

Another generic drug maker, Glenmark Pharmaceuticals, agreed to pay a $30 million criminal penalty and to divest its pravastatin business as well.

In a statement, the U.S. arm of Israel-based Teva blamed a single former employee for striking agreements with Teva competitors that limited competition between 2013 and 2015. That employee left the company in 2016, Teva said.

DOJ had charged seven generic drug makers, including Teva and Glenmark, with price fixing, bid rigging and market allocation schemes. The seven companies have settled their cases with deferred prosecution agreements. Had any of the cases gone to trial, guilty verdicts could have led to mandatory bans from participation in Medicare, Medicaid and other federal health programs.

The companies collectively agreed to pay $681 million in fines in addition to other penalties.

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August 21, 2023
Mexico shutters 23 pharmacies at Caribbean coast resorts after US warned of dangerous pill sales

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MEXICO CITY — Mexico has shuttered 23 pharmacies at Caribbean coast resorts, six months after a research report warned that drug stores in Mexico were offering foreigners pills they passed off as Oxycodone, Percocet and Adderall without prescriptions, authorities said Tuesday.

A four-day inspection raid targeted drugstores in Cancun, Playa del Carmen and Tulum.

In March, the U.S. State Department issued a travel warning about sales of such pills, and the practice appears to be widespread.

The Navy Department said Tuesday that irregular sales were found at 23 of the 55 drug stores inspected.

The Navy said the pharmacies usually offered the pills only to tourists, and the drugstores advertised such pills, and even offered home delivery services for them.

The Navy said it found outdated medications and some for which there was no record of the supplier, as well as blank or unsigned prescription forms.

In February, the University of California, Los Angeles announced that researchers there had found that 68% of the 40 Mexican pharmacies visited in four northern Mexico cities sold Oxycodone, Xanax or Adderall, and that 27% of those pharmacies were selling fake pills.

UCLA said the study, published in January, found that “brick and mortar pharmacies in Northern Mexican tourist towns are selling counterfeit pills containing fentanyl, heroin, and methamphetamine. These pills are sold mainly to US tourists, and are often passed off as controlled substances such as Oxycodone, Percocet, and Adderall.”

“These counterfeit pills represent a serious overdose risk to buyers who think they are getting a known quantity of a weaker drug,” Chelsea Shover, assistant professor-in-residence of medicine at the David Geffen School of Medicine at UCLA, said in February.

And the U.S. State Department travel warning in March said the counterfeit pills being sold at pharmacies in Mexico “may contain deadly doses of fentanyl.”

The Mexican Navy did not confirm that any fentanyl-laced pills had been found in last week’s raid, but said medications had been seized to test whether they contained fentanyl.

Fentanyl is a synthetic opioid far more powerful than morphine, and it has been blamed for about 70,000 overdose deaths per year in the United States. Mexican cartels produce it from precursor chemical smuggled in from China, and then often press it into pills designed to look like other medications.

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August 8, 2023
The first pill to treat postpartum depression has been approved by US health officials

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WASHINGTON — Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of new mothers in the U.S. each year.

The Food and Drug Administration on Friday granted approval of the drug, Zurzuvae, for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once a day for 14 days.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” said Dr. Tiffany Farchione, FDA’s director of psychiatric drugs, in a statement.

Postpartum depression affects an estimated 400,000 people a year, and while it often ends on its own within a couple weeks, it can continue for months or even years. Standard treatment includes counseling or antidepressants, which can take weeks to work and don’t help everyone.

The new pill is from Sage Therapeutics, which has a similar infused drug that’s given intravenously over three days in a medical facility. The FDA approved that drug in 2019, though it isn’t widely used because of its $34,000 price tag and the logistics of administering it.

The FDA’s pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill. The benefits, measured using a psychiatric test, appeared within three days for many patients.

Sahar McMahon, 39, had never experienced depression until after the birth of her second daughter in late 2021. She agreed to enroll in a study of the drug, known chemically as zuranolone, after realizing she no longer wanted to spend time with her children.

“I planned my pregnancies, I knew I wanted those kids but I didn’t want to interact with them,” said McMahon, who lives in New York City. She says her mood and outlook started improving within days of taking the first pills.

“It was a quick transition for me just waking up and starting to feel like myself again,” she said.

Dr. Kimberly Yonkers of Yale University said the Zurzuvae effect is “strong” and the drug likely will be prescribed for women who haven’t responded to antidepressants. She wasn’t involved in testing the drug.

Still, she said, the FDA should have required Sage to submit more follow-up data on how women fared after additional months.

“The problem is we don’t know what happens after 45 days,” said Yonkers, a psychiatrist who specializes in postpartum depression. “It could be that people are well or it could be that they relapse.”

Sage did not immediately announce how it would price the pill, and Yonkers said that’ll be a key factor in how widely its prescribed.

Side effects with the new drug are milder than the IV version, and include drowsiness and dizziness. The drug was co-developed with fellow Massachusetts pharmaceutical company Biogen.

Both the pill and IV forms mimic a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy. Levels of the hormone can plunge after childbirth.

Sage’s drugs are part of an emerging class of medications dubbed neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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August 4, 2023
The first pill to treat postpartum depression has been approved by US health officials

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WASHINGTON — Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of new mothers in the U.S. each year.

The Food and Drug Administration on Friday granted approval of the drug, Zurzuvae, for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once a day for 14 days.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” said Dr. Tiffany Farchione, FDA’s director of psychiatric drugs, in a statement.

Postpartum depression affects an estimated 400,000 people a year, and while it often ends on its own within a couple weeks, it can continue for months or even years. Standard treatment includes counseling or antidepressants, which can take weeks to work and don’t help everyone.

The new pill is from Sage Therapeutics, which has a similar infused drug that’s given intravenously over three days in a medical facility. The FDA approved that drug in 2019, though it isn’t widely used because of its $34,000 price tag and the logistics of administering it.

The FDA’s pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill. The benefits, measured using a psychiatric test, appeared within three days for many patients.

Sahar McMahon, 39, had never experienced depression until after the birth of her second daughter in late 2021. She agreed to enroll in a study of the drug, known chemically as zuranolone, after realizing she no longer wanted to spend time with her children.

“I planned my pregnancies, I knew I wanted those kids but I didn’t want to interact with them,” said McMahon, who lives in New York City. She says her mood and outlook started improving within days of taking the first pills.

“It was a quick transition for me just waking up and starting to feel like myself again,” she said.

Dr. Kimberly Yonkers of Yale University said the Zurzuvae effect is “strong” and the drug likely will be prescribed for women who haven’t responded to antidepressants. She wasn’t involved in testing the drug.

Still, she said, the FDA should have required Sage to submit more follow-up data on how women fared after additional months.

“The problem is we don’t know what happens after 45 days,” said Yonkers, a psychiatrist who specializes in postpartum depression. “It could be that people are well or it could be that they relapse.”

Sage did not immediately announce how it would price the pill, and Yonkers said that’ll be a key factor in how widely its prescribed.

Side effects with the new drug are milder than the IV version, and include drowsiness and dizziness. The drug was co-developed with fellow Massachusetts pharmaceutical company Biogen.

Both the pill and IV forms mimic a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy. Levels of the hormone can plunge after childbirth.

Sage’s drugs are part of an emerging class of medications dubbed neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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August 4, 2023
Cyprus allows human COVID-19 medications to be used on cats to fight deadly virus mutation

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Veterinarians in Cyprus are lauding a government decision to allow its stock of human COVID-19 medication to be used against a feline virus that has killed thousands of cats on the Mediterranean island

FILE – A cat crosses a pedestrian road at the main linear park, in the capital Nicosia, Cyprus, on July 19, 2023. Cyprus’ veterinarians association on Friday Aug. 4, 2023 lauded a government decision to allow its stock of human coronavirus medication to be used on cats to fight a local mutation of a feline virus that has killed thousands of animals on the Mediterranean island. (AP Photo/Petros Karadjias, File)

The Associated Press

NICOSIA, Cyprus — Cyprus’ veterinarians association on Friday lauded a government decision to allow its stock of human coronavirus medication to be used on cats to fight a local mutation of a feline virus that has killed thousands of animals on the Mediterranean island.

The association said in a statement that it had petitioned the government for access to the medication at “reasonable prices” from the beginning of this year, when the mutation that causes lethal Feline Infectious Peritonitis (FIP) began to noticeably crop up in the island’s cat population.

“We want to assure that we will continue to investigate and control the rise in case of FCov-2023,” the association said.

Local animal activists had claimed that the mutation had killed as many as 300,000 cats, but Association President Nektaria Ioannou Arsenoglou says that’s an exaggeration.

Arsenoglou had told The Associated Press that an association survey of 35 veterinary clinics indicated an island-wide total of about 8,000 deaths.

According to Arsenoglou, FIP is nearly always lethal if left untreated, but medication can nurse cats back to health in approximately 85% of cases in both the “wet” and “dry” forms of the illness.

What made FIP treatment difficult was the high price of the medication that activists said put it out of reach of many cat care givers.

Spread through contact with cat feces, neither the virus or its mutation can be passed on to humans. The feline coronavirus has been around since 1963. Previous epidemics eventually fizzled out without the use of any medication, Arsenoglou said.

Measures have already been enacted to prevent the export of the mutation through mandatory medical check-ups of all felines destined for adoption abroad.

It’s unclear how many feral cats live in Cyprus, where they are generally beloved and have a long history dating back thousands of years.

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August 4, 2023
Babies should get new drug that prevents RSV, CDC panel says

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A panel of U.S. health advisers is recommending that babies get a new drug to protect them against a respiratory virus

ByCARLA K. JOHNSON AP Medical Writer

FILE – This illustration provided by AstraZeneca depicts packaging for their medication Beyfortus. On Thursday, Aug. 3, 2023, a panel of outside advisers to the Centers for Disease Control and Prevention recommended that babies get the drug to protect them against a respiratory virus that sends tens of thousands of American children to the hospital each year. (AstraZeneca via AP, File)

The Associated Press

Infants should get a new drug to protect them against a respiratory virus that sends tens of thousands of American children to the hospital each year, heath advisers recommended Thursday.

An infection with RSV is a coldlike nuisance for most healthy people, but it can be life-threatening for the very young and the elderly. There are no vaccines for babies yet so the new drug, a lab-made antibody that helps the immune system fight off the virus, is expected to fill a critical need.

The drug, developed by AstraZeneca and Sanofi, is expected to be ready in the fall before the RSV season, typically November through March. In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die.

A panel of outside advisers to the Centers for Disease Control and Prevention recommended the one-time shot for infants born just before or during the RSV season and for those less than 8 months old before the season starts. They also recommended a dose for some 8- to 19-months-olds at higher risk of a serious illness from RSV.

The CDC director was expected to sign off on the panel’s recommendations.

The drug, to be sold under the brand name Beyfortus, is expected to cost $495 per dose, and to be covered by insurance. Panelists acknowledged that it will be a challenge at first to give the shot and for providers to be reimbursed by insurers.

In May, the Food and Drug Administration approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In August, the FDA is expected to make a decision on approving Pfizer’s vaccine for pregnant women, with the aim of passing along protection to their newborns.

Although the new drug is not a vaccine, the expert panel also supported including it in Vaccines for Children, a government program providing free immunizations. The American Academy of Pediatrics is urging hospitals to stock Beyfortus so that newborns can get it during RSV season before they go home.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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August 3, 2023
Thermo Fisher Scientific settles with family of Henrietta Lacks, whose HeLa cells uphold medicine

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BALTIMORE — More than 70 years after doctors at Johns Hopkins Hospital took Henrietta Lacks’ cervical cells without her knowledge, a lawyer for her descendants said they have reached a settlement with a biotechnology company that they accused of reaping billions of dollars from a racist medical system.

Tissue taken from the Black woman’s tumor before she died of cervical cancer became the first human cells to continuously grow and reproduce in lab dishes. HeLa cells went on to become a cornerstone of modern medicine, enabling countless scientific and medical innovations, including the development of the polio vaccine, genetic mapping and even COVID-19 vaccines.

Despite that incalculable impact, the Lacks family had never been compensated.

Lacks’ cells were harvested in 1951, when it was not illegal to so without a patient’s permission. But lawyers for her family argued that Thermo Fisher Scientific Inc., of Waltham, Massachusetts, continued to commercialize the results well after the origins of the HeLa cell line became well known. The company unjustly enriched itself off Lacks’ cells, the family argued in their lawsuit, filed in 2021.

The settlement came after closed-door negotiations that lasted all day Monday inside the federal courthouse in Baltimore. Some of Lacks’ grandchildren were among the family members who attended the talks.

Attorney Ben Crump, who represents the family, announced the settlement late Monday. He said the terms are confidential.

“The parties are pleased that they were able to find a way to resolve this matter outside of Court and will have no further comment about the settlement,” Thermo Fisher representatives and attorneys for the Lacks family said in a joint statement.

HeLa cells were discovered to have unique properties. While most cell samples died shortly after being removed from the body, her cells survived and thrived in laboratories. They became known as the first immortalized human cell line because scientists could cultivate her cells indefinitely. That meant scientists anywhere could reproduce studies using identical cells.

The remarkable science involved — and the impact on the Lacks family, some of whom had chronic illnesses and no health insurance — were documented in a bestselling book by Rebecca Skloot, “The Immortal Life of Henrietta Lacks.” Oprah Winfrey portrayed her daughter in an HBO movie about the story.

A poor tobacco farmer from southern Virginia, Lacks got married and moved with her husband to Turner Station, a historically Black community outside Baltimore. They were raising five children when doctors discovered a tumor in Lacks’ cervix and saved a sample of her cancer cells collected during a biopsy.

Lacks died at age 31 in the “colored ward” of Johns Hopkins Hospital. She was buried in an unmarked grave.

Johns Hopkins said it never sold or profited from the cell lines, but many companies have patented ways of using them.

In their complaint, Lacks’ grandchildren and other descendants argued that her treatment illustrates a much larger issue that persists today: racism inside the U.S. medical system.

“The exploitation of Henrietta Lacks represents the unfortunately common struggle experienced by Black people throughout history,” the complaint reads. “Too often, the history of medical experimentation in the United States has been the history of medical racism.”

Thermo Fisher argued the case should be dismissed because it was filed after the statute of limitations expired, but attorneys for the family said that shouldn’t apply because the company continues to benefit from the cells.

In a statement posted to their website, Johns Hopkins Medicine officials said they reviewed all interactions with Lacks and her family after the 2010 publication of Skloot’s book. While acknowledging an ethical responsibility, it said the medical system “has never sold or profited from the discovery or distribution of HeLa cells and does not own the rights to the HeLa cell line.”

Though her relatives hadn’t received financial compensation, they did reach an agreement with the National Institutes of Health in 2013 that gave them some control over how the DNA code from HeLa cells is used. The deal came after the family raised privacy concerns about making Lacks’ genetic makeup public.

Crump, a civil rights attorney, has become well known for representing victims of police violence and calling for racial justice, especially in the aftermath of George Floyd’s murder. The Lacks family joined him Tuesday morning near Baltimore’s waterfront to announce the settlement and pay tribute to Lacks on what would have been her 103rd birthday. The group brought balloons and a cake to celebrate.

“We did it — and what a birthday present today,” Crump said during the news conference.

Lacks’ only surviving child, Lawrence Lacks Sr., lives to see justice done, grandson Alfred Lacks Carter Jr. said. Now 86, Lawrence Lacks was 16 when his mother died.

“There couldn’t have been a more fitting day for her to have justice, for her family to have relief,” Carter said. “It was a long fight — over 70 years — and Henrietta Lacks gets her day.”

Last week, U.S. Sens. Chris Van Hollen and Ben Cardin, both Maryland Democrats, introduced a bill to posthumously award Lacks the Congressional Gold Medal.

“Henrietta Lacks changed the course of modern medicine,” Van Hollen said in a statement announcing the bill. “It is long past time that we recognize her life-saving contributions to the world.”

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August 1, 2023