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Hong Kong is criminalizing CBD as a ‘dangerous drug’ alongside heroin

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Hong Kong
CNN
 — 

Two years ago, cannabidiol was booming in Hong Kong. The compound, known as CBD, was popping up in cafes, restaurants and stores, with businesses eager to join an exciting new market already well-established in countries around the world.

That all came to an end on Wednesday, when CBD was criminalized in the city and declared a “dangerous drug” on the same level as heroin and fentanyl.

CBD is a chemical found in hemp and marijuana plants. It’s non-psychoactive, meaning it won’t get you high; instead, CBD is often marketed for everything from helping to relieve pain and inflammation to reducing stress and anxiety.

It has surged in global popularity in recent years, with brands adding it to shampoos, drinks, body oils, gummy bears and dog treats. In the United States and Europe, you might find it sold in coffee shops and farmers’ markets, mom-and-pop and high-end department stores, and even drugstore chain CVS.

But last June, draft legislation banning CBD was introduced to Hong Kong lawmakers, and went into effect February 1.

Under the new legislation, possession and consumption of any amount of CBD is punishable by seven years in prison and a fine of 1 million Hong Kong dollars ($127,607). Manufacturing, importing or exporting CBD is punishable by life imprisonment.

Even travelers could face penalties, with the government warning people not to risk “buying these products or bringing them back to Hong Kong.”

The same penalties and conditions apply for cannabis, also known as marijuana.

The ban has forced CBD-focused businesses to close, while other brands have had to roll back or get rid of CBD products.

“It’s a shame because there’s a missed opportunity for sure,” said Luke Yardley, founder of Yardley Brothers Craft Brewery, which had previously sold four products containing CBD – a lager and three nonalcoholic drinks. “I think that anything that you can’t get intoxicated from, and helps you to relax, is probably a good thing.”

The health benefits and risks of CBD have long been debated. In the US, most CBD products are not regulated by the Food and Drug Administration (FDA), which means that people can purchase items off the shelf.

Some research has found that the compound can ease pain and may be useful for those who have trouble sleeping. The FDA has approved one drug with CBD to treat rare, severe forms of epilepsy.

But concerns have also been raised, with some experts saying there isn’t enough scientific research into how CBD works or its potential effects.

In January, the FDA announced CBD products will require a new regulatory pathway in the US, saying: “We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”

In Hong Kong, which has strict cannabis laws, the government’s concern revolves around the possible presence of its sister compound THC (tetrahydrocannabinol) in CBD products. THC is also found in cannabis plants and is responsible for the “high.”

In the US and Europe, CBD products can carry up to 0.3% – a trace amount – of THC, but even that is not acceptable in Hong Kong. And while CBD products could avoid this trace amount by using a pure form of CBD, most manufacturers mix other compounds for higher potency.

From 2019 to early 2022, Hong Kong authorities launched nearly 120 “operations” seizing and testing CBD products from restaurants and shops to warehouses, Secretary for Security Tang Ping-keung said last year. He added that more than 3,800 products were found to contain THC, though did not give further detail on the proportion or percentage of THC in those products.

In a written response to questions raised in the Legislative Council, Tang suggested the government’s traditionally tough stance on THC should be applied to CBD “to protect public heath.”

“We have adopted ‘zero tolerance’ towards drugs and we understand that it is a matter of public concern,” he said. “Therefore, the government plans to control CBD.”

The Action Committee Against Narcotics, a group of representatives from “the fields of social work, education, medical and community service” that advises the government on anti-drug policy, said in a statement last November that it supported the CBD ban and the government’s goal of “a drug-free Hong Kong.”

Many businesses began bracing themselves for regulatory changes in 2022, ahead of the government’s official announcement this January.

Yardley Brothers Craft Brewery stopped making its CBD beverages late last year in anticipation of the ban, and all its leftover products had sold out by December, said Yardley.

He said the CBD drinks had been “very popular,” amounting to roughly 8% of the business, as they offered adults a nonalcoholic option to enjoy when out with friends. At some bars, regulars “come in every weekend for a glass of CBD lemonade,” he said.

Now “there’s less choice for consumers in Hong Kong. That’s not necessarily a step in the right direction,” he said.

Some companies have been forced to shut down completely.

Med Chef, a restaurant that opened in 2021, once boasted of offering Hong Kong’s “first full menu of CBD-infused cocktails, appetizers and entrees.” In a news release during its launch, the restaurant founder emphasized the health and wellness benefits of CBD.

But by early November 2022, it had closed its doors. “We have worked hard in the past to present CBD in its most acceptable form and integrate our food and beverage concepts,” the restaurant wrote in a farewell post on Instagram. “It’s a pity that things didn’t go the way we hoped. Under the latest policies of those in power, we ultimately aren’t able to continue forward with everyone.”

Hong Kong’s first CBD cafe, Found, had also made headlines when it opened in 2020. It sold a variety of CBD products including infused coffee and beers, oils to help sleep, powder to sprinkle into food and pet products to help ease stiff joints.

It closed at the end of September 2022, telling patrons on Instagram that their positive feedback had shown that “CBD could help to cope with the stresses of daily life.”

“Sadly, in spite of the demonstrable positive impact, it has now become apparent that the Hong Kong government intends to adopt new legislation to prohibit the sale and possession of CBD,” it wrote.

Yardley said the government’s concerns about THC were valid – but argued they could have implemented better regulations, such as requiring certifications or standards of safety around CBD samples.

“It’s quite an extreme response to just fully ban it,” he said.

And while the brewery will continue operating, with plans for alternative nonalcoholic beverages to fill the gap, Yardley hopes CBD will be back on the menu. “I hope for the future that it might become legal again,” he said.

This story has been updated to include details of the draft legislation and its introduction.



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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States

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CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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Business

FDA wants to simplify the use and updating of Covid-19 vaccines

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CNN
 — 

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online on Monday. That could include streamlining the vaccine composition, immunization schedules and periodic updates of Covid-19 vaccines.

The FDA said it expects to assess circulating strains of the virus that causes Covid-19 at least annually and decide in June which strains to select for the fall season, much like the process to update annual flu vaccines.

Moving forward, the agency said, most people may need only one dose of the latest Covid-19 shot to restore protection, regardless of how many shots they have already received. Two doses may be needed for people who are very young and haven’t been exposed, or for the elderly or immune-compromised, according to the FDA’s briefing document for its vaccine advisers.

The agency is urging a shift toward only one vaccine composition, rather than a combination of monovalent vaccines, which are currently used for primary shots and target only one strain, and bivalent vaccines, which are currently used for booster doses and target more than one strain.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.

The FDA’s plan was first reported by National Public Radio.

The agency’s independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, are scheduled to meet on Thursday to discuss the future of Covid-19 vaccine regimens, and will be asked to vote on whether they recommend parts of FDA’s plan.

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World

Indonesia: Warning issued over ‘dragon’s breath’ viral video trend

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CNN
 — 

Indonesia is warning people against consuming liquid nitrogen after more than 20 children were harmed eating a street snack known as “dragon’s breath” that’s at the center of a dangerous new viral video trend.

The children suffered burns to their skin, severe stomach pains and food poisoning after consuming the colorful candies, according to Indonesia’s Ministry of Health, which is urging parents, teachers and local health authorities to be vigilant.

The candies are dipped in liquid nitrogen to create a vapor effect when eaten. They are popular with children, dozens of whom have uploaded clips to short-form video app TikTok showing them blowing the fumes out of their mouths, noses and ears. One video showing the preparation of the snack by a street vendor has been viewed close to 10 million times.

Around 25 children have been hurt consuming the candies, including two who were hospitalized, said the ministry’s director general Maxi Rein Rondonuwu. No deaths have been reported.

Using liquid nitrogen in food preparation is not illegal. Top chefs often use the vapors to create theatrical effects when serving dishes. It is clear, colorless and odorless, and commonly used in medical settings and as an ingredient to freeze food.

However, when not used properly, it can be hazardous.

”Liquid nitrogen is not only dangerous when consumed, it can cause severe breathing difficulties from nitrogen fumes that are inhaled over a long time,” Maxi said.

The first case was reported in July 2022, according to the ministry, when a child from a village in the Ponorogo Regency in East Java suffered cold burns on his skin after eating the snack.

More cases were reported in November and December, including a 4-year-old boy who was admitted to hospital in the capital Jakarta with severe stomach pain.

“Schools must educate children in the community about the dangers of liquid nitrogen in food (to) prevent more cases of severe food poisoning,” Maxi said.

– Source:
HLN
” data-fave-thumbnails=”{“big”:{“uri”:”https://media.cnn.com/api/v1/images/stellar/prod/180811080208-dragon-breath.jpg?q=x_86,y_251,h_663,w_1179,c_crop/h_540,w_960″},”small”:{“uri”:”https://media.cnn.com/api/v1/images/stellar/prod/180811080208-dragon-breath.jpg?q=x_86,y_251,h_663,w_1179,c_crop/h_540,w_960″}}” data-vr-video=”” data-show-name=”Weekend Express” data-show-url=”https://www.cnn.com/shows/weekend-express” data-check-event-based-preview=”” data-network-id=”” data-details=””>

New liquid nitrogen cereal sparks controversy

In 2018, the US Food and Drug Administration (FDA) issued safety alerts warning that serious injury could result from eating foods like ice cream, cereal or cocktails prepared with liquid nitrogen.

“Injuries have occurred from handling or eating products prepared by adding liquid nitrogen immediately before consumption, even after the liquid nitrogen has fully evaporated due to the extremely low temperature of the food,” the FDA said.

“This is a hazardous chemical compound,” said Clarence Yeo, a Singapore-based doctor. “It irritates the stomach and can cause burns in the mouth and esophagus. Children would be especially sensitive to (its effects) if it is eaten in large amounts.”

Yeo warned he “wouldn’t advise anyone to eat it.”

“You could end up in hospital and the worst case scenario could be organ damage,” he said.

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CDC identifies possible safety issue with Pfizer’s updated Covid-19 vaccine but says people should still get boosted

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CNN
 — 

The US Centers for Disease Control and Prevention said Friday that there is a possible safety issue with the bivalent Covid-19 vaccine made by Pfizer and BioNTech but that it is unlikely to represent a true risk. The agency said it continues to recommend that people stay up-to-date with Covid-19 vaccines.

The CDC said one of its vaccine safety monitoring systems – a “near real-time surveillance system” called the Vaccine Safety Datalink – detected a possible increase in a certain kind of stroke in people 65 and older who recently got one of Pfizer’s updated booster shots.

A rapid response analysis of that signal revealed that seniors who got an bivalent booster might be more likely to have ischemic strokes within the first three weeks after their shots, compared with weeks four through six.

Ischemic strokes, the most common form, are blockages of blood to the brain. They’re usually caused by clots.

The Vaccine Safety Datalink, or VSD, is a network of large health systems across the nation that provides data about the safety and efficacy of vaccines through patients’ electronic health records. The CDC said it had identified possible confounding factors in the data coming from the VSD that may be biasing the data and need further investigation.

Of about 550,000 seniors who got Pfizer bivalent boosters and were tracked by the VSD, 130 had strokes in the three weeks after the shot, according to a CDC official who spoke to CNN on condition of anonymity because they weren’t authorized to share the data. None of the 130 people died.

The number of strokes detected is relatively small, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices’ Covid-19 Vaccine Work Group.

“These strokes are not a confirmed adverse event at the moment,” he said. “It’s like a radar system. You’re getting a blip on the radar, and you have to do further investigation to discover whether that airplane is friend or foe.”

The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice.

The agency noted that it has looked for and failed to find the same increase in strokes in other large collections of medical records, including those maintained by Medicare, the US Department of Veterans Affairs, as well as its Vaccine Adverse Event Reporting System, known as VAERS.

Neither Pfizer nor other countries that are using the vaccine have seen any increase in this kind of stroke, the agency said, and the signal was not detected in any other databases.

The CDC says that it does not recommend any change to vaccination practices at this time and that the risks of Covid-19 for older adults continue to outweigh any possible safety issues with the vaccine.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the notice says.

“CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.”

Pfizer said in a statement Friday, “Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.

“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”

The bivalent boosters from Pfizer/BioNTech and Moderna protect against the original strain of the coronavirus as well as the Omicron BA.4 and BA.5 subvariants. Only about 50 million Americans ages 5 and up have gotten them since they were authorized last fall, according to CDC data.

Schaffner said he was part of a briefing Thursday with members of the Covid-19 Vaccine Work Group. He couldn’t share specific details about the briefing but said the safety signal was discussed.

His biggest takeaway was that the safety surveillance system is working.

It’s very likely that this is a false signal, he said, but it’s being investigated, which is important.

“You want a surveillance system that occasionally sends up false signals. If you don’t get any signals, you’re worried that you’re missing stuff.”

Schaffner said he would absolutely tell people to get their Covid-19 booster if they haven’t done so yet – even those 65 and older.

“Undoubtedly, the risk of a whole series of adverse events, including hospitalization, is much, much greater with Covid-19 than it is from the vaccine,” he said.

He also said the signal – if real – may be more a factor of numbers than an indication that one manufacturer’s vaccine is riskier than the other.

Nearly two-thirds of the people in the US who’ve gotten an updated booster – 32 million – have gotten Pfizer, compared with about 18 million Moderna shots.

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Alzheimer’s drug lecanemab receives accelerated FDA approval amid safety concerns

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CNN
 — 

The US Food and Drug Administration granted accelerated approval Friday for the Alzheimer’s disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Lecanemab will be marketed as Leqembi, the FDA statement said. It has shown “potential” as an Alzheimer’s disease treatment by appearing to slow progression, according to Phase 3 trial results, but it has raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.

In July, the FDA accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway and granted the drug priority review, according to the company. The accelerated approval program allows for earlier approval of medications that treat serious conditions and “fill an unmet medical need” while the drugs continue to be studied in larger and longer trials.

If those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval. But if the confirmatory trial does not show benefit, the FDA has the regulatory procedures that could lead to taking the drug off the market.

Lecanemab, a monoclonal antibody, is not a cure but works by binding to amyloid beta, a hallmark of Alzheimer’s disease. In late November, results from an 18-month Phase 3 clinical trial published in The New England Journal of Medicine showed that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events.”

The results also showed that about 6.9% of the trial participants given lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared with 2.9% of those given a placebo. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group.

The most common adverse events in the lecanemab group were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening.

Some people who get ARIA may not have symptoms, but it can occasionally lead to hospitalization or lasting impairment. And the frequency of ARIA appeared to be higher in people who had a gene called APOE4, which can raise the risk of Alzheimer’s disease or other dementias. ARIA “were numerically less common” among APOE4 noncarriers, the study showed.

The drug’s prescribing information carries a warning about ARIA, the FDA says.

The trial results also showed that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group.

The Alzheimer’s Association welcomed Friday’s decision.

“By slowing progression of the disease when taken in the early stages of Alzheimer’s, individuals will have more time to participate in daily life and live independently,” President and CEO Joanne Pike said. “This could mean more months of recognizing their spouse, children and grandchildren. This could also mean more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”

More than 6.5 million people in the United States live with Alzheimer’s disease, according to the Alzheimer’s Association, and that number is expected to grow to 13.8 million by 2060.

Lecanemab will carry a wholesale price of $26,500 per patient per year, the drug’s manufacturers announced Friday.

Biogen and Eisai have listed the drug slightly below the reduced price of the Alzheimer’s medication Aduhelm, which now costs an average patient about $28,200. The companies had to lower the cost of Aduhelm – originally set at $56,000 per patient per year – after insurers balked at covering it.

In justifying the cost of Leqembi, the companies said in a news release that based on the estimated quality of life gained by people who take it, the value of the medication to society is around $37,000 a year, but they chose to go lower “aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability.”

The wholesale cost of a drug is akin to a car’s sticker price. It isn’t necessarily what patients will pay after insurance or other discounts are factored in.

Insurance coverage for this medication is not a given, however. Medicare restricted its coverage of lecanemab’s sister drug, Aduhelm, after clinical trials showed questionable benefits to patients. The agency agreed to cover the drug only for people enrolled in registered clinical trials, which limited access to the medication.

Center for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure said after the FDA’s decision Friday that her office would quickly review Leqembi, but for now, because of its accelerated approval, it will be covered the same way Aduhelm is covered.

“At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” Brooks-LaSure said in a statement.

Last month, the Alzheimer’s Association filed a formal request asking CMS to provide “full and unrestricted coverage” Alzheimer’s treatments approved by the FDA.

“What the FDA did today in granting accelerated approval to Leqembi was the right decision. But what CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong,” Pike said in a statement Friday.

“The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug’s evidence. CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer’s. Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months – memories, skills and independence. They’re losing time.”

CMS told CNN that it will review and respond to the association’s request. The agency also noted that it continues to stay informed about ongoing clinical trials, including the most recent lecanemab results published in the New England Journal of Medicine. Also, it has met with drugmakers to learn about their efforts since CMS’s coverage decision was announced.

The FDA approved Aduhelm for early phases of Alzheimer’s disease in 2021 – but that decision has been shrouded in controversy as a congressional investigation found last week that the FDA’s “atypical collaboration” to approve the high-priced drug was “rife with irregularities.”

Before Aduhelm, the FDA had not approved a novel therapy for the condition since 2003.

Aduhelm’s FDA approval and initial hefty price tag hit Medicare’s Part B premiums, driving up the 2022 standard monthly payments by 14.5% to $170.10.

About $10 of the premium spike – or just under half the amount – was due to Aduhelm, a CMS official told CNN in late 2021.

The premium increase was set before Medicare announced its limited coverage of the drug, but its actuaries had to make sure that the program had sufficient funding in case Aduhelm was covered.

Medicare’s decision, as well as Biogen’s slashing of the drug’s cost, prompted a decline in monthly premiums for 2023 to $164.90.

The FDA’s accelerated approval of lecanemab was expected, said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine.

Isaacson said lecanemab can be “another tool” in his toolbox to fight Alzheimer’s disease.

“I will prescribe this drug in the right person, at the right dose and in a very carefully monitored way, but this drug is not for everyone,” he said.

“I would do genetic testing for APOE4 first. I would have a frank discussion with my patients,” he said. “If someone is having side effects, if someone is on a blood-thinning medication, if someone has a problem, they need to discuss this with the treating physician, and they need to seek medical attention immediately.”

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Covid-19 vaccine boosters for kids age 5 and under

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CNN
 — 

Last week, the US Food and Drug Administration authorized the bivalent Covid-19 booster for children 6 months to 5 years old. The US Centers for Disease Control and Prevention has since recommended the booster, and now everyone 6 months and older is able to receive the updated coronavirus vaccine except kids who got three doses produced by Pfizer/BioNTech.

Which young children are now eligible to receive the booster? What if kids haven’t started or completed the full series — do they now get the updated booster or the original monovalent vaccine? Can parents and guardians choose between the updated booster and the original shot? What are possible side effects? What if kids had Covid-19 already? And which families should consider the updated booster now and who could wait?

To help us answer these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician, public health expert, and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also author of “Lifelines: A Doctor’s Journey in the Fight for Public Health” and the mother of two young children, ages 2 and 5.

CNN: Let’s start with what has just changed in the recommendations: Which young children who received either the Pfizer or Moderna vaccine are now eligible to receive the booster?

Dr. Leana Wen: There are two vaccines authorized for young children: Moderna and Pfizer. For the youngest age group, the Moderna vaccine was designed to be a two-dose primary vaccine, while the Pfizer version was designed to be a three-dose primary vaccine. That means young children are considered to have completed their primary series if they completed two doses of the Moderna vaccine or if they completed three doses of Pfizer.

As a reminder, there is now a bivalent booster available for older children and adults. This combines the original (also called monovalent) vaccine with a vaccine that specifically targets the BA.4 and BA.5 Omicron subvariants. Because Omicron subvariants constitute virtually all new infections, the hope is that the bivalent booster will provide better, more directed protection.

What federal health officials have now said is that children 6 months through 5 years old who received both doses of the original Moderna vaccine are able to get the updated bivalent vaccine — if it has been at least two months since they completed the primary vaccine series.

For children who received the Pfizer vaccine, the guidance is a little different, because the primary series already involves three doses. Federal health officials have said that children 6 months through 4 years old who have not yet completed their three vaccine doses can receive the third dose as the bivalent vaccine. Let’s say a child has started this series and has had one or two doses of the original Pfizer vaccine. The third dose can now be the updated booster.

CNN: What if kids haven’t started or completed the full series — do they now get the updated booster or the original monovalent vaccine?

Wen: The answer is different for Moderna vs. Pfizer. For Moderna, the primary series is two doses, so a child needs to complete the two initial shots with the original formulation. The booster — the third dose — is the bivalent vaccine. For Pfizer, the primary series is three doses. The first two doses still need to be the original formulation, but the third shot is now the bivalent vaccine.

CNN: What about young children who completed three doses of the Pfizer vaccine — are they eligible for a fourth dose?

Wen: No. The FDA explicitly says that children 6 months through 4 years old who have completed their three-dose primary series with the original Pfizer vaccine are not eligible for a fourth shot of the bivalent booster. That’s because the primary series of three vaccine doses is still expected to have strong protection against severe illness to Omicron. This recommendation will be reevaluated as new data comes out.

CNN: Can parents and caregivers who have not completed the primary series of Moderna choose the bivalent vaccine as their second dose?

Wen: No. The FDA authorization for the adult primary series for Moderna — the two doses — is for the original monovalent vaccine. Similarly, there is no choice for which vaccine formulation is administered as the booster for Pfizer in adults. Only the bivalent booster is available as the third shot, not the original monovalent, which is still given as doses one and two. This mirrors the authorization given for adults — the primary series is the monovalent vaccine, with the only booster for Pfizer and Moderna for adults being the updated booster.

CNN: What are possible side effects from the updated booster?

Wen: It’s expected that children who get the updated booster will have similar types of side effects to the original vaccines. These side effects tend to be mild and short-lasting, usually resolving in the first 24 hours after inoculation. Adverse reactions can include pain and swelling in the injection site, fatigue, crankiness, sleepiness, headache, muscle aches and sometimes fever. Many children experience no side effects. The risk of serious side effects, such as myocarditis (an inflammation of the heart muscle), is expected to be exceedingly rare in this younger age group.

CNN: What if kids had Covid-19 already?

Wen: People who had Covid-19 can wait three months until after they have recovered from the coronavirus to receive another vaccine dose, according to the CDC. They probably have very good protection against infection in this period.

Many studies have shown that hybrid immunity — recovery from Covid-19 combined with vaccination — conveys very strong protection, arguably even more so than vaccination and boosters alone. In my opinion, I believe a case can be made that if a young child received the primary series and already had Covid, they could wait to receive another booster dose. This is especially true if they had Covid recently, in the last year. To my knowledge, there is no research that shows additional benefit of boosters to young children who recently had Covid-19 infection and who have received their primary vaccinations.

CNN: Which families should consider the updated booster now and who should wait?

Wen: First, I think it’s important to point out that the uptake of the primary series of the Covid-19 vaccines among young children is very low. According to the CDC, less than 5% of kids 5 and younger are fully vaccinated. That means we are referring to a very small pool of kids newly eligible for the updated boosters.

There’s one group that I would definitely recommend getting the updated booster. That’s the group of kids who received their first one or two doses of the Pfizer vaccine. These kids need to complete their primary series. The third dose of that series is now the updated bivalent booster. There’s no reason for families of these children to wait; they should complete the primary series, and it’s a bonus that the third dose is updated to target Omicron.

For children who received the two doses of the Moderna vaccine, I think the decision-making is different and will depend on families’ individual circumstances. Some families are very concerned about Covid-19 infection. Perhaps their child has underlying medical conditions, or they live with someone who is elderly, immunocompromised or otherwise very vulnerable to severe outcomes from Covid-19. Perhaps the family is welcoming a newborn soon, and that baby will be particularly vulnerable to coronavirus infection. I think it’s reasonable to decide that, since Covid-19 cases are rising, this is the time to get their young child the updated booster.

I also think it’s reasonable to wait. My children (ages 2 and 5) received the Moderna vaccines over the summer. They are eligible to be boosted, but I am holding off because the protection that they have against severe illness remains strong. The booster will convey additional protection against symptomatic infection, but that effect is probably short-lasting, according to a June study.

To be clear, I believe it’s crucial for older adults and vulnerable individuals to receive the updated booster. I also think it’s generally a good thing that people can choose the booster if they wish, as there are compelling individual reasons for different households.

Parents and caregivers who have questions should consult their pediatrician to decide the best course of action for their family’s specific circumstances. Finally, families whose children have yet to receive any Covid-19 vaccines should consider starting, especially if their kids are not known to have had Covid-19.

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In wake of baby formula crisis, critical report recommends major food safety changes at FDA

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CNN
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To help prevent outbreaks of food-related illness and problems like the formula shortage that left many parents in the US without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind of leadership, and it has to act with more urgency, according to a highly critical new report.

After the agency faced serious criticism for its handling of the formula shortage, FDA Commissioner Dr. Robert Califf commissioned the review of the Human Foods Program in July from the Reagan-Udall Foundation, an independent group of experts.

The need for a review was considered so urgent that Califf asked the group to submit the report in 60 business days – lightning speed for government-focused reports. It was submitted to the FDA on Tuesday.

About 48 million Americans get some kind of foodborne illness every year, according to the US Centers for Disease Control and Prevention. Of those, 128,000 are hospitalized, and 3,000 die. Produce alone in 2019 was responsible for 46% of foodborne illness outbreaks, according to the US Department of Agriculture.

The FDA oversees the safety of 78% of the US human food supply.

It enforces food safety regulations, works with local governments on food safety information, promotes dietary guidelines, and develops food safety information and education, as well as overseeing nutrition labels on most food and being responsible for promoting good nutrition practices to the US public.

The US food supply is generally recognized as safe, the Reagan-Udall Foundation’s report said, but the FDA needs to be much more proactive in dealing with foodborne pathogens in order to protect Americans.

“An approach that is primarily focused on identifying and reacting to acute outbreaks of foodborne illness and death is unacceptable,” the report says.

Americans’ nutrition can also improve, the report says. Most people don’t follow the US dietary recommendations, and more than a million die of diseases that can be linked to diet such as heart disease, type 2 diabetes and cancer each year, according to the FDA

“Relying solely on food labeling and consumer education to drive the needed changes in the food supply is also an unacceptable strategy for reducing diet-related chronic diseases,” the new report says.

The report suggests that the agency needs major reform in order to do a better job managing food in the US. Some of the proposed changes would require congressional approval.

The report has several suggestions for ways to reach these goals. One would create a separate Center for Nutrition within the US Department of Health and Human Services. Another would have the FDA develop a strategy to increase funding for the Human Foods Program, with help from Congress. The agency could also connect its technology systems so they better communicate with each other.

The FDA could seek to amend the Federal Food, Drug, and Cosmetic Act to allow the disclosure of more information to local agencies. Or it could get regulatory authority to request records from food manufacturers in advance or in lieu of inspection.

The report recommends that the FDA explore applying its authority to require infant formula manufacturers, for instance, to keep microbiological testing records that are available on request so there is real-time disclosure of results.

It also suggests that the FDA use its mandatory recall authority more often and that there should be a process by which accommodations are made for products that are considered life-sustaining, like formula. At the moment, food recalls are usually voluntarily initiated by a manufacturer or food distributor.

The report also notes that the food program is run under the leadership of several managers. This “lack of a single, clearly identified person” to lead the program has led to a culture of “constant turmoil” and “indecisiveness and inaction” that has created “disincentives for collaboration,” according to the report.

That turmoil was partly to blame for the agency’s problematic handling of the formula shortage, the report says.

Experts have said the agency failed to act quickly enough on sanitation complaints at an Abbott Nutrition formula manufacturing facility in Michigan, and because of a lack of communication across departments, it didn’t circumvent what became a massive shortage of formula after the plant shut down.

“A review of events indicates that lack of communication and engagement across the Agency accounted, in part, for missteps,” the new report says. “There was little motivation, and apparently no requirement, to share information and interact across the Agency to facilitate critical thinking and proactive decision-making.

“This is especially problematic in a crisis, where decisions should be made quickly and be vetted properly.”

The report suggests that the FDA create a new structure with clear roles and leaders. It also encourages development of a culture that is more transparent, that acts quickly and collaborates.

“The current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal” of protecting public health,” the report says.

Califf said Tuesday that the agency has not had the opportunity to review the report in depth but that the report provides “significant observations” and options to consider.

“The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” Califf said in a news release.

Some critics have suggested that food safety takes a back seat to the FDA’s regulations of drugs and medical devices. Califf acknowledged that food policy was important to the agency, citing the decline in life expectancy in the US largely due to chronic diseases that can be improved with good nutrition.

“The Human Foods Program is a top priority for the agency. America’s food supply is as safe as it’s ever been,” he said. “That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.”

The FDA will inform the public about how it is moving forward on the panel’s suggestions by the end of January and will provide additional updates at the end of February, including on any structural or procedural changes it will make, Califf said.

He said he’s putting together a group of leaders at the FDA that will advise him on how to “operationalize these findings,” and he expects these leaders to be “bold and focused on the transformative opportunities ahead for the FDA’s food program.”

In April, a coalition of 30 organizations that represent industry, local regulators and consumers sent a letter to the FDA asking for the creation of a deputy commissioner for foods with direct line authority over all the agency’s food components.

One of the organizations, Consumer Reports, has called for months for more accountability and focused leadership from the FDA.

“We need strengthened leadership and accountability at the FDA to implement a culture of prevention, respond more quickly to problems as they arise, and take timely action on proposed food safety rules and initiatives,” Brian Ronholm, Consumer Reports’ director of food policy, said Tuesday.

Ronholm called the new report a “very encouraging first step.”

“We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the FDA’s ability to protect the public and ensure our food is safe,” he said in a statement.

The Consumer Brands Association, a trade association for food manufacturers that also signed the April letter, said Tuesday that the lack of a single leader on food policy leads to “a lot of inefficiencies.”

“A siloed approach across FDA makes it harder for industry to engage,” said Sarah Gallo, the organization’s vice president for product policy. “It is just really complicated when you don’t have somebody looking over the different parts of the agency that have some form of jurisdiction over all those things.

“We can’t ignore what happened with the formula crisis,” Gallo added, a tangible example of what can happen when the FDA is not functioning at its best.

Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association, agreed that if there were one person in charge, they could make sure the inspection and policy parts of the FDA would work together.

Wagner added that the food industry has embraced a more prevention-oriented kind of philosophy when it comes to safety. “Quite frankly, the problem is, FDA’s inspection force has not modernized itself or its approaches to basically mirror that prevention-oriented system and philosophy,” Wagner said.

The FDA food division has its work cut out for it, though, added Wagner, who worked with the agency in several capacities before joining the association.

“Think about it: The FDA has to keep up with hundreds of thousands of farms and facilities,” she said. “If you have these siloed operations, you’re not having these really critical conversations about where we should be and what should we be doing out there.

“We all want an FDA with a strong foods program. We want consumers not to worry about what they’re eating or whether they’re going to be able to get that certain needed food product,” Wagner added.

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FDA approves first treatment to delay onset of type 1 diabetes

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CNN
 — 

A biologic therapy that delays the onset of type 1 diabetes received approval from the US Food and Drug Administration on Thursday.

It is the first therapy approved for prevention of type 1 diabetes.

The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield, from ProventionBio and Sanofi is given through intravenous infusion.

It is thought to work by turning down the body’s misdirected attack on its own insulin-producing cells. The idea is that protecting these cells buys people more time before they become dependent on insulin to manage their condition.

In clinical trials, Tzield delayed progression to full-blown diabetes by a little over two years. But the benefits have lasted much longer in some of the study participants.

One of them, Mikayla Olsten, was screened for diabetes after her 9-year old sister, Mia, suddenly developed a life-threatening episode of diabetic ketoacidosis and was diagnosed with diabetes. There was no history of diabetes in the family, and Mikayla wasn’t sick, but she had four of the five types of autoantibodies that doctors look for to assess a person’s risk.

“They told us when somebody has that many markers, it’s not if they’re going to develop diabetes, it’s when,” said her mom, Tracy.

Mikayla was 15 when she joined the study and received teplizumab. She’s now 21 and a senior in college. She gets an annual battery of tests to check her pancreas and blood markers, and Tracy Olsten says her condition hasn’t progressed in six years.

According to a scientific statement from the Juvenile Diabetes Research Foundation, the Endocrine Society and the American Diabetes Association, when a person has markers for autoimmune disease and episodes of uncontrolled blood sugar, the five-year risk for progression to insulin-dependent symptomatic disease is 75%. The lifetime risk of developing insulin-dependent diabetes is nearly 100%.

So far, Mikayla seems to be beating those odds.

Tracy said that for Mia, who is dependent on insulin, managing her diabetes is a constant chore.

“She has a tremendous amount of juggling that her peers don’t have to do. She has to plan ahead when she has a basketball game or practice on making sure she carbs up and decreases her insulin levels,” Tracy said. “She cannot go a minute or a day without thinking about it nonstop, and to be able to give Mikayla the opportunity where she doesn’t have to think about it 24/7 is amazing.”

Aaron Kowalski, CEO of the Juvenile Diabetes Research Foundation, says the main challenge in prescribing Tzield will be finding people who need it. The drug is approved for people who don’t have any symptoms of the disease and may not know they’re on the road to getting it.

“Screening becomes a really big issue, because what we know is, about 85% of type 1 diagnoses today are in families that don’t have a known family history,” Kowalski said. “Our goal is to do general population screening” with blood tests to look for markers of the disease.

Tzield is approved for use in people 8 and older who are in stage 2 of their type 1 diabetes. In that stage, doctors can measure antibodies that attack insulin-producing beta cells in the person’s blood, and they have abnormal blood sugar levels, but their body can still make insulin.

“The way in which not just industry but our medical system go about managing autoimmune diseases, and especial type 1 diabetes, is really suboptimal in today’s day and age,” ProventionBio co-founder and CEO Ashleigh Palmer said. “What we do is, we wait until the symptoms of the disease present to doctors, and then doctors treat the patient’s symptoms chronically for a lifetime. The trouble is that in type 1 diabetes, when the symptoms first present, it’s too late.”

The treatment comes in a single 14-day course of infusions that each last 30 to 60 minutes.

The most common side effects reported in the trial participants were low white blood cells and lymph cells, rash and headache.

With type 1 diabetes, a person’s immune system attacks cells called beta cells in the pancreas that produce insulin, a hormone that helps blood sugar enter cells, where it’s used for energy. The attack can happen for years before any symptoms of diabetes appear. Without insulin, blood sugar can build up in the bloodstream and break down the body’s own fat and muscle.

Palmer says Tzield holds off the disease before symptoms appear by stopping the autoimmune disease process and the underlying destruction of beta cells. The treatment essentially reboots the immune system, preserving beta cell function.

“We really have no preventative measure for type 1 diabetes to date, and that is despite [the National Institutes of Health] funding hundreds of millions of dollars over the last 20-plus years of a program called TrialNet that has tested many, many different things, including this, and some of this came out of that work,” said Dr. Robert Gabbay, chief scientific and medical officer for the American Diabetes Association. “Finally, there is something that delays the onset of type 1 diabetes, and it’s so exciting.”

Unlike type 2 diabetes, which can be prevented with lifestyle changes like losing weight and exercising, type 1 is a genetic disease that has not had any prevention options until now.

“For some reason, we don’t screen for type 1 diabetes, even though there are biomarkers available to show that the autoimmune disease process is already underway,” Palmer said. He added that the hopes the drug will catalyze the medical system to start population-based screening during routine childhood well visits in order to intercept the disease and delay its onset.

With Tzield, doctors would screen individual family members of people with type 1 diabetes to see whether they have those specific antibodies. If antibody levels are high and it appears that the person is about to develop diabetes, the treatment will delay that process.

“If somebody has type 1, a common question that comes up is ‘well, what about my child? Are they going to develop type 1?’ It’s only about a 5% risk, so more often than not, they won’t, but if you could find the ones that would and treat them, that can make a big difference,” Gabbay said.

A delayed diagnosis of type 1 diabetes could have a significant impact.

“Obviously, the quality of life is substantially impacted, negatively impacted, if you are diagnosed with type 1 diabetes. It’s a disease that never goes away,” Palmer said.

People who are type 1 diabetics must monitor their blood glucose levels around the clock, affecting how they exercise and eat. High blood sugar can lead to diabetic ketoacidosis, in which the body starts to break down fat as its fuel, and can cause a buildup of acids called ketones in the bloodstream. That condition can lead to hospitalization, coma or death.

As of 2019, about 1.9 million people have type 1 diabetes in the United States, according to the American Diabetes Association, including 244,000 children and adolescents. Type 1 affects 8% of everyone with diabetes.

“The incidence of the type 1 is mainly in kids and teenagers, and when you are in the turmoil of adolescence, when you just want to forget that you have it,” said Olivier Bogillot, Sanofi’s head of US general medicines. “So when you have the ability with a treatment to just delay the onset of the disease, you can change the way the quality of life is impacted for families and for those kids.”

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Lab-grown meat is OK for human consumption, FDA says

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CNN
 — 

The US Food and Drug Administration has given a safety clearance to lab-grown meat for the first time.

Upside Foods, a California-based company that makes meat from cultured chicken cells, will be able to begin selling its products once its facilities have been inspected by the US Department of Agriculture.

The agency said it had evaluated the information submitted by Upside Foods and it had “no further questions at this time about the firm’s safety conclusion.”

“Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock, poultry, and seafood in the production of food, with these products expected to be ready for the U.S. market in the near future,” Dr. Robert M. Califf, the FDA’s commissioner of food and drugs and Susan T. Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said in a statement.

“The FDA’s goal is to support innovation in food technologies while always maintaining as our first priority the safety of the foods available to U.S. consumers,” the statement added.

Upside Foods founder and CEO Uma Valeti said on Twitter that its cultivated chicken “was one step closer to being on tables everywhere.”

“UPSIDE has received our ‘No Questions Letter’ from the FDA,” Valeti tweeted. “They’ve accepted our conclusion that our cultivated chicken is safe to eat.”

He told CNN earlier this year that the process of making cultivated meat was “similar to brewing beer, but instead of growing yeast or microbes, we grow animal cells.”

“These products are not vegan, vegetarian or plant-based – they are real meat, made without the animal.”

Singapore was the first country to allow the sale of cultured meat. It granted San Francisco start-up Eat Just Inc. regulatory approval in 2020 to sell its laboratory-grown chicken in Singapore.

Advocates hope that cultured meat will reduce the need to slaughter animals for food and help with the climate crisis. The food system is responsible for about a quarter of global greenhouse gas emissions, most of which are from animal agriculture.

“We are thrilled at FDA’s historic announcement that, after a rigorous evaluation, UPSIDE Foods has become the first company in the world to receive the US FDA greenlight for cultivated chicken,” David Kay, director of communications at Upside Foods, said via email.

“At scale, cultivated meat is projected to use substantially less water and land than conventionally-produced meat.”

Although not technically an approval, the FDA said that a thorough pre-market consultation process had been completed. The clearance only applies to food made from cultured chicken cells by Upside, but the statement said the FDA “is ready to work with additional firms developing cultured animal cell food.”



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