Tag: pharmaceuticals

Report shares new details about death possibly linked to experimental Alzheimer’s drug | CNN

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CNN
 — 

The death of a participant in a clinical trial of an antibody treatment for Alzheimer’s disease, which is now under consideration by the US Food and Drug Administration, may be linked to the experimental drug, a new report shows.

The research letter, published Wednesday in the New England Journal of Medicine, shares details about what happened to the participant in the open-label extension phase of the trial of lecanemab.

In an open-label extension, there is no placebo arm; rather, all the participants get the medication in question because an earlier part of the trial has shown so much potential.

In this case, a 65-year-old who was in the early stages of Alzheimer’s was taken to an emergency room in a Chicago-area hospital within 30 minutes of the first signs of a stroke, the report says. Doctors at the Northwestern University Feinberg School of Medicine learned that the patient had gotten infusions of lecanemab four days before.

This patient is not the only one to die during the open-arm extension. The health publication Stat reported that an investigator told it about the death of another participant who had bleeding in the brain that may have been related to the drug. In that case, drugmaker Eisai pointed to other possible factors.

Lecanemab is meant to slow the progression of Alzheimer’s. In November, the company released a study showing that it slowed the progression of cognitive decline by 27% compared with a placebo. It also reduced amyloid levels – a protein that is one of the hallmarks of Alzheimer’s – and had positive effects on cognition and the ability to perform everyday tasks when compared with a placebo.

The research also showed that about 2.8% of trial participants who took the drug had a symptomatic side effect called ARIA-E, which involves swelling in the brain. None of the participants who got a placebo had that.

The new report says the medical team at the hospital gave the patient a common medication to break up blood clots that could cause a stroke, called t-PA bolus. Nothing in the patient’s medical background suggested that they would have a problem with that drug. But less than an hour into the treatment, their blood pressure shot up, so doctors stopped the infusion.

A CT scan showed extensive bleeding in the brain.

The doctors then administered a medicine that can control the bleeding, but the patient became severely agitated and developed communication problems. The patient also had frequent nonconvulsive seizures.

The medical team was able to treat the seizures, but the person’s condition did not get better.

After three days in the hospital, the person got a tube in their windpipe to help them breathe. Even with that and other supportive care, the patient died.

An autopsy showed that the patient had extensive brain bleeding and amyloid deposits within many of the blood vessels in their brain that probably contributed to the hemorrhage, the report said.

Essentially, the report says, the blood vessels in the patient’s brain must have burst after being exposed to the blood clot medicine t-PA.

“The extensive number and variation in sizes of the cerebral hemorrhages in this patient would be unusual as a complication of t-PA solely related to cerebrovascular amyloid,” the report says. But the combination of the clot-busting drug with lecanemab may have led to the cerebral hemorrhages.

Northwestern Medicine declined CNN’s request to interview the authors of the new report but said in a statement that it was “an effort to provide relevant data to the medical and scientific community.”

Eisai said it did not have an official response because of patient privacy.

The company and Northwestern Medicine pointed to a response published alongside the new report from clinicians and researchers who were involved in the lecanemab clinical trials.

Drs. Marwan Sabbagh and Christopher H. van Dyck wrote in that response that they “agree that this case raises important management issues for patients with Alzheimer’s disease.”

It is an “unusual case, and we understand why the authors want to highlight a potential concern,” they said.

Their response also pointed to other potential factors in the deaths of both trial participants.

In this case, the brain bleed could have been connected to a period of time after the stroke when the patient’s blood pressure was exceptionally high, they said. And the other trial participant was taking a drug for atrial fibrillation that may have been a contributing factor.

The doctors also write in the response that other patients who have gotten t-PA have died with these amyloid deposits within blood vessels in the brain.

Dr. Sharon Cohen, a behavioral neurologist who works with Alzheimer’s patients at the Toronto Memory Program and an investigator in the lecanemab trial, says it’s been difficult to develop a therapeutic for Alzheimer’s.

Cohen said that doctors have known for years that almost all of the drugs in this class can come with a side effect of ARIA, which stands for amyloid-related imaging abnormalities.

The safety of the drug “looks very acceptable,” she said. “It’s within the range of adverse events that we expected and seems very reasonable for this patient population.”

The rate of bleeding in the trial is considered very low, and most of the microbleeds seen in the trial have been asymptomatic, she said.

In the case of the patient in the new report, Cohen thinks the death was probably related to the blood clot drug but said the combination of that drug and lecanemab “gives us pause.”

If the FDA approves the treatment, there may be some discretion in terms of patient choice and what the prescribing physician feels is best for for someone who is taking anticoagulants or has other risk factors for hemorrhaging, she said.

In general, lecanemab has in many ways exceeded our expectations, she said, “because we haven’t seen such consistently positive results in an Alzheimer’s disease modification trial at all until now.”

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Myths and facts about treating a hangover | CNN

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CNN
 — 

Are you celebrating the first day of 2023 with a hangover?

If so, you might be looking for a method to ease your misery. There are certainly a lot of so-called hangover cures, some dating back centuries.

“The ancient Greeks believed that eating cabbage could cure a hangover, and the Romans thought that a meal of fried canaries would do the trick,” said Dr. John Brick, former chief of research at the Center of Alcohol Studies, Education and Training Division at Rutgers University in New Jersey, who authored “The Doctor’s Hangover Handbook.”

“Today, some Germans believe that a hearty breakfast of red meat and bananas cures hangovers. You might find some French drinking strong coffee with salt, or some Chinese drinking spinach tea,” he said. “Some of the more unusual hangover cures are used by some people in Puerto Rico, who rub half a lemon under their drinking arm.”

In truth, the only cure for a hangover is time, according to the National Institute on Alcohol Abuse and Alcoholism.

“A person must wait for the body to finish clearing the toxic byproducts of alcohol metabolism, to rehydrate, to heal irritated tissue, and to restore immune and brain activity to normal,” according to the institute. That recovery process can take up to 24 hours.

Are there things you can do to ease your transition? Possibly, experts say, but many common hangover “cures” may make your hangover worse. Here’s how to separate fact from fiction.

Having another drink, or the “hair of the dog that bit you,” is a well-known cure for a hangover, right? Not really, experts say.

The reason some people believe it works is because once the calming effects of alcohol pass, the brain on a hangover is overstimulated. (It’s also the reason you wake up in the middle of the night once your body has metabolized alcohol.)

“You’ve got this hyperexcitability in the brain after the alcohol is gone,” said Dr. Robert Swift, a professor of psychiatry and human behavior at Brown University’s Warren Alpert Medical School in Providence, Rhode Island.

“If you look at the brain of somebody with a hangover, even though the person might feel tired, their brain is actually overexcited,” he said.

Consuming more alcohol normalizes the brain again, “because you’re adding a sedative to your excited brain,” Swift said. “You feel better until the alcohol goes away and the cycle repeats in a way.”

The answer is yes, depending on hangover symptoms, Brick said. If you’re a coffee drinker, skipping your morning cup of joe may lead to caffeine withdrawal on top of your hangover.

But coffee can irritate the stomach lining, which is already inflamed by alcohol, Brick said. So if you are queasy and nauseous, coffee may only make matters worse.

“If you have a hangover, have a quarter of a cup of coffee,” Brick suggested. “See if you feel better — it takes about 20 minutes for the caffeine to start to have some noticeable effect.

“If coffee doesn’t make you feel better, don’t drink anymore. Obviously, that’s not the cure for your hangover.”

Forget eating a greasy breakfast in the wee hours after a night of drinking — you’re adding insult to injury, Swift said: “Greasy food is harder to digest, so it’s probably good to avoid it.”

Eating greasy food also doesn’t make much sense. The alcohol we drink, called ethyl alcohol or ethanol, is the byproduct of fermenting carbohydrates and starches, usually some sort of grain, grape or berry. While it may create some tasty beverages, ethanol is also a solvent, Brick said.

“It cuts through grease in your stomach much the same way it cleans grease off oily car parts,” he said.

Instead, experts suggest using food to prevent hangovers, by eating before you have that first drink.

“Eating food loaded with protein and carbohydrates can significantly slow down the absorption of alcohol,” Brick said. “The slower the alcohol gets to your brain, the less rapid the ‘shock’ to your brain.”

Alcohol dehydrates, so a headache and other hangover symptoms may be partly due to constricted blood vessels and a loss of electrolytes, essential minerals such as sodium, calcium and potassium that your body needs.

If you’ve vomited, you’ve lost even more electrolytes, and all of this can lead to fatigue, confusion, irregular heart rate, digestive problems and more.

Replacing lost fluids with water or a type of sports drink with extra electrolytes can help boost recovery from a hangover, Swift said.

Taking over-the-counter pain meds can be dangerous, especially if you take too many while intoxicated, experts say. Taking an acetaminophen, such as Tylenol, can further damage your overtaxed liver, while aspirin and ibuprofen can irritate your stomach lining.

“You should never, never take alcohol with acetaminophen or Tylenol,” Swift said. “You can actually cause liver damage from an overdose of Tylenol.”

But aspirin, ibuprofen and naproxen are “theoretically” OK, he added.

“Even though they tend to be anti-inflammatory in the body, they can cause inflammation in the stomach,” Swift said. “Don’t take them on an empty stomach; always take anti-inflammatories with food.”

While most alcohol is handled by the liver, a small amount leaves the body unchanged through sweat, urine and breathing.

Get up, do some light stretching and walking, and drink plenty of water to encourage urination, Brick said.

“Before you go to sleep and when you wake up, drink as much water as you comfortably can handle,” he said. You can also take a multivitamin “before you hit the shower in the morning (to) replenish lost vitamins, minerals and other nutrients.”

If you would rather have something warm and soothing, Brick suggested broth or other homemade soups.

“These will also help to replace lost salts, including potassium and other substances,” he said, “but will not make you sober up faster or improve impairment due to intoxication or hangover.”

Store shelves are packed with so-called hangover cures. Unfortunately, there’s no proof they work. In 2020, researchers published what they called the “world’s largest randomised double-blind placebo-controlled” trial of supplements containing vitamins, minerals, plant extracts and antioxidants and found no real improvement in hangover symptoms.

Even if one solution works, it likely won’t fix all your symptoms, experts say.

“The effects of alcohol and alcoholic beverages are so complicated, so complex,” Swift said, “that any solution might address one or two of the symptoms but won’t address them all.”

What does work for a hangover? Time. It will take time for your body to release all the toxins causing your misery, experts say. And the only way to prevent a hangover is to abstain.

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Home delivery of medications can help improve access, especially when time is tight | CNN

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CNN
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Covid-19 hospitalizations are on the rise in the United States, with more than 34,000 new admissions last week, but millions of vaccines and doses of antiviral treatments that could help prevent severe outcomes from the virus remain unused.

Research has found that many who could benefit most from the Covid-19 medication Paxlovid – including the elderly and Black and Hispanic people, groups that have disproportionately had the most severe illness – are less likely to take it.

As the supply of Paxlovid has grown, efforts have been made to improve timely, equitable access to the treatment.

“The driving distance to the nearest site or the geographic accessibility of the places where Paxlovid is being offered doesn’t seem to be the primary driver of why these populations are not getting the treatments they need,” said Dr. Rohan Khazanchi, a resident at Harvard Medical School and health equity consultant for the New York City health department.

Transportation is one significant barrier to health care access for many people, experts say, but creating equitable outcomes will involve a much more comprehensive approach.

In response to the White House’s call for pharmacies to help make this winter a healthier one for Americans, Walgreens launched a program Thursday in partnership with DoorDash and Uber Health that offers free home delivery of Paxlovid for those with a prescription. The initiative is meant to increase access to Covid-19 treatment, particularly for those in socially vulnerable or medically underserved communities.

Millions of Americans get prescriptions through the mail, a service that research has shown is used more frequently among seniors, adults with poor health and others who are also at high risk of severe outcomes for Covid-19.

But Paxlovid is most effective when taken within five days of symptoms starting, making timely treatment a critical piece of the puzzle and traditional mail-order delivery too slow.

Walgreens also plans to expand the service to include HIV treatment – in line with the Biden administration’s goals to accelerate efforts to end the HIV/AIDS epidemic in the US.

As with Paxlovid, early uptake is key with HIV treatment. And people who miss doses of HIV treatment risk developing drug resistance, making it crucial that they stick with the prescription.

“There are places across the patient journey that would divert a patient from being able to get treated and back to feeling better. But that’s where our teams have been working on really understanding that patient journey and then offering and identifying solutions to help address that,” said Rina Shah, vice president of pharmacy strategy at Walgreens.

Rite Aid adopted a prescription delivery program during the Covid-19 pandemic through a partnership with ScriptDrop. Service fees are currently waived for all eligible prescriptions, which excludes controlled substances and refrigerated medications but includes Paxlovid.

CVS also has one- or two-day delivery in most locations and on-demand delivery at some, which is provided free to people enrolled in the membership program.

In March, the Biden administration launched a federal Test-to-Treat initiative that streamlined access to Paxlovid for people who had Covid-19, with testing and prescribing all happening in one visit. In May, the program was broadened to specifically reach more vulnerable communities.

Khazanchi was author of a study published last month that found that Black and Hispanic people were more likely to live closer to Test-to-Treat sites than White people. But despite the physical proximity, these groups were less likely to get outpatient Covid-19 therapeutics – even though they’re at elevated risk of infection and severe disease.

Even if someone has a car or another way to get to the doctor’s office, pharmacy or other Test-to-Treat location, they’re often challenged by the time required to make that trip, said Dr. Rachel Werner, executive director of the University of Pennsylvania’s Leonard Davis Institute of Health Economics.

“It’s a combination of things that prevent access to care,” said Werner, whose research has focused on health equity. “Often, people have to take time off of work to do that, and they don’t always have paid sick leave. Everyone’s lives are complicated, and sometimes it’s hard to balance competing priorities.”

According to a report from health analytics company IQVIA, 9% of all new prescriptions in 2019 were “abandoned” at pharmacies, representing a gap in physician-recommended care that was not received by the patient. But home delivery programs that have expanded throughout the Covid-19 pandemic may help.

“I think it may be important to think about other medications or conditions where the time to treatment really matters. And those may be the ones that I think would be ripe for this kind of home-based delivery system,” Werner said. “These are urgent things that people might otherwise show up to an urgent clinic or ER for and instead could just get a medication.”

With the expansion of things like telehealth and options for home care, experts say, the Covid-19 pandemic helped widen the picture of what health care can look like.

“For far too long, we’ve been bound by the idea that health care is something that occurs within the four walls of a hospital or clinic,” Werner said. “What the Covid pandemic really did, which is important, is it made people realize that health care should be accessible where and when people need it, and it doesn’t have to be delivered in the physical structure of a health care setting.”

Experts say that while it’s critical to break down barriers in terms of access to medication, it’s important to also address the issue of trust.

In the research about accessibility to Test-to-Treat sites, Khazanchi and his co-authors suggested that programs should leverage trusted community stakeholders like local health-care providers for in-person outreach and other “low-tech, high-touch” methods to ensure equitable use.

Dr. Kedar Mate, president and CEO of the Institute for Healthcare Improvement and assistant professor at Weill Cornell Medical College, thinks about it in terms of supply and demand.

“Getting treatments to people who need them is principally an issue around access and ensuring that the supply goes to where the people are,” he said. “There’s a different problem, though, on the demand side. Are patients willing or interested to get tested and then get treated if they are found to be positive? That has everything to do with a totally different set of challenges which have to do with trust, information, disinformation, misinformation and belief in the health system overall.”

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New boosters add limited protection against Covid-19 illness, first real-world study shows | CNN

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CNN
 — 

Updated Covid-19 boosters that carry instructions to arm the body against currently circulating Omicron subvariants offer some protection against infections, according to the first study to look at how the boosters are performing in the real world. However, the protection is not as high as that provided by the original vaccine against earlier coronavirus variants, the researchers say.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the new data “really quite good.”

“Please, for your own safety, for that of your family, get your updated Covid-19 shot as soon as you’re eligible to protect yourself, your family and your community,” Fauci said at a White House briefing Tuesday.

Uptake of the bivalent boosters, which protect against the BA.4/5 subvariants as well as the original virus strain, has been remarkably slow. Only 11% of eligible Americans have gotten them since they became available in early September.

The new study found that the updated boosters work about like the original boosters. They protect against symptomatic infection in the range of 40% to 60%, meaning that even when vaccine protection is its most potent, about a month after getting the shot, people may still be vulnerable to breakthrough infections.

That’s in about the same range as typical efficacy for flu vaccines. Over the past 10 years, CDC data shows, the effectiveness of the seasonal flu vaccines has ranged from a low of 19% to a high of around 52% against needing to see a doctor because of the flu. The effectiveness varies depending on how similar the strains in the vaccine are to the strains that end up making people sick.

The authors of the new study say people should realize that the Covid-19 vaccines are no longer more than 90% protective against symptomatic infections, as they were when they were first introduced in 2020.

“Unfortunately, the 90% to 100% protection was what we saw during like pre-Delta time. And so with Delta, we saw it drop into the 70% range, and then for Omicron, we saw it drop even lower, to the 50% range. And so I think what we’re seeing here is that the bivalent vaccine really brings you back to that sort of effectiveness that we would have seen immediately after past boosters, which is great. That’s where we want it to get,” said Dr. Ruth Link-Gelles, an epidemiologist at the US Centers for Disease Control and Prevention.

“This protection is not 100%, but it is something,” Link-Gelles said. “Especially going into the holidays where you’re likely to be traveling, spending time with elderly relatives, with vulnerable people. I think having some protection from infection and therefore some protection from infecting your loved one is better than having no protection at all.”

Link-Gelles says it also means that people should continue to adopt a layered approach to protection, utilizing rapid tests, good-quality masks and ventilation as a comprehensive approach, rather than relying on vaccines alone.

“This should be sort of one of the things in your toolbox for protecting yourself and your family,” she said. “Personally, we’re my family is all vaccinated up to date, but I think if we go to the airport tomorrow, we’ll be wearing our N95 [masks] because we’re seeing elderly relatives this weekend. And while we of course trust the vaccines, and I’m not super worried about a mild infection in myself or my healthy husband, we certainly would not want to infect his grandmother.”

Link-Gelles added that she expects that vaccine protection against severe outcomes from Covid-19, like hospitalization and death, will be higher, but that data isn’t in yet.

The study, which was led by CDC scientists, relied on health records from more than 360,000 tests given at nearly 10,000 retail pharmacies between Sept. 14 and Nov. 11, a period when the BA.4 and BA.5 subvariants were causing most Covid-19 infections in the US. The study included people ages 18 and up who had Covid-19 symptoms and were not immunocompromised.

The study looked at how effective the boosters were in two ways: Researchers calculated a value called absolute vaccine effectiveness, which compared the odds of symptomatic infection in people who received bivalent boosters with those who reported being unvaccinated. They also calculated relative vaccine effectiveness, which looked at the odds of symptomatic infection in people who received updated bivalent boosters compared with those who had two, three or four doses of the original single-strain vaccine.

Compared with people who were unvaccinated, adults 18 to 49 who had gotten bivalent boosters were 43% less likely to get sick with a Covid-19 infection. Older adults, who tend to have weaker immune function, got less protection. Those ages 50 to 64 were 28% less likely, and those ages 65 and up were 22% less likely to get sick with Covid-19 than the unvaccinated group.

The relative vaccine effectiveness showed the added protection people might expect on top of whatever protection they had left after previous vaccine doses. If a person was two to three months past their last vaccine dose, the bivalent boosters added an average of 30% protection for those who were ages 18 to 49, 31% more protection if they were 50 to 64, and 28% more protection if they were 65 or older. At 3 months after their last booster, people ages 50 and older still had about 20% protection from Covid-19 illness, CDC data show. So overall, the updated boosters got them to around 50% effectiveness against symptomatic infection.

If a person was more than eight months away from their last vaccine dose, they got more protection from the boosters. But Link-Gelles said that by eight months, there was little protection left from previous shots against Omicron and its variants, meaning the vaccine effectiveness for this group was probably close to their overall protection against infection.

Those ages 18 to 49 who were eight months or more past their last dose of a vaccine had 56% added protection against a Covid-19 infection with symptoms; adults 50 to 64 had 48% added protection, and adults over 65 had 43% added protection, on top of whatever was left from previous vaccinations.

John Moore, an immunologist and microbiologist at Weill Cornell Medicine, said it boils down to the fact that that boosters will probably cut your risk of getting sick by about 50%, and that protection probably won’t last.

“Having a booster will give you some additional protection against infection for a short term, which is always what we see with a booster, but it won’t last long. It’ll decline, and it will decline more as the more resistant variants spread,” said Moore, who was not involved in the new research.

The immunity landscape in the United States is more complex than ever. According to CDC data, roughly two-thirds of Americans have completed at least their primary series of Covid-19 vaccines. And data from blood tests shows that almost all Americans have some immunity against the virus, thanks to infection, vaccination or both.

A new preprint study from researchers at Harvard and Yale estimates that 94% of Americans have been infected with the virus that causes Covid-19 at least once, and 97% have been infected or vaccinated, increasing protection against a new Omicron infection from an estimated 22% in December 2021 to 63% by November 10, 2022. Population protection against severe disease rose from an estimated 61% in December 2021 to around 89%, on average, this November.

All of this means the US is in a better spot, defensively at least, than it ever has been against the virus – which is not to say that the country couldn’t see another Covid-19 wave, especially if a new variant emerges that is very different from what we’ve seen, if immunity continues to wane or if behavior shifts dramatically.



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