New Amgen Drug MariTide Shows Promising Weight Loss in Early Data

The drug, which is named MariTide and delivered in a monthly injection, is years from being sold, but caused an average of up to 20 percent weight loss in a small group of patients.The pharmaceutical manufacturer Amgen announced on Tuesday that an experimental obesity drug helped patients lose an average of up to 20 percent of their weight in a year. The drug, using the brand name MariTide, is given by injection once a month, compared with once a week for other obesity drugs like Wegovy and Mounjaro that are already on the market.The data came from a clinical trial involving nearly 600 people. It was a Phase 2 trial, testing effectiveness as well as safety. The drug still must go through additional clinical trial phases involving many more patients, and then receive approval from the Food and Drug Administration before being sold to patients. The company has yet to set a price for the drug.Amgen also did not provide detailed data — that will come in later in a peer-reviewed study and will be presented at a meeting, the company said. Instead, to meet requirements of the federal Securities and Exchange Commission, it provided so called top-line data that could affect its stock price.Dr. Jeffrey Flier, a diabetes and obesity researcher at Harvard, said the results were “promising,” adding that MariTide “could be a future player in a highly competitive market.”Dr. Jay Bradner, the company’s chief scientific officer, noted a surprising effect of the drug: When the trial ended, many participants maintained their weight loss for as long as 150 days. That leaves open the possibility of less frequent injections or even of patients not staying on the drug permanently.Amgen also tested MariTide in a population with Type 2 diabetes, a group that tends to lose less weight with the new obesity drugs. On average they lost up to 17 percent of their initial weight.Some patients experienced side effects that included nausea that lasted an average of six days, and vomiting that persisted an average of one to two days. In each case, the averse effects resolved themselves.The Amgen drug differs in how it works from obesity drugs that are currently being sold, Wegovy by Novo Nordisk and Zepbound from Eli Lilly. Those are GLP-1’s, which means they bind to a protein on the surface of cells that respond to the gut hormone GLP-1. But MariTide is an antibody, a type of drug that is long lasting in the body. Sticking out from the antibody are two peptides that also bind to GLP-1 receptors.The antibody itself blocks the effects of another gut hormone known as GIP. Dr. Bradner said the company decided to block GIP because it had genetic data from Iceland indicating that people who had a variant that stops GIP from working were naturally thinner.Why the drug is effective remains a mystery. Eli Lilly’s drugs — Mounjaro, for diabetes, and Zepbound, for obesity — activate GIP. So why would a drug like MariTide, which inhibits it, be so effective? The company is sponsoring studies in mice to try to figure that out.This is a developing story.

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Can RFK Jr. Limit Ozempic Access as HHS Chief? Here’s What to Know

President-elect Donald J. Trump is set to nominate Robert F. Kennedy Jr. to lead the Health and Human Services Department, where he would have limited power over drugs.Ozempic? Robert F. Kennedy Jr. is not a fan.“If we just gave good food, three meals a day, to every man, woman and child in our country, we could solve the obesity and diabetes epidemic overnight,” he said to Greg Gutfeld on Fox News before the election. He added that the drug’s maker, Novo Nordisk, is “counting on selling it to Americans because we are so stupid and so addicted to drugs.”His opinions might remain just that — opinions. But now that President-elect Donald J. Trump has said he will nominate Mr. Kennedy to lead the federal Department of Health and Human Services, he may gain powers to turn some of his opinions into federal policies.Mr. Kennedy has not said he will limit access to Ozempic or other drugs. He did not reply to requests for comment about what he may do as secretary of health and human services.Here is a look at what powers he would have in that role.Can a health secretary reverse a drug’s approval?The short answer is no.The Food and Drug Administration is part of the Health and Human Services Department, but the secretary does not directly approve drugs. Any attempt to withdraw the approval of the obesity drugs would have to be initiated by the F.D.A.Holly Fernandez Lynch, an associate professor of law at the University of Pennsylvania who specializes in F.D.A. drug approval standards, explained what it would take.The grounds for withdrawal, she said, include compelling evidence that a drug is not safe or effective. Drugs can also be withdrawn if a company submitted “untruths in the application materials,” she said, or did not provide adequate records or make required reports. Another reason, she added, is “manufacturing concerns,” which might include contamination of the drug or inconsistency in its formulation.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Pancreatic Cancer Surge May Be Less Worrisome Than It Seemed

A rise in the disease in younger people was not followed by an increase in deaths, a study found, and might be a sign of overdiagnosis.One of the first warnings came in a paper published in 2021. There was an unexpected rise in pancreatic cancer among young people in the United States from 2000 to 2018. The illness can be untreatable by the time it is discovered, a death sentence.With publication of that report, by Dr. Srinivas Gaddam, a gastroenterologist at Cedars-Sinai Medical Center, researchers began searching for reasons. Could the increase be caused by obesity? Ultraprocessed foods? Was it toxins in the environment?Alternatively, a new study published on Monday in The Annals of Internal Medicine suggests, the whole alarm could be misguided.The authors of the paper, led by Dr. Vishal R. Patel a surgical resident at Brigham and Women’s Hospital in Boston, did not dispute the data showing a rising incidence. They report that from 2001 to 2019 the number of young people — ages 15 to 39 — diagnosed with pancreatic cancer soared. The rate of pancreatic surgeries more than doubled in women and men.The problem is that the expected consequence of such a rise in cancers did not occur. With more pancreatic cancers in young people, there should be more pancreatic cancer deaths. And there were not. Nor were more young people getting diagnosed with later-stage cancers. Instead, the increase was confined to cancers that were in very early stages.Many cancers will never cause harm if left alone, but with increasingly sensitive tools, doctors are finding more and more of them. Because there usually is no way to know if they are dangerous, doctors tend to treat them aggressively. But they would never have shown up in death statistics if they had not been found.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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ChatGPT Defeated Doctors at Diagnosing Illness

A small study found ChatGPT outdid human physicians when assessing medical case histories, even when those doctors were using a chatbot.Dr. Adam Rodman, an expert in internal medicine at Beth Israel Deaconess Medical Center in Boston, confidently expected that chatbots built to use artificial intelligence would help doctors diagnose illnesses.He was wrong.Instead, in a study Dr. Rodman helped design, doctors who were given ChatGPT-4 along with conventional resources did only slightly better than doctors who did not have access to the bot. And, to the researchers’ surprise, ChatGPT alone outperformed the doctors.“I was shocked,” Dr. Rodman said.The chatbot, from the company OpenAI, scored an average of 90 percent when diagnosing a medical condition from a case report and explaining its reasoning. Doctors randomly assigned to use the chatbot got an average score of 76 percent. Those randomly assigned not to use it had an average score of 74 percent.The study showed more than just the chatbot’s superior performance.It unveiled doctors’ sometimes unwavering belief in a diagnosis they made, even when a chatbot potentially suggests a better one.And the study illustrated that while doctors are being exposed to the tools of artificial intelligence for their work, few know how to exploit the abilities of chatbots. As a result, they failed to take advantage of A.I. systems’ ability to solve complex diagnostic problems and offer explanations for their diagnoses.A.I. systems should be “doctor extenders,” Dr. Rodman said, offering valuable second opinions on diagnoses.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Richard Pazdur, FDA Cancer Chief, Discusses 25 Years of Innovation

Twenty five years ago, cancer was almost a different disease. Despite the so-called War on Cancer, declared in 1971 by President Richard Nixon, treatments had mostly remained the same blunt instruments — brutal chemotherapy, surgery and radiation. It seemed as if cancer had won the war.Now, cancer medicine is in a new place. An increasing array of treatments precisely target the cancer itself. And for some cancers, researchers have learned to direct the immune system to kill the malignant cells. Cures are possible for some cancers that had seemed incurable. Many patients can live longer and better lives than ever seemed possible. Cancer death rates have been plunging, and researchers attribute most of that to improved treatments.Overseeing this change at the Food and Drug Administration has been Dr. Richard Pazdur, currently the director of the Oncology Center of Excellence. Trained as an oncologist, he leads the agency and its cancer specialists in determining how cancer drugs are tested and approved.Through 25 years at the agency in a variety of roles, he has been present from the start of the new era and has seen firsthand how scientific discoveries completely changed the prospects for many cancer patients. In two edited and condensed conversations, he discussed what he has seen, and what he hopes for.What was it like to be a cancer doctor when you first began, and what has changed?When I started in medical oncology in 1979, we had less than 40 oncology drugs for all cancers. I came to the F.D.A. in 1999, thinking that most drug development would be done by the National Cancer Institute. I thought industry would have very little interest because most drugs were short course with excessive toxicity and many patients had a poor prognosis.I couldn’t have been more wrong. For many patients, things have changed dramatically. From 1999 until the present, we approved 201 cancer drugs. When I came to the F.D.A. there were about 10 medical oncologists at the agency. Now there are 100.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Sugar Rationing Lowered Diabetes and Hypertension in British Children

British data shows that children conceived and born during a period of sugar rationing were less likely to develop diabetes or high blood pressure later in life.People who were restricted to limited amounts of sugar in the first few years of life were less likely to develop diabetes and high blood pressure decades later, a new study has found.The study, published Thursday in the journal Science, took advantage of a unique situation in the United Kingdom. The country was under strict rationing during World War II and its aftermath. When the rationing ended, in September 1953, the average sugar intake by people in Britain doubled. That provided a natural experiment and allowed the researchers to ask: What happened to the health of people who were conceived and born when sugar was rationed compared with people conceived and born just after sugar rationing ended?To find out, the researchers, Tadeja Gracner, an economist at the University of Southern California, and her colleagues, Claire Boone of McGill University and Paul J. Gertler of the University of California, Berkeley, turned to the UK Biobank. It contains genetic and medical information on half a million people, and steps have been taken to preserve contributors’ privacy. Using the data, the investigators analyzed the health of 60,183 people who were born from October 1951 through March 1956, and were age 51 to 60 when they were surveyed.The investigators reported that those exposed to sugar rationing early in life had a 35 percent lower risk of diabetes and a 20 percent lower risk of high blood pressure in middle age. The onset of those chronic diseases was also delayed by four years for diabetes and two years for high blood pressure. They also found that disease protection was greatest for those who had been conceived during sugar rationing and were babies while rationing continued. Those who were exposed to sugar rationing only before birth and then grew up with higher sugar intake had higher disease rates.The results contribute to a body of evidence suggesting that nutrition very early in life can affect health much later. But because of the unique circumstances of British sugar rationing, the new study provides additional rigor, experts said.For example, a study of military records of men whose mothers were in the first half of pregnancy during the Dutch famine, or Hunger Winter, during World War II found that the men were more likely to be obese at age 19 than men born after that event. Another study found that women whose mothers were pregnant during the famine were heavier at age 50 than women born later.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Ozempic and Wegovy Ease Knee Osteoarthritis Pain in Large Study

A large trial showed that semaglutide, sold as Ozempic for diabetes and as Wegovy for obesity, was better than any current medications in alleviating symptoms.The blockbuster drug semaglutide, sold as Ozempic for diabetes and as Wegovy for weight loss, now has a new proven benefit: It markedly soothed knee pain in people who are obese and have moderate to severe osteoarthritis, according to a large study.The effect was so pronounced that some arthritis experts not involved with the clinical trial were taken aback.“The magnitude of the improvement is of a scope we haven’t seen before with a drug,” said Dr. Bob Carter, deputy director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. “They had an almost 50 percent reduction in their knee pain. That’s huge.”Dr. David T. Felson, an arthritis expert and professor of medicine at Boston University School of Medicine, said the study “changes the landscape,” adding that the pain reduction is greater than anything that can be achieved short of knee replacement surgery.The results were published Wednesday in the New England Journal of Medicine.Knee osteoarthritis affects nearly one in five Americans over the age of 45. Those with obesity are especially likely to develop it because their weight puts more stress on the knee and because obesity is associated with inflammation, which contributes to deterioration of cartilage.There are no good medical treatments. Doctors can suggest patients take over-the-counter pain relievers like acetaminophen or ibuprofen. But long-term use of those medications can damage vital organs.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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What to Know About Test Alternatives to Colonoscopies for Colon Cancer Screening

Doctors can provide alternative forms of screening for colon and rectal cancer but sometimes have a good reason to stick with the colonoscope.This year about 53,000 Americans are expected to die from colon or rectal cancer. Doctors say most people should start getting screened at age 45. Yet many who are eligible skip testing.When most people in this country think of colon cancer screening, they think of colonoscopies, which let doctors examine the colon but can be inconvenient. Yet there are other equally acceptable options for screening.If more people knew about other kinds of colorectal cancer testing, some experts hope, perhaps some who put off colonoscopies would be screened and deaths from colon cancer could be avoided.Here’s what you need to know about colonoscopies and fecal tests, which to ask for, and why your doctor might be recommending one over the other.How do colonoscopies and fecal tests work?Colonoscopies are widely used, but there is another option available: fecal tests.Both types of test attempt to find cancers and large polyps — growths on the wall of the colon — that occasionally turn into cancers. Cancers that are found early often can be cured when doctors simply cut them out. Finding and removing polyps can also prevent cancers.Colonoscopies start with a patient’s taking strong laxatives to empty the colon. On the day of the test, the patient is sedated. Then, a doctor inserts a colonoscope — a flexible tube with a video camera at the end — into the rectum and colon and looks for polyps and cancers to remove. The doctor may also take samples for study in a lab.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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An Agonizing Dilemma: When Obesity Prevents a Joint Replacement

Many doctors say it is too dangerous to perform the common surgeries on people with high body mass indexes, but patients say they are facing discrimination.The last time Alicia Kline walked unassisted was in January 2021. She is in constant pain from hip arthritis and uses a walker and a wheelchair.The problem is her obesity — her body mass index, or B.M.I., is over 50. And for someone like Ms. Kline, 54, of Reading, Pa., finding a doctor who is willing to give her a joint replacement that may ease the pain can be a near-impossible task.Dilemmas like hers are roiling orthopedic medicine as obesity levels soar, and with them arthritis. What should orthopedists do when confronted with patients whose B.M.I. is very high?While the science of body mass index is frequently criticized, doctors say the risks of operating on patients with B.M.I.s that fall in the upper ranges of obesity can be dire, including infections deep in the prosthetic joint that can lead to amputations and even death. And the risks escalate as a patient’s B.M.I. increases.Professional organizations —- the American Academy of Orthopedic Surgeons and the American Association of Hip and Knee Surgeons — do not have firm B.M.I. cutoffs for operations, but orthopedists have their own.Less than half of orthopedic surgeons in a survey published last year said they would operate on a patient with a B.M.I. over 40 — more than 22 million American adults fell into that category in 2017-18. Only 11 percent would operate on one of the 3.9 million Americans with a B.M.I. over 50. And patients with a B.M.I. over 55 would be rejected almost everywhere. Just 3 percent of U.S. orthopedists would operate.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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An Obesity Drug Prevents Covid Deaths, Study Suggests

People taking Wegovy were not protected from infection. But in a large trial, their death rates were markedly lower, for reasons that are not clear.Wegovy, the popular obesity drug, may have yet another surprising benefit. In a large clinical trial, people taking the drug during the pandemic were less likely to die of Covid-19, researchers reported on Friday.People on Wegovy still got Covid, and at the same rate as people randomly assigned to take a placebo. But their chances of dying from the infection plunged by 33 percent, the study found. And the protective effect occurred immediately — before participants had lost significant amounts of weight.In addition, the death rate from all causes was lower among subjects taking Wegovy, a very rare finding in clinical trials of new treatments. The result suggests that lower life expectancy among people with obesity is actually caused by the disease itself, and that it can be improved by treating obesity.“Stunning,” Dr. Jeremy Faust, an emergency room physician at Brigham and Women’s Hospital who wrote an editorial accompanying the study, said of the data. The study was published in The Journal of the American College of Cardiology.The study was not originally designed to look at the effects of taking Wegovy on people with Covid. But the participants taking the drug were not healthier than the others, said Dr. Harlan Krumholz, a cardiologist at Yale and the editor in chief of the journal.“It is a randomized trial and the infection rates were similar, so this represents top-notch evidence,” he said.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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