Publisher Health

New vaccines are often evaluated in trials in which some participants receive a placebo. But not all studies can be designed this way.The Department of Health and Human Services last week announced a new standard for testing the safety of vaccines, a “radical departure from past practices.”All new vaccines will be evaluated against a placebo, an inert look-alike that serves as a point of comparison, the department said. Health Secretary Robert F. Kennedy Jr., as well as many anti-vaccine groups, has long argued that placebo-controlled trials were the only way to fully understand vaccine side effects.To scientists who have spent their careers evaluating vaccines, the plan did not seem so radical. New vaccines are often tested against a placebo in clinical trials. One researcher has created a crowdsourced spreadsheet of more than a hundred examples.But it also concerned vaccine experts that Mr. Kennedy seemed not to recognize the circumstances when placebo groups are neither ethical nor practical. The idea is widely accepted by scientists and enshrined in ethics frameworks for medical research.“He’s asking for something that’s not ethical,” said Arthur Caplan, a leading bioethicist at the New York University Grossman School of Medicine.Why Are Placebos Used in Vaccine Trials?Randomized placebo-controlled trials are often described as the “gold standard” of research: they allow scientists to tease out whether the effects they observe result from the drug itself or some other factor, such as the expectation of treatment.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.

The most extensive research on Medicaid coverage to date found that it reduced the risk of death by 21 percent.The expansion of Medicaid has saved more than 27,000 lives since 2010, according to the most definitive study yet on the program’s health effects.Poor adults who gained Medicaid coverage after the Affordable Care Act expanded access were 21 percent less likely to die during a given year than those not enrolled, the research shows. By analyzing federal records on 37 million Americans, two economists found that deaths fell not only among older enrollees but also among those in their 20s and 30s — a group often assumed to have few medical needs, and who would have been far less likely to qualify for Medicaid before the expansion.The findings were published this month in a National Bureau of Economic Research working paper, as House Republicans were drafting a plan that could significantly cut Medicaid, which covers 71 million low-income or disabled Americans. The House Energy and Commerce Committee, which oversees the program, approved a suite of policies on Wednesday that the Congressional Budget Office estimated would cause millions of people to lose their coverage in the years ahead.The study’s authors said that the publication timing was coincidental — their research has been in progress for two years — but acknowledged that the findings were especially relevant to the current budget discussions.The researchers found that, on average, it costs Medicaid $179,000 to save a year of life — similar to the amounts spent on health care interventions like cervical cancer screenings and leukemia treatment. It is less than the combined public and private spending on interventions like safety inspections for cars or the removal of asbestos from buildings.

The Danish drugmaker, which makes Ozempic and Wegovy, has seen its stock tumble as competition in the weight-loss drug market has grown fiercer.Novo Nordisk will replace its chief executive, Lars Fruergaard Jorgensen, the company announced Friday, citing a sharp decline in its stock price that stemmed from increased competition for its popular weight-loss drug.The Danish drugmaker said it was searching for a new chief executive to soon replace Mr. Jorgensen, who has led Novo Nordisk for eight years.The move reflects a remarkable fall in fortune for the maker of one of the most well-known drugs in the world, which is sold as Ozempic for diabetes and Wegovy for obesity. The company’s stock has fallen by 50 percent in the past year.

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Source: FactSetBy The New York TimesSales of that drug created boom times for Novo Nordisk. In 2023, the company’s extraordinary success prompted the Danish central bank to keep interest rates lower than it otherwise would. For more than a year, Novo Nordisk’s market value surpassed Denmark’s entire gross domestic product.But investors have soured on the company as it has faced increasingly fierce competition. Lower-cost copycat versions of the weight-loss drugs made through a process known as compounding have cut into Novo Nordisk’s sales. Even more damaging has been competition from Eli Lilly, the maker of the drug sold as Mounjaro and Zepbound.Novo Nordisk had a head start, winning approval to market its drug for obesity more than two years before Eli Lilly. But Novo Nordisk has been rapidly losing market share to its competitor: American patients have filled more prescriptions this year for Zepbound than for Wegovy, and the gap has been widening, according to the industry data provider IQVIA.Eli Lilly is also developing new weight-loss drugs, including a daily pill, that are expected to set up years of blockbuster sales for the company. Novo Nordisk has a hazier path forward.

When most people think of obsessive-compulsive disorder, they may picture behaviors they’ve seen on TV — like repetitive hand-washing, flicking light switches on and off and meticulously arranging small items over and over.But the disorder manifests in many other ways. Some patients obsess over thoughts that they might hurt someone, while others fixate on certain aspects of their personal relationships.The comedian Maria Bamford, for example, has called her O.C.D. “unwanted thoughts syndrome.” On “The Late Show With Stephen Colbert,” she shared a story about how she couldn’t stop thinking horrific thoughts about her family members. On social media, people describe many types of obsessions and compulsions: “relationship O.C.D.,” “sexual orientation O.C.D.” or “emotional contamination O.C.D.” These aren’t separate diagnoses, but rather they are different expressions of the same disorder — much like how people with phobias can suffer from different fears, said Dr. Carolyn Rodriguez, an O.C.D. expert and a professor of psychiatry and behavioral sciences at Stanford Medicine.Understanding these distinctions can help clinicians tailor a precise treatment plan, she added. And they’re important for the public to grasp as well. Otherwise, people who experience the disorder might not even recognize they have it, Dr. Rodriguez said.People who are fearful of harming others might think, “Maybe I am a murderer,” she added. “If I tell anybody these things, I’m going to be put in jail.”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.

The U.S. is slashing funding for scientific research, after decades of deep investment. Here’s some of what those taxpayer dollars created.Science seldom works in straight lines. Sometimes it’s “applied” to solve specific problems: Let’s put people on the moon; we need a Covid vaccine. Much of the time it’s “basic,” aimed at understanding, say, cell division or the physics of cloud formation, with the hope that — somehow, someday — the knowledge will prove useful. Basic science is applied science that hasn’t been applied yet.That’s the premise on which the United States, since World War II, has invested heavily in science. The government spends $200 billion annually on research and development, knowing that payoffs might be decades away; that figure would drop sharply under President Trump’s proposed 2026 budget. “Basic research is the pacemaker of technological progress,” Vannevar Bush, who laid out the postwar schema for government research support, wrote in a 1945 report to President Franklin D. Roosevelt. Look no further than Google, which got its start in 1994 with a $4 million federal grant to help build digital libraries; the company is now a $2 trillion verb.Here are nine more life-altering advances that government investment made possible.GPSThe first commercial GPS unit, a $3,000 brick for hikers and boaters, was made in 1988. The technology is now so ubiquitous — in cars, planes, phones, smartwatch running apps — that its existence can seem almost preordained.In fact its path was long, indirect and paved with federal money. Start in 1957: Two researchers at the Johns Hopkins University Applied Physics Laboratory realized that they could pinpoint the whereabouts of Sputnik, Russia’s new orbiting satellite, from the changing frequency of its radio signal as it moved. Now reverse that logic: If a fixed receiver on Earth can locate a moving satellite, then a satellite with known coordinates should be able to find a “lost” receiver on Earth, its location unknown.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.

33 minutes agoShareSaveSam FrancisPolitical reporterHarry FarleyPolitical correspondentShareSaveGetty ImagesMPs will debate a bill to legalise assisted dying in England and Wales for the first time since significant changes were made to it.The bill passed the first stage of the Commons last November – but since then the details have been pored over and dozens of amendments added by both sides.A vote to pass or reject the bill is not likely to take place on Friday, but rather in June.Friday’s debate comes as the government quietly made changes to its impact assessment on assisted dying, admitting errors in calculating how many people could take up the service if it becomes law.It reduced its upper estimate for the number of assisted deaths in the first year from 787 to 647.Several MPs opposed to the bill have described the process as “chaotic”.But Kim Leadbeater, the Labour MP behind the bill, said it was coming back to the Commons “even stronger”.She urged MPs to “grasp this opportunity with both hands”.”The law as it stands is not working for dying people or their loved ones; that much is clear,” she said.”A majority of MPs recognised this when they backed my bill in November. When they come to debate it once again today, they can be confident that it returns even stronger.”Leadbeater’s Terminally Ill Adults (End of Life) Bill – which would allow some terminally ill adults in England and Wales to choose to end their own lives – cleared its first parliamentary hurdle by 330 to 275 votes back in November. Since then, the bill has gone through six months of intense scrutiny by a parliamentary committee and several changes, including removing the need for a High Court judge to sign off each request for an assisted death. Instead, a panel of experts – including a legal professional, psychiatrist and social worker – would oversee the process.Another amendment would prevent doctors from discussing the option of an assisted death with under 18s, unless the patient has raised it first.MPs have been given a free vote, meaning they can decide based on their conscience rather than having to follow a party line.The issue has split Parliament, with strong opinions on both sides.Those opposed to assisted dying say the mood has altered among MPs, but so far only a handful have said they’ve changed their minds since November and it would take dozens to block the bill.The Commons is unlikely to vote to give the bill final approval until 13 June at the earliest.On 2 May, the government published its long-awaited impact report on the bill – projecting NHS savings ranging from £919,000 to £10.3 million.But on Wednesday, officials published a “correction notice” at the bottom of the 150-page document.The change revises the upper estimate for the number of assisted deaths in the first year after the bill is published from up to 787 to 647.Labour MP Melanie Ward, who previously voted against the bill, told the BBC: “This shows just how chaotic this whole process has been.”With the bill being amended by supporters just days before it is debated and the impact assessment being quietly corrected, MPs on either side of the debate can’t really know what they are being asked to vote on.”It calls into question again whether this bill is fit for purpose and whether this private member’s bill process is suited to deal with such significant and profound issues of life and death.”Independent peer Paralympian Baroness Tanni Grey-Thompson, who has campaigned against the bill and will get a vote if the bill goes to the Lords, said it had been “very disappointing to see this process”.The amended impact assessment “has come out the night before very important debates,” she said.”It might make the numbers look marginally better but it’s a significant error – what else have they got wrong?”Meanwhile, Sarah Pochin, Reform’s newest MP after winning the Runcorn by-election earlier this month, confirmed she would support the bill, telling ITV she was “confident” there were enough checks and balances to ensure terminally ill people were protected.Broadcaster Dame Esther Rantzen, who has been campaigning for assisted dying after revealing her terminal lung cancer diagnosis last year, accused opponents of having “undeclared personal religious beliefs which mean no precautions would satisfy” their concerns. Labour MP Jess Asato, who voted against the bill, described Dame Esther’s comments as “particularly distasteful” and “disrespectful to those with faith and without”.The new bill in England and Wales would allow any doctor to be involved in assisted dying. GPs are often a large part of the practice in countries where it is legal.A BBC investigation found family doctors in England are deeply divided on the issue.Of the 1,000 GPs who responded to a survey conducted by the BBC, 500 said they were against an assisted dying law, with 400 saying they were in favour.The Royal College of Physicians (RCP) said it believed there were “concerning deficiencies” with the bill that would need addressing, including tougher safeguards such as using doctors known to the patient for prognosis, face-to-face checks to prevent coercion and no cuts to other care. Earlier this week, the Royal College of Psychiatrists said it had “serious concerns” and could not support the bill in its current form.Both colleges said they remained neutral on the principle of assisted dying.

With new testing requirements, it’s not even clear how new Covid or flu shots can be made available this fall.Come this fall, only older Americans and those with chronic health problems may be urged to get the Covid shot — assuming the vaccine is available at all.For years now, scientific advisers to the Centers for Disease Control and Prevention have been debating whether to continue to recommend that Americans 6 months of age and older be immunized, or to switch to a so-called risk-based strategy targeting only the most vulnerable, as is the practice now in most other countries.The advisers are expected to decide on a way forward at a meeting in June. But the debate may have become irrelevant. New requirements for clinical testing of vaccines, announced earlier this month, may delay the availability of shots that had formerly been updated annually without complicated trials.“Substantial updates to existing vaccines — such as those related to seasonal strain changes or antigenic drift — may qualify as ‘new products’ and therefore require additional clinical evaluation,” the Department of Health and Human Services said in a statement.That category includes the Covid shots and “may” even include the seasonal flu vaccine, according to Andrew Nixon, a spokesman for H.H.S.The Food and Drug Administration has already asked Novavax for more clinical data before approving its Covid vaccine. (Currently it has emergency use authorization, not full approval, for people aged 12 and older.)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.

For months, the Harvard researcher Kseniia Petrova has challenged efforts to deport her to her native Russia for a customs violation. This week, the government charged her with a criminal felony.Kseniia Petrova, a Harvard researcher from Russia who has been fighting deportation proceedings since February, will now face felony smuggling charges in Massachusetts, a federal judge in Louisiana said on Thursday.Ms. Petrova made a brief court appearance Thursday morning via video from a jail in Monroe, La., near the Immigration and Customs Enforcement detention center where she has been held for nearly three months.During the hearing, Ms. Petrova listened quietly as U.S. Magistrate Judge Kayla D. McClusky read her the criminal complaint in the smuggling case, which carries a sentence of up to 20 years in prison. “Yes, I understand,” she said.After her attorney expressed Ms. Petrova’s desire to be transferred to Massachusetts for further proceedings, Judge McClusky agreed to allow the transfer back to Boston.The smuggling charges against Ms. Petrova came unexpectedly, and legal experts said the decision to bring criminal charges at this stage in an immigration case was unusual.The charges were announced just as Ms. Petrova’s legal challenge to her detention appeared to move in her favor. She was initially detained at the airport in Boston in February, after failing to declare frog embryos that she was carrying into the country at the request of her Harvard supervisor to use as scientific samples.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.

Restrictions on payments to foreign partners may jeopardize studies of cancer and other conditions that would benefit Americans.One of the studies threatened by a new administration policy regarding international research is focused on prolonging the lives of women with the most common kind of breast cancer.Up to one in five women with estrogen-fueled breast cancer experiences a life-threatening recurrence after being in remission for 10 years or even longer. If those women could be identified in advance, doctors can treat them before the cancer comes back. The medicines already exist.But the research project, conducted with scientists in Denmark, may well be shut down. The National Institutes of Health said earlier this month that it will stop awarding grants to scientists if the projects include making a payment, called a sub-award, to a foreign collaborator.The policy jeopardizes thousands of active international research projects that rely on partnerships with scientists and universities in other countries.Federal health officials said they had made the change because inconsistencies across internal systems and databases make it difficult to accurately track the sub-award payments, a problem documented in several reports by the Government Accountability Office.“This lack of visibility is unacceptable and is exactly why radical change is needed,” an N.I.H. official said in an email, even though stricter monitoring requirements were put in place in 2023, after a critical G.A.O. report.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.

30 minutes agoShareSaveJim ReedHealth reporterShareSaveGetty ImagesThe government ignored an early warning by two Nobel prize-winning scientists that all healthcare workers should be routinely tested for coronavirus in the pandemic, the Covid inquiry has heard.The advice came in a strongly-worded letter sent in April 2020 by the chief executive of the Francis Crick Institute, Sir Paul Nurse, and its research director, Sir Peter Ratcliffe, to the then health secretary Matt Hancock.NHS and care home staff were not offered Covid tests until November 2020 in England, unless they had symptoms of the disease.Matt Hancock is due to appear at the inquiry next week, along with other health ministers from the four nations of the UK.Giving evidence, Sir Paul, who won the Nobel prize for medicine in 2001, said it was “disturbing” that he did not receive a response to his concerns until July 2020.”For the secretary of state to ignore a letter from two Nobel laureates in physiology or medicine for three months is a little surprising, I would say,” he told the inquiry.”Rather than acknowledge they couldn’t do it, because that would have indicated a mistake in their overall strategy, they remained silent.”It was likely that the decision not to routinely test NHS and care home staff led to an increase in infections and deaths in the early stages of the pandemic, he added.Hospitals and care homesIn the first six months of Covid, there was a frantic drive to increase testing for the disease. Matt Hancock set a target of 100,000 tests a day by the end of April 2020 in England.By this time it had become clear to scientists across the world that Covid could be spread by people who had not developed symptoms, such as a cough or fever.Sir Paul Nurse, Sir Peter Ratcliffe and their colleague Dr Sam Barrell wrote to Mr Hancock on 14 April 2020 saying they had “grave concerns” about “asymptomatic transmission” between healthcare staff and patients.”We advise you that all NHS trusts and healthcare providers should be required to set up surveillance systems for the regular testing of all healthcare workers and patients with immediate effect,” the letter said.The scientists received a response on 6 July 2020, signed by a junior official in the Department of Health. That reply did not directly address the subject of healthcare workers, instead stating that testing was a “key part” of the government’s strategy and that capacity was being “rapidly expanded”.Lighthouse labsThe Frances Crick Institute, headquartered in north London, is one of the largest biomedical research centres in the world.As Covid hit, a team of 300 volunteers started using the organisation’s laboratory space and equipment to process Covid tests for dozens of hospitals, GP surgeries and care homes in the local area.It had the capacity to carry out 4,000 tests a day and to increase that to 10,000 with more funding, according to Prof Nurse.In March 2020, he wrote to the government offering to help with the national testing effort.Instead ministers decided to set up a network of giant privately-run Lighthouse laboratories.In his evidence, Prof Nurse accepted that the larger sites were needed, but said “insufficient attention” was paid to universities and other publicly-funded institutions, which could have quickly processed tests for healthcare workers, particularly in the early stages of the pandemic.The sixth part of the Covid inquiry, which looks at the performance of test, trace and quarantine systems across the UK, runs until the end of May.