F.D.A. Poised to Restrict Access to Covid Vaccines

Agency leaders said they wanted to restore trust in the shots with further studies. But the proposed criteria may reduce access to the vaccines for many people who want them.The Food and Drug Administration may require data from additional clinical trials before approving updated Covid-19 vaccines for healthy Americans younger than 65, according to new rules detailed on Tuesday by agency officials.New doses of the vaccines offer “uncertain” benefit to those under 65 who have previously been vaccinated or have had Covid, the officials said in The New England Journal of Medicine.Citing low uptake of recent Covid shots, “the American people, along with many health care providers, remain unconvinced,” wrote Dr. Vinay Prasad, the F.D.A.’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner.During the pandemic, both officials sharply criticized vaccine mandates and other public health measures intended to turn back the coronavirus. “The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” Dr. Prasad and Dr. Makary wrote. Robert F. Kennedy Jr., the health secretary, is a prominent vaccine skeptic who spent years campaigning against the Covid shots. Under his leadership, the Department of Health and Human Services has taken a more critical view of vaccines in general, raising questions about their safety and whether they should be so widely administered.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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The Lampard Inquiry: What has happened so far?

6 hours agoShareSaveNikki FoxBBC health correspondent, East of EnglandShareSavePAEight months into its 25-month timeline, the Lampard Inquiry is beginning to expose deep-rooted issues in NHS mental health services in Essex. With more than 2,000 deaths in inpatient units between 2000 and the end of 2023, the inquiry is examining not only local failings but also whether these reflect wider national problems. Here is what has emerged so far.A system under scrutinyThe inquiry is named after its chairwoman, Baroness Kate Lampard.She is a former barrister who oversaw the NHS investigations into abuse by former television presenter Jimmy Savile.It is primarily focused on Essex Partnership University NHS Foundation Trust (EPUT), formed in 2017 from the merger of North and South Essex Partnership Trusts. It is also looking at the deaths of patients from Essex at inpatient units run by private providers and 215 facilities run by other NHS organisations, such as North East London NHS Foundation Trust.The former health ombudsman Sir Rob Behrens said on average, 5% of all mental health cases received by his team between 2011 and 2023 were related to Essex.He called the failures in care “the National Health Service at its worst”.During testimony from the relatives and friends of those who died, it emerged that they were individuals from a range of backgrounds, including a chef, bus driver, heating engineer, former head teacher, and parish councillor.LAMPARD INQUIRYLack of staffThe inquiry has heard evidence of a long-term reduction in registered mental health nurses, with increased reliance on healthcare support workers across England. This shift has been linked to reduced patient engagement and increased risk.Former chief nurse Maria Nelligan told the inquiry this was because healthcare support workers were “cheaper” and said the shift compromised therapeutic care.Dr Paul Davidson, a consultant psychiatrist, described how staff across England were “rushed off their feet,” contributing to a workplace culture where professionals feared being blamed “whatever decision they took”. Paul Scott, chief executive of EPUT, stated the trust had reduced its use of agency staff by 30%. Poor data STUART WOODWARD/BBCThe inquiry has also highlighted issues with data collection and transparency. Deborah Cole, from the charity Inquest, described how there was no “complete set of statistics in relation to those who die in mental health detention”. Dr Davidson added: “There is good information in relation to deaths by suicide, [but] this is not a helpful tool by which to assess how mental services are being provided overall.”Baroness Lampard has warned that the inquiry may never uncover the full scale of deaths linked to failings in Essex mental health services.She stated that while a figure would be published, it was likely to be approximate, due to incomplete or inconsistent data over the 24-year period under reviewRegulating trustsThe inquiry has examined the complexity of the regulatory system overseeing NHS trusts. Mr Scott described being “overwhelmed” by the number of regulatory bodies -19 in total – each issuing recommendations. This, he said, made it difficult to implement consistent change.Away from the inquiry, in October 2024, the health secretary stated that the government intended to reform the regulatory system.This was in response to a review of the way the Care Quality Commission (CQC) inspected trusts, called the Penny Dash Review, which said the framework was too complicated.The Lampard Inquiry will consider the CQC’s role in relation to events in Essex.AnalysisThree systemic issues raised by the inquiry – staff shortages, poor data, and regulatory complexity – have been longstanding concerns. The Royal College of Nursing, the CQC and a 2023 Public Accounts Committee report all flagged staffing shortages and burnout. A 2023 review found Norfolk and Suffolk NHS Foundation Trust had lost track of patient death data, while a 2025 Health Services Safety Investigations Body (HSSIB) report called for a unified national dataset. Regulatory reform is also under way following multiple critical reviews. While Baroness Lampard is expected to reference these reports, the inquiry is also under pressure to uncover new evidence.Some families have expressed concern regarding its pace, and limited focus so far on cultural change.They have also noted that safeguarding issues, such as patients absconding from units, have received little attention – a relevant issue given a recent inquest into the death of an 18-year-old who died while on escorted leave from an EPUT unit.Transparency and whistleblowingOnly 11 out of 14,000 staff came forward during the earlier non-statutory phase of the inquiry. Baroness Lampard has said she will use statutory powers to compel evidence if necessary. Mr Scott acknowledged that “closed cultures” existed at EPUT but said the trust was encouraging openness. During a recent inquest into the death of a 16-year-old patient, a manager testified that staff were reluctant to raise safety concerns. Brian O’Donnell, clinical lead at the St Aubyn Centre in Colchester, said there was a “real concern about safety on the wards, and staff are too worried to say anything about it”.Families have also raised concerns about delays in evidence disclosure, including a postponed inquiry session on a Oxevision, an infrared monitoring system, due to late submission of information by EPUT.But Baroness Lampard said her decision to delay the hearing “should not be viewed in any way as enabling EPUT to avoid answering questions about its use of Oxevision”.ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUSTWhat comes next?PAIn July, the inquiry will focus on the two former trusts that merged to form EPUT. Mr Scott has said, when he arrived at the trust in 2000, the legacy of the merger was that “there was too much focus on governance and management and not enough on patient safety”.Families are calling for detailed scrutiny of individual deaths, but the inquiry is more likely to use selected cases to illustrate broader systemic issues such as governance, and culture.Mr Scott has apologised for deaths under the trust’s care and stated that he believes EPUT should remain the provider of mental health services in Essex. More on this storyRelated internet links

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A Genetic Clue to Why Men Are Taller Than Women

Researchers studied data from a million people and found evidence that a height gene shared by both sexes is amplified in men.Men are taller than women, by an average of about five inches. But why? It’s not a genetic inevitability — there are many species in the tree of life where females outclass males.A new study, published on Monday in the Proceedings of the National Academy of Sciences that involved genetic data from a million people, has found a partial explanation.It involves a gene called SHOX, which is known to be associated with height. SHOX is present on both the X chromosome — females have two X chromosomes — and the Y chromosome; males have one X and one Y.The researchers suspected that SHOX might explain differences in male and female height, but there was a problem with that hypothesis. Since SHOX is on both the X and Y chromosomes, it would need to have a different effect on each chromosome.Does it, the researchers asked?To investigate the hypothesis, they asked if an extra Y chromosome boosted a person’s height more than an extra X chromosome.There are rare conditions in which people are born with an extra X or an extra Y, or have a missing X or Y. To find people with these conditions, researchers plumbed data from three biobanks, or repositories of deidentified genetic and medical data from individuals. One biobank was from Britain, and the other two were from the United States.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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Is ‘Reef-Safe’ Sunscreen Really Better for the Environment?

Some of the sunscreen you slather on this summer will end up in lakes, streams or the ocean, even if you don’t go swimming. And a growing body of evidence suggests that ultraviolet filters, the active ingredients in sunscreens, can harm creatures that live in the water.Some products are marketed as “reef safe” or friendly to aquatic life. But has that been proved? We talked to a dermatologist, several ecologists and toxicologists, and a chemical engineer to find out the best way to protect your skin and the environment, too.Your sunscreen optionsThere are two kinds of UV filters in sunscreens on the market today.Mineral sunscreens create a physical barrier on your skin that reflects UV rays like a mirror, while chemical sunscreens are absorbed into the skin and convert the UV radiation into harmless heat. (Chemical sunscreens are also sometimes labeled “organic,” but that’s a chemistry term, not a claim of environmental friendliness.)Any sunscreen you apply will eventually end up in water. Researchers estimate that between 25 and 50 percent of sunscreen comes off during a dip. The rest goes down the drain when you shower or enters the wastewater system through the laundry when you wash your beach towels.Most standard treatment plants aren’t effective at removing trace levels of UV filters from wastewater, said Dunia Santiago, a chemical engineer at the University of Las Palmas de Gran Canaria in Spain who studies how treatment plants process contaminants. That means the chemicals are still in the water that flows out of the plant and into the world.And, since many UV filters don’t biodegrade well, levels can build up over time in the environment, floating around, settling into sediment and being eaten by animals, especially in shallow areas popular with swimmers.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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The U.S. Under Trump: Alone in Its Climate Denial

The administration is not only allowing more greenhouse gases. It is undermining the nation’s ability to understand and respond to a hotter planet.When the Trump administration declared two weeks ago that it would largely disregard the economic cost of climate change as it sets policies and regulations, it was just the latest step in a multipronged effort to erase global warming from the American agenda.But President Trump is doing more than just turning a blind eye to the fact that the planet is growing hotter. He is weakening the country’s capacity to understand global warming and to prepare for its consequences.The administration has dismantled climate research, firing some of the nation’s top scientists, and gutted efforts to chart how fast greenhouse gases are building up in the atmosphere and what that means for the economy, employment, agriculture, health and other aspects of American society. The government will no longer track major sources of greenhouse gases, data that has been used to measure the scale and identify sources of the problem for the past 15 years.“We’re not doing that climate change, you know, crud, anymore,” Agriculture Secretary Brooke Rollins told Fox Business on May 8.By getting rid of data, the administration is trying to halt the national discussion about how to deal with global warming, said Daniel Swain, a climate scientist at the University of California, Los Angeles. “The notion of there being any shared factual reality just seems to be completely out the window,” he said.At the same time, through cuts to the National Weather Service and by denying disaster relief through the Federal Emergency Management Agency, the administration has weakened the country’s ability to prepare for and recover from hurricanes, wildfires, droughts and other extreme weather that is being made worse by climate change.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 we know about Biden’s prostate cancer diagnosis

33 minutes agoShareSaveYang Tian and James ChaterBBC NewsShareSaveReutersFormer US President Joe Biden has been diagnosed with an aggressive form of prostate cancer that has spread to his bones.Biden received the news on Friday after he saw a doctor last week for urinary symptoms.Here’s what you need to know about prostate cancer and its treatment options.What is prostate cancer?Prostate cancer affects tissue of the prostate gland, the part of the male reproductive system that helps make semen. It is located between the penis and the bladder.According to the NHS, it usually develops slowly, so it can often grow unnoticed for years. That means some people can live for decades without needing treatment. But it also means symptoms often don’t appear until the cancer is already advanced.Biden was diagnosed following urinary symptoms, one of the most common signs of prostate cancer. That’s because it is often detected only when the prostate is big enough to have impacted the urethra, the tube that connects the bladder to the penis.Those symptoms can include needing to urinate more frequently, as well as a slow or weak urinary stream.Screening for prostate cancer is part of routine presidential health inspections, according to Dr Jeffrey Kuhlman, former White House doctor under President Barack Obama.Prostate cancer is the second-leading cause of cancer death in American men, according to the American Cancer Society, behind lung cancer.There will be more than 300,000 new cases in the US this year, according to projections by the American Cancer Society. About one in 8 men will be diagnosed with prostate cancer during their lifetime.While it is “not uncommon” for men in their 80s to be diagnosed with prostate cancer, the grade and stage of Biden’s cancer are “more advanced than most men would encounter” at diagnosis, Dr Ryan Cleary, urologist at MedStar Health, told the BBC.What is the Gleason score? The former president’s prostate cancer is “characterised by a Gleason score of 9”, his office said in the statement announcing his diagnosis.The Gleason score is the most common way of grading how likely the disease will advance and spread – also known as metastatic cancer.Specifically, it refers to how abnormal the cancer cells look in a sample under a microscope. The scale runs from six to 10, with a higher number indicating a more aggressive cancer.The scale starts at six because it is calculated by combining the two most common patterns of cancer cells found in a patient. The lowest score assigned to cancerous cells is three. That’s why the lowest Gleason score for a cancer diagnosis is six.A Gleason score of nine, such as Biden’s, means it is a “high-grade cancer”. Cancer cells with a score of nine look very abnormal and are likely to grow quickly.What are Biden’s treatment options?In Biden’s case, the cancer is aggressive in nature and has already spread to his bones.According to Dr Jamin Vinod Brahmbhatt, a urologist at Orlando Health Medical Group, this level of spread does limit the treatment options.While there are medical based treatments such as chemotherapy, steroids and hormone therapy available, none of them are “curative”, he said.”There are more medical options to stabilise the patient and control the cancer, but it never gets rid of the cancer completely.”Biden’s cancer is also said to be hormone sensitive, which means the cancer uses hormones to grow or develop.These types of cancers can be managed by drugs that block or lower the amount of hormones in the body.Dr Brahmbhatt said while this “opens up the toolkit” of treatment options for Biden, it was going to take “weeks or months” to see how he responds.Dr Kuhlman said Biden could also have the option of entering “clinical trials for advanced disease” if he meets the inclusion criteria.Biden and his family are said to be reviewing treatment options.What is his prognosis?In Sunday’s statement, Biden’s office said since the cancer appeared to be hormone-sensitive, that “allows for effective management”.The full details of Biden’s case is not known. Dr Cleary said: “Generally about a third of patients will still be alive after five years of metastatic prostate cancer.”Advanced stages of prostate cancer can limit a person’s lifespan and lead to symptoms that make daily life harder.Dr Kuhlman describes “10 to 15 years of function” when looking at aggressive cancer treatments and said it was important to consider treatments that maintain Biden’s quality of life in the next few years.”If there’s any inspiration in this, it is to go and get yourself checked out whether you have symptoms or not,” Dr Brahmbhatt said.

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Joe Biden Is Diagnosed With an Aggressive Form of Prostate Cancer

The cancer has metastasized to the bone, according to a statement from Mr. Biden’s personal office.Former President Joseph R. Biden Jr. was diagnosed on Friday with an aggressive form of prostate cancer that has spread to his bones, his office said in a statement on Sunday.The diagnosis came after Mr. Biden reported urinary symptoms, which led doctors to find a “small nodule” on his prostate. Mr. Biden’s cancer is “characterized by a Gleason score of 9” with “metastasis to the bone,” the statement said.The Gleason score is used to describe how prostate cancers look under a microscope; 9 and 10 are the most aggressive. The cancer is Stage 4, which means it has spread.“While this represents a more aggressive form of the disease, the cancer appears to be hormone-sensitive which allows for effective management,” according to the statement from Mr. Biden’s office, which was unsigned. “The president and his family are reviewing treatment options with his physicians.”Mr. Biden, 82, left office in January as the oldest-serving president in American history. Throughout his presidency, Mr. Biden faced questions about his age and his health, ultimately leading him to abandon his re-election campaign under pressure from his own party.Prostate cancer experts say that Mr. Biden’s diagnosis is serious, and that once the cancer has spread to the bones — where it tends to go — it cannot be cured. But Dr. Judd Moul, a prostate cancer expert at Duke University, said men whose prostate cancer has spread “can live five, seven, 10 or more years.”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 a Prostate Cancer Diagnosis Like Biden’s Means for Patients

While prognoses for prostate cancer patients were once measured in months, experts say that advances in treatment and diagnosis now improve survival by years.Prostate cancer experts say that former President Joseph R. Biden’s diagnosis is serious. Announced on Sunday by his office, the cancer has spread to his bones. And it is Stage 4, the most deadly of stages for the illness. It cannot be cured.But the good news, prostate cancer specialists said, is that recent advances in diagnosing and treating prostate cancer — based in large part on research sponsored by the National Institutes of Health and the Defense Department — have changed what was once an exceedingly grim picture for men with advanced disease.“Life is measured in years now, not months,” said Dr. Daniel W. Lin, a prostate cancer specialist at the University of Washington.Dr. Judd Moul, a prostate cancer expert at Duke University, said that men whose prostate cancer has spread to their bones, “can live 5, 7, 10 or more years” with current treatments. A man like Mr. Biden, in his 80s, “could hopefully pass away from natural causes and not from prostate cancer,” he said.Mr. Biden’s office said the former president had urinary symptoms, which led him to seek medical attention.But, Dr. Lin said, “I highly doubt his symptoms were due to cancer.”Instead, he said, the most likely scenario is that a doctor did an exam, noticed a nodule on Mr. Biden’s prostate and did a blood test, the prostate-specific antigen test. The PSA test looks for a protein released by cancer cells, and can be followed up by an M.R.I. The blood test and the M.R.I. would have pointed to the cancer.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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GPs to help NHS find more infected blood victims

GPs in England are to help the NHS find more undiagnosed patients affected by the contaminated blood scandal.It is thought thousands of people could have been exposed to the hepatitis C virus through contaminated blood transfusions in the 1970s, 80s and 90s; part of a scandal which affected more than 30,000 people in the UK.From June, patients signing up to a GP practice, who received a blood transfusion before 1996, will be offered a test for hepatitis C.The BBC revealed the scale of undiagnosed cases last year, as people with life-threatening liver damage caused by the virus over many years continue to be identified.Hepatitis C can now be treated by modern anti-viral drugs to eliminate the virus for most patients.But if it goes undetected and undiagnosed there may not be any noticeable symptoms for some time and it can infect the liver and cause serious damage, leaving the organ beyond repair.Maureen Arkley, who died last year, was diagnosed with hepatitis C and cirrhosis of the liver in 2023, more than 40 years after she had an operation involving multiple blood transfusions. These were on her medical records but she was not told by her GP or anyone in the NHS that she could have been exposed to the virus.BBC News highlighted her case as one of many people let down by the lack of testing following the infected blood scandal.It is one of the biggest treatment disasters in NHS history – 3,000 people who were infected with HIV and hepatitis C after being given contaminated blood products have died.Many of the victims were haemophiliacs, who were given infected blood products as part of their treatment.Many thousands more were given transfusions using contaminated blood after accidents, emergencies or childbirth.Maureen died in February 2024, five months after her diagnosis and 47 years after a blood transfusion infected her. “The end was utterly horrific, she weighed less than four stone when she died,” her daughter Victoria told the BBC.NHS England says around 400,000 people each year, born before 1996, will be asked if they have ever had a blood transfusion through the online GP registration form.This was a move recommended in the Infected Blood Inquiry report, published in May 2024.If a previous blood transfusion is confirmed, patients will be able to test themselves for hepatitis C at home, using a finger prick blood test which is then posted to a lab for analysis.Tests can also be carried out at GP surgeries, sexual health clinics and other places, NHS England says.The charity Hepatitis C Trust is also encouraging anyone who had a blood transfusion before 1996, including current GP patients, to get tested.”Every two weeks we hear from someone infected with hepatitis C through a transfusion who is only now finding out,” said the charity’s chief executive, Rachel Halford.”All of these people have had hepatitis C for more than three decades; some are very ill. A more proactive approach is critical to reaching and diagnosing those who remain unaware of their infection.”NHS England medical director Prof Stephen Powis said the “simple change” to the GP registration process was “a vital step forward” to ensure nobody affected by contaminated blood is “undiagnosed and unsupported”.”The failures of the contaminated blood scandal have had a horrifying impact for patients and their families for decades, and I would like to reiterate our deepest apologies for the role the health service played in the suffering and loss for so many,” he added.Health officials say the risk of getting an infection from a blood transfusion or from blood products since screening of blood donations was introduced, is very low.All blood donations have been screened for HIV, hepatitis B, and hepatitis C since September 1991.

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