Latest news with #EricRubin
Medscape
27-05-2025
- Health
- Medscape
FDA Advisers Recommend No Changes to COVID Vaccine for Fall
US Food and Drug Administration (FDA) advisers recommended that manufacturers make no changes to the COVID-19 vaccine that will be available for boosters later this summer. The Vaccines and Related Biological Products Advisory Committee (VRBAC) voted 9-0 that the 2025-26 vaccines should stay the same, containing a single JN.1 strain, which has been dominant globally since 2024. 'There is efficacy,' said Panel Member Eric J. Rubin, MD, PhD, editor-in-chief of The New England Journal of Medicine and adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, Boston. 'It's not fantastic. It's not what it was originally,' he said, adding but that in a population that has broad immunity to the SARS-COV-2 virus, 'it wasn't bad.' The agency usually follows its panels' advice, but nothing is certain for the vaccines this fall. As reported by Medscape Medical News , FDA Commissioner Martin Makary, MD, and FDA Center for Biologics Evaluation and Research Director Vinay Prasad, MD, in a 'town hall' on May 20 and in a paper in TheNew England Journal of Medicine said the agency planned to start requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans who are younger than 65 years. Approvals of boosters over the last 4 years have been based on observational data, and the vaccines have been recommended for all Americans aged 6 months or older. The FDA has not held any further meetings nor issued a final rule or policy to clarify whether this year's COVID vaccine boosters would be required to conduct new trials. The agency may have signaled where it is headed with its May 17 full approval for Novavax's COVID-19 vaccine, which previously only had emergency use authorization. The FDA limited the vaccine's use to adults older than 65 years and anyone older than 12 years at high risk. Some panelists were concerned that a randomized trial requirement might cause delays. 'Is there a possibility that if we choose a different vaccine [strain], it is actually going to be different regulatory measures that are taken that would delay the vaccine getting to the market?' asked Stanley M. Perlman, MD, PhD, chair of microbiology and immunology at Carver College of Medicine, University of Iowa, Iowa City, Iowa. Rubin said he believes the observational data presented by COVID vaccine makers 'has a lot more richness,' than a randomized trial, given the various exposures to illness and vaccines in a widely varied population. 'I don't think the randomized, controlled trial is feasible,' said Rubin. David C. Kaslow, MD, director of the Office of Vaccines Research and Review at FDA, said that although the agency is still discussing how it will regulate COVID vaccines, 'I think there's a shared desired outcome for the timely availability of vaccines to prevent COVID-19.' Kaslow said the proposed new regulatory framework could be a 'potential topic for a future VRBPAC meeting.' Representatives from Pfizer, Moderna, and Novavax all said they would have vaccines ready for the fall. 'We look forward to working with the agency to ensure timely provision of appropriate data to support COVID-19 vaccine approval for those who need it most,' said Kayvon Modjarrad, MD, PhD, executive director of Viral Vaccines and Immunology Vaccine Research and Development at Pfizer. Continuing Burden, Low Vaccine Uptake At the meeting, US Centers for Disease Control and Prevention (CDC) officials and vaccine makers said that COVID-19 is still dangerous, especially for those at highest risk, primarily individuals older than 75 years and children younger than 6 months. The CDC estimates that 30,000-50,000 people have died from COVID since October. Few Americans choose to get a COVID vaccine, hovering around 25% for adults aged 18 years to 64 years, rising to 50% for those older than 75 years, said Ruth Link-Gelles, PhD, MPH, of the CDC's National Center for Immunization and Respiratory Diseases. Vaccine effectiveness against hospitalization and critical illness in immunocompetent adults older than 65 years was around 40%-50%, said Link-Gelles. It was the same or slightly lower for immunocompromised adults in the same age group. Pfizer estimated that COVID vaccines prevented some 107,000 hospitalizations and 6700 in-hospital deaths in 2024. The vaccine makers argued that their products are safe and effective. 'Our vaccines are among the most extensively-monitored products licensed,' said Pfizer's Modjarrad. The FDA, however, has recently instructed Pfizer and Moderna also to update labeling to expand a warning about myocarditis and pericarditis. Pfizer's label warned of an elevated risk in men 12- to 17-year-olds, Moderna's in men 18- to 24-year-olds. Both will now cite an elevated risk for men aged 16 years to 25 years. In its letter, the agency cited data from a Lancet study of patients with COVID-19- vaccine–associated myocarditis 'showing persistence of abnormal cardiac magnetic resonance imaging findings that are a marker for myocardial injury at a median follow-up of approximately 5 months.' Some Call for Withdrawal, Others for More Access During the hour-long public hearing portion of the meeting, most speakers asked the FDA to immediately recall all COVID vaccines, citing a variety of harms — many of them unproven. 'Rewind now and pull these shots,' said Brian Hooker, PhD, the chief scientific officer of Children's Health Defense — the organization formerly run by current Health and Human Services Department Secretary Robert F. Kennedy, Jr. Hooker cited myocarditis as a concern. 'Based on this alone, the product should have been completely withdrawn,' said Hooker. He also said that COVID vaccines 'have been also strongly associated with clotting disorders, including stroke, pulmonary embolism,' and other disorders. Kaitlin Sundling, MD, PhD, assistant professor of pathology and laboratory medicine at the Wisconsin State Lab of Hygiene, said COVID vaccines should be more widely available. 'All people, regardless of age and medical history, need broad access to regularly updated COVID vaccine formulations,' said Sundling, who added she was concerned about the FDA's potential requirement for randomized trials and to limit vaccine approvals to those older than 65 years or at high risk. Noting that the panel had essentially been asked to not talk about that proposed new COVID regulatory framework at the meeting, Sundling said 'There is a very real concern that this committee is being used as a pawn to eliminate vaccine access for the US population.'
Forbes
07-05-2025
- Health
- Forbes
Medical Journals Under Scrutiny From Justice Department
Prior Editor of New England Journal of Medicine Dr. Marcia Angell holding papers while standing ... More outside office; journal's logo on glass door in back. (Photo by) Getty Images The interim U.S. attorney for the District of Columbia has been sending letters to a handful of influential medical journals asking questions concerning influence from funders, competing viewpoints and misinformation. Among the journals targeted include the New England Journal of Medicine, CHEST and JAMA. Dr. Eric Rubin, the editor-in-chief of The New England Journal of Medicine, said , 'we were concerned because there were questions that suggested that we may be biased in the research we report.' These threatening letters to multiple medical journals set a dangerous precedent to science and journalism because free speech in medical journals should be protected under the First Amendment. Medical journals, particularly the ones that have been targeted by the federal government, engage in a rigorous peer-review process before articles are accepted for publication. When an article is submitted to a journal, most medical journals utilize double-blinded peer review, meaning the article is sent out typically to two to four medical experts to assess the validity of the manuscript and if publication is warranted. The reviewers have no knowledge of who the authors are, and the authors similarly do not know who their reviewers are. In addition, authors are always asked to acknowledge any funding they have received for the research they are presenting and writing about. In this way, medical journals are constantly and meticulously reducing and eliminating bias in the publication process. Medical journals are critical for the general public because they serve as the foundation for evidence-based medicine. Medical journals play an integral role in shaping healthcare guidelines, vaccine recommendations as well as influencing preventive screening guidelines for important diseases like cancer. They ensure this important information is accessible for the general public to understand and support informed decision-making to empower doctors, patients and news outlets to make informed decisions about health. Journals are responsible for disseminating cutting-edge research that leads to improved diagnostics and potential cures for diseases that could be life-threatening. Finally, the rigorous peer-review from scientific journals ensures that all the medical information reaching the public is accurate and credible. Make no mistake about this- the letters sent to some of the most influential medical journals by the federal government are a threat to science, free speech and public health. These letters are an attempt to influence scientists and potentially silence them, particularly if what they are publishing is contradictory to what the current administration believes about vaccines, diseases and health. The Trump administration as already purged important health information from websites, halted flu vaccination campaigns and curtailed studies about misinformation. Medical journals should be free and safe from any sort of political censorship. These journals do not spread propaganda, they are carefully peer-reviewed and are designed to educate Americans and the public with evidence-based information that help save lives. It is through medical journals we know that vaccines are safe and effective in combating measles, as opposed to other therapies like steroids or cod liver oil. When evidence-based information, particularly with respect to health gets censored, it impacts the health of all Americans. It provides a medium for misinformation to go unchecked and spread instantaneously, faster than any virus given how fast information can spread on social media. Americans are already paying the price on misinformation, given the measles outbreaks throughout America with parents giving their children vitamin A as opposed to vaccines in an attempt to treat and prevent measles. Guidance for health should never be shaped by a particularly ideology, but rather by data and evidence, and this is precisely what medical journals provide. The right to scientific expression is fundamental to democracy, the first amendment and any free society. If the federal government interferes with the content of medical journals, they are not just silencing scientists, they are silencing all Americans. Americans lose access to high quality information that can be life-saving, they lose the ability to make informed decisions on what medications to take and they lose the ability to decide if they need to vaccinate themselves and their families against an infectious disease. If medical journals are silenced; democracy, free speech, health, well-being and our very lives are all on the line.
New York Times
25-04-2025
- Politics
- New York Times
‘Vaguely Threatening': Federal Prosecutor Queries Leading Medical Journal
A federal prosecutor in Washington has contacted The New England Journal of Medicine, considered the world's most prestigious medical journal, with questions that suggested without evidence that it was biased against certain views and influenced by external pressures. Dr. Eric Rubin, the editor in chief of N.E.J.M., described the letter as 'vaguely threatening' in an interview with The New York Times. At least three other journals have received similar letters from Edward Martin Jr., a Republican activist serving as interim U.S. attorney in Washington. Mr. Martin has been criticized for using his office to target opponents of the administration. His letters accused the publications of being 'partisans in various scientific debates' and asked a series of accusatory questions about bias and the selection of research articles. Do they accept submissions from scientists with 'competing viewpoints'? What do they do if the authors whose work they published 'may have misled their readers'? Are they transparent about influence from 'supporters, funders, advertisers and others'? News of the letter to N.E.J.M. was reported earlier by STAT, a health news outlet. Mr. Martin also asked about the role of the National Institutes of Health, which funds some of the research the journals publish, and the agency's role 'in the development of submitted articles.' Amanda Shanor, a First Amendment expert at the University of Pennsylvania, said the information published in reputable medical journals like N.E.J.M. is broadly protected by the Constitution. In most cases, journals have the same robust rights that apply to newspapers — the strongest the Constitution provides, she added. 'There is no basis to say that anything other than the most stringent First Amendment protections apply to medical journals,' she said. 'It appears aimed at creating a type of fear and chill that will have effects on people's expression — that's a constitutional concern.' It's unclear how many journals have received these letters or the criteria that Mr. Martin used to decide which publications to target. The U.S. attorney's office in Washington did not respond to a request for comment. 'Our job is to evaluate science and evaluate it in an unbiased fashion,' Dr. Rubin said. 'That's what we do and I think we do it well. The questions seem to suggest that there's some bias in what we do — that's where the vaguely threatening part comes in.' Jeremy Berg, the former editor in chief of the journal Science, said he thought the letters were designed to 'intimidate journals to bend over backward' to publish papers that align with the administration's beliefs — on climate change and vaccines, for example — even if the quality of the research is poor. Robert F. Kennedy Jr., the nation's health secretary, singled out N.E.J.M in an interview with the 'Dr. Hyman Show' podcast last year as an example of a medical journal that has participated in 'lying to the public' and 'retracting the real science.' Andrew Nixon, a spokesman for the Health and Human Services Department, declined to comment on whether Mr. Kennedy had any involvement with the letters. In the interview, Mr. Kennedy said he would seek to prosecute medical journals under federal anti-corruption laws. 'I'm going to litigate against you under the racketeering laws, under the general tort laws,' he said. 'I'm going to find a way to sue you unless you come up with a plan right now to show how you're going to start publishing real science.' Dr. Jay Bhattacharya, the new director of N.I.H., has vigorously criticized the leadership of scientific journals. Recently he co-founded a new journal as an alternative to traditional scientific publishing. It has published contrarian views on Covid. Other prominent journals said they had not received the letter. On Friday, The Lancet, which is based in Britain, published a scathing editorial in solidarity, calling the letters 'an obvious ruse to strike fear into journals and impinge on their right to independent editorial oversight.' 'Science and medicine in the U.S.A. are being violently dismembered while the world watches,' the editorial said. One of Mr. Martin's letters was sent to the journal Chest, a low-profile publication that publishes highly technical studies on topics like lung cancer and pneumonia. The New York Times reported last week that at least two other publishers had received nearly identically worded letters. They declined to speak publicly for fear of retribution from the Trump administration. Dr. Rubin said he, too, was worried about political backlash. Scientific journals rely on public funds in several indirect ways — for example, universities often use federal grants to pay for subscriptions. 'Are we concerned? Of course we are,' he said. 'But we want to do the right thing.' Mr. Martin gave the journals until May 2 to respond to his questions. N.E.J.M. has already responded to Mr. Martin with a statement that pushes back against his characterization of the journal. 'We use rigorous peer review and editorial processes to ensure the objectivity and reliability of the research we publish,' the statement read. 'We support the editorial independence of medical journals and their First Amendment rights to free expression.' This is not the N.E.J.M's first brush with a Trump administration. In 2020, the journal published an editorial condemning the president's response to the pandemic — the first time the journal had supported or condemned a political candidate in its 208-year history. Dr. Rubin said he doubted Mr. Martin's letter was related to the editorial. The journal Chest didn't write about Trump's first term yet received a letter, he noted.
