
Top US Vaccine Official Resigns Citing RFK ‘Misinformation' Push
The Food and Drug Administration 's top vaccine regulator abruptly resigned Friday, citing what he called Health and Human Services Secretary Robert F. Kennedy Jr.'s efforts to spread misinformation about the safety of immunizations, according to a letter obtained by Bloomberg.
Peter Marks, who was a key figure in Operation Warp Speed, stepped down from his position as the director of the FDA's Center for Biologics Evaluation and Research, which is responsible for the safety and effectiveness of vaccines, along with gene therapies and blood products.
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Fox News
18 minutes ago
- Fox News
Sam's Club nearly done with plan to remove 40 harmful ingredients from its food and drink
Heeding the call of HHS Secretary Robert F. Kennedy Jr. to remove synthetic dyes from the foods and beverages of Americans, Sam's Club is one of the latest organizations to hop on board. The brand's "Made Without" initiative has reached 96% of its goal of removing artificial colors, additives, dyes and high-fructose corn syrup from its Member's Mark food and beverages, its private brand. The "Made Without" initiative lists 40 ingredients that the membership-based warehouse hopes to remove by 2025. "This accomplishment underscores how Sam's Club prioritizes what matters most to members, by aligning its offerings with evolving dietary preferences and developing products made with simpler, more recognizable ingredients," Sam's Club announced in a press release. "It also highlights the Member's Mark brand's broader purpose — to provide access to a better quality of life — through high-quality products made without certain ingredients," the release also noted. Sam's Club pointed to the demands of its customers, noting that 72% of its members surveyed are "actively seeking minimally processed foods" and 90% want to either "live or aspire to live a healthier lifestyle." The Make America Healthy Again Commission, chaired by Sec. Kennedy, released a recent report assessing chronic diseases, particularly those suffered by children. The report said that nearly 70% of calories consumed by American children come from ultraprocessed foods, which are "high in added sugars, chemical additives, and saturated fats, while lacking sufficient intakes of fruits and vegetables." Ultraprocessed foods have been linked to chronic diseases, including obesity, type 2 diabetes, cardiovascular disease and certain cancers, the report states. Julie Barber, chief merchant at Sam's Club, said in the press release that the company takes "pride in the high-quality ingredients that go into our products." "What truly differentiates us are the ingredients we consciously leave out … Our 'Made Without' commitment underscores our aspiration to be members' go-to destination for quality at a disruptive value," said Barber. Aside from food, the "Made Without" list also includes phthalates, which are commonly used in personal care products, food packaging and synthetic fabrics. "Continuous exposure to certain phthalates can trigger hormone dysregulation and reproductive and developmental problems for babies in-utero and infants," noted the MAHA report. "The FDA has restricted the use of several phthalates in food packaging and industry has discontinued use over time." Fox News Digital reached out to Walmart, owner of Sam's Club, for further comment.


New York Times
28 minutes ago
- New York Times
F.D.A. Looks to A.I. to Enhance Efficiency
The Food and Drug Administration is planning to use artificial intelligence to 'radically increase efficiency' in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA. Another initiative involves a review of chemicals and other 'concerning ingredients' that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count. 'The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,' Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article. The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration's efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly. Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device. 'I don't want to be dismissive of speeding reviews at the F.D.A.,' said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. 'I think that there is great potential here, but I'm not seeing the beef yet.' Want all of The Times? Subscribe.


Politico
an hour ago
- Politico
HHS justifies decision to stop recommending Covid shots during pregnancy with studies supporting the shots' safety
The Department of Health and Human Services is circulating a document on Capitol Hill to explain its decision to remove the Covid-19 vaccine recommendation for pregnant women — citing studies that largely found the shot is safe. The document, which HHS sent to lawmakers days before Secretary Robert F. Kennedy Jr. announced his plan to fire the panel that advises the CDC on immunizations, says that studies have shown that women who got the vaccine during pregnancy had higher rates of various complications. And it claims that 'a number of studies in pregnant women showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy,' footnoting a research paper on vaccination during pregnancy. But Dr. Maria P. Velez of McGill University, the lead author of one of the studies, told POLITICO in an email that 'the results of our manuscript were misinterpreted.' The 2023 study shows a slightly higher rate of miscarriages among women who were immunized against Covid-19 during their pregnancies. But, Velez said, that after adjusting for 'variables that can confound a crude association,' like 'age, rurality, neighbourhood income quintile, immigration status, comorbidity' and other factors that could affect the outcome, Canadian researchers found 'no association between SARS-CoV-2 vaccination and an increased risk of miscarriage.' Raw numbers don't account for significant differences among the groups being compared — such as underlying conditions and when during pregnancy the people were vaccinated, said Katelyn Jetelina, an epidemiologist who's consulted for the Centers for Disease Control and Prevention. Scientists, including the Canadian researchers, use statistical methods to adjust for those factors, she said, which is how they determined the vaccine wasn't associated with miscarriage. In a statement, HHS spokesperson Andrew Nixon pointed to the raw study data, which showed a slightly higher rate of miscarriage in the first half of pregnancy for women who were vaccinated against Covid compared with those who weren't. 'The underlying data speaks for itself — and it raises legitimate safety concerns,' he said. 'HHS will not ignore that evidence or downplay early pregnancy loss.' Nixon added that HHS and the CDC encourage people to talk to their providers 'about any personal medical decision.' Vaccine researchers and obstetricians criticized the decision to remove the recommendation for pregnant women, and researchers cited in the HHS document largely dismissed any connection between Covid vaccination and miscarriages. 'Given that COVID-19 infection during pregnancy is associated with serious maternal and neonatal morbidity, the current study can inform healthcare providers, pregnant women and those considering a pregnancy about the safety of SARS-CoV-2 vaccination in relation to miscarriage risk,' Velez and her co-authors wrote in the study. That research was based on health-system data from Ontario, Canada, and aligned with similar population studies in the U.S., Scotland and Norway. Similarly, HHS cited an April 2022 study in its document concerning mRNA vaccination in people undergoing in-vitro fertilization, which also found no adverse effects on conception rates or on early pregnancy outcomes. 'Administration of COVID-19 mRNA vaccines was not associated with an adverse effect on stimulation or early pregnancy outcomes after IVF,' the New York City-based researchers at the Icahn School of Medicine at Mount Sinai and Mount Sinai West hospital wrote in the study. 'Our findings contribute to the growing body of evidence regarding the safety of COVID-19 vaccination in women who are trying to conceive.' The HHS document also includes an incorrect link for that study, instead leading to a different study — also cited in HHS' document — by Israeli researchers that found the vaccine 'appears to be safe during pregnancy,' with no increase in preterm labor or in newborns with low birth weight. That February 2022 study did note a possible increase in preterm birth rates for women vaccinated during the second trimester, and the authors suggested future investigations of outcomes based on the timing of immunization. HHS' assertion about significant risks to pregnant women 'contradicts the bulk of published studies,' said Dr. Paul Offit, an expert who has served as an outside adviser on vaccines to the FDA and the CDC. HHS deviated from past practice when it changed the Covid vaccine guidance last month, announcing the decision without the endorsement of an existing outside panel of expert advisers. Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told POLITICO at the time that he was disappointed by HHS' decision, and pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid. 'In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than 6 months of age — those who are not yet eligible for vaccination — born to unvaccinated mothers,' Fleischman said.