Login
FDA Chief Says Biden Administration Withheld Data on Heart Risk From Covid Vaccines
The Biden administration withheld data from the public on the risks of myocarditis from the COVID-19 vaccine, the U.S. Food and Drug Administration (FDA) Commissioner Marty Makary claimed Thursday — a bold accusation that clashes with years of public statements from federal health officials.
“We have done more to study myocarditis and to go back and look at deaths of people, of children from the Covid vaccine,” Makary told NBC News in an interview. “Internal data submitted on myocarditis, we found that the Biden administration was sitting on data on myocarditis in young people, and it was not made public.”
Makary’s claim comes less than a week after Vinay Prasad, the FDA’s top vaccine regulator, told agency staff in a memo that an internal review found that at least 10 children died “after and because of receiving” the COVID-19 shot. Prasad suggested — without evidence to support his claim — that the child deaths were tied to myocarditis.
Myocarditis, an inflammation of the heart muscle, is a known — but small — risk of the mRNA COVID-19 vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.
The FDA has not released its new findings publicly, nor has the agency published them in a peer-reviewed journal. On Wednesday, a dozen former FDA leaders issued a scathing denunciation of the new assertions.
HHS Clarifies Which Health Records Doctors Can’t Hide From Parents
The U.S. Department of Health and Human Services’ (HHS) actions against a school that illegally vaccinated a child demonstrates that the agency will not tolerate information on a child’s gender transition being withheld from parents, The Daily Signal has learned. HHS opened an investigation on Wednesday into a Midwestern school that vaccinated a child without parental consent.
HHS penned a Dear Colleague letter reminding health care providers that the Health Insurance Portability and Accountability Act of 1996, or HIPAA, requires them to provide parents access to their children’s health information. The agency also directed the Health Resources and Services Administration to add a grant requirement saying that federally funded health centers must comply with parental rights laws. These actions, that reinforce parent legal authority to direct their children’s health care decisions, carry implications extending beyond vaccination, according to an HHS official.
HHS’ move is a warning to health care providers that the agency will enforce parental rights law if those providers or schools seek to hide transgender procedures on children from their parents. “The HIPAA Privacy Rule is clear: Providers must share health care information about minors to their parents,” the HHS official told The Daily Signal.
“Anyone intentionally hiding this data may have ulterior motives, which could include the desire to hide sex-rejecting procedures or vaccinations from a child’s parents.” “Today’s Dear Colleague letter is a warning shot that HHS will not abide by violations of HIPAA,” the official continued.
US Dietary Guidelines Delayed Until Early 2026
The new Dietary Guidelines for Americans have been pushed to early 2026, delaying the release of the government’s official recommendations for a healthy diet. “The Dietary Guidelines will be released soon after the first of the year,” a spokesperson for the U.S. Department of Health and Human Services (HHS) told Reuters on Thursday.
In November, U.S. Health Secretary Robert F. Kennedy Jr. said the Trump administration would release new dietary guidelines in December, aimed at changing the country’s food culture and to reduce high rates of obesity. The updated guidelines, which shape school lunches, medical advice and nutrition standards, have been expected since summer. The HHS and the U.S. Department of Agriculture publish the guidelines jointly every five years. The release was delayed due to the recent government shutdown, a federal official said.
The New York Times reported the postponement earlier on Thursday. The new guidelines are expected to address saturated fat, found mainly in meat and certain oils, and ultra-processed food, along with modified suggestions related to dairy consumption, sources familiar with the process told Reuters in June. The current dietary guidelines recommend limiting saturated fat to less than 10% of total calories consumed daily, and do not address ultra-processed food.
Cardiologists on Board With FDA’s Proposed Food Package Labels
The American College of Cardiology (ACC) officially backed front-of-package (FOP) nutrition labeling as the expected launch of the public health tool by federal officials draws closer. “FOP labeling provides a pragmatic strategy to operationalize dietary recommendations in clinical practice.
By emphasizing nutrients most relevant to cardiovascular risk — saturated fat, sodium, and added sugars, and facilitating rapid comparison of food products, FOP labels enhance the translation of evidence-based nutrition science into everyday decisions,” according to ACC writing committee chair Kim Williams, MD, of the University of Louisville in Kentucky, and colleagues.
“When coupled with clinician education and culturally sensitive counseling, FOP labeling helps overcome barriers related to health literacy, culture, and socioeconomic constraints,” the authors wrote, explaining their position in a concise clinical guidance document published in the Journal of the American College of Cardiology.
