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Trump Says RFK Jr. Will Study Possible Link Between Childhood Vaccines and Autism as HHS Secretary
President-elect Donald Trump said on Dec. 8 that he will give Robert F. Kennedy Jr. the freedom to investigate the potential link between vaccines and autism if the latter gains Senate confirmation to become Secretary of Health and Human Services (HHS).
Kennedy has said for years that autism is likely tied to childhood vaccines. He was nominated to serve as HHS secretary by Trump last month and has promised sweeping changes to agencies under the HHS, like the Centers for Disease Control and Prevention, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration.
The NIH supports and funds research into autism, as well as potential new vaccines.
Kennedy told The Epoch Times in September that he would revamp the NIH to focus on the causes of autism, autoimmune diseases, and neurodevelopment diseases instead of developing drugs and serving as an incubator for pharmaceutical products.
FDA Recalls More Than 233,000 Bottles of Antidepressant Over Possible Cancerous Chemical
More than 233,000 bottles of an antidepressant have been recalled by public health officials due to a chemical containing the risk of cancer. The U.S. Food and Drug Administration (FDA) classified capsules of duloxetine, sold by New Jersey-based company Rising Pharmaceuticals, as a Class II risk on Dec. 5. The risk level is the FDA’s second most severe level as it could cause “temporary or medically reversible adverse health consequences.”
The bottles contain the “presence” of nitrosamine drug substance impurity, N-nitroso-duloxetine, that exceeds the recommended interim limit, according to the FDA. Rising Pharmaceuticals, who the FDA reported issued a voluntary recall on Nov. 19, did not immediately respond to USA TODAY’s request for comment.
McKinsey to Pay $650 Million Over Role in OxyContin Epidemic
International consulting firm McKinsey & Company agreed Friday to resolve criminal charges with federal prosecutors in two states for its role in helping Purdue Pharma boost sales of OxyContin and other opioid painkillers, fueling an addiction epidemic.
McKinsey agreed to pay $650 million as part of a deferred prosecution agreement, according to court documents filed Friday.
As part of the agreement, McKinsey will “not do any work related to the marketing, sale, promotion or distribution of controlled substances” and will not contest the facts of the government’s criminal charges. Those agreed-upon facts said McKinsey “knew the risks and dangers associated with OxyContin” but “designed strategies to help Purdue Pharma” to “turbocharge” OxyContin prescriptions.
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AstraZeneca Chided by Marketing Watchdog After Complainant Aims Allegations
AstraZeneca has refuted allegations its staff “refuse to cooperate and respect” the U.K. marketing code. The drugmaker successfully defended itself against claims senior staff ignored requests to unlike LinkedIn posts but the U.K. marketing watchdog still found the company had brought discredit on the industry in two cases.
The Prescription Medicines Code of Practice Authority, or PMCPA said one of the cases was triggered by “an anonymous, contactable complainant who described themselves as an AstraZeneca employee, and had later become non-contactable.” The complainant sent screenshots of LinkedIn posts that were liked by senior global U.K.-based AstraZeneca employees. One post described the start of a phase 3 trial. The other post focused on an AstraZeneca drug combination.
The complainant laid into the two employees who liked the posts, claiming they had ignored repeated requests “to unlike and thus stop sharing” the materials. According to the complaint sent in June 2023, “you can see the pattern of behaviour of promoting to the public on LinkedIn continues till day, repeated by a selection of senior, care free colleagues.”
After Moderna’s Pediatric RSV Vaccine Trial Hold, Expert Panel Says More Testing Is Needed
Two days after the U.S. Food and Drug Administration (FDA) revealed that it had halted enrollment in trials of respiratory syncytial virus (RSV) vaccines that involve young children, experts from an FDA advisory panel expressed their frustration at being unable to draw conclusions about the safety and effectiveness of the shots and said more testing is needed. “This all seems like an incredible conundrum with lots of unanswered questions remaining — lots to still learn,” Henry Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell, said Thursday.
The meeting of the Vaccines and Related Biological Products Advisory Committee came after the agency said in a briefing document Tuesday that it had halted pediatric RSV vaccine trials in the U.S. that were enrolling children under two, as well as those that were enrolling children ages two through five who are RSV-naïve.
The FDA Hasn’t Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly
The drug potassium chloride has been on the market for decades, widely prescribed to help the nerves and muscles — including the heart — function properly in patients with low potassium. Too much of it, however, can kill you. At high doses, it is so effective at stopping the heart that some states have used injections of it for executions. So the danger was obvious in May, when Indian drugmaker Glenmark Pharmaceuticals recalled nearly 47 million capsules for a dire flaw: The extended-release medication wasn’t dissolving properly, a defect that could lead to a perilous spike in potassium.
The U.S. Food and Drug Administration (FDA) deemed it the most serious kind of recall, a defective drug that had the potential to kill people. At the time of the recall, the FDA, which is charged with protecting Americans from unsafe drugs, was already on notice about troubles at Glenmark.
