Top FDA Official Sees More Vaccine Scrutiny in Trump’s Presidency
The U.S. Food and Drug Administration (FDA) is likely to come under tighter scrutiny over vaccine development and safety testing once Donald Trump takes over as the country’s president, a top official at the agency said on Thursday.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at an industry conference that the agency could be asked to be more transparent and meet more often with outside advisers to discuss vaccines. “I don’t necessarily view that as a bad thing,” he said at the conference hosted by brokerage Jefferies. “That may turn out to be an opportunity to have an open dialogue.”
Marks said the FDA could also shift its messaging on vaccines by emphasizing that the benefits of taking them outweigh the risks. He said that outside of vaccines, he does not expect major changes in regulations of other biological drugs, including gene and cell therapies.
Dr Oz Nominated to Lead CMS Despite Big Pharma Ties
Pharmaceutical Technology reported:
Television personality Dr. Mehmet Oz has been nominated by President-elect Donald Trump to lead the Centers for Medicare and Medicaid Services. The position will oversee Medicare and Medicaid services, as well as plans under the Affordable Care Act (ACA).
Known for his show “Dr. Oz” and his unsupported homeopathy recommendations, he represents the latest in a series of controversial nominations by the President-elect. If approved by the Senate, Oz will work alongside Robert F Kennedy Jr to “take on the illness industrial complex, and all the horrible chronic diseases left in its wake,” according to a statement by Trump. The statement lauded Oz’s expertise, saying that “America is facing a healthcare crisis, and there may be no physician more qualified and capable than Dr Oz to Make America Healthy Again.”
Oz is a trained cardiothoracic surgeon with a degree in biology magna cum laude from Harvard University and experience working at New York City’s Presbyterian Hospital and Columbia University. However, critics are concerned that Oz’s medical background has become tinted by his celebrity status and (more consequentially) his financial interest in big pharma.
Flu, COVID Vaccination Rates Remain Low as Winter Nears
Worn down by pandemic-era vaccine overload, many Americans are ignoring pleas by health officials to get immunized against the flu and COVID-19, new data shows. According to the Centers for Disease Control and Prevention data for immunizations as of Nov. 9, only about a third (34.7%) of U.S. adults say they’ve gotten the influenza vaccine, while just 17.9% say they’ve received the latest COVID-19 booster.
The data could still be a bit early, however: According to the CDC report, up to 41% of adults say they were either still on the fence about getting the two shots, or would “definitely or probably” do so. The reports are published in the journal MMWR. Morbidity and Mortality Weekly Report. A third vaccine, for the respiratory syncytial virus (RSV), is especially important for elderly people, the CDC noted. As of Nov. 9, close to 40% of people aged 75 or older said they had ever gotten an RSV vaccine.
Education may be key to upping RSV protection, the report’s authors said. Rates of vaccination for COVID-19 and RSV were significantly lower in southern states, the report found. According to the researchers, “misinformation and doubt” about the effectiveness and safety of vaccines is still making too many people who could benefit balk at getting immunized.
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Exclusive: US FDA Finds Widely Used Asthma Drug Impacts the Brain
U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co. may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters. The researchers found that the drug, sold under the brand name Singulair and generically as montelukast, attaches to multiple brain receptors critical to psychiatric functioning.
Singulair was a blockbuster product for Merck after its launch in 1998, offering relief in a pill as an alternative to an inhaler. In early advertising, the company said the side effects were so benign that they were “similar to a sugar pill,” while the label said any distribution in the brain was “minimal.” Generic versions are still prescribed to millions of adults and children every year.
But by 2019, thousands of reports of neuropsychiatric episodes, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and in the U.S. Food and Drug Administration’s tracking system. Such “adverse event” reports do not prove a causal link between a medicine and a side effect, but are used by the FDA to determine whether more study of a drug’s risks are warranted. After years of analysis, the reports and new scientific research led the FDA in 2020 to add a “black box” warning to the montelukast prescribing label, flagging serious mental health risks like suicidal thinking or actions.
Wisconsin Sen. Ron Johnson Threatens Legal Action to Get COVID-19 Vaccine Data
U.S. Sen. Ron Johnson has threatened to issue a subpoena when he becomes chairman of the Permanent Subcommittee on Investigations if three federal health agencies continue to withhold data on the adverse health effects wrought by the COVID-19 vaccine. In a letter addressed to the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the Department of Health and Human Services, Johnson demanded that the agencies preserve all records referring to the development, safety, and side effects of COVID-19 vaccines, and to produce the records without redactions by Dec. 3.
“While your agencies have largely ignored or failed to fully cooperate with my oversight efforts, I can assure you that your obstruction will soon come to an end,” Johnson wrote Tuesday. “Your agencies’ refusal to provide complete and unredacted responses and documents to my numerous oversight letters on the development and safety of the COVID-19 vaccines has hindered Congressional oversight and has jeopardized the public’s health.”
Johnson has requested full versions of three sections within a FOIA from May 2021, which the CDC so heavily redacted that no scientific data was revealed.
As J&J Tries to Wrap up US Talc Litigation, the Company Now Faces Threat of Class Action in UK
While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the U.S., its baby powder problems are only just beginning in the U.K., according to several news outlets in the country.
A British law firm representing 1,900 talc claimants has sent a letter to J&J, giving advance notice of a group-action lawsuit that it plans to file in the High Court in London, according to The Financial Times. The claims would be the first of their kind in England against the U.S. healthcare giant, the newspaper reports, citing KP Law, the firm involved. The litigation is expected to begin next year.
