Latest news with #GoldStandardofScience
Time Magazine
08-05-2025
- Health
- Time Magazine
Marty Makary
Before being confirmed as the head of the U.S. Food and Drug Administration (FDA) on March 25, Dr. Marty Makary was an influential critic of the medical establishment, targeting hospitals on patient safety and criticizing the necessity of vaccine mandates. His book Blind Spots, published in Sept. 2024, became an instant New York Times bestseller and asserted that groupthink has plagued mainstream research on health and medicine. The Johns Hopkins pancreatic surgeon has continued this contrarian streak as FDA Commissioner, even as his agency battles low morale after losing around 3,500 workers—about 20% of the staff—to layoffs. Now, he is questioning whether the FDA will approve COVID-19 vaccines for next winter; requiring Novovax to run another clinical trial for its updated COVID-19 vaccine, a version of which has been out since 2022; and asking food companies to cut Red Dye No. 3 faster than planned. 'Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma companies 'tens of millions of dollars,'' he wrote, on a post on X, about the Novovax clinical trial.
Yahoo
06-05-2025
- Health
- Yahoo
Exclusive-Kennedy aide and vaccine critic questions recent expert recommendations
Yahoo is using AI to generate takeaways from this article. This means the info may not always match what's in the article. Reporting mistakes helps us improve the experience. Yahoo is using AI to generate takeaways from this article. This means the info may not always match what's in the article. Reporting mistakes helps us improve the experience. Yahoo is using AI to generate takeaways from this article. This means the info may not always match what's in the article. Reporting mistakes helps us improve the experience. Generate Key Takeaways By Dan Levine and Leah Douglas (Reuters) -An aide to U.S. Health Secretary Robert F. Kennedy Jr. is seeking more information about three vaccines recommended by a panel of outside experts last month, according to documents reviewed by Reuters and two sources familiar with the situation. The advisory panel to the Centers for Disease Control and Prevention had made recommendations regarding the use of separate shots approved to help protect against RSV, meningitis and chikungunya. The CDC is not required to adopt their recommendations, but when it does, they become guidelines for medical practitioners to follow. Dr. William 'Reyn' Archer III joined the Health and Human Services Department, which oversees CDC, as a counselor in the secretary's office after Kennedy took over in February, HHS records show. A critic of vaccines on social media for the past several years, Archer served as Texas state health commissioner in the late 1990s. Archer's hiring and activity at HHS have not previously been reported. His role reviewing the Advisory Committee on Immunization Practices' recommendations is the latest indication of how Kennedy, who has spent decades raising doubts about the safety and efficacy of vaccines, is reshaping U.S. policy. HHS spokesman Andrew Nixon said the agency "will ensure that all recommendations adhere to the Gold Standard of Science." As part of his HHS role, Archer has in recent days posed questions to the CDC about the advisory committee recommendations, according to the documents and the two sources. One recommendation would expand eligibility for RSV vaccines made by Pfizer and GSK to high-risk adults aged 50-59 from a current threshold age of at least 60 years. In response, Archer asked for more justification of the expansion given what he described as a 'possible decline in efficacy with a second dose,' according to the documents and two sources. It is unclear what decline in efficacy data Archer is referring to. At the ACIP meeting, a GSK representative presented clinical trial results the company described as showing 'robust' immune responses following re-vaccination at 24 and 36 months. A GSK spokesperson said the data showed waning efficacy of a single dose over time, but not enough to justify revaccination yet. A Pfizer spokesperson did not immediately respond to requests for comment. ACIP also voted to recommend expanded use of GSK's vaccine for meningitis, and Archer questioned how providers administer it. In addition, ACIP recommended the use of a new chikungunya vaccine from Bavarian Nordic, which Archer has not disputed. However, Kennedy's aide asked for more information about a recommendation to expand the use of a vaccine for the mosquito-borne virus made by Valneva, the documents show. Archer also asked to know what adjuvants and platforms are being used for all the vaccines discussed at the ACIP meeting, and their length of immunity. FROM TEXAS TO WASHINGTON Kennedy is currently reviewing the latest ACIP recommendations in the absence of a CDC director, and it is unclear whether the HHS secretary will ultimately sign off on them. The decision will impact public health and major drug companies. Pfizer and GSK last month touted ACIP's vote to lower the age at which adults can be eligible for their respective RSV vaccines, decisions that affect whether insurers will likely pay for them. The FDA previously approved the age expansion. Kennedy says he is not opposed to vaccination, but described them as a personal choice in the midst of a large U.S. measles outbreak mostly among the unvaccinated. Kennedy argues that the nation's health bureaucracy should focus on chronic illness. Archer is a trained obstetrician who served in the early 1990s as a deputy assistant secretary of HHS under the administration of George H.W. Bush. At HHS, he helped implement a so-called gag rule restricting medical providers at federally-funded clinics from advising patients on abortion, according to court documents and media reports. He was appointed by then-Texas Governor George W. Bush to serve as commissioner of the state's Department of Health. He resigned in 2000 after a Black administrator in the department secretly recorded him making comments about her race, according to an Associated Press report at the time. Archer later served as chief of staff for Congressman Jeff Fortenberry of Nebraska from 2016 to 2022, according to his LinkedIn profile. Fortenberry, who opposed COVID-19 vaccine mandates during his tenure, was subsequently charged with lying to federal authorities about a campaign donation. The Justice Department dropped those charges after President Donald Trump took office in January. On his personal Facebook page, Archer posted repeatedly from 2020 to 2022 about the "limitations" of the COVID vaccine, Reuters found. In a deleted post on X, accessed with the Internet Archive, Archer said as Texas health commissioner he felt pressure to support vaccine mandates without "scientific counterfactual.' "My own son developed autism in early years then took his life at 16," he said in the post, which linked to a Trump campaign ad critical of the measles vaccine. Kennedy had long promoted a debunked link between vaccines and autism, contrary to scientific evidence, and last month promised a study to determine the cause of the condition. (Reporting by Dan Levine in San Francisco and Leah Douglas in Washington; Editing by Michele Gershberg and Bill Berkrot)
The Star
06-05-2025
- Health
- The Star
Exclusive-Kennedy aide and vaccine critic questions recent expert recommendations
(Reuters) -An aide to U.S. Health Secretary Robert F. Kennedy Jr. is seeking more information about three vaccines recommended by a panel of outside experts last month, according to documents reviewed by Reuters and two sources familiar with the situation. The advisory panel to the Centers for Disease Control and Prevention had made recommendations regarding the use of separate shots approved to help protect against RSV, meningitis and chikungunya. The CDC is not required to adopt their recommendations, but when it does, they become guidelines for medical practitioners to follow. Dr. William 'Reyn' Archer III joined the Health and Human Services Department, which oversees CDC, as a counselor in the secretary's office after Kennedy took over in February, HHS records show. A critic of vaccines on social media for the past several years, Archer served as Texas state health commissioner in the late 1990s. Archer's hiring and activity at HHS have not previously been reported. His role reviewing the Advisory Committee on Immunization Practices' recommendations is the latest indication of how Kennedy, who has spent decades raising doubts about the safety and efficacy of vaccines, is reshaping U.S. policy. HHS spokesman Andrew Nixon said the agency "will ensure that all recommendations adhere to the Gold Standard of Science." As part of his HHS role, Archer has in recent days posed questions to the CDC about the advisory committee recommendations, according to the documents and the two sources. One recommendation would expand eligibility for RSV vaccines made by Pfizer and GSK to high-risk adults aged 50-59 from a current threshold age of at least 60 years. In response, Archer asked for more justification of the expansion given what he described as a 'possible decline in efficacy with a second dose,' according to the documents and two sources. It is unclear what decline in efficacy data Archer is referring to. At the ACIP meeting, a GSK representative presented clinical trial results the company described as showing 'robust' immune responses following re-vaccination at 24 and 36 months. A GSK spokesperson said the data showed waning efficacy of a single dose over time, but not enough to justify revaccination yet. A Pfizer spokesperson did not immediately respond to requests for comment. ACIP also voted to recommend expanded use of GSK's vaccine for meningitis, and Archer questioned how providers administer it. In addition, ACIP recommended the use of a new chikungunya vaccine from Bavarian Nordic, which Archer has not disputed. However, Kennedy's aide asked for more information about a recommendation to expand the use of a vaccine for the mosquito-borne virus made by Valneva, the documents show. Archer also asked to know what adjuvants and platforms are being used for all the vaccines discussed at the ACIP meeting, and their length of immunity. FROM TEXAS TO WASHINGTON Kennedy is currently reviewing the latest ACIP recommendations in the absence of a CDC director, and it is unclear whether the HHS secretary will ultimately sign off on them. The decision will impact public health and major drug companies. Pfizer and GSK last month touted ACIP's vote to lower the age at which adults can be eligible for their respective RSV vaccines, decisions that affect whether insurers will likely pay for them. The FDA previously approved the age expansion. Kennedy says he is not opposed to vaccination, but described them as a personal choice in the midst of a large U.S. measles outbreak mostly among the unvaccinated. Kennedy argues that the nation's health bureaucracy should focus on chronic illness. Archer is a trained obstetrician who served in the early 1990s as a deputy assistant secretary of HHS under the administration of George H.W. Bush. At HHS, he helped implement a so-called gag rule restricting medical providers at federally-funded clinics from advising patients on abortion, according to court documents and media reports. He was appointed by then-Texas Governor George W. Bush to serve as commissioner of the state's Department of Health. He resigned in 2000 after a Black administrator in the department secretly recorded him making comments about her race, according to an Associated Press report at the time. Archer later served as chief of staff for Congressman Jeff Fortenberry of Nebraska from 2016 to 2022, according to his LinkedIn profile. Fortenberry, who opposed COVID-19 vaccine mandates during his tenure, was subsequently charged with lying to federal authorities about a campaign donation. The Justice Department dropped those charges after President Donald Trump took office in January. On his personal Facebook page, Archer posted repeatedly from 2020 to 2022 about the "limitations" of the COVID vaccine, Reuters found. In a deleted post on X, accessed with the Internet Archive, Archer said as Texas health commissioner he felt pressure to support vaccine mandates without "scientific counterfactual.' "My own son developed autism in early years then took his life at 16," he said in the post, which linked to a Trump campaign ad critical of the measles vaccine. Kennedy had long promoted a debunked link between vaccines and autism, contrary to scientific evidence, and last month promised a study to determine the cause of the condition. (Reporting by Dan Levine in San Francisco and Leah Douglas in Washington; Editing by Michele Gershberg and Bill Berkrot)
Yahoo
02-05-2025
- Health
- Yahoo
RFK Jr. calls for 'new' vaccines to undergo placebo-controlled trials
Health and Human Services Secretary Robert F. Kennedy Jr. will require new vaccines to undergo placebo testing, marking what a department spokesperson called "a radical departure from past practices." The policy change would force vaccines, in order to be approved for human use, to undergo studies in which half of individuals in a study receive a placebo – typically a saline shot – to compare results against the vaccine. Placebo-controlled trials are already used to test new drugs or vaccines for safety and efficacy, but some experts consider it unethical to conduct such trials when a vaccine or treatment is already considered safe and efficacious. For example, they say, giving half of the kids in a trial a placebo for the measles vaccine when an already proven vaccine exists would put those participants unnecessarily at risk for the virus. It remains unclear what HHS considers a "new" vaccine and whether that includes the flu and COVID vaccines, which are updated on an annual basis to better protect against currently circulating strains. "FDA Commissioner Dr. Marty Makary has indicated that significant updates to existing vaccines—such as those addressing seasonal strain changes or antigenic drift—may be considered 'new products' requiring additional clinical evaluation," the department spokesperson told ABC News. MORE: RFK Jr. has a goal to study what's 'behind' autism by September. How realistic is it? But the spokesperson indicated the yearly flu vaccine might not be affected by the policy, calling it "tried and tested for more than 80 years." It appears, instead, that the policy could impact the rollout of future COVID vaccines, which are updated annually. When asked to elaborate on what the department considers a "new" vaccine, the spokesperson said that federal health agencies would follow the "Gold Standard of Science". Kennedy has long questioned the safety of vaccines and argued that placebo-based trials are needed to ensure vaccines aren't doing more harm than good. Even as thousands were dying during the COVID-19 public health emergency, COVID vaccines still underwent placebo-controlled studies with more than 100,000 volunteers from diverse populations. Experts say the practice is necessary to determine if a vaccine is not only effective, but also safe. MORE: RFK Jr. unveils plan to phase out 8 artificial food dyes in the US Many childhood vaccines were originally tested with placebo trials. Others have been available for decades, providing data from millions of people showing those vaccines are overwhelmingly safe and effective. Once a vaccine for a disease is approved safe and effective, future versions of the shot are tested in clinical trials against the already approved shot. Clinical trials test whether the updated vaccines generate an immune response that's comparable to or better than previous versions of the vaccine. Even after vaccines are made available to the public, scientists continue to monitor them for safety. They also review any reports of side effects or reactions and share these facts with the public. RFK Jr. calls for 'new' vaccines to undergo placebo-controlled trials originally appeared on
02-05-2025
- Health
RFK Jr. calls for 'new' vaccines to undergo placebo-controlled trials
Health and Human Services Secretary Robert F. Kennedy Jr. will require new vaccines to undergo placebo testing, marking what a department spokesperson called "a radical departure from past practices." The policy change would force vaccines, in order to be approved for human use, to undergo studies in which half of individuals in a study receive a placebo – typically a saline shot – to compare results against the vaccine. Placebo-controlled trials are already used to test new drugs or vaccines for safety and efficacy, but some experts consider it unethical to conduct such trials when a vaccine or treatment is already considered safe and efficacious. For example, they say, giving half of the kids in a trial a placebo for the measles vaccine when an already proven vaccine exists would put those participants unnecessarily at risk for the virus. It remains unclear what HHS considers a "new" vaccine and whether that includes the flu and COVID vaccines, which are updated on an annual basis to better protect against currently circulating strains. "FDA Commissioner Dr. Marty Makary has indicated that significant updates to existing vaccines—such as those addressing seasonal strain changes or antigenic drift—may be considered 'new products' requiring additional clinical evaluation," the department spokesperson told ABC News. But the spokesperson indicated the yearly flu vaccine might not be affected by the policy, calling it "tried and tested for more than 80 years." It appears, instead, that the policy could impact the rollout of future COVID vaccines, which are updated annually. When asked to elaborate on what the department considers a "new" vaccine, the spokesperson said that federal health agencies would follow the "Gold Standard of Science". Kennedy has long questioned the safety of vaccines and argued that placebo-based trials are needed to ensure vaccines aren't doing more harm than good. Even as thousands were dying during the COVID-19 public health emergency, COVID vaccines still underwent placebo-controlled studies with more than 100,000 volunteers from diverse populations. Experts say the practice is necessary to determine if a vaccine is not only effective, but also safe. Many childhood vaccines were originally tested with placebo trials. Others have been available for decades, providing data from millions of people showing those vaccines are overwhelmingly safe and effective. Once a vaccine for a disease is approved safe and effective, future versions of the shot are tested in clinical trials against the already approved shot. Clinical trials test whether the updated vaccines generate an immune response that's comparable to or better than previous versions of the vaccine. Even after vaccines are made available to the public, scientists continue to monitor them for safety. They also review any reports of side effects or reactions and share these facts with the public.
