Latest news with #PeterLurie
Time Magazine
08-05-2025
- Health
- Time Magazine
Peter Lurie
The U.S. Food and Drug Administration (FDA) banned Red Dye #3 in January 2025—an act that was a long time coming for the federal government, the American public, and Dr. Peter Lurie. Back in 1984, during a gap year from medical school, Lurie helped a public interest group called Public Citizen advocate against harmful synthetic chemicals in food, including Red Dye #3. Research has linked Red Dye #3 to cancer and ADHD-like symptoms in children. Since then, whether as a physician, academic researcher, or federal official, his work has often focused on ridding the food supply of toxic chemicals. As the president and executive director of Center for Science in the Public Interest (CSPI), he directed his organization in 2022 to petition the FDA to ban Red Dye #3. But from previously working at the FDA, Lurie knew that their best shot was to pressure the agency—through the states. In California, CSPI helped develop legislation that led to a state-level ban and the removal of certain food dyes from the school meal program in 2024. After four decades, Lurie was 'thrilled' when the FDA finally passed a federal ban. Just weeks later, his team successfully helped pressure the agency to define 'healthy' food labels, so that they better align with nutrition science. 'Most people believe the government is protecting them, but it often isn't,' Lurie says. 'That's where we step in.'
Global News
02-05-2025
- Health
- Global News
RFK Jr. wants placebo testing for ‘new' vaccines, experts say it's unethical
The U.S. health department, under the guidance of Health Secretary Robert F. Kennedy Jr., says it intends to add the requirement of a placebo testing phase in vaccine trials to provide more transparency about medical products, but experts warn the process could threaten immunization access and create public mistrust in the efficacy and validity of inoculations. In a statement to the Washington Post this week, a spokesperson for the Department of Health and Human Services (HHS) said, 'All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices.' If implemented, the new regulations would require some test subjects to receive vaccine doses, while others would be injected with a non-reactive substance. Story continues below advertisement Vaccines that target new infectious agents are often tested using the placebo method, but for well-known and researched diseases, health experts say using a placebo poses ethical issues because the group receiving it will not know if they are actually protected against the illness. Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. Sign up for weekly health newsletter Sign Up By providing your email address, you have read and agree to Global News' Terms and Conditions and Privacy Policy The health department did not provide details on how the proposed changes will be enforced or to which vaccine trials they will apply. It also did not define what it meant by 'new vaccine,' though it said the policy would not include the flu shot, which is updated yearly. Health experts have argued that updated COVID-19 vaccines may be included, which they say could delay access. Peter Lurie, a former Food and Drug Administration (FDA) official, told the BBC, 'It's hard to tell exactly what is being proposed.' 'But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point.' An HHS spokesperson also told the BBC that Kennedy's goal is to achieve 'radical transparency,' which means 'being honest and straightforward about what we know—and what we don't know—about medical products, including vaccines.' The statement went on to claim that none of the vaccines recommended for children in the U.S., except the COVID-19 shot, had gone through placebo testing, which the health department says leaves it knowing 'very little about the actual risk profiles of these products.' Story continues below advertisement However, health experts warn that the statement is misleading because vaccines administered to children, including for hepatitis A and B, polio, and mumps, were all tested against a placebo during their development stages. The BBC adds that all new immunizations go through a type of random testing where one test group receives the vaccine and the other is given a placebo. But in the new system proposed by HHS, experts say vaccines under testing may not undergo the same randomized process, because it is unethical to withhold an injection that is known to be safe from a particular group, and because shots that are updated yearly go through minimal alterations. For example, the COVID-19 vaccine has endured scrupulous testing for years, and all of that is necessary to update it for a different Omicron variant than the one used the year prior, Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told the BBC. Story continues below advertisement Nevertheless, an HHS spokesperson said that 'significant updates to existing vaccines' could be seen as 'new products,' which could necessitate additional trials. 'A four-year-old trial is also not a blank cheque for new vaccines each year without clinical trial data, unlike the flu shot, which has been tried and tested for more than 80 years,' the spokesperson told the BBC. Meanwhile, Lurie says requiring placebo tests for basic updates to existing vaccines that are proven to work would be expensive and could lead to drug companies opting not to upgrade them altogether.
Yahoo
02-05-2025
- Health
- Yahoo
RFK Jr plans placebo-trial testing for 'all new vaccines'
The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns. In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices". The agency did not provide details on which "new vaccines" would be included. But officials have suggested that updated Covid-19 shots may be included, which vaccine experts say could slow down vaccine access. Peter Lurie, a former official with the Food and Drug Administration (FDA), said "it's hard to tell exactly what is being proposed." "But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point." HHS has not offered details on the timing of the placebo plan or specify the vaccines involved. An HHS spokesperson told the BBC in a statement that health secretary Robert F Kennedy Jr's goal of "radical transparency" means being "honest and straightforward about what we know — and what we don't know — about medical products, including vaccines". The statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products". But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot. But newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said. The coronavirus shot, for example, already has gone through rigorous safety testing, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "We have a lot of information about the safety of the vaccine," he said. "All we're doing this year is using a different Omicron variant that we used last year and the year before that." Still, FDA Commissioner Marty Makary said this week that the agency was "taking a look" at updated coronavirus shots, telling the BBC's US partner CBS News that there is a "void of data". An HHS spokesperson told the BBC that "significant updates to existing vaccines" may be considered "new products" requiring additional clinical evaluation. "A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," the spokesperson said. Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie. Before taking office - and since assuming the role as secretary - Kennedy has spread false claims about vaccine safety. His tenure has coincided with one of the worst measles outbreaks in a decade; two children have died and 660 people have been infected in Texas. This week, he encouraged parents to "do their own research" about the measles vaccine - which has been considered safe and 97% effective for decades - and raised questions about whether the shot could cause seizures or neurological issues. For months, he has at times endorsed the MMR shot, and at other times, called it a "personal" decision. Kennedy also promoted alternative treatments, which doctors say patients should not use without medical supervision. Deadly measles outbreak does little to counter vaccine scepticism in Texas Love on the Spectrum cast questions RFK Jr's comments about autistic people RFK Jr pledges to find the cause of autism by September
Yahoo
01-05-2025
- Health
- Yahoo
RFK Jr plans placebo-trial testing for 'all new vaccines'
The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns. In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices". The agency did not provide details on which "new vaccines" would be included. But officials have suggested that updated Covid-19 shots may be included, which vaccine experts say could slow down vaccine access. Peter Lurie, a former official with the Food and Drug Administration (FDA), said "it's hard to tell exactly what is being proposed." "But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point." HHS has not offered details on the timing of the placebo plan or specify the vaccines involved. An HHS spokesperson told the BBC in a statement that health secretary Robert F Kennedy Jr's goal of "radical transparency" means being "honest and straightforward about what we know — and what we don't know — about medical products, including vaccines". The statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products". But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot. But newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said. The coronavirus shot, for example, already has gone through rigorous safety testing, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "We have a lot of information about the safety of the vaccine," he said. "All we're doing this year is using a different Omicron variant that we used last year and the year before that." Still, FDA Commissioner Marty Makary said this week that the agency was "taking a look" at updated coronavirus shots, telling the BBC's US partner CBS News that there is a "void of data". An HHS spokesperson told the BBC that "significant updates to existing vaccines" may be considered "new products" requiring additional clinical evaluation. "A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," the spokesperson said. Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie. Before taking office - and since assuming the role as secretary - Kennedy has spread false claims about vaccine safety. His tenure has coincided with one of the worst measles outbreaks in a decade; two children have died and 660 people have been infected in Texas. This week, he encouraged parents to "do their own research" about the measles vaccine - which has been considered safe and 97% effective for decades - and raised questions about whether the shot could cause seizures or neurological issues. For months, he has at times endorsed the MMR shot, and at other times, called it a "personal" decision. Kennedy also promoted alternative treatments, which doctors say patients should not use without medical supervision. Deadly measles outbreak does little to counter vaccine scepticism in Texas Love on the Spectrum cast questions RFK Jr's comments about autistic people RFK Jr pledges to find the cause of autism by September
BBC News
01-05-2025
- Health
- BBC News
crkx3egk3ygo (GIF Image, 1 × 1 pixels)
The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns. In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices". The agency did not provide details on which "new vaccines" would be included. But officials have suggested that updated Covid-19 shots may be included, which vaccine experts say could slow down vaccine access. Peter Lurie, a former official with the Food and Drug Administration (FDA), said "it's hard to tell exactly what is being proposed." "But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point." HHS has not offered details on the timing of the placebo plan or specify the vaccines involved. An HHS spokesperson told the BBC in a statement that health secretary Robert F Kennedy Jr's goal of "radical transparency" means being "honest and straightforward about what we know — and what we don't know — about medical products, including vaccines". The statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products". But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot. But newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said. The coronavirus shot, for example, already has gone through rigorous safety testing, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "We have a lot of information about the safety of the vaccine," he said. "All we're doing this year is using a different Omicron variant that we used last year and the year before that." Still, FDA Commissioner Marty Makary said this week that the agency was "taking a look" at updated coronavirus shots, telling the BBC's US partner CBS News that there is a "void of data". An HHS spokesperson told the BBC that "significant updates to existing vaccines" may be considered "new products" requiring additional clinical evaluation. "A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," the spokesperson said. Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie. Before taking office - and since assuming the role as secretary - Kennedy has spread false claims about vaccine safety. His tenure has coincided with one of the worst measles outbreaks in a decade; two children have died and 660 people have been infected in Texas. This week, he encouraged parents to "do their own research" about the measles vaccine - which has been considered safe and 97% effective for decades - and raised questions about whether the shot could cause seizures or neurological issues. For months, he has at times endorsed the MMR shot, and at other times, called it a "personal" decision. Kennedy also promoted alternative treatments, which doctors say patients should not use without medical supervision.
