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.
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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.
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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.'
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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.
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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.
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Toronto Star
2 hours ago
- Toronto Star
NIH scientists publish declaration criticizing Trump's deep cuts in public health research
WASHINGTON (AP) — In his confirmation hearings to lead the National Institutes of Health, Jay Bhattacharya pledged his openness to views that might conflict with his own. 'Dissent,' he said, 'is the very essence of science.' That commitment is being put to the test. On Monday, scores of scientists at the agency sent their Trump-appointed leader a letter titled the Bethesda Declaration, a frontal challenge to 'policies that undermine the NIH mission, waste public resources, and harm the health of Americans and people across the globe.' It says: 'We dissent.' In a capital where insiders often insist on anonymity to say such things publicly, more than 90 NIH researchers, program directors, branch chiefs and scientific review officers put their signatures on the letter — and their careers on the line. ARTICLE CONTINUES BELOW Confronting a 'culture of fear' They went public in the face of a 'culture of fear and suppression' they say President Donald Trump's administration has spread through the federal civil service. 'We are compelled to speak up when our leadership prioritizes political momentum over human safety and faithful stewardship of public resources,' the declaration says. Named for the agency's headquarters location in Maryland, the Bethesda Declaration details upheaval in the world's premier public health research institution over the course of mere months. It addresses the abrupt termination of 2,100 research grants valued at more than $12 billion and some of the human costs that have resulted, such as cutting off medication regimens to participants in clinical trials or leaving them with unmonitored device implants. In one case, an NIH-supported study of multi-drug-resistant tuberculosis in Haiti had to be stopped, ceasing antibiotic treatment mid-course for patients. In a number of cases, trials that were mostly completed were rendered useless without the money to finish and analyze the work, the letter says. 'Ending a $5 million research study when it is 80% complete does not save $1 million,' it says, 'it wastes $4 million.' The mask comes off The four-page letter, addressed to Bhattacharya but also sent to Health Secretary Robert F. Kennedy Jr. and members of Congress who oversee the NIH, was endorsed by 250 anonymous employees of the agency besides the 92 who signed. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Jenna Norton, who oversees health disparity research at the agency's National Institute of Diabetes and Digestive and Kidney Diseases, recently appeared at a forum by Sen. Angela Alsobrooks, D-Md., to talk about what's happening at the NIH. At the event, she masked to conceal her identity. Now the mask is off. She was a lead organizer of the declaration. 'I want people to know how bad things are at NIH,' Norton told The Associated Press. The signers said they modeled their indictment after Bhattacharya's own Great Barrington Declaration of October 2020, when he was a professor at Stanford University Medical School. His declaration drew together likeminded infectious disease epidemiologists and public health scientists who dissented from what they saw as excessive COVID-19 lockdown policies and felt ostracized by the larger public health community that pushed those policies, including the NIH. 'He is proud of his statement, and we are proud of ours,' said Sarah Kobrin, a branch chief at the NIH's National Cancer Institute who signed the Bethesda Declaration. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Cancer research is sidelined As chief of the Health Systems and Interventions Research Branch, Kobrin provides scientific oversight of researchers across the country who've been funded by the cancer institute or want to be. But sudden cuts in personnel and money have shifted her work from improving cancer care research to what she sees as minimizing its destruction. 'So much of it is gone — my work,' she said. The 21-year NIH veteran said she signed because 'I don't want to be a collaborator' in the political manipulation of biomedical science. Ian Morgan, a postdoctoral fellow with the National Institute of General Medical Sciences, also signed the declaration. 'We have a saying in basic science,' he said. 'You go and become a physician if you want to treat thousands of patients. You go and become a researcher if you want to save billions of patients. 'We are doing the research that is going to go and create the cures of the future,' he added. But that won't happen, he said, if Trump's Republican administration prevails with its searing cuts to grants. The NIH employees interviewed by the AP emphasized they were speaking for themselves and not for their institutes or the NIH. Dissenters range across the breadth of NIH Employees from all 27 NIH institutes and centers gave their support to the declaration. Most who signed are intimately involved with evaluating and overseeing extramural research grants. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW The letter asserts that 'NIH trials are being halted without regard to participant safety' and that the agency is shirking commitments to trial participants who 'braved personal risk to give the incredible gift of biological samples, understanding that their generosity would fuel scientific discovery and improve health.' The Trump administration has gone at public health research on several fronts, both directly, as part of its broad effort to root out diversity, equity and inclusion values throughout the bureaucracy, and as part of its drive to starve some universities of federal money. A blunt ax swings This has forced 'indiscriminate grant terminations, payment freezes for ongoing research, and blanket holds on awards regardless of the quality, progress, or impact of the science,' the declaration says. Some NIH employees have previously come forward in televised protests to air grievances, and many walked out of Bhattacharya's town hall with staff. The declaration is the first cohesive effort to register agency-wide dismay with the NIH's direction. A Signal group became the place for participants to sort through NIH chatter on Reddit, discern rumor from reality and offer mutual support. The declaration took shape in that group and as word spread neighbor to neighbor in NIH offices. The dissenters remind Bhattacharya in their letter of his oft-stated ethic that academic freedom must be a lynchpin in science. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW With that in place, he said in a statement in April, 'NIH scientists can be certain they are afforded the ability to engage in open, academic discourse as part of their official duties and in their personal capacities without risk of official interference, professional disadvantage or workplace retaliation.' Now it will be seen whether that's enough to protect those NIH employees challenging the Trump administration and him. 'There's a book I read to my kids, and it talks about how you can't be brave if you're not scared,' said Norton, who has three young children. 'I am so scared about doing this, but I am trying to be brave for my kids because it's only going to get harder to speak up. 'Maybe I'm putting my kids at risk by doing this,' she added. 'And I'm doing it anyway because I couldn't live with myself otherwise.' ___ Associated Press Medical Writer Lauran Neergaard contributed to this report.
Toronto Star
3 hours ago
- Toronto Star
NIH scientists go public to criticize Trump's deep cuts in public health research
WASHINGTON (AP) — In his confirmation hearings to lead the National Institutes of Health, Jay Bhattacharya pledged his openness to views that might conflict with his own. 'Dissent,' he said, 'is the very essence of science.' That commitment is being put to the test. On Monday, scores of scientists at the agency sent their Trump-appointed leader a letter titled the Bethesda Declaration, a frontal challenge to 'policies that undermine the NIH mission, waste public resources, and harm the health of Americans and people across the globe.' It says: 'We dissent.' In a capital where insiders often insist on anonymity to say such things publicly, more than 90 NIH researchers, program directors, branch chiefs and scientific review officers put their signatures on the letter — and their careers on the line. ARTICLE CONTINUES BELOW Confronting a 'culture of fear' They went public in the face of a 'culture of fear and suppression' they say President Donald Trump's administration has spread through the federal civil service. 'We are compelled to speak up when our leadership prioritizes political momentum over human safety and faithful stewardship of public resources,' the declaration says. Named for the agency's headquarters location in Maryland, the Bethesda Declaration details upheaval in the world's premier public health research institution over the course of mere months. It addresses the abrupt termination of 2,100 research grants valued at more than $12 billion and some of the human costs that have resulted, such as cutting off medication regimens to participants in clinical trials or leaving them with unmonitored device implants. In one case, an NIH-supported study of multi-drug-resistant tuberculosis in Haiti had to be stopped, ceasing antibiotic treatment mid-course for patients. In a number of cases, trials that were mostly completed were rendered useless without the money to finish and analyze the work, the letter says. 'Ending a $5 million research study when it is 80% complete does not save $1 million,' it says, 'it wastes $4 million.' The mask comes off The four-page letter, addressed to Bhattacharya but also sent to Health Secretary Robert F. Kennedy Jr. and members of Congress who oversee the NIH, was endorsed by 250 anonymous employees of the agency besides the 92 who signed. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Jenna Norton, who oversees health disparity research at the agency's National Institute of Diabetes and Digestive and Kidney Diseases, recently appeared at a forum by Sen. Angela Alsobrooks, D-Md., to talk about what's happening at the NIH. At the event, she masked to conceal her identity. Now the mask is off. She was a lead organizer of the declaration. 'I want people to know how bad things are at NIH,' Norton told The Associated Press. The signers said they modeled their indictment after Bhattacharya's own Great Barrington Declaration of October 2020, when he was a professor at Stanford University Medical School. His declaration drew together likeminded infectious disease epidemiologists and public health scientists who dissented from what they saw as excessive COVID-19 lockdown policies and felt ostracized by the larger public health community that pushed those policies, including the NIH. 'He is proud of his statement, and we are proud of ours,' said Sarah Kobrin, a branch chief at the NIH's National Cancer Institute who signed the Bethesda Declaration. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Cancer research is sidelined As chief of the Health Systems and Interventions Research Branch, Kobrin provides scientific oversight of researchers across the country who've been funded by the cancer institute or want to be. But sudden cuts in personnel and money have shifted her work from improving cancer care research to what she sees as minimizing its destruction. 'So much of it is gone — my work,' she said. The 21-year NIH veteran said she signed because 'I don't want to be a collaborator' in the political manipulation of biomedical science. Ian Morgan, a postdoctoral fellow with the National Institute of General Medical Sciences, also signed the declaration. 'We have a saying in basic science,' he said. 'You go and become a physician if you want to treat thousands of patients. You go and become a researcher if you want to save billions of patients. 'We are doing the research that is going to go and create the cures of the future,' he added. But that won't happen, he said, if Trump's Republican administration prevails with its searing cuts to grants. The NIH employees interviewed by the AP emphasized they were speaking for themselves and not for their institutes or the NIH. Dissenters range across the breadth of NIH Employees from all 27 NIH institutes and centers gave their support to the declaration. Most who signed are intimately involved with evaluating and overseeing extramural research grants. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW The letter asserts that 'NIH trials are being halted without regard to participant safety' and that the agency is shirking commitments to trial participants who 'braved personal risk to give the incredible gift of biological samples, understanding that their generosity would fuel scientific discovery and improve health.' The Trump administration has gone at public health research on several fronts, both directly, as part of its broad effort to root out diversity, equity and inclusion values throughout the bureaucracy, and as part of its drive to starve some universities of federal money. A blunt ax swings This has forced 'indiscriminate grant terminations, payment freezes for ongoing research, and blanket holds on awards regardless of the quality, progress, or impact of the science,' the declaration says. Some NIH employees have previously come forward in televised protests to air grievances, and many walked out of Bhattacharya's town hall with staff. The declaration is the first cohesive effort to register agency-wide dismay with the NIH's direction. A Signal group became the place for participants to sort through NIH chatter on Reddit, discern rumor from reality and offer mutual support. The declaration took shape in that group and as word spread neighbor to neighbor in NIH offices. The dissenters remind Bhattacharya in their letter of his oft-stated ethic that academic freedom must be a lynchpin in science. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW With that in place, he said in a statement in April, 'NIH scientists can be certain they are afforded the ability to engage in open, academic discourse as part of their official duties and in their personal capacities without risk of official interference, professional disadvantage or workplace retaliation.' Now it will be seen whether that's enough to protect those NIH employees challenging the Trump administration and him. 'There's a book I read to my kids, and it talks about how you can't be brave if you're not scared,' said Norton, who has three young children. 'I am so scared about doing this, but I am trying to be brave for my kids because it's only going to get harder to speak up. 'Maybe I'm putting my kids at risk by doing this,' she added. 'And I'm doing it anyway because I couldn't live with myself otherwise.' ___ Associated Press Medical Writer Lauran Neergaard contributed to this report.
Winnipeg Free Press
3 hours ago
- Winnipeg Free Press
NIH scientists go public to criticize Trump's deep cuts in public health research
WASHINGTON (AP) — In his confirmation hearings to lead the National Institutes of Health, Jay Bhattacharya pledged his openness to views that might conflict with his own. 'Dissent, he said, 'is the very essence of science.' That commitment is being put to the test. On Monday, scores of scientists at the agency sent their Trump-appointed leader a letter titled the Bethesda Declaration, a frontal challenge to 'policies that undermine the NIH mission, waste public resources, and harm the health of Americans and people across the globe.' It says: 'We dissent.' In a capital where insiders often insist on anonymity to say such things publicly, more than 90 NIH researchers, program directors, branch chiefs and scientific review officers put their signatures on the letter — and their careers on the line. Confronting a 'culture of fear' They went public in the face of a 'culture of fear and suppression' they say President Donald Trump's administration has spread through the federal civil service. 'We are compelled to speak up when our leadership prioritizes political momentum over human safety and faithful stewardship of public resources,' the declaration says. Named for the agency's headquarters location in Maryland, the Bethesda Declaration details upheaval in the world's premier public health research institution over the course of mere months. It addresses the abrupt termination of 2,100 research grants valued at more than $12 billion and some of the human costs that have resulted, such as cutting off medication regimens to participants in clinical trials or leaving them with unmonitored device implants. In one case, an NIH-supported study of multi-drug-resistant tuberculosis in Haiti had to be stopped, ceasing antibiotic treatment mid-course for patients. In a number of cases, trials that were mostly completed were rendered useless without the money to finish and analyze the work, the letter says. 'Ending a $5 million research study when it is 80% complete does not save $1 million,' it says, 'it wastes $4 million.' The mask comes off The four-page letter, addressed to Bhattacharya but also sent to Health Secretary Robert F. Kennedy Jr. and members of Congress who oversee the NIH, was endorsed by 250 anonymous employees of the agency besides the 92 who signed. Jenna Norton, who oversees health disparity research at the agency's National Institute of Diabetes and Digestive and Kidney Diseases, recently appeared at a forum by Sen. Angela Alsobrooks, D-Md., to talk about what's happening at the NIH. At the event, she masked to conceal her identity. Now the mask is off. She was a lead organizer of the declaration. 'I want people to know how bad things are at NIH,' Norton told The Associated Press. The signers said they modeled their indictment after Bhattacharya's own Great Barrington Declaration of October 2020, when he was a professor at Stanford University Medical School. His declaration drew together likeminded infectious disease epidemiologists and public health scientists who dissented from what they saw as excessive COVID-19 lockdown policies and felt ostracized by the larger public health community that pushed those policies, including the NIH. 'He is proud of his statement, and we are proud of ours,' said Sarah Kobrin, a branch chief at the NIH's National Cancer Institute who signed the Bethesda Declaration. Cancer research is sidelined As chief of the Health Systems and Interventions Research Branch, Kobrin provides scientific oversight of researchers across the country who've been funded by the cancer institute or want to be. But sudden cuts in personnel and money have shifted her work from improving cancer care research to what she sees as minimizing its destruction. 'So much of it is gone — my work,' she said. The 21-year NIH veteran said she signed because 'I don't want to be a collaborator' in the political manipulation of biomedical science. Ian Morgan, a postdoctoral fellow with the National Institute of General Medical Sciences, also signed the declaration. 'We have a saying in basic science,' he said. 'You go and become a physician if you want to treat thousands of patients. You go and become a researcher if you want to save billions of patients. 'We are doing the research that is going to go and create the cures of the future,' he added. But that won't happen, he said, if Trump's Republican administration prevails with its searing cuts to grants. The NIH employees interviewed by the AP emphasized they were speaking for themselves and not for their institutes or the NIH. Dissenters range across the breadth of NIH Employees from all 27 NIH institutes and centers gave their support to the declaration. Most who signed are intimately involved with evaluating and overseeing extramural research grants. The letter asserts that 'NIH trials are being halted without regard to participant safety' and that the agency is shirking commitments to trial participants who 'braved personal risk to give the incredible gift of biological samples, understanding that their generosity would fuel scientific discovery and improve health.' The Trump administration has gone at public health research on several fronts, both directly, as part of its broad effort to root out diversity, equity and inclusion values throughout the bureaucracy, and as part of its drive to starve some universities of federal money. A blunt ax swings This has forced 'indiscriminate grant terminations, payment freezes for ongoing research, and blanket holds on awards regardless of the quality, progress, or impact of the science,' the declaration says. Some NIH employees have previously come forward in televised protests to air grievances, and many walked out of Bhattacharya's town hall with staff. The declaration is the first cohesive effort to register agency-wide dismay with the NIH's direction. A Signal group became the place for participants to sort through NIH chatter on Reddit, discern rumor from reality and offer mutual support. The declaration took shape in that group and as word spread neighbor to neighbor in NIH offices. The dissenters remind Bhattacharya in their letter of his oft-stated ethic that academic freedom must be a lynchpin in science. With that in place, he said in a statement in April, 'NIH scientists can be certain they are afforded the ability to engage in open, academic discourse as part of their official duties and in their personal capacities without risk of official interference, professional disadvantage or workplace retaliation.' Wednesdays Columnist Jen Zoratti looks at what's next in arts, life and pop culture. Now it will be seen whether that's enough to protect those NIH employees challenging the Trump administration and him. 'There's a book I read to my kids, and it talks about how you can't be brave if you're not scared,' said Norton, who has three young children. 'I am so scared about doing this, but I am trying to be brave for my kids because it's only going to get harder to speak up. 'Maybe I'm putting my kids at risk by doing this,' she added. 'And I'm doing it anyway because I couldn't live with myself otherwise.' ___ Associated Press Medical Writer Lauran Neergaard contributed to this report.
