Health and Human Services Secretary Robert F. Kennedy Jr. has said he wants all health research stakeholders to commit to a “gold standard” when it comes to scientific research, including testing all new vaccines against a placebo before the Food and Drug Administration can approve them.
“Our commitment is clear: every innovation in vaccine development must be grounded in gold standard science and transparency, and subjected to the highest standards of safety and efficacy testing,” Kennedy said in a statement in May.
But doctors and the medical community at large say that requiring placebo-testing is not always good science, and it can be unethical.
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HHS spokesman Andrew Nixon said in a May statement that the new policy on vaccine testing would be a “radical departure from past practices.”
Nixon incorrectly claimed that “None of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products.”
When pressed for more details before a Senate subcommittee in May, Kennedy said “I’m not suggesting we go back and placebo test all childhood vaccines.” His department did not respond to an email from PBS News seeking more clarity about plans for placebo testing.
The ‘Make America Health report’ released by HHS on Tuesday touts the development of a vaccine framework that will modernize vaccines, ensure the “best childhood vaccine schedule” and study vaccine injuries, but it does not specifically address placebo testing.
Most of the vaccines on the childhood schedule were, at some point, tested against a placebo, which involves giving one group an active treatment, and another an inactive substance or treatment which has no effect on the condition the vaccine is intended to treat.
Some were first tested and approved decades ago, when standards and requirements were different, such as the early vaccine trials for whooping cough in the 1930s and ‘40s. Modern scholars say the way researchers set up the initial trial for the vaccine was flawed — participants opted in to the experimental vaccine, rather than be randomly selected. But it led the way to the development of a successful pertussis vaccine, now administered as a combined shot that also protects against tetanus and diphtheria.
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Today, if there is a known vaccine treatment for a disease, the medical establishment considers it unethical to withhold that drug from trial participants, as would happen in a placebo group.
“It remains unclear under which circumstances, if any, a placebo-controlled clinical trial design is ethically justifiable when an efficacious or partially efficacious vaccine already exists,” experts wrote in a 2013 World Health Organization report.
That means that even if a previously approved vaccine is improved upon, many times over, those new trials are not conducted against a placebo, but rather, the previous version of the vaccine.
“You can’t compare that new vaccine to no vaccine, because the standard of care is the old vaccine,” said Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. “As a result, you don’t have a true no-vaccine control group. And you can’t, ethically.”
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At least one vaccine on the childhood schedule was not tested against a placebo when it was first introduced, and for ethical reasons, its principal investigator said. In the late 1990s, the first trial of the effects of the 7-valent pneumococcal conjugate vaccine, known as Prevnar, was conducted against a different vaccine, for meningococcal disease.
“The reason that the PCV7 trial was not placebo controlled was due to the ethical concern of requiring the more than 15,000 control patients in the trial having to receive four doses of a placebo vaccine with no potential for benefit,” Dr. Steven Black, the co-director of the Global Vaccine Data Network, told PBS News in an email.
“The ethics review board and I as the principal investigator felt that by giving the control group the [meningococcal] vaccine, this group would have potential benefit from participating without interfering with the primary endpoint – efficacy,” wrote Black, who previously directed the Kaiser Permanente Vaccine Study Center.
Health and Human Services Secretary Robert F. Kennedy Jr. speaks as he attends a press conference June 23 in Washington, D.C. Kennedy has said he wants all health research stakeholders to commit to a “gold standard” when it comes to scientific research, including testing all new vaccines against a placebo before the Food and Drug Administration can approve them. Photo by Kevin Mohatt/Reuters
Black also noted that the trial incorporated the largest safety assessment in a Phase III trial that had been conducted up to that point, with evaluations of all hospitalizations and emergency visits experienced by participants.
Some proponents of placebo-controlled trials for existing vaccines argue that this kind of study can be done ethically if the placebo is administered to people who wouldn’t be getting the vaccine anyway.
Discussing the logistics of conducting randomized controlled trials when standards of care are already established, Dr. Mark Hyman, a family physician focused on functional medicine and a wellness influencer, said on his podcast, “You gotta go to populations that are unvaccinated, like the Amish or Mennonites or groups like that.”
Plus, using only members of closed communities where unvaccinated rates might be higher may skew the results, as the participants may have other health and lifestyle factors that contribute to their outcomes, Salmon said.
“If you’re talking about an observational study, the Amish are a terrible control group, because not only do they not use vaccines as much – although some do – they’ll do all these other things that are different,” he said. “They utilize health care systems and health care very differently.”
Also, if the population receiving a placebo is predetermined, the trial in which they are participating is no longer randomized, said Natalie Dean, associate professor of biostatistics at Emory University’s Rollins School of Public Health.
“If that’s just the control group, then you’ve reinvented an observational study, which is not ‘gold standard science,’” Dean said.
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