RFK Jr. says he’s following ‘gold standard’ science. Here’s what to know
The message is hammered home again and again, in press conferences, hearings and executive orders: President Donald Trump and his Health Secretary, Robert F. Kennedy Jr., say they want the government to follow the “scientific gold standard.”
Scientists say the problem is that they often do just the opposite, relying on preliminary studies, marginal science, or simply hunches to make claims, cast doubt on proven treatments, or even establish policy.
This week, the nation’s top public health agency changed its website to contradict the scientific conclusion that vaccines do not cause autism. The move shocked health experts nationwide.
Dr. Daniel Jernigan, who resigned from the Centers for Disease Control and Prevention in August, told reporters Wednesday that Kennedy appears to be “moving from evidence-based decision-making to evidence-based decision-making.”
This is the latest example of the Trump administration’s challenge to established science.
In September, the Republican president gave medical advice based on weak, if any, evidence. Speaking directly to pregnant women and parents, he told them not to take acetaminophen, the active ingredient in Tylenol. He has repeatedly made the fraudulent and long-disproven connection between autism and vaccines, claiming his assessment was based on a hunch.
“I’ve always had very strong feelings about autism and how it develops and where it comes from,” he said.
At a two-day meeting this fall, Kennedy’s hand-picked vaccine advisers to the CDC raised questions about vaccinating babies against hepatitis B, an inoculation that has long been shown to significantly reduce illness and death.
“The discussion that has been raised regarding safety is not based on evidence other than case reports and anecdotes,” said Dr. Flor Munoz, a pediatric infectious disease expert at Baylor College of Medicine and Texas Children’s Hospital.
During the nation’s worst year for measles in more than three decades, Kennedy cast doubt on the measles vaccine while defending unproven treatments and alleging that unvaccinated children who died were “already sick.”
Scientists say the process of marketing and recommending drugs and vaccines in the United States has until now generally relied on gold standard science. The process is so rigorous and transparent that much of the rest of the world is following the lead of U.S. regulators, only authorizing treatments after U.S. approval.
The gold standard may differ because science and medicine are complicated and not everything can be tested the same way. This term simply refers to the best possible evidence that can be gathered.
“It depends entirely on what question you’re trying to answer,” said Dr. Jake Scott, an infectious disease physician and researcher at Stanford University.
There are many different types of studies. The most rigorous is the randomized clinical trial.
It randomly creates two groups of subjects that are identical in every way except the drug, treatment, or other question being tested. Many are “blinded studies,” meaning that neither the subjects nor the researchers know who belongs to which group. This helps eliminate bias.
It is not always possible or ethical to perform these tests. That’s sometimes the case with vaccine trials, “because we have so much data showing how safe and effective they are, it would be unethical to withhold vaccines from a particular group,” said Jessica Steier, a public health scientist and founder of the Unbiased Science podcast.
Studying the long-term effect of a behavior may be impossible. For example, scientists could not study the long-term benefits of exercise by depriving a group of people from exercise for years.
Instead, researchers should conduct observational studies, in which they follow participants and monitor their health and behavior without manipulating any variables. Such studies helped scientists discover that fluoride reduces cavities, and subsequent laboratory studies showed how fluoride strengthens tooth enamel.
But these studies have their limitations, as they often can only prove correlation and not causation. For example, some observational studies have raised the possibility of a link between autism risk and acetaminophen use during pregnancy, but others have not found a link. The big problem is that these kinds of studies can’t determine whether the painkiller actually made a difference or whether it was the fever or other health problem that drove the need for the pill.
Scientists can learn even more when they see how something affects large numbers of people in their daily lives.
This real-world evidence can be valuable in proving a product’s effectiveness – and when there are rare side effects that could never be detected in trials.
Such evidence on vaccines has proven useful both ways. Scientists now know that some vaccines can cause rare side effects and can alert doctors to be on the lookout. Data has proven that vaccines provide extraordinary protection against disease. For example, measles has been eliminated in the United States, but it continues to reappear among unvaccinated groups.
This same data proves that vaccines are safe.
“If vaccines had caused a wave of chronic diseases, our security systems — which can detect one in a million events — would have detected it. They didn’t,” Scott told a U.S. Senate subcommittee in September.
Simply publishing an article online is not enough to qualify it as open and transparent. Specific things to look for include:
— Researchers formulate their hypothesis before starting the study and do not modify it.
— Authors disclose their conflicts of interest and sources of funding.
— The research has been peer-reviewed by subject matter experts who have nothing to do with this particular study.
— The authors show their work, publish and explain the data underlying their analyses.
— They cite reliable sources.
This transparency allows science to self-monitor. Dr. Steven Woloshin, a professor at Dartmouth College, has spent much of his career questioning the scientific findings that underpin health policy.
“I can only do this because they are transparent about what they did, what the underlying sources were, so you can draw your own conclusion,” he said. “That’s how science works.”
Anecdotes can be powerful. This is not data.
Case studies can even be published in leading journals, to help doctors or other professionals learn from a particular situation. But they are not used to making decisions about how to treat large numbers of patients, because each situation is unique.
Even isolated studies must be considered in the context of previous research. A new blockbuster one-off study that appears to definitively answer all the questions or reach a conclusion that runs counter to other well-conducted studies requires very careful consideration.
Uncertainty is rooted in science.
“Science is not about achieving certainty,” Woloshin said. “It’s about trying to reduce uncertainty to the point where you can say, ‘I’m confident that if we do X, we’ll get outcome Y.’” But there are no guarantees.
If you come across a research paper online, in a news article, or cited by officials to change your mind about something, here are some questions to ask:
—Who did the research? What is their expertise? Do they disclose conflicts of interest?
— Who funded this research? Who could benefit from it?
— Is it published in a reputable journal? Has it been peer reviewed?
— What question are researchers asking? Who or what are they studying? Do they even make comparisons between groups?
— Is there a “limitations” section where the authors point out what their research cannot prove, other factors that might influence their results, or other potential blind spots? What does it say?
— Does he make bold and definitive assertions? Is this part of the scientific consensus or does it call it into question? Is it too good or too bad to be true?
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AP Medical Writers Lauran Neergaard in Washington and Mike Stobbe in New York contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
