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The message is repeated over and over again in news conferences, hearings and executive orders: President donald trump and his Secretary of Health, Robert F. Kennedy Jr. says he wants the government to follow “gold standard” science.
Scientist The problem is that they are often doing exactly the opposite by relying on preliminary studies, marginalizing science or only claims, casting doubt on proven treatments, or even dictating policy.
This week, the nation’s top public health agency changed its website to refute the scientific conclusion that vaccines do not cause autism. The move stunned health experts across the country.
Dr. Daniel Jernigan, who resigned Centers for Disease Control and Prevention In August, Wednesday told reporters that Kennedy was “moving from evidence-based decision making to evidence-based decision making.”
It was the latest example of the Trump administration’s challenge to established science.
on September, republican The President gave medical advice based on weak or no evidence. Speaking directly to pregnant women and parents, he told them not to take acetaminophen, the active ingredient in Tylenol. He repeatedly reiterated the fraudulent and long-discredited connection between autism and vaccines, saying that his assessment was based on a guess.
“I’ve always had very strong feelings about autism and how it happened and where it came from,” he said.
At a two-day meeting this fall, Kennedy’s hand-picked vaccine advisers to the CDC raised questions about vaccinating infants against hepatitis B, a vaccination that has long been shown to reduce disease and death.
“The discussion that has emerged regarding safety is not based on evidence other than case reports and anecdotes,” said Dr. Flor Munoz, a pediatric infectious disease specialist 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 supporting unproven treatments and charging that children who died without vaccination were “already sick.”
Scientists say the process for bringing drugs and vaccines to market and recommending United States of America Until now, the gold standard has generally relied on science. The process is so rigorous and transparent that most parts of the world follow US regulators, approving treatments only after US approval.
gold standard science
Gold standards may vary because science and medicine are complex and not everything can be tested the same way. The term refers only to the best possible evidence that can be collected.
“It totally depends on what question you’re trying to answer,” said Dr. Jake Scott, an infectious disease physician and researcher at Stanford University.
What produces the best possible evidence?
There are many types of studies. The most rigorous is the randomized clinical trial.
It randomly creates two groups of subjects who are identical in every way except the drug, treatment, or other question being tested. Many are “blind studies”, meaning that neither the subjects nor the researchers know who is in which group. This helps in eliminating prejudice.
It is not always possible or ethical to administer these tests. Jessica Steer, a public health scientist and founder of the Unbiased Science podcast, said sometimes in the case of vaccine trials, “because we have so much data that shows how safe and effective they are, it would be unethical to withhold vaccines from a particular group.”
It may be impossible to study the long-term effects of a behavior. For example, scientists cannot possibly study the long-term benefits of exercise by having a group not exercise for years.
Instead, researchers should conduct observational studies, where they follow participants and track their health and behavior without manipulating any variables. Such studies helped scientists discover that fluoride reduces cavities, and later laboratory studies showed how fluoride strengthens tooth enamel.
But studies have limitations because they can often only prove correlation, not causation. For example, some observational studies have raised the possibility of an association between autism risk and acetaminophen use during pregnancy, but other studies have found no association. The big problem is that these types of studies can’t determine whether the painkiller actually made a difference or whether the fever or other health problem caused the need for the pill.
Real-world evidence can be especially powerful
Scientists can learn even more when they see how something affects large numbers of people in their daily lives.
Real-world evidence can be valuable in proving how well something works – and when there are rare side effects that might never have been detected in trials.
Such evidence on vaccines has proven useful both ways. Scientists now know that some vaccines can have rare side effects and caution doctors to be careful. Data has proven that the vaccines provide exceptional protection against the disease. For example, measles has been eliminated in the US but it still occurs in unvaccinated groups.
The same data proves that the vaccines are safe.
Scott told a U.S. Senate subcommittee in September, “If vaccines caused a wave of chronic disease, our security systems – which can detect a one-in-a-million event – would have seen it. They haven’t.”
The best science is open and transparent
Simply publishing a paper online is not enough to call it open and transparent. Typical things to look for include:
—Researchers set their hypothesis before starting the study and do not change it.
– Authors disclose their conflicts of interest and their funding sources.
– The research has gone through peer review by subject matter experts who have no connection to the particular study.
– Authors showcase their work by publishing and explaining the data underlying their analyses.
– They cite reliable sources.
This transparency allows science to examine itself. Dartmouth College professor Dr. Steven Voloshin has spent much of his career challenging the scientific findings underlying health policy.
“I’m only able to do that because they’re transparent about what they did, what the underlying source resources were, so you can come to your own conclusions,” he said. “That’s how science works.”
Know the limitations of anecdotes and single studies
Anecdotes can be powerful. They are not data.
Case studies may also be published in top 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 every situation is unique.
Even a single study must be considered in the context of previous research. A new blockbuster study that appears to definitively answer every question or reaches a conclusion that contradicts other well-conducted studies needs to be viewed very carefully.
Uncertainty is included in science.
Voloshin said, “Science is not about reaching certainty.” “It’s about trying to reduce uncertainty to the point where you can say, ‘I’m pretty confident that if we do X, we’ll see outcome Y.’ But there is no guarantee.”
Are you doing your own research? questions to ask
If you find a research paper in the news online or cited by authorities that changes 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 paid for this research? Who can benefit from this?
— Has it been published in any reputable magazine? Did it go through peer review?
– What questions are researchers asking? Who or what are they reading? Are they even making comparisons between groups?
– Is there a “Limitations” section where the authors explain what their research cannot prove, other factors that might influence their results, or other potential blind spots? What does it say?
— Does it make bold, definitive claims? Does it fit into the scientific consensus or challenge it? Is it too good or 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. AP is solely responsible for all content.