Episode 4797: Trump Throws Down On Big Pharma; Americas Autism Epidemic
Episode Stats
Length
1 hour and 3 minutes
Words per Minute
161.8797
Summary
Learn English with President Trump. Today, the Administration will act on a potential link between acetaminophen use during pregnancy and ADHD and autism in young children. The agency will also launch a nationwide public service campaign to inform families and protect public health.
Transcript
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...and we have fast-tracked research and guidance.
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Historically, NIH has focused almost solely on politically safe
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and entirely fruitless research about the genetic drivers of autism.
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And that would be like studying the genetic drivers of lung cancer
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And that's what NIH has been doing for 20 years.
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As a result, we don't have an answer to this critical question.
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Despite the cataclysmic impact of the epidemic on our nation's children,
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we are now replacing the institutional culture of politicized science
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NIH research teams are currently testing multiple hypotheses
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We promise transparency as we uncover the potential causes and treatments,
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and we will notify the public regularly of our progress.
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Today, we are announcing two important findings from our autism work
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that are vital for parents to know as they make these decisions.
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The FDA is responding to clinical and laboratory studies
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that suggest a potential association between acetaminophen used during pregnancy
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Scientists have proposed biological mechanisms linking prenatal acetaminophen exposure
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We have also evaluated the contrary studies that show no association.
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Today, the FDA will issue a physician's notice about the risk of acetaminophen during pregnancy
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and begin the process to initiate a safety label change.
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HHS will launch a nationwide public service campaign to inform families and protect public health.
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FDA also recognized that acetaminophen is often the only tool for fevers and pain in pregnancy,
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as other alternatives have well-documented adverse effects.
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HHS wants, therefore, to encourage clinicians to exercise their best judgment
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in the use of acetaminophen for fevers and pain in pregnancy
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by prescribing the lowest effective dose for the shortest necessary duration
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Furthermore, thanks to also to the politicization of science,
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the safety of acetaminophen against the risk of neurodevelopmental disorders
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Prudent medicine, therefore, suggests caution in acetaminophen use of young children,
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especially since strong evidence also has associated it with liver toxicity.
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Some studies have also found that use of acetaminophen in children
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FDA will drive new research to safeguard mothers, children, and families.
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In addition to a possible acetaminophen connection to autism for pregnant women, infants, and toddlers,
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our research has revealed that folate deficiency in a child's brain can lead to autism.
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We have also identified an exciting therapy that may benefit large numbers of children who suffer from autism.
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Peer-reviewed literature has documented that up to 60% of folate-deficient children with ASD
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can improve verbal communications if given leukovorin.
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I have instructed NIH, FDA, and CMS to help doctors treat children appropriately.
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Jay will help tell that story, which started with sound science, the kind that restores faith in government.
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This announcement also represents a historic collaboration between NIH, FDA, CDC, and CMS.
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We expect this to be the first of many announcements over the coming years
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that deliver actionable information to parents on underlying cause of autism
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and the potential paths for prevention and reversal.
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Finally, autism is a complex disorder with multifactorial etiology.
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We are continuing to investigate a multiplicity of potential causes with no areas of taboo.
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One area that we are closely examining, as the president mentioned, is vaccines.
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Some 40 to 70% of mothers who have children with autism believe that their child was injured by a vaccine.
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President Trump believes that we should be listening to these mothers instead of gaslighting and marginalizing them like prior administrations.
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Some of our friends like to say that we should believe all women.
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Some of the same people have been silencing and demonizing these mothers for three decades
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because research on the potential link between autism and vaccines has been actively suppressed in the past.
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It will take time for an honest look at this topic by scientists.
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But I want to reassure the people in the autism community that we will be uncompromising and relentless in our search for answers.
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We will perform the studies that should have been performed 25 years ago.
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Whatever the answer is, we will tell you what we find.
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We are researching this issue to all three agencies.
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Jay will discuss one of our research initiatives at NIH.
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This model of unleashing unbiased, depoliticized, gold standard scientific research and academic freedom
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to deliver actionable information to prevent and reverse disease
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will be a model for the framework to deliver similar results
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from any other chronic conditions that plague Americans.
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I'm proud to announce today that the NIH has launched the Autism Data Science Initiative
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to turbocharge autism research, devoting an additional $50 million
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Nearly 250 research teams from across the country applied, sent in their applications
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and were peer-reviewed by the NIH review panels.
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The NIH peer-reviewers chose the 13 best projects focused on root causes and therapies
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with replication and validation studies to guarantee gold standard science.
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The studies feature a new kind of science called exposomics,
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where scientists consider environmental and medical factors, nutrition, events during pregnancy,
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in combination with biology and genetics to answer vital questions about autism.
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Science like this, conducted in partnership with families and physicians,
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is the best way to arrest and reverse the autism epidemic.
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Autism spectrum disorder encompasses a very wide range of symptoms,
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ranging from mild difficulties with social interactions
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to profoundly autistic children who experience severe disabilities in speech and behavior.
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Given this wide range of symptoms across the spectrum,
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it seems certain that there will be a wide range of biological contributors to explaining the cause.
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The great thing about the new NIH initiative on autism is that scientists will use rigorous advanced methods
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in causal inference, machine learning, organoids, and other fresh approaches to the problem.
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The sharp rise in the prevalence of autism deserves an urgent response by the scientific community.
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As Bobby said, the NIH has invested a lot of money to study autism over the years,
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but the research has not produced the answers that families and parents of autistic children deserve,
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For too long, it's been taboo to ask some questions for fear that scientific work might reveal a politically incorrect answer.
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Because of this restricted focus in scientific investigations,
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the answers for families have been similarly restricted,
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often pointing families to behavioral therapies that don't work for every kid,
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or suggest non-modifiable genetic factors as the cause.
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But genetics alone can't explain such a sharp rise in autism prevalence over just a few decades,
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In coming months and years, as NIH scientists learn more that can help autistic children and other families,
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we won't delay, like scientists often like to do.
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I can say as a scientist myself, it's really tempting to delay,
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but in the face of a problem like this, you have to move fast.
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But we will not delay before telling American people what we find,
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and we will win the public trust with transparency and rigor.
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Already, our broadened focus on autism research has pointed to two items
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that will help families prevent and treat some cases of autism.
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I'll leave the good news on these two items to my close friends and colleagues,
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We've been working together closely on this problem for the past six months,
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and our cooperation represents an unprecedented collaboration
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with Secretary Kennedy's Department of Health and Human Services and with President Trump.
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Commissioner of the Food and Drug Administration,
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who will tell you about these announcements of practical help for families with autism.
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Mr. President, this is the start of a historic shift in medical culture.
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Remember, this administration is working together to ask big questions
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about why our nation's children are getting sick so fast.
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Too often, medicine is doing small little studies, giving us answers we already knew.
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You've given us a charge to identify root causes,
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and we are not going to stop so that we can end the suffering we are watching.
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And if you've seen a kid with autism, with severe autism, it's hard to watch.
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They can be crying because they want to speak and they can't speak.
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For an epidemiologist, that child is an expanding statistic.
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But for a child, it can be brutal to have autism.
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Today, the FDA is taking action to update the label on acetaminophen
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and sending a letter to all U.S. doctors letting them know about the risks in pregnancy.
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There's a very large study, the Boston Birth Cohort,
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with researchers from Johns Hopkins, my former institution, and Boston University,
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found, quote, unquote, consistent associations between acetaminophen in pregnancy and autism.
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And the Nurses' Health Study, with researchers from Yale, Columbia, and Harvard looking at 9,000 kids,
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found that acetaminophen use in pregnancy was associated with neurodevelopmental disorders.
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And four weeks ago, a Mount Sinai-Harvard study reviewed all the existing literature
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and found the overwhelming body of evidence points to an association.
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Sure, you'll be able to find a study to the contrary.
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But to quote the dean of the Harvard School of Public Health,
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there is a causal relationship between prenatal acetaminophen use
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and neurodevelopmental disorders of ADHD and autism spectrum disorder.
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And honestly, there's been this perfunctory, reactionary, mindless practice in medicine.
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And I learned it in medical school and residency.
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Just treat all fevers, low-grade fevers, treat them with acetaminophen.
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A study out of Hopkins actually showed that treating a fever
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can prolong the duration of illness in a young kid.
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Maybe that's because a fever is a body's natural way of ridding an infection.
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When my wife was pregnant and delivered our son a few months ago,
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they pushed her to take acetaminophen for a low-grade fever.
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She said no, and then they looked to me, and I said, absolutely new.
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Today, the FDA is filing a Federal Register notice to change the label
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on an exciting treatment called prescription lucavorin
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so that it can be available to children with autism.
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You know, autism may also be due to an autoimmune reaction to a folate receptor on the brain,
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not allowing that important vitamin to get into the brain cells.
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Again, we have a duty to let doctors and the public know
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we are going to change the label to make it available.
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Hundreds of thousands of kids, in my opinion, will benefit.
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One study found that with kids with autism and chronic folate deficiency,
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two-thirds of kids with autism symptoms had improvement,
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Mr. President, you told us to do what's medically right,
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to go bold, and not worry about the corporations and the lobbyists,
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I think you all appreciate the passion in the President's voice.
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Yes, we've been hearing that since the inauguration.
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the President was upset about what he spoke to today.
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who's made it his life's work to address some of these challenges with autism,
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They wanted no silos to break down what the NIH would do,
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They insisted that the physician leaders bust through the clutter
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if we didn't do what every other prior administration had done,
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which is to let people function within their siloed environments.
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The response to the autism crisis is going to continue to come to you
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and the President wouldn't have it any other way, as you've heard.
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how will patients and parents get access to the treatment?
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Therefore, because they're covered in Medicaid and CHIP,
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state Medicaid programs, in partnership with CMS,
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will cover prescription lukevorin around the country.
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to make sure that this is safe and effective treatment,
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while also maintaining the privacy of all patients,
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which is what many of you have been asking us to do,
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demanded by the president and by the secretary,
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for the first FDA-recognized treatment pathway for autism.
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without the leadership of the president and the secretary.
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thought it would take five years to get this data.