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Hello and welcome to Healthbeat’s weekly report on stories shaping public health in the United States.
I am Dr. Jay K. Varma, a physician, epidemiologist, and public health expert currently serving as chief medical officer at Fedcap, a global nonprofit that promotes economic mobility and well-being for vulnerable communities. Views expressed here are my own.
This week I am reminded how little we know about the brain and how that lack of understanding impairs our ability to address two of the most serious public health problems in America: severe mental illness and dementia.
A White House event was either a historic turning point for mental health or a dangerous workaround of the Food and Drug Administration’s safety regulations; and a new report found that Alzheimer’s drugs have almost no benefit.
We also saw updates to two important stories involving the Centers for Disease Control and Prevention and a chance to highlight one of the most important, but least well known, programs it runs.
Psychedelics and mental health: promising, but let’s do this right
In the past decade, there have been several positive developments in mental health, including a growing willingness of prominent people — athletes, elected officials, musicians — to talk about their struggles and reduce stigma. Unfortunately, there has not been an equivalent increase in access to services, and most treatment approaches have limited effectiveness or durability.
That is why there has been so much excitement recently around a new approach to serious mental illness: psychedelic-assisted therapy. We saw a remarkable event at the White House last week. President Donald Trump, flanked by Health and Human Services Secretary Robert F. Kennedy Jr. and podcaster Joe Rogan, signed an executive order directing federal agencies to accelerate research into psychedelic medicines and expand access to them for treating serious mental illness.
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Psychedelics are a group of compounds either derived from naturally occurring organisms, such as psilocybin from “magic mushrooms” and ibogaine from a shrub found in Gabon, or synthesized in laboratories, such as LSD and MDMA. While chemically distinct, psychedelics have in common the ability to profoundly alter perception, cognition, and consciousness.
In mental health therapy, psychedelics work very differently from conventional pharmacology. Antidepressants and other approved psychiatric medications primarily seek to alleviate symptoms. Patients must take them daily, and symptoms recur when they stop.
In contrast, psychedelic therapy involves one structured session or a few sessions in which the person takes the psychedelic and undergoes talk therapy before, during, and after. Rather than suppressing emotions or thoughts as with traditional psychiatric medications, these compounds create a window of openness in which patients can access deeply buried feelings, e.g., grief, shame, trauma, and help to rewire the way people feel and think about problems.
As a JAMA editorial put it, the approach “addresses the cause of symptoms rather than merely suppressing them.”
Psychedelic therapy is primarily being evaluated for severe depression, post-traumatic stress disorder, obsessive-compulsive disorder, and substance-use disorders — conditions for which existing treatments often produce only modest, short-lived benefit.
The executive order commits $50 million to ibogaine research and directs the FDA to prioritize review of psychedelics holding the agency’s Breakthrough Therapy designation, reserved for drugs showing early evidence of substantial improvement over existing treatments.
I am genuinely excited about this research. And I am also concerned that the way it’s being rolled out could undermine its promise. While the early data are impressive, making therapy available at scale requires the government to ensure safety and efficacy the way we do for other medications.
The executive order expands access through the Right to Try Act, a pathway designed for terminally ill patients to obtain experimental treatments outside clinical trials. This administration has shown a fondness, unfortunately, for treating unproven compounds as standard consumer goods rather than medications.
For example, Kennedy has used a similar approach to peptides, arguing that individual freedom matters more than safety and efficacy. While there is substantial real-world data on the safety of most psychedelics, we need high-quality research to demonstrate the effectiveness of different dosages and treatment protocols. I believe this study on MDMA-assisted psychotherapy for PTSD, although somewhat controversial, shows what can and should be done to advance the field.
What I want is something modeled after the work of HIV/AIDS activists, such as Treatment Action Group. They believed — correctly — that access and evidence do not have to compete with each other. You can modernize trial designs to accelerate data collection and mobilize staffing to accelerate regulatory review, so that you can have safety, efficacy, and access.
Another more recent example was Operation Warp Speed for Covid vaccines. The result was faster access to medical interventions that actually worked. That is what I want for psychedelics.
Alzheimer’s drugs: when statistical significance isn’t enough
For decades, the leading hypothesis for Alzheimer’s disease has been that dementia is caused by the buildup of a protein called amyloid-beta in the brain, forming plaques that disrupt neurons and cause progressive cognitive decline. This “amyloid hypothesis” has driven billions of dollars in drug development.
The Cochrane Collaboration, an international network that systematically reviews the best available evidence, published an analysis this month of seven monoclonal antibody drugs developed to clear amyloid from the brain. The review examined 17 randomized controlled trials involving more than 20,000 patients and concluded that the clinical benefit of these drugs is, at best, trivial.
Cognitive function, dementia severity, and ability to manage daily activities showed little to no meaningful change after 18 months of treatment. The drugs can also increase the risk of brain swelling and bleeding, though in most patients these side effects cause no symptoms.
Some Alzheimer’s experts argue that the Cochrane review improperly lumps failed drugs together with the two most recently approved treatments. One critic compared it to mixing rotten ingredients with fresh food and declaring the meal inedible. While that is a legitimate methodological concern, even the trial results for those two recently approved drugs showed only modest slowing of cognitive decline, i.e., patients got worse, but just not as quickly as they would have without treatment.
Whether patients or their families can perceive that difference is genuinely unclear. As one Cochrane author put it, the benefit was “far below the minimal effect that’s needed to be noticeable at all for patients and caregivers.”
This points to one of the most underappreciated problems in pharmaceutical regulation: the gap between statistical significance and clinical significance. A drug can clear an approval threshold based on an effect large enough to be measurable, but too small to matter to anyone living with the disease.
One of the successes of public health is longevity: People are living longer across the world. But our ability to prevent and manage conditions of aging is not advancing fast enough. This latest study shows that even the best available pharmacological therapies are not worth using.
CDC: one step backward, one step forward, and one cause for celebration
Two weeks ago, I wrote about how the CDC had been blocked from publishing a study showing that Covid vaccines reduced hospitalizations by about 55% during the past winter season. An HHS spokesman confirmed last week it will not be published, citing methodological concerns, even though a flu vaccine study using the exact same methods was published in the Morbidity and Mortality Weekly Report just one week before the Covid study was blocked.
Unfortunately, this confirms what I have been worried about all along. Even with widespread uproar in the media that a methodologically sound study was being blocked, the current administration will continue to hide data that demonstrate the harms of the Covid virus and the benefits of Covid vaccines.
On a more hopeful note, the White House nominated Dr. Erica Schwartz, a former deputy surgeon general and retired Coast Guard officer, to serve as the permanent CDC director. Dr. Jennifer Shuford, Texas state health commissioner, was announced as incoming CDC chief medical officer. I think the public health community needs to see this as a minor victory in the ongoing battle to protect the CDC from further damage.
I have heard from many current and former CDC colleagues that they have concerns about Schwartz’s actions when she was deputy surgeon general, but they are absolutely elated by the choice of Shuford as chief medical officer.
Many people who have worked with Shuford in the past, including during the large Texas measles outbreak in 2024, have praised her knowledge, skills, and temperament and are holding out hope that she can serve as an effective counterbalance to some of the anti-science positions that HHS leadership continues to push.
Finally, I want to highlight the 75th anniversary of one of the most important and least known public health programs in the country: The CDC’s Epidemic Intelligence Service. I entered the program after completing my medical residency, and EIS taught me skills I could not have learned anywhere else.
I learned to design epidemiologic studies by investigating real outbreaks, received hands-on mentorship in policy development and public communication, and worked with government agencies at every level, domestically and globally over two years.
Since 1951, EIS has trained more than 4,300 people — including physicians, veterinarians, nurses, pharmacists, lawyers — who have investigated nearly every major public health crisis of the past seven decades: smallpox, HIV/AIDS, Ebola, influenza pandemics, the 2001 anthrax attacks, and Covid-19.
Today, 1 in 3 state epidemiologists in the United States is an EIS alumnus, and 4 of the 12 CDC directors in history completed the program. At a moment when the CDC’s institutional capacity is under serious strain, it is worth recognizing what 75 years of investment in training has built and what would be lost if that were allowed to erode.
While many lay people hear about the limits of science and turn away to other approaches, I think we should see those limits as a reason to demand more. We need more trials, more rigorous review of data, and more protection of the institutions, like EIS, that have spent 75 years turning science into health promotion and disease prevention.
Until next week,
Jay
Dr. Jay K. Varma, who is recognized globally for his leadership in the prevention and control of infectious disease, writes about public health for Healthbeat. He has guided epidemic responses, developed policies, and implemented programs that have saved lives across Asia, Africa, and the United States. He is based in New York. Contact Jay at jvarma@healthbeat.org.