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• More than 61% of American adults are projected to have some type of cardiovascular disease by 2050, American Heart Association research shows.
• This will be driven by an aging and more diverse population, as well as an increase in risk factors such as obesity and high blood pressure.
• Some risk factors for cardiovascular disease, though, will decline, including smoking and lack of regular physical activity.

More than 61% of American adults are expected to have some type of cardiovascular disease by 2050, according to new research from the American Heart Association (AHA). The healthcare and related costs resulting from this are projected to be $1.8 trillion.

This trend will be driven by an older, more diverse population and a large increase in risk factors such as high blood pressure and obesity.

Cardiovascular disease includes heart disease, heart attack, stroke, heart failure, abnormal heart rhythm such as atrial fibrillation or AFib, and heart valve problems. High blood pressure is also a type of cardiovascular disease, as well as a major risk factor for heart disease and stroke.

In spite of advances in treatments for these conditions, heart disease has been the leading cause of death in the United States for decades, resulting in 695,000 deaths in 2021. Stroke is the fifth leading cause of death.

In research published June 4, the AHA predicts that in 2050, 15% of American adults will have cardiovascular disease — including stroke, but excluding high blood pressure — up from 11.3% in 2020.

The percentage of people affected by stroke will nearly double during that time, from 3.9% to 6.4% of adults, AHA research shows. In addition, 61% of adults will have high blood pressure in 2050, an increase from 51.2% in 2020.

Changing population a key driver

An aging population is one of the key factors behind these trends — as people age, their chance of developing cardiovascular disease increases.

By 2050, 22% of Americans will be over the age of 65, an increase from 17% in 2020, according to the U.S. Census Bureau.

The United States is also becoming more diverse, and communities of color tend to be impacted more by cardiovascular disease.

By 2060, people who identify as Hispanic will make up 27.5% of the population, versus 17.8% in 2016, and people who identify as Black will be 15% of the population, up from 13.3% in 2016. The share who identify as Asian will increase from 5.7% to 9.1% during that time.

In 2050, Hispanic adults are projected to have the largest increase in cardiovascular disease, in terms of total numbers of people, the AHA research shows.

In addition, Black adults are projected to have the highest rates of high blood pressure, diabetes and obesity. They also are expected to have the highest rates of inadequate sleep and poor diet. These all contribute to the development of cardiovascular disease.

“Many Americans live with food insecurity, often in food ‘deserts’ without access to nutritious fruits and vegetables, subsisting on calorie-dense, nutrient-poor, unhealthy processed and fast food,” said Nate E. Lebowitz, MD, a cardiologist at Hackensack University Medical Center, who was not involved in the AHA research.

“According to the AHA research, the underserved populations subject to these food deserts are expected to suffer a magnified impact,” he told Healthline.

Increasing risk factors for heart disease

In addition to the expected increase in the rate of high blood pressure, other risk factors for cardiovascular disease are likely to rise over the next two decades.

Obesity is projected to increase from 43.1% of adults in 2020 to 60.6% in 2050, and diabetes will increase from 16.3% to 26.8%. Adults under 65 will see the highest growth for obesity, with the AHA research predicting that more than 70 million young adults will have a poor diet in 2050.

The research also looked at projections for children, finding concerning trends for certain risk factors. For example, obesity among 2- to 19-year-olds is projected to rise from 20.6% in 2020 to 33% in 2050.

In addition, poor diet and inadequate physical activity among children is expected to remain at nearly 60% each, the research found.

Americans, however, will see progress on certain risk factors. The percentage of adults with inadequate physical activity levels will drop from 33.5% in 2020 to 24.2% in 2050. Cigarette smoking rates are projected to drop by nearly half during that time, from 15.8% to 8.4%.

In addition, rates of high cholesterol will drop from 45.8% to 24.0%, in part due to an increase in the number of people taking cholesterol-lowering drugs called statins.

A 2023 study found that 92 million adults 40 years or older, or 35% of that age group, took a statin in 2018-2019, an increase from 12% in 2008-2009.

“I wish I could say that [the projected decline in high cholesterol] is due to improving diet and dropping obesity rates, but in reality it’s thanks to new, highly advanced medications we are starting to employ that dramatically lower cholesterol,” said Lebowitz.

“We know that [lowering cholesterol] drops the rates of coronary artery disease, so the report could have been much worse,” he said.

Turning things around

While the AHA projections paint a stark picture of cardiovascular disease two-and-a-half decades from now, study author Dhruv S. Kazi, MD, director of the cardiac critical care unit at Beth Israel Deaconess Medical Center in Boston, said in a release that these trends can be slowed, but “this will require strategic investments in cardiovascular prevention and treatment.”

Right now, though, preventing cardiovascular disease may not get as much attention as treatment.

“The U.S. spends a massive amount on high tech expensive interventions for acute cardiovascular illness, but doesn’t spend anywhere near as much on the far less expensive measures that could prevent the need for those interventions,” said Lebowitz.

For example, “after a heart attack or an acute coronary hospitalization with a stent or bypass surgery, half of patients don’t even get their cholesterol checked and there is a 42% readmission rate by 6 months,” he said.

In contrast, Cuba spends a fraction of what the United States does on healthcare, yet the two countries have similar average life expectancies.

In Cuba, doctors are “responsible for making sure the basics are covered for a certain number of people in their neighborhood,” said Lebowitz. “The majority of their responsibility focuses on blood pressure, body weight, cholesterol, nutrition, smoking cessation, etc. — the very basics that we don’t put enough effort into [in the United States].”

Also, “there is less processed food [in Cuba],” he said. “This reduces the development of chronic diseases, and as a result there is less need for high-tech expensive interventions for which [Americans] spend all that money.”

Lebowitz thinks more resources should be put into ensuring everyone has access to fresh, nutritious food, such as supporting community gardens.

“Simply switching calories by 20% from ultra-processed and fast foods to fruits and vegetables, lean meats and eggs (unprocessed food) can have a proven, magnified impact in disease prevention,” he said. “We need to make doing so cheaper and a priority, especially in the underserved food deserts.”

Takeaway

New research by the American Heart Association projected future rates of cardiovascular disease and risk factors. The study found that in 2050, more than 61% of American adults will have some type of cardiovascular disease, including high blood pressure.

This trend is driven by an aging population and a more diverse population. Communities of color tend to be impacted more by cardiovascular disease.

Rates of cigarette smoking, inadequate physical activity and high cholesterol are projected to drop by 2050. But experts say more work is needed to slow these trends, including ensuring that all Americans have access to healthy foods.

• The Body Roundness Index is a novel body composition measurement that is touted as being a more accurate alternative to Body Mass Index.
• In a large retrospective study of 33,000 US adults, researchers found a “U-shaped” curve, indicating those with a BRI below and above the normal range had an increased risk of death from any cause.
• The study also found that over a 20-year period, BRI showed an upward trend, another indicator of the USA’s obesity epidemic.

Is “body roundness” a good indicator of your weight and health risks? New research says, yes.

Scientists are turning to a novel way to calculate obesity using a system known as the Body Roundness Index, which is touted as a more accurate measurement than Body Mass Index (BMI).

In a new study published in JAMA Network Open, researchers found that a higher BRI was associated with an increased risk of death from any cause in a large retrospective study involving nearly 33,000 US adults.

The research is yet another confirmation of the US’s growing obesity epidemic, but also an indicator of a potential new tool in the fight against obesity. The authors conclude that the BRI is a tool that is almost as easy to perform as BMI, but offers a more accurate assessment of body composition and health risks.

“Our findings provide compelling evidence for the application of BRI as a noninvasive and easy to obtain screening tool for estimation of mortality risk and identification of high-risk individuals, a novel concept that could be incorporated into public health practice pending consistent validation in other independent studies,” the authors wrote.

Body roundness and mortality risk

The study included health data from a large cohort of nearly 33,000 American adults. Researchers pulled the data from the NHANES health database, a self-reported survey that assesses the health and nutrition of Americans.

Researchers looked at a 20-year period of NHANES data between 1999-2018. The average age of cohort members was 46 years old. Half of the group was women. The group was predominantly white (68.26%), but also included Black individuals (10.92%), and Mexican Americans (8.53%).

Then, using BRI which is a slightly more complex body measurement than BMI, they assessed one major outcome: all-cause mortality. The major finding: a “U-shaped” curve of mortality risk associated with BRI score. A U-shaped curve, as its name suggests, shows high risk at either end of a given spectrum, and lower risk in the middle. 

In this case, individuals with a BRI below and above the normal range were at greater risk of death from any cause. Meanwhile those in the middle, in the normal range, had the lowest risk. Individuals with a BRI less than 3.4 had a 25% increased mortality risk compared to the normal range, while those with a BRI of 6.9 had 49% increased risk.

Beverly Tchang, MD, an endocrinologist, Spokesperson for the Obesity Society and Assistant Professor of clinical medicine at Weill Cornell Medicine, told Healthline, “It is worthwhile that they are investigating other metrics of adiposity given the known limitations of the body mass index (BMI). 

“This is a more direct measure of central adiposity, which strongly correlates with metabolic diseases like type 2 diabetes,” she added. 

Researchers also documented a steady increase in average BRI over the 20 year period from 4.8 to 5.62. The trend was more obvious within certain groups, including women, the elderly, and those who identified as Mexican American.

What is the Body Roundness Index?

The Body Roundness Index is similar to the Body Mass Index, but relies on more anthropometric variables.

The BRI which was first proposed in 2013, uses height, weight, waist circumference, and sometimes hip circumference for its calculation. Throw in a dash of theory from 17th century German astronomer Johannes Kepler, and you’ve got the BRI.

Diana M. Thomas, PhD, a Professor of Mathematics at the United States Military Academy at West Point authored the initial paper detailing the concept of BRI explained the concept to Healthline:

“It has to do with geometry. So if you look at Body Mass Index, you can come up with a geometrical explanation.”

Using the necessary variables, you create an image of a circle, but the circle could be more egg-shaped, cylindrical, or maybe totally round. It uses the concept of “eccentricity,” which Johannes Kepler used to quantify planetary orbits. Eccentricity describes how round (like a circle) or narrow (like an ellipse) something is. It represents a number between zero, for a perfect circle, and one. 

“With BMI you’re actually using just two measurements. You’re using weight and height. In the Body Roundness Index, we’re using a few more measurements on the human body to capture that shape,” said Thomas.

That BRI number can then be used to make a more accurate calculation of body composition. The closer to zero, the rounder your body, and the greater the risk of all-cause mortality. 

How BMI compares

BMI is a simple measurement of body size based on your height and weight that has been used for decades as a general health assessment. Your BMI is a crude measurement of whether or not you fall into a healthy weight range. However, the measurement is far from perfect: it doesn’t distinguish between muscle and fat, for example; so an individual with obesity could very likely have the same BMI as, say, a bodybuilder.

Even with its flaws, BMI is still an important indicator of future health problems. The higher your BMI above normal (anything above 25), and the greater your risk for things like type 2 diabetes, high blood pressure, and cardiovascular disease.

BMI vs BRI

There are plenty of critics of BMI, but there’s no sign that it is going anywhere.

BMI is easy to assess in a doctor’s office or at home. Meanwhile, measuring body fat is more difficult, costly, and time-consuming. It’s not something that can readily be performed during a checkup.

However, BRI could offer a new method of assessing body composition and health risk in a manner that is still simple to perform but offers a more accurate assessment. Forget all that talk about Kepler’s orbiting eccentricities, you don’t need to actually know physics or geometry to perform a BRI test. You just need a few measurements. In fact, you can even plug them into an online calculator if you’re curious about your own BRI.

BRI is still a novel technique that needs further validation, which the study authors note in their paper, so it’s far from commonplace today. 

Tchang also notes that the name itself could be a barrier to its future use: “I don’t think BRI is going to catch on simply because “roundness” is a potentially offensive term,” she said.

The bottom line

Researchers used 20 years of American health data to look at mortality risk using the Body Roundness Index.

The BRI is a novel body composition test first proposed in 2013, that some experts believe offers a more accurate alternative to BMI that is similarly easy to perform.

The study found confirmatory evidence of America’s obesity epidemic in gradually increasing BRI over the twenty-year period. The authors also found a “U-shaped” curve indicating greater all-cause mortality risk for individuals with a BRI above and below the normal range.

• Sticking to the Mediterranean diet was associated with a decreased risk of mortality, according to a new study.
• The Mediterranean diet helps lower cardiometabolic risk factors, such as insulin resistance, BMI and blood pressure.
• The diet includes high amounts of vegetables, fruits, whole grains, and heart-healthy fats.

A new study showed higher adherence to the Mediterranean diet was linked with a reduced risk of all-cause mortality.

The findings were published in JAMA Network Open on May 31.

Researchers looked at health information from 25,315 women, which included blood samples, biomarker measurements, and dietary data between 1993 and 1996. These women were followed up for 25 years.

Results showed a 23% decrease in all-cause mortality risk, which may be partially explained by cardiometabolic risk factors. These include biomarkers of inflammation, insulin resistance, metabolism, and body mass index (BMI).

Health benefits of the Mediterranean diet

“When it comes to cardiovascular disease there are various risk factors which are modifiable – meaning we have control over them,” said Nicole Roach, a registered dietitian at Northwell Lenox Hill Hospital. “Diet is a major modifiable risk favor.”

To address cardiovascular disease, often times the Mediterranean diet will be recommended. There are several benefits to following a Mediterranean diet. 

• Lowering “bad cholesterol.” The Mediterranean diet avoids food rich in saturated fat, this can help lower our LDL Cholesterol, often known as “Bad Cholesterol.”
• A Mediterranean diet can also help raise our “Good Cholesterol,” otherwise known as HDL.
• This diet may promote weight loss by encouraging healthier, more nutritious food choices. However, it can also help maintain a healthy weight if you are not looking to lose weight.
• This diet may help lower blood pressure by avoiding processed foods, which often contain high sodium levels due to added salt.
• Following a Mediterranean diet can also help increase fiber intake as this diet is rich in whole fruits and vegetables. Fiber supports bowel movements and gut health, helps maintain blood sugars within targeted goals, and helps promote satiety, which can aid in weight loss or maintenance.
• Choosing foods known to have anti-inflammatory properties may help decrease overall inflammation within the body. Decreased inflammation is beneficial to the heart and reduces the risk for various types of cancer.
• May be helpful for mood, cognitive function, and healthy brain aging.

“All of the above benefits of a Mediterranean diet can result in improved heart health as well as improved over all health,” Roach stated. 

This study suggested that the diet helped reduce: inflammation, triglyceride-rich lipoproteins, insulin resistance, and body mass index. These factors likely contributed to why people with higher adherence to this diet had lower mortality risk.

Mediterranean diet and decreased risk of all-cause mortality

The blood metabolites measured explained some of the effects of the Mediterranean diet on mortality.

“This included having lower molecules that are involved in inflammation and lipids that cause deposits in arteries that can lead to heart disease,” Dr. Marie-Pierre St-Onge, associate professor of nutritional medicine at Columbia University Vagelos College of Physicians and Surgeons, stated. “Lower blood pressure and better glucose control also contribute to the reduced risk of mortality.”

John Higgins, MD, a sports cardiologist at UTHealth Houston, agreed.

“Improved cardiovascular risk factors (blood pressure, cholesterol, blood glucose) as well as improved vascular function, improved coagulation profile, and less chance of an angry plaque (lower inflammatory markers) would result in lower rates of cardiovascular events (heart attack, stroke, peripheral arterial disease),” Higgins said.

In the current study, researchers found that improvements in measures of blood pressure, HDL and LDL cholesterol, and blood glucose control, such as hemoglobin A1C, were not as strongly associated with reduced mortality risk from adherence to the Mediterranean diet as some other biomarkers. However, they did acknowledge that previous studies have reported such associations.

More specifically, the researchers found biomarkers of metabolism and inflammation, triglyceride-rich lipoproteins, insulin resistance, and body mass index may contribute the most to the reduced mortality risk associated with the Mediterranean diet.

“The Mediterranean diet is rich in many nutrients and dietary components like polyphenols, that have anti-inflammatory properties,” said St-Onge. “It is high in fiber and low in sugar, which contribute to better glucose control, and is low in saturated [fat] while being higher in monounsaturated fat, which are known to produce [a] better lipid profile with lower LDL cholesterol and triglycerides and higher HDL cholesterol.”

The foundations of the Mediterranean diet include fatty fish, nuts, extra virgin olive oil, legumes, vegetables and fruit.  

Julia Zumpano a registered dietitian with the Cleveland Clinic Center for Human Nutrition, said foods high in omega 3 fatty acids such as certain fish, walnuts, flax seeds and chia seeds when combined with foods that reduce inflammation, such as legumes, fruits and vegetables, “have been shown to reduce blood sugars, reduce insulin, improve gut health and regularity.”

Zumpano recommends eating grains that are whole grains, in addition to minimally processed foods.  Zumpano recommends avoiding commercial baked goods, sugar-sweetened beverages or processed meats, which have been shown to increase inflammation, blood sugars, triglycerides, weight and risk of chronic diseases.

Takeaway

A new study found that sticking to the Mediterranean diet was linked with a decreased risk of all-cause mortality in women.

The Mediterranean diet may help reduce cardiometabolic risk factors, such as insulin resistance, BMI, and inflammation.

There are other factors that need to be taken into consideration which are family history, exercise habits and lifestyle.

• An expert panel of the Food and Drug Administration reviewed two studies on MDMA-assisted therapy for the treatment of PTSD.
• The studies showed that the therapy improved symptoms of PTSD over 18 weeks and lasted for several months after treatment.
• Issues with the study design and safety led many committee members to vote against recommending the approval of this treatment right now.

A expert panel of the Food and Drug Administration (FDA) voted against recommending MDMA-assisted therapy as a treatment for PTSD.

Findings from two clinical trials presented at a public meeting on June 4 showed that MDMA-assisted therapy improved symptoms of PTSD over 18 weeks of treatment. These improvements appear to last for several months after the treatment period, researchers found.

However, the FDA meeting raised a number of ethical and safety issues about the two clinical trials that drug manufacturer Lykos Therapeutics used to make their case to the FDA’s Psychopharmacologic Drugs Advisory Committee.

When considering whether MDMA is effective in patients with post-traumatic stress disorder, the committee voted 2-to-9 against.

For the question of whether the benefits of MDMA, with FDA’s proposed risk evaluation and mitigation strategy (REMS), outweighs its risks for the treatment of PTSD, the committee voted 1-to-10 against.

Prior to the meeting, the FDA extended the public comment period, allowing more time for critics and supporters to weigh in on MDMA as a treatment for PTSD. Several veterans groups submitted public comments urging the FDA to approve MDMA-assisted therapy.

About 7% of veterans will experience PTSD at some point during their lifetime, compared to about 6% in the general population, according to the U.S. Department of Veterans Affairs. However, for some groups of veterans the rate is as high as 29%.

In the end, concerns about the trials outweighed the benefits of MDMA-assisted therapy seen in the trials.

“I think that some of the data was promising, but given that 40% [of participants] had previously used MDMA” may have impacted the efficacy and durability of the treatment, said Elizabeth Joniak-Grant, PhD, a sociologist and qualitative research consultant at the University of North Carolina, Chapel Hill, said in the meeting.

In addition, “I am concerned with the lack of diversity and what that would mean for the general population,” she added.

This research is “on the right track,” Walter S. Dunn, MD, PhD, assistant clinical professor at University of California Los Angeles, said during the meeting. “A tweak here and there can address some of the safety concerns we brought up.”

“We are in dire need of new treatments for PTSD … and this has the potential to make a difference,” he added.

MDMA used previously for therapy

MDMA is a synthetic oral drug that acts as a stimulant and a hallucinogen. It was first synthesized in 1912 and was used as a treatment by some psychiatrists and therapists until the mid 1980s.

Around that time, MDMA became a popular street drug, known as “ecstasy” or “molly.” This led to the Drug Enforcement Agency (DEA) classifying it as a Schedule I drug. This restricted use of the drug as a treatment for psychiatric diseases.

However, in 2017 the FDA granted MDMA breakthrough therapy designation for its use with psychotherapy for PTSD. This allowed additional clinical trials to be carried out.

“MDMA is not a new drug, and while it can be misunderstood due to its illicit counterpart, it actually has a well-documented history in the psychiatric field,” Amy Laverdiere, program lead at Lykos, said during the meeting.

She explained that MDMA is thought to work by “[catalyzing] the effectiveness of psychotherapy by facilitating memory recollection and extending the patient’s window of tolerance for revisiting distressing thoughts or experiences.”

Studies also show that MDMA improves self-awareness and enhances the therapeutic relationship between a patient and their therapist, Laverdiere said.

PTSD affects millions

In 2020, an estimated 13 million Americans had PTSD, not all of them veterans.

“Although PTSD is associated with exposure to deployment and combat, consequent to a number of potential experiences, civilian trauma is actually more common,” Jerry Rosenbaum, MD, director of the Center for Neuroscience of Psychedelics at Massachusetts General Hospital Research Institute, and professor of psychiatry at Harvard Medical School, said during the meeting.

“Individuals exposed to sexual violence, for example, or an unexpected death in the family or a life-threatening traumatic event may also develop PTSD,” he said.

Current treatment options for PTSD include psychotherapy and serotonin reuptake inhibitors (SSRIs). 

Rosenbaum said while psychotherapy can lead to clinically meaningful reductions in PTSD symptoms, many patients stop therapy due to increased distress. In addition, there is limited access to this type of treatment.

Clinical studies show that SSRIs improve symptoms of PTSD more than placebo, although fewer than 60% of people with PTSD benefit from these drugs, and less than 30% of patients have full remission of their symptoms, according to the FDA’s briefing document.

In addition, “several pharmacologic agents are used off-label and concurrently, despite lacking evidence of efficacy and not being approved for the PTSD indication,” said Rosenbaum, “which speaks to the demand from prescribers for novel-indicated therapeutics to provide our patients new tools to alleviate symptoms.”

Clinical trials of MDMA-assisted therapy

In the meeting, Lykos presented data from its two phase 3 clinical trials, named MAPP1 and MAPP2. In these trials, people with PTSD underwent three treatment cycles of MDMA-assisted therapy over 9 to 15 weeks. Treatments were scheduled 3 to 5 weeks apart.

On average, people undergoing MDMA-assisted therapy saw a greater improvement in PTSD symptoms over 18 weeks, compared to the placebo group. 

People taking MDMA also experienced functional improvements such as being able to pursue personal goals and maintain strong relationships.

The data also show that 67% of participants taking MDMA no longer met the diagnostic criteria for PTSD after 18 weeks, compared to 33% of the placebo group. Also 33% of participants treated with MDMA were in disease remission after three sessions, versus 5% in the placebo group.

“In this combination treatment, the acute effectiveness of MDMA facilitates the psychotherapy — strengthening the therapeutic alliance, facilitating the patient’s development of insights and tools, and continuing to cultivate long after the acute effects are worn off,” Kelley O’Donnell, MD, PhD, research assistant professor of psychiatry at NYU Grossman School of Medicine and director of clinical training at the NYU Langone Center for Psychedelic Medicine, said during the meeting.

In the trials, certain adverse events occurred more often in the MDMA group than the placebo group, including muscle tightness, decreased appetite, nausea, excessive sweating, and feeling hot or cold. People treated with MDMA also had a short-term increase in blood pressure and heart rate.

Researchers did not see an increase in suicidal thoughts in people taking MDMA, although Lykos’ documents for the meeting indicated that this is an “expected key risk in patients treated with [MDMA-assisted therapy].”

Committee raises concerns about studies

Tiffany R. Farchione, MD, director of the division of psychiatry in the office of neuroscience at the FDA, said the adverse events seen in the trials were consistent with the known effects of MDMA. 

However, adverse events related to the potential misuse of the drug — such as euphoria or elated mood — were not adequately collected or reported, she said during the meeting.

“It is the lack of data collection on the subjective effects of MDMA that may have the greatest impact on our regulatory decision-making,” she said.

Further, the effects of MDMA can last for several hours, which can leave patients impaired and vulnerable during that time.

As a result, “if this product were to be approved, we believe the REMS [FDA’s risk evaluation and mitigation strategy] will be necessary to ensure safe use, and to mitigate the risk of serious harm that can result from patient impairment,” said Farchione.

The FDA’s REMS proposal included requirements that patients be informed about the risk of impairment that can result from MDMA use, as well as ensuring that two or more healthcare providers are at the clinic to monitor patients for at least 8 hours after treatment.

Another key concern cited in the FDA review released last week was the potential for “functional unblinding” of participants. The studies were designed as double-blind trials, which means participants are not supposed to know whether they received the MDMA capsule or a non-active placebo. 

However, the effects of MDMA are so distinct that many trial participants in the MAPP2 study correctly guessed whether they received MDMA or placebo, the FDA review showed.

This unblinding could affect their treatment. It is also a common problem with clinical trials of psychedelics such as MDMA, LSD and psilocybin, and psychoactives such as cannabis.

“We rely on data from adequate and well-controlled trials to provide the basis for a substantial evidence of effectiveness,” David Millis, MD, clinical reviewer in the division of psychiatry at the FDA, said during the meeting. 

“Among other characteristics, to be considered adequate and well-controlled, a study must incorporate a design that permits valid comparison with a control condition, and measures must be taken to minimize bias,” he said.

He added that the FDA had suggested that Lykos use active comparators — such as niacin or low-dose MDMA — instead of placebo in the trials. The company and the FDA, though, did not reach an agreement on how to handle the blinding for the studies, he said.

The FDA’s review pointed out other limitations of the trials. For example, around 25% of participants dropped out between the parent study and the follow-up visit. Further, some participants also had other treatments for PTSD. These could affect the study results.

Takeaway

An expert panel of the Food and Drug Administration reviewed finding from two phase 3 clinical trials looking at the use of MDMA-assisted therapy for the treatment of PTSD.

The studies showed that symptoms of PTSD improved in people who took MDMA with psychotherapy, compared to those who took an inactive placebo. People who took MDMA in combination with psychotherapy also had improvements in their daily functioning.

Committee members raised concerns about the design of the trial, safety concerns of MDMA-assisted therapy, and ethical concerns with the trial. As a result, a majority of members voted against recommending approval of this as a treatment for PTSD.

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