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Ultraprocessed Foods, Cognitive Decline, and FDA's MDMA Stance for PTSD · Morning Medical with Dr. Chow

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  Welcome to Morning Medical with Dr.
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  Chow.
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  I am your host, Dr.
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  Chi-Ming Chow, and today we have an intriguing lineup of topics to dive into.
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  We will be discussing the ubiquitous presence of ultraprocessed foods in our diets, the
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  cognitive decline in husbands after a spouse's cardiovascular disease event, and the potential
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  impact of MDMA rejection on psychedelic research.
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  But first, let's talk about ultraprocessed foods.
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  Whether they know it or not, most Americans do not go a day—or often a single meal—without
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  eating ultraprocessed foods.
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  From sugary cereals at breakfast to frozen pizzas at dinner, plus in-between snacks of
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  potato chips, sodas, and ice cream, ultraprocessed foods make up about sixty
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  percent of the U.S.
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  diet.
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  For kids and teens, it is even higher—about two-thirds of what they eat.
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  That is concerning because ultraprocessed foods have been linked to a host of negative health
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  effects, from obesity and diabetes to heart disease, depression, dementia, and more.
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  One recent study suggested that eating these foods may raise the risk of early death.
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  Nutrition science is tricky, though, and most research so far has found connections, not
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  proof, regarding the health consequences of these foods.
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  Food manufacturers argue that processing boosts food safety and supplies and offers a cheap,
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  convenient way to provide a diverse and nutritious diet.
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  Even if the science were clear, it is hard to know what practical advice to give when
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  ultraprocessed foods account for what one study estimates is seventy-three percent of the U.S.
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  food supply.
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  So, what exactly are ultraprocessed foods?
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  Most foods are processed, whether it is by freezing, grinding, fermentation,
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  pasteurization, or other means.
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  In 2009, Brazilian epidemiologist Carlos Monteiro and colleagues first proposed a system
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  that classifies foods according to the amount of processing they undergo, not by nutrient
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  content.
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  At the top of the four-tier scale are foods created through industrial processes and with
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  ingredients such as additives, colors, and preservatives that you could not duplicate in a
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  home kitchen, said Kevin Hall, a researcher who focuses on metabolism and diet at the National
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  Institutes of Health.
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  'These are most, but not all, of the packaged foods you see,' Hall said.
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  Such foods are often made to be both cheap and irresistibly delicious, said Dr.
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  Neena Prasad, director of the Bloomberg Philanthropies’ Food Policy Program.
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  'They have just the right combination of sugar, salt, and fat and you just cannot stop eating
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  them,' Prasad said.
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  However, the level of processing alone doesn’t determine whether a food is unhealthy or not,
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  Hall noted.
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  Whole-grain bread, yogurt, tofu, and infant formula are all highly processed, for instance,
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  but they are also nutritious.
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  So, are ultraprocessed foods harmful?
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  Here’s the tricky part.
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  Many studies suggest that diets high in such foods are linked to negative health outcomes.
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  But these kinds of studies cannot say whether the foods are the cause of the negative
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  effects—or whether there is something else about the people who eat these foods that might
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  be responsible.
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  At the same time, ultraprocessed foods, as a group, tend to have higher amounts of sodium,
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  saturated fat, and sugar, and tend to be lower in fiber and protein.
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  It is not clear whether it is just these nutrients that are driving the effects.
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  Hall and his colleagues were the first to conduct a small but influential experiment that
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  directly compared the results of eating similar diets made of ultraprocessed versus unprocessed
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  foods.
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  Published in 2019, the research included twenty adults who went to live at a National
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  Institutes of Health center for a month.
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  They received diets of ultraprocessed and unprocessed foods matched for calories, sugar,
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  fat, fiber, and macronutrients for two weeks each and were told to eat as much as they
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  liked.
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  When participants ate the diet of ultraprocessed foods, they consumed about five
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  hundred calories per day more than when they ate unprocessed foods, researchers found—and
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  they gained an average of about two pounds (one kilogram) during the study period.
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  When they ate only unprocessed foods for the same amount of time, they lost about two pounds
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  (one kilogram).
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  Hall is conducting a more detailed study now, but the process is slow and costly and results
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  are not expected until late next year.
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  He and others argue that such definitive research is needed to determine exactly how
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  ultraprocessed foods affect consumption.
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  'It is better to understand the mechanisms by which they drive the deleterious health
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  consequences, if they’re driving them,' he said.
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  Should ultraprocessed foods be regulated?
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  Some advocates, like Prasad, argue that the large body of research linking ultraprocessed
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  foods to poor health should be more than enough to spur government and industry to change
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  policies.
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  She calls for actions such as increased taxes on sugary drinks, stricter sodium restrictions
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  for manufacturers, and cracking down on marketing of such foods to children, the same
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  way tobacco marketing is curtailed.
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  “Do we want to risk our kids getting sicker while we wait for this perfect evidence to
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  emerge?” Prasad said.
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  Earlier this year, FDA Commissioner Robert Califf broached the subject, telling a
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  conference of food policy experts that ultraprocessed foods are 'one of the most
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  complex things I have ever dealt with.' But, he concluded, 'We have got to have the scientific
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  basis and then we have got to follow through.'
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  How should consumers manage ultraprocessed foods at home?
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  In countries like the U.S., it is hard to avoid highly processed foods—and not clear which ones
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  should be targeted, said Aviva Musicus, science director for the Center for Science in the
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  Public Interest, which advocates for food policies.
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  “The range of ultraprocessed foods is just so wide,” she said.
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  Instead, it is better to be mindful of the ingredients in foods.
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  Check the labels and make choices that align with the current U.S.
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  Dietary Guidelines, she suggested.
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  “We have really good evidence that added sugar is not great for us.
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  We have evidence that high-sodium foods are not great for us,” she said.
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  'We have great evidence that fruits and vegetables which are minimally processed are
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  really good for us.'
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  It is important not to vilify certain foods, she added.
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  Many consumers do not have the time or money to cook most meals from scratch.
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  'I think foods should be joyous and delicious and should not involve moral judgment,' Musicus
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  said.
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  Incident cardiovascular disease in one spouse was followed by the other developing dementia
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  more often than expected in a large Japanese cohort study.
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  In the study's predominantly male cohort of seniors, the dementia diagnosis incidence rate
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  ratio was 1.32 over a median 24 months of follow-up after a spouse's cardiovascular
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  disease event compared with those whose spouse had no cardiovascular disease event, reported
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  Kosuke Inoue, Doctor of Medicine, Doctor of Philosophy, of Kyoto University in Japan, and
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  colleagues in JAMA Neurology.
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  'This is one of the first and largest studies investigating potential interpersonal pathways
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  associated with elevated dementia risk,' Inoue's group wrote.
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  'Identifying how one spouse's health is associated with the other spouse's health can
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  help direct timely, needed resources for people at risk of dementia.'
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  Without a clear explanation for their finding, the authors pointed to the possibility that a
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  traumatic occurrence such as incident cardiovascular disease or a death may affect
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  the spouse's cognitive function or that a change in a spouse's lifestyle may have taken
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  place after the index person's cardiovascular disease event.
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  It is also possible that the index spouse had some baseline cognitive impairment that only
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  became more apparent with the added stress and high-level needs of caring for the spouse with
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  cardiovascular disease, according to epidemiologist Michelle Mielke, Doctor of
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  Philosophy, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, who
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  was not involved with the study.
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  In any case, Ambar Kulshreshtha, Doctor of Medicine, Doctor of Philosophy, a family
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  physician at Emory Healthcare in Atlanta, agreed with directing attention and resources
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  to families of cardiovascular disease patients based on the Japanese data.
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  'This finding is particularly important for primary care clinicians who often provide
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  continuity of care to multiple members of the same family and often spouses.
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  Following these stressful life events, primary care clinicians can provide access to resources
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  such as behavioral health referrals to help spouses and family members with better coping
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  strategies and emphasize self-care,' he commented in an email.
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  'Timely screening, controlling risk factors, and advance care planning should be addressed
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  at every opportunity.'
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  Notably, the people compared in the study were by and large husbands with or without spouses
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  with cardiovascular disease -- with fewer than four percent of the index patients being women.
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  'Because caregiving burdens and social isolation could vary by sex, further research
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  with enough female samples is needed to establish the sex-specific association,' the
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  investigators acknowledged.
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  Peter Vitaliano, Master of Science, Doctor of Philosophy, a stress researcher at the
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  University of Washington in Seattle, emphasized the male dominance of the study, noting that
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  'relationships between cardiovascular disease factors and dementia may differ for men and
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  women because of social and biochemical factors.'
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  'It should be noted that, although the last several years have seen an increased interest
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  in relationships of caregiver cognition to care-recipient diseases, research in this area
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  has been going on since 2003,' said Vitaliano.
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  'At that time, our group showed that spouse caregivers of persons with Alzheimer's disease
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  had worse short-term memory than spouses who were not caregivers and not married to someone
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  with Alzheimer's disease.
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  We also showed that higher levels of depression and sleep problems in caregivers helped to
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  explain this difference.'
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  He told MedPage Today that later longitudinal analysis suggested a role played by higher
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  glucose and insulin in caregivers than non-caregivers.
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  'These are all risk factors for dementia,' as well as coronary heart disease, he stressed.
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  Inoue's cohort study included individuals 65 and older in the Japan Health Insurance
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  Association insurance program who were dementia-free when their spouse experienced a
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  cardiovascular disease event from 2016 to 2022.
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  Investigators performed a target trial emulation analysis to try to adjust for
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  confounding; each index person was matched to a comparator whose spouse had no cardiovascular
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  disease event during the study window.
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  After matching, there were 93,396 index individuals included in the analysis with a
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  mean age of 68.8 years, 96.2 percent of whom were men.
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  There was no information provided about the spouses' activities or rates of depression,
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  anger, and anxiety relative to the spouses of people who did not have cardiovascular disease.
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  Inoue's group acknowledged that study limitations included short follow-up, potential
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  for uncontrolled confounding, and lack of important socioeconomic variables in the
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  database.
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  Additionally, Vitaliano cautioned that the study likely did not fully control for
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  education, and it was unclear if any of the women were taking any hormone replacement
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  therapy linked to cardiovascular disease and dementia.
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  Now, let's shift our focus to a recent development that could have significant
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  implications for the future of psychedelic research.
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  Earlier this month, the Food and Drug Administration declined to approve
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  midomafetamine, also known as MDMA, for the treatment of post-traumatic stress disorder.
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  This decision has experts concerned that it could set back the field of psychedelic
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  research.
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  Jerrold Rosenbaum, Doctor of Medicine, the director of the Center for Neuroscience of
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  Psychedelics at Massachusetts General Hospital in Boston, expressed his disappointment,
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  saying, 'I was disappointed that a treatment that looked like it could be helpful to people
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  would not be available.' This sentiment is shared by many in the field who see the
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  decision as a significant setback.
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  The Food and Drug Administration's decision followed overwhelmingly negative votes from an
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  advisory committee in June.
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  The Psychopharmacologic Drugs Advisory Committee voted nine to two that the available
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  data failed to show MDMA was effective in treating patients with post-traumatic stress
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  disorder and ten to one that its risks outweigh the benefits, even with a proposed risk
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  evaluation and mitigation strategy.
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  This decision appears to indicate that both the Food and Drug Administration and the medical
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  community want more data before introducing a psychedelic drug to the market.
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  While psychedelic research has experienced a revival in the past decade, some of the data
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  have been challenged.
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  For instance, the British Medical Journal placed an expression of concern on a
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  meta-analysis of psilocybin trials, suggesting its methodology overestimated benefits for
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  depression.
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  Additionally, three papers about MDMA-assisted therapy published in the journal
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  Psychopharmacology were retracted due to concerns about unethical conduct.
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  Concerns about misconduct during the trials—specifically, an incident where an
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  unlicensed therapist was accused of sexual misconduct with a patient from the study—were
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  also aired at the Food and Drug Administration advisory meeting.
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  The agency has recently intensified its investigation into these allegations, according
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  to the Wall Street Journal.
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  Despite these setbacks, leaders in the field of psychedelic research believe the Food and Drug
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  Administration's rejection could be an opportunity to regroup.
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  Companies are preparing to follow in Lykos Therapeutics' footsteps with other psychedelic
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  drugs in the coming years.
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  Paul Hutson, Doctor of Pharmacy, the director of the Transdisciplinary Center for Research in
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  Psychoactive Substances at the University of Wisconsin-Madison, mentioned that the field is
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  waiting to see what the complete response letter from the Food and Drug Administration
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  will say.
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  He expressed concern that leaders could take away the wrong lessons without this full
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  explanation.
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  One issue of particular concern is whether the Food and Drug Administration took issue with
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  the psychotherapy involved in Lykos' trials.
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  'I am concerned that there will be some protocol that makes it even more onerous to
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  provide the skilled therapy along with the drug therapy,' Hutson said.
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  He added that the entire field of psychedelic research would be focused on whether the Food
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  and Drug Administration clarifies how psychotherapy should be approached for future
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  psychedelic treatments.
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  Frederick Barrett, Doctor of Philosophy, the director of the Center for Psychedelic and
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  Consciousness Research at Johns Hopkins University in Baltimore, noted that functional
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  unblinding was a significant concern for the Food and Drug Administration advisory
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  committee.
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  However, he argued that it would not be a major issue for the field moving forward.
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  Instead, better trial design will be needed to account for these issues.
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  Barrett emphasized that several useful study designs could prove a psychedelic's efficacy
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  and safety without relying on blinding.
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  He pointed out that the Food and Drug Administration's regulatory code outlines
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  several study design options, including dose comparison control, no-treatment control,
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  active-treatment control, or historical control.
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  'This is written into law as the definition of the canonical ways that the Food and Drug
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  Administration thinks about and can consider controls in trials,' Barrett said.
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  He explained that psychedelic researchers should be running studies in all of these
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  different designs and then look at the sum total, because each of these designs has flaws
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  and benefits.
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  The process has already begun.
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  Several studies have shown promising results for psilocybin for depression, specifically for
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  patients with treatment-resistant bipolar type two depression and as a therapy with or without
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  antidepressants.
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  Notably, Compass Pathways is working on phase three research on psilocybin for patients with
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  treatment-resistant depression.
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  Earlier this month, Cybin announced plans to start its own phase three program on the use of
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  psilocybin for the treatment of major depressive disorder.
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  Rachel Yehuda, Doctor of Philosophy, the director of the Center for Psychedelic
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  Psychotherapy and Trauma Research at Mount Sinai in New York City, told MedPage Today that
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  the setback was likely the result of people outside the field deciding that more needed to
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  be proven.
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  'In the last few years, there has been so much hype that it has almost seemed like a foregone
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  conclusion: This is happening, this is coming,' Yehuda said.
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  'And the people that were not so sure about it were not necessarily speaking or were not
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  necessarily being heard.'
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  Yehuda highlighted the importance of moving forward and addressing these concerns,
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  especially since there are few good treatments for many of these conditions right now.
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  She noted that throughout the discussion around this approval process, 'nobody thought that the
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  psychedelic drug was dangerous.'
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  'The events of the last few months underscore the need for more really good research
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  conducted in the way that standard research is conducted—generally by academics and in
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  conservative, safe environments,' Yehuda concluded.
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  That brings us to the end of today's episode.
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  We have covered a lot, from the pervasive presence of ultraprocessed foods in our diets
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  to the cognitive decline in husbands after a spouse's cardiovascular disease event, and
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  finally, the potential impact of the Food and Drug Administration's decision to reject MDMA
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  on psychedelic research.
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  Thank you for joining me, Dr.
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  Chi-Ming Chow, on Morning Medical with Dr.
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  Chow.
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  Stay tuned for more updates on the latest in medical and health news.
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  Until next time, stay healthy and informed.