Psychoactive Drugs Are Having a Moment. The FDA Will Soon Weigh In.
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Lori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives.
Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endured layers of trauma that eventually forced her to seek treatment for crippling anxiety and hypervigilance. For 10 years nothing helped, and she began to wonder if she was “unfixable.”
Then she answered an ad for a clinical trial for MDMA-assisted therapy to treat post-traumatic stress disorder. Tipton said the results were immediate, and she is convinced the drug could help a lot of people. But even as regulators weigh approval of the first MDMA-based treatment, she’s worried that it won’t reach those who need it most.
“The main thing that I’m always concerned about is just accessibility,” the 43-year-old nonprofit project manager said. “I don’t want to see this become just another expensive add-on therapy for people who can afford it when people are dying every day by their own hand because of PTSD.”
MDMA is part of a new wave of psychoactive drugs that show great potential for treating conditions such as severe depression and PTSD. Investors are piling into the nascent field, and a host of medications based on MDMA, LSD, psychedelic mushrooms, ketamine, the South American plant mixture ayahuasca, and the African plant ibogaine are now under development, and in some cases vying for approval by the Food and Drug Administration.
Proponents hope the efforts could yield the first major new therapies for mental illness since the introduction of modern antidepressants in the 1980s. But not all researchers are convinced that their benefits have been validated, or properly weighed against the risks. And they can be difficult to assess using traditional clinical trials.
The first MDMA-assisted assisted therapy appeared to be on track for FDA approval this August, but a recent report from an independent review committee challenged the integrity of the trial data from the drug’s maker, Lykos Therapeutics, a startup founded by a psychedelic research and advocacy group. The FDA will convene a panel of independent investigators on June 4 to determine whether to recommend the drug’s approval.
Proponents of the new therapies also worry that the FDA will impose treatment protocols, such as requiring multiple trained clinicians to monitor a patient for extended periods, that will render them far too expensive for most people.
Tipton’s MDMA-assisted therapy included three eight-hour medication sessions overseen by two therapists, each followed by an overnight stay at the facility and an integration session the following day.
“It does seem that some of these molecules can be administered safely,” said David Olson, director of the University of California-Davis Institute for Psychedelics and Neurotherapeutics. “I think the question is can they be administered safely at the scale needed to really make major improvements in mental health care.”
Breakthrough Therapies?
Psychedelics and other psychoactive substances, among the medicines with the oldest recorded use, have long been recognized for their potential therapeutic benefits. Modern research on them started in the mid-20th century, but clinical trial results didn’t live up to the claims of advocates, and they eventually got a bad name both from their use as party drugs and from rogue CIA experiments that involved dosing unsuspecting individuals.
The 1970 Controlled Substances Act made most psychoactive drugs illegal before any treatments were brought to market, and MDMA was classified as a Schedule 1 substance in 1985, which effectively ended any research. It wasn’t until 2000 that scientists at Johns Hopkins University were granted regulatory approval to study psilocybin anew.
Ketamine was in a different category, having been approved as an anesthetic in 1970. In the early 2000s, researchers discovered its antidepressant effects, and a ketamine-based therapy, Spravato, received FDA approval in 2019. Doctors can also prescribe generic ketamine off-label, and hundreds of clinics have sprung up across the nation. A clinical trial is underway to evaluate ketamine’s effectiveness in treating suicidal depression when used with other psychiatric medications.
Ketamine’s apparent effectiveness sparked renewed interest in the therapeutic potential of other psychoactive substances.
They fall into distinct categories: MDMA is an entactogen, also known as an empathogen, which induces a sense of connectedness and emotional communion, while LSD, psylocibin, and ibogaine are psychedelics, which create altered perceptual states. Ketamine is a dissociative anesthetic, though it can produce hallucinations at the right dose.
Despite the drugs’ differences, Olson said they all create neuroplasticity and allow the brain to heal damaged neural circuits, which imaging shows can be shriveled up in patients with addiction, depression, and PTSD.
“All of these brain conditions are really disorders of neural circuits,” Olson said. “We’re basically looking for medicines that can regrow these neurons.”
Psychedelics are particularly good at doing this, he said, and hold promise for treating diseases including Alzheimer’s.
A number of psychoactive drugs have now received the FDA’s “breakthrough therapy” designation, which expedites development and review of drugs with the potential to treat serious conditions.
But standard clinical trials, in which one group of patients is given the drug and a control group is given a placebo, have proven problematic, for the simple reason that people have no trouble determining whether they’ve gotten the real thing.
The final clinical trial for Lykos’ MDMA treatment showed that 71% of participants no longer met the criteria for PTSD after 18 weeks of taking the drug versus 48% in the control group.
A March report by the Institute for Clinical and Economic Review, an independent research group, questioned the company’s clinical trial results and challenged the objectivity of MDMA advocates who participated in the study as both patients and therapists. The institute also questioned the drug’s cost-effectiveness, which insurers factor into coverage decisions.
Lykos, a public benefit company, was formed in 2014 as an offshoot of the Multidisciplinary Association for Psychedelic Studies, a nonprofit that has invested more than $150 million into psychedelic research and advocacy.
The company said its researchers developed their studies in partnership with the FDA and used independent raters to ensure the reliability and validity of the results.
“We stand behind the design and results of our clinical trials,” a Lykos spokesperson said in an email.
There are other hazards too. Psychoactive substances can put patients in vulnerable states, making them potential victims for financial exploitation or other types of abuse. In Lykos’ second clinical trial, two therapists were found to have spooned, cuddled, blindfolded, and pinned down a female patient who was in distress.
The substances can also cause shallow breathing, heart issues, and hyperthermia.
To mitigate risks, the FDA can put restrictions on how drugs are administered.
“These are incredibly potent molecules and having them available in vending machines is probably a bad idea,” said Hayim Raclaw of Negev Capital, a venture capital fund focused on psychedelic drug development.
But if the protocols are too stringent, access is likely to be limited.
Rachel del Dosso, a trauma therapist in the greater Los Angeles area who offers ketamine-assisted therapy, said she’s been following the research on drugs like MDMA and psilocybin and is excited for their therapeutic potential but has reservations about the practicalities of treatment.
“As a therapist in clinical practice, I’ve been thinking through how could I make that accessible,” she said. “Because it would cost a lot for [patients] to have me with them for the whole thing.”
Del Dosso said a group therapy model, which is sometimes used in ketamine therapy, could help scale the adoption of other psychoactive treatments, too.
Artificial Intelligence and Analogs
Researchers expect plenty of new discoveries in the field. One of the companies Negev has invested in, Mindstate Design Labs, uses artificial intelligence to analyze “trip reports,” or self-reported drug experiences, to identify potentially therapeutic molecules. Mindstate has asked the FDA to green-light a clinical trial of the first molecule identified through this method, 5-MeO-MiPT, also known as moxy.
AlphaFold, an AI program developed by Google’s DeepMind, has identified thousands of potential psychedelic molecules.
There’s also a lot of work going into so-called analog compounds, which have the therapeutic effects of hallucinogens but without the hallucinations. The maker of a psilocybin analog announced in March that the FDA had granted it breakthrough therapy status.
“If you can harness the neuroplasticity-promoting properties of LSD while also creating an antipsychotic version of it, then that can be pretty powerful,” Olson said.
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
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Protein: How Much Do We Need, Really?
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Mythbusting Protein!
Yesterday, we asked you for your policy on protein consumption. The distribution of responses was as follows:
- A marginal majority (about 55%) voted for “Protein is very important, but we can eat too much of it”
- A large minority (about 35%) voted for “We need lots of protein; the more, the better!”
- A handful (about 4%) voted for “We should go as light on protein as possible”
- A handful (6%) voted for “If we don’t eat protein, our body will create it from other foods”
So, what does the science say?
If we don’t eat protein, our body will create it from other foods: True or False?
Contingently True on an absurd technicality, but for all practical purposes False.
Our body requires 20 amino acids (the building blocks of protein), 9 of which it can’t synthesize and absolutely must get from food. Normally, we get those amino acids from protein in our diet, and we can also supplement them by buying amino acid supplements.
Specifically, we require (per kg of bodyweight) a daily average of:
- Histidine: 10 mg
- Isoleucine: 20 mg
- Leucine: 39 mg
- Lysine: 30 mg
- Methionine: 10.4 mg
- Phenylalanine*: 25 mg
- Threonine: 15 mg
- Tryptophan: 4 mg
- Valine: 26 mg
*combined with the non-essential amino acid tyrosine
Source: Protein and Amino Acid Requirements In Human Nutrition: WHO Technical Report
However, to get the requisite amino acid amounts, without consuming actual protein, would require gargantuan amounts of supplementation (bearing in mind bioavailability will never be 100%, so you’ll always need to take more than it seems), using supplements that will have been made by breaking down proteins anyway.
So unless you live in a laboratory and have access to endless amounts of all of the required amino acids (you can’t miss even one; you will die), and are willing to do that for the sake of proving a point, then you do really need to eat protein.
Your body cannot, for example, simply break down sugar and use it to make the protein you need.
On another technical note… Do bear in mind that many foods that we don’t necessarily think of as being sources of protein, are sources of protein.
Grains and grain products, for example, all contain protein; we just don’t think of them as that because their macronutritional profile is heavily weighted towards carbohydrates.
For that matter, even celery contains protein. How much, you may ask? Almost none! But if something has DNA, it has protein. Which means all plants and animals (at least in their unrefined forms).
So again, to even try to live without protein would very much require living in a laboratory.
We can eat too much protein: True or False?
True. First on an easy technicality; anything in excess is toxic. Even water, or oxygen. But also, in practical terms, there is such a thing as too much protein. The bar is quite high, though:
❝Based on short-term nitrogen balance studies, the Recommended Dietary Allowance of protein for a healthy adult with minimal physical activity is currently 0.8 g protein per kg bodyweight per day❞
❝To meet the functional needs such as promoting skeletal-muscle protein accretion and physical strength, dietary intake of 1.0, 1.3, and 1.6 g protein per kg bodyweight per day is recommended for individuals with minimal, moderate, and intense physical activity, respectively❞
❝Long-term consumption of protein at 2 g per kg bodyweight per day is safe for healthy adults, and the tolerable upper limit is 3.5 g per kg bodyweight per day for well-adapted subjects❞
❝Chronic high protein intake (>2 g per kg bodyweight per day for adults) may result in digestive, renal, and vascular abnormalities and should be avoided❞
Source: Dietary protein intake and human health
To put this into perspective, if you weigh about 160lbs (about 72kg), this would mean eating more than 144g protein per day, which grabbing a calculator means about 560g of lean beef, or 20oz, or 1¼lb.
If you’re eating quarter-pounder burgers though, that’s not usually so lean, so you’d need to eat more than nine quarter-pounder burgers per day to get too much protein.
High protein intake damages the kidneys: True or False?
True if you have kidney damage already; False if you are healthy. See for example:
- Effects of dietary protein restriction on the progression of advanced renal disease in the modification of diet in renal disease study
- A high protein diet has no harmful effects: a one-year crossover study in healthy male athletes
High protein intake increases cancer risk: True or False?
True or False depending on the source of the protein, so functionally false:
- Eating protein from red meat sources has been associated with higher risk for many cancers
- Eating protein from other sources has been associated with lower risk for many cancers
Source: Red Meat Consumption and Mortality Results From 2 Prospective Cohort Studies
High protein intake increase risk of heart disease: True or False?
True or False depending on the source of the protein, so, functionally false:
- Eating protein from red meat sources has been associated with higher risk of heart disease
- Eating protein from other sources has been associated with lower risk of heart disease
Source: Major Dietary Protein Sources and Risk of Coronary Heart Disease in Women
In summary…
Getting a good amount of good quality protein is important to health.
One can get too much, but one would have to go to extremes to do so.
The source of protein matters:
- Red meat is associated with many health risks, but that’s not necessarily the protein’s fault.
- Getting plenty of protein from (ideally: unprocessed) sources such as poultry, fish, and/or plants, is critical to good health.
- Consuming “whole proteins” (that contain all 9 amino acids that we can’t synthesize) are best.
Learn more: Complete proteins vs. incomplete proteins (explanation and examples)
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How Useful Are Our Dreams
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What’s In A Dream?
We were recently asked:
❝I have a question or a suggestion for coverage in your “Psychology Sunday”. Dreams: their relevance, meanings ( if any) interpretations? I just wondered what the modern psychological opinions are about dreams in general.❞
~ 10almonds subscriber
There are two main schools of thought, and one main effort to reconcile those two. The third one hasn’t quite caught on so far as to be considered a “school of thought” yet though.
The Top-Down Model (Psychoanalysts)
Psychoanalysts broadly follow the theories of Freud, or at least evolved from there. Freud was demonstrably wrong about very many things. Most of his theories have been debunked and ditched—hence the charitable “or at least evolved from there” phrasing when it comes to modern psychoanalytic schools of thought. Perhaps another day, we’ll go into all the ways Freud went wrong. However, for today, one thing he wasn’t bad at…
According to Freud, our dreams reveal our subconscious desires and fears, sometimes directly and sometimes dressed in metaphor.
Examples of literal representations might be:
- sex dreams (revealing our subconscious desires; perhaps consciously we had not thought about that person that way, or had not considered that sex act desirable)
- getting killed and dying (revealing our subconscious fear of death, not something most people give a lot of conscious thought to most of the time)
Examples of metaphorical representations might be:
- dreams of childhood (revealing our subconscious desires to feel safe and nurtured, or perhaps something else depending on the nature of the dream; maybe a return to innocence, or a clean slate)
- dreams of being pursued (revealing our subconscious fear of bad consequences of our actions/inactions, for example, responsibilities to which we have not attended, debts are a good example for many people; or social contact where the ball was left in our court and we dropped it, that kind of thing)
One can read all kinds of guides to dream symbology, and learn such arcane lore as “if you dream of your teeth crumbling, you have financial worries”, but the truth is that “this thing means that other thing” symbolic equations are not only highly personal, but also incredibly culture-bound.
For example:
- To one person, bees could be a symbol of feeling plagued by uncountable small threats; to another, they could be a symbol of abundance, or of teamwork
- One culture’s “crow as an omen of death” is another culture’s “crow as a symbol of wisdom”
- For that matter, in some cultures, white means purity; in others, it means death.
Even such classically Freudian things as dreaming of one’s mother and/or father (in whatever context) will be strongly informed by one’s own waking-world relationship (or lack thereof) with same. Even in Freud’s own psychoanalysis, the “mother” for the sake of such analysis was the person who nurtured, and the “father” was the person who drew the nurturer’s attention away, so they could be switched gender roles, or even different people entirely than one’s parents.
The only real way to know what, if anything, your dreams are trying to tell you, is to ask yourself. You can do that…
- by reflection and personal interrogation (see for example: The Easiest Way To Take Up Journaling)
- or by externalising parts of your subconscious (as in Internal Family Systems therapy)
- or by talking directly to your subconscious where it is, by means of lucid dreaming.
The idea with lucid dreaming is that since any dream character is a facet of your subconscious generated by your own mind, by talking to that character you can ask questions directly of your subconscious (the popular 2010 movie “Inception” was actually quite accurate in this regard, by the way).
To read more about how to do this kind of self-therapy through lucid dreaming, you might want to check out this book we reviewed previously; it is the go-to book of lucid dreaming enthusiasts, and will honestly give you everything you need in one go:
Lucid Dreaming: A Concise Guide to Awakening in Your Dreams and in Your Life – by Dr. Stephen LaBerge
The Bottom-Up Model (Neuroscientists)
This will take a lot less writing, because it’s practically a null hypothesis (i.e., the simplest default assumption before considering any additional evidence that might support or refute it; usually some variant of “nothing unusual going on here”).
The Bottom-Up model holds that our brains run regular maintenance cycles during REM sleep (a biological equivalent of defragging a computer), and the brain interprets these pieces of information flying by and, because of the mind’s tendency to look for patterns, fills in the rest (much like how modern generative AI can “expand” a source image to create more of the same and fill in the blanks), resulting in the often narratively wacky, but ultimately random, vivid hallucinations that we call dreams.
The Hybrid Model (per Cartwright, 2012)
This is really just one woman’s vision, but it’s an incredibly compelling one, that takes the Bottom-Up model and asks “what if we did all that bio-stuff, and then our subconscious mind influenced the interpretation of the random patterns, to create dreams that are subjectively meaningful, and thus do indeed represent our subconscious?
It’s best explained in her own words, though, so it’s time for another book recommendation (we’ve reviewed this one before, too):
Enjoy!
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Macadamias vs Hazelnuts – Which is Healthier?
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Our Verdict
When comparing macadamias to hazelnuts, we picked the hazelnuts.
Why?
In terms of macros first, hazelnuts have 2x the protein, and slightly more carbs and fiber. We call this a win for hazelnuts.
When it comes to vitamins, macadamias have more of vitamins B1, B2, and B3, while hazelnuts have more of vitamins A, B5, B6, B7, B9, C, and E. Notably, 28x more vitamin E, so that’s not inconsiderable. Also 10x the vitamin B9, and 5x the vitamin C, and the rest, more modest wins. In any case, clearly a strong win for hazelnuts here.
In the category of minerals, macadamias have more selenium, while hazelnuts have more calcium, copper, iron, magnesium, manganese, phosphorus, potassium, and zinc. Another clear win for hazelnuts.
In short, hazelnuts win in all categories. However, by all means enjoy either or both (unless you have a nut allergy, in which case, obviously don’t).
Want to learn more?
You might like to read:
Why You Should Diversify Your Nuts
Take care!
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Apples vs Bananas – Which is Healthier?
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Our Verdict
When comparing apples to bananas, we picked the bananas.
Why?
Both apples and bananas contain lots of vitamins, but bananas contain far more of Vitamins A, B, and C.
Apples beat bananas only for vitamins E and K.
This may seem like “well that’s 2 vs 3; that’s pretty close” until one remembers that vitamin B is actually eight vitamins in a trenchcoat. Bananas have more of vitamins B1, B2, B3, B5, B6, and B9.
If you’re wondering about the other numbers: neither fruit contains vitamins B7 (biotin) or B12 (cobalamins of various kinds). Vitamins B4, B8, B10, and B11 do not exist as such (due to changes in how vitamins are classified).
Both apples and bananas contain lots of minerals, but bananas contain far more of iron, magnesium, phosphorus, potassium, zinc, copper, manganese, and selenium.
Apples beat bananas only for calcium (and then, only very marginally)
Both apples and bananas have plenty of fiber.
Apples have marginally less sugar, but given the fiber content, this is pretty much moot when it comes to health considerations, and apples are higher in fructose in any case.
In short, both are wonderful fruits (and we encourage you to enjoy both!), and/but bananas beat apples healthwise in almost all measures.
PS: top tip if you find it challenging to get bananas at the right level of ripeness for eating… Try sun-dried! Not those hard chip kinds (those are mechanically and/or chemically dried, and usually have added sugar and preservatives), but sun-dried.
Here’s an example product on Amazon
Warning: since there aren’t many sun-dried bananas available on Amazon, double-check you haven’t been redirected to mechanically/chemically dried ones, as Amazon will try that sometimes!
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Rewire Your OCD Brain – by Dr. Catherine Pittman & Dr. William Youngs
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OCD is just as misrepresented in popular media as many other disorders, and in this case, it’s typically not “being a neat freak” or needing to alphabetize things, so much as having uncontrollable obsessive intrusive thoughts, and often in response to those, unwanted compulsions. This can come from unchecked spiralling anxiety, and/or PTSD, for example.
What Drs. Pittman & Young offer is an applicable set of solutions, to literally rewire the brain (insofar as synapses can be considered neural wires). Leveraging neuroplasticity to work with us rather than against us, the authors talk us through picking apart the crossed wires, and putting them back in more helpful ways.
This is not, by the way, a book of CBT, though it does touch on that too.
Mostly, the book explains—clearly and simply and sometimes with illustrations—what is going wrong for us neurologically, and how to neurologically change that.
Bottom line: whether you have OCD or suffer from anxiety or just need help dealing with obsessive thoughts, this book can help a lot in, as the title suggests, rewiring that.
Click here to check out Rewire Your OCD Brain, and banish obsessive thoughts!
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Chocolate & Health
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Chocolate & Health: Fact or Fiction?
“Chocolate Is Good For The Heart”
“When making chocolate chip cookies, you don’t measure using cups, you measure by heart”
…but how good is chocolate when it comes to heart health?
First, what is heart health?
A healthy heart typically has a low resting pulse rate and a strong, steady beat. This is affected strongly by exercise habits, and diet plays only a support role (can’t exercise without energy from food!).
It is also important to have blood pressure within a healthy range (with high blood pressure being a more common problem than low, so things that lower blood pressure are generally considered good).
- Flavanols, flavonoids, and polyphenols in chocolate contribute to lower blood pressure
- Dark chocolate is best for these, as milk chocolate contains much less cocoa solids and more unhelpful fats
- White chocolate contains no cocoa solids and is useless for this
- Some of the fats in most commercial chocolate can contribute to atherosclerosis which raises blood pressure and ultimately can cause heart attacks.
- If you’re diabetic, you will probably not get the usual heart-related benefits from chocolate (sorry)
The Verdict: dark chocolate, in moderation, can support good heart health.
“Chocolate Is Good For The Brain”
Chocolate has been considered a “brain food”… why?
- The brain uses more calories than any other organ (chocolate has many calories)
- The heart benefits we listed above mean improved blood flow—including to your brain
- Chocolate contains phenylethylamine, a powerful chemical that has a similar effect to amphetamines… But it’s metabolized in digestion and never makes it to the central nervous system (so basically, this one’s a miss; we had a good run with the other two, though!)
The Verdict: dark chocolate, in moderation, can support good brain health
“Chocolate Is An Aphrodisiac”
“If chocolate be the food of love, pass me that cocoa; I’m starving”
Most excitingly, chocolate contains phenylethylamine, the “molecule of love” or, more accurately, lust. It has an effect similar to amphetamines, and while we can synthesize it in the body, we can also get it from certain foods. But…
Our body is so keen to get it that most of it is metabolized directly during digestion and doesn’t make it to the brain. Also, chocolate is not as good a source as cabbage—do with that information what you will!
However!
Chocolate contains theobromine and small amounts of caffeine, both stimulants and both generally likely to improve mood; it also contains flavonoids which in turn stimulate production of nitric oxide, which is a relaxant. All in all, things that are convivial to having a good time.
On the other hand…
That relaxation comes specifically with a reduction in blood pressure—something typically considered good for the health for most people most of the time… but that means lowering blood pressure in all parts of your body, which could be the opposite of what you want in intimate moments.
Chocolate also contains zinc, which is essential for hormonal health for most people—the body uses it to produce testosterone and estrogen, respectively. Zinc supplements are popularly sold to those wishing to have more energy in general and good hormonal health in particular, and rightly so. However…
This approach requires long-term supplementation—you can’t just pop a zinc tablet / bar of chocolate / almond before bed and expect immediate results. And if your daily zinc supplementation takes the form of a 3.5oz (100g) bar of chocolate, then you may find it has more effects on your health, and not all of them good!
The Verdict: dark chocolate, in moderation, may promote “the mood”, but could be a double-edged sword when it comes to “the ability”.
“Chocolate Is Good During Menstruation”
The popular wisdom goes that chocolate is rich in iron (of which more is needed during menstruation), and indeed, if you eat 7oz (150g) of dark chocolate made with 85% cocoa, you’ll get a daily a dose of iron (…and nearly 1,000 calories).
More bang-for-buck dietary sources of iron include chickpeas and broccoli, but for some mysterious reason, these are not as commonly reported as popular cravings.
The real explanation for chocolate cravings is more likely that eating chocolate—a food high in sugar and fat along with a chemical bombardment of more specialized “hey, it’s OK, you can relax now” molecules (flavanols/flavonoids, polyphenols, phenylamines, even phenylethylamine, etc) gives a simultaneous dopamine kick (the body’s main “reward” chemical) with a whole-body physiological relaxation… so, little wonder we might crave it in times of stress and discomfort!
The Verdict: it helps, not because it serves a special nutritional purpose, but rather, because the experience of eating chocolate makes us feel good.
Fun fact: Tiramisu (this writer’s favorite dessert) is literally Italian for “pick-me-up”
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