The Joy of Saying No – by Natalie Lue
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Superficially, this seems an odd topic for an entire book. “Just say no”, after all, surely! But it’s not so simple as that, is it?
Lue looks into what underpins people-pleasing, first. Then, she breaks it down into five distinct styles of people-pleasing that each come from slightly different motivations and ways of perceiving how we interact with those around us.
Lest this seem overly complicated, those five styles are what she calls: gooding, efforting, avoiding, saving, suffering.
She then looks out how to have a healthier relationship with our yes/no decisions; first by observing, then by creating healthy boundaries. “Healthy” is key here; this isn’t about being a jerk to everyone! Quite the contrary, it involves being honest about what we can and cannot reasonably take on.
The last section is about improving and troubleshooting this process, and constitutes a lot of the greatest value of the book, since this is where people tend to err the most.
Bottom line: this book is informative, clear, and helpful. And far from disappointing everyone with “no”, we can learn to really de-stress our relationships with others—and ourselves.
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He Fell Ill on a Cruise. Before He Boarded the Rescue Boat, They Handed Him the Bill.
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Vincent Wasney and his fiancée, Sarah Eberlein, had never visited the ocean. They’d never even been on a plane. But when they bought their first home in Saginaw, Michigan, in 2018, their real estate agent gifted them tickets for a Royal Caribbean cruise.
After two years of delays due to the coronavirus pandemic, they set sail in December 2022.
The couple chose a cruise destined for the Bahamas in part because it included a trip to CocoCay, a private island accessible to Royal Caribbean passengers that featured a water park, balloon rides, and an excursion swimming with pigs.
It was on that day on CocoCay when Wasney, 31, started feeling off, he said.
The next morning, as the couple made plans in their cabin for the last full day of the trip, Wasney made a pained noise. Eberlein saw him having a seizure in bed, with blood coming out of his mouth from biting his tongue. She opened their door to find help and happened upon another guest, who roused his wife, an emergency room physician.
Wasney was able to climb into a wheelchair brought by the ship’s medical crew to take him down to the medical facility, where he was given anticonvulsants and fluids and monitored before being released.
Wasney had had seizures in the past, starting about 10 years ago, but it had been a while since his last one. Imaging back then showed no tumors, and doctors concluded he was likely epileptic, he said. He took medicine initially, but after two years without another seizure, he said, his doctors took him off the medicine to avoid liver damage.
Wasney had a second seizure on the ship a few hours later, back in his cabin. This time he stopped breathing, and Eberlein remembered his lips being so purple, they almost looked black. Again, she ran to find help but, in her haste, locked herself out. By the time the ship’s medical team got into the cabin, Wasney was breathing again but had broken blood vessels along his chest and neck that he later said resembled tiger stripes.
Wasney was in the ship’s medical center when he had a third seizure — a grand mal, which typically causes a loss of consciousness and violent muscle contractions. By then, the ship was close enough to port that Wasney could be evacuated by rescue boat. He was put on a stretcher to be lowered by ropes off the side of the ship, with Eberlein climbing down a rope ladder to join him.
But before they disembarked, the bill came.
The Patient: Vincent Wasney, 31, who was uninsured at the time.
Medical Services: General and enhanced observation, a blood test, anticonvulsant medicine, and a fee for services performed outside the medical facility.
Service Provider: Independence of the Seas Medical Center, the on-ship medical facility on the cruise ship operated by Royal Caribbean International.
Total Bill: $2,500.22.
What Gives: As part of Royal Caribbean’s guest terms, cruise passengers “agree to pay in full” all expenses incurred on board by the end of the cruise, including those related to medical care. In addition, Royal Caribbean does not accept “land-based” health insurance plans.
Wasney said he was surprised to learn that, along with other charges like wireless internet, Royal Caribbean required he pay his medical bills before exiting the ship — even though he was being evacuated urgently.
“Are we being held hostage at this point?” Eberlein remembered asking. “Because, obviously, if he’s had three seizures in 10 hours, it’s an issue.”
Wasney said he has little memory of being on the ship after his first seizure — seizures often leave victims groggy and disoriented for a few hours afterward.
But he certainly remembers being shown a bill, the bulk of which was the $2,500.22 in medical charges, while waiting for the rescue boat.
Still groggy, Wasney recalled saying he couldn’t afford that and a cruise employee responding: “How much can you pay?”
They drained their bank accounts, including money saved for their next house payment, and maxed out Wasney’s credit card but were still about $1,000 short, he said.
Ultimately, they were allowed to leave the ship. He later learned his card was overdrafted to cover the shortfall, he said.
Royal Caribbean International did not respond to multiple inquiries from KFF Health News.
Once on land, in Florida, Wasney was taken by ambulance to the emergency room at Broward Health Medical Center in Fort Lauderdale, where he incurred thousands of dollars more in medical expenses.
He still isn’t entirely sure what caused the seizures.
On the ship he was told it could have been extreme dehydration — and he said he does remember being extra thirsty on CocoCay. He also has mused whether trying escargot for the first time the night before could have played a role. Eberlein’s mother is convinced the episode was connected to swimming with pigs, he said. And not to be discounted, Eberlein accidentally broke a pocket mirror three days before their trip.
Wasney, who works in a stone shop, was uninsured when they set sail. He said that one month before they embarked on their voyage, he finally felt he could afford the health plan offered through his employer and signed up, but the plan didn’t start until January 2023, after their return.
They also lacked travel insurance. As inexperienced travelers, Wasney said, they thought it was for lost luggage and canceled trips, not unexpected medical expenses. And because the cruise was a gift, they were never prompted to buy coverage, which often happens when tickets are purchased.
The Resolution: Wasney said the couple returned to Saginaw with essentially no money in their bank account, several thousand dollars of medical debt, and no idea how they would cover their mortgage payment. Because he was uninsured at the time of the cruise, Wasney did not try to collect reimbursement for the cruise bill from his new health plan when his coverage began weeks later.
The couple set up payment plans to cover the medical bills for Wasney’s care after leaving the ship: one each with two doctors he saw at Broward Health, who billed separately from the hospital, and one with the ambulance company. He also made payments on a bill with Broward Health itself. Those plans do not charge interest.
But Broward Health said Wasney missed two payments to the hospital, and that bill was ultimately sent to collections.
In a statement, Broward Health spokesperson Nina Levine said Wasney’s bill was reduced by 73% because he was uninsured.
“We do everything in our power to provide the best care with the least financial impact, but also cannot stress enough the importance of taking advantage of private and Affordable Care Act health insurance plans, as well as travel insurance, to lower risks associated with unplanned medical issues,” she said.
The couple was able to make their house payment with $2,690 they raised through a GoFundMe campaign that Wasney set up. Wasney said a lot of that help came from family as well as friends he met playing disc golf, a sport he picked up during the pandemic.
“A bunch of people came through for us,” Wasney said, still moved to tears by the generosity. “But there’s still the hospital bill.”
The Takeaway: Billing practices differ by cruise line, but Joe Scott, chair of the cruise ship medicine section of the American College of Emergency Physicians, said medical charges are typically added to a cruise passenger’s onboard account, which must be paid before leaving the ship. Individuals can then submit receipts to their insurers for possible reimbursement.
More from Bill of the Month
- Sign Here? Financial Agreements May Leave Doctors in the Driver’s Seat Apr 30, 2024
- A Mom’s $97,000 Question: How Was Her Baby’s Air-Ambulance Ride Not Medically Necessary? Mar 25, 2024
- Without Medicare Part B’s Shield, Patient’s Family Owes $81,000 for a Single Air-Ambulance Flight Feb 27, 2024
He recommended that those planning to take a cruise purchase travel insurance that specifically covers their trips. “This will facilitate reimbursement if they do incur charges and potentially cover a costly medical evacuation if needed,” Scott said.
Royal Caribbean suggests that passengers who receive onboard care submit their paid bills to their health insurer for possible reimbursement. Many health plans do not cover medical services received on cruise ships, however. Medicare will sometimes cover medically necessary health care services on cruise ships, but not if the ship is more than six hours away from a U.S. port.
Travel insurance can be designed to address lots of out-of-town mishaps, like lost baggage or even transportation and lodging for a loved one to visit if a traveler is hospitalized.
Travel medical insurance, as well as plans that offer “emergency evacuation and repatriation,” are two types that can specifically assist with medical emergencies. Such plans can be purchased individually. Credit cards may offer travel medical insurance among their benefits, as well.
But travel insurance plans come with limitations. For instance, they may not cover care associated with preexisting conditions or what the plans consider “risky” activities, such as rock climbing. Some plans also require that travelers file first with their primary health insurance before seeking reimbursement from travel insurance.
As with other insurance, be sure to read the fine print and understand how reimbursement works.
Wasney said that’s what they plan to do before their next Royal Caribbean cruise. They’d like to go back to the Bahamas on basically the same trip, he said — there’s a lot about CocoCay they didn’t get to explore.
Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
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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Next-Level Headache Hacks
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A Muscle With A Lot Of Therapeutic Value
First, a quick anatomy primer, so that the rest makes sense. We’re going to be talking about your sternocleidomastoid (SCM) muscle today.
To find it, there are two easy ways:
- look in a mirror, turn your head to one side and it’ll stick out on the opposite side of your neck
- look at this diagram
(we’re going to talk about it in the singular, but you have one on each side)
This muscle is interesting for very many reasons, but what we’re going to focus on today is that massaging/stretching it (correctly!) can benefit several things that are right next to it and/or behind it, namely:
- The tenth cranial nerve
- The eleventh cranial nerve
- The carotid artery
Why do we care about these?
Well, we would die quickly without the first and last of those. However, more practically, massaging each has benefits:
The tenth cranial nerve
This one is also known by its superhero alter-ego name:
The Vagus Nerve (And How You Can Make Use Of It)
The eleventh cranial nerve
This one’s not nearly so critical to life, but it does facilitate most of the motor functions in that general part of the body—including some mechanics of speech production, and maintaining posture of the shoulders/neck/head (which in turn strongly affects presence/absence of certain kinds of headaches).
The carotid artery
We suspect you know what this one does already; it supplies the brain (and the rest of your head, for that matter) with oxygenated blood.
What is useful to know today, is that it can be massaged, via the SCM, in a way that brings about a gentler version of this “one weird trick” to cure a lot of kinds of headaches:
Curing Headaches At Home With Actual Science
How (And Why) To Massage Your SCM
…to relieve many kinds of headache, migraine, eye-ache, and tension or pain the jaw. It’s not a magical cure all so this comes with no promises, but it can and will help with a lot of things.
In few words: turn your ahead away from the side where it hurts (if both, just pick one and then repeat for the other side), and slightly downwards. When your SCM sticks out a bit on the other side, gently pinch and rub it, working from the bottom to the top.
If you prefer videos, here is a demonstration:
How (And Why) To Stretch Your SCM
The above already includes a little stretch, but you can stretch it in a way that specifically stimulates your vagus nerve (this is good for many things).
In few words: stand (or sit) up straight, and interlace your fingers together. Put your hands on the back of your neck, thumbs-downwards, and (keeping your face forward) look to one side with your eyes only, and hold that until you feel the urge to yawn (it’ll probably take between about 3 seconds and 30 seconds). Then repeat on the other side.
If you prefer videos, this one is a very slight variation of what we just described but works the same way:
Take care!
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The Diet Myth – by Dr. Tim Spector
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Why are we supposed to go low-carb, but get plenty of whole grains? Avoid saturated fat, but olive oil is one of the healthiest fats around? Will cheese kill us or save us? Even amongst the well-informed, there’s a lot of confusion. This book addresses these and many such topics.
A main theme of the book is howa lot of it relates to the state of our gut microbiome, and what is good or bad for that. He also discusses, for example, how microbes predict obesity better than genes, and the good news is: we can change our microbes a lot more easily than we can change our genes!
In the category of criticism, he repeats some decades-old bad science in some areas outside of his field (i.e. unrelated to nutrition), so that’s unfortunate, and/but doesn’t detract from the value of the book if we keep to the main topic.
Bottom line: if you’d like to understand better the physiology and microbiology behind why dieting does work for most people (and how to do it better), then this is a great book for that.
Click here to check out The Diet Myth, and learn the science behind the confusion!
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Unprocessed 10th Anniversary Edition – by Abbie Jay
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The main premise of this book is cooking…
- With nutritious whole foods
- Without salt, oil, sugar (“SOS”)
It additionally does it without animal products and without gluten, and (per “nutritious whole foods”), and, as the title suggests, avoiding anything that’s more than very minimally processed. Remember, for example, that if something is fermented, then that fermentation is a process, so the food has been processed—just, minimally.
This is a revised edition, and it’s been adjusted to, for example, strip some of the previous “no salt” low-sodium options (such as tamari with 233mg/tsp sodium, compared to salt’s 2,300mg/tsp sodium).
You may be wondering: what’s left? Tasty, well-seasoned, plant-based food, that leans towards the “comfort food” culinary niche.
Enough to sate the author, after her own battles with anorexia and obesity (in that order) and finally, after various hospital trips, getting her diet where it needed to be for the healthy lifestyle that she lives now, while still getting to eat such dishes as “Chef AJ’s Disappearing Lasagna” and peanut butter fudge truffles and 151 more.
Bottom line: if you want whole-food plant-based comfort-food cooking that’s healthy in general and especially heart-healthy, this book has plenty of that.
Click here to check out Unprocessed: 10th Anniversary Edition, and… Enjoy!
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What Would a Second Trump Presidency Look Like for Health Care?
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On the presidential campaign trail, former President Donald Trump is, once again, promising to repeal and replace the Affordable Care Act — a nebulous goal that became one of his administration’s splashiest policy failures.
“We’re going to fight for much better health care than Obamacare. Obamacare is a catastrophe,” Trump said at a campaign stop in Iowa on Jan. 6.
The perplexing revival of one of Trump’s most politically damaging crusades comes at a time when the Obama-era health law is even more popular and widely used than it was in 2017, when Trump and congressional Republicans proved unable to pass their own plan to replace it. That failed effort was a big part of why Republicans lost control of the House of Representatives in the 2018 midterms.
Despite repeated promises, Trump never presented his own Obamacare replacement. And much of what Trump’s administration actually accomplished in health care has been reversed by the Biden administration.
Still, Trump secured some significant policy changes that remain in place today, including efforts to bring more transparency to prices charged by hospitals and paid by health insurers.
Trying to predict Trump’s priorities in a second term is even more difficult given that he frequently changes his positions on issues, sometimes multiple times.
The Trump campaign did not respond to a request for comment.
Perhaps Trump’s biggest achievement is something he rarely talks about on the campaign trail. His administration’s “Operation Warp Speed” managed to create, test, and bring to market a covid-19 vaccine in less than a year, far faster than even the most optimistic predictions.
Many of Trump’s supporters, though, don’t support — and some even vehemently oppose — covid vaccines.
Here is a recap of Trump’s health care record:
Public Health
Trump’s pandemic response dominates his overall record on health care.
More than 400,000 Americans died from covid over Trump’s last year in office. His travel bans and other efforts to prevent the global spread of the virus were ineffective, his administration was slower than other countries’ governments to develop a diagnostic test, and he publicly clashed with his own government’s health officials over the response.
Ahead of the 2020 election, Trump resumed large rallies and other public campaign events that many public health experts regarded as reckless in the face of a highly contagious, deadly virus. He personally flouted public health guidance after contracting covid himself and ending up hospitalized.
At the same time, despite what many saw as a politicization of public health by the White House, Trump signed a massive covid relief bill (after first threatening to veto it). He also presided over some of the largest boosts for the National Institutes of Health’s budget since the turn of the century. And the mRNA-based vaccines Operation Warp Speed helped develop were an astounding scientific breakthrough credited with helping save millions of lives while laying the groundwork for future shots to fight other diseases including cancer.
Abortion
Trump’s biggest contribution to abortion policy was indirect: He appointed three Supreme Court justices, who were instrumental in overturning the constitutional right to an abortion.
During his 2024 campaign, Trump has been all over the place on the red-hot issue. Since the Supreme Court overturned Roe v. Wade in 2022, Trump has bemoaned the issue as politically bad for Republicans; criticized one of his rivals, Florida Gov. Ron DeSantis, for signing a six-week abortion ban; and vowed to broker a compromise with “both sides” on abortion, promising that “for the first time in 52 years, you’ll have an issue that we can put behind us.”
He has so far avoided spelling out how he’d do that, or whether he’d support a national abortion ban after any number of weeks.
More recently, however, Trump appears to have mended fences over his criticism of Florida’s six-week ban and more with key abortion opponents, whose support helped him get elected in 2016 — and whom he repaid with a long list of policy changes during his presidency.
Among the anti-abortion actions taken by the Trump administration were a reinstatement of the “Mexico City Policy” that bars giving federal funds to international organizations that support abortion rights; a regulation to bar Planned Parenthood and other organizations that provide abortions from the federal family planning program, Title X; regulatory changes designed to make it easier for health care providers and employers to decline to participate in activities that violate their religious and moral beliefs; and other changes that made it harder for NIH scientists to conduct research using fetal tissue from elective abortions.
All of those policies have since been overturned by the Biden administration.
Health Insurance
Unlike Trump’s policies on reproductive health, many of his administration’s moves related to health insurance still stand.
For example, in 2020, Trump signed into law the No Surprises Act, a bipartisan measure aimed at protecting patients from unexpected medical bills stemming from payment disputes between health care providers and insurers. The bill was included in the $900 billion covid relief package he opposed before signing, though Trump had expressed support for ending surprise medical bills.
His administration also pushed — over the vehement objections of health industry officials — price transparency regulations that require hospitals to post prices and insurers to provide estimated costs for procedures. Those requirements also remain in place, although hospitals in particular have been slow to comply.
Medicaid
While first-time candidate Trump vowed not to cut popular entitlement programs like Medicare, Medicaid, and Social Security, his administration did not stick to that promise. The Affordable Care Act repeal legislation Trump supported in 2017 would have imposed major cuts to Medicaid, and his Department of Health and Human Services later encouraged states to require Medicaid recipients to prove they work in order to receive health insurance.
Drug Prices
One of the issues the Trump administration was most active on was reducing the price of prescription drugs for consumers — a top priority for both Democratic and Republican voters. But many of those proposals were blocked by the courts.
One Trump-era plan that never took effect would have pegged the price of some expensive drugs covered by Medicare to prices in other countries. Another would have required drug companies to include prices in their television advertisements.
A regulation allowing states to import cheaper drugs from Canada did take effect, in November 2020. However, it took until January 2024 for the FDA, under Trump’s successor, to approve the first importation plan, from Florida. Canada has said it won’t allow exports that risk causing drug shortages in that country, leaving unclear whether the policy is workable.
Trump also signed into law measures allowing pharmacists to disclose to patients when the cash price of a drug is lower than the cost using their insurance. Previously pharmacists could be barred from doing so under their contracts with insurers and pharmacy benefit managers.
Veterans’ Health
Trump is credited by some advocates for overhauling Department of Veterans Affairs health care. However, while he did sign a major bill allowing veterans to obtain care outside VA facilities, White House officials also tried to scuttle passage of the spending needed to pay for the initiative.
Medical Freedom
Trump scored a big win for the libertarian wing of the Republican Party when he signed into law the “Right to Try Act,” intended to make it easier for patients with terminal diseases to access drugs or treatments not yet approved by the FDA.
But it is not clear how many patients have managed to obtain treatment using the law because it is aimed at the FDA, which has traditionally granted requests for “compassionate use” of not-yet-approved drugs anyway. The stumbling block, which the law does not address, is getting drug companies to release doses of medicines that are still being tested and may be in short supply.
Trump said in a Jan. 10 Fox News town hall that the law had “saved thousands and thousands” of lives. There’s no evidence for the claim.
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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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.
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