current events – Page 17 – Go Retire Psychiatrist

The FDA Did Send a 252 Page Recommendation to Reschedule Marijuana

Finally, I have found a copy of the FDA recommendation to the DEA to reschedule Marijuana from Schedule I to Schedule III. The whole document is in Dropbox and is 252 pages long. The actual recommendation starts on page 62. The basis for the recommendation is three-fold:

Marijuana has less abuse potential other drugs in Schedule I and II
Marijuana has a currently accepted medical use in treatment in the U.S.
Abuse of marijuana may lead to moderate or low physical dependence or high psychological dependence

The third one sounds like a reason not to reschedule marijuana until you read the clarifying text, which indicates low likelihood of serious outcomes.

On the other hand, the FDA did request feedback from professional organizations on the level of concern that might lead to not recommending marijuana. Only the American Psychiatric Association had reservations against it (pages 27-28):

“FDA also considered position statements from professional organizations relevant to the indications discussed. The vast majority of professional organizations did not recommend the use of marijuana in their respective specialty; however, none specifically recommended against it, with the exception of the American Psychiatric Association (APA), which stated that marijuana is known to worsen certain psychiatric conditions.”

Further, in Iowa which has passed restricted legislation since 2017, there is disagreement about a new bill, House Study Bill 665, which would add more regulation to the sale of some hemp products. Hemp product growers are less than pleased with it. It would restrict minors from access to all hemp products, even those not containing THC. Mental health advocates, while supporting medical marijuana, are understandably concerned about the psychiatric risks attributed to cannabis, especially in adolescents.

There is a recently published paper written by Canadian authors who raise concerns about the emergency room evaluations of children in the context of marijuana exposures. (Crocker CE, Emsley J, Tibbo PG. Mental health adverse events with cannabis use diagnosed in the Emergency Department: what are we finding now and are our findings accurate? Front Psychiatry. 2023 May 25;14:1093081. doi: 10.3389/fpsyt.2023.1093081. PMID: 37304435; PMCID: PMC10247977.):

“There are more studies on the impact of cannabis on mental health in the adolescent population since our last review. One recent study using sentinel surveillance of self-harm using the electronic Canadian Hospitals Injury Reporting and Prevention Program from 2011 to 2019 showed an increase of 15.9% per year in self harm with intentional substance-related injuries exceeding unintentional injury cases and 92.3% of the cannabis-related self-harm being in the 10–19 years of age group.”

I’m ambivalent about the FDA recommendation to reschedule marijuana. On the one hand, marijuana is probably less dangerous than alcohol. On the other hand, if it’s your child that has the bad outcome related to marijuana, you’d likely be opposed to making a change.

DEA to Reschedule Marijuana or Not?

I’ve seen an article posted in February of this year on the American Veterinary Medical Association (AVMA) about there being a plan afoot to change marijuana from DEA Schedule I to III or remove it from the Controlled Substances Act. I couldn’t find out anything about it except in in the AVMA article.

I can’t find what the FDA, HHS, or the DEA may or may not be doing as far as taking any action on about this, if any. I think it’s interesting that the AVMA reports the HHS plan to ask the DEA to change the scheduling of marijuana was “leaked” to the news outlets. There is a link to a New York Times story about it. I guess that’s better than nothing, though some might argue the point.

The AVMA article also linked to a letter from several members of congress urging the DEA to change the scheduling of marijuana, remove it from the Controlled Substances Act or risk getting their knuckles rapped with a ruler by Senator Chuck Schumer. Huh, what’s up with that?

I looked at the HHS website and found nothing suggesting that they are going after the DEA with a fire hose to get this done. The DEA is not mentioning anything about the project on their Drug Information web page.

The only ones talking about this publicly so far are the banks, the weed growers, and the AVMA as far as I can tell. The impression I get is that something is going to happen in a matter of months about decriminalizing and rescheduling marijuana. Things usually don’t happen that quickly in government.

I thought I was finished with this post until yesterday when I read U.S. Senator Mitt Romney’s letter to the DEA urging it not to move marijuana from Schedule I to Schedule III because it would violate something I needed to learn more about, which is an international treaty called the Single Convention.

The Single Convention was ratified by the U.S. Senate in 1967 and it’s part of an international treaty which says marijuana must remain classified as either Class I or II—until a congressman can clearly demonstrate the ability to walk heel to toe in a straight line for a distance not less than 10 yards after smoking a standard large bong of high-grade marijuana.

One thing I can gather from Senator Romney’s letter is that it verifies HHS’ did in fact recommend that the DEA reschedule marijuana.

Today is National Spinach Day!

Sena just told me today is National Spinach Day. Naturally this means she is going to prepare a big whopping mess of spinach for us to eat. She also recently ordered a 100-gallon keg of Super Beets supplement capsules as part of her health food project. She drank the Super Beet Kool-Aid, if you know what I mean.

I guess Popeye the sailor man is still one of the best spokespersons for spinach, which I actually sort of like when it’s soaked in vinegar for about a year or so. When I was a kid, I used to watch Popeye cartoons. The basic storyline is Bluto uses Popeye for punching bag until a can of spinach weighing a metric ton drops out of the sky on Bluto. This never taught Bluto a lesson.

In honor of National Spinach Day, we’ll probably have a platter of Florentine chicken fricassee with a pound of spinach simmered with extraterrestrial brain lobes paired with Bigfoot armpit glands and a glass of chilled free range beagle pee layered with beet juice. Yum.

Maybe just a salad. Happy National Spinach Day!

spinach, beets and leeks and fig vinaigrette

Picture credit: Pixydotorg. I’m not sure about exactly when Popeye goes into the public domain. There are different dates on the web. But the picture is free on Pixydotorg.

National Spinach Day!

We Put on the Ritz for the Solar Eclipse!

We’re putting on the Ritz for the solar eclipse next month! We got our crazy T-shirts and the eclipse glasses and solar filter.

We didn’t know we’d be blind after donning the glasses. You don’t want to go for a walk wearing them because you’re likely to trip over something, mainly other eclipse observers.

We’ve got instructions for snapping photos of the eclipse safely. We’ve got our fingers crossed that it won’t be overcast on the big day—April 8, 2024.

Thoughts on the FDA Settling Lawsuit Over Social Media Post on Ivermectin

I just saw the news item about the FDA settling a lawsuit brought by three Texas doctors who opposed the FDA’s social media posts as well as an FDA website page entitled “Why You Should Not Use Ivermectin to Treat or Prevent Covid-19.” I have highlighted a link to that article which is cited by the NIH article on Ivermectin.

I wrote a blog post in 2021 about the tweets the FDA wrote advising against Ivermectin for Covid-19. I initially doubted they were made by the FDA because the language didn’t sound professional. I guess I was wrong. The FDA will be deleting the social media posts and the FDA web page.

I think the social media posts were unprofessional because of they had a mocking tone. I’m not sure why the FDA should delete the article on their website. I can’t see that it’s very different from the NIH article, which cites it. The NIH tells it like it is. Will they be compelled to retract their article as well based on the idea that they’re interfering with medical practice?

I understand the concept of using drugs off-label. There are psychiatric drugs in that category (the anesthesia drug ketamine being used now for depression, for example). And there are good reasons for allowing off-label uses of some drugs.

However, as one expert points out, it can lead to shortages of the drug for other FDA-approved purposes. One example is Ozempic, the Type II diabetes drug (GLP-1 receptor agonist), which has been prescribed for weight loss so much that it has led to a shortage of it for diabetes. And I just found out that Oprah Winfrey had to leave Weight Watchers because she revealed she’d been taking a GLP-1 receptor agonist.

Incredibly, some have entirely misconstrued the lawsuit judgment. The FDA definitely still does not approve Ivermectin for treating or preventing Covid-19.

Update: I forgot about a blog post mentioning Oprah Winfrey and GLP-1 receptor agonists by Dr. George Dawson (Real Psychiatry) posted on December 19, 2023, “The Ultimate Key Opinion Leader.” Dr. Dawson wrote at length about key opinion leaders in medicine and psychiatry.

Will Iowans Get the Whole Enchilada with The Upcoming Total Solar Eclipse?

So, are Iowans going to get “the whole enchilada” when it comes to seeing the total solar eclipse on April 8, 2024? No, but we’ll see a partial eclipse. The T-shirt Sena got for me says “Total Eclipse” on it—but it also has extraterrestrials on it, which I really like.

The paths of these total eclipses are narrow. The path of the Total Solar Eclipse on August 21, 2017 would not have been visible in the totality phase for Iowans either. So, no whole enchilada then either.

In fact, I don’t remember the 2017 solar eclipse at all. Sena watched it on TV when CNN televised a special program about it. She noticed that it got dark, probably in the early afternoon. I don’t know what I was doing, but I was no doubt running around the hospital responding to psychiatry consultation requests. I probably wouldn’t have noticed a gigantic enchilada stalking the earth.

In fact, to see a total eclipse back then and next month, we’d have to drive to Carbondale, Illinois. That’s at least a 6-hour drive and probably longer since a lot of people would be on the road with the same goal. There are already warnings from some officials about traffic jams, cell phone problems, and other disasters which can happen during the mad rush to see the whole enchilada.

Which brings me to the question: do you know the origin of the phrase “the whole enchilada”?

I guess the history of the expression is a little dark, in a manner of speaking. Some people don’t define it and bail by comparing it to other similar phrases like “the whole nine yards” or whatever. On the other hand, there are variations on another story of the origin that date back to the Watergate tapes scandal in the era of President Nixon’s administration in the 1970s. Supposedly, John Ehrlichmann called Attorney John N. Mitchell “the big enchilada.”

In general, it means the whole thing, the entirety, everything. So, if we want to see the whole enchilada as far as the total solar eclipse on April 8, 2024, we’d have to drive 6 hours to either Carbondale, Illinois or Poplar Bluff, Missouri. We’ll pass on that.

However, Sena did make the whole enchilada last night for dinner.

Getting Ready for the Solar Eclipse!

Sena has placed the order for our eclipse glasses and eclipse T-shirts. They should get here in plenty of time for the solar eclipse on April 8, 2024. And if the weather is really crappy that day—we have 30 days to return them.

There is an interesting history of eclipses on the NASA website. It mentions how Einstein hypothesized that gravity warped space and time, distorting the universe. The sun is big enough that its gravity could bend light. In fact, during the eclipse on May 29, 1919, scientists noted that some stars were in the wrong place, proving Einstein’s theory.

And now for some eclipse jokes:

What do you call it when you fall in love on April 8, 2024? A total eclipse of the heart.

What will the moon bring to the beach on April 8, 2024? Sunblock.

Jupiter to the moon on April 8, 2024: Do you remember the sun?

Moon: No, I blocked it out.

Sena: How do you organize a solar eclipse party?

Jim: I don’t know. How?

Sena: You planet!

An interesting Iowa history story is about the solar eclipse of 1869. Several small markers were placed in various locations to mark the event. Many were lost. They were plowed out or covered up. The author mentions the upcoming 2024 solar eclipse and wonders if anyone will leave markers to remember it.

I think what some may leave behind are tattered eclipse glasses and cheeseburger wrappers. But we’ll have our memories to pass on in stories, pictures, and dad jokes—a living monument.

Solar Eclipse in April!

We just found out there’s going to be a total solar eclipse on April 8, 2024. We hope to get some solar eclipse glasses before then if they don’t run out of stock everywhere. They’re selling fast.

We’ve seen a couple of lunar eclipses and those were fun. The most recent one was during cold weather in November 2022. I had to wear a winter coat.

In Iowa City, it starts at about 1:00 PM on April 8, 2024 and runs until a little after 3:00 PM. We missed the last one in 2017. The next one visible in the U.S. won’t be until 2044. We think we better see the one next month.

Good Luck Dr. Chris Buresh

Sena was looking up the meaning of a four-leaf clover the other day. You might call it a shamrock although that’s usually reserved for the 3-leaf variety. It’s fitting for St. Patrick’s Day to say the four-leaf clover is special because it’s rare to see one. The four leaves represent faith, luck, love, and hope.

The trouble going on in Haiti is regrettable to say the least. However, it also reminded us of how lucky it was for us to have known one of my former colleagues, Dr. Christopher T. Buresh, MD. He was an emergency room physician at the University of Iowa Hospital until just a few years ago, when he and his family moved to Seattle, Washington. Dr. Buresh is now an Associate Professor in the Department of Emergency Medicine with the University of Washington. He’s also Assistant Program Director of their Emergency Medicine Residency Program.

The connection between Dr. Buresh and Haiti goes back a long way. Many Haitians were lucky he and other physicians volunteered to help provide medical care for them on an annual basis for years.

Chris is really a humble, likeable, and practical guy. He and his family were our next-door neighbors for a while and fascinating things were going on there at times. We remember they built this really cool tree house that sort of looked like it grew out of their main home. They even had an apparatus for a zip line between the two structures. I don’t think the zip line ever actually got installed, but it was intriguing.

He and I sometimes saw each other in the emergency room at University of Iowa Hospital. His energy, compassion, and dedication to patient care were an inspiration to colleagues and learners at all levels. Sena saw one of his presentations about his volunteer work in Haiti. He never mentioned the difficult politics of the situation. He emphasized the work of caring for the Haitians most of all and gave credit to members of the team doing everything they could in that challenging and, I’m sure, sometimes horrifying environment.

It would be easy to just sit and wonder why he left Iowa, and to be sorry about that. On the other hand, when you thing about the 4-leaf clover, you really have to wonder about something else. Maybe he had one in his pocket with all four of what we all want: faith, luck, love, and hope.

New Compound MM-120 Related to LSD Gets FDA Nod

I saw the story in Psychiatric Times about the compound MM-120, which the FDA recently granted breakthrough designation. MM-120 is related to LSD. Breakthrough designation is defined by the FDA as, “…a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

The compound is made by the company MindMed. This is not to be confused with mind meld, a Star Trek thing related to Vulcans like Spock who can do this telepathic touch thing. The MindMed organization made MM-120 to help treat people who suffer from Generalized Anxiety Disorder. Their study shows the drug could be used as a standalone treatment for the disorder.

According to one story about it published in the December issue of Drug Discovery and Development, it’s not likely MM-120 will be stocked in pharmacies next to the antihistamines and decongestants. The authors believe it would be more likely included in a Risk Evaluation and Mitigation Strategies (REMS) program.

This brings back nightmares about the Clozapine REMS program, which many psychiatrists found almost impossible to enroll in several years ago because of glitches in the web-based application. In fact, the FDA was still not happy with it a couple of years ago, to the extent they had to “temporarily exercise enforcement discretion” over aspects of the program.

Anway, the article goes on to say that the drug has a pretty good safety profile, although concede that the study found the higher dose of MM-120 led to “…perhaps some more challenging experiences….” There were no incidents of suicidal or self-injurious behavior.

I wonder what the “challenging experiences” were, exactly. After all, MM-120 is basically LSD, which was invented in 1938 by the Swiss chemist, Albert Hofmann. He was doing research into crop fungus. He thought it could be used to treat mental illness, even after he accidentally ingested some of it and hallucinated a future in which a guy named Timothy Leary would advise everyone to “turn on, tune in, drop out.”

That whole fungus research issue reminds me of the still unsettled question of how a whole town in France got higher than a kite (leading to some deaths) back in 1951. Ergot poisoning was the initial theory, although later somebody believed it might have been perpetrated as a secret LSD experiment by the CIA. I think the mystery is still unsolved.

However, there is also the history of MK-Ultra, which apparently actually was a classified CIA project running during the Cold War which involved giving LSD to certain unlucky subjects, some of whom didn’t know they were getting it—with disastrous results in some cases.

Just to let you know, I don’t suspect there is some conspiracy between extraterrestrials and the pentagon to get the world population so confused on LSD that we start believing all those crop circles are being created by two guys using a board and a rope. Forget what Agent Mulder says.