Category: science

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.

The Science on Super Beets?

Sena recently got her bottle of Super Beets with Grape Seed Extract delivered the other day. They are capsules and the label enthusiastically advertises that they are “non-GMO” and will enable the average human to leap tall buildings in a single bound within just minutes of swallowing a total of 9,000 capsules (3 caps per serving and 90 servings per bottle). Just kidding. Sena will take only one capsule a day for now.

They are made and marketed by HumanN and they prominently display important information on the bottle:

“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Just so you know, the FDA doesn’t approve dietary supplements for safety or effectiveness, although they recently put together a review of scientific data on Cannabis for the HHS which may lead to the DEA changing the schedule of marijuana from Schedule I to Schedule III along with the scientific conclusion that certain formulations of the product may enable the user to leap tall buildings in a single bound—or least feel like he can. Just kidding.

Wait till you see the data on their new product, Chupacabra Chewables. The chews are shaped like little chupacabras and mutilated chickens. Just kidding, they don’t make anything like that, and even if they did, you can be sure it would be non-GMO.

Even though the FDA does not approve dietary supplements (or disapprove of marijuana apparently), that non-GMO detail is something the FDA does have an opinion about. They say on their Agricultural Biotechnology web page that “GMO foods are as healthful and safe to eat as their non-GMO counterparts.”

I searched the internet for studies on super beets and grape seed extract and it turns out there has been some research published about them. There was a meta-analysis in 2017 in which the results that beet juice has blood pressure lowering effects:

Bahadoran Z, Mirmiran P, Kabir A, Azizi F, Ghasemi A. The Nitrate-Independent Blood Pressure-Lowering Effect of Beetroot Juice: A Systematic Review and Meta-Analysis. Adv Nutr. 2017 Nov 15;8(6):830-838. doi: 10.3945/an.117.016717. Erratum in: Adv Nutr. 2018 May 1;9(3):274. PMID: 29141968; PMCID: PMC5683004.

And there was a randomized, placebo-controlled study also published in 2017 (a good year for supplement studies evidently) showing that grape seed extract modulated blood pressure. It also relieved perceived stress:

Schön C, Allegrini P, Engelhart-Jentzsch K, Riva A, Petrangolini G. Grape Seed Extract Positively Modulates Blood Pressure and Perceived Stress: A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Volunteers. Nutrients. 2021 Feb 17;13(2):654. doi: 10.3390/nu13020654. PMID: 33671310; PMCID: PMC7922661.

I’m going to pass for now on the beet and grape seed extract caps. I can already leap tall buildings in a single bound.

The Changing Role of the Psychiatrist in Managing Depression with Medical Illness

This post is mainly a reminiscence about my days as a consultation-liaison psychiatrist. I often evaluated patients who had chronic hepatitis C. The liver disease itself and the treatment (interferon alfa) often led to patients struggling with depression.

The impetus for this came from noticing a couple of items. One is the recent l blog post about treatment of depression by George Dawson, MD (“Are Medication Trials for Depression Too Long in Duration?”). The other is a Psychiatric Times article about the Star-*D depression treatment study published in Psychiatric Times (“Star*D: It’s Time to Atone and Retract” by Nicolas Badre, MD and Jason Compton, MD).

Back in the day, I thought it made sense to use depression rating scales in my clinic practice. I use the term “clinic practice” reservedly because in actual practice I was too often running the hospital psychiatry consultation service to see outpatients regularly.

There has been a recent call to retract the Star*D study. I wasn’t involved in the study, of course. I was too busy running around the hospital responding to consultation requests. I noticed the criticism in the Psychiatric Times article by Badre and Compton of the specific depression rating scale, the QIDS-SR (which stands for Quick Inventory of Depressive Symptomatology (Self-Report).

I tried to integrate into my practice the QIDS-SR as well as the Clinically Useful Depression Outcome Scale (CUDOS). The latter was designed by psychiatrist Dr. Mark Zimmerman around 2008. I believed in the principle of measurement-based assessment of psychiatric symptoms and did my level best to integrate them into my practice.

It was very difficult to do. My patients were typically suffering from both medical and psychiatric illness. Often, they had physical symptoms that you could attribute to either the medical problem itself or “depression”—or both. This is a common challenge in consultation psychiatry.

Returning to my experience with patients who had chronic hepatitis C, in my early career, some of them who were on interferon alfa would not uncommonly develop depressive symptoms during treatment. Sometimes that meant stopping the treatment. Moreover, they sometimes had other side effects including thyroid function abnormalities, which can also cause mood disturbance.

There have been debates about whether to count physical symptoms in depression because of the overlapping symptoms: fatigue, appetite loss, trouble sleeping and the like. There’s also what has been called the “fallacy of good reasons.” Wouldn’t you be depressed too if you were sick and tired of being sick and tired? This could lead to undertreatment of depression. Some diagnostic models suggested counting all symptoms regardless of etiology.

Some randomized controlled trials of antidepressants in the past showed antidepressants were effective in the medically ill with depression. Others showed they were not better than placebo.

Nowadays there is a new pharmacologic approach to treating hepatitis C and those are in the category of direct-acting antivirals (DAA). According to fairly recent literature, the DAAs offer a better chance of cure of hepatitis C and less psychiatric side effects. That doesn’t mean psychiatrists are no longer needed. The common issues such as comorbid substance use and cognitive disorders, highlighting the ongoing need for collaborative care between medicine and psychiatry.

Closing the Loop on All Domain Anomaly Resolution Office Search for Extraterrestrials?

Just in case you haven’t already heard, the All-domain Anomaly Resolution Office (AARO) revealed the lack of evidence proving the existence of extraterrestrials from the reports about what we used to call UFOs.

And NASA has said basically the same thing.

So, is there anything left to say about this? Probably not from the official side of the issue. But I don’t think this will be the end of reports of UFOs from the public.

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.

The FDA Announcement on Kratom

Just in case you missed it, the FDA posted an announcement about Kratom in February this year. According to the FDA:

“Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia. Products prepared from kratom leaves are available in the U.S. through sales on the Internet and at brick-and-mortar stores. Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal.”

The other day as we were driving home on Highway 1 through Iowa City, I saw a sign advertising Kratom on a small store. I thought that might be illegal, but when I checked the Iowa Office of Drug Control and Policy, I found out it’s currently legal in the state.

Opinions vary about risks of using Kratom. The DEA tried to place in on the Schedule I, but the American Kratom Association and other supporters apparently prevented that simply by protesting it. The pharmacist who wrote the article (link above) raised a note of irony by questioning why marijuana is still regulated as a Schedule I drug.

The legality of Kratom also varies across the country. There is a very detailed review article about it that attempts to examine the use of Kratom from both the medical practitioner and patient points of view.

Picture Credit: By Psychonaught – Own work, Public Domain, https://commons.wikimedia.org/w/index.php?curid=8255742