Just a reminder: the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on May 16, 2024 to make recommendations on Covid-19 strain selections for the fall vaccine of 2024-2025.
Category: health care
Is it About the Nail or Not?
I saw this essay about getting your hamster off the treadmill and being in the moment. It’s not just for University of Iowa employees. I do the mindfulness thing, I juggle, I make dumb YouTube videos. And for a little over a month now, I have not scrolled past the first few headlines at the top of the on-line news outlets. It’s a little easier than I thought to give up FOMO zombie-scrolling news habit, if you can even call it the news.
And the nail video is a hoot.
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.
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.
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.
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
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.
Remember The Calling
I recommend Dr. George Dawson’s recent posts on seeing the practice of medicine as a calling and his passing a big milestone with 2 million reads on his blog.
I wrote a post entitled “Remembering Our Calling: MLK Day 2015.” It was republished in a local newspaper, the Iowa City Press-Citizen on January 19, 2015. And I reposted it in 2019 on this blog.
The trainees I taught also taught each other about psychiatry and medicine when they rotated on the consultation-liaison service at the hospital. We put them into the format of short presentations. I called mine the Dirty Dozen. The trainees and I also presented the Clinical Problems in Clinical Psychiatry (CPCP).
There were many of those meetings, which were necessarily short and to the point because the service was busy. We got called from all over the hospital. We answered those calls and learned something new every time.
I posted a lot of the trainees’ presentations in my previous blog, The Practical C-L Psychiatrist, which was replaced by this present blog. I haven’t posted the presentations partly because I wanted to give the younger teachers their due by naming them as they did on their title slides. But I would want to ask their permission first. They are long gone and far flung. Many are leaders now and have been for many years. I still have their slides. I’m very proud of their work. When they were called, they always showed up.
So, you’ll just have to put up with my work and my cornball jokes.
Go Retire Psychiatrist 