health care – Page 11 – Go Retire Psychiatrist

What Does “Design Defect” of a Vaccine Mean In the Iowa Bill to Require Vaccine Manufacturers to Waive Immunity from Lawsuits?

Beats me. Sorry, just kidding. I’m just a little bleary from looking at the web sites about the definition of “design defect” related to vaccines as it applies to the Iowa bill to make vaccine manufacturers waive their immunity from lawsuits about vaccine related injuries.

I am sympathetic to anyone who in fact has suffered a vaccine related injury.

That term “design defect” has been bugging me for days now and I just found out that this has been the subject of states vs federal legal wrangling for years. I’m not up to explaining all the legalese but there is a really tangled trail of cases in Georgia and Pennsylvania roughly around 15 years ago that ultimately led to a U.S. Supreme Court decision saying, essentially, the Vaccine Injury Compensation Program and the federal Childhood Vaccine Injury Act of the 1980s preempts all state level vaccine design defect claims.

I think that explains why the Iowa bill says that vaccine manufacturers have to waive their immunity from suits if they want Iowans to get their vaccines.

I can hear the groans and shouts of dissent even as I write this. Hey, you can’t make this up. Talk to your legislator or lawyer about it.

I’m not sure why Iowa would want to repeat the grind that Georgia and Pennsylvania went through which led to the conclusion that you can file vaccine design defect claims at the state level and not have to repeat history which would likely lead to any decisions made there being reversed in federal court.

And I’m not sure why any vaccine manufacturer would want to fight that battle in Iowa either. They might just steer around us and take their vaccines elsewhere.

The beginning of the Georgia story.

The end of the Georgia story.

The beginning and the end of the Pennsylvania story.

Vaccines aren’t perfect. They are neither 100% safe nor 100% effective. However, I support having vaccines available to help keep us healthy and the right to choose getting a vaccine. That’s why I don’t support a bill that I believe would make them less accessible.

New Wrinkle on Iowa Bill to Oppose mRNA Vaccines in Iowa

This is a follow up to yesterday’s post about the Iowa legislature’s proposition of a new law that would essentially ban mRNA vaccines in Iowa. I don’t understand the numbers and codes on the new sections, but the new one proposes that manufacturers of vaccines would have to waive immunity from lawsuits arising from “a design defect of the vaccine.”

I’m not sure if that’s addition to being charged with a simple misdemeanor, subject to a $500 fine for administering the vaccine. I oppose this one too because I think it would essentially make vaccines difficult to access and harder to persuade new medical staff to come to Iowa.

There’s going to be a meeting about the bill at 4:30 PM CST. I can’t remember if it’s at the state house or at the Exile Brewing Co. for sandwiches and Ruthie’s beer.

In any case, the comment section is overwhelmingly in opposition to the bill. I saw several comments mentioning that we already have the National Vaccine Injury Compensation Program (NVIP), which is designed to field requests for compensation to those who believe they’ve been injured by certain vaccines. I had not heard of it before. It’s administered by the federal government, Health Resources & Services Administration, which is under the Health and Human Resources department.

There is a nice easy to read summary about the complicated story of vaccine safety and liability at the Children’s Hospital of Philadelphia website. It was reviewed by Dr. Paul A. Offit, MD last year. He attends meeting of the Centers for Disease Control and Prevention, although I think he missed the one last month about the flu vaccine because it was cancelled.

If I see anything earth shaking about the meeting this afternoon on HF712, I’ll make an addendum to this post.

Proposed Bill Would Ban mRNA Vaccines in Iowa

Sena just alerted me to a bill in the Iowa legislature right now that proposes mRNA vaccines (like the Covid vaccine for example) be banned in Iowa. Part of it says that any person who provides or administers such a vaccine would be guilty of a simple misdemeanor and subject to a $500 fine. I do not support it although I also support the right of others to disagree.

The bill advanced out of subcommittee yesterday and I’m not sure how although, admittedly, I don’t know what exactly that means about its chance of being ultimately passed into law. There were hundreds of comments against it. It moves for further consideration to the Iowa Senate Health and Human Services Committee according to a story in the Daily Iowan.

This sent me to the web to find out what other silly laws Iowa has passed. A few of them are below:

“Any person who attempts to pass off margarine, oleo, or oleomargarine as real butter is guilty of a simple misdemeanor in Iowa. This one originated in 1943, but is still in force today.”

“In Marshalltown, horses are forbidden to eat fire hydrants.”

“It is illegal for a mustached man to kiss a woman in public.”

All of the above are on this Iowa State University web page.

The Connection Between Vitamin A and Measles Is Not Just About Carrots

The measles outbreak is big in the news and the issue of the role of Vitamin A in measles reminded me of something I saw back in the 1970s. I was working as a drafter and survey crew assistant for WHKS & Co (consulting engineers in Mason City, Iowa) at the time. As I was working on a drawing, a co-worker walked by my desk and I noticed her skin was the color of a carrot. She was orange. She explained that she and her husband had been taking high doses of beta-carotene, which is a precursor for Vitamin A. She and her husband both worked at WHKS & Co but I think he was home sick that day, from taking too much beta carotene.

So that segues into what I found out about the connection between measles and Vitamin A. The Centers for Disease Control and Prevention (CDC) has a web page on it and cites references for the role of Vitamin A. Vitamin A does not prevent measles. But in children who are severely ill and hospitalized from measles and under a physician’s supervision, age-specific doses of Vitamin A can be given for a limited period of time.

There are two references for the administration of Vitamin A in the context of kids with measles, available through weblinks from the CDC. One of them is the World Health Organization (WHO), which recommends Vitamin A for vitamin deficient children and because measles infection by itself can cause acute Vitamin A deficiency, resulting in xerophthalmia (severe dry eyes). This can lead to blindness.

Usually this is more of a problem in developing countries, but the WHO recommends it even for children in the US.

The other reference is Red Book. This is not the magazine for American women looking for tips on beauty. The Red Book is from the American Academy of Pediatrics and it notes the WHO recommendation to administer Vitamin A to patients “…regardless of their country of residence.”

The caveat is that you can get either not enough or too much of a good thing. Beta-carotene is a precursor to Vitamin A. Vitamin A toxicity is bad.

And you could avoid all this because there is an effective vaccine for measles. Don’t take my word for it. Talk to your pediatrician.

More on the Focused Practice Designation in Emergency Psychiatry

This post just provides further information (in addition to what was in yesterday’s post) on the evolution of the Focused Practice Designation (FPD) for consultation-liaison psychiatrists who might be interested in certifying to work in emergency departments. I use the word “certifying” because it seems clear that the FPD pathway has been intended to follow the board certification pathway, which I wondered about.

There’s a little background on the progress to the FPD path (established by ABMS in 2017) that began a few years ago in the article below:

Simpson S, Brooks V, DeMoss D, Lawrence R. The Case for Fellowship Training in Emergency Psychiatry. MedEdPublish (2016). 2020 Nov 11;9:252. doi: 10.15694/mep.2020.000252.1. PMID: 38058898; PMCID: PMC10697437.

The take home message is quoted below:

“-Over 10 million emergency department encounters a year in the United States are for behavioral health concerns, but quality emergency psychiatric care remains inconsistently available.

-New emergency psychiatry fellowship programs are being developed to train expert clinicians and prepare leaders in the subspecialty.

-These efforts will improve access to high quality mental health treatment for all patients regardless of treatment setting.”

And there is a 55-page form on the web from the American Board of Medical Specialties (ABMS) Committee on Certification (COCERT). There are several endorsements from various stakeholders including but not limited to the Academy of Consultation-Liaison Psychiatry (ACLP) and the American Board of Psychiatry & Neurology (ABPN) which make it clear there is a consensus about the value of “board certification” because most of the endorsement letters specify that. These letters are dated from just last year.

The University of Iowa Health Care system, based on the website does not (yet) offer an emergency psychiatry fellowship. They do offer a consultation-liaison psychiatry fellowship, which the ABMS supports as contributing to the attainment of the FPD credential.

However, I’m unclear if the FPD pathway won’t soon become yet another ongoing certification challenge for clinicians, many of whom find it more of an interference to their practice than a benefit. Although I believe that appropriately trained psychiatrists are helpful in the emergency room (after all, I did that for a long time), I have a nagging doubt that it will unclog the overcrowding there. Dr. George Dawson pointed that out yesterday in his comment to my post.

In the Purpose, Status, and Need section of the ABMS 55-page application form, starting on p.2 of the pdf, the American Board of Emergency Medicine (ABEM) specifies that the PFD would not be yet another subspecialty. The proposed 12-month fellowship in Emergency Behavioral Health (EBH) “…would not be ACGME-accredited training…” which distinguishes it from a subspecialty—yet they would be “recognized” for having the FPD.

Further, the application asserts that the EBH would “…address the mental health crisis in the US.” The reference to the “moral injury” that our colleagues suffer in the emergency room is not lost on me. I believe in the all for one and one for all concept. However, I’m less confident that this would lead to fewer patients boarding in emergency rooms. These days, entire hospitals often have no or too few beds available for either psychiatric or non-psychiatric patients.

Under the “Eligibility and Assessment” section, the emergency room psychiatrist seeking FPD status must hold ABEM or ABPN primary psychiatry certification. They would also be required to meet continuing certification requirements in EBH to maintain active FPD status. There is presently a “Practice Pathway” to the FPD, but that would eventually close. After that, the psychiatrist would need to complete a 12-month ABEM-approved EBH fellowship. The cycle length for the FPD in EBH would be 5 years, beyond which the applicant would be subject to re-verification of ongoing EBH practice experience “…to meet continuing certification requirements.”

You can learn more about FPD (including frequently asked questions) at this ABMS web site.

It sounds like board mandated MOC to me, and I don’t know how many clinicians will choose that route. It could discourage some psychiatrists from pursuing the FPD pathway. I’m also unsure how this will address the practical issue of emergency room boarding of patients with psychiatric illness, since doctors ultimately don’t control hospital bed capacity.

New Consultation-Liaison Psychiatry Focused Practice Designation in Emergency Behavioral Certification in Emergency Rooms

I just found out about the American Board of Medical Specialties (ABMS) announcement of a new addition to the Consultation-Liaison Psychiatry subspecialty: Focused Practice Designation. It looks like it’s going to be administered by the American Board of Emergency Medicine (ABEM), possibly in collaboration with the American Board of Psychiatry & Neurology (ABPN).

I’m unsure of the nuts and bolts, but on the surface, it looks like it might be a promising way to address meeting the needs of the many patients who appear in hospital emergency rooms.

On the other hand, I’m unclear on whether this might also lead to the addition of yet another layer of medical and psychiatry board maintenance of certification exams and fees. It looks like some boards of medicine and surgery require those who want to pursue the Focused Practice Designation (FPD) specialization route sit for an initial certification exam which would be time-limited followed by something called “continuous certification” which is a form of maintenance of certification (MOC). This often entails periodic exams and fees which many physicians find burdensome and expensive, leading to petitions opposing MOC and finding alternatives to fulfill the continuing education needs in less costly and time-consuming ways. One notable alternative is the National Board of Physicians and Surgeons (NBAS).

I’m not sure why another layer of bureaucracy needs to be added to achieve the goal of ensuring that emergency room patients with mental health challenges have access to mental health professionals. In fact, there is an American Association for Emergency Psychiatry open to membership which includes psychiatrists, physician assistants, psychologists, nurses, social workers and other professionals. However, the goal behind the FPD route is to increase the presence of physicians in the emergency room. This creates a specific and arguably needed role for consultation-liaison (C-L) psychiatrists.

I get the impression the exact way this will be rolled out is under construction, so to speak. Although I can’t find language in the announcements for the new FPD specifically saying that there’s going to be another MOC for C-L psychiatrists, there doesn’t seem to be any language assuring there won’t be. The FPD web page for the American Board of Obstetrics & Gynecology (ABOG) makes it pretty clear—there’s a MOC for that.

Just because you don’t see anything currently on the ABEM and ABPN web sites about MOC being required for the FPD doesn’t mean that it won’t appear in the near future. For now, the ABMS table outlining the differences between the certification requirements for specialty/subspecialty designation and the FDP doesn’t specify extra certification for the FDP for C-L psychiatrists per se.

I’m hoping for the best for patients and doctors.

FDA Announces Clozapine REMS Program Eliminated

As of February 24, 2025, the FDA has eliminated the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program. See the FDA link for details. Below is the announcement.

“Latest Update

February 24, 2025 – Beginning today, FDA does not expect prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine or to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine. FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing Boxed Warnings.

Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine. FDA has notified the manufacturers that the clozapine REMS must be eliminated. FDA has instructed the clozapine manufacturers to formally submit a modification to eliminate the Clozapine REMS and to update the prescribing information, including removing mandatory reporting of ANC blood tests to the REMS program.

In the coming months, FDA will work with the clozapine manufacturers to update the prescribing information and eliminate the Clozapine REMS.”–FDA

Addiction Not the Same as Neuroadaptation

It’s common to read or hear people say they’re “addicted” to all sorts of things, like chocolate, but there’s a difference between addiction and adaptation. Adaptation can also be called “dependence” or the fancier “neuroadaptation.”

This can foster a discussion about whether you can be addicted to antidepressants, which by extension, could mean it’s difficult to discontinue them. Presumably, that would point to withdrawal symptoms being the obstacle to “getting off” them. Comparing them in terms of which one is more difficult to quit (as noted in the news lately) is fraught with difficulty.

Because I’m a retired psychiatrist, I searched the medical literature to refresh my knowledge about the issue. It turns out, according to a recent review, that it’s important to distinguish between dependence (neuroadaptation) and addiction.

The thing about addiction is that it’s about misusing or abusing substances in a compulsive way despite adverse consequences. Medical students used to remember it (for exams) as the 4 C’s: compulsion, craving, control (the loss of), and consequences (negative). I remember one doctor who added another c: conniving (to obtain substances).

On the other hand, dependence is marked by the adaptation of brain receptors to a substance and which doesn’t involve any of the c’s. This is the way to differentiate addiction from dependence, the latter being a consequence of taking antidepressants. One recent review article does a pretty good job of explaining this:

“Physical dependence to antidepressants may occur in some patients, caused by adaptation of the brain to long-term use of the medication. As pharmacologically defined, this physical dependence is a distinct phenomenon from addiction, and is manifested by a drug withdrawal syndrome.” — Horowitz MA, Framer A, Hengartner MP, Sørensen A, Taylor D. Estimating Risk of Antidepressant Withdrawal from a Review of Published Data. CNS Drugs. 2023 Feb;37(2):143-157. doi: 10.1007/s40263-022-00960-y. Epub 2022 Dec 14. PMID: 36513909; PMCID: PMC9911477.

The authors make the point that pretty much all antidepressants can cause dependence if you take them long enough. But with the possible exception of tranylcypromine (Parnate), they don’t lead to abuse or addiction. That was an interesting reminder. Parnate has a chemical structure similar to amphetamine and there are old case reports describing patients who usually have other substance use disorders abusing Parnate.

Anyway, antidepressants can lead to dependence which can be detected only if they stop using them. Withdrawal can be extremely uncomfortable and can last weeks to months, uncommonly for years.

Withdrawal syndromes vary among different substances. Alcohol and heroin can cause severe withdrawal that has to be managed in a hospital. That’s not to say it’s impossible to suffer antidepressant withdrawal serious enough to warrant hospitalization, but it would be rare. Partly that’s due to the difference in neuroreceptors.

Serotonergic receptors, for example, can be occupied by serotonergic antidepressants and lead to dependence mediated by neuroadaptation. If the antidepressant is abruptly stopped, there will be withdrawal, partly depending on the chemical half-life of the drug. Withdrawal can be marked by headache, dizziness, falls, electric shock sensations, and suicide attempts, for example.

Opioid and benzodiazepine withdrawal are mediated by opioid and Gamma Amino Butyric Acid (GABA) receptors respectively. Withdrawal symptoms can include but are not limited to tremor, sweating, seizures and delirium for benzodiazepine withdrawal, and muscle jerks, sweating, bone pain, nausea and vomiting, diarrhea, and muscle spasms for opioids such as heroin. Both may require medical detoxification in a hospital.

Who’s to say which withdrawal syndrome is worse? They’re both bad.

There’s not a lot of scientific literature out there on antidepressant withdrawal. The authors of the article cited above ended up with only 11 papers over a 20-odd year span after their search.

On average, antidepressants with shorter half-lives tend to be associated with withdrawal. Table 5 in the article cited above identifies the ones with lower to higher risk. Table 6 is a preliminary effort to categorize the level of risk to develop antidepressant withdrawal for an individual patient.

Are There Clear and Consistent Racial Differences in Immunity?

So, the short answer is “Probably not.” I did a little digging on this because I heard the recently confirmed HHS Secretary Robert F. Kennedy Jr (RFK Jr) cite studies which he says did indicate there are differences in humoral immunity between Caucasians and African Americans.

Now remember, I’m a retired general hospital psychiatric consultant and my immunology background consists of the standard immunology lecture in medical school. The class I remember most vividly was the one in which the lecturer stopped her lecture abruptly, sighed deeply and looked defeated, probably because she saw the look of confusion on our faces.

Now that you know my credentials, let me just review what I found in a far from exhaustive review of the scientific literature on the topic of whether or not African Americans have, as RFK Jr. remarked, a “better” immune system than Caucasians.

On my own, I found what RFK Jr referred to variously (depending what social media web source you use) as the “Poland” or “pollen” studies as the scientific source of information supporting his view. I suspect it’s this, in which the last author in the citation is GA Poland:

Haralambieva IH, Salk HM, Lambert ND, Ovsyannikova IG, Kennedy RB, Warner ND, Pankratz VS, Poland GA. Associations between race, sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014 Apr 7;32(17):1946-53. doi: 10.1016/j.vaccine.2014.01.090. Epub 2014 Feb 13. PMID: 24530932; PMCID: PMC3980440.

It was later in the day that I finally also found the NPR news story, the author of which pointed out the same article.

I also found a couple of other articles which tend to contradict the findings of the Poland et al study. One of them was published in eClinicalMedicine in 2023:

Martin CA, Nazareth J, Jarkhi A, Pan D, Das M, Logan N, Scott S, Bryant L, Abeywickrama N, Adeoye O, Ahmed A, Asif A, Bandi S, George N, Gohar M, Gray LJ, Kaszuba R, Mangwani J, Martin M, Moorthy A, Renals V, Teece L, Vail D, Khunti K, Moss P, Tattersall A, Hallis B, Otter AD, Rowe C, Willett BJ, Haldar P, Cooper A, Pareek M. Ethnic differences in cellular and humoral immune responses to SARS-CoV-2 vaccination in UK healthcare workers: a cross-sectional analysis. EClinicalMedicine. 2023 Apr;58:101926. doi: 10.1016/j.eclinm.2023.101926. Epub 2023 Apr 4. PMID: 37034357; PMCID: PMC10071048.

The list of references include the Poland study (reference 27) cited above. The bottom line is the African American immune response to Covid is not “better” than that of white health care workers but the Asian immune response was stronger. I thought it was interesting that in the section “Evidence before this study,” the authors point out that in one previous study, African Americans had lower antibody responses to vaccination than Whites.

I looked at only one other study, published in Clinical Microbiology Review in 2019;

Zimmermann P, Curtis N2019.Factors That Influence the Immune Response to Vaccination. Clin Microbiol Rev 32:10.1128/cmr.00084-18.https://doi.org/10.1128/cmr.00084-18

OK, so I didn’t hunt through all 582 references, but I thought it was enough to note that the authors didn’t mention race as even being relevant anywhere in the body of the paper.

That said, I suspect the more important fact to focus on is racial disparity regarding African Americans even getting vaccines, especially the Covid vaccine. Vaccine hesitancy is common in this population and probably more important to address rather than whether or not there are significant racial differences in immunogenicity. The major challenge is providing accurate information about vaccines in general and Covid vaccines in particular.

The CDC Advisory Committee includes African American members who attend each meeting and emphasize the importance of including black people in vaccination campaigns. OK, so why was the meeting this month cancelled, postponed, or whatever?

Hey, I’m just an old psychiatrist, so don’t take my word for it about anything here. Ask an immunologist. If the immunologist gives you a blank look, you could try a Ouija Board.

Rounding@Iowa Podcast: “Challenges in Transitioning Seriously Ill Patients from Pediatric to Adult Systems of Care”

I listened to the Rounding@Iowa podcast of February 11, 2025, “Challenges in Transitioning Seriously Ill Patients from Pediatric to Adult Systems of Care.”

89: Tick-borne Illnesses – Rounding@IOWA

Join Dr. Clancy, Dr. Appenheimer & Dr. Barker as they discuss prevention, diagnosis and treatment of various tick-borne illnesses. CME Credit Available: https://uiowa.cloud-cme.com/course/courseoverview?eid=82296 Host: Gerard Clancy, MD Senior Associate Dean for External Affairs Professor of Psychiatry and Emergency Medicine University of Iowa Carver College of Medicine Guests: Ben Appenheimer, MD Clinical Associate Professor of Internal Medicine-Infectious Diseases Assistant Director, Infectious Diseases Fellowship Program Associate Clinical Director, Infectious Diseases Co-Medical Director, TelePrEP, University of Iowa Health Care University of Iowa Carver College of Medicine Jason Barker, MD Associate Professor of Internal Medicine-Infectious Diseases University of Iowa Carver College of Medicine Financial Disclosures: Dr. Gerard Clancy, his guests, and Rounding@IOWA planning committee members have disclosed no relevant financial relationships. Nurse: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this activity for a maximum of 1.0 ANCC contact hour. Pharmacist and Pharmacy Tech: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this knowledge-based activity for a maximum of 1.0 ACPE contact hours. Credit will be uploaded to the NABP CPE Monitor within 60 days after the activity completion. Pharmacists must provide their NABP ID and DOB (MMDD) to receive credit. JA0000310-0000-26-038-H01 Physician: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Other Health Care Providers: A certificate of completion will be available after successful completion of the course. (It is the responsibility of licensees to determine if this continuing education activity meets the requirements of their professional licensure board.)

This was a very interesting presentation about the challenges of helping persons with life-limiting conditions (for example, hemophilia, cystic fibrosis, sickle cell anemia and more) transition from pediatric to adult systems of care. Most of the discussion was about the difficulty in finding doctors who would be willing and able to assume care of patients who had survived to adulthood who had been previously seen in pediatrics throughout childhood.

I listened very carefully to the whole podcast, waiting to hear about what the role of mental health care professionals would be in this kind of transition. There was no mention of it, not even after one of the presenters described a patient who was starting to have hallucinations.

My role as a consulting psychiatrist in a general hospital was mainly to see those with chronic diseases who were being treated by colleagues during a bout of cystic fibrosis or sickle cell crisis. I remember they were young adults, struggling with emotional distress and disruptive behavior.

I was surprised at the lack of discussion about the role of mental health assessments, diagnoses, and treatment including psychotherapy during transitions from pediatric to adult health care. Not that I would have had much to offer other than questions about how mental health professionals could be helpful regarding transitions—but I think they would have not been out of place.

I took a quick look at the resources provided. One of them was a University of Iowa website, the Iowa Center for Disabilities and Development: Transition to Adulthood Clinic For Teens and Young Adult Ages 14-30. Even here, the role of a psychologist was to evaluate learning problems.

One of the discussants mentioned a program called Got Transition, which has a very comprehensive website. There was a section for Special Populations and a list of resources and research when I searched the site using the term “mental health.” It was hard to find a section specific to the population under discussion in the podcast. On the other hand, it was very comprehensive.

In this podcast, discussants talked about the importance of a team approach to transitions. I wonder if there’s a place on the team for psychiatry.