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Implicit bias in medicine and beyond
Recently, I reported to the Washtenaw County Circuit Courthouse in Ann Arbor, Mich., to fulfill my civic responsibility of jury duty. After check-in, a pool of 250 potential jurors were shown a video about implicit bias and shuttled off to different courtrooms for the jury selection process (voir dire, or “to speak the truth” in French). While not personally called up to the juror box on this day, I did have the opportunity to observe the attorneys and judge as they questioned potential jurors to uncover any indication that they might not be fair or impartial in judging the facts of this criminal case. After over 3 hours of questioning and several peremptory challenges, a jury was empaneled, and the rest of us were dismissed for the day.
In the legal system, implicit bias can adversely affect legal outcomes by impacting the beliefs and attitudes of multiple stakeholders, including attorneys and judges, litigants, witnesses, and of course jurors, threatening one of our society’s most fundamental principles of equal justice under the law. In the health care arena, implicit bias has been shown to impact patient-clinician communication and contribute to racial and ethnic disparities in patient outcomes. As a medical community, acknowledging and accepting the existence of implicit bias, its manifestations, and its impact is a critical first step to ensuring that every patient that walks into our exam rooms receives equitable care, and we can begin to move the needle in addressing persistent health disparities in patients with gastrointestinal diseases and beyond. While this is regrettably a politically charged topic in our current environment, I urge you to join me in reflecting on whether and how unconscious attitudes or stereotypes may unintentionally color the way in which you interact with patients in the clinic and serve to create or perpetuate inequities in treatment. (I also urge you to show up for jury duty!)
Turning to our April issue, we highlight two recent studies from AGA’s flagship journals, one showing an unexpected rise in pancreatic cancer incidence among women under the age of 55, and another evaluating survival outcomes by fibrosis stage in biopsy-proven nonalcoholic fatty liver disease. In this month’s Member Spotlight column, we introduce you to gastroenterologist Daniel Leffler, MD, who shares his experiences transitioning from a traditional academic career to a job in industry to further scientific advancements in celiac disease treatment. We hope you enjoy these articles and all the content included in our April issue!
Megan A. Adams, MD, JD, MSc
Recently, I reported to the Washtenaw County Circuit Courthouse in Ann Arbor, Mich., to fulfill my civic responsibility of jury duty. After check-in, a pool of 250 potential jurors were shown a video about implicit bias and shuttled off to different courtrooms for the jury selection process (voir dire, or “to speak the truth” in French). While not personally called up to the juror box on this day, I did have the opportunity to observe the attorneys and judge as they questioned potential jurors to uncover any indication that they might not be fair or impartial in judging the facts of this criminal case. After over 3 hours of questioning and several peremptory challenges, a jury was empaneled, and the rest of us were dismissed for the day.
In the legal system, implicit bias can adversely affect legal outcomes by impacting the beliefs and attitudes of multiple stakeholders, including attorneys and judges, litigants, witnesses, and of course jurors, threatening one of our society’s most fundamental principles of equal justice under the law. In the health care arena, implicit bias has been shown to impact patient-clinician communication and contribute to racial and ethnic disparities in patient outcomes. As a medical community, acknowledging and accepting the existence of implicit bias, its manifestations, and its impact is a critical first step to ensuring that every patient that walks into our exam rooms receives equitable care, and we can begin to move the needle in addressing persistent health disparities in patients with gastrointestinal diseases and beyond. While this is regrettably a politically charged topic in our current environment, I urge you to join me in reflecting on whether and how unconscious attitudes or stereotypes may unintentionally color the way in which you interact with patients in the clinic and serve to create or perpetuate inequities in treatment. (I also urge you to show up for jury duty!)
Turning to our April issue, we highlight two recent studies from AGA’s flagship journals, one showing an unexpected rise in pancreatic cancer incidence among women under the age of 55, and another evaluating survival outcomes by fibrosis stage in biopsy-proven nonalcoholic fatty liver disease. In this month’s Member Spotlight column, we introduce you to gastroenterologist Daniel Leffler, MD, who shares his experiences transitioning from a traditional academic career to a job in industry to further scientific advancements in celiac disease treatment. We hope you enjoy these articles and all the content included in our April issue!
Megan A. Adams, MD, JD, MSc
Recently, I reported to the Washtenaw County Circuit Courthouse in Ann Arbor, Mich., to fulfill my civic responsibility of jury duty. After check-in, a pool of 250 potential jurors were shown a video about implicit bias and shuttled off to different courtrooms for the jury selection process (voir dire, or “to speak the truth” in French). While not personally called up to the juror box on this day, I did have the opportunity to observe the attorneys and judge as they questioned potential jurors to uncover any indication that they might not be fair or impartial in judging the facts of this criminal case. After over 3 hours of questioning and several peremptory challenges, a jury was empaneled, and the rest of us were dismissed for the day.
In the legal system, implicit bias can adversely affect legal outcomes by impacting the beliefs and attitudes of multiple stakeholders, including attorneys and judges, litigants, witnesses, and of course jurors, threatening one of our society’s most fundamental principles of equal justice under the law. In the health care arena, implicit bias has been shown to impact patient-clinician communication and contribute to racial and ethnic disparities in patient outcomes. As a medical community, acknowledging and accepting the existence of implicit bias, its manifestations, and its impact is a critical first step to ensuring that every patient that walks into our exam rooms receives equitable care, and we can begin to move the needle in addressing persistent health disparities in patients with gastrointestinal diseases and beyond. While this is regrettably a politically charged topic in our current environment, I urge you to join me in reflecting on whether and how unconscious attitudes or stereotypes may unintentionally color the way in which you interact with patients in the clinic and serve to create or perpetuate inequities in treatment. (I also urge you to show up for jury duty!)
Turning to our April issue, we highlight two recent studies from AGA’s flagship journals, one showing an unexpected rise in pancreatic cancer incidence among women under the age of 55, and another evaluating survival outcomes by fibrosis stage in biopsy-proven nonalcoholic fatty liver disease. In this month’s Member Spotlight column, we introduce you to gastroenterologist Daniel Leffler, MD, who shares his experiences transitioning from a traditional academic career to a job in industry to further scientific advancements in celiac disease treatment. We hope you enjoy these articles and all the content included in our April issue!
Megan A. Adams, MD, JD, MSc
GI lends itself to multiple career paths, says Boston physician
Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.
“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”
Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.
“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”
He discussed the events that led to this career change in an interview with GI & Hepatology News.
Q: Why did you choose GI?
Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.
Q: What gives you the most joy in your day-to-day practice?
Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.
Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.
Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.
I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
Q: What teacher or mentor had the greatest impact on you?
Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.
Q: What habits have you established that have benefited your career most?
Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.
Lightening round
Superpower?
Optimism
Favorite movie to quote?
The Big Lebowski
What is your favorite form of exercise?
Elliptical
Name one thing on your bucket list.
Ethiopia travel
How many cups of coffee do you drink per day?
Two-ish
Dr. Leffler is on LinkedIn.
Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.
“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”
Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.
“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”
He discussed the events that led to this career change in an interview with GI & Hepatology News.
Q: Why did you choose GI?
Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.
Q: What gives you the most joy in your day-to-day practice?
Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.
Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.
Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.
I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
Q: What teacher or mentor had the greatest impact on you?
Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.
Q: What habits have you established that have benefited your career most?
Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.
Lightening round
Superpower?
Optimism
Favorite movie to quote?
The Big Lebowski
What is your favorite form of exercise?
Elliptical
Name one thing on your bucket list.
Ethiopia travel
How many cups of coffee do you drink per day?
Two-ish
Dr. Leffler is on LinkedIn.
Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.
“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”
Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.
“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”
He discussed the events that led to this career change in an interview with GI & Hepatology News.
Q: Why did you choose GI?
Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.
Q: What gives you the most joy in your day-to-day practice?
Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.
Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.
Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.
I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
Q: What teacher or mentor had the greatest impact on you?
Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.
Q: What habits have you established that have benefited your career most?
Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.
Lightening round
Superpower?
Optimism
Favorite movie to quote?
The Big Lebowski
What is your favorite form of exercise?
Elliptical
Name one thing on your bucket list.
Ethiopia travel
How many cups of coffee do you drink per day?
Two-ish
Dr. Leffler is on LinkedIn.
Frustration over iPLEDGE evident at FDA meeting
During 2 days of after the chaotic rollout of the new REMS platform at the end of 2021.
On March 29, at the end of the FDA’s joint meeting of two advisory committees that addressed ways to improve the iPLEDGE program, most panelists voted to change the 19-day lockout period for patients who can become pregnant, and the requirement that every month, providers must document counseling of those who cannot get pregnant and are taking the drug for acne.
However, there was no consensus on whether there should be a lockout at all or for how long, and what an appropriate interval for counseling those who cannot get pregnant would be, if not monthly. Those voting on the questions repeatedly cited a lack of data to make well-informed decisions.
The meeting of the two panels, the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, was held March 28-29, to discuss proposed changes to iPLEDGE requirements, to minimize the program’s burden on patients, prescribers, and pharmacies – while maintaining safe use of the highly teratogenic drug.
Lockout based on outdated reasoning
John S. Barbieri, MD, a dermatologist and epidemiologist, and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston, speaking as deputy chair of the American Academy of Dermatology Association (AADA) iPLEDGE work group, described the burden of getting the drug to patients. He was not on the panel, but spoke during the open public hearing.
“Compared to other acne medications, the time it takes to successfully go from prescribed (isotretinoin) to when the patient actually has it in their hands is 5- to 10-fold higher,” he said.
Among the barriers is the 19-day lockout period for people who can get pregnant and miss the 7-day window for picking up their prescriptions. They must then wait 19 days to get a pregnancy test to clear them for receiving the medication.
Gregory Wedin, PharmD, pharmacovigilance and risk management director of Upsher-Smith Laboratories, who spoke on behalf of the Isotretinoin Products Manufacturer Group (IPMG), which manages iPLEDGE, said, “The rationale for the 19-day wait is to ensure the next confirmatory pregnancy test is completed after the most fertile period of the menstrual cycle is passed.”
Many don’t have a monthly cycle
But Dr. Barbieri said that reasoning is outdated.
“The current program’s focus on the menstrual cycle is really an antiquated approach,” he said. “Many patients do not have a monthly cycle due to medical conditions like polycystic ovarian syndrome, or due to [certain kinds of] contraception.”
He added, “By removing this 19-day lockout and, really, the archaic timing around the menstrual cycle in general in this program, we can simplify the program, improve it, and better align it with the real-world biology of our patients.” He added that patients are often missing the 7-day window for picking up their prescriptions through no fault of their own. Speakers at the hearing also mentioned insurance hassles and ordering delays.
Communication with IPMG
Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and outgoing chair of the AADA iPLEDGE work group, cited difficulty in working with IPMG on modifications as another barrier. She also spoke during the open public hearing.
“Despite many, many attempts to work with the IPMG, we are not aware of any organizational structure or key leaders to communicate with. Instead we have been given repeatedly a generic email address for trying to establish a working relationship and we believe this may explain the inaction of the IPMG since our proposals 4 years ago in 2019.”
Among those proposals, she said, were allowing telemedicine visits as part of the iPLEDGE REMS program and reducing counseling attestation to every 6 months instead of monthly for those who cannot become pregnant.
She pointed to the chaotic rollout of modifications to the iPLEDGE program on a new website at the end of 2021.
In 2021, she said, “despite 6 months of notification, no prescriber input was solicited before revamping the website. This lack of transparency and accountability has been a major hurdle in improving iPLEDGE.”
Dr. Barbieri called the rollout “a debacle” that could have been mitigated with communication with IPMG. “We warned about every issue that happened and talked about ways to mitigate it and were largely ignored,” he said.
“By including dermatologists and key stakeholders in these discussions, as we move forward with changes to improve this program, we can make sure that it’s patient-centered.”
IPMG did not address the specific complaints about the working relationship with the AADA workgroup at the meeting.
Monthly attestation for counseling patients who cannot get pregnant
Dr. Barbieri said the monthly requirement to counsel patients who cannot get pregnant and document that counseling unfairly burdens clinicians and patients. “We’re essentially asking patients to come in monthly just to tell them not to share their drugs [or] donate blood,” he said.
Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among the panel members voting not to continue the 19-day lockout.
“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”
IPMG representative Dr. Wedin, said, “while we cannot support eliminating or extending the confirmation interval to a year, the [iPLEDGE] sponsors are agreeable [to] a 120-day confirmation interval.”
He said that while an extension to 120 days would reduce burden on prescribers, it comes with the risk in reducing oversight by a certified iPLEDGE prescriber and potentially increasing the risk for drug sharing.
“A patient may be more likely to share their drug with another person the further along with therapy they get as their condition improves,” Dr. Wedin said.
Home pregnancy testing
The advisory groups were also tasked with discussing whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most committee members and those in the public hearing who spoke on the issue agreed that home tests should continue in an effort to increase access and decrease burden.
During the pandemic, iPLEDGE rules have been relaxed from having a pregnancy test done only at a Clinical Laboratory Improvement Amendments–certified laboratory.
Lindsey Crist, PharmD, a risk management analyst at the FDA, who presented the FDA review committee’s analysis, said that the FDA’s review committee recommends ending the allowance of home tests, citing insufficient data on use and the discovery of instances of falsification of pregnancy tests.
“One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results,” Dr. Crist said.
Dr. Crist added, however, that the review committee recommends allowing the tests to be done in a provider’s office as an alternative.
Workaround to avoid falsification
Advisory committee member Brian P. Green, DO, associate professor of dermatology at Penn State University, Hershey, Pa., spoke in support of home pregnancy tests.
“What we have people do for telemedicine is take the stick, write their name, write the date on it, and send a picture of that the same day as their visit,” he said. “That way we have the pregnancy test the same day. Allowing this to continue to happen at home is important. Bringing people in is burdensome and costly.”
Emmy Graber, MD, a dermatologist who practices in Boston, and a director of the American Acne and Rosacea Society (AARS), relayed an example of the burden for a patient using isotretinoin who lives 1.5 hours away from the dermatology office. She is able to meet the requirements of iPLEDGE only through telehealth.
“Home pregnancy tests are highly sensitive, equal to the ones done in CLIA-certified labs, and highly accurate when interpreted by a dermatology provider,” said Dr. Graber, who spoke on behalf of the AARS during the open public hearing.
“Notably, CLIA [Clinical Laboratory Improvement Amendments] certification is not required by other REMS programs” for teratogenic drugs, she added.
Dr. Graber said it’s important to note that in the time the pandemic exceptions have been made for isotretinoin patients, “there has been no reported spike in pregnancy in the past three years.
“We do have some data to show that it is not imposing additional harms,” she said.
Suggestions for improvement
At the end of the hearing, advisory committee members were asked to propose improvements to the iPLEDGE REMS program.
Dr. Green advocated for the addition of an iPLEDGE mobile app.
“Most people go to their phones rather than their computers, particularly teenagers and younger people,” he noted.
Advisory committee member Megha M. Tollefson, MD, professor of dermatology and pediatric and adolescent medicine at Mayo Clinic in Rochester, Minn., echoed the need for an iPLEDGE app.
The young patients getting isotretinoin “don’t respond to email, they don’t necessarily go onto web pages. If we’re going to be as effective as possible, it’s going to have to be through an app-based system.”
Dr. Tollefson said she would like to see patient counseling standardized through the app. “I think there’s a lot of variability in what counseling is given when it’s left to the individual prescriber or practice,” she said.
Exceptions for long-acting contraceptives?
Advisory committee member Abbey B. Berenson, MD, PhD, professor of obstetrics and gynecology at University of Texas Medical Branch in Galveston, said that patients taking long-acting reversible contraceptives (LARCs) may need to be considered differently when deciding the intervals for attestation or whether to have a lockout period.
“LARC methods’ rate of failure is extremely low,” she said. “While it is true, as it has been pointed out, that all methods can fail, when they’re over 99% effective, I think that we can treat those methods differently than we treat methods such as birth control pills or abstinence that fail far more often. That is one way we could minimize burden on the providers and the patients.”
She also suggested using members of the health care team other than physicians to complete counseling, such as a nurse or pharmacist.
Prescriptions for emergency contraception
Advisory committee member Sascha Dublin, MD, PhD, senior scientific investigator for Kaiser Permanente Washington Health Research Institute in Seattle, said most patients taking the drug who can get pregnant should get a prescription for emergency contraception at the time of the first isotretinoin prescription.
“They don’t have to buy it, but to make it available at the very beginning sets the expectation that it would be good to have in your medicine cabinet, particularly if the [contraception] choice is abstinence or birth control pills.”
Dr. Dublin also called for better transparency surrounding the role of IPMG.
She said IPMG should be expected to collect data in a way that allows examination of health disparities, including by race and ethnicity and insurance status. Dr. Dublin added that she was concerned about the poor communication between dermatological societies and IPMG.
“The FDA should really require that IPMG hold periodic, regularly scheduled stakeholder forums,” she said. “There has to be a mechanism in place for IPMG to listen to those concerns in real time and respond.”
The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.
During 2 days of after the chaotic rollout of the new REMS platform at the end of 2021.
On March 29, at the end of the FDA’s joint meeting of two advisory committees that addressed ways to improve the iPLEDGE program, most panelists voted to change the 19-day lockout period for patients who can become pregnant, and the requirement that every month, providers must document counseling of those who cannot get pregnant and are taking the drug for acne.
However, there was no consensus on whether there should be a lockout at all or for how long, and what an appropriate interval for counseling those who cannot get pregnant would be, if not monthly. Those voting on the questions repeatedly cited a lack of data to make well-informed decisions.
The meeting of the two panels, the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, was held March 28-29, to discuss proposed changes to iPLEDGE requirements, to minimize the program’s burden on patients, prescribers, and pharmacies – while maintaining safe use of the highly teratogenic drug.
Lockout based on outdated reasoning
John S. Barbieri, MD, a dermatologist and epidemiologist, and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston, speaking as deputy chair of the American Academy of Dermatology Association (AADA) iPLEDGE work group, described the burden of getting the drug to patients. He was not on the panel, but spoke during the open public hearing.
“Compared to other acne medications, the time it takes to successfully go from prescribed (isotretinoin) to when the patient actually has it in their hands is 5- to 10-fold higher,” he said.
Among the barriers is the 19-day lockout period for people who can get pregnant and miss the 7-day window for picking up their prescriptions. They must then wait 19 days to get a pregnancy test to clear them for receiving the medication.
Gregory Wedin, PharmD, pharmacovigilance and risk management director of Upsher-Smith Laboratories, who spoke on behalf of the Isotretinoin Products Manufacturer Group (IPMG), which manages iPLEDGE, said, “The rationale for the 19-day wait is to ensure the next confirmatory pregnancy test is completed after the most fertile period of the menstrual cycle is passed.”
Many don’t have a monthly cycle
But Dr. Barbieri said that reasoning is outdated.
“The current program’s focus on the menstrual cycle is really an antiquated approach,” he said. “Many patients do not have a monthly cycle due to medical conditions like polycystic ovarian syndrome, or due to [certain kinds of] contraception.”
He added, “By removing this 19-day lockout and, really, the archaic timing around the menstrual cycle in general in this program, we can simplify the program, improve it, and better align it with the real-world biology of our patients.” He added that patients are often missing the 7-day window for picking up their prescriptions through no fault of their own. Speakers at the hearing also mentioned insurance hassles and ordering delays.
Communication with IPMG
Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and outgoing chair of the AADA iPLEDGE work group, cited difficulty in working with IPMG on modifications as another barrier. She also spoke during the open public hearing.
“Despite many, many attempts to work with the IPMG, we are not aware of any organizational structure or key leaders to communicate with. Instead we have been given repeatedly a generic email address for trying to establish a working relationship and we believe this may explain the inaction of the IPMG since our proposals 4 years ago in 2019.”
Among those proposals, she said, were allowing telemedicine visits as part of the iPLEDGE REMS program and reducing counseling attestation to every 6 months instead of monthly for those who cannot become pregnant.
She pointed to the chaotic rollout of modifications to the iPLEDGE program on a new website at the end of 2021.
In 2021, she said, “despite 6 months of notification, no prescriber input was solicited before revamping the website. This lack of transparency and accountability has been a major hurdle in improving iPLEDGE.”
Dr. Barbieri called the rollout “a debacle” that could have been mitigated with communication with IPMG. “We warned about every issue that happened and talked about ways to mitigate it and were largely ignored,” he said.
“By including dermatologists and key stakeholders in these discussions, as we move forward with changes to improve this program, we can make sure that it’s patient-centered.”
IPMG did not address the specific complaints about the working relationship with the AADA workgroup at the meeting.
Monthly attestation for counseling patients who cannot get pregnant
Dr. Barbieri said the monthly requirement to counsel patients who cannot get pregnant and document that counseling unfairly burdens clinicians and patients. “We’re essentially asking patients to come in monthly just to tell them not to share their drugs [or] donate blood,” he said.
Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among the panel members voting not to continue the 19-day lockout.
“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”
IPMG representative Dr. Wedin, said, “while we cannot support eliminating or extending the confirmation interval to a year, the [iPLEDGE] sponsors are agreeable [to] a 120-day confirmation interval.”
He said that while an extension to 120 days would reduce burden on prescribers, it comes with the risk in reducing oversight by a certified iPLEDGE prescriber and potentially increasing the risk for drug sharing.
“A patient may be more likely to share their drug with another person the further along with therapy they get as their condition improves,” Dr. Wedin said.
Home pregnancy testing
The advisory groups were also tasked with discussing whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most committee members and those in the public hearing who spoke on the issue agreed that home tests should continue in an effort to increase access and decrease burden.
During the pandemic, iPLEDGE rules have been relaxed from having a pregnancy test done only at a Clinical Laboratory Improvement Amendments–certified laboratory.
Lindsey Crist, PharmD, a risk management analyst at the FDA, who presented the FDA review committee’s analysis, said that the FDA’s review committee recommends ending the allowance of home tests, citing insufficient data on use and the discovery of instances of falsification of pregnancy tests.
“One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results,” Dr. Crist said.
Dr. Crist added, however, that the review committee recommends allowing the tests to be done in a provider’s office as an alternative.
Workaround to avoid falsification
Advisory committee member Brian P. Green, DO, associate professor of dermatology at Penn State University, Hershey, Pa., spoke in support of home pregnancy tests.
“What we have people do for telemedicine is take the stick, write their name, write the date on it, and send a picture of that the same day as their visit,” he said. “That way we have the pregnancy test the same day. Allowing this to continue to happen at home is important. Bringing people in is burdensome and costly.”
Emmy Graber, MD, a dermatologist who practices in Boston, and a director of the American Acne and Rosacea Society (AARS), relayed an example of the burden for a patient using isotretinoin who lives 1.5 hours away from the dermatology office. She is able to meet the requirements of iPLEDGE only through telehealth.
“Home pregnancy tests are highly sensitive, equal to the ones done in CLIA-certified labs, and highly accurate when interpreted by a dermatology provider,” said Dr. Graber, who spoke on behalf of the AARS during the open public hearing.
“Notably, CLIA [Clinical Laboratory Improvement Amendments] certification is not required by other REMS programs” for teratogenic drugs, she added.
Dr. Graber said it’s important to note that in the time the pandemic exceptions have been made for isotretinoin patients, “there has been no reported spike in pregnancy in the past three years.
“We do have some data to show that it is not imposing additional harms,” she said.
Suggestions for improvement
At the end of the hearing, advisory committee members were asked to propose improvements to the iPLEDGE REMS program.
Dr. Green advocated for the addition of an iPLEDGE mobile app.
“Most people go to their phones rather than their computers, particularly teenagers and younger people,” he noted.
Advisory committee member Megha M. Tollefson, MD, professor of dermatology and pediatric and adolescent medicine at Mayo Clinic in Rochester, Minn., echoed the need for an iPLEDGE app.
The young patients getting isotretinoin “don’t respond to email, they don’t necessarily go onto web pages. If we’re going to be as effective as possible, it’s going to have to be through an app-based system.”
Dr. Tollefson said she would like to see patient counseling standardized through the app. “I think there’s a lot of variability in what counseling is given when it’s left to the individual prescriber or practice,” she said.
Exceptions for long-acting contraceptives?
Advisory committee member Abbey B. Berenson, MD, PhD, professor of obstetrics and gynecology at University of Texas Medical Branch in Galveston, said that patients taking long-acting reversible contraceptives (LARCs) may need to be considered differently when deciding the intervals for attestation or whether to have a lockout period.
“LARC methods’ rate of failure is extremely low,” she said. “While it is true, as it has been pointed out, that all methods can fail, when they’re over 99% effective, I think that we can treat those methods differently than we treat methods such as birth control pills or abstinence that fail far more often. That is one way we could minimize burden on the providers and the patients.”
She also suggested using members of the health care team other than physicians to complete counseling, such as a nurse or pharmacist.
Prescriptions for emergency contraception
Advisory committee member Sascha Dublin, MD, PhD, senior scientific investigator for Kaiser Permanente Washington Health Research Institute in Seattle, said most patients taking the drug who can get pregnant should get a prescription for emergency contraception at the time of the first isotretinoin prescription.
“They don’t have to buy it, but to make it available at the very beginning sets the expectation that it would be good to have in your medicine cabinet, particularly if the [contraception] choice is abstinence or birth control pills.”
Dr. Dublin also called for better transparency surrounding the role of IPMG.
She said IPMG should be expected to collect data in a way that allows examination of health disparities, including by race and ethnicity and insurance status. Dr. Dublin added that she was concerned about the poor communication between dermatological societies and IPMG.
“The FDA should really require that IPMG hold periodic, regularly scheduled stakeholder forums,” she said. “There has to be a mechanism in place for IPMG to listen to those concerns in real time and respond.”
The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.
During 2 days of after the chaotic rollout of the new REMS platform at the end of 2021.
On March 29, at the end of the FDA’s joint meeting of two advisory committees that addressed ways to improve the iPLEDGE program, most panelists voted to change the 19-day lockout period for patients who can become pregnant, and the requirement that every month, providers must document counseling of those who cannot get pregnant and are taking the drug for acne.
However, there was no consensus on whether there should be a lockout at all or for how long, and what an appropriate interval for counseling those who cannot get pregnant would be, if not monthly. Those voting on the questions repeatedly cited a lack of data to make well-informed decisions.
The meeting of the two panels, the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, was held March 28-29, to discuss proposed changes to iPLEDGE requirements, to minimize the program’s burden on patients, prescribers, and pharmacies – while maintaining safe use of the highly teratogenic drug.
Lockout based on outdated reasoning
John S. Barbieri, MD, a dermatologist and epidemiologist, and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston, speaking as deputy chair of the American Academy of Dermatology Association (AADA) iPLEDGE work group, described the burden of getting the drug to patients. He was not on the panel, but spoke during the open public hearing.
“Compared to other acne medications, the time it takes to successfully go from prescribed (isotretinoin) to when the patient actually has it in their hands is 5- to 10-fold higher,” he said.
Among the barriers is the 19-day lockout period for people who can get pregnant and miss the 7-day window for picking up their prescriptions. They must then wait 19 days to get a pregnancy test to clear them for receiving the medication.
Gregory Wedin, PharmD, pharmacovigilance and risk management director of Upsher-Smith Laboratories, who spoke on behalf of the Isotretinoin Products Manufacturer Group (IPMG), which manages iPLEDGE, said, “The rationale for the 19-day wait is to ensure the next confirmatory pregnancy test is completed after the most fertile period of the menstrual cycle is passed.”
Many don’t have a monthly cycle
But Dr. Barbieri said that reasoning is outdated.
“The current program’s focus on the menstrual cycle is really an antiquated approach,” he said. “Many patients do not have a monthly cycle due to medical conditions like polycystic ovarian syndrome, or due to [certain kinds of] contraception.”
He added, “By removing this 19-day lockout and, really, the archaic timing around the menstrual cycle in general in this program, we can simplify the program, improve it, and better align it with the real-world biology of our patients.” He added that patients are often missing the 7-day window for picking up their prescriptions through no fault of their own. Speakers at the hearing also mentioned insurance hassles and ordering delays.
Communication with IPMG
Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and outgoing chair of the AADA iPLEDGE work group, cited difficulty in working with IPMG on modifications as another barrier. She also spoke during the open public hearing.
“Despite many, many attempts to work with the IPMG, we are not aware of any organizational structure or key leaders to communicate with. Instead we have been given repeatedly a generic email address for trying to establish a working relationship and we believe this may explain the inaction of the IPMG since our proposals 4 years ago in 2019.”
Among those proposals, she said, were allowing telemedicine visits as part of the iPLEDGE REMS program and reducing counseling attestation to every 6 months instead of monthly for those who cannot become pregnant.
She pointed to the chaotic rollout of modifications to the iPLEDGE program on a new website at the end of 2021.
In 2021, she said, “despite 6 months of notification, no prescriber input was solicited before revamping the website. This lack of transparency and accountability has been a major hurdle in improving iPLEDGE.”
Dr. Barbieri called the rollout “a debacle” that could have been mitigated with communication with IPMG. “We warned about every issue that happened and talked about ways to mitigate it and were largely ignored,” he said.
“By including dermatologists and key stakeholders in these discussions, as we move forward with changes to improve this program, we can make sure that it’s patient-centered.”
IPMG did not address the specific complaints about the working relationship with the AADA workgroup at the meeting.
Monthly attestation for counseling patients who cannot get pregnant
Dr. Barbieri said the monthly requirement to counsel patients who cannot get pregnant and document that counseling unfairly burdens clinicians and patients. “We’re essentially asking patients to come in monthly just to tell them not to share their drugs [or] donate blood,” he said.
Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among the panel members voting not to continue the 19-day lockout.
“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”
IPMG representative Dr. Wedin, said, “while we cannot support eliminating or extending the confirmation interval to a year, the [iPLEDGE] sponsors are agreeable [to] a 120-day confirmation interval.”
He said that while an extension to 120 days would reduce burden on prescribers, it comes with the risk in reducing oversight by a certified iPLEDGE prescriber and potentially increasing the risk for drug sharing.
“A patient may be more likely to share their drug with another person the further along with therapy they get as their condition improves,” Dr. Wedin said.
Home pregnancy testing
The advisory groups were also tasked with discussing whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most committee members and those in the public hearing who spoke on the issue agreed that home tests should continue in an effort to increase access and decrease burden.
During the pandemic, iPLEDGE rules have been relaxed from having a pregnancy test done only at a Clinical Laboratory Improvement Amendments–certified laboratory.
Lindsey Crist, PharmD, a risk management analyst at the FDA, who presented the FDA review committee’s analysis, said that the FDA’s review committee recommends ending the allowance of home tests, citing insufficient data on use and the discovery of instances of falsification of pregnancy tests.
“One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results,” Dr. Crist said.
Dr. Crist added, however, that the review committee recommends allowing the tests to be done in a provider’s office as an alternative.
Workaround to avoid falsification
Advisory committee member Brian P. Green, DO, associate professor of dermatology at Penn State University, Hershey, Pa., spoke in support of home pregnancy tests.
“What we have people do for telemedicine is take the stick, write their name, write the date on it, and send a picture of that the same day as their visit,” he said. “That way we have the pregnancy test the same day. Allowing this to continue to happen at home is important. Bringing people in is burdensome and costly.”
Emmy Graber, MD, a dermatologist who practices in Boston, and a director of the American Acne and Rosacea Society (AARS), relayed an example of the burden for a patient using isotretinoin who lives 1.5 hours away from the dermatology office. She is able to meet the requirements of iPLEDGE only through telehealth.
“Home pregnancy tests are highly sensitive, equal to the ones done in CLIA-certified labs, and highly accurate when interpreted by a dermatology provider,” said Dr. Graber, who spoke on behalf of the AARS during the open public hearing.
“Notably, CLIA [Clinical Laboratory Improvement Amendments] certification is not required by other REMS programs” for teratogenic drugs, she added.
Dr. Graber said it’s important to note that in the time the pandemic exceptions have been made for isotretinoin patients, “there has been no reported spike in pregnancy in the past three years.
“We do have some data to show that it is not imposing additional harms,” she said.
Suggestions for improvement
At the end of the hearing, advisory committee members were asked to propose improvements to the iPLEDGE REMS program.
Dr. Green advocated for the addition of an iPLEDGE mobile app.
“Most people go to their phones rather than their computers, particularly teenagers and younger people,” he noted.
Advisory committee member Megha M. Tollefson, MD, professor of dermatology and pediatric and adolescent medicine at Mayo Clinic in Rochester, Minn., echoed the need for an iPLEDGE app.
The young patients getting isotretinoin “don’t respond to email, they don’t necessarily go onto web pages. If we’re going to be as effective as possible, it’s going to have to be through an app-based system.”
Dr. Tollefson said she would like to see patient counseling standardized through the app. “I think there’s a lot of variability in what counseling is given when it’s left to the individual prescriber or practice,” she said.
Exceptions for long-acting contraceptives?
Advisory committee member Abbey B. Berenson, MD, PhD, professor of obstetrics and gynecology at University of Texas Medical Branch in Galveston, said that patients taking long-acting reversible contraceptives (LARCs) may need to be considered differently when deciding the intervals for attestation or whether to have a lockout period.
“LARC methods’ rate of failure is extremely low,” she said. “While it is true, as it has been pointed out, that all methods can fail, when they’re over 99% effective, I think that we can treat those methods differently than we treat methods such as birth control pills or abstinence that fail far more often. That is one way we could minimize burden on the providers and the patients.”
She also suggested using members of the health care team other than physicians to complete counseling, such as a nurse or pharmacist.
Prescriptions for emergency contraception
Advisory committee member Sascha Dublin, MD, PhD, senior scientific investigator for Kaiser Permanente Washington Health Research Institute in Seattle, said most patients taking the drug who can get pregnant should get a prescription for emergency contraception at the time of the first isotretinoin prescription.
“They don’t have to buy it, but to make it available at the very beginning sets the expectation that it would be good to have in your medicine cabinet, particularly if the [contraception] choice is abstinence or birth control pills.”
Dr. Dublin also called for better transparency surrounding the role of IPMG.
She said IPMG should be expected to collect data in a way that allows examination of health disparities, including by race and ethnicity and insurance status. Dr. Dublin added that she was concerned about the poor communication between dermatological societies and IPMG.
“The FDA should really require that IPMG hold periodic, regularly scheduled stakeholder forums,” she said. “There has to be a mechanism in place for IPMG to listen to those concerns in real time and respond.”
The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.
Premedical Student Interest in and Exposure to Dermatology at Howard University
Diversity of health care professionals improves medical outcomes and quality of life in patients. 1 There is a lack of diversity in dermatology, with only 4.2% of dermatologists identifying as Hispanic and 3% identifying as African American, 2 possibly due to a lack of early exposure to dermatology among high school and undergraduate students, a low number of underrepresented students in medical school, a lack of formal mentorship programs geared to underrepresented students, and implicit biases. 1-4 Furthermore, the field is competitive, with many more applicants than available positions. In 2022, there were 851 applicants competing for 492 residency positions in dermatology. 5 Thus, it is important to educate young students about dermatology and understand root causes as to why the number of u nderrepresented in medicine (UiM) dermatologists remains stagnant.
According to Pritchett et al,4 it is crucial for dermatologists to interact with high school and college students to foster an early interest in dermatology. Many racial minority students do not progress from high school to college and then from college to medical school, which leaves a substantially reduced number of eligible UiM applicants who can progress into dermatology.6 Increasing the amount of UiM students going to medical school requires early mediation. Collaborating with pre-existing premedical school organizations through presentations and workshops is another way to promote an early interest in dermatology.4 Special consideration should be given to students who are UiM.
Among the general medical school curriculum, requirements for exposure to dermatology are not high. In one study, the median number of clinical and preclinical hours required was 10. Furthermore, 20% of 33 medical schools did not require preclinical dermatology hours (hours done before medical school rotations begin and in an academic setting), 36% required no clinical hours (rotational hours), 8% required no dermatology hours whatsoever, and only 10% required clinical dermatology rotation.3 Based on these findings, it is clear that dermatology is not well incorporated into medical school curricula. Furthermore, curricula have historically neglected to display adequate representation of skin of color.7 As a result, medical students generally have limited exposure to dermatology3 and are exposed even less to presentations of dermatologic issues in historically marginalized populations.7
Given the paucity of research on UiM students’ perceptions of dermatology prior to medical school, our cross-sectional survey study sought to evaluate the level of interest in dermatology of UiM premedical undergraduates. This survey specifically evaluated exposure to dermatology, preconceived notions about the field, and mentorship opportunities. By understanding these factors, dermatologists and dermatology residency programs can use this information to create mentorship opportunities and better adjust existing programs to meet students’ needs.
Methods
A 19-question multiple-choice survey was administered electronically (SurveyMonkey) in May 2020 to premedical students at Howard University (Washington, DC). One screening question was used: “What is your major?” Those who considered themselves a science major and/or with premedical interest were allowed to complete the survey. All students surveyed were members of the Health Professions Society at Howard University. Students who were interested in pursuing medical school were invited to respond. Approval for this study was obtained from the Howard University institutional review board (FWA00000891).
The survey was divided into 3 sections: Demographics, Exposure to Medicine and Dermatology, and Perceptions of Dermatology. The Demographics section addressed gender, age, and race/ethnicity. The Exposure to Medicine and Dermatology section addressed interest in attending medical school, shadowing experience, exposure to dermatology, and mentoring. The Perceptions of Dermatology section addressed preconceived notions about the field (eg, “dermatology is interesting and exciting”).
Statistical Analysis—The data represented are percentages based on the number of respondents who answered each question. Answers in response to “Please enter any comments” were organized into themes, and the number of respondents who discussed each theme was quantified into a table.
Results
A total of 271 survey invitations were sent to premedical students at Howard University. Students were informed of the study protocol and asked to consent before proceeding to have their responses anonymously collected. Based on the screening question, 152 participants qualified for the survey, and 152 participants completed it (response rate, 56%; completion rate, 100%). Participants were asked to complete the survey only once.
Demographics—Eighty-four percent of respondents identified as science majors, and the remaining 16% identified as nonscience premedical. Ninety-four percent of participants identified as Black or African American; 3% as Asian or Asian American; and the remaining 3% as Other. Most respondents were female (82%), 16% were male, and 2% were either nonbinary or preferred not to answer. Ninety-nine percent were aged 18 to 24 years, and 1% were aged 25 to 34 years (Table 1).
Exposure to Medicine and Dermatology—Ninety-three percent of participants planned on attending medical school, and most students developed an interest in medicine from an early age. Ninety-six percent cited that they became interested in medicine prior to beginning their undergraduate education, and 4% developed an interest as freshmen or sophomores. When asked what led to their interest in medicine, family influence had the single greatest impact on students’ decision to pursue medicine (33%). Classes/school were the second most influential factor (24%), followed by volunteering (15%), shadowing (13%), other (7%), and peer influence (3%)(Figure 1).
Many (56%) premedical students surveyed had shadowing experience to varying degrees. Approximately 18% had fewer than 8 hours of shadowing experience, 24% had 8 to 40 hours, and 14% had more than 40 hours. However, many (43%) premedical students had no shadowing experience (Figure 2). Similarly, 30% of premedical students responded to having a physician as a mentor.
Regarding exposure to dermatology, 42% of premedical students had none. However, 58% of students had exposure to dermatology by being a patient themselves, 40% through seeing a dermatologist with a family member, 21% through seeing a dermatologist on television or social media, 5% through shadowing or volunteering, 3% through mentorship, and 1% through dermatology research (Figure 3).
Of students who said they were interested in dermatology (32%), 16% developed their interest before undergraduate education, while 9% developed interest in their freshman or sophomore year and 7% in their junior or senior year of undergraduate education. Three percent of respondents indicated that they had a dermatology mentorship.
Perceptions of Dermatology—To further evaluate the level of interest that UiM premedical students have in the field of dermatology, students were asked how much they agree or disagree on whether the field of dermatology is interesting. Sixty-three percent of the students agreed that the field of dermatology is interesting, 34% remained uncertain, and 3% disagreed. Additionally, students were asked whether they would consider dermatology as a career; 54% of respondents would consider dermatology as a career, 30% remained uncertain, and 16% would not consider dermatology as a career choice.
Nearly all (95%) students agreed that dermatologists do valuable work that goes beyond the scope of cosmetic procedures such as neuromodulators, fillers, chemical peels, and lasers. Some students also noted they had personal experiences interacting with a dermatologist. For example, one student described visiting the dermatologist many times to get a treatment regimen for their eczema.
Overall themes from the survey are depicted in Table 2. Major themes found in the comments included the desire for more dermatology-related opportunities, mentorship, exposure, connections, and a discussion of disparities faced by Black patients and students within dermatology. Students also expressed an interest in dermatology and the desire to learn more about the specialty.
Comment
Interest in Dermatology—In this cross-sectional survey study of 152 UiM undergraduate students, it was found that many students were interested in dermatology as a career, and more than 70% would be interested in attending events that increased exposure to the field of dermatology. Of the students who had any exposure to dermatology, less than 5% had shadowed an actual dermatologist. The survey showed that there is great potential interest in exposing UiM undergraduate students to the field of dermatology. We found that UiM students are interested in learning more about dermatology, with 80% indicating that they would be willing to participate in dermatology-focused events if they were available. Overall, students mentioned a lack of opportunities, mentorship, exposure, and connections in dermatology despite their interest in the field.
Racial Disparities in Dermatology—Additionally, students discussed disparities they encountered with dermatology due to a lack of patient-provider race concordance and the perceived difference in care when encountering a race-concordant dermatologist. One student noted that they went to multiple White dermatologists for their eczema, and “it wasn’t until I was evaluated by a Black dermatologist (diagnosed with eczema as well) [that I was] prescribed . . . the perfect medication.” Another student noted how a Black dermatologist sparked their interest in getting to know more about the field and remarked that they “think it is an important field that lacks representation for Black people.” This research stresses the need for more dermatology mentorship among UiM undergraduates.
Family Influence on Career Selection—The majority of UiM students in our study became interested in medicine because of family, which is consistent with other studies. In a cross-sectional survey of 300 Pakistani students (150 medical and 150 nonmedical), 87% of students stated that their family had an influence on their career selection.8 In another study of 15 junior doctors in Sierra Leone, the most common reasons for pursuing medicine were the desire to help and familial and peer influence.9 This again showcases how family can have a positive impact on career selection for medical professionals and highlights the need for early intervention.
Shadowing—One way in which student exposure to dermatology can be effectively increased is by shadowing. In a study evaluating a 30-week shadowing program at the Pediatric Continuity Clinic in Los Angeles, California, a greater proportion of premedical students believed they had a good understanding of the job of a resident physician after the program’s completion compared to before starting the program (an increase from 78% to 100%).10 The proportion of students reporting a good understanding of the patient-physician relationship after completing the program also increased from 33% to 78%. Furthermore, 72% of the residents stated that having the undergraduates in the clinic was a positive experience.10 Thus, increasing shadowing opportunities is one extremely effective way to increase student knowledge and awareness of and exposure to dermatology.
Dermatology Mentors—Although 32% of students were interested in dermatology, 3% of students had mentorship in dermatology. In prior studies, it has been shown that mentorship is of great importance in student success and interest in pursuing a specialty. A report from the Association of American Medical Colleges 2019 Medical School Graduation Questionnaire found that the third most influential factor (52.1%) in specialty selection was role model influence.11 In fact, having a role model is consistently one of the top 3 influences on student specialty choice and interest in the last 5 years of survey research. Some studies also have shown mentorship as a positive influence in specialty interest at the undergraduate and graduate levels. A study on an undergraduate student interest group noted that surgeon mentorship and exposure were positive factors to students’ interests in surgery.12 In fact, the Association of American Medical Colleges noted that some surgical specialties, such as orthopedic surgery, had 45% of respondents who were interested in the specialty before medical school pursue their initial preference in medical school.13 Another survey corroborated these findings; more orthopedic-bound students compared with other specialties indicated they were more likely to pursue their field because of experiences prior to medical school.14
One of the reasons students might not have been exposed to as many opportunities for mentorship in dermatology is because the specialty is one of the smaller fields in medicine and tends to be concentrated in more well-resourced metropolitan areas.15 Dermatologists make up only 1.3% of the physician workforce.16 Because there might not be as much exposure to the field, students might also explore their interests in dermatology through other fields, such as through shadowing and observing primary care physicians who often treat patients with dermatologic issues. Skin diseases are a common reason for primary care visits, and one study suggested dermatologic diseases can make up approximately 8.4% of visits in primary care.17
Moreover, only 1% of medical schools require an elective in dermatology.18 With exposure being a crucial component to pursuing the specialty, it also is important to pursue formal mentorship within the specialty itself. One study noted that formal mentorship in dermatology was important for most (67%) respondents when considering the specialty; however, 39% of respondents mentioned receiving mentorship in the past. In fact, dermatology was one of the top 3 specialties for which respondents agreed that formal mentorship was important.19
Mentorship also has been shown to provide students with a variety of opportunities to develop personally and professionally. Some of these opportunities include increased confidence in their personal and professional success, increased desire to pursue a career in a field of interest, networking opportunities, career coaching, and support and research guidance.20 A research study among medical students at Albert Einstein College of Medicine in New York, New York, found that US Medical Licensing Examination Step 1 scores, clinical grades, and the chance of not matching were important factors preventing them from applying to dermatology.21
Factors in Dermatology Residency Selection—A survey was conducted wherein 95 of 114 dermatology program directors expressed that among the top 5 criteria for dermatology resident selection were Step 1 scores and clinical grades, supporting the notion that academic factors were given a great emphasis during residency selection.22 Furthermore, among underrepresented minority medical students, a lack of diversity, the belief that minority students are seen negatively by residencies, socioeconomic factors, and not having mentors were major reasons for being dissuaded from applying to dermatology.21 These results showcase the heightened importance of mentors for underrepresented minority medical students in particular.
In graduate medical education, resources such as wikis, social networking sites, and blogs provide media through which trainees can communicate, exchange ideas, and enhance their medical knowledge.23,24 A survey of 9606 osteopathic medical students showed that 35% of 992 respondents had used social media to learn more about residencies, and 10% believed that social media had influenced their choice of residency.25 Given the impact social media has on recruitment, it also can be employed in a similar manner by dermatologists and dermatology residency programs to attract younger students to the field.
Access to More Opportunities to Learn About Dermatology—Besides shadowing and mentorship, other avenues of exposure to dermatology are possible and should be considered. In our study, 80% of students agreed that they would attend an event that increases exposure to dermatology if held by the premedical group, which suggests that students are eager to learn more about the field and want access to more opportunities, which could include learning procedures such as suturing or how to use a dermatoscope, attending guest speaker events, or participating in Learn2Derm volunteer events.
Learn2Derm was a skin cancer prevention fair first organized by medical students at George Washington University in Washington, DC. Students and residents sought to deliver sunscreens to underserved areas in Washington, DC, as well as teach residents about the importance of skin health. Participating in such events could be an excellent opportunity for all students to gain exposure to important topics in dermatology.26
General Opinions of Dermatology—General opinions about dermatology and medicine were collected from the students through the optional “Additional Comments” section. Major themes found in the comments included the desire for more opportunities, mentorship, exposure, connections, and a discussion of disparities faced by Black patients/students within dermatology. Students also expressed an interest in dermatology and the desire to learn more about the specialty. From these themes, it can be gleaned that students are open to and eager for more opportunities to gain exposure and connections, and increasing the number of minority dermatologists is of importance.
Limitations—An important limitation of this study was the potential for selection bias, as the sample was chosen from a population at one university, which is not representative of the general population. Further, we only sampled students who were premedical and likely from a UiM racial group due to the demographics of the student population at the university, but given that the goal of the survey was to understand exposure to dermatology in underrepresented groups, we believe it was the appropriate population to target. Additionally, results were not compared with other more represented racial groups to see if these findings were unique to UiM undergraduate students.
Conclusion
Among premedical students, dermatology is an area of great interest with minimal opportunities available for exposure and learning because it is a smaller specialty with fewer experiences available for shadowing and mentorship. Although most UiM premedical students who were surveyed were exposed to the field through either the media or being a dermatology patient, fewer were exposed to the field through clinical experiences (such as shadowing) or mentorship. Most respondents found dermatology to be interesting and have considered pursuing it as a career. In particular, race-concordant mentoring in dermatologic care was valued by many students in garnering their interest in the field.
Most UiM students wanted more exposure to dermatology-related opportunities as well as mentorship and connections. Increasing shadowing, research, pipeline programs, and general events geared to dermatology are some modalities that could help improve exposure to dermatology for UiM students, especially for those interested in pursuing the field. This increased exposure can help positively influence more UiM students to pursue dermatology and help close the diversity gap in the field. Additionally, many were interested in attending potential dermatology informational events.
Given the fact that dermatology is a small field and mentorship may be hard to access, increasing informational events may be a more reasonable approach to inspiring and supporting interest. These events could include learning how to use certain tools and techniques, guest speaker events, or participating in educational volunteer efforts such as Learn2Derm.26
Future research should focus on identifying beneficial factors of UiM premedical students who retain an interest in dermatology throughout their careers and actually apply to dermatology programs and become dermatologists. Those who do not apply to the specialty can be identified to understand potential dissuading factors and obstacles. Ultimately, more research and development of exposure opportunities, including mentorship programs and informational events, can be used to close the gap and improve diversity and health outcomes in dermatology.
- Pandya AG, Alexis AF, Berger TG, et al. Increasing racial and ethnic diversity in dermatology: a call to action. J Am Acad Dermatol. 2016;74:584-587.
- Bae G, Qiu M, Reese E, et al. Changes in sex and ethnic diversity in dermatology residents over multiple decades. JAMA Dermatol. 2016;152:92-94.
- McCleskey PE, Gilson RT, DeVillez RL. Medical student core curriculum in dermatology survey. J Am Acad Dermatol. 2009;61:30-35.e4.
- Pritchett EN, Pandya AG, Ferguson NN, et al. Diversity in dermatology: roadmap for improvement. J Am Acad Dermatol. 2018;79:337-341.
- National Resident Matching Program. Results and Data: 2022 Main Residency Match. National Resident Matching Program; 2022. Accessed March 19, 2023. https://www.nrmp.org/wp-content/uploads/2022/11/2022-Main-Match-Results-and-Data-Final-Revised.pdf
- 6. Akhiyat S, Cardwell L, Sokumbi O. Why dermatology is the second least diverse specialty in medicine: how did we get here? Clin Dermatol. 2020;38:310-315.
- Perlman KL, Williams NM, Egbeto IA, et al. Skin of color lacks representation in medical student resources: a cross-sectional study. Int J Womens Dermatol. 2021;7:195-196.
- Saad SM, Fatima SS, Faruqi AA. Students’ views regarding selecting medicine as a profession. J Pak Med Assoc. 2011;61:832-836.
- Woodward A, Thomas S, Jalloh M, et al. Reasons to pursue a career in medicine: a qualitative study in Sierra Leone. Global Health Res Policy. 2017;2:34.
- Thang C, Barnette NM, Patel KS, et al. Association of shadowing program for undergraduate premedical students with improvements in understanding medical education and training. Cureus. 2019;11:E6396.
- Murphy B. The 11 factors that influence med student specialty choice. American Medical Association. December 1, 2020. Accessed March 14, 2023. https://www.ama-assn.org/residents-students/specialty-profiles/11-factors-influence-med-student-specialty-choice
- Vakayil V, Chandrashekar M, Hedberg J, et al. An undergraduate surgery interest group: introducing premedical students to the practice of surgery. Adv Med Educ Pract. 2020;13:339-349.
- 2021 Report on Residents Executive Summary. Association of American Medical Colleges; 2021. Accessed March 14, 2023. https://www.aamc.org/data-reports/students-residents/data/report-residents/2021/executive-summary
- Johnson AL, Sharma J, Chinchilli VM, et al. Why do medical students choose orthopaedics as a career? J Bone Joint Surg Am. 2012;94:e78.
- Feng H, Berk-Krauss J, Feng PW, et al. Comparison of dermatologist density between urban and rural counties in the United States. JAMA Dermatol. 2018;154:1265-1271.
- Active Physicians With a U.S. Doctor of Medicine (U.S. MD) Degree by Specialty, 2019. Association of American Medical Colleges; 2019. Accessed March 14, 2023. https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2019
- Rübsam ML, Esch M, Baum E, et al. Diagnosing skin disease in primary care: a qualitative study of GPs’ approaches. Fam Pract. 2015;32:591-595.
- Cahn BA, Harper HE, Halverstam CP, et al. Current status of dermatologic education in US medical schools. JAMA Dermatol. 2020;156:468-470.
- Mylona E, Brubaker L, Williams VN, et al. Does formal mentoring for faculty members matter? a survey of clinical faculty members. Med Educ. 2016;50:670-681.
- Ratnapalan S. Mentoring in medicine. Can Fam Physician. 2010;56:198.
- Soliman YS, Rzepecki AK, Guzman AK, et al. Understanding perceived barriers of minority medical students pursuing a career in dermatology. JAMA Dermatol. 2019;155:252-254.
- Gorouhi F, Alikhan A, Rezaei A, et al. Dermatology residency selection criteria with an emphasis on program characteristics: a national program director survey. Dermatol Res Pract. 2014;2014:692760.
- Choo EK, Ranney ML, Chan TM, et al. Twitter as a tool for communication and knowledge exchange in academic medicine: a guide for skeptics and novices. Med Teach. 2015;37:411-416.
- McGowan BS, Wasko M, Vartabedian BS, et al. Understanding the factors that influence the adoption and meaningful use of social media by physicians to share medical information. J Med Internet Res. 2012;14:e117.
- Schweitzer J, Hannan A, Coren J. The role of social networking web sites in influencing residency decisions. J Am Osteopath Assoc. 2012;112:673-679.
- Medical students lead event addressing disparity in skin cancer morbidity and mortality. Dermatology News. August 19, 2021. Accessed March 14, 2023. https://www.mdedge.com/dermatology/article/244488/diversity-medicine/medical-students-lead-event-addressing-disparity-skin
Diversity of health care professionals improves medical outcomes and quality of life in patients. 1 There is a lack of diversity in dermatology, with only 4.2% of dermatologists identifying as Hispanic and 3% identifying as African American, 2 possibly due to a lack of early exposure to dermatology among high school and undergraduate students, a low number of underrepresented students in medical school, a lack of formal mentorship programs geared to underrepresented students, and implicit biases. 1-4 Furthermore, the field is competitive, with many more applicants than available positions. In 2022, there were 851 applicants competing for 492 residency positions in dermatology. 5 Thus, it is important to educate young students about dermatology and understand root causes as to why the number of u nderrepresented in medicine (UiM) dermatologists remains stagnant.
According to Pritchett et al,4 it is crucial for dermatologists to interact with high school and college students to foster an early interest in dermatology. Many racial minority students do not progress from high school to college and then from college to medical school, which leaves a substantially reduced number of eligible UiM applicants who can progress into dermatology.6 Increasing the amount of UiM students going to medical school requires early mediation. Collaborating with pre-existing premedical school organizations through presentations and workshops is another way to promote an early interest in dermatology.4 Special consideration should be given to students who are UiM.
Among the general medical school curriculum, requirements for exposure to dermatology are not high. In one study, the median number of clinical and preclinical hours required was 10. Furthermore, 20% of 33 medical schools did not require preclinical dermatology hours (hours done before medical school rotations begin and in an academic setting), 36% required no clinical hours (rotational hours), 8% required no dermatology hours whatsoever, and only 10% required clinical dermatology rotation.3 Based on these findings, it is clear that dermatology is not well incorporated into medical school curricula. Furthermore, curricula have historically neglected to display adequate representation of skin of color.7 As a result, medical students generally have limited exposure to dermatology3 and are exposed even less to presentations of dermatologic issues in historically marginalized populations.7
Given the paucity of research on UiM students’ perceptions of dermatology prior to medical school, our cross-sectional survey study sought to evaluate the level of interest in dermatology of UiM premedical undergraduates. This survey specifically evaluated exposure to dermatology, preconceived notions about the field, and mentorship opportunities. By understanding these factors, dermatologists and dermatology residency programs can use this information to create mentorship opportunities and better adjust existing programs to meet students’ needs.
Methods
A 19-question multiple-choice survey was administered electronically (SurveyMonkey) in May 2020 to premedical students at Howard University (Washington, DC). One screening question was used: “What is your major?” Those who considered themselves a science major and/or with premedical interest were allowed to complete the survey. All students surveyed were members of the Health Professions Society at Howard University. Students who were interested in pursuing medical school were invited to respond. Approval for this study was obtained from the Howard University institutional review board (FWA00000891).
The survey was divided into 3 sections: Demographics, Exposure to Medicine and Dermatology, and Perceptions of Dermatology. The Demographics section addressed gender, age, and race/ethnicity. The Exposure to Medicine and Dermatology section addressed interest in attending medical school, shadowing experience, exposure to dermatology, and mentoring. The Perceptions of Dermatology section addressed preconceived notions about the field (eg, “dermatology is interesting and exciting”).
Statistical Analysis—The data represented are percentages based on the number of respondents who answered each question. Answers in response to “Please enter any comments” were organized into themes, and the number of respondents who discussed each theme was quantified into a table.
Results
A total of 271 survey invitations were sent to premedical students at Howard University. Students were informed of the study protocol and asked to consent before proceeding to have their responses anonymously collected. Based on the screening question, 152 participants qualified for the survey, and 152 participants completed it (response rate, 56%; completion rate, 100%). Participants were asked to complete the survey only once.
Demographics—Eighty-four percent of respondents identified as science majors, and the remaining 16% identified as nonscience premedical. Ninety-four percent of participants identified as Black or African American; 3% as Asian or Asian American; and the remaining 3% as Other. Most respondents were female (82%), 16% were male, and 2% were either nonbinary or preferred not to answer. Ninety-nine percent were aged 18 to 24 years, and 1% were aged 25 to 34 years (Table 1).
Exposure to Medicine and Dermatology—Ninety-three percent of participants planned on attending medical school, and most students developed an interest in medicine from an early age. Ninety-six percent cited that they became interested in medicine prior to beginning their undergraduate education, and 4% developed an interest as freshmen or sophomores. When asked what led to their interest in medicine, family influence had the single greatest impact on students’ decision to pursue medicine (33%). Classes/school were the second most influential factor (24%), followed by volunteering (15%), shadowing (13%), other (7%), and peer influence (3%)(Figure 1).
Many (56%) premedical students surveyed had shadowing experience to varying degrees. Approximately 18% had fewer than 8 hours of shadowing experience, 24% had 8 to 40 hours, and 14% had more than 40 hours. However, many (43%) premedical students had no shadowing experience (Figure 2). Similarly, 30% of premedical students responded to having a physician as a mentor.
Regarding exposure to dermatology, 42% of premedical students had none. However, 58% of students had exposure to dermatology by being a patient themselves, 40% through seeing a dermatologist with a family member, 21% through seeing a dermatologist on television or social media, 5% through shadowing or volunteering, 3% through mentorship, and 1% through dermatology research (Figure 3).
Of students who said they were interested in dermatology (32%), 16% developed their interest before undergraduate education, while 9% developed interest in their freshman or sophomore year and 7% in their junior or senior year of undergraduate education. Three percent of respondents indicated that they had a dermatology mentorship.
Perceptions of Dermatology—To further evaluate the level of interest that UiM premedical students have in the field of dermatology, students were asked how much they agree or disagree on whether the field of dermatology is interesting. Sixty-three percent of the students agreed that the field of dermatology is interesting, 34% remained uncertain, and 3% disagreed. Additionally, students were asked whether they would consider dermatology as a career; 54% of respondents would consider dermatology as a career, 30% remained uncertain, and 16% would not consider dermatology as a career choice.
Nearly all (95%) students agreed that dermatologists do valuable work that goes beyond the scope of cosmetic procedures such as neuromodulators, fillers, chemical peels, and lasers. Some students also noted they had personal experiences interacting with a dermatologist. For example, one student described visiting the dermatologist many times to get a treatment regimen for their eczema.
Overall themes from the survey are depicted in Table 2. Major themes found in the comments included the desire for more dermatology-related opportunities, mentorship, exposure, connections, and a discussion of disparities faced by Black patients and students within dermatology. Students also expressed an interest in dermatology and the desire to learn more about the specialty.
Comment
Interest in Dermatology—In this cross-sectional survey study of 152 UiM undergraduate students, it was found that many students were interested in dermatology as a career, and more than 70% would be interested in attending events that increased exposure to the field of dermatology. Of the students who had any exposure to dermatology, less than 5% had shadowed an actual dermatologist. The survey showed that there is great potential interest in exposing UiM undergraduate students to the field of dermatology. We found that UiM students are interested in learning more about dermatology, with 80% indicating that they would be willing to participate in dermatology-focused events if they were available. Overall, students mentioned a lack of opportunities, mentorship, exposure, and connections in dermatology despite their interest in the field.
Racial Disparities in Dermatology—Additionally, students discussed disparities they encountered with dermatology due to a lack of patient-provider race concordance and the perceived difference in care when encountering a race-concordant dermatologist. One student noted that they went to multiple White dermatologists for their eczema, and “it wasn’t until I was evaluated by a Black dermatologist (diagnosed with eczema as well) [that I was] prescribed . . . the perfect medication.” Another student noted how a Black dermatologist sparked their interest in getting to know more about the field and remarked that they “think it is an important field that lacks representation for Black people.” This research stresses the need for more dermatology mentorship among UiM undergraduates.
Family Influence on Career Selection—The majority of UiM students in our study became interested in medicine because of family, which is consistent with other studies. In a cross-sectional survey of 300 Pakistani students (150 medical and 150 nonmedical), 87% of students stated that their family had an influence on their career selection.8 In another study of 15 junior doctors in Sierra Leone, the most common reasons for pursuing medicine were the desire to help and familial and peer influence.9 This again showcases how family can have a positive impact on career selection for medical professionals and highlights the need for early intervention.
Shadowing—One way in which student exposure to dermatology can be effectively increased is by shadowing. In a study evaluating a 30-week shadowing program at the Pediatric Continuity Clinic in Los Angeles, California, a greater proportion of premedical students believed they had a good understanding of the job of a resident physician after the program’s completion compared to before starting the program (an increase from 78% to 100%).10 The proportion of students reporting a good understanding of the patient-physician relationship after completing the program also increased from 33% to 78%. Furthermore, 72% of the residents stated that having the undergraduates in the clinic was a positive experience.10 Thus, increasing shadowing opportunities is one extremely effective way to increase student knowledge and awareness of and exposure to dermatology.
Dermatology Mentors—Although 32% of students were interested in dermatology, 3% of students had mentorship in dermatology. In prior studies, it has been shown that mentorship is of great importance in student success and interest in pursuing a specialty. A report from the Association of American Medical Colleges 2019 Medical School Graduation Questionnaire found that the third most influential factor (52.1%) in specialty selection was role model influence.11 In fact, having a role model is consistently one of the top 3 influences on student specialty choice and interest in the last 5 years of survey research. Some studies also have shown mentorship as a positive influence in specialty interest at the undergraduate and graduate levels. A study on an undergraduate student interest group noted that surgeon mentorship and exposure were positive factors to students’ interests in surgery.12 In fact, the Association of American Medical Colleges noted that some surgical specialties, such as orthopedic surgery, had 45% of respondents who were interested in the specialty before medical school pursue their initial preference in medical school.13 Another survey corroborated these findings; more orthopedic-bound students compared with other specialties indicated they were more likely to pursue their field because of experiences prior to medical school.14
One of the reasons students might not have been exposed to as many opportunities for mentorship in dermatology is because the specialty is one of the smaller fields in medicine and tends to be concentrated in more well-resourced metropolitan areas.15 Dermatologists make up only 1.3% of the physician workforce.16 Because there might not be as much exposure to the field, students might also explore their interests in dermatology through other fields, such as through shadowing and observing primary care physicians who often treat patients with dermatologic issues. Skin diseases are a common reason for primary care visits, and one study suggested dermatologic diseases can make up approximately 8.4% of visits in primary care.17
Moreover, only 1% of medical schools require an elective in dermatology.18 With exposure being a crucial component to pursuing the specialty, it also is important to pursue formal mentorship within the specialty itself. One study noted that formal mentorship in dermatology was important for most (67%) respondents when considering the specialty; however, 39% of respondents mentioned receiving mentorship in the past. In fact, dermatology was one of the top 3 specialties for which respondents agreed that formal mentorship was important.19
Mentorship also has been shown to provide students with a variety of opportunities to develop personally and professionally. Some of these opportunities include increased confidence in their personal and professional success, increased desire to pursue a career in a field of interest, networking opportunities, career coaching, and support and research guidance.20 A research study among medical students at Albert Einstein College of Medicine in New York, New York, found that US Medical Licensing Examination Step 1 scores, clinical grades, and the chance of not matching were important factors preventing them from applying to dermatology.21
Factors in Dermatology Residency Selection—A survey was conducted wherein 95 of 114 dermatology program directors expressed that among the top 5 criteria for dermatology resident selection were Step 1 scores and clinical grades, supporting the notion that academic factors were given a great emphasis during residency selection.22 Furthermore, among underrepresented minority medical students, a lack of diversity, the belief that minority students are seen negatively by residencies, socioeconomic factors, and not having mentors were major reasons for being dissuaded from applying to dermatology.21 These results showcase the heightened importance of mentors for underrepresented minority medical students in particular.
In graduate medical education, resources such as wikis, social networking sites, and blogs provide media through which trainees can communicate, exchange ideas, and enhance their medical knowledge.23,24 A survey of 9606 osteopathic medical students showed that 35% of 992 respondents had used social media to learn more about residencies, and 10% believed that social media had influenced their choice of residency.25 Given the impact social media has on recruitment, it also can be employed in a similar manner by dermatologists and dermatology residency programs to attract younger students to the field.
Access to More Opportunities to Learn About Dermatology—Besides shadowing and mentorship, other avenues of exposure to dermatology are possible and should be considered. In our study, 80% of students agreed that they would attend an event that increases exposure to dermatology if held by the premedical group, which suggests that students are eager to learn more about the field and want access to more opportunities, which could include learning procedures such as suturing or how to use a dermatoscope, attending guest speaker events, or participating in Learn2Derm volunteer events.
Learn2Derm was a skin cancer prevention fair first organized by medical students at George Washington University in Washington, DC. Students and residents sought to deliver sunscreens to underserved areas in Washington, DC, as well as teach residents about the importance of skin health. Participating in such events could be an excellent opportunity for all students to gain exposure to important topics in dermatology.26
General Opinions of Dermatology—General opinions about dermatology and medicine were collected from the students through the optional “Additional Comments” section. Major themes found in the comments included the desire for more opportunities, mentorship, exposure, connections, and a discussion of disparities faced by Black patients/students within dermatology. Students also expressed an interest in dermatology and the desire to learn more about the specialty. From these themes, it can be gleaned that students are open to and eager for more opportunities to gain exposure and connections, and increasing the number of minority dermatologists is of importance.
Limitations—An important limitation of this study was the potential for selection bias, as the sample was chosen from a population at one university, which is not representative of the general population. Further, we only sampled students who were premedical and likely from a UiM racial group due to the demographics of the student population at the university, but given that the goal of the survey was to understand exposure to dermatology in underrepresented groups, we believe it was the appropriate population to target. Additionally, results were not compared with other more represented racial groups to see if these findings were unique to UiM undergraduate students.
Conclusion
Among premedical students, dermatology is an area of great interest with minimal opportunities available for exposure and learning because it is a smaller specialty with fewer experiences available for shadowing and mentorship. Although most UiM premedical students who were surveyed were exposed to the field through either the media or being a dermatology patient, fewer were exposed to the field through clinical experiences (such as shadowing) or mentorship. Most respondents found dermatology to be interesting and have considered pursuing it as a career. In particular, race-concordant mentoring in dermatologic care was valued by many students in garnering their interest in the field.
Most UiM students wanted more exposure to dermatology-related opportunities as well as mentorship and connections. Increasing shadowing, research, pipeline programs, and general events geared to dermatology are some modalities that could help improve exposure to dermatology for UiM students, especially for those interested in pursuing the field. This increased exposure can help positively influence more UiM students to pursue dermatology and help close the diversity gap in the field. Additionally, many were interested in attending potential dermatology informational events.
Given the fact that dermatology is a small field and mentorship may be hard to access, increasing informational events may be a more reasonable approach to inspiring and supporting interest. These events could include learning how to use certain tools and techniques, guest speaker events, or participating in educational volunteer efforts such as Learn2Derm.26
Future research should focus on identifying beneficial factors of UiM premedical students who retain an interest in dermatology throughout their careers and actually apply to dermatology programs and become dermatologists. Those who do not apply to the specialty can be identified to understand potential dissuading factors and obstacles. Ultimately, more research and development of exposure opportunities, including mentorship programs and informational events, can be used to close the gap and improve diversity and health outcomes in dermatology.
Diversity of health care professionals improves medical outcomes and quality of life in patients. 1 There is a lack of diversity in dermatology, with only 4.2% of dermatologists identifying as Hispanic and 3% identifying as African American, 2 possibly due to a lack of early exposure to dermatology among high school and undergraduate students, a low number of underrepresented students in medical school, a lack of formal mentorship programs geared to underrepresented students, and implicit biases. 1-4 Furthermore, the field is competitive, with many more applicants than available positions. In 2022, there were 851 applicants competing for 492 residency positions in dermatology. 5 Thus, it is important to educate young students about dermatology and understand root causes as to why the number of u nderrepresented in medicine (UiM) dermatologists remains stagnant.
According to Pritchett et al,4 it is crucial for dermatologists to interact with high school and college students to foster an early interest in dermatology. Many racial minority students do not progress from high school to college and then from college to medical school, which leaves a substantially reduced number of eligible UiM applicants who can progress into dermatology.6 Increasing the amount of UiM students going to medical school requires early mediation. Collaborating with pre-existing premedical school organizations through presentations and workshops is another way to promote an early interest in dermatology.4 Special consideration should be given to students who are UiM.
Among the general medical school curriculum, requirements for exposure to dermatology are not high. In one study, the median number of clinical and preclinical hours required was 10. Furthermore, 20% of 33 medical schools did not require preclinical dermatology hours (hours done before medical school rotations begin and in an academic setting), 36% required no clinical hours (rotational hours), 8% required no dermatology hours whatsoever, and only 10% required clinical dermatology rotation.3 Based on these findings, it is clear that dermatology is not well incorporated into medical school curricula. Furthermore, curricula have historically neglected to display adequate representation of skin of color.7 As a result, medical students generally have limited exposure to dermatology3 and are exposed even less to presentations of dermatologic issues in historically marginalized populations.7
Given the paucity of research on UiM students’ perceptions of dermatology prior to medical school, our cross-sectional survey study sought to evaluate the level of interest in dermatology of UiM premedical undergraduates. This survey specifically evaluated exposure to dermatology, preconceived notions about the field, and mentorship opportunities. By understanding these factors, dermatologists and dermatology residency programs can use this information to create mentorship opportunities and better adjust existing programs to meet students’ needs.
Methods
A 19-question multiple-choice survey was administered electronically (SurveyMonkey) in May 2020 to premedical students at Howard University (Washington, DC). One screening question was used: “What is your major?” Those who considered themselves a science major and/or with premedical interest were allowed to complete the survey. All students surveyed were members of the Health Professions Society at Howard University. Students who were interested in pursuing medical school were invited to respond. Approval for this study was obtained from the Howard University institutional review board (FWA00000891).
The survey was divided into 3 sections: Demographics, Exposure to Medicine and Dermatology, and Perceptions of Dermatology. The Demographics section addressed gender, age, and race/ethnicity. The Exposure to Medicine and Dermatology section addressed interest in attending medical school, shadowing experience, exposure to dermatology, and mentoring. The Perceptions of Dermatology section addressed preconceived notions about the field (eg, “dermatology is interesting and exciting”).
Statistical Analysis—The data represented are percentages based on the number of respondents who answered each question. Answers in response to “Please enter any comments” were organized into themes, and the number of respondents who discussed each theme was quantified into a table.
Results
A total of 271 survey invitations were sent to premedical students at Howard University. Students were informed of the study protocol and asked to consent before proceeding to have their responses anonymously collected. Based on the screening question, 152 participants qualified for the survey, and 152 participants completed it (response rate, 56%; completion rate, 100%). Participants were asked to complete the survey only once.
Demographics—Eighty-four percent of respondents identified as science majors, and the remaining 16% identified as nonscience premedical. Ninety-four percent of participants identified as Black or African American; 3% as Asian or Asian American; and the remaining 3% as Other. Most respondents were female (82%), 16% were male, and 2% were either nonbinary or preferred not to answer. Ninety-nine percent were aged 18 to 24 years, and 1% were aged 25 to 34 years (Table 1).
Exposure to Medicine and Dermatology—Ninety-three percent of participants planned on attending medical school, and most students developed an interest in medicine from an early age. Ninety-six percent cited that they became interested in medicine prior to beginning their undergraduate education, and 4% developed an interest as freshmen or sophomores. When asked what led to their interest in medicine, family influence had the single greatest impact on students’ decision to pursue medicine (33%). Classes/school were the second most influential factor (24%), followed by volunteering (15%), shadowing (13%), other (7%), and peer influence (3%)(Figure 1).
Many (56%) premedical students surveyed had shadowing experience to varying degrees. Approximately 18% had fewer than 8 hours of shadowing experience, 24% had 8 to 40 hours, and 14% had more than 40 hours. However, many (43%) premedical students had no shadowing experience (Figure 2). Similarly, 30% of premedical students responded to having a physician as a mentor.
Regarding exposure to dermatology, 42% of premedical students had none. However, 58% of students had exposure to dermatology by being a patient themselves, 40% through seeing a dermatologist with a family member, 21% through seeing a dermatologist on television or social media, 5% through shadowing or volunteering, 3% through mentorship, and 1% through dermatology research (Figure 3).
Of students who said they were interested in dermatology (32%), 16% developed their interest before undergraduate education, while 9% developed interest in their freshman or sophomore year and 7% in their junior or senior year of undergraduate education. Three percent of respondents indicated that they had a dermatology mentorship.
Perceptions of Dermatology—To further evaluate the level of interest that UiM premedical students have in the field of dermatology, students were asked how much they agree or disagree on whether the field of dermatology is interesting. Sixty-three percent of the students agreed that the field of dermatology is interesting, 34% remained uncertain, and 3% disagreed. Additionally, students were asked whether they would consider dermatology as a career; 54% of respondents would consider dermatology as a career, 30% remained uncertain, and 16% would not consider dermatology as a career choice.
Nearly all (95%) students agreed that dermatologists do valuable work that goes beyond the scope of cosmetic procedures such as neuromodulators, fillers, chemical peels, and lasers. Some students also noted they had personal experiences interacting with a dermatologist. For example, one student described visiting the dermatologist many times to get a treatment regimen for their eczema.
Overall themes from the survey are depicted in Table 2. Major themes found in the comments included the desire for more dermatology-related opportunities, mentorship, exposure, connections, and a discussion of disparities faced by Black patients and students within dermatology. Students also expressed an interest in dermatology and the desire to learn more about the specialty.
Comment
Interest in Dermatology—In this cross-sectional survey study of 152 UiM undergraduate students, it was found that many students were interested in dermatology as a career, and more than 70% would be interested in attending events that increased exposure to the field of dermatology. Of the students who had any exposure to dermatology, less than 5% had shadowed an actual dermatologist. The survey showed that there is great potential interest in exposing UiM undergraduate students to the field of dermatology. We found that UiM students are interested in learning more about dermatology, with 80% indicating that they would be willing to participate in dermatology-focused events if they were available. Overall, students mentioned a lack of opportunities, mentorship, exposure, and connections in dermatology despite their interest in the field.
Racial Disparities in Dermatology—Additionally, students discussed disparities they encountered with dermatology due to a lack of patient-provider race concordance and the perceived difference in care when encountering a race-concordant dermatologist. One student noted that they went to multiple White dermatologists for their eczema, and “it wasn’t until I was evaluated by a Black dermatologist (diagnosed with eczema as well) [that I was] prescribed . . . the perfect medication.” Another student noted how a Black dermatologist sparked their interest in getting to know more about the field and remarked that they “think it is an important field that lacks representation for Black people.” This research stresses the need for more dermatology mentorship among UiM undergraduates.
Family Influence on Career Selection—The majority of UiM students in our study became interested in medicine because of family, which is consistent with other studies. In a cross-sectional survey of 300 Pakistani students (150 medical and 150 nonmedical), 87% of students stated that their family had an influence on their career selection.8 In another study of 15 junior doctors in Sierra Leone, the most common reasons for pursuing medicine were the desire to help and familial and peer influence.9 This again showcases how family can have a positive impact on career selection for medical professionals and highlights the need for early intervention.
Shadowing—One way in which student exposure to dermatology can be effectively increased is by shadowing. In a study evaluating a 30-week shadowing program at the Pediatric Continuity Clinic in Los Angeles, California, a greater proportion of premedical students believed they had a good understanding of the job of a resident physician after the program’s completion compared to before starting the program (an increase from 78% to 100%).10 The proportion of students reporting a good understanding of the patient-physician relationship after completing the program also increased from 33% to 78%. Furthermore, 72% of the residents stated that having the undergraduates in the clinic was a positive experience.10 Thus, increasing shadowing opportunities is one extremely effective way to increase student knowledge and awareness of and exposure to dermatology.
Dermatology Mentors—Although 32% of students were interested in dermatology, 3% of students had mentorship in dermatology. In prior studies, it has been shown that mentorship is of great importance in student success and interest in pursuing a specialty. A report from the Association of American Medical Colleges 2019 Medical School Graduation Questionnaire found that the third most influential factor (52.1%) in specialty selection was role model influence.11 In fact, having a role model is consistently one of the top 3 influences on student specialty choice and interest in the last 5 years of survey research. Some studies also have shown mentorship as a positive influence in specialty interest at the undergraduate and graduate levels. A study on an undergraduate student interest group noted that surgeon mentorship and exposure were positive factors to students’ interests in surgery.12 In fact, the Association of American Medical Colleges noted that some surgical specialties, such as orthopedic surgery, had 45% of respondents who were interested in the specialty before medical school pursue their initial preference in medical school.13 Another survey corroborated these findings; more orthopedic-bound students compared with other specialties indicated they were more likely to pursue their field because of experiences prior to medical school.14
One of the reasons students might not have been exposed to as many opportunities for mentorship in dermatology is because the specialty is one of the smaller fields in medicine and tends to be concentrated in more well-resourced metropolitan areas.15 Dermatologists make up only 1.3% of the physician workforce.16 Because there might not be as much exposure to the field, students might also explore their interests in dermatology through other fields, such as through shadowing and observing primary care physicians who often treat patients with dermatologic issues. Skin diseases are a common reason for primary care visits, and one study suggested dermatologic diseases can make up approximately 8.4% of visits in primary care.17
Moreover, only 1% of medical schools require an elective in dermatology.18 With exposure being a crucial component to pursuing the specialty, it also is important to pursue formal mentorship within the specialty itself. One study noted that formal mentorship in dermatology was important for most (67%) respondents when considering the specialty; however, 39% of respondents mentioned receiving mentorship in the past. In fact, dermatology was one of the top 3 specialties for which respondents agreed that formal mentorship was important.19
Mentorship also has been shown to provide students with a variety of opportunities to develop personally and professionally. Some of these opportunities include increased confidence in their personal and professional success, increased desire to pursue a career in a field of interest, networking opportunities, career coaching, and support and research guidance.20 A research study among medical students at Albert Einstein College of Medicine in New York, New York, found that US Medical Licensing Examination Step 1 scores, clinical grades, and the chance of not matching were important factors preventing them from applying to dermatology.21
Factors in Dermatology Residency Selection—A survey was conducted wherein 95 of 114 dermatology program directors expressed that among the top 5 criteria for dermatology resident selection were Step 1 scores and clinical grades, supporting the notion that academic factors were given a great emphasis during residency selection.22 Furthermore, among underrepresented minority medical students, a lack of diversity, the belief that minority students are seen negatively by residencies, socioeconomic factors, and not having mentors were major reasons for being dissuaded from applying to dermatology.21 These results showcase the heightened importance of mentors for underrepresented minority medical students in particular.
In graduate medical education, resources such as wikis, social networking sites, and blogs provide media through which trainees can communicate, exchange ideas, and enhance their medical knowledge.23,24 A survey of 9606 osteopathic medical students showed that 35% of 992 respondents had used social media to learn more about residencies, and 10% believed that social media had influenced their choice of residency.25 Given the impact social media has on recruitment, it also can be employed in a similar manner by dermatologists and dermatology residency programs to attract younger students to the field.
Access to More Opportunities to Learn About Dermatology—Besides shadowing and mentorship, other avenues of exposure to dermatology are possible and should be considered. In our study, 80% of students agreed that they would attend an event that increases exposure to dermatology if held by the premedical group, which suggests that students are eager to learn more about the field and want access to more opportunities, which could include learning procedures such as suturing or how to use a dermatoscope, attending guest speaker events, or participating in Learn2Derm volunteer events.
Learn2Derm was a skin cancer prevention fair first organized by medical students at George Washington University in Washington, DC. Students and residents sought to deliver sunscreens to underserved areas in Washington, DC, as well as teach residents about the importance of skin health. Participating in such events could be an excellent opportunity for all students to gain exposure to important topics in dermatology.26
General Opinions of Dermatology—General opinions about dermatology and medicine were collected from the students through the optional “Additional Comments” section. Major themes found in the comments included the desire for more opportunities, mentorship, exposure, connections, and a discussion of disparities faced by Black patients/students within dermatology. Students also expressed an interest in dermatology and the desire to learn more about the specialty. From these themes, it can be gleaned that students are open to and eager for more opportunities to gain exposure and connections, and increasing the number of minority dermatologists is of importance.
Limitations—An important limitation of this study was the potential for selection bias, as the sample was chosen from a population at one university, which is not representative of the general population. Further, we only sampled students who were premedical and likely from a UiM racial group due to the demographics of the student population at the university, but given that the goal of the survey was to understand exposure to dermatology in underrepresented groups, we believe it was the appropriate population to target. Additionally, results were not compared with other more represented racial groups to see if these findings were unique to UiM undergraduate students.
Conclusion
Among premedical students, dermatology is an area of great interest with minimal opportunities available for exposure and learning because it is a smaller specialty with fewer experiences available for shadowing and mentorship. Although most UiM premedical students who were surveyed were exposed to the field through either the media or being a dermatology patient, fewer were exposed to the field through clinical experiences (such as shadowing) or mentorship. Most respondents found dermatology to be interesting and have considered pursuing it as a career. In particular, race-concordant mentoring in dermatologic care was valued by many students in garnering their interest in the field.
Most UiM students wanted more exposure to dermatology-related opportunities as well as mentorship and connections. Increasing shadowing, research, pipeline programs, and general events geared to dermatology are some modalities that could help improve exposure to dermatology for UiM students, especially for those interested in pursuing the field. This increased exposure can help positively influence more UiM students to pursue dermatology and help close the diversity gap in the field. Additionally, many were interested in attending potential dermatology informational events.
Given the fact that dermatology is a small field and mentorship may be hard to access, increasing informational events may be a more reasonable approach to inspiring and supporting interest. These events could include learning how to use certain tools and techniques, guest speaker events, or participating in educational volunteer efforts such as Learn2Derm.26
Future research should focus on identifying beneficial factors of UiM premedical students who retain an interest in dermatology throughout their careers and actually apply to dermatology programs and become dermatologists. Those who do not apply to the specialty can be identified to understand potential dissuading factors and obstacles. Ultimately, more research and development of exposure opportunities, including mentorship programs and informational events, can be used to close the gap and improve diversity and health outcomes in dermatology.
- Pandya AG, Alexis AF, Berger TG, et al. Increasing racial and ethnic diversity in dermatology: a call to action. J Am Acad Dermatol. 2016;74:584-587.
- Bae G, Qiu M, Reese E, et al. Changes in sex and ethnic diversity in dermatology residents over multiple decades. JAMA Dermatol. 2016;152:92-94.
- McCleskey PE, Gilson RT, DeVillez RL. Medical student core curriculum in dermatology survey. J Am Acad Dermatol. 2009;61:30-35.e4.
- Pritchett EN, Pandya AG, Ferguson NN, et al. Diversity in dermatology: roadmap for improvement. J Am Acad Dermatol. 2018;79:337-341.
- National Resident Matching Program. Results and Data: 2022 Main Residency Match. National Resident Matching Program; 2022. Accessed March 19, 2023. https://www.nrmp.org/wp-content/uploads/2022/11/2022-Main-Match-Results-and-Data-Final-Revised.pdf
- 6. Akhiyat S, Cardwell L, Sokumbi O. Why dermatology is the second least diverse specialty in medicine: how did we get here? Clin Dermatol. 2020;38:310-315.
- Perlman KL, Williams NM, Egbeto IA, et al. Skin of color lacks representation in medical student resources: a cross-sectional study. Int J Womens Dermatol. 2021;7:195-196.
- Saad SM, Fatima SS, Faruqi AA. Students’ views regarding selecting medicine as a profession. J Pak Med Assoc. 2011;61:832-836.
- Woodward A, Thomas S, Jalloh M, et al. Reasons to pursue a career in medicine: a qualitative study in Sierra Leone. Global Health Res Policy. 2017;2:34.
- Thang C, Barnette NM, Patel KS, et al. Association of shadowing program for undergraduate premedical students with improvements in understanding medical education and training. Cureus. 2019;11:E6396.
- Murphy B. The 11 factors that influence med student specialty choice. American Medical Association. December 1, 2020. Accessed March 14, 2023. https://www.ama-assn.org/residents-students/specialty-profiles/11-factors-influence-med-student-specialty-choice
- Vakayil V, Chandrashekar M, Hedberg J, et al. An undergraduate surgery interest group: introducing premedical students to the practice of surgery. Adv Med Educ Pract. 2020;13:339-349.
- 2021 Report on Residents Executive Summary. Association of American Medical Colleges; 2021. Accessed March 14, 2023. https://www.aamc.org/data-reports/students-residents/data/report-residents/2021/executive-summary
- Johnson AL, Sharma J, Chinchilli VM, et al. Why do medical students choose orthopaedics as a career? J Bone Joint Surg Am. 2012;94:e78.
- Feng H, Berk-Krauss J, Feng PW, et al. Comparison of dermatologist density between urban and rural counties in the United States. JAMA Dermatol. 2018;154:1265-1271.
- Active Physicians With a U.S. Doctor of Medicine (U.S. MD) Degree by Specialty, 2019. Association of American Medical Colleges; 2019. Accessed March 14, 2023. https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2019
- Rübsam ML, Esch M, Baum E, et al. Diagnosing skin disease in primary care: a qualitative study of GPs’ approaches. Fam Pract. 2015;32:591-595.
- Cahn BA, Harper HE, Halverstam CP, et al. Current status of dermatologic education in US medical schools. JAMA Dermatol. 2020;156:468-470.
- Mylona E, Brubaker L, Williams VN, et al. Does formal mentoring for faculty members matter? a survey of clinical faculty members. Med Educ. 2016;50:670-681.
- Ratnapalan S. Mentoring in medicine. Can Fam Physician. 2010;56:198.
- Soliman YS, Rzepecki AK, Guzman AK, et al. Understanding perceived barriers of minority medical students pursuing a career in dermatology. JAMA Dermatol. 2019;155:252-254.
- Gorouhi F, Alikhan A, Rezaei A, et al. Dermatology residency selection criteria with an emphasis on program characteristics: a national program director survey. Dermatol Res Pract. 2014;2014:692760.
- Choo EK, Ranney ML, Chan TM, et al. Twitter as a tool for communication and knowledge exchange in academic medicine: a guide for skeptics and novices. Med Teach. 2015;37:411-416.
- McGowan BS, Wasko M, Vartabedian BS, et al. Understanding the factors that influence the adoption and meaningful use of social media by physicians to share medical information. J Med Internet Res. 2012;14:e117.
- Schweitzer J, Hannan A, Coren J. The role of social networking web sites in influencing residency decisions. J Am Osteopath Assoc. 2012;112:673-679.
- Medical students lead event addressing disparity in skin cancer morbidity and mortality. Dermatology News. August 19, 2021. Accessed March 14, 2023. https://www.mdedge.com/dermatology/article/244488/diversity-medicine/medical-students-lead-event-addressing-disparity-skin
- Pandya AG, Alexis AF, Berger TG, et al. Increasing racial and ethnic diversity in dermatology: a call to action. J Am Acad Dermatol. 2016;74:584-587.
- Bae G, Qiu M, Reese E, et al. Changes in sex and ethnic diversity in dermatology residents over multiple decades. JAMA Dermatol. 2016;152:92-94.
- McCleskey PE, Gilson RT, DeVillez RL. Medical student core curriculum in dermatology survey. J Am Acad Dermatol. 2009;61:30-35.e4.
- Pritchett EN, Pandya AG, Ferguson NN, et al. Diversity in dermatology: roadmap for improvement. J Am Acad Dermatol. 2018;79:337-341.
- National Resident Matching Program. Results and Data: 2022 Main Residency Match. National Resident Matching Program; 2022. Accessed March 19, 2023. https://www.nrmp.org/wp-content/uploads/2022/11/2022-Main-Match-Results-and-Data-Final-Revised.pdf
- 6. Akhiyat S, Cardwell L, Sokumbi O. Why dermatology is the second least diverse specialty in medicine: how did we get here? Clin Dermatol. 2020;38:310-315.
- Perlman KL, Williams NM, Egbeto IA, et al. Skin of color lacks representation in medical student resources: a cross-sectional study. Int J Womens Dermatol. 2021;7:195-196.
- Saad SM, Fatima SS, Faruqi AA. Students’ views regarding selecting medicine as a profession. J Pak Med Assoc. 2011;61:832-836.
- Woodward A, Thomas S, Jalloh M, et al. Reasons to pursue a career in medicine: a qualitative study in Sierra Leone. Global Health Res Policy. 2017;2:34.
- Thang C, Barnette NM, Patel KS, et al. Association of shadowing program for undergraduate premedical students with improvements in understanding medical education and training. Cureus. 2019;11:E6396.
- Murphy B. The 11 factors that influence med student specialty choice. American Medical Association. December 1, 2020. Accessed March 14, 2023. https://www.ama-assn.org/residents-students/specialty-profiles/11-factors-influence-med-student-specialty-choice
- Vakayil V, Chandrashekar M, Hedberg J, et al. An undergraduate surgery interest group: introducing premedical students to the practice of surgery. Adv Med Educ Pract. 2020;13:339-349.
- 2021 Report on Residents Executive Summary. Association of American Medical Colleges; 2021. Accessed March 14, 2023. https://www.aamc.org/data-reports/students-residents/data/report-residents/2021/executive-summary
- Johnson AL, Sharma J, Chinchilli VM, et al. Why do medical students choose orthopaedics as a career? J Bone Joint Surg Am. 2012;94:e78.
- Feng H, Berk-Krauss J, Feng PW, et al. Comparison of dermatologist density between urban and rural counties in the United States. JAMA Dermatol. 2018;154:1265-1271.
- Active Physicians With a U.S. Doctor of Medicine (U.S. MD) Degree by Specialty, 2019. Association of American Medical Colleges; 2019. Accessed March 14, 2023. https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2019
- Rübsam ML, Esch M, Baum E, et al. Diagnosing skin disease in primary care: a qualitative study of GPs’ approaches. Fam Pract. 2015;32:591-595.
- Cahn BA, Harper HE, Halverstam CP, et al. Current status of dermatologic education in US medical schools. JAMA Dermatol. 2020;156:468-470.
- Mylona E, Brubaker L, Williams VN, et al. Does formal mentoring for faculty members matter? a survey of clinical faculty members. Med Educ. 2016;50:670-681.
- Ratnapalan S. Mentoring in medicine. Can Fam Physician. 2010;56:198.
- Soliman YS, Rzepecki AK, Guzman AK, et al. Understanding perceived barriers of minority medical students pursuing a career in dermatology. JAMA Dermatol. 2019;155:252-254.
- Gorouhi F, Alikhan A, Rezaei A, et al. Dermatology residency selection criteria with an emphasis on program characteristics: a national program director survey. Dermatol Res Pract. 2014;2014:692760.
- Choo EK, Ranney ML, Chan TM, et al. Twitter as a tool for communication and knowledge exchange in academic medicine: a guide for skeptics and novices. Med Teach. 2015;37:411-416.
- McGowan BS, Wasko M, Vartabedian BS, et al. Understanding the factors that influence the adoption and meaningful use of social media by physicians to share medical information. J Med Internet Res. 2012;14:e117.
- Schweitzer J, Hannan A, Coren J. The role of social networking web sites in influencing residency decisions. J Am Osteopath Assoc. 2012;112:673-679.
- Medical students lead event addressing disparity in skin cancer morbidity and mortality. Dermatology News. August 19, 2021. Accessed March 14, 2023. https://www.mdedge.com/dermatology/article/244488/diversity-medicine/medical-students-lead-event-addressing-disparity-skin
Practice Points
- Many premedical students desire more exposure to dermatology than they have been receiving, particularly in mentorship and shadowing. Most exposure has been through social media or as patients in a dermatology clinic.
- Diverse mentorship and diversity of dermatology care are important to underrepresented in medicine premedical students and needs to be further incorporated.
‘Excess’ deaths surging, but why?
This transcript has been edited for clarity.
“Excess deaths.” You’ve heard the phrase countless times by now. It is one of the myriad of previously esoteric epidemiology terms that the pandemic brought squarely into the zeitgeist.
As a sort of standard candle of the performance of a state or a region or a country in terms of health care, it has a lot of utility – if for nothing more than Monday-morning quarterbacking. But this week, I want to dig in on the concept a bit because, according to a new study, the excess death gap between the United States and Western Europe has never been higher.
You might imagine that the best way to figure this out is for some group of intelligent people to review each death and decide, somehow, whether it was expected or not. But aside from being impractical, this would end up being somewhat subjective. That older person who died from pneumonia – was that an expected death? Could it have been avoided?
Rather, the calculation of excess mortality relies on large numbers and statistical inference to compare an expected number of deaths with those that are observed.
The difference is excess mortality, even if you can never be sure whether any particular death was expected or not.
As always, however, the devil is in the details. What data do you use to define the expected number of deaths?
There are options here. Probably the most straightforward analysis uses past data from the country of interest. You look at annual deaths over some historical period of time and compare those numbers with the rates today. Two issues need to be accounted for here: population growth – a larger population will have more deaths, so you need to adjust the historical population with current levels, and demographic shifts – an older or more male population will have more deaths, so you need to adjust for that as well.
But provided you take care of those factors, you can estimate fairly well how many deaths you can expect to see in any given period of time.
Still, you should see right away that excess mortality is a relative concept. If you think that, just perhaps, the United States has some systematic failure to deliver care that has been stable and persistent over time, you wouldn’t capture that failing in an excess mortality calculation that uses U.S. historical data as the baseline.
The best way to get around that is to use data from other countries, and that’s just what this article – a rare single-author piece by Patrick Heuveline – does, calculating excess deaths in the United States by standardizing our mortality rates to the five largest Western European countries: the United Kingdom, France, Germany, Italy, and Spain.
Controlling for the differences in the demographics of that European population, here is the expected number of deaths in the United States over the past 5 years.
Note that there is a small uptick in expected deaths in 2020, reflecting the pandemic, which returns to baseline levels by 2021. This is because that’s what happened in Europe; by 2021, the excess mortality due to COVID-19 was quite low.
Here are the actual deaths in the US during that time.
Highlighted here in green, then, is the excess mortality over time in the United States.
There are some fascinating and concerning findings here.
First of all, you can see that even before the pandemic, the United States has an excess mortality problem. This is not entirely a surprise; we’ve known that so-called “deaths of despair,” those due to alcohol abuse, drug overdoses, and suicide, are at an all-time high and tend to affect a “prime of life” population that would not otherwise be expected to die. In fact, fully 50% of the excess deaths in the United States occur in those between ages 15 and 64.
Excess deaths are also a concerning percentage of total deaths. In 2017, 17% of total deaths in the United States could be considered “excess.” In 2021, that number had doubled to 35%. Nearly 900,000 individuals in the United States died in 2021 who perhaps didn’t need to.
The obvious culprit to blame here is COVID, but COVID-associated excess deaths only explain about 50% of the excess we see in 2021. The rest reflect something even more concerning: a worsening of the failures of the past, perhaps exacerbated by the pandemic but not due to the virus itself.
Of course, we started this discussion acknowledging that the calculation of excess mortality is exquisitely dependent on how you model the expected number of deaths, and I’m sure some will take issue with the use of European numbers when applied to Americans. After all, Europe has, by and large, a robust public health service, socialized medicine, and healthcare that does not run the risk of bankrupting its citizens. How can we compare our outcomes to a place like that?
How indeed.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale University’s Clinical and Translational Research Accelerator in New Haven,Conn. He reported no relevant conflicts of interest.
A version of this article originally appeared on Medscape.com.
This transcript has been edited for clarity.
“Excess deaths.” You’ve heard the phrase countless times by now. It is one of the myriad of previously esoteric epidemiology terms that the pandemic brought squarely into the zeitgeist.
As a sort of standard candle of the performance of a state or a region or a country in terms of health care, it has a lot of utility – if for nothing more than Monday-morning quarterbacking. But this week, I want to dig in on the concept a bit because, according to a new study, the excess death gap between the United States and Western Europe has never been higher.
You might imagine that the best way to figure this out is for some group of intelligent people to review each death and decide, somehow, whether it was expected or not. But aside from being impractical, this would end up being somewhat subjective. That older person who died from pneumonia – was that an expected death? Could it have been avoided?
Rather, the calculation of excess mortality relies on large numbers and statistical inference to compare an expected number of deaths with those that are observed.
The difference is excess mortality, even if you can never be sure whether any particular death was expected or not.
As always, however, the devil is in the details. What data do you use to define the expected number of deaths?
There are options here. Probably the most straightforward analysis uses past data from the country of interest. You look at annual deaths over some historical period of time and compare those numbers with the rates today. Two issues need to be accounted for here: population growth – a larger population will have more deaths, so you need to adjust the historical population with current levels, and demographic shifts – an older or more male population will have more deaths, so you need to adjust for that as well.
But provided you take care of those factors, you can estimate fairly well how many deaths you can expect to see in any given period of time.
Still, you should see right away that excess mortality is a relative concept. If you think that, just perhaps, the United States has some systematic failure to deliver care that has been stable and persistent over time, you wouldn’t capture that failing in an excess mortality calculation that uses U.S. historical data as the baseline.
The best way to get around that is to use data from other countries, and that’s just what this article – a rare single-author piece by Patrick Heuveline – does, calculating excess deaths in the United States by standardizing our mortality rates to the five largest Western European countries: the United Kingdom, France, Germany, Italy, and Spain.
Controlling for the differences in the demographics of that European population, here is the expected number of deaths in the United States over the past 5 years.
Note that there is a small uptick in expected deaths in 2020, reflecting the pandemic, which returns to baseline levels by 2021. This is because that’s what happened in Europe; by 2021, the excess mortality due to COVID-19 was quite low.
Here are the actual deaths in the US during that time.
Highlighted here in green, then, is the excess mortality over time in the United States.
There are some fascinating and concerning findings here.
First of all, you can see that even before the pandemic, the United States has an excess mortality problem. This is not entirely a surprise; we’ve known that so-called “deaths of despair,” those due to alcohol abuse, drug overdoses, and suicide, are at an all-time high and tend to affect a “prime of life” population that would not otherwise be expected to die. In fact, fully 50% of the excess deaths in the United States occur in those between ages 15 and 64.
Excess deaths are also a concerning percentage of total deaths. In 2017, 17% of total deaths in the United States could be considered “excess.” In 2021, that number had doubled to 35%. Nearly 900,000 individuals in the United States died in 2021 who perhaps didn’t need to.
The obvious culprit to blame here is COVID, but COVID-associated excess deaths only explain about 50% of the excess we see in 2021. The rest reflect something even more concerning: a worsening of the failures of the past, perhaps exacerbated by the pandemic but not due to the virus itself.
Of course, we started this discussion acknowledging that the calculation of excess mortality is exquisitely dependent on how you model the expected number of deaths, and I’m sure some will take issue with the use of European numbers when applied to Americans. After all, Europe has, by and large, a robust public health service, socialized medicine, and healthcare that does not run the risk of bankrupting its citizens. How can we compare our outcomes to a place like that?
How indeed.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale University’s Clinical and Translational Research Accelerator in New Haven,Conn. He reported no relevant conflicts of interest.
A version of this article originally appeared on Medscape.com.
This transcript has been edited for clarity.
“Excess deaths.” You’ve heard the phrase countless times by now. It is one of the myriad of previously esoteric epidemiology terms that the pandemic brought squarely into the zeitgeist.
As a sort of standard candle of the performance of a state or a region or a country in terms of health care, it has a lot of utility – if for nothing more than Monday-morning quarterbacking. But this week, I want to dig in on the concept a bit because, according to a new study, the excess death gap between the United States and Western Europe has never been higher.
You might imagine that the best way to figure this out is for some group of intelligent people to review each death and decide, somehow, whether it was expected or not. But aside from being impractical, this would end up being somewhat subjective. That older person who died from pneumonia – was that an expected death? Could it have been avoided?
Rather, the calculation of excess mortality relies on large numbers and statistical inference to compare an expected number of deaths with those that are observed.
The difference is excess mortality, even if you can never be sure whether any particular death was expected or not.
As always, however, the devil is in the details. What data do you use to define the expected number of deaths?
There are options here. Probably the most straightforward analysis uses past data from the country of interest. You look at annual deaths over some historical period of time and compare those numbers with the rates today. Two issues need to be accounted for here: population growth – a larger population will have more deaths, so you need to adjust the historical population with current levels, and demographic shifts – an older or more male population will have more deaths, so you need to adjust for that as well.
But provided you take care of those factors, you can estimate fairly well how many deaths you can expect to see in any given period of time.
Still, you should see right away that excess mortality is a relative concept. If you think that, just perhaps, the United States has some systematic failure to deliver care that has been stable and persistent over time, you wouldn’t capture that failing in an excess mortality calculation that uses U.S. historical data as the baseline.
The best way to get around that is to use data from other countries, and that’s just what this article – a rare single-author piece by Patrick Heuveline – does, calculating excess deaths in the United States by standardizing our mortality rates to the five largest Western European countries: the United Kingdom, France, Germany, Italy, and Spain.
Controlling for the differences in the demographics of that European population, here is the expected number of deaths in the United States over the past 5 years.
Note that there is a small uptick in expected deaths in 2020, reflecting the pandemic, which returns to baseline levels by 2021. This is because that’s what happened in Europe; by 2021, the excess mortality due to COVID-19 was quite low.
Here are the actual deaths in the US during that time.
Highlighted here in green, then, is the excess mortality over time in the United States.
There are some fascinating and concerning findings here.
First of all, you can see that even before the pandemic, the United States has an excess mortality problem. This is not entirely a surprise; we’ve known that so-called “deaths of despair,” those due to alcohol abuse, drug overdoses, and suicide, are at an all-time high and tend to affect a “prime of life” population that would not otherwise be expected to die. In fact, fully 50% of the excess deaths in the United States occur in those between ages 15 and 64.
Excess deaths are also a concerning percentage of total deaths. In 2017, 17% of total deaths in the United States could be considered “excess.” In 2021, that number had doubled to 35%. Nearly 900,000 individuals in the United States died in 2021 who perhaps didn’t need to.
The obvious culprit to blame here is COVID, but COVID-associated excess deaths only explain about 50% of the excess we see in 2021. The rest reflect something even more concerning: a worsening of the failures of the past, perhaps exacerbated by the pandemic but not due to the virus itself.
Of course, we started this discussion acknowledging that the calculation of excess mortality is exquisitely dependent on how you model the expected number of deaths, and I’m sure some will take issue with the use of European numbers when applied to Americans. After all, Europe has, by and large, a robust public health service, socialized medicine, and healthcare that does not run the risk of bankrupting its citizens. How can we compare our outcomes to a place like that?
How indeed.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale University’s Clinical and Translational Research Accelerator in New Haven,Conn. He reported no relevant conflicts of interest.
A version of this article originally appeared on Medscape.com.
FDA panels vote to modify isotretinoin iPLEDGE REMS
At a joint meeting of a drug for severe, nodular acne that is highly teratogenic.
The first vote was on whether to continue the 19-day lockout period for patients who can become pregnant and do not pick up their first prescription of isotretinoin within the 7-day prescription window. Those patients currently have to wait 19 days to get their second pregnancy test and receive the medication.
Most (17) of the 22 voting members voted not to continue the 19-day period; 4 voted to keep it; and 1 abstained. But there was no consensus on when the second pregnancy test should occur if the 19-day lockout is changed.
Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among those voting not to continue the 19-day lockout.
“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”
The second question concerned patients who cannot become pregnant, and it asked when REMS should require that the prescriber document counseling the patient in the iPLEDGE system. The current requirement is monthly.
Listed options and the number of votes for each were:
- Only with the first prescription as part of patient enrollment (10)
- Monthly (1)
- Every 120 days (6)
- Some other frequency (5)
For this question too, while the members largely agreed the current monthly requirement is too burdensome, there was little agreement on what the most appropriate interval should be.
Lack of data
On both questions, several advisory committee members cited a lack of data on which they could base their decision.
On the documentation question, Megha Tollefson, MD, professor of dermatology at the Mayo Clinic, Rochester, Minn., said she voted for the fourth option (some other frequency) with the thought of yearly attestation.
“As a part of this, providers have to provide monthly counseling,” Dr. Tollefson said. “This is just a documentation requirement in the iPLEDGE system. I think most prescribers do document their monthly counseling in their own medical records. I would say it would be okay not to redocument that in iPLEDGE.”
The two votes came at the end of the second day of a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee in which experts addressed ways to improve the iPLEDGE REMS for isotretinoin. A transition to a new platform for the iPLEDGE program caused chaos after its rollout at the end of 2021, resulting in extensive delays and denial of prescriptions.
The committees sought to balance reducing burden with maintaining safety and preventing fetal exposures to isotretinoin.
They were also tasked with discussing other REMS requirements without taking a vote on each topic.
Among those topics was whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most who spoke to the issue agreed that home tests should continue in an effort to increase access and decrease burden. Members suggested safeguards against falsified results that have been documented, including assigning names and barcodes to the test results and uploading the verification to the iPLEDGE website.
The advisory committees also discussed recommendations to encourage more participation in the iPLEDGE Pregnancy Registry.
The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.
A version of this article first appeared on Medscape.com.
At a joint meeting of a drug for severe, nodular acne that is highly teratogenic.
The first vote was on whether to continue the 19-day lockout period for patients who can become pregnant and do not pick up their first prescription of isotretinoin within the 7-day prescription window. Those patients currently have to wait 19 days to get their second pregnancy test and receive the medication.
Most (17) of the 22 voting members voted not to continue the 19-day period; 4 voted to keep it; and 1 abstained. But there was no consensus on when the second pregnancy test should occur if the 19-day lockout is changed.
Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among those voting not to continue the 19-day lockout.
“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”
The second question concerned patients who cannot become pregnant, and it asked when REMS should require that the prescriber document counseling the patient in the iPLEDGE system. The current requirement is monthly.
Listed options and the number of votes for each were:
- Only with the first prescription as part of patient enrollment (10)
- Monthly (1)
- Every 120 days (6)
- Some other frequency (5)
For this question too, while the members largely agreed the current monthly requirement is too burdensome, there was little agreement on what the most appropriate interval should be.
Lack of data
On both questions, several advisory committee members cited a lack of data on which they could base their decision.
On the documentation question, Megha Tollefson, MD, professor of dermatology at the Mayo Clinic, Rochester, Minn., said she voted for the fourth option (some other frequency) with the thought of yearly attestation.
“As a part of this, providers have to provide monthly counseling,” Dr. Tollefson said. “This is just a documentation requirement in the iPLEDGE system. I think most prescribers do document their monthly counseling in their own medical records. I would say it would be okay not to redocument that in iPLEDGE.”
The two votes came at the end of the second day of a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee in which experts addressed ways to improve the iPLEDGE REMS for isotretinoin. A transition to a new platform for the iPLEDGE program caused chaos after its rollout at the end of 2021, resulting in extensive delays and denial of prescriptions.
The committees sought to balance reducing burden with maintaining safety and preventing fetal exposures to isotretinoin.
They were also tasked with discussing other REMS requirements without taking a vote on each topic.
Among those topics was whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most who spoke to the issue agreed that home tests should continue in an effort to increase access and decrease burden. Members suggested safeguards against falsified results that have been documented, including assigning names and barcodes to the test results and uploading the verification to the iPLEDGE website.
The advisory committees also discussed recommendations to encourage more participation in the iPLEDGE Pregnancy Registry.
The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.
A version of this article first appeared on Medscape.com.
At a joint meeting of a drug for severe, nodular acne that is highly teratogenic.
The first vote was on whether to continue the 19-day lockout period for patients who can become pregnant and do not pick up their first prescription of isotretinoin within the 7-day prescription window. Those patients currently have to wait 19 days to get their second pregnancy test and receive the medication.
Most (17) of the 22 voting members voted not to continue the 19-day period; 4 voted to keep it; and 1 abstained. But there was no consensus on when the second pregnancy test should occur if the 19-day lockout is changed.
Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among those voting not to continue the 19-day lockout.
“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”
The second question concerned patients who cannot become pregnant, and it asked when REMS should require that the prescriber document counseling the patient in the iPLEDGE system. The current requirement is monthly.
Listed options and the number of votes for each were:
- Only with the first prescription as part of patient enrollment (10)
- Monthly (1)
- Every 120 days (6)
- Some other frequency (5)
For this question too, while the members largely agreed the current monthly requirement is too burdensome, there was little agreement on what the most appropriate interval should be.
Lack of data
On both questions, several advisory committee members cited a lack of data on which they could base their decision.
On the documentation question, Megha Tollefson, MD, professor of dermatology at the Mayo Clinic, Rochester, Minn., said she voted for the fourth option (some other frequency) with the thought of yearly attestation.
“As a part of this, providers have to provide monthly counseling,” Dr. Tollefson said. “This is just a documentation requirement in the iPLEDGE system. I think most prescribers do document their monthly counseling in their own medical records. I would say it would be okay not to redocument that in iPLEDGE.”
The two votes came at the end of the second day of a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee in which experts addressed ways to improve the iPLEDGE REMS for isotretinoin. A transition to a new platform for the iPLEDGE program caused chaos after its rollout at the end of 2021, resulting in extensive delays and denial of prescriptions.
The committees sought to balance reducing burden with maintaining safety and preventing fetal exposures to isotretinoin.
They were also tasked with discussing other REMS requirements without taking a vote on each topic.
Among those topics was whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most who spoke to the issue agreed that home tests should continue in an effort to increase access and decrease burden. Members suggested safeguards against falsified results that have been documented, including assigning names and barcodes to the test results and uploading the verification to the iPLEDGE website.
The advisory committees also discussed recommendations to encourage more participation in the iPLEDGE Pregnancy Registry.
The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.
A version of this article first appeared on Medscape.com.
Sweaty treatment for social anxiety could pass the sniff test
Getting sweet on sweat
Are you the sort of person who struggles in social situations? Have the past 3 years been a secret respite from the terror and exhaustion of meeting new people? We understand your plight. People kind of suck. And you don’t have to look far to be reminded of it.
Unfortunately, on occasion we all have to interact with other human beings. If you suffer from social anxiety, this is not a fun thing to do. But new research indicates that there may be a way to alleviate the stress for those with social anxiety: armpits.
Specifically, sweat from the armpits of other people. Yes, this means a group of scientists gathered up some volunteers and collected their armpit sweat while the volunteers watched a variety of movies (horror, comedy, romance, etc.). Our condolences to the poor unpaid interns tasked with gathering the sweat.
Once they had their precious new medicine, the researchers took a group of women and administered a round of mindfulness therapy. Some of the participants then received the various sweats, while the rest were forced to smell only clean air. (The horror!) Lo and behold, the sweat groups had their anxiety scores reduced by about 40% after their therapy, compared with just 17% in the control group.
The researchers also found that the source of the sweat didn’t matter. Their study subjects responded the same to sweat excreted during a scary movie as they did to sweat from a comedy, a result that surprised the researchers. They suggested chemosignals in the sweat may affect the treatment response and advised further research. Which means more sweat collection! They plan on testing emotionally neutral movies next time, and if we can make a humble suggestion, they also should try the sweatiest movies.
Before the Food and Drug Administration can approve armpit sweat as a treatment for social anxiety, we have some advice for those shut-in introverts out there. Next time you have to interact with rabid extroverts, instead of shaking their hands, walk up to them and take a deep whiff of their armpits. Establish dominance. Someone will feel awkward, and science has proved it won’t be you.
The puff that vaccinates
Ever been shot with a Nerf gun or hit with a foam pool tube? More annoying than painful, right? If we asked if you’d rather get pelted with one of those than receive a traditional vaccine injection, you would choose the former. Maybe someday you actually will.
During the boredom of the early pandemic lockdown, Jeremiah Gassensmith, PhD, of the department of chemistry and biochemistry at the University of Texas, Dallas, ordered a compressed gas–powered jet injection system to fool around with at home. Hey, who didn’t? Anyway, when it was time to go back to the lab he handed it over to one of his grad students, Yalini Wijesundara, and asked her to see what could be done with it.
In her tinkering she found that the jet injector could deliver metal-organic frameworks (MOFs) that can hold a bunch of different materials, like proteins and nucleic acids, through the skin.
Thus the “MOF-Jet” was born!
Jet injectors are nothing new, but they hurt. The MOF-Jet, however, is practically painless and cheaper than the gene guns that veterinarians use to inject biological cargo attached to the surface of a metal microparticle.
Changing the carrier gas also changes the time needed to break down the MOF and thus alters delivery of the drug inside. “If you shoot it with carbon dioxide, it will release its cargo faster within cells; if you use regular air, it will take 4 or 5 days,” Ms. Wijesundara explained in a written statement. That means the same drug could be released over different timescales without changing its formulation.
While testing on onion cells and mice, Ms. Wijesundara noted that it was as easy as “pointing and shooting” to distribute the puff of gas into the cells. A saving grace to those with needle anxiety. Not that we would know anything about needle anxiety.
More testing needs to be done before bringing this technology to human use, obviously, but we’re looking forward to saying goodbye to that dreaded prick and hello to a puff.
Your hippocampus is showing
Brain anatomy is one of the many, many things that’s not really our thing, but we do know a cool picture when we see one. Case in point: The image just below, which happens to be a full-scale, single-cell resolution model of the CA1 region of the hippocampus that “replicates the structure and architecture of the area, along with the position and relative connectivity of the neurons,” according to a statement from the Human Brain Project.
“We have performed a data mining operation on high resolution images of the human hippocampus, obtained from the BigBrain database. The position of individual neurons has been derived from a detailed analysis of these images,” said senior author Michele Migliore, PhD, of the Italian National Research Council’s Institute of Biophysics in Palermo.
Yes, he did say BigBrain database. BigBrain is – we checked and it’s definitely not this – a 3D model of a brain that was sectioned into 7,404 slices just 20 micrometers thick and then scanned by MRI. Digital reconstruction of those slices was done by supercomputer and the results are now available for analysis.
Dr. Migliore and his associates developed an image-processing algorithm to obtain neuronal positioning distribution and an algorithm to generate neuronal connectivity by approximating the shapes of dendrites and axons. (Our brains are starting to hurt just trying to write this.) “Some fit into narrow cones, others have a broad complex extension that can be approximated by dedicated geometrical volumes, and the connectivity to nearby neurons changes accordingly,” explained lead author Daniela Gandolfi of the University of Modena (Italy) and Reggio Emilia.
The investigators have made their dataset and the extraction methodology available on the EBRAINS platform and through the Human Brain Project and are moving on to other brain regions. And then, once everyone can find their way in and around the old gray matter, it should bring an end to conversations like this, which no doubt occur between male and female neuroscientists every day:
“Arnold, I think we’re lost.”
“Don’t worry, Bev, I know where I’m going.”
“Stop and ask this lady for directions.”
“I said I can find it.”
“Just ask her.”
“Fine. Excuse me, ma’am, can you tell us how to get to the corpora quadrigemina from here?
Getting sweet on sweat
Are you the sort of person who struggles in social situations? Have the past 3 years been a secret respite from the terror and exhaustion of meeting new people? We understand your plight. People kind of suck. And you don’t have to look far to be reminded of it.
Unfortunately, on occasion we all have to interact with other human beings. If you suffer from social anxiety, this is not a fun thing to do. But new research indicates that there may be a way to alleviate the stress for those with social anxiety: armpits.
Specifically, sweat from the armpits of other people. Yes, this means a group of scientists gathered up some volunteers and collected their armpit sweat while the volunteers watched a variety of movies (horror, comedy, romance, etc.). Our condolences to the poor unpaid interns tasked with gathering the sweat.
Once they had their precious new medicine, the researchers took a group of women and administered a round of mindfulness therapy. Some of the participants then received the various sweats, while the rest were forced to smell only clean air. (The horror!) Lo and behold, the sweat groups had their anxiety scores reduced by about 40% after their therapy, compared with just 17% in the control group.
The researchers also found that the source of the sweat didn’t matter. Their study subjects responded the same to sweat excreted during a scary movie as they did to sweat from a comedy, a result that surprised the researchers. They suggested chemosignals in the sweat may affect the treatment response and advised further research. Which means more sweat collection! They plan on testing emotionally neutral movies next time, and if we can make a humble suggestion, they also should try the sweatiest movies.
Before the Food and Drug Administration can approve armpit sweat as a treatment for social anxiety, we have some advice for those shut-in introverts out there. Next time you have to interact with rabid extroverts, instead of shaking their hands, walk up to them and take a deep whiff of their armpits. Establish dominance. Someone will feel awkward, and science has proved it won’t be you.
The puff that vaccinates
Ever been shot with a Nerf gun or hit with a foam pool tube? More annoying than painful, right? If we asked if you’d rather get pelted with one of those than receive a traditional vaccine injection, you would choose the former. Maybe someday you actually will.
During the boredom of the early pandemic lockdown, Jeremiah Gassensmith, PhD, of the department of chemistry and biochemistry at the University of Texas, Dallas, ordered a compressed gas–powered jet injection system to fool around with at home. Hey, who didn’t? Anyway, when it was time to go back to the lab he handed it over to one of his grad students, Yalini Wijesundara, and asked her to see what could be done with it.
In her tinkering she found that the jet injector could deliver metal-organic frameworks (MOFs) that can hold a bunch of different materials, like proteins and nucleic acids, through the skin.
Thus the “MOF-Jet” was born!
Jet injectors are nothing new, but they hurt. The MOF-Jet, however, is practically painless and cheaper than the gene guns that veterinarians use to inject biological cargo attached to the surface of a metal microparticle.
Changing the carrier gas also changes the time needed to break down the MOF and thus alters delivery of the drug inside. “If you shoot it with carbon dioxide, it will release its cargo faster within cells; if you use regular air, it will take 4 or 5 days,” Ms. Wijesundara explained in a written statement. That means the same drug could be released over different timescales without changing its formulation.
While testing on onion cells and mice, Ms. Wijesundara noted that it was as easy as “pointing and shooting” to distribute the puff of gas into the cells. A saving grace to those with needle anxiety. Not that we would know anything about needle anxiety.
More testing needs to be done before bringing this technology to human use, obviously, but we’re looking forward to saying goodbye to that dreaded prick and hello to a puff.
Your hippocampus is showing
Brain anatomy is one of the many, many things that’s not really our thing, but we do know a cool picture when we see one. Case in point: The image just below, which happens to be a full-scale, single-cell resolution model of the CA1 region of the hippocampus that “replicates the structure and architecture of the area, along with the position and relative connectivity of the neurons,” according to a statement from the Human Brain Project.
“We have performed a data mining operation on high resolution images of the human hippocampus, obtained from the BigBrain database. The position of individual neurons has been derived from a detailed analysis of these images,” said senior author Michele Migliore, PhD, of the Italian National Research Council’s Institute of Biophysics in Palermo.
Yes, he did say BigBrain database. BigBrain is – we checked and it’s definitely not this – a 3D model of a brain that was sectioned into 7,404 slices just 20 micrometers thick and then scanned by MRI. Digital reconstruction of those slices was done by supercomputer and the results are now available for analysis.
Dr. Migliore and his associates developed an image-processing algorithm to obtain neuronal positioning distribution and an algorithm to generate neuronal connectivity by approximating the shapes of dendrites and axons. (Our brains are starting to hurt just trying to write this.) “Some fit into narrow cones, others have a broad complex extension that can be approximated by dedicated geometrical volumes, and the connectivity to nearby neurons changes accordingly,” explained lead author Daniela Gandolfi of the University of Modena (Italy) and Reggio Emilia.
The investigators have made their dataset and the extraction methodology available on the EBRAINS platform and through the Human Brain Project and are moving on to other brain regions. And then, once everyone can find their way in and around the old gray matter, it should bring an end to conversations like this, which no doubt occur between male and female neuroscientists every day:
“Arnold, I think we’re lost.”
“Don’t worry, Bev, I know where I’m going.”
“Stop and ask this lady for directions.”
“I said I can find it.”
“Just ask her.”
“Fine. Excuse me, ma’am, can you tell us how to get to the corpora quadrigemina from here?
Getting sweet on sweat
Are you the sort of person who struggles in social situations? Have the past 3 years been a secret respite from the terror and exhaustion of meeting new people? We understand your plight. People kind of suck. And you don’t have to look far to be reminded of it.
Unfortunately, on occasion we all have to interact with other human beings. If you suffer from social anxiety, this is not a fun thing to do. But new research indicates that there may be a way to alleviate the stress for those with social anxiety: armpits.
Specifically, sweat from the armpits of other people. Yes, this means a group of scientists gathered up some volunteers and collected their armpit sweat while the volunteers watched a variety of movies (horror, comedy, romance, etc.). Our condolences to the poor unpaid interns tasked with gathering the sweat.
Once they had their precious new medicine, the researchers took a group of women and administered a round of mindfulness therapy. Some of the participants then received the various sweats, while the rest were forced to smell only clean air. (The horror!) Lo and behold, the sweat groups had their anxiety scores reduced by about 40% after their therapy, compared with just 17% in the control group.
The researchers also found that the source of the sweat didn’t matter. Their study subjects responded the same to sweat excreted during a scary movie as they did to sweat from a comedy, a result that surprised the researchers. They suggested chemosignals in the sweat may affect the treatment response and advised further research. Which means more sweat collection! They plan on testing emotionally neutral movies next time, and if we can make a humble suggestion, they also should try the sweatiest movies.
Before the Food and Drug Administration can approve armpit sweat as a treatment for social anxiety, we have some advice for those shut-in introverts out there. Next time you have to interact with rabid extroverts, instead of shaking their hands, walk up to them and take a deep whiff of their armpits. Establish dominance. Someone will feel awkward, and science has proved it won’t be you.
The puff that vaccinates
Ever been shot with a Nerf gun or hit with a foam pool tube? More annoying than painful, right? If we asked if you’d rather get pelted with one of those than receive a traditional vaccine injection, you would choose the former. Maybe someday you actually will.
During the boredom of the early pandemic lockdown, Jeremiah Gassensmith, PhD, of the department of chemistry and biochemistry at the University of Texas, Dallas, ordered a compressed gas–powered jet injection system to fool around with at home. Hey, who didn’t? Anyway, when it was time to go back to the lab he handed it over to one of his grad students, Yalini Wijesundara, and asked her to see what could be done with it.
In her tinkering she found that the jet injector could deliver metal-organic frameworks (MOFs) that can hold a bunch of different materials, like proteins and nucleic acids, through the skin.
Thus the “MOF-Jet” was born!
Jet injectors are nothing new, but they hurt. The MOF-Jet, however, is practically painless and cheaper than the gene guns that veterinarians use to inject biological cargo attached to the surface of a metal microparticle.
Changing the carrier gas also changes the time needed to break down the MOF and thus alters delivery of the drug inside. “If you shoot it with carbon dioxide, it will release its cargo faster within cells; if you use regular air, it will take 4 or 5 days,” Ms. Wijesundara explained in a written statement. That means the same drug could be released over different timescales without changing its formulation.
While testing on onion cells and mice, Ms. Wijesundara noted that it was as easy as “pointing and shooting” to distribute the puff of gas into the cells. A saving grace to those with needle anxiety. Not that we would know anything about needle anxiety.
More testing needs to be done before bringing this technology to human use, obviously, but we’re looking forward to saying goodbye to that dreaded prick and hello to a puff.
Your hippocampus is showing
Brain anatomy is one of the many, many things that’s not really our thing, but we do know a cool picture when we see one. Case in point: The image just below, which happens to be a full-scale, single-cell resolution model of the CA1 region of the hippocampus that “replicates the structure and architecture of the area, along with the position and relative connectivity of the neurons,” according to a statement from the Human Brain Project.
“We have performed a data mining operation on high resolution images of the human hippocampus, obtained from the BigBrain database. The position of individual neurons has been derived from a detailed analysis of these images,” said senior author Michele Migliore, PhD, of the Italian National Research Council’s Institute of Biophysics in Palermo.
Yes, he did say BigBrain database. BigBrain is – we checked and it’s definitely not this – a 3D model of a brain that was sectioned into 7,404 slices just 20 micrometers thick and then scanned by MRI. Digital reconstruction of those slices was done by supercomputer and the results are now available for analysis.
Dr. Migliore and his associates developed an image-processing algorithm to obtain neuronal positioning distribution and an algorithm to generate neuronal connectivity by approximating the shapes of dendrites and axons. (Our brains are starting to hurt just trying to write this.) “Some fit into narrow cones, others have a broad complex extension that can be approximated by dedicated geometrical volumes, and the connectivity to nearby neurons changes accordingly,” explained lead author Daniela Gandolfi of the University of Modena (Italy) and Reggio Emilia.
The investigators have made their dataset and the extraction methodology available on the EBRAINS platform and through the Human Brain Project and are moving on to other brain regions. And then, once everyone can find their way in and around the old gray matter, it should bring an end to conversations like this, which no doubt occur between male and female neuroscientists every day:
“Arnold, I think we’re lost.”
“Don’t worry, Bev, I know where I’m going.”
“Stop and ask this lady for directions.”
“I said I can find it.”
“Just ask her.”
“Fine. Excuse me, ma’am, can you tell us how to get to the corpora quadrigemina from here?
Stutz: The psychiatrist as movie star
For as long as I can remember, psychiatrists have talked about what the appropriate boundaries are for self-disclosure about personal issues with patients. There is obviously no exact answer as to what is acceptable to disclose; this depends on the doctor, the patient, the “brand” of psychotherapy, the patient’s issues, the nature of what is being disclosed, and maybe the alignment of the stars on that particular day. “Stutz,” the Netflix documentary that Oscar-nominated actor/director Jonah Hill has made about his psychiatrist, Phil Stutz, MD, adds a whole new chapter to the discussion.
“Okay, entertain me,” Dr. Stutz says as his patient takes a seat. The therapeutic relationship and the paradigm Dr. Stutz has created to help his patients has been healing for Jonah Hill. The very serious and intimate dialogue that follows unfolds with moments of humor, warmth, and open affection. Hill candidly tells us why he is making this documentary – to share what he has learned and to honor his therapist – but we don’t know why Dr. Stutz has agreed to the endeavor and we’re left to our own inferences.
Dr. Stutz is the coauthor, with Barry Michels, of a best-selling self-help book, “The Tools: 5 Tools to Help You Find Courage, Creativity, and Willpower – and Inspire You to Live Life in Forward Motion.” He talks about his restlessness with the psychodynamic method during his training as a resident in New York – he wanted to offer his patients more immediate relief and a supervisor told him, “Don’t you dare!”
In the film, he talks about giving patients hope and direction. And Hill makes the comment, “In traditional therapy, you’re paying this person and you save all your problems for them, and they just listen, and your friends – who are idiots – give you advice, unsolicited, and you want your friends just to listen, and you want your therapist to give you advice!” Dr. Stutz gives advice and he is like no other therapist Jonah has ever had.
The premise of the film is that we are watching a single therapy session and Dr. Stutz will discuss the use of his tools and techniques that Hill has found helpful. Jonah is the interviewer, and when the doctor suggests it would be helpful if Jonah talked about his life, the patient/director rebuffs him; this documentary is about the psychiatrist.
Early in the film an alarm goes off, Dr. Stutz does not hear it, and Jonah has to remind him that it’s time for him to take his pills. The psychiatrist has Parkinson’s disease and how it has affected him becomes one focal point for the film. We later learn that he lost a younger brother as a child (something Hill did not know before they started filming) and grew up in the shadow of that loss. His extroverted father made it clear that medicine was the only acceptable career path for his son, and his introverted and depressed mother spent her days proclaiming that all men were as awful as her own abusive father.
About a third of the way through the film, the focus shifts. Jonah suddenly confesses that he is feeling stuck with regard to the movie, that he is troubled by the fact that he has not been able to share his distress with Dr. Stutz during their real-life, unfilmed therapy sessions, and the viewers learn that the single-session concept was disingenuous – they have been filming this documentary for two years, against a green screen and not in an office, always wearing the same clothes, and Jonah pulls off a wig that he wears to disguise the fact that he changed his hairstyle months earlier.
It’s a bit unnerving as they throw the wig around, and Jonah agrees to be more open about the issues he has struggled with. He acknowledges that this has been difficult, and he says, “I just keep asking myself, like, was this a f***ing horrible idea for a patient to make a movie about his therapist?” From my perspective as a psychiatrist-viewer, it’s a good question to ask!
Dr. Stutz reassures Jonah that it is okay to be vulnerable. “Failure, weakness, vulnerability – it’s like a connector, it connects you to the rest of the world.” A super-sized cardboard cutout of an obese 14-year-old Jonah now joins the room, and we learn that he continues to struggle with his self-image. Things get more real.
Peppered throughout the film, there are lessons from Dr. Stutz about his “tools,” constructs he uses to help people restructure their worlds and take action to move forward. One such construct he calls “the maze,” which occurs when one person in an interpersonal relationship is waiting for fairness and becomes preoccupied with feeling injured.
Jonah inquires about Dr. Stutz’s romantic life and the therapist replies with a transparency that overrides our usual professional boundaries. We all learn that Dr. Stutz is not in a relationship, he’s never been married, but there is a woman he has had some involvement with on and off for 40 years. Jonah’s line of questioning rivals that of any therapist. “How do you think it affects you, having your mom hate men and you being a man?” Dr. Stutz admits that he can never feel safe with women. “Did you ever override that wall you built with your mom and get close to a woman?” When Jonah professes, “I don’t feel anything but love for you and I just want you to be happy,” my own feeling was that the tables had turned too far, that the therapist’s failed romantic life risked being a burden to the patient.
Still, there is something about the relationship between the two men that is touching and beautiful. Dr. Stutz as a therapist is charismatic, caring, self-assured, and optimistic, and he radiates hope and certainty. He mixes an intense intimacy with humor in a way that is both authentic and entertaining. The interspersed jokes break the intensity, but they don’t diminish his wisdom and the healing he imparts.
Dr. Stutz is a psychiatrist, and his strength is clearly as a psychotherapist, yet there is not a single mention of psychotropic medications – there is a banter about recreational drugs and medications for Parkinson’s disease. If Hill is taking medication for depression or anxiety, and if prescribing is part of Dr. Stutz’s arsenal, the viewer is not made aware of this.
Dr. Stutz eschews the slow, detached, and “neutral” pace of psychodynamic therapy and the whole concept of the therapist as a blank wall for the transference to play out on, but here the transference screams: Jonah loves him, he respect and honors him, he wants him to be happy, and he is afraid of losing him.
“Stutz” is a movie about a larger-than-life psychiatrist, one whose warmth and inspiration are healing. I imagine his tools are helpful, but his personality is what carries the load. If a viewer has not had experience with psychiatry, and this film inspires him to begin therapy, there may be a good deal of disappointment. In this case, the patient is a successful actor, and one might wonder if that, together with the entire years-long project of filming, has altered the relationship well beyond the usual therapeutic hour.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore.
For as long as I can remember, psychiatrists have talked about what the appropriate boundaries are for self-disclosure about personal issues with patients. There is obviously no exact answer as to what is acceptable to disclose; this depends on the doctor, the patient, the “brand” of psychotherapy, the patient’s issues, the nature of what is being disclosed, and maybe the alignment of the stars on that particular day. “Stutz,” the Netflix documentary that Oscar-nominated actor/director Jonah Hill has made about his psychiatrist, Phil Stutz, MD, adds a whole new chapter to the discussion.
“Okay, entertain me,” Dr. Stutz says as his patient takes a seat. The therapeutic relationship and the paradigm Dr. Stutz has created to help his patients has been healing for Jonah Hill. The very serious and intimate dialogue that follows unfolds with moments of humor, warmth, and open affection. Hill candidly tells us why he is making this documentary – to share what he has learned and to honor his therapist – but we don’t know why Dr. Stutz has agreed to the endeavor and we’re left to our own inferences.
Dr. Stutz is the coauthor, with Barry Michels, of a best-selling self-help book, “The Tools: 5 Tools to Help You Find Courage, Creativity, and Willpower – and Inspire You to Live Life in Forward Motion.” He talks about his restlessness with the psychodynamic method during his training as a resident in New York – he wanted to offer his patients more immediate relief and a supervisor told him, “Don’t you dare!”
In the film, he talks about giving patients hope and direction. And Hill makes the comment, “In traditional therapy, you’re paying this person and you save all your problems for them, and they just listen, and your friends – who are idiots – give you advice, unsolicited, and you want your friends just to listen, and you want your therapist to give you advice!” Dr. Stutz gives advice and he is like no other therapist Jonah has ever had.
The premise of the film is that we are watching a single therapy session and Dr. Stutz will discuss the use of his tools and techniques that Hill has found helpful. Jonah is the interviewer, and when the doctor suggests it would be helpful if Jonah talked about his life, the patient/director rebuffs him; this documentary is about the psychiatrist.
Early in the film an alarm goes off, Dr. Stutz does not hear it, and Jonah has to remind him that it’s time for him to take his pills. The psychiatrist has Parkinson’s disease and how it has affected him becomes one focal point for the film. We later learn that he lost a younger brother as a child (something Hill did not know before they started filming) and grew up in the shadow of that loss. His extroverted father made it clear that medicine was the only acceptable career path for his son, and his introverted and depressed mother spent her days proclaiming that all men were as awful as her own abusive father.
About a third of the way through the film, the focus shifts. Jonah suddenly confesses that he is feeling stuck with regard to the movie, that he is troubled by the fact that he has not been able to share his distress with Dr. Stutz during their real-life, unfilmed therapy sessions, and the viewers learn that the single-session concept was disingenuous – they have been filming this documentary for two years, against a green screen and not in an office, always wearing the same clothes, and Jonah pulls off a wig that he wears to disguise the fact that he changed his hairstyle months earlier.
It’s a bit unnerving as they throw the wig around, and Jonah agrees to be more open about the issues he has struggled with. He acknowledges that this has been difficult, and he says, “I just keep asking myself, like, was this a f***ing horrible idea for a patient to make a movie about his therapist?” From my perspective as a psychiatrist-viewer, it’s a good question to ask!
Dr. Stutz reassures Jonah that it is okay to be vulnerable. “Failure, weakness, vulnerability – it’s like a connector, it connects you to the rest of the world.” A super-sized cardboard cutout of an obese 14-year-old Jonah now joins the room, and we learn that he continues to struggle with his self-image. Things get more real.
Peppered throughout the film, there are lessons from Dr. Stutz about his “tools,” constructs he uses to help people restructure their worlds and take action to move forward. One such construct he calls “the maze,” which occurs when one person in an interpersonal relationship is waiting for fairness and becomes preoccupied with feeling injured.
Jonah inquires about Dr. Stutz’s romantic life and the therapist replies with a transparency that overrides our usual professional boundaries. We all learn that Dr. Stutz is not in a relationship, he’s never been married, but there is a woman he has had some involvement with on and off for 40 years. Jonah’s line of questioning rivals that of any therapist. “How do you think it affects you, having your mom hate men and you being a man?” Dr. Stutz admits that he can never feel safe with women. “Did you ever override that wall you built with your mom and get close to a woman?” When Jonah professes, “I don’t feel anything but love for you and I just want you to be happy,” my own feeling was that the tables had turned too far, that the therapist’s failed romantic life risked being a burden to the patient.
Still, there is something about the relationship between the two men that is touching and beautiful. Dr. Stutz as a therapist is charismatic, caring, self-assured, and optimistic, and he radiates hope and certainty. He mixes an intense intimacy with humor in a way that is both authentic and entertaining. The interspersed jokes break the intensity, but they don’t diminish his wisdom and the healing he imparts.
Dr. Stutz is a psychiatrist, and his strength is clearly as a psychotherapist, yet there is not a single mention of psychotropic medications – there is a banter about recreational drugs and medications for Parkinson’s disease. If Hill is taking medication for depression or anxiety, and if prescribing is part of Dr. Stutz’s arsenal, the viewer is not made aware of this.
Dr. Stutz eschews the slow, detached, and “neutral” pace of psychodynamic therapy and the whole concept of the therapist as a blank wall for the transference to play out on, but here the transference screams: Jonah loves him, he respect and honors him, he wants him to be happy, and he is afraid of losing him.
“Stutz” is a movie about a larger-than-life psychiatrist, one whose warmth and inspiration are healing. I imagine his tools are helpful, but his personality is what carries the load. If a viewer has not had experience with psychiatry, and this film inspires him to begin therapy, there may be a good deal of disappointment. In this case, the patient is a successful actor, and one might wonder if that, together with the entire years-long project of filming, has altered the relationship well beyond the usual therapeutic hour.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore.
For as long as I can remember, psychiatrists have talked about what the appropriate boundaries are for self-disclosure about personal issues with patients. There is obviously no exact answer as to what is acceptable to disclose; this depends on the doctor, the patient, the “brand” of psychotherapy, the patient’s issues, the nature of what is being disclosed, and maybe the alignment of the stars on that particular day. “Stutz,” the Netflix documentary that Oscar-nominated actor/director Jonah Hill has made about his psychiatrist, Phil Stutz, MD, adds a whole new chapter to the discussion.
“Okay, entertain me,” Dr. Stutz says as his patient takes a seat. The therapeutic relationship and the paradigm Dr. Stutz has created to help his patients has been healing for Jonah Hill. The very serious and intimate dialogue that follows unfolds with moments of humor, warmth, and open affection. Hill candidly tells us why he is making this documentary – to share what he has learned and to honor his therapist – but we don’t know why Dr. Stutz has agreed to the endeavor and we’re left to our own inferences.
Dr. Stutz is the coauthor, with Barry Michels, of a best-selling self-help book, “The Tools: 5 Tools to Help You Find Courage, Creativity, and Willpower – and Inspire You to Live Life in Forward Motion.” He talks about his restlessness with the psychodynamic method during his training as a resident in New York – he wanted to offer his patients more immediate relief and a supervisor told him, “Don’t you dare!”
In the film, he talks about giving patients hope and direction. And Hill makes the comment, “In traditional therapy, you’re paying this person and you save all your problems for them, and they just listen, and your friends – who are idiots – give you advice, unsolicited, and you want your friends just to listen, and you want your therapist to give you advice!” Dr. Stutz gives advice and he is like no other therapist Jonah has ever had.
The premise of the film is that we are watching a single therapy session and Dr. Stutz will discuss the use of his tools and techniques that Hill has found helpful. Jonah is the interviewer, and when the doctor suggests it would be helpful if Jonah talked about his life, the patient/director rebuffs him; this documentary is about the psychiatrist.
Early in the film an alarm goes off, Dr. Stutz does not hear it, and Jonah has to remind him that it’s time for him to take his pills. The psychiatrist has Parkinson’s disease and how it has affected him becomes one focal point for the film. We later learn that he lost a younger brother as a child (something Hill did not know before they started filming) and grew up in the shadow of that loss. His extroverted father made it clear that medicine was the only acceptable career path for his son, and his introverted and depressed mother spent her days proclaiming that all men were as awful as her own abusive father.
About a third of the way through the film, the focus shifts. Jonah suddenly confesses that he is feeling stuck with regard to the movie, that he is troubled by the fact that he has not been able to share his distress with Dr. Stutz during their real-life, unfilmed therapy sessions, and the viewers learn that the single-session concept was disingenuous – they have been filming this documentary for two years, against a green screen and not in an office, always wearing the same clothes, and Jonah pulls off a wig that he wears to disguise the fact that he changed his hairstyle months earlier.
It’s a bit unnerving as they throw the wig around, and Jonah agrees to be more open about the issues he has struggled with. He acknowledges that this has been difficult, and he says, “I just keep asking myself, like, was this a f***ing horrible idea for a patient to make a movie about his therapist?” From my perspective as a psychiatrist-viewer, it’s a good question to ask!
Dr. Stutz reassures Jonah that it is okay to be vulnerable. “Failure, weakness, vulnerability – it’s like a connector, it connects you to the rest of the world.” A super-sized cardboard cutout of an obese 14-year-old Jonah now joins the room, and we learn that he continues to struggle with his self-image. Things get more real.
Peppered throughout the film, there are lessons from Dr. Stutz about his “tools,” constructs he uses to help people restructure their worlds and take action to move forward. One such construct he calls “the maze,” which occurs when one person in an interpersonal relationship is waiting for fairness and becomes preoccupied with feeling injured.
Jonah inquires about Dr. Stutz’s romantic life and the therapist replies with a transparency that overrides our usual professional boundaries. We all learn that Dr. Stutz is not in a relationship, he’s never been married, but there is a woman he has had some involvement with on and off for 40 years. Jonah’s line of questioning rivals that of any therapist. “How do you think it affects you, having your mom hate men and you being a man?” Dr. Stutz admits that he can never feel safe with women. “Did you ever override that wall you built with your mom and get close to a woman?” When Jonah professes, “I don’t feel anything but love for you and I just want you to be happy,” my own feeling was that the tables had turned too far, that the therapist’s failed romantic life risked being a burden to the patient.
Still, there is something about the relationship between the two men that is touching and beautiful. Dr. Stutz as a therapist is charismatic, caring, self-assured, and optimistic, and he radiates hope and certainty. He mixes an intense intimacy with humor in a way that is both authentic and entertaining. The interspersed jokes break the intensity, but they don’t diminish his wisdom and the healing he imparts.
Dr. Stutz is a psychiatrist, and his strength is clearly as a psychotherapist, yet there is not a single mention of psychotropic medications – there is a banter about recreational drugs and medications for Parkinson’s disease. If Hill is taking medication for depression or anxiety, and if prescribing is part of Dr. Stutz’s arsenal, the viewer is not made aware of this.
Dr. Stutz eschews the slow, detached, and “neutral” pace of psychodynamic therapy and the whole concept of the therapist as a blank wall for the transference to play out on, but here the transference screams: Jonah loves him, he respect and honors him, he wants him to be happy, and he is afraid of losing him.
“Stutz” is a movie about a larger-than-life psychiatrist, one whose warmth and inspiration are healing. I imagine his tools are helpful, but his personality is what carries the load. If a viewer has not had experience with psychiatry, and this film inspires him to begin therapy, there may be a good deal of disappointment. In this case, the patient is a successful actor, and one might wonder if that, together with the entire years-long project of filming, has altered the relationship well beyond the usual therapeutic hour.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore.
FDA approves OTC naloxone, but will cost be a barrier?
Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”
“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.
“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.
Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.
Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.
Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.
“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.
Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
A version of this article first appeared on Medscape.com.
Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”
“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.
“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.
Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.
Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.
Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.
“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.
Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
A version of this article first appeared on Medscape.com.
Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.
Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.
“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”
“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.
“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.
“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.
Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.
Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.
A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.
Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.
Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.
The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.
In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.
Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.
Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.
“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.
Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
A version of this article first appeared on Medscape.com.
Plant-based diets not always healthy; quality is key
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN