What’s Changed in Asthma Treatment? Quite a Bit

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This transcript has been edited for clarity.

I’m Dr. Neil Skolnik, and today I am going to talk about the 2023 update to the Global Strategy for Asthma Management and Prevention. We treat a lot of asthma, and there are some important changes, particularly around the use of albuterol. There are two main guidelines when it comes to asthma, the Global Initiative for Asthma (GINA) guideline and the US National Heart, Lung, and Blood Institute Guidelines. While I had the privilege of serving on the expert working group for the US guidelines, what I like about the GINA guidelines is that they are updated annually, and so they really help us keep up with rapid changes in the field.

Today, I’m going to focus on assessment and treatment.
 

Four Questions to Assess Asthma Control

Because over half of patients with asthma are not well controlled, it is important to assess control at every asthma visit. Asthma control has two domains: symptom control and the risk for future exacerbations. It is not enough to simply ask, “How is your asthma?” because many patients overrate their control and live with ongoing symptoms. There are many assessment tools; the Asthma Control Test (ACT) focuses on symptoms, and the new Asthma Impairment and Risk Questionnaire (AIRQ) assesses both symptoms and risk for exacerbations. The GINA assessment is probably the easiest to implement, with just four questions relevant to the past 4 weeks:

  • Have you had daytime symptoms more than twice in one week?
  • Have you had any night waking due to asthma?
  • Have you needed short-acting beta-agonist (SABA), such as albuterol, rescue more than twice in one week?
  • Have you had any activity limitation due to asthma?

Well-controlled asthma is defined as a negative response to all four of these questions, partly controlled asthma is one or two “yes” answers, and uncontrolled asthma is three to four positive responses. You can’t modify a patient’s therapy if you don’t know whether their asthma is well or poorly controlled. You’ll notice that these questions focus on symptom control. It is important also to ask about risk factors for exacerbations, particularly previous exacerbations.
 

Asthma Treatment Changes

The goals of treatment are control of symptoms and avoidance of exacerbations. The GINA guidelines emphasize that even patients with mild asthma can have severe or fatal exacerbations.

GINA recommends two management tracks. The preferred track uses inhaled corticosteroid (ICS)-formoterol as both maintenance and reliever therapy (MART). Track 2, without the use of ICS-formoterol for MART, is also offered, recognizing that the use of ICS-formoterol for MART is not approved by the US Food and Drug Administration. There is an easy-to-follow stepped-care diagram that is worth looking at; it’s on page 66 of the GINA guideline PDF.

For patients who have symptoms less than twice a month, begin with Step 1 therapy:

  • Track 1: as-needed low-dose ICS-formoterol.
  • Track 2: treatment with albuterol; also use ICS whenever albuterol is used.
 

 

For patients with symptoms more than twice a month (but not most days of the week) treatment can start with Step 2 therapy:

  • Track 1: as-needed low-dose ICS-formoterol
  • Track 2: daily low-dose ICS plus as-needed SABA

An option for rescue therapy for Track 2 across all steps of therapy is to use an ICS whenever a SABA is used for rescue to reduce the likelihood of exacerbation.

For patients with more severe asthma symptoms most days of the week, or whose asthma is waking them from sleep one or more times weekly, then you can start with Step 3 therapy as follows:

  • Track 1: low dose ICS-formoterol as MART
  • Track 2: low-dose ICS with long-acting beta-agonist (LABA) for maintenance, plus as needed SABA or as needed ICS-SABA

That’s going to cover most of our patients. As we see people back, if escalation of therapy is needed, then Step 4 therapy is:

  • Track 1: medium-dose ICS-formoterol as MART
  • Track 2: medium-dose ICS-LABA plus as needed SABA or as-needed ICS-SABA

For patients who remain uncontrolled, it’s important to realize that Step 5 gives you the option to add a long-acting muscarinic antagonist (LAMA). In my experience this can be very helpful. We can also consider going to high-dose ICS-LABS for maintenance. At this step, the patient usually has pretty severe, uncontrolled asthma and we can think about checking eosinophil counts, ordering pulmonary function tests, and referring to our specialist colleagues for consideration of biologic therapy.

It is important to see patients back regularly, and to assess asthma control. If a patient is not well controlled or has had exacerbations, consider stepping up therapy, or changing from albuterol alone as rescue to albuterol plus ICS for rescue. If they have been well controlled for a long time, consider de-escalation of therapy among patients on one of the higher therapy steps.

Dr. Skolnik has disclosed the following relevant financial relationships: Serve(d) on the advisory board for AstraZeneca, Teva, Eli Lilly and Company, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck; and Bayer; serve(d) as a speaker or a member of a speakers bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline. Received research grant from Sanofi, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Bayer; and received income in an amount equal to or greater than $250 from AstraZeneca, Teva, Eli Lilly and Company, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity.

I’m Dr. Neil Skolnik, and today I am going to talk about the 2023 update to the Global Strategy for Asthma Management and Prevention. We treat a lot of asthma, and there are some important changes, particularly around the use of albuterol. There are two main guidelines when it comes to asthma, the Global Initiative for Asthma (GINA) guideline and the US National Heart, Lung, and Blood Institute Guidelines. While I had the privilege of serving on the expert working group for the US guidelines, what I like about the GINA guidelines is that they are updated annually, and so they really help us keep up with rapid changes in the field.

Today, I’m going to focus on assessment and treatment.
 

Four Questions to Assess Asthma Control

Because over half of patients with asthma are not well controlled, it is important to assess control at every asthma visit. Asthma control has two domains: symptom control and the risk for future exacerbations. It is not enough to simply ask, “How is your asthma?” because many patients overrate their control and live with ongoing symptoms. There are many assessment tools; the Asthma Control Test (ACT) focuses on symptoms, and the new Asthma Impairment and Risk Questionnaire (AIRQ) assesses both symptoms and risk for exacerbations. The GINA assessment is probably the easiest to implement, with just four questions relevant to the past 4 weeks:

  • Have you had daytime symptoms more than twice in one week?
  • Have you had any night waking due to asthma?
  • Have you needed short-acting beta-agonist (SABA), such as albuterol, rescue more than twice in one week?
  • Have you had any activity limitation due to asthma?

Well-controlled asthma is defined as a negative response to all four of these questions, partly controlled asthma is one or two “yes” answers, and uncontrolled asthma is three to four positive responses. You can’t modify a patient’s therapy if you don’t know whether their asthma is well or poorly controlled. You’ll notice that these questions focus on symptom control. It is important also to ask about risk factors for exacerbations, particularly previous exacerbations.
 

Asthma Treatment Changes

The goals of treatment are control of symptoms and avoidance of exacerbations. The GINA guidelines emphasize that even patients with mild asthma can have severe or fatal exacerbations.

GINA recommends two management tracks. The preferred track uses inhaled corticosteroid (ICS)-formoterol as both maintenance and reliever therapy (MART). Track 2, without the use of ICS-formoterol for MART, is also offered, recognizing that the use of ICS-formoterol for MART is not approved by the US Food and Drug Administration. There is an easy-to-follow stepped-care diagram that is worth looking at; it’s on page 66 of the GINA guideline PDF.

For patients who have symptoms less than twice a month, begin with Step 1 therapy:

  • Track 1: as-needed low-dose ICS-formoterol.
  • Track 2: treatment with albuterol; also use ICS whenever albuterol is used.
 

 

For patients with symptoms more than twice a month (but not most days of the week) treatment can start with Step 2 therapy:

  • Track 1: as-needed low-dose ICS-formoterol
  • Track 2: daily low-dose ICS plus as-needed SABA

An option for rescue therapy for Track 2 across all steps of therapy is to use an ICS whenever a SABA is used for rescue to reduce the likelihood of exacerbation.

For patients with more severe asthma symptoms most days of the week, or whose asthma is waking them from sleep one or more times weekly, then you can start with Step 3 therapy as follows:

  • Track 1: low dose ICS-formoterol as MART
  • Track 2: low-dose ICS with long-acting beta-agonist (LABA) for maintenance, plus as needed SABA or as needed ICS-SABA

That’s going to cover most of our patients. As we see people back, if escalation of therapy is needed, then Step 4 therapy is:

  • Track 1: medium-dose ICS-formoterol as MART
  • Track 2: medium-dose ICS-LABA plus as needed SABA or as-needed ICS-SABA

For patients who remain uncontrolled, it’s important to realize that Step 5 gives you the option to add a long-acting muscarinic antagonist (LAMA). In my experience this can be very helpful. We can also consider going to high-dose ICS-LABS for maintenance. At this step, the patient usually has pretty severe, uncontrolled asthma and we can think about checking eosinophil counts, ordering pulmonary function tests, and referring to our specialist colleagues for consideration of biologic therapy.

It is important to see patients back regularly, and to assess asthma control. If a patient is not well controlled or has had exacerbations, consider stepping up therapy, or changing from albuterol alone as rescue to albuterol plus ICS for rescue. If they have been well controlled for a long time, consider de-escalation of therapy among patients on one of the higher therapy steps.

Dr. Skolnik has disclosed the following relevant financial relationships: Serve(d) on the advisory board for AstraZeneca, Teva, Eli Lilly and Company, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck; and Bayer; serve(d) as a speaker or a member of a speakers bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline. Received research grant from Sanofi, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Bayer; and received income in an amount equal to or greater than $250 from AstraZeneca, Teva, Eli Lilly and Company, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

I’m Dr. Neil Skolnik, and today I am going to talk about the 2023 update to the Global Strategy for Asthma Management and Prevention. We treat a lot of asthma, and there are some important changes, particularly around the use of albuterol. There are two main guidelines when it comes to asthma, the Global Initiative for Asthma (GINA) guideline and the US National Heart, Lung, and Blood Institute Guidelines. While I had the privilege of serving on the expert working group for the US guidelines, what I like about the GINA guidelines is that they are updated annually, and so they really help us keep up with rapid changes in the field.

Today, I’m going to focus on assessment and treatment.
 

Four Questions to Assess Asthma Control

Because over half of patients with asthma are not well controlled, it is important to assess control at every asthma visit. Asthma control has two domains: symptom control and the risk for future exacerbations. It is not enough to simply ask, “How is your asthma?” because many patients overrate their control and live with ongoing symptoms. There are many assessment tools; the Asthma Control Test (ACT) focuses on symptoms, and the new Asthma Impairment and Risk Questionnaire (AIRQ) assesses both symptoms and risk for exacerbations. The GINA assessment is probably the easiest to implement, with just four questions relevant to the past 4 weeks:

  • Have you had daytime symptoms more than twice in one week?
  • Have you had any night waking due to asthma?
  • Have you needed short-acting beta-agonist (SABA), such as albuterol, rescue more than twice in one week?
  • Have you had any activity limitation due to asthma?

Well-controlled asthma is defined as a negative response to all four of these questions, partly controlled asthma is one or two “yes” answers, and uncontrolled asthma is three to four positive responses. You can’t modify a patient’s therapy if you don’t know whether their asthma is well or poorly controlled. You’ll notice that these questions focus on symptom control. It is important also to ask about risk factors for exacerbations, particularly previous exacerbations.
 

Asthma Treatment Changes

The goals of treatment are control of symptoms and avoidance of exacerbations. The GINA guidelines emphasize that even patients with mild asthma can have severe or fatal exacerbations.

GINA recommends two management tracks. The preferred track uses inhaled corticosteroid (ICS)-formoterol as both maintenance and reliever therapy (MART). Track 2, without the use of ICS-formoterol for MART, is also offered, recognizing that the use of ICS-formoterol for MART is not approved by the US Food and Drug Administration. There is an easy-to-follow stepped-care diagram that is worth looking at; it’s on page 66 of the GINA guideline PDF.

For patients who have symptoms less than twice a month, begin with Step 1 therapy:

  • Track 1: as-needed low-dose ICS-formoterol.
  • Track 2: treatment with albuterol; also use ICS whenever albuterol is used.
 

 

For patients with symptoms more than twice a month (but not most days of the week) treatment can start with Step 2 therapy:

  • Track 1: as-needed low-dose ICS-formoterol
  • Track 2: daily low-dose ICS plus as-needed SABA

An option for rescue therapy for Track 2 across all steps of therapy is to use an ICS whenever a SABA is used for rescue to reduce the likelihood of exacerbation.

For patients with more severe asthma symptoms most days of the week, or whose asthma is waking them from sleep one or more times weekly, then you can start with Step 3 therapy as follows:

  • Track 1: low dose ICS-formoterol as MART
  • Track 2: low-dose ICS with long-acting beta-agonist (LABA) for maintenance, plus as needed SABA or as needed ICS-SABA

That’s going to cover most of our patients. As we see people back, if escalation of therapy is needed, then Step 4 therapy is:

  • Track 1: medium-dose ICS-formoterol as MART
  • Track 2: medium-dose ICS-LABA plus as needed SABA or as-needed ICS-SABA

For patients who remain uncontrolled, it’s important to realize that Step 5 gives you the option to add a long-acting muscarinic antagonist (LAMA). In my experience this can be very helpful. We can also consider going to high-dose ICS-LABS for maintenance. At this step, the patient usually has pretty severe, uncontrolled asthma and we can think about checking eosinophil counts, ordering pulmonary function tests, and referring to our specialist colleagues for consideration of biologic therapy.

It is important to see patients back regularly, and to assess asthma control. If a patient is not well controlled or has had exacerbations, consider stepping up therapy, or changing from albuterol alone as rescue to albuterol plus ICS for rescue. If they have been well controlled for a long time, consider de-escalation of therapy among patients on one of the higher therapy steps.

Dr. Skolnik has disclosed the following relevant financial relationships: Serve(d) on the advisory board for AstraZeneca, Teva, Eli Lilly and Company, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck; and Bayer; serve(d) as a speaker or a member of a speakers bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline. Received research grant from Sanofi, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Bayer; and received income in an amount equal to or greater than $250 from AstraZeneca, Teva, Eli Lilly and Company, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

A version of this article appeared on Medscape.com.

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The Small Office Vibe

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Changed
Wed, 03/06/2024 - 11:24

My first civilian job after finishing my training was as an associate and eventually a partner of a pediatrician whose office was in a wing of his large 19th-century home. The pediatrician in the neighboring town had his office in a small house next to his home. This model of small one- or two -provider offices in or nearby their homes was replicated up and down the coast. After 7 years, the 12-minute drive from my home to the office became intolerable and I asked to dissolve what was otherwise a successful partnership. I opened a one-provider office with a 6-minute bike ride commute and my wife served as the billing clerk and bookkeeper.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Those next 10 years of solo practice were the most rewarding, both economically and professionally. Eventually faced with the need to add another provider, I reluctantly joined a recently formed group of primary care physicians who, like me, had been running one- or two-provider offices often with spouses as support staff — basically Mom and Pop operations. However, the group was gradually absorbed by increasingly larger entities and our practices that once were as individual as our personalities became homogenized. Neither my patients nor I liked the new feel of the office.

Still pining for that small office vibe, I continue to wonder if it could be scaled up and adapted to today’s healthcare realities. I recently read a New York Times article describing how a pediatrician has launched such a practice model into the uncharted waters of Greater New York City.

At age 34, Dr. Michel Cohen, a Moroccan-French émigré, opened his storefront pediatric practice in 1994. The upper story housed his loft apartment. A self-described “hippie doctor,” Dr. Cohen developed a following based on his book on parenting and publicity surrounding his role in the even more popular book on French-style parenting titled Bringing up Bebe by Pamela Druckerman. By 2009 his practice had grown to three small storefront offices. However, they weren’t sufficiently profitable. He decided to shun the distractions of his celebrity practice trappings and instead focus on growth, hoping that the gravitas associated with even more office locations would allow him to offer better service and improve the bottom line. Sort of an “economy of scale” notion applied to the small office setting.

He now has 48 offices having added 12 new sites last year with 5 more planned for next year. These are all one- or two-physician installations with two exam rooms per provider. The offices are bright and colorful, focused on appealing to a child’s taste. The furniture is blond wood, most of it based on Dr. Cohen’s designs and in some cases handmade. Current staffing is 112 physicians and nurse practitioners and volume exceeds 100,000 visits per year.

The volume has allowed the practice to add a user-friendly patient portal and offer an after-hours call-in option. The larger volume means that staffing can be more easily adjusted to illness and vacations. The goal is to have the practitioners become identified with their sites and the patients assigned to them whenever possible. Uniformity in office designs allow a provider filling in from another site to easily find supplies and function within a familiar system.

While the sites have generally served upscale gentrified neighborhoods, the practice has recently expanded to less affluent areas and accepts Medicaid. Dr. Cohen’s dream is to expand his network nationally as a nonprofit in which low-income sites would be subsidized by the more profitable offices. A previous attempt at expansion with two offices in Southern California did not work out because the time zone difference didn’t mesh well with the Internet portal.

Wanting to hear a firsthand account from a family on how the Tribeca Pediatric system works, I contacted a neighbor who has recently moved his young family here to Brunswick. His impression was generally positive. He gave high marks to the patient portal for the ability to get school and camp forms and vaccination records quickly. Appointments made electronically was a plus, although the after-hours response time sometimes took an hour or two. He would have preferred to see their assigned provider for a higher percentage of visits, but this seems to be a common complaint even in systems with the greatest availability. Care was dispensed efficiently but didn’t seem to be overly rushed.

In the NY Times article there is one complaint by a former provider who felt she was getting burned out by the system and leaned on 10 minutes for sick visits and 20 minutes for well visits. Personally, I don’t see this as a problem. The length of a visit and the quality of the care are not always related. Given good support services and an efficiently run office, those slot guidelines seem very reasonable, realizing that a skilled clinician must have already learned to adjust his or her pace to the realities of the patient mix. However, as the pediatric sick population has leaned more toward behavioral and mental health problems, a primary care practice should be offering some option for these patients either in-house or with reliable referral relationships. Although the NY Times article doesn’t provide any numbers, it does mention that the providers are generally young and there is some turnover, possibly as providers use the practice as a “stepping stone.”

To some extent Dr. Cohen’s success seems to be the result of his real estate acumen and business sense. Because the majority of recent medical school graduates enter the work force with a substantial debt, it is difficult to imagine that a young physician would have Dr. Cohen’s entrepreneurial passion. However, clearly his success, at least in the short term, demonstrates that there is a substantial percentage of both patients and providers who prefer small personalized offices if given the option. It will be interesting to see if and how Tribeca Pediatrics expands and whether any of the larger existing networks attempt to imitate it.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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My first civilian job after finishing my training was as an associate and eventually a partner of a pediatrician whose office was in a wing of his large 19th-century home. The pediatrician in the neighboring town had his office in a small house next to his home. This model of small one- or two -provider offices in or nearby their homes was replicated up and down the coast. After 7 years, the 12-minute drive from my home to the office became intolerable and I asked to dissolve what was otherwise a successful partnership. I opened a one-provider office with a 6-minute bike ride commute and my wife served as the billing clerk and bookkeeper.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Those next 10 years of solo practice were the most rewarding, both economically and professionally. Eventually faced with the need to add another provider, I reluctantly joined a recently formed group of primary care physicians who, like me, had been running one- or two-provider offices often with spouses as support staff — basically Mom and Pop operations. However, the group was gradually absorbed by increasingly larger entities and our practices that once were as individual as our personalities became homogenized. Neither my patients nor I liked the new feel of the office.

Still pining for that small office vibe, I continue to wonder if it could be scaled up and adapted to today’s healthcare realities. I recently read a New York Times article describing how a pediatrician has launched such a practice model into the uncharted waters of Greater New York City.

At age 34, Dr. Michel Cohen, a Moroccan-French émigré, opened his storefront pediatric practice in 1994. The upper story housed his loft apartment. A self-described “hippie doctor,” Dr. Cohen developed a following based on his book on parenting and publicity surrounding his role in the even more popular book on French-style parenting titled Bringing up Bebe by Pamela Druckerman. By 2009 his practice had grown to three small storefront offices. However, they weren’t sufficiently profitable. He decided to shun the distractions of his celebrity practice trappings and instead focus on growth, hoping that the gravitas associated with even more office locations would allow him to offer better service and improve the bottom line. Sort of an “economy of scale” notion applied to the small office setting.

He now has 48 offices having added 12 new sites last year with 5 more planned for next year. These are all one- or two-physician installations with two exam rooms per provider. The offices are bright and colorful, focused on appealing to a child’s taste. The furniture is blond wood, most of it based on Dr. Cohen’s designs and in some cases handmade. Current staffing is 112 physicians and nurse practitioners and volume exceeds 100,000 visits per year.

The volume has allowed the practice to add a user-friendly patient portal and offer an after-hours call-in option. The larger volume means that staffing can be more easily adjusted to illness and vacations. The goal is to have the practitioners become identified with their sites and the patients assigned to them whenever possible. Uniformity in office designs allow a provider filling in from another site to easily find supplies and function within a familiar system.

While the sites have generally served upscale gentrified neighborhoods, the practice has recently expanded to less affluent areas and accepts Medicaid. Dr. Cohen’s dream is to expand his network nationally as a nonprofit in which low-income sites would be subsidized by the more profitable offices. A previous attempt at expansion with two offices in Southern California did not work out because the time zone difference didn’t mesh well with the Internet portal.

Wanting to hear a firsthand account from a family on how the Tribeca Pediatric system works, I contacted a neighbor who has recently moved his young family here to Brunswick. His impression was generally positive. He gave high marks to the patient portal for the ability to get school and camp forms and vaccination records quickly. Appointments made electronically was a plus, although the after-hours response time sometimes took an hour or two. He would have preferred to see their assigned provider for a higher percentage of visits, but this seems to be a common complaint even in systems with the greatest availability. Care was dispensed efficiently but didn’t seem to be overly rushed.

In the NY Times article there is one complaint by a former provider who felt she was getting burned out by the system and leaned on 10 minutes for sick visits and 20 minutes for well visits. Personally, I don’t see this as a problem. The length of a visit and the quality of the care are not always related. Given good support services and an efficiently run office, those slot guidelines seem very reasonable, realizing that a skilled clinician must have already learned to adjust his or her pace to the realities of the patient mix. However, as the pediatric sick population has leaned more toward behavioral and mental health problems, a primary care practice should be offering some option for these patients either in-house or with reliable referral relationships. Although the NY Times article doesn’t provide any numbers, it does mention that the providers are generally young and there is some turnover, possibly as providers use the practice as a “stepping stone.”

To some extent Dr. Cohen’s success seems to be the result of his real estate acumen and business sense. Because the majority of recent medical school graduates enter the work force with a substantial debt, it is difficult to imagine that a young physician would have Dr. Cohen’s entrepreneurial passion. However, clearly his success, at least in the short term, demonstrates that there is a substantial percentage of both patients and providers who prefer small personalized offices if given the option. It will be interesting to see if and how Tribeca Pediatrics expands and whether any of the larger existing networks attempt to imitate it.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

My first civilian job after finishing my training was as an associate and eventually a partner of a pediatrician whose office was in a wing of his large 19th-century home. The pediatrician in the neighboring town had his office in a small house next to his home. This model of small one- or two -provider offices in or nearby their homes was replicated up and down the coast. After 7 years, the 12-minute drive from my home to the office became intolerable and I asked to dissolve what was otherwise a successful partnership. I opened a one-provider office with a 6-minute bike ride commute and my wife served as the billing clerk and bookkeeper.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Those next 10 years of solo practice were the most rewarding, both economically and professionally. Eventually faced with the need to add another provider, I reluctantly joined a recently formed group of primary care physicians who, like me, had been running one- or two-provider offices often with spouses as support staff — basically Mom and Pop operations. However, the group was gradually absorbed by increasingly larger entities and our practices that once were as individual as our personalities became homogenized. Neither my patients nor I liked the new feel of the office.

Still pining for that small office vibe, I continue to wonder if it could be scaled up and adapted to today’s healthcare realities. I recently read a New York Times article describing how a pediatrician has launched such a practice model into the uncharted waters of Greater New York City.

At age 34, Dr. Michel Cohen, a Moroccan-French émigré, opened his storefront pediatric practice in 1994. The upper story housed his loft apartment. A self-described “hippie doctor,” Dr. Cohen developed a following based on his book on parenting and publicity surrounding his role in the even more popular book on French-style parenting titled Bringing up Bebe by Pamela Druckerman. By 2009 his practice had grown to three small storefront offices. However, they weren’t sufficiently profitable. He decided to shun the distractions of his celebrity practice trappings and instead focus on growth, hoping that the gravitas associated with even more office locations would allow him to offer better service and improve the bottom line. Sort of an “economy of scale” notion applied to the small office setting.

He now has 48 offices having added 12 new sites last year with 5 more planned for next year. These are all one- or two-physician installations with two exam rooms per provider. The offices are bright and colorful, focused on appealing to a child’s taste. The furniture is blond wood, most of it based on Dr. Cohen’s designs and in some cases handmade. Current staffing is 112 physicians and nurse practitioners and volume exceeds 100,000 visits per year.

The volume has allowed the practice to add a user-friendly patient portal and offer an after-hours call-in option. The larger volume means that staffing can be more easily adjusted to illness and vacations. The goal is to have the practitioners become identified with their sites and the patients assigned to them whenever possible. Uniformity in office designs allow a provider filling in from another site to easily find supplies and function within a familiar system.

While the sites have generally served upscale gentrified neighborhoods, the practice has recently expanded to less affluent areas and accepts Medicaid. Dr. Cohen’s dream is to expand his network nationally as a nonprofit in which low-income sites would be subsidized by the more profitable offices. A previous attempt at expansion with two offices in Southern California did not work out because the time zone difference didn’t mesh well with the Internet portal.

Wanting to hear a firsthand account from a family on how the Tribeca Pediatric system works, I contacted a neighbor who has recently moved his young family here to Brunswick. His impression was generally positive. He gave high marks to the patient portal for the ability to get school and camp forms and vaccination records quickly. Appointments made electronically was a plus, although the after-hours response time sometimes took an hour or two. He would have preferred to see their assigned provider for a higher percentage of visits, but this seems to be a common complaint even in systems with the greatest availability. Care was dispensed efficiently but didn’t seem to be overly rushed.

In the NY Times article there is one complaint by a former provider who felt she was getting burned out by the system and leaned on 10 minutes for sick visits and 20 minutes for well visits. Personally, I don’t see this as a problem. The length of a visit and the quality of the care are not always related. Given good support services and an efficiently run office, those slot guidelines seem very reasonable, realizing that a skilled clinician must have already learned to adjust his or her pace to the realities of the patient mix. However, as the pediatric sick population has leaned more toward behavioral and mental health problems, a primary care practice should be offering some option for these patients either in-house or with reliable referral relationships. Although the NY Times article doesn’t provide any numbers, it does mention that the providers are generally young and there is some turnover, possibly as providers use the practice as a “stepping stone.”

To some extent Dr. Cohen’s success seems to be the result of his real estate acumen and business sense. Because the majority of recent medical school graduates enter the work force with a substantial debt, it is difficult to imagine that a young physician would have Dr. Cohen’s entrepreneurial passion. However, clearly his success, at least in the short term, demonstrates that there is a substantial percentage of both patients and providers who prefer small personalized offices if given the option. It will be interesting to see if and how Tribeca Pediatrics expands and whether any of the larger existing networks attempt to imitate it.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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Unexpectedly Helpful Effects of Drugs Used For Other Reasons

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A 73-year-old man with hypertension is evaluated for right great toe pain. A tap of the toe reveals uric acid crystals. He has a history of hypertension and hyperlipidemia. His current medications are hydrochlorothiazide, amlodipine, and atorvastatin.

Which blood pressure medication would you recommend to replace his hydrochlorothiazide?

A. Furosemide

B. Chlorthalidone

C. Lisinopril

D. Losartan

E. Irbesartan

Losartan

Diuretics should be avoided if possible in a patient with gout, as they increase uric acid levels. Of the other three options, losartan offers the added benefit of lowering uric acid levels. Losartan has uricosuric effects — a property that is unique to losartan of the angiotensin receptor blockers (ARBs) that have been studied.1,2 The uric acid lowering appears to be a probenecid-like effect.

Dr. Douglas S. Paauw

Losartan has also been evaluated to see whether using it in combination with a thiazide diuretic can reduce the rise in uric acid that occurs with thiazides. Matsumura and colleagues looked at data from the COMFORT trial, focusing on the effect of combining losartan with hydrochlorothiazide on uric acid levels.3 They looked at a group of 118 patients on an ARB other than losartan plus a diuretic, who were then randomly assigned to losartan 50 mg/hydrochlorothiazide 12.5 mg or continuation of another ARB plus a diuretic. Blood pressure control was the same between groups, but the patients who received the losartan combination had lower uric acid levels (P = .01).

Ferreira and colleagues looked at the difference in uric acid lowering between high-dose (150 mg/day) vs low-dose losartan (50 mg/day).4 Compared with low-dose, high-dose losartan reduced serum uric acid by 0.27 (0.34 to 0.21) mg/dL, P < .001.
 

SGLT2 inhibitors

SGLT2 inhibitors also lower uric acid. Suijik and colleagues conducted an analysis of two randomized trials of SGLT2 inhibitors (empagliflozin and dapagliflozin), and concluded that SGLT2 inhibitors induce uric acid excretion, which is strongly linked to urinary glucose excretion.5

Metformin

Metformin is used as a firstline drug for the treatment of diabetes. It also has evidence for decreasing colonic polyps. Cho and colleagues looked at over 12,000 patients with diabetes over a 12-year period; 3775 underwent colonoscopies.6 They compared frequency of polyps in patients who were using metformin with those who were not treated with metformin. The polyp detection rate was lower in the metformin group than in the no metformin group (39.4% vs. 62.4%, P < .01).

Higurashi and colleagues performed a double-blind, placebo-controlled trial of metformin in nondiabetic patients for the prevention of colon polyps.7 The dose of metformin used in this study was very low (250 mg/day). There were significantly fewer adenomas in the metformin group (22 of 71 patients) than in the placebo group (32 of 62) (relative risk, 0.60; 95% confidence interval, 0.39-0.92, P = .016).
 

Thiazide diuretics

Thiazide diuretics have long been used to help prevent kidney stones in addition to treating hypertension. They decrease urinary calcium excretion, which may reduce kidney stones. Could this reduction in calcium excretion be good for bones?

Xiao and colleagues did a meta-analysis of 11 prospective studies involving 2,193,160 participants.8 Thiazide diuretic users had a significant 14% reduction in the risk of all fractures (RR, 0.86; 95% CI, 0.80-0.93; P = .009) and an 18% reduction in the risk of hip fracture (RR, 0.82; 95% CI, 0.80-0.93; P = .009). Kruse and colleagues found that long duration and continuity of thiazide exposure seemed to be important to obtain this protective effect on fracture risk.9

Pearls:

  • Losartan, but not other ARBs, lowers uric acid levels and may be helpful in managing hypertension in gout patients; higher doses lower uric acid more.
  • Metformin use appears to decrease colon polyp formation.
  • Thiazide diuretics may reduce fracture risk while patients are taking them.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Würzner G et al. Comparative effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia and gout. J Hypertens. 2001 Oct;19(10):1855-60.

2. Puig JG et al. Effect of eprosartan and losartan on uric acid metabolism in patients with essential hypertension. J Hypertens. 1999 Jul;17(7):1033-9.

3. Matsumura K et al. Effect of losartan on serum uric acid in hypertension treated with a diuretic: The COMFORT study. Clin Exp Hypertens. 2015;37(3):192-6.

4. Ferreira JP et al. High- versus low-dose losartan and uric acid: An analysis from HEAAL. J Cardiol. 2023 Jul;82(1):57-61.

5. Suijk DLS et al. SGLT2 inhibition and uric acid excretion in patients with type 2 diabetes and normal kidney function. Soc Nephrol. 2022 May;17(5):663-71.

6. Youn Hee Cho et al. Does metformin affect the incidence of colonic polyps and adenomas in patients with type 2 diabetes mellitus? Intestinal Res. 2014 Apr;12(2):139-45.

7. Higurashi T et al. Metformin for chemoprevention of metachronous colorectal adenoma or polyps in post-polypectomy patients without diabetes: A multicentre double-blind, placebo-controlled, randomised phase 3 trial. Lancet Oncol. 2016;17:475-83.

8. Xiao X et al. Thiazide diuretic usage and risk of fracture: a meta-analysis of cohort studies. Osteoporos Int. 2018 Jul;29(7):1515-24.

9. Kruse C et al. Continuous and long-term treatment is more important than dosage for the protective effect of thiazide use on bone metabolism and fracture risk. J Intern Med. 2016 Jan;279(1):110-22.

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A 73-year-old man with hypertension is evaluated for right great toe pain. A tap of the toe reveals uric acid crystals. He has a history of hypertension and hyperlipidemia. His current medications are hydrochlorothiazide, amlodipine, and atorvastatin.

Which blood pressure medication would you recommend to replace his hydrochlorothiazide?

A. Furosemide

B. Chlorthalidone

C. Lisinopril

D. Losartan

E. Irbesartan

Losartan

Diuretics should be avoided if possible in a patient with gout, as they increase uric acid levels. Of the other three options, losartan offers the added benefit of lowering uric acid levels. Losartan has uricosuric effects — a property that is unique to losartan of the angiotensin receptor blockers (ARBs) that have been studied.1,2 The uric acid lowering appears to be a probenecid-like effect.

Dr. Douglas S. Paauw

Losartan has also been evaluated to see whether using it in combination with a thiazide diuretic can reduce the rise in uric acid that occurs with thiazides. Matsumura and colleagues looked at data from the COMFORT trial, focusing on the effect of combining losartan with hydrochlorothiazide on uric acid levels.3 They looked at a group of 118 patients on an ARB other than losartan plus a diuretic, who were then randomly assigned to losartan 50 mg/hydrochlorothiazide 12.5 mg or continuation of another ARB plus a diuretic. Blood pressure control was the same between groups, but the patients who received the losartan combination had lower uric acid levels (P = .01).

Ferreira and colleagues looked at the difference in uric acid lowering between high-dose (150 mg/day) vs low-dose losartan (50 mg/day).4 Compared with low-dose, high-dose losartan reduced serum uric acid by 0.27 (0.34 to 0.21) mg/dL, P < .001.
 

SGLT2 inhibitors

SGLT2 inhibitors also lower uric acid. Suijik and colleagues conducted an analysis of two randomized trials of SGLT2 inhibitors (empagliflozin and dapagliflozin), and concluded that SGLT2 inhibitors induce uric acid excretion, which is strongly linked to urinary glucose excretion.5

Metformin

Metformin is used as a firstline drug for the treatment of diabetes. It also has evidence for decreasing colonic polyps. Cho and colleagues looked at over 12,000 patients with diabetes over a 12-year period; 3775 underwent colonoscopies.6 They compared frequency of polyps in patients who were using metformin with those who were not treated with metformin. The polyp detection rate was lower in the metformin group than in the no metformin group (39.4% vs. 62.4%, P < .01).

Higurashi and colleagues performed a double-blind, placebo-controlled trial of metformin in nondiabetic patients for the prevention of colon polyps.7 The dose of metformin used in this study was very low (250 mg/day). There were significantly fewer adenomas in the metformin group (22 of 71 patients) than in the placebo group (32 of 62) (relative risk, 0.60; 95% confidence interval, 0.39-0.92, P = .016).
 

Thiazide diuretics

Thiazide diuretics have long been used to help prevent kidney stones in addition to treating hypertension. They decrease urinary calcium excretion, which may reduce kidney stones. Could this reduction in calcium excretion be good for bones?

Xiao and colleagues did a meta-analysis of 11 prospective studies involving 2,193,160 participants.8 Thiazide diuretic users had a significant 14% reduction in the risk of all fractures (RR, 0.86; 95% CI, 0.80-0.93; P = .009) and an 18% reduction in the risk of hip fracture (RR, 0.82; 95% CI, 0.80-0.93; P = .009). Kruse and colleagues found that long duration and continuity of thiazide exposure seemed to be important to obtain this protective effect on fracture risk.9

Pearls:

  • Losartan, but not other ARBs, lowers uric acid levels and may be helpful in managing hypertension in gout patients; higher doses lower uric acid more.
  • Metformin use appears to decrease colon polyp formation.
  • Thiazide diuretics may reduce fracture risk while patients are taking them.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Würzner G et al. Comparative effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia and gout. J Hypertens. 2001 Oct;19(10):1855-60.

2. Puig JG et al. Effect of eprosartan and losartan on uric acid metabolism in patients with essential hypertension. J Hypertens. 1999 Jul;17(7):1033-9.

3. Matsumura K et al. Effect of losartan on serum uric acid in hypertension treated with a diuretic: The COMFORT study. Clin Exp Hypertens. 2015;37(3):192-6.

4. Ferreira JP et al. High- versus low-dose losartan and uric acid: An analysis from HEAAL. J Cardiol. 2023 Jul;82(1):57-61.

5. Suijk DLS et al. SGLT2 inhibition and uric acid excretion in patients with type 2 diabetes and normal kidney function. Soc Nephrol. 2022 May;17(5):663-71.

6. Youn Hee Cho et al. Does metformin affect the incidence of colonic polyps and adenomas in patients with type 2 diabetes mellitus? Intestinal Res. 2014 Apr;12(2):139-45.

7. Higurashi T et al. Metformin for chemoprevention of metachronous colorectal adenoma or polyps in post-polypectomy patients without diabetes: A multicentre double-blind, placebo-controlled, randomised phase 3 trial. Lancet Oncol. 2016;17:475-83.

8. Xiao X et al. Thiazide diuretic usage and risk of fracture: a meta-analysis of cohort studies. Osteoporos Int. 2018 Jul;29(7):1515-24.

9. Kruse C et al. Continuous and long-term treatment is more important than dosage for the protective effect of thiazide use on bone metabolism and fracture risk. J Intern Med. 2016 Jan;279(1):110-22.

A 73-year-old man with hypertension is evaluated for right great toe pain. A tap of the toe reveals uric acid crystals. He has a history of hypertension and hyperlipidemia. His current medications are hydrochlorothiazide, amlodipine, and atorvastatin.

Which blood pressure medication would you recommend to replace his hydrochlorothiazide?

A. Furosemide

B. Chlorthalidone

C. Lisinopril

D. Losartan

E. Irbesartan

Losartan

Diuretics should be avoided if possible in a patient with gout, as they increase uric acid levels. Of the other three options, losartan offers the added benefit of lowering uric acid levels. Losartan has uricosuric effects — a property that is unique to losartan of the angiotensin receptor blockers (ARBs) that have been studied.1,2 The uric acid lowering appears to be a probenecid-like effect.

Dr. Douglas S. Paauw

Losartan has also been evaluated to see whether using it in combination with a thiazide diuretic can reduce the rise in uric acid that occurs with thiazides. Matsumura and colleagues looked at data from the COMFORT trial, focusing on the effect of combining losartan with hydrochlorothiazide on uric acid levels.3 They looked at a group of 118 patients on an ARB other than losartan plus a diuretic, who were then randomly assigned to losartan 50 mg/hydrochlorothiazide 12.5 mg or continuation of another ARB plus a diuretic. Blood pressure control was the same between groups, but the patients who received the losartan combination had lower uric acid levels (P = .01).

Ferreira and colleagues looked at the difference in uric acid lowering between high-dose (150 mg/day) vs low-dose losartan (50 mg/day).4 Compared with low-dose, high-dose losartan reduced serum uric acid by 0.27 (0.34 to 0.21) mg/dL, P < .001.
 

SGLT2 inhibitors

SGLT2 inhibitors also lower uric acid. Suijik and colleagues conducted an analysis of two randomized trials of SGLT2 inhibitors (empagliflozin and dapagliflozin), and concluded that SGLT2 inhibitors induce uric acid excretion, which is strongly linked to urinary glucose excretion.5

Metformin

Metformin is used as a firstline drug for the treatment of diabetes. It also has evidence for decreasing colonic polyps. Cho and colleagues looked at over 12,000 patients with diabetes over a 12-year period; 3775 underwent colonoscopies.6 They compared frequency of polyps in patients who were using metformin with those who were not treated with metformin. The polyp detection rate was lower in the metformin group than in the no metformin group (39.4% vs. 62.4%, P < .01).

Higurashi and colleagues performed a double-blind, placebo-controlled trial of metformin in nondiabetic patients for the prevention of colon polyps.7 The dose of metformin used in this study was very low (250 mg/day). There were significantly fewer adenomas in the metformin group (22 of 71 patients) than in the placebo group (32 of 62) (relative risk, 0.60; 95% confidence interval, 0.39-0.92, P = .016).
 

Thiazide diuretics

Thiazide diuretics have long been used to help prevent kidney stones in addition to treating hypertension. They decrease urinary calcium excretion, which may reduce kidney stones. Could this reduction in calcium excretion be good for bones?

Xiao and colleagues did a meta-analysis of 11 prospective studies involving 2,193,160 participants.8 Thiazide diuretic users had a significant 14% reduction in the risk of all fractures (RR, 0.86; 95% CI, 0.80-0.93; P = .009) and an 18% reduction in the risk of hip fracture (RR, 0.82; 95% CI, 0.80-0.93; P = .009). Kruse and colleagues found that long duration and continuity of thiazide exposure seemed to be important to obtain this protective effect on fracture risk.9

Pearls:

  • Losartan, but not other ARBs, lowers uric acid levels and may be helpful in managing hypertension in gout patients; higher doses lower uric acid more.
  • Metformin use appears to decrease colon polyp formation.
  • Thiazide diuretics may reduce fracture risk while patients are taking them.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Würzner G et al. Comparative effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia and gout. J Hypertens. 2001 Oct;19(10):1855-60.

2. Puig JG et al. Effect of eprosartan and losartan on uric acid metabolism in patients with essential hypertension. J Hypertens. 1999 Jul;17(7):1033-9.

3. Matsumura K et al. Effect of losartan on serum uric acid in hypertension treated with a diuretic: The COMFORT study. Clin Exp Hypertens. 2015;37(3):192-6.

4. Ferreira JP et al. High- versus low-dose losartan and uric acid: An analysis from HEAAL. J Cardiol. 2023 Jul;82(1):57-61.

5. Suijk DLS et al. SGLT2 inhibition and uric acid excretion in patients with type 2 diabetes and normal kidney function. Soc Nephrol. 2022 May;17(5):663-71.

6. Youn Hee Cho et al. Does metformin affect the incidence of colonic polyps and adenomas in patients with type 2 diabetes mellitus? Intestinal Res. 2014 Apr;12(2):139-45.

7. Higurashi T et al. Metformin for chemoprevention of metachronous colorectal adenoma or polyps in post-polypectomy patients without diabetes: A multicentre double-blind, placebo-controlled, randomised phase 3 trial. Lancet Oncol. 2016;17:475-83.

8. Xiao X et al. Thiazide diuretic usage and risk of fracture: a meta-analysis of cohort studies. Osteoporos Int. 2018 Jul;29(7):1515-24.

9. Kruse C et al. Continuous and long-term treatment is more important than dosage for the protective effect of thiazide use on bone metabolism and fracture risk. J Intern Med. 2016 Jan;279(1):110-22.

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Shining a Light on Colorectal Cancer

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For more than two decades, March has been designated Colorectal Cancer Awareness Month. This annual observance serves as a reminder to spread the word in our local and national communities regarding the value of colorectal cancer screening and prevention. CRC prevention through screening and surveillance is a core part of our practice as gastroenterologists and plays a critical role in improving outcomes and reducing mortality from the second leading cause of cancer deaths in the US.

Dr. Megan A. Adams

While we have made great strides in increasing awareness among patients of the need for screening, overall screening rates remain well below our national target of 80% and significant disparities in screening persist. By disseminating key information about risk factors, promoting early detection through evidence-based screening, continuing to improve access to care by reducing financial and other barriers, and educating patients about available screening options that best fit their needs and preferences, we can continue to move the needle in improving overall screening rates and optimizing outcomes.

In this month’s issue of GIHN, we feature an excellent narrative review by Dr. Samir Gupta and colleagues describing the phenomenon of “birth cohort CRC,” which is thought to explain recent changes in CRC epidemiology, including rising incidence of early-onset colorectal cancer. We also highlight a timely study out of Kaiser Permanente investigating how best to communicate with patients with prior low-risk adenomas regarding updated colonoscopy intervals given recent guideline changes extending surveillance intervals from 5 to 7-10 years. This question is particularly relevant to resource-constrained healthcare settings, where proactive de-implementation of outdated surveillance intervals could improve access for other patients with more immediate need.

In our March Member Spotlight, we feature Dr. Andy Tau of Austin Gastroenterology, who shares important insights regarding his career as a GI hospitalist, a growing area of GI practice. Finally, in this month’s Perspectives column, Drs. Michael Weinstein of Capital Digestive Care and Paul Berggreen of GI Alliance provide powerful contrasting perspectives highlighting the pros and cons of private equity in GI and how to evaluate if it’s right for your practice. I found it to be a particularly fascinating read!
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

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For more than two decades, March has been designated Colorectal Cancer Awareness Month. This annual observance serves as a reminder to spread the word in our local and national communities regarding the value of colorectal cancer screening and prevention. CRC prevention through screening and surveillance is a core part of our practice as gastroenterologists and plays a critical role in improving outcomes and reducing mortality from the second leading cause of cancer deaths in the US.

Dr. Megan A. Adams

While we have made great strides in increasing awareness among patients of the need for screening, overall screening rates remain well below our national target of 80% and significant disparities in screening persist. By disseminating key information about risk factors, promoting early detection through evidence-based screening, continuing to improve access to care by reducing financial and other barriers, and educating patients about available screening options that best fit their needs and preferences, we can continue to move the needle in improving overall screening rates and optimizing outcomes.

In this month’s issue of GIHN, we feature an excellent narrative review by Dr. Samir Gupta and colleagues describing the phenomenon of “birth cohort CRC,” which is thought to explain recent changes in CRC epidemiology, including rising incidence of early-onset colorectal cancer. We also highlight a timely study out of Kaiser Permanente investigating how best to communicate with patients with prior low-risk adenomas regarding updated colonoscopy intervals given recent guideline changes extending surveillance intervals from 5 to 7-10 years. This question is particularly relevant to resource-constrained healthcare settings, where proactive de-implementation of outdated surveillance intervals could improve access for other patients with more immediate need.

In our March Member Spotlight, we feature Dr. Andy Tau of Austin Gastroenterology, who shares important insights regarding his career as a GI hospitalist, a growing area of GI practice. Finally, in this month’s Perspectives column, Drs. Michael Weinstein of Capital Digestive Care and Paul Berggreen of GI Alliance provide powerful contrasting perspectives highlighting the pros and cons of private equity in GI and how to evaluate if it’s right for your practice. I found it to be a particularly fascinating read!
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

For more than two decades, March has been designated Colorectal Cancer Awareness Month. This annual observance serves as a reminder to spread the word in our local and national communities regarding the value of colorectal cancer screening and prevention. CRC prevention through screening and surveillance is a core part of our practice as gastroenterologists and plays a critical role in improving outcomes and reducing mortality from the second leading cause of cancer deaths in the US.

Dr. Megan A. Adams

While we have made great strides in increasing awareness among patients of the need for screening, overall screening rates remain well below our national target of 80% and significant disparities in screening persist. By disseminating key information about risk factors, promoting early detection through evidence-based screening, continuing to improve access to care by reducing financial and other barriers, and educating patients about available screening options that best fit their needs and preferences, we can continue to move the needle in improving overall screening rates and optimizing outcomes.

In this month’s issue of GIHN, we feature an excellent narrative review by Dr. Samir Gupta and colleagues describing the phenomenon of “birth cohort CRC,” which is thought to explain recent changes in CRC epidemiology, including rising incidence of early-onset colorectal cancer. We also highlight a timely study out of Kaiser Permanente investigating how best to communicate with patients with prior low-risk adenomas regarding updated colonoscopy intervals given recent guideline changes extending surveillance intervals from 5 to 7-10 years. This question is particularly relevant to resource-constrained healthcare settings, where proactive de-implementation of outdated surveillance intervals could improve access for other patients with more immediate need.

In our March Member Spotlight, we feature Dr. Andy Tau of Austin Gastroenterology, who shares important insights regarding his career as a GI hospitalist, a growing area of GI practice. Finally, in this month’s Perspectives column, Drs. Michael Weinstein of Capital Digestive Care and Paul Berggreen of GI Alliance provide powerful contrasting perspectives highlighting the pros and cons of private equity in GI and how to evaluate if it’s right for your practice. I found it to be a particularly fascinating read!
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

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Private Equity in GI

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Dear colleagues,

In this issue of Perspectives we will explore the business of medicine. With changes in reimbursement models and health care regulation over the past decades, private practice gastroenterology has evolved. Many gastroenterologists are now employed or are part of larger consolidated organizations. A key part of this evolution has been the influx of private equity in GI. The impact of private equity is still being written, and while many have embraced this business model, others have been critical of its influence.

In this issue, Dr. Paul J. Berggreen discusses his group’s experience with private equity and how it has helped improve the quality of patient care that they provide.

Dr. Gyanprakash A. Ketwaroo


Dr. Michael L. Weinstein provides the counterpoint, discussing potential issues with the private equity model, and also highlighting an alternative path taken by his practice. An important topic for gastroenterologists of all ages. We welcome your experience with this issue. Please share with us on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

The Future of Medical Practice

BY DR. PAUL J. BERGGREEN

The future of medicine is being written as we speak. Trends that began in past decades have accelerated. Consolidation among massive hospital systems and health insurance conglomerates has gained momentum.

Physicians have been slow to organize and slower to mobilize. We spend our time caring for patients while national forces shape the future of our profession.

Courtesy Dr. Berggreen
Dr. Paul J. Berggreen

These trends have motivated many physicians to explore vehicles that allow them to remain independent. Creating business relationships with financial entities, including private equity, is one of those methods.

Before exploring those models, some background is instructive.

More than 100,000 doctors have left private practice and become employees of hospitals and other corporate entities since 2019. Today, approximately 75% of physicians are employees of larger health care entities – a record high.

This trend ought to alarm patients and policymakers. Research shows that independent medical practices often deliver better outcomes for patients than hospitals. Physician-owned practices also have lower per-patient costs, fewer preventable hospital admissions, and fewer re-admissions than their larger hospital-owned counterparts.

The business of medicine is very different than it was 40 years ago, when more than three in four doctors cared for patients in their own medical practices. The cost of managing a practice has surged. Labor, rent, and malpractice insurance have grown more expensive. Physicians have had to make significant investments in information technology and electronic health records.

Medicare’s reimbursement rates have not kept pace with these higher operational costs. In fact, Medicare payments to doctors have declined more than 25% in the last two decades after accounting for inflation.

By contrast, reimbursement for inpatient and outpatient hospital services as well as skilled nursing facilities has outpaced inflation since 2001.

Given these economic headwinds – and the mounting administrative and financial burdens that government regulation poses – many independent practitioners have concluded that they have little choice but to sell to larger entities like hospitals, health systems, or insurers.

If they do, they lose autonomy. Patients lose the personal touch an independent practice can offer.

To stay independent, many physicians are partnering with management services organizations (MSOs), which provide nonclinical services such as compliance, contracting, legal and IT support, cybersecurity, marketing, community outreach, recruiting assistance, billing, accounts payable, and guidance on the transition to value-based care.

MSOs are typically backed by investors: perhaps a public company, or a private equity firm. But it’s important to note that the clinical entity – the practice – remains separate from the MSO. Physicians retain control over clinical decision-making after partnering with an MSO.

Private equity is best viewed as a neutral financing mechanism that provides independent practices access to capital so they can build the business, clinical, and technological infrastructure to compete against the vertically integrated health systems that dominate medicine.

Private equity firms don’t “acquire” independent practices. A partnership with a private equity-backed MSO is often what empowers a practice to resist acquisition by a larger hospital or health care system.

The experience of my own practice, Arizona Digestive Health, is instructive. We partnered with GI Alliance – a private equity-backed, gastroenterologist-led MSO – in 2019.

My physician colleagues and I have retained complete clinical autonomy. But we now have the financial and operational support we need to remain independent – and deliver better care for our patients.

For example, we led the development of a GI-focused, population-based clinical dashboard that aggregates real-time data from almost 3 million patients across 16 states who are treated by practices affiliated with GI Alliance.

By drawing on that data, we’ve been able to implement comprehensive care-management programs. In the case of inflammatory bowel disease, for instance, we’ve been able to identify the highest-cost, most at-risk patients and implement more proactive treatment protocols, including dedicated care managers and hotlines. We’ve replicated this model in other disease states as well.

This kind of ongoing, high-touch intervention improves patient outcomes and reduces overall cost by minimizing unplanned episodes of care – like visits to the emergency room.

It’s not possible to provide this level of care in a smaller setting. I should know. I tried to implement a similar approach for the 55 doctors that comprise Arizona Digestive Health in Phoenix. We simply didn’t have the capital or resources to succeed.

Our experience at Arizona Digestive Health is not an outlier. I have seen numerous independent practices in gastroenterology and other specialties throughout the country leverage the resources of private equity-backed MSOs to enhance the level of care they provide – and improve patient outcomes and experiences.

In 2022, the physician leadership of GI Alliance spearheaded a transaction that resulted in the nearly 700 physicians whose independent gastroenterology practices were part of the alliance to grow their collective equity stake in the MSO to more than 85%. Our independent physicians now have voting control of the MSO board of directors.

This evolution of GI Alliance has enabled us to remain true to our mission of putting patients first while enhancing our ability to shape the business support our partnered gastroenterology practices need to expand access to the highest-quality, most affordable care in our communities.

Doctors caring for patients in their own practices used to be the foundation of the U.S. health care system – and for good reason. The model enables patients to receive more personalized care and build deeper, more longitudinal, more trusting relationships with their doctors. That remains the goal of physicians who value autonomy and independence.

Inaction will result in more of the same, with hospitals and insurance companies snapping up independent practices. It’s encouraging to see physicians take back control of their profession. But the climb remains steep.

The easiest way to predict the future is to invent it. Doing so in a patient-centric, physician-led, and physician-owned group is a great start to that journey.

Dr. Paul Berggreen is board chair and president of the American Independent Medical Practice Association. He is founder and president of Arizona Digestive Health, chief strategy officer for the GI Alliance, and chair of data analytics for the Digestive Health Physicians Association. He is also a consultant to Specialty Networks, which is not directly relevant to this article.

Thinking Strategically About Gastroenterology Practice

BY MICHAEL L. WEINSTEIN, MD

Whether you are a young gastroenterologist assessing your career opportunities, or a gastroenterology practice trying to assure your future success, you are likely considering how a private equity transaction might influence your options. In this column, I am going to share what I’ve learned and why my practice chose not to go the route of a private equity investment partner.

In 2018, Capital Digestive Care was an independent practice of 70 physicians centered around Washington, DC. Private equity firms were increasingly investing in health care, seeking to capitalize on the industry’s fragmentation, recession-proof business, and ability to leverage consolidation. Our leadership chose to spend a weekend on a strategic planning retreat to agree on our priorities and long-term goals. I highly recommend that you and/or your practice sit down to list your priorities as your first task.

Capital Digestive Care
Dr. Michael L. Weinstein

After defining priorities, a SWOT analysis of your position today and what you project over the next decade will determine a strategy. There is a current shortage of more than 1,400 gastroenterologists in the United States. That gives us a pretty powerful “strength.” However, the consolidation of commercial payers and hospital systems is forcing physicians to accept low reimbursement and navigate a maze of administrative burdens. The mountain of regulatory, administrative, and financial functions can push physicians away from independent practice. Additionally, recruiting, training, and managing an office of medical personnel is not what most gastroenterologists want to do with their time.

The common denominator to achieve success with all of these practice management issues is size. So before providing thoughts about private equity, I recommend consolidation of medical practices as the strategy to achieving long-term goals. Practice size will allow physicians to spread out the administrative work, the cost of the business personnel, the IT systems, and the specialized resources. Purchasing power and negotiation relevance is achieved with size. Our priorities are taking care of our patients, our staff, and our practice colleagues. If we are providing high-value service and have a size relevant to the insurance companies, then we can negotiate value-based contracts, and at the end of the day, we will be financially well-off.

In contrast to the list of priorities a physician would create, the private equity fund manager’s goal is to generate wealth for themselves and their investors. Everything else, like innovation, enhanced service, employee satisfaction, and great quality, takes a back seat to accumulating profit. Their investments are made with a life-cycle of 4-6 years during which money is deployed by acquiring companies, improving the company bottom line profit through cost cutting or bolt-on acquisitions, increasing company profit distributions by adding leveraged debt to the corporate ledger, and then selling the companies often to another private equity fund. Physicians are trained to provide care to patients, and fund managers are trained to create wealth.

The medical practice as a business can grow over a career and provides physicians with top tier incomes. We are proud of the businesses we build and believe they are valuable. Private equity funds acquire medical practices for the future revenue and not the past results. They value a medical practice based on a multiple of the portion of future income the practice wants to sell. They ensure their future revenue through agreements that provide them management fees plus 25%-35% of future physician income for the current and all future physicians. The private equity company will say that the physicians are still independent but in reality all providers become employees of the company with wages defined by a formula. The private equity-owned Management Services Organization (MSO) controls decisions on carrier contracts, practice investments, purchasing, hiring, and the operations of the medical office. To get around corporate practice of medicine regulations, the ownership of the medical practice is placed in the hands of a single friendly physician who has a unique relationship to the MSO.

In my opinion, private equity is not the best strategy to achieve a successful medical practice, including acquiring the needed technology and human resources. It comes at a steep price, including loss of control and a permanent forfeiture of income (“the scrape”). The rhetoric professes that there will be income repair, monetization of practice value, and opportunity for a “second bite of the apple” when the private equity managers sell your practice to the next owner. Private equity’s main contribution for their outsized gains is the capital they bring to the practice. Everything else they bring can be found without selling the income of future partners to create a little more wealth for current partners.

The long-term results of private equity investment in gastroenterology practices has yet to be written. The experience in other specialties is partly documented in literature but the real stories are often hidden behind non-disparagement and non-disclosure clauses. Several investigations show that private equity ownership of health care providers leads to higher costs to patients and payers, employee dissatisfaction, diminished patient access, and worse health outcomes. The Federal Trade Commission and Department of Justice have vowed to scrutinize private equity deals because of mounting evidence that the motive for profit can conflict with maintaining quality.

In 2019, Capital Digestive Care chose Physicians Endoscopy as our strategic partner with the goal of separating and expanding our back-office functions into an MSO capable of providing business services to a larger practice and services to other practices outside of our own. Physicians Endoscopy has since been acquired by Optum/SCA. PE GI Solutions, the MSO, is now a partnership of CDC physician partners and Optum/SCA. Capital Digestive Care remains a practice owned 100% by the physicians. A Business Support Services Agreement defines the services CDC receives and the fees paid to the PE GI Solutions. We maintain MSO Board seats and have input into the operations of the MSO.

Consider your motivations and the degree of control you need. Do you recognize your gaps of knowledge and are you willing to hire people to advise you? Will your practice achieve a balance between the interests of older and younger physicians? Becoming an employed physician in a large practice is an option to manage the concerns about future career stability. Improved quality, expanded service offerings, clout to negotiate value-based payment deals with payers, and back-office business efficiency does not require selling yourself to a private equity fund.
 

Dr. Michael L. Weinstein is a founder and now chief executive officer of Capital Digestive Care. He is a founder and past president of the Digestive Health Physicians Association, previous counselor on the Governing Board of the American Gastroenterological Association. He reports no relevant conflicts.

References

The FTC and DOJ have vowed to scrutinize private equity deals. Here’s what it means for health care. FIERCE Healthcare, 2022, Oct. 21.

The Effect of Private Equity Investment in Health Care. Penn LDI. 2023 Mar. 10.

Olson, LK. Ethically challenged: Private equity storms US health care. Baltimore: Johns Hopkins University Press. 2022.

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Dear colleagues,

In this issue of Perspectives we will explore the business of medicine. With changes in reimbursement models and health care regulation over the past decades, private practice gastroenterology has evolved. Many gastroenterologists are now employed or are part of larger consolidated organizations. A key part of this evolution has been the influx of private equity in GI. The impact of private equity is still being written, and while many have embraced this business model, others have been critical of its influence.

In this issue, Dr. Paul J. Berggreen discusses his group’s experience with private equity and how it has helped improve the quality of patient care that they provide.

Dr. Gyanprakash A. Ketwaroo


Dr. Michael L. Weinstein provides the counterpoint, discussing potential issues with the private equity model, and also highlighting an alternative path taken by his practice. An important topic for gastroenterologists of all ages. We welcome your experience with this issue. Please share with us on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

The Future of Medical Practice

BY DR. PAUL J. BERGGREEN

The future of medicine is being written as we speak. Trends that began in past decades have accelerated. Consolidation among massive hospital systems and health insurance conglomerates has gained momentum.

Physicians have been slow to organize and slower to mobilize. We spend our time caring for patients while national forces shape the future of our profession.

Courtesy Dr. Berggreen
Dr. Paul J. Berggreen

These trends have motivated many physicians to explore vehicles that allow them to remain independent. Creating business relationships with financial entities, including private equity, is one of those methods.

Before exploring those models, some background is instructive.

More than 100,000 doctors have left private practice and become employees of hospitals and other corporate entities since 2019. Today, approximately 75% of physicians are employees of larger health care entities – a record high.

This trend ought to alarm patients and policymakers. Research shows that independent medical practices often deliver better outcomes for patients than hospitals. Physician-owned practices also have lower per-patient costs, fewer preventable hospital admissions, and fewer re-admissions than their larger hospital-owned counterparts.

The business of medicine is very different than it was 40 years ago, when more than three in four doctors cared for patients in their own medical practices. The cost of managing a practice has surged. Labor, rent, and malpractice insurance have grown more expensive. Physicians have had to make significant investments in information technology and electronic health records.

Medicare’s reimbursement rates have not kept pace with these higher operational costs. In fact, Medicare payments to doctors have declined more than 25% in the last two decades after accounting for inflation.

By contrast, reimbursement for inpatient and outpatient hospital services as well as skilled nursing facilities has outpaced inflation since 2001.

Given these economic headwinds – and the mounting administrative and financial burdens that government regulation poses – many independent practitioners have concluded that they have little choice but to sell to larger entities like hospitals, health systems, or insurers.

If they do, they lose autonomy. Patients lose the personal touch an independent practice can offer.

To stay independent, many physicians are partnering with management services organizations (MSOs), which provide nonclinical services such as compliance, contracting, legal and IT support, cybersecurity, marketing, community outreach, recruiting assistance, billing, accounts payable, and guidance on the transition to value-based care.

MSOs are typically backed by investors: perhaps a public company, or a private equity firm. But it’s important to note that the clinical entity – the practice – remains separate from the MSO. Physicians retain control over clinical decision-making after partnering with an MSO.

Private equity is best viewed as a neutral financing mechanism that provides independent practices access to capital so they can build the business, clinical, and technological infrastructure to compete against the vertically integrated health systems that dominate medicine.

Private equity firms don’t “acquire” independent practices. A partnership with a private equity-backed MSO is often what empowers a practice to resist acquisition by a larger hospital or health care system.

The experience of my own practice, Arizona Digestive Health, is instructive. We partnered with GI Alliance – a private equity-backed, gastroenterologist-led MSO – in 2019.

My physician colleagues and I have retained complete clinical autonomy. But we now have the financial and operational support we need to remain independent – and deliver better care for our patients.

For example, we led the development of a GI-focused, population-based clinical dashboard that aggregates real-time data from almost 3 million patients across 16 states who are treated by practices affiliated with GI Alliance.

By drawing on that data, we’ve been able to implement comprehensive care-management programs. In the case of inflammatory bowel disease, for instance, we’ve been able to identify the highest-cost, most at-risk patients and implement more proactive treatment protocols, including dedicated care managers and hotlines. We’ve replicated this model in other disease states as well.

This kind of ongoing, high-touch intervention improves patient outcomes and reduces overall cost by minimizing unplanned episodes of care – like visits to the emergency room.

It’s not possible to provide this level of care in a smaller setting. I should know. I tried to implement a similar approach for the 55 doctors that comprise Arizona Digestive Health in Phoenix. We simply didn’t have the capital or resources to succeed.

Our experience at Arizona Digestive Health is not an outlier. I have seen numerous independent practices in gastroenterology and other specialties throughout the country leverage the resources of private equity-backed MSOs to enhance the level of care they provide – and improve patient outcomes and experiences.

In 2022, the physician leadership of GI Alliance spearheaded a transaction that resulted in the nearly 700 physicians whose independent gastroenterology practices were part of the alliance to grow their collective equity stake in the MSO to more than 85%. Our independent physicians now have voting control of the MSO board of directors.

This evolution of GI Alliance has enabled us to remain true to our mission of putting patients first while enhancing our ability to shape the business support our partnered gastroenterology practices need to expand access to the highest-quality, most affordable care in our communities.

Doctors caring for patients in their own practices used to be the foundation of the U.S. health care system – and for good reason. The model enables patients to receive more personalized care and build deeper, more longitudinal, more trusting relationships with their doctors. That remains the goal of physicians who value autonomy and independence.

Inaction will result in more of the same, with hospitals and insurance companies snapping up independent practices. It’s encouraging to see physicians take back control of their profession. But the climb remains steep.

The easiest way to predict the future is to invent it. Doing so in a patient-centric, physician-led, and physician-owned group is a great start to that journey.

Dr. Paul Berggreen is board chair and president of the American Independent Medical Practice Association. He is founder and president of Arizona Digestive Health, chief strategy officer for the GI Alliance, and chair of data analytics for the Digestive Health Physicians Association. He is also a consultant to Specialty Networks, which is not directly relevant to this article.

Thinking Strategically About Gastroenterology Practice

BY MICHAEL L. WEINSTEIN, MD

Whether you are a young gastroenterologist assessing your career opportunities, or a gastroenterology practice trying to assure your future success, you are likely considering how a private equity transaction might influence your options. In this column, I am going to share what I’ve learned and why my practice chose not to go the route of a private equity investment partner.

In 2018, Capital Digestive Care was an independent practice of 70 physicians centered around Washington, DC. Private equity firms were increasingly investing in health care, seeking to capitalize on the industry’s fragmentation, recession-proof business, and ability to leverage consolidation. Our leadership chose to spend a weekend on a strategic planning retreat to agree on our priorities and long-term goals. I highly recommend that you and/or your practice sit down to list your priorities as your first task.

Capital Digestive Care
Dr. Michael L. Weinstein

After defining priorities, a SWOT analysis of your position today and what you project over the next decade will determine a strategy. There is a current shortage of more than 1,400 gastroenterologists in the United States. That gives us a pretty powerful “strength.” However, the consolidation of commercial payers and hospital systems is forcing physicians to accept low reimbursement and navigate a maze of administrative burdens. The mountain of regulatory, administrative, and financial functions can push physicians away from independent practice. Additionally, recruiting, training, and managing an office of medical personnel is not what most gastroenterologists want to do with their time.

The common denominator to achieve success with all of these practice management issues is size. So before providing thoughts about private equity, I recommend consolidation of medical practices as the strategy to achieving long-term goals. Practice size will allow physicians to spread out the administrative work, the cost of the business personnel, the IT systems, and the specialized resources. Purchasing power and negotiation relevance is achieved with size. Our priorities are taking care of our patients, our staff, and our practice colleagues. If we are providing high-value service and have a size relevant to the insurance companies, then we can negotiate value-based contracts, and at the end of the day, we will be financially well-off.

In contrast to the list of priorities a physician would create, the private equity fund manager’s goal is to generate wealth for themselves and their investors. Everything else, like innovation, enhanced service, employee satisfaction, and great quality, takes a back seat to accumulating profit. Their investments are made with a life-cycle of 4-6 years during which money is deployed by acquiring companies, improving the company bottom line profit through cost cutting or bolt-on acquisitions, increasing company profit distributions by adding leveraged debt to the corporate ledger, and then selling the companies often to another private equity fund. Physicians are trained to provide care to patients, and fund managers are trained to create wealth.

The medical practice as a business can grow over a career and provides physicians with top tier incomes. We are proud of the businesses we build and believe they are valuable. Private equity funds acquire medical practices for the future revenue and not the past results. They value a medical practice based on a multiple of the portion of future income the practice wants to sell. They ensure their future revenue through agreements that provide them management fees plus 25%-35% of future physician income for the current and all future physicians. The private equity company will say that the physicians are still independent but in reality all providers become employees of the company with wages defined by a formula. The private equity-owned Management Services Organization (MSO) controls decisions on carrier contracts, practice investments, purchasing, hiring, and the operations of the medical office. To get around corporate practice of medicine regulations, the ownership of the medical practice is placed in the hands of a single friendly physician who has a unique relationship to the MSO.

In my opinion, private equity is not the best strategy to achieve a successful medical practice, including acquiring the needed technology and human resources. It comes at a steep price, including loss of control and a permanent forfeiture of income (“the scrape”). The rhetoric professes that there will be income repair, monetization of practice value, and opportunity for a “second bite of the apple” when the private equity managers sell your practice to the next owner. Private equity’s main contribution for their outsized gains is the capital they bring to the practice. Everything else they bring can be found without selling the income of future partners to create a little more wealth for current partners.

The long-term results of private equity investment in gastroenterology practices has yet to be written. The experience in other specialties is partly documented in literature but the real stories are often hidden behind non-disparagement and non-disclosure clauses. Several investigations show that private equity ownership of health care providers leads to higher costs to patients and payers, employee dissatisfaction, diminished patient access, and worse health outcomes. The Federal Trade Commission and Department of Justice have vowed to scrutinize private equity deals because of mounting evidence that the motive for profit can conflict with maintaining quality.

In 2019, Capital Digestive Care chose Physicians Endoscopy as our strategic partner with the goal of separating and expanding our back-office functions into an MSO capable of providing business services to a larger practice and services to other practices outside of our own. Physicians Endoscopy has since been acquired by Optum/SCA. PE GI Solutions, the MSO, is now a partnership of CDC physician partners and Optum/SCA. Capital Digestive Care remains a practice owned 100% by the physicians. A Business Support Services Agreement defines the services CDC receives and the fees paid to the PE GI Solutions. We maintain MSO Board seats and have input into the operations of the MSO.

Consider your motivations and the degree of control you need. Do you recognize your gaps of knowledge and are you willing to hire people to advise you? Will your practice achieve a balance between the interests of older and younger physicians? Becoming an employed physician in a large practice is an option to manage the concerns about future career stability. Improved quality, expanded service offerings, clout to negotiate value-based payment deals with payers, and back-office business efficiency does not require selling yourself to a private equity fund.
 

Dr. Michael L. Weinstein is a founder and now chief executive officer of Capital Digestive Care. He is a founder and past president of the Digestive Health Physicians Association, previous counselor on the Governing Board of the American Gastroenterological Association. He reports no relevant conflicts.

References

The FTC and DOJ have vowed to scrutinize private equity deals. Here’s what it means for health care. FIERCE Healthcare, 2022, Oct. 21.

The Effect of Private Equity Investment in Health Care. Penn LDI. 2023 Mar. 10.

Olson, LK. Ethically challenged: Private equity storms US health care. Baltimore: Johns Hopkins University Press. 2022.

 

Dear colleagues,

In this issue of Perspectives we will explore the business of medicine. With changes in reimbursement models and health care regulation over the past decades, private practice gastroenterology has evolved. Many gastroenterologists are now employed or are part of larger consolidated organizations. A key part of this evolution has been the influx of private equity in GI. The impact of private equity is still being written, and while many have embraced this business model, others have been critical of its influence.

In this issue, Dr. Paul J. Berggreen discusses his group’s experience with private equity and how it has helped improve the quality of patient care that they provide.

Dr. Gyanprakash A. Ketwaroo


Dr. Michael L. Weinstein provides the counterpoint, discussing potential issues with the private equity model, and also highlighting an alternative path taken by his practice. An important topic for gastroenterologists of all ages. We welcome your experience with this issue. Please share with us on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

The Future of Medical Practice

BY DR. PAUL J. BERGGREEN

The future of medicine is being written as we speak. Trends that began in past decades have accelerated. Consolidation among massive hospital systems and health insurance conglomerates has gained momentum.

Physicians have been slow to organize and slower to mobilize. We spend our time caring for patients while national forces shape the future of our profession.

Courtesy Dr. Berggreen
Dr. Paul J. Berggreen

These trends have motivated many physicians to explore vehicles that allow them to remain independent. Creating business relationships with financial entities, including private equity, is one of those methods.

Before exploring those models, some background is instructive.

More than 100,000 doctors have left private practice and become employees of hospitals and other corporate entities since 2019. Today, approximately 75% of physicians are employees of larger health care entities – a record high.

This trend ought to alarm patients and policymakers. Research shows that independent medical practices often deliver better outcomes for patients than hospitals. Physician-owned practices also have lower per-patient costs, fewer preventable hospital admissions, and fewer re-admissions than their larger hospital-owned counterparts.

The business of medicine is very different than it was 40 years ago, when more than three in four doctors cared for patients in their own medical practices. The cost of managing a practice has surged. Labor, rent, and malpractice insurance have grown more expensive. Physicians have had to make significant investments in information technology and electronic health records.

Medicare’s reimbursement rates have not kept pace with these higher operational costs. In fact, Medicare payments to doctors have declined more than 25% in the last two decades after accounting for inflation.

By contrast, reimbursement for inpatient and outpatient hospital services as well as skilled nursing facilities has outpaced inflation since 2001.

Given these economic headwinds – and the mounting administrative and financial burdens that government regulation poses – many independent practitioners have concluded that they have little choice but to sell to larger entities like hospitals, health systems, or insurers.

If they do, they lose autonomy. Patients lose the personal touch an independent practice can offer.

To stay independent, many physicians are partnering with management services organizations (MSOs), which provide nonclinical services such as compliance, contracting, legal and IT support, cybersecurity, marketing, community outreach, recruiting assistance, billing, accounts payable, and guidance on the transition to value-based care.

MSOs are typically backed by investors: perhaps a public company, or a private equity firm. But it’s important to note that the clinical entity – the practice – remains separate from the MSO. Physicians retain control over clinical decision-making after partnering with an MSO.

Private equity is best viewed as a neutral financing mechanism that provides independent practices access to capital so they can build the business, clinical, and technological infrastructure to compete against the vertically integrated health systems that dominate medicine.

Private equity firms don’t “acquire” independent practices. A partnership with a private equity-backed MSO is often what empowers a practice to resist acquisition by a larger hospital or health care system.

The experience of my own practice, Arizona Digestive Health, is instructive. We partnered with GI Alliance – a private equity-backed, gastroenterologist-led MSO – in 2019.

My physician colleagues and I have retained complete clinical autonomy. But we now have the financial and operational support we need to remain independent – and deliver better care for our patients.

For example, we led the development of a GI-focused, population-based clinical dashboard that aggregates real-time data from almost 3 million patients across 16 states who are treated by practices affiliated with GI Alliance.

By drawing on that data, we’ve been able to implement comprehensive care-management programs. In the case of inflammatory bowel disease, for instance, we’ve been able to identify the highest-cost, most at-risk patients and implement more proactive treatment protocols, including dedicated care managers and hotlines. We’ve replicated this model in other disease states as well.

This kind of ongoing, high-touch intervention improves patient outcomes and reduces overall cost by minimizing unplanned episodes of care – like visits to the emergency room.

It’s not possible to provide this level of care in a smaller setting. I should know. I tried to implement a similar approach for the 55 doctors that comprise Arizona Digestive Health in Phoenix. We simply didn’t have the capital or resources to succeed.

Our experience at Arizona Digestive Health is not an outlier. I have seen numerous independent practices in gastroenterology and other specialties throughout the country leverage the resources of private equity-backed MSOs to enhance the level of care they provide – and improve patient outcomes and experiences.

In 2022, the physician leadership of GI Alliance spearheaded a transaction that resulted in the nearly 700 physicians whose independent gastroenterology practices were part of the alliance to grow their collective equity stake in the MSO to more than 85%. Our independent physicians now have voting control of the MSO board of directors.

This evolution of GI Alliance has enabled us to remain true to our mission of putting patients first while enhancing our ability to shape the business support our partnered gastroenterology practices need to expand access to the highest-quality, most affordable care in our communities.

Doctors caring for patients in their own practices used to be the foundation of the U.S. health care system – and for good reason. The model enables patients to receive more personalized care and build deeper, more longitudinal, more trusting relationships with their doctors. That remains the goal of physicians who value autonomy and independence.

Inaction will result in more of the same, with hospitals and insurance companies snapping up independent practices. It’s encouraging to see physicians take back control of their profession. But the climb remains steep.

The easiest way to predict the future is to invent it. Doing so in a patient-centric, physician-led, and physician-owned group is a great start to that journey.

Dr. Paul Berggreen is board chair and president of the American Independent Medical Practice Association. He is founder and president of Arizona Digestive Health, chief strategy officer for the GI Alliance, and chair of data analytics for the Digestive Health Physicians Association. He is also a consultant to Specialty Networks, which is not directly relevant to this article.

Thinking Strategically About Gastroenterology Practice

BY MICHAEL L. WEINSTEIN, MD

Whether you are a young gastroenterologist assessing your career opportunities, or a gastroenterology practice trying to assure your future success, you are likely considering how a private equity transaction might influence your options. In this column, I am going to share what I’ve learned and why my practice chose not to go the route of a private equity investment partner.

In 2018, Capital Digestive Care was an independent practice of 70 physicians centered around Washington, DC. Private equity firms were increasingly investing in health care, seeking to capitalize on the industry’s fragmentation, recession-proof business, and ability to leverage consolidation. Our leadership chose to spend a weekend on a strategic planning retreat to agree on our priorities and long-term goals. I highly recommend that you and/or your practice sit down to list your priorities as your first task.

Capital Digestive Care
Dr. Michael L. Weinstein

After defining priorities, a SWOT analysis of your position today and what you project over the next decade will determine a strategy. There is a current shortage of more than 1,400 gastroenterologists in the United States. That gives us a pretty powerful “strength.” However, the consolidation of commercial payers and hospital systems is forcing physicians to accept low reimbursement and navigate a maze of administrative burdens. The mountain of regulatory, administrative, and financial functions can push physicians away from independent practice. Additionally, recruiting, training, and managing an office of medical personnel is not what most gastroenterologists want to do with their time.

The common denominator to achieve success with all of these practice management issues is size. So before providing thoughts about private equity, I recommend consolidation of medical practices as the strategy to achieving long-term goals. Practice size will allow physicians to spread out the administrative work, the cost of the business personnel, the IT systems, and the specialized resources. Purchasing power and negotiation relevance is achieved with size. Our priorities are taking care of our patients, our staff, and our practice colleagues. If we are providing high-value service and have a size relevant to the insurance companies, then we can negotiate value-based contracts, and at the end of the day, we will be financially well-off.

In contrast to the list of priorities a physician would create, the private equity fund manager’s goal is to generate wealth for themselves and their investors. Everything else, like innovation, enhanced service, employee satisfaction, and great quality, takes a back seat to accumulating profit. Their investments are made with a life-cycle of 4-6 years during which money is deployed by acquiring companies, improving the company bottom line profit through cost cutting or bolt-on acquisitions, increasing company profit distributions by adding leveraged debt to the corporate ledger, and then selling the companies often to another private equity fund. Physicians are trained to provide care to patients, and fund managers are trained to create wealth.

The medical practice as a business can grow over a career and provides physicians with top tier incomes. We are proud of the businesses we build and believe they are valuable. Private equity funds acquire medical practices for the future revenue and not the past results. They value a medical practice based on a multiple of the portion of future income the practice wants to sell. They ensure their future revenue through agreements that provide them management fees plus 25%-35% of future physician income for the current and all future physicians. The private equity company will say that the physicians are still independent but in reality all providers become employees of the company with wages defined by a formula. The private equity-owned Management Services Organization (MSO) controls decisions on carrier contracts, practice investments, purchasing, hiring, and the operations of the medical office. To get around corporate practice of medicine regulations, the ownership of the medical practice is placed in the hands of a single friendly physician who has a unique relationship to the MSO.

In my opinion, private equity is not the best strategy to achieve a successful medical practice, including acquiring the needed technology and human resources. It comes at a steep price, including loss of control and a permanent forfeiture of income (“the scrape”). The rhetoric professes that there will be income repair, monetization of practice value, and opportunity for a “second bite of the apple” when the private equity managers sell your practice to the next owner. Private equity’s main contribution for their outsized gains is the capital they bring to the practice. Everything else they bring can be found without selling the income of future partners to create a little more wealth for current partners.

The long-term results of private equity investment in gastroenterology practices has yet to be written. The experience in other specialties is partly documented in literature but the real stories are often hidden behind non-disparagement and non-disclosure clauses. Several investigations show that private equity ownership of health care providers leads to higher costs to patients and payers, employee dissatisfaction, diminished patient access, and worse health outcomes. The Federal Trade Commission and Department of Justice have vowed to scrutinize private equity deals because of mounting evidence that the motive for profit can conflict with maintaining quality.

In 2019, Capital Digestive Care chose Physicians Endoscopy as our strategic partner with the goal of separating and expanding our back-office functions into an MSO capable of providing business services to a larger practice and services to other practices outside of our own. Physicians Endoscopy has since been acquired by Optum/SCA. PE GI Solutions, the MSO, is now a partnership of CDC physician partners and Optum/SCA. Capital Digestive Care remains a practice owned 100% by the physicians. A Business Support Services Agreement defines the services CDC receives and the fees paid to the PE GI Solutions. We maintain MSO Board seats and have input into the operations of the MSO.

Consider your motivations and the degree of control you need. Do you recognize your gaps of knowledge and are you willing to hire people to advise you? Will your practice achieve a balance between the interests of older and younger physicians? Becoming an employed physician in a large practice is an option to manage the concerns about future career stability. Improved quality, expanded service offerings, clout to negotiate value-based payment deals with payers, and back-office business efficiency does not require selling yourself to a private equity fund.
 

Dr. Michael L. Weinstein is a founder and now chief executive officer of Capital Digestive Care. He is a founder and past president of the Digestive Health Physicians Association, previous counselor on the Governing Board of the American Gastroenterological Association. He reports no relevant conflicts.

References

The FTC and DOJ have vowed to scrutinize private equity deals. Here’s what it means for health care. FIERCE Healthcare, 2022, Oct. 21.

The Effect of Private Equity Investment in Health Care. Penn LDI. 2023 Mar. 10.

Olson, LK. Ethically challenged: Private equity storms US health care. Baltimore: Johns Hopkins University Press. 2022.

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‘Less is More’ in Myeloma

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As an avid student of myeloma clinical trial history, I greatly appreciate the groundwork laid by past efforts. All that hard work has helped ease my journey as a junior hematologist with a focus on myeloma. Delving into old trials is not just an academic exercise; it provides pearls and insights that continue to shape our day-to-day approach to patient care.

Among those that intrigue me most are the pioneering “less is more” trials that challenged conventional practices and remain relevant today. One such trial was inspired by a patient’s dissatisfaction with high doses of dexamethasone and its side effects.

Dr. Mohyuddin
Dr. Manni Mohyuddin

Unlike the prevailing norm of frequent high doses, this trial compared a steroid dose administered weekly (as opposed to doses given several days a week). Lo and behold, the lower steroid dosage was associated with significantly better survival rates. At 1-year follow-up, 96% of patients in the lower-dose group were alive, compared with 87% in the higher-dose group.

Another noteworthy “less-is more” trial that I love, spearheaded by an Italian team, also focused on steroid dosage. This trial investigated discontinuing dexamethasone after nine cycles, along with reducing the dose of lenalidomide, versus maintaining long-term treatment without reductions. The findings revealed comparable progression-free survival with reduced toxicity, highlighting the potential benefits of this less-is-more approach.

While these trials are inspirational, a closer examination of myeloma trial history, especially those that led to regulatory approvals, reveals a preponderance of “add-on” trials. You add a potentially effective drug to an existing backbone, and you get an improvement in an outcome such as response rate (shrinking cancer) or duration of remission or progression free survival (amount of time alive and in remission).

Such trials have led to an abundance of effective options. But these same trials have almost always been a comparison of three drugs versus two drugs, and almost never three drugs versus three. And the drugs are often given continuously, especially the “newer” added drug, without a break. As a result, we are left completely unsure of how to sequence our drugs, and whether a finite course of the new drug would be equivalent to administering that new drug forever.

This problem is not unique to myeloma. Yet it is very apparent in myeloma, because we have been lucky to have so many good drugs (or at least “potentially” good drugs) that make it to phase 3 trials.

Unfortunately, the landscape of clinical trials is heavily influenced by the pharmaceutical industry, with limited funding available from alternative sources. As a result, there is a scarcity of trials exploring “less is more” approaches, despite their potential to optimize treatment outcomes and quality of life. 

Even government-funded trials run by cooperative groups require industry buy-in or are run by people who have very close contacts and conflicts of interest with industry. We need so many more of these less-is-more trials, but we have limited means to fund them.

These are the kinds of discussions I have with my patients daily. We grapple with questions about the necessity of lifelong (or any) maintenance therapy or the feasibility of treatment breaks for patients with stable disease. While we strive to provide the best care possible, the lack of definitive data often leaves us making tough decisions in the clinic.

I am grateful to those who are working tirelessly to facilitate trials that prioritize quality of life and “less is more” approaches. Your efforts are invaluable. Looking forward, I aspire to contribute to this important work.

Dr. Mohyuddin is assistant professor in the multiple myeloma program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City. 

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As an avid student of myeloma clinical trial history, I greatly appreciate the groundwork laid by past efforts. All that hard work has helped ease my journey as a junior hematologist with a focus on myeloma. Delving into old trials is not just an academic exercise; it provides pearls and insights that continue to shape our day-to-day approach to patient care.

Among those that intrigue me most are the pioneering “less is more” trials that challenged conventional practices and remain relevant today. One such trial was inspired by a patient’s dissatisfaction with high doses of dexamethasone and its side effects.

Dr. Mohyuddin
Dr. Manni Mohyuddin

Unlike the prevailing norm of frequent high doses, this trial compared a steroid dose administered weekly (as opposed to doses given several days a week). Lo and behold, the lower steroid dosage was associated with significantly better survival rates. At 1-year follow-up, 96% of patients in the lower-dose group were alive, compared with 87% in the higher-dose group.

Another noteworthy “less-is more” trial that I love, spearheaded by an Italian team, also focused on steroid dosage. This trial investigated discontinuing dexamethasone after nine cycles, along with reducing the dose of lenalidomide, versus maintaining long-term treatment without reductions. The findings revealed comparable progression-free survival with reduced toxicity, highlighting the potential benefits of this less-is-more approach.

While these trials are inspirational, a closer examination of myeloma trial history, especially those that led to regulatory approvals, reveals a preponderance of “add-on” trials. You add a potentially effective drug to an existing backbone, and you get an improvement in an outcome such as response rate (shrinking cancer) or duration of remission or progression free survival (amount of time alive and in remission).

Such trials have led to an abundance of effective options. But these same trials have almost always been a comparison of three drugs versus two drugs, and almost never three drugs versus three. And the drugs are often given continuously, especially the “newer” added drug, without a break. As a result, we are left completely unsure of how to sequence our drugs, and whether a finite course of the new drug would be equivalent to administering that new drug forever.

This problem is not unique to myeloma. Yet it is very apparent in myeloma, because we have been lucky to have so many good drugs (or at least “potentially” good drugs) that make it to phase 3 trials.

Unfortunately, the landscape of clinical trials is heavily influenced by the pharmaceutical industry, with limited funding available from alternative sources. As a result, there is a scarcity of trials exploring “less is more” approaches, despite their potential to optimize treatment outcomes and quality of life. 

Even government-funded trials run by cooperative groups require industry buy-in or are run by people who have very close contacts and conflicts of interest with industry. We need so many more of these less-is-more trials, but we have limited means to fund them.

These are the kinds of discussions I have with my patients daily. We grapple with questions about the necessity of lifelong (or any) maintenance therapy or the feasibility of treatment breaks for patients with stable disease. While we strive to provide the best care possible, the lack of definitive data often leaves us making tough decisions in the clinic.

I am grateful to those who are working tirelessly to facilitate trials that prioritize quality of life and “less is more” approaches. Your efforts are invaluable. Looking forward, I aspire to contribute to this important work.

Dr. Mohyuddin is assistant professor in the multiple myeloma program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City. 

As an avid student of myeloma clinical trial history, I greatly appreciate the groundwork laid by past efforts. All that hard work has helped ease my journey as a junior hematologist with a focus on myeloma. Delving into old trials is not just an academic exercise; it provides pearls and insights that continue to shape our day-to-day approach to patient care.

Among those that intrigue me most are the pioneering “less is more” trials that challenged conventional practices and remain relevant today. One such trial was inspired by a patient’s dissatisfaction with high doses of dexamethasone and its side effects.

Dr. Mohyuddin
Dr. Manni Mohyuddin

Unlike the prevailing norm of frequent high doses, this trial compared a steroid dose administered weekly (as opposed to doses given several days a week). Lo and behold, the lower steroid dosage was associated with significantly better survival rates. At 1-year follow-up, 96% of patients in the lower-dose group were alive, compared with 87% in the higher-dose group.

Another noteworthy “less-is more” trial that I love, spearheaded by an Italian team, also focused on steroid dosage. This trial investigated discontinuing dexamethasone after nine cycles, along with reducing the dose of lenalidomide, versus maintaining long-term treatment without reductions. The findings revealed comparable progression-free survival with reduced toxicity, highlighting the potential benefits of this less-is-more approach.

While these trials are inspirational, a closer examination of myeloma trial history, especially those that led to regulatory approvals, reveals a preponderance of “add-on” trials. You add a potentially effective drug to an existing backbone, and you get an improvement in an outcome such as response rate (shrinking cancer) or duration of remission or progression free survival (amount of time alive and in remission).

Such trials have led to an abundance of effective options. But these same trials have almost always been a comparison of three drugs versus two drugs, and almost never three drugs versus three. And the drugs are often given continuously, especially the “newer” added drug, without a break. As a result, we are left completely unsure of how to sequence our drugs, and whether a finite course of the new drug would be equivalent to administering that new drug forever.

This problem is not unique to myeloma. Yet it is very apparent in myeloma, because we have been lucky to have so many good drugs (or at least “potentially” good drugs) that make it to phase 3 trials.

Unfortunately, the landscape of clinical trials is heavily influenced by the pharmaceutical industry, with limited funding available from alternative sources. As a result, there is a scarcity of trials exploring “less is more” approaches, despite their potential to optimize treatment outcomes and quality of life. 

Even government-funded trials run by cooperative groups require industry buy-in or are run by people who have very close contacts and conflicts of interest with industry. We need so many more of these less-is-more trials, but we have limited means to fund them.

These are the kinds of discussions I have with my patients daily. We grapple with questions about the necessity of lifelong (or any) maintenance therapy or the feasibility of treatment breaks for patients with stable disease. While we strive to provide the best care possible, the lack of definitive data often leaves us making tough decisions in the clinic.

I am grateful to those who are working tirelessly to facilitate trials that prioritize quality of life and “less is more” approaches. Your efforts are invaluable. Looking forward, I aspire to contribute to this important work.

Dr. Mohyuddin is assistant professor in the multiple myeloma program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City. 

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‘Miracle’ Drugs

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Thu, 02/29/2024 - 16:15

We toss the word “miracle” around a lot — the ’69 Mets; the 1980 U.S. mens hockey team; Charlton Heston scowling into the wind, parting the waters of the Red Sea (or at least a Hollywood backlot).

We especially like to use it for medications, as in “miracle drug.”

Those of us who do this long enough know there ain’t no such thing, but the term keeps coming up — aspirin, penicillin, Botox ...

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Recently, the popular press has hung the moniker on the GLP-1 drugs, like Ozempic, as “miracles.” While certainly useful, most of this comes from the drug’s reputation as the American dream of something that causes weight loss without the bother of diet and exercise. Of course, it’s also useful for diabetes, and is being investigated for numerous other conditions.

But the real truth is that it’s not a miracle (in fairness, none of the manufacturers of these drugs are making such a ridiculous claim). Nothing is. The word is tossed around for so many things that it’s almost become meaningless.

This isn’t a knock on the GLP-1 agents as much as it’s how people are. We want to be believe something will cure whatever ails us without side effects or other fuss. Of course, such a drug will never exist, in spite of all the claims on various Internet sites about miracle cures that Big Medicine is hiding from the public.

People are similar, but not the same, and too heterogeneous to know which drug will work/not work or cause a given side effect. We all deal with the uncertainties of medicine being a trial and error process. We try our best to communicate this to people, with varying degrees of success.

Unfortunately, human nature is such that we often hear only what we want to hear. You can run down the whole list of concerns, but some people stopped paying attention when they heard “weight loss” or “migraine relief” or whatever. Every physician ever has had to deal with this, as will those who follow us.

Medicine changes. People ... not so much.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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We toss the word “miracle” around a lot — the ’69 Mets; the 1980 U.S. mens hockey team; Charlton Heston scowling into the wind, parting the waters of the Red Sea (or at least a Hollywood backlot).

We especially like to use it for medications, as in “miracle drug.”

Those of us who do this long enough know there ain’t no such thing, but the term keeps coming up — aspirin, penicillin, Botox ...

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Recently, the popular press has hung the moniker on the GLP-1 drugs, like Ozempic, as “miracles.” While certainly useful, most of this comes from the drug’s reputation as the American dream of something that causes weight loss without the bother of diet and exercise. Of course, it’s also useful for diabetes, and is being investigated for numerous other conditions.

But the real truth is that it’s not a miracle (in fairness, none of the manufacturers of these drugs are making such a ridiculous claim). Nothing is. The word is tossed around for so many things that it’s almost become meaningless.

This isn’t a knock on the GLP-1 agents as much as it’s how people are. We want to be believe something will cure whatever ails us without side effects or other fuss. Of course, such a drug will never exist, in spite of all the claims on various Internet sites about miracle cures that Big Medicine is hiding from the public.

People are similar, but not the same, and too heterogeneous to know which drug will work/not work or cause a given side effect. We all deal with the uncertainties of medicine being a trial and error process. We try our best to communicate this to people, with varying degrees of success.

Unfortunately, human nature is such that we often hear only what we want to hear. You can run down the whole list of concerns, but some people stopped paying attention when they heard “weight loss” or “migraine relief” or whatever. Every physician ever has had to deal with this, as will those who follow us.

Medicine changes. People ... not so much.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

We toss the word “miracle” around a lot — the ’69 Mets; the 1980 U.S. mens hockey team; Charlton Heston scowling into the wind, parting the waters of the Red Sea (or at least a Hollywood backlot).

We especially like to use it for medications, as in “miracle drug.”

Those of us who do this long enough know there ain’t no such thing, but the term keeps coming up — aspirin, penicillin, Botox ...

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Recently, the popular press has hung the moniker on the GLP-1 drugs, like Ozempic, as “miracles.” While certainly useful, most of this comes from the drug’s reputation as the American dream of something that causes weight loss without the bother of diet and exercise. Of course, it’s also useful for diabetes, and is being investigated for numerous other conditions.

But the real truth is that it’s not a miracle (in fairness, none of the manufacturers of these drugs are making such a ridiculous claim). Nothing is. The word is tossed around for so many things that it’s almost become meaningless.

This isn’t a knock on the GLP-1 agents as much as it’s how people are. We want to be believe something will cure whatever ails us without side effects or other fuss. Of course, such a drug will never exist, in spite of all the claims on various Internet sites about miracle cures that Big Medicine is hiding from the public.

People are similar, but not the same, and too heterogeneous to know which drug will work/not work or cause a given side effect. We all deal with the uncertainties of medicine being a trial and error process. We try our best to communicate this to people, with varying degrees of success.

Unfortunately, human nature is such that we often hear only what we want to hear. You can run down the whole list of concerns, but some people stopped paying attention when they heard “weight loss” or “migraine relief” or whatever. Every physician ever has had to deal with this, as will those who follow us.

Medicine changes. People ... not so much.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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SUID and a Cardboard Box

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Thu, 02/29/2024 - 09:41

In this February’s issue of the journal Pediatrics there is an interesting paper that explores the demographics and sleep environments of the more than 8000 sudden unexpected infant death (SUID) victims who died in the United States between 2011 and 2020. The authors’ broad conclusion was “Most SUID, regardless of sleep location, had multiple unsafe sleep factors present demonstrating the need for comprehensive sleep counseling for every family at every encounter.”

From the perspective of a former busy primary care physician I shudder when I read a statement this broad because it doesn’t acknowledge the realities of my professional life. A sentence containing “comprehensive” and two “every’s” won’t be taken seriously by most of the practicing pediatricians I know. However, there is an abundance of information generated by these investigators that could help a pediatrician target his advice to the individual families in his practice without having to resort to time-consuming comprehensive counseling, which is likely to sound like just so much chatter to families overwhelmed by the new challenge of raising a child.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

For example, nearly 60% of SUID cases were sharing a sleep surface when they died, and surface-sharing infants were more likely to not have a crib in their home. It seems to me that one should start with the simple question, “Do your have a crib in your home ... in all the homes where the baby will sleep?” And, it should be asked in the hospital prior to discharge.

In 1993, our second-born daughter went home from a teaching hospital in a cardboard box. So did all of her nursery mates. It was decorated with a stork motif and had served as her bassinet. Since early in the last century, families in Finland have been offered a similar box filled with baby supplies. Shrinkflation has caused a scale back in its contents, but the box itself has remained as a safe and inexpensive sleep surface for income-challenged families.

Many babies in this country are put to sleep in a variety of places as they are shuttled around to where the inexpensive childcare is available. Offering families as many boxes as they need may avoid the tragedy of their infant smothering on Aunt Louise’s couch or Cousin Martha’s bed littered with pillows. This is particularly important in a family with multiples (twins, triplets, etc.) who are overrepresented in the SUID population. The opening question about crib availability is likely to alert the healthcare provider to a social situation dominated by poverty that may include lower parental education and a higher likelihood of residential insecurity, all of which are associated with surface-sharing.

The authors observe “surface-sharing in and of itself may not be what caregiver education should focus on.” A simple cardboard box, however, is not a sleep surface likely to be shared with an adult.

For the families for whom surface-sharing is a choice and not a necessity, the investigators encourage us to engage families on their motivation for surface-sharing. This is a discussion that clinicians should be initiating, regardless of our concern of SUID prevention, by simply asking “How are you and your baby sleeping?” Is the baby being nursed to sleep? Where? While the authors acknowledge that their raw data did not allow them to make any observations on a relationship between surface-sharing and breastfeeding, my anecdotal observations have found an unfortunate number of mothers who have become human pacifiers for their babies and are co-sleeping. This association can result in a sleep-deprived parent(s) with unhealthy consequences. Although it can be difficult to uncouple breastfeeding from settling, early intervention triggered by asking a simple question can improve the chances of resolution.

Although I may quibble with the wording of authors’ final conclusion, this is an excellent paper worth looking at. SUID while infrequent and for the most part still mysterious is a tragedy that we should be able to prevent.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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In this February’s issue of the journal Pediatrics there is an interesting paper that explores the demographics and sleep environments of the more than 8000 sudden unexpected infant death (SUID) victims who died in the United States between 2011 and 2020. The authors’ broad conclusion was “Most SUID, regardless of sleep location, had multiple unsafe sleep factors present demonstrating the need for comprehensive sleep counseling for every family at every encounter.”

From the perspective of a former busy primary care physician I shudder when I read a statement this broad because it doesn’t acknowledge the realities of my professional life. A sentence containing “comprehensive” and two “every’s” won’t be taken seriously by most of the practicing pediatricians I know. However, there is an abundance of information generated by these investigators that could help a pediatrician target his advice to the individual families in his practice without having to resort to time-consuming comprehensive counseling, which is likely to sound like just so much chatter to families overwhelmed by the new challenge of raising a child.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

For example, nearly 60% of SUID cases were sharing a sleep surface when they died, and surface-sharing infants were more likely to not have a crib in their home. It seems to me that one should start with the simple question, “Do your have a crib in your home ... in all the homes where the baby will sleep?” And, it should be asked in the hospital prior to discharge.

In 1993, our second-born daughter went home from a teaching hospital in a cardboard box. So did all of her nursery mates. It was decorated with a stork motif and had served as her bassinet. Since early in the last century, families in Finland have been offered a similar box filled with baby supplies. Shrinkflation has caused a scale back in its contents, but the box itself has remained as a safe and inexpensive sleep surface for income-challenged families.

Many babies in this country are put to sleep in a variety of places as they are shuttled around to where the inexpensive childcare is available. Offering families as many boxes as they need may avoid the tragedy of their infant smothering on Aunt Louise’s couch or Cousin Martha’s bed littered with pillows. This is particularly important in a family with multiples (twins, triplets, etc.) who are overrepresented in the SUID population. The opening question about crib availability is likely to alert the healthcare provider to a social situation dominated by poverty that may include lower parental education and a higher likelihood of residential insecurity, all of which are associated with surface-sharing.

The authors observe “surface-sharing in and of itself may not be what caregiver education should focus on.” A simple cardboard box, however, is not a sleep surface likely to be shared with an adult.

For the families for whom surface-sharing is a choice and not a necessity, the investigators encourage us to engage families on their motivation for surface-sharing. This is a discussion that clinicians should be initiating, regardless of our concern of SUID prevention, by simply asking “How are you and your baby sleeping?” Is the baby being nursed to sleep? Where? While the authors acknowledge that their raw data did not allow them to make any observations on a relationship between surface-sharing and breastfeeding, my anecdotal observations have found an unfortunate number of mothers who have become human pacifiers for their babies and are co-sleeping. This association can result in a sleep-deprived parent(s) with unhealthy consequences. Although it can be difficult to uncouple breastfeeding from settling, early intervention triggered by asking a simple question can improve the chances of resolution.

Although I may quibble with the wording of authors’ final conclusion, this is an excellent paper worth looking at. SUID while infrequent and for the most part still mysterious is a tragedy that we should be able to prevent.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In this February’s issue of the journal Pediatrics there is an interesting paper that explores the demographics and sleep environments of the more than 8000 sudden unexpected infant death (SUID) victims who died in the United States between 2011 and 2020. The authors’ broad conclusion was “Most SUID, regardless of sleep location, had multiple unsafe sleep factors present demonstrating the need for comprehensive sleep counseling for every family at every encounter.”

From the perspective of a former busy primary care physician I shudder when I read a statement this broad because it doesn’t acknowledge the realities of my professional life. A sentence containing “comprehensive” and two “every’s” won’t be taken seriously by most of the practicing pediatricians I know. However, there is an abundance of information generated by these investigators that could help a pediatrician target his advice to the individual families in his practice without having to resort to time-consuming comprehensive counseling, which is likely to sound like just so much chatter to families overwhelmed by the new challenge of raising a child.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

For example, nearly 60% of SUID cases were sharing a sleep surface when they died, and surface-sharing infants were more likely to not have a crib in their home. It seems to me that one should start with the simple question, “Do your have a crib in your home ... in all the homes where the baby will sleep?” And, it should be asked in the hospital prior to discharge.

In 1993, our second-born daughter went home from a teaching hospital in a cardboard box. So did all of her nursery mates. It was decorated with a stork motif and had served as her bassinet. Since early in the last century, families in Finland have been offered a similar box filled with baby supplies. Shrinkflation has caused a scale back in its contents, but the box itself has remained as a safe and inexpensive sleep surface for income-challenged families.

Many babies in this country are put to sleep in a variety of places as they are shuttled around to where the inexpensive childcare is available. Offering families as many boxes as they need may avoid the tragedy of their infant smothering on Aunt Louise’s couch or Cousin Martha’s bed littered with pillows. This is particularly important in a family with multiples (twins, triplets, etc.) who are overrepresented in the SUID population. The opening question about crib availability is likely to alert the healthcare provider to a social situation dominated by poverty that may include lower parental education and a higher likelihood of residential insecurity, all of which are associated with surface-sharing.

The authors observe “surface-sharing in and of itself may not be what caregiver education should focus on.” A simple cardboard box, however, is not a sleep surface likely to be shared with an adult.

For the families for whom surface-sharing is a choice and not a necessity, the investigators encourage us to engage families on their motivation for surface-sharing. This is a discussion that clinicians should be initiating, regardless of our concern of SUID prevention, by simply asking “How are you and your baby sleeping?” Is the baby being nursed to sleep? Where? While the authors acknowledge that their raw data did not allow them to make any observations on a relationship between surface-sharing and breastfeeding, my anecdotal observations have found an unfortunate number of mothers who have become human pacifiers for their babies and are co-sleeping. This association can result in a sleep-deprived parent(s) with unhealthy consequences. Although it can be difficult to uncouple breastfeeding from settling, early intervention triggered by asking a simple question can improve the chances of resolution.

Although I may quibble with the wording of authors’ final conclusion, this is an excellent paper worth looking at. SUID while infrequent and for the most part still mysterious is a tragedy that we should be able to prevent.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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Different cultures, same wiring

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Tue, 02/27/2024 - 10:59

Some things are universal, or at least worldwide.

She didn’t speak a word of English, but I don’t speak any Mandarin. Fortunately, her concerned son was fluent in both.

A nice lady in her 60s, here from China to visit her son and his family for a month. The visit was going fine until she abruptly developed double vision. Through the modern miracle of email she contacted her doctor in Beijing, who told her to find a neurologist here or go to an ER.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

I’d had a last minute cancellation a few minutes before her son called and so was able to see her that afternoon. Both were scared that I was going to admit her to a hospital.

Fortunately, people are wired the same no matter where they’re from. The electrical fibers of the nervous system are predictable across international borders, as are the maladies.

A history and exam made the diagnosis of a diabetic cranial nerve palsy most likely, and I was able to reassure them. I ordered the usual imaging studies (fortunately she’d bought travelers’ insurance in advance). As anticipated, they were normal.

Her son and I spoke by phone to close things out, with her in the background and him translating between us. By the time she left 2 weeks later the symptoms were resolving. I made sure she went home with copies of my notes and the MRI reports, figuring someone there would be able to translate them for her physician.

These sorts of encounters are uncommon in my little solo practice, but still drive home the point that people around the world have more in common than not. Disease prevalence varies by regions, and there are certain genetic issues one has to take into account, but the basic principles of medicine are the same.

Not to mention families. The mother traveling around the world to see her son and grandchildren. The child concerned for the welfare of his parent and helping her get care. These, too, are human universals, regardless of the language spoken. There isn’t a culture on Earth that doesn’t value family connections, nor is there one that didn’t develop (albeit in different forms) doctors.

The human population is 8 billion. Everyone is different, and yet everyone, overall, is the same. Fellow travelers on a small planet.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Some things are universal, or at least worldwide.

She didn’t speak a word of English, but I don’t speak any Mandarin. Fortunately, her concerned son was fluent in both.

A nice lady in her 60s, here from China to visit her son and his family for a month. The visit was going fine until she abruptly developed double vision. Through the modern miracle of email she contacted her doctor in Beijing, who told her to find a neurologist here or go to an ER.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

I’d had a last minute cancellation a few minutes before her son called and so was able to see her that afternoon. Both were scared that I was going to admit her to a hospital.

Fortunately, people are wired the same no matter where they’re from. The electrical fibers of the nervous system are predictable across international borders, as are the maladies.

A history and exam made the diagnosis of a diabetic cranial nerve palsy most likely, and I was able to reassure them. I ordered the usual imaging studies (fortunately she’d bought travelers’ insurance in advance). As anticipated, they were normal.

Her son and I spoke by phone to close things out, with her in the background and him translating between us. By the time she left 2 weeks later the symptoms were resolving. I made sure she went home with copies of my notes and the MRI reports, figuring someone there would be able to translate them for her physician.

These sorts of encounters are uncommon in my little solo practice, but still drive home the point that people around the world have more in common than not. Disease prevalence varies by regions, and there are certain genetic issues one has to take into account, but the basic principles of medicine are the same.

Not to mention families. The mother traveling around the world to see her son and grandchildren. The child concerned for the welfare of his parent and helping her get care. These, too, are human universals, regardless of the language spoken. There isn’t a culture on Earth that doesn’t value family connections, nor is there one that didn’t develop (albeit in different forms) doctors.

The human population is 8 billion. Everyone is different, and yet everyone, overall, is the same. Fellow travelers on a small planet.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Some things are universal, or at least worldwide.

She didn’t speak a word of English, but I don’t speak any Mandarin. Fortunately, her concerned son was fluent in both.

A nice lady in her 60s, here from China to visit her son and his family for a month. The visit was going fine until she abruptly developed double vision. Through the modern miracle of email she contacted her doctor in Beijing, who told her to find a neurologist here or go to an ER.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

I’d had a last minute cancellation a few minutes before her son called and so was able to see her that afternoon. Both were scared that I was going to admit her to a hospital.

Fortunately, people are wired the same no matter where they’re from. The electrical fibers of the nervous system are predictable across international borders, as are the maladies.

A history and exam made the diagnosis of a diabetic cranial nerve palsy most likely, and I was able to reassure them. I ordered the usual imaging studies (fortunately she’d bought travelers’ insurance in advance). As anticipated, they were normal.

Her son and I spoke by phone to close things out, with her in the background and him translating between us. By the time she left 2 weeks later the symptoms were resolving. I made sure she went home with copies of my notes and the MRI reports, figuring someone there would be able to translate them for her physician.

These sorts of encounters are uncommon in my little solo practice, but still drive home the point that people around the world have more in common than not. Disease prevalence varies by regions, and there are certain genetic issues one has to take into account, but the basic principles of medicine are the same.

Not to mention families. The mother traveling around the world to see her son and grandchildren. The child concerned for the welfare of his parent and helping her get care. These, too, are human universals, regardless of the language spoken. There isn’t a culture on Earth that doesn’t value family connections, nor is there one that didn’t develop (albeit in different forms) doctors.

The human population is 8 billion. Everyone is different, and yet everyone, overall, is the same. Fellow travelers on a small planet.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Oxaliplatin in Older Adults With Resected Colorectal Cancer: Is There a Benefit?

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Changed
Mon, 04/08/2024 - 11:00

 

This transcript has been edited for clarity.

One of my abiding interests, part of my daily routine as a cancer physician, is considering whether we should or should not recommend adjuvant therapy for patients who have just had potentially curative resection of their colorectal cancer.

Our group, the QUASAR Group, made a very significant contribution in terms of trials and knowledge in this field. One of the things that we still need to discuss and think about in our wider community is the impact of adjuvant chemotherapy in older patients.

Colorectal cancer is a disease of the elderly, with the median age of presentation around 72. We know that, at presentation, more than 50% of patients are aged 65 or over and one third of patients are 75 or over. It’s a disease predominantly of the elderly. Are we justified in giving combination chemotherapy with oxaliplatin to high-risk resected colorectal cancer patients?

There’s a very nice report of a meta-analysis by Dottorini and colleagues that came out recently in the Journal of Clinical Oncology. It’s an excellent group. They did their meta-analytical work according to a strict, rational protocol. Their statistical analyses were on point, and they collected data from all the relevant trials.

According to the results of their study, it could be concluded that the addition of oxaliplatin to adjuvant therapy for resected high-risk colorectal cancer in older patients — patients older than 70 — doesn’t result in any statistically significant gain in terms of preventing recurrences or saving lives.

When we did our QUASAR trials, initially we were looking at control vs fluoropyrimidine chemotherapy. Although there was an overall impact on survival of the whole trial group (the 5000 patients in our study), when we looked by decile, there was a significant diminution of benefit even to fluoropyrimidine therapy in our trial in patients aged 70 or above. I think this careful meta-analysis must make us question the use of oxaliplatin in elderly patients.

What could the explanation be? Why could the well-known and described benefits of oxaliplatin, particularly for stage III disease, attenuate in older people? It may be to do with reduction in dose intensity. Older people have more side effects; therefore, the chemotherapy isn’t completed as planned. Although, increasingly these days, we tend only to be giving 3 months of treatment.

Is there something biologically in terms of the biology or the somatic mutational landscape of the tumor in older people? I don’t think so. Certainly, in terms of their capacity, in terms of stem cell reserve to be as resistant to the side effects of chemotherapy as younger people, we know that does attenuate with age.

Food for thought: The majority of patients I see in the clinic for the adjuvant treatment are elderly. The majority are coming these days with high-risk stage II or stage III disease. There is a real question mark about whether we should be using oxaliplatin at all.

Clearly, one would say that we need more trials of chemotherapy in older folk to see if the addition of drugs like oxaliplatin to a fluoropyrimidine backbone really does make a difference. I’ve said many times before that we, the medical community recommending adjuvant treatment, need to have better risk stratifiers. We need to have better prognostic markers. We need to have better indices that would allow us to perhaps consider these combination treatments in a more focused group of patients who may have a higher risk for recurrence.

Have a look at the paper and see what you think. I think it’s well done. It’s certainly given me pause for thought about the treatment that we will offer our elderly patients.

Have a think about it. Let me know if there are any comments that you’d like to make. For the time being, over and out.

Dr. Kerr is Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford; Professor of Cancer Medicine, Oxford Cancer Centre, Oxford, United Kingdom. He disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer HealthCare Pharmaceuticals, Genomic Health, Merck Serono, and Roche.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity.

One of my abiding interests, part of my daily routine as a cancer physician, is considering whether we should or should not recommend adjuvant therapy for patients who have just had potentially curative resection of their colorectal cancer.

Our group, the QUASAR Group, made a very significant contribution in terms of trials and knowledge in this field. One of the things that we still need to discuss and think about in our wider community is the impact of adjuvant chemotherapy in older patients.

Colorectal cancer is a disease of the elderly, with the median age of presentation around 72. We know that, at presentation, more than 50% of patients are aged 65 or over and one third of patients are 75 or over. It’s a disease predominantly of the elderly. Are we justified in giving combination chemotherapy with oxaliplatin to high-risk resected colorectal cancer patients?

There’s a very nice report of a meta-analysis by Dottorini and colleagues that came out recently in the Journal of Clinical Oncology. It’s an excellent group. They did their meta-analytical work according to a strict, rational protocol. Their statistical analyses were on point, and they collected data from all the relevant trials.

According to the results of their study, it could be concluded that the addition of oxaliplatin to adjuvant therapy for resected high-risk colorectal cancer in older patients — patients older than 70 — doesn’t result in any statistically significant gain in terms of preventing recurrences or saving lives.

When we did our QUASAR trials, initially we were looking at control vs fluoropyrimidine chemotherapy. Although there was an overall impact on survival of the whole trial group (the 5000 patients in our study), when we looked by decile, there was a significant diminution of benefit even to fluoropyrimidine therapy in our trial in patients aged 70 or above. I think this careful meta-analysis must make us question the use of oxaliplatin in elderly patients.

What could the explanation be? Why could the well-known and described benefits of oxaliplatin, particularly for stage III disease, attenuate in older people? It may be to do with reduction in dose intensity. Older people have more side effects; therefore, the chemotherapy isn’t completed as planned. Although, increasingly these days, we tend only to be giving 3 months of treatment.

Is there something biologically in terms of the biology or the somatic mutational landscape of the tumor in older people? I don’t think so. Certainly, in terms of their capacity, in terms of stem cell reserve to be as resistant to the side effects of chemotherapy as younger people, we know that does attenuate with age.

Food for thought: The majority of patients I see in the clinic for the adjuvant treatment are elderly. The majority are coming these days with high-risk stage II or stage III disease. There is a real question mark about whether we should be using oxaliplatin at all.

Clearly, one would say that we need more trials of chemotherapy in older folk to see if the addition of drugs like oxaliplatin to a fluoropyrimidine backbone really does make a difference. I’ve said many times before that we, the medical community recommending adjuvant treatment, need to have better risk stratifiers. We need to have better prognostic markers. We need to have better indices that would allow us to perhaps consider these combination treatments in a more focused group of patients who may have a higher risk for recurrence.

Have a look at the paper and see what you think. I think it’s well done. It’s certainly given me pause for thought about the treatment that we will offer our elderly patients.

Have a think about it. Let me know if there are any comments that you’d like to make. For the time being, over and out.

Dr. Kerr is Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford; Professor of Cancer Medicine, Oxford Cancer Centre, Oxford, United Kingdom. He disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer HealthCare Pharmaceuticals, Genomic Health, Merck Serono, and Roche.

A version of this article appeared on Medscape.com.

 

This transcript has been edited for clarity.

One of my abiding interests, part of my daily routine as a cancer physician, is considering whether we should or should not recommend adjuvant therapy for patients who have just had potentially curative resection of their colorectal cancer.

Our group, the QUASAR Group, made a very significant contribution in terms of trials and knowledge in this field. One of the things that we still need to discuss and think about in our wider community is the impact of adjuvant chemotherapy in older patients.

Colorectal cancer is a disease of the elderly, with the median age of presentation around 72. We know that, at presentation, more than 50% of patients are aged 65 or over and one third of patients are 75 or over. It’s a disease predominantly of the elderly. Are we justified in giving combination chemotherapy with oxaliplatin to high-risk resected colorectal cancer patients?

There’s a very nice report of a meta-analysis by Dottorini and colleagues that came out recently in the Journal of Clinical Oncology. It’s an excellent group. They did their meta-analytical work according to a strict, rational protocol. Their statistical analyses were on point, and they collected data from all the relevant trials.

According to the results of their study, it could be concluded that the addition of oxaliplatin to adjuvant therapy for resected high-risk colorectal cancer in older patients — patients older than 70 — doesn’t result in any statistically significant gain in terms of preventing recurrences or saving lives.

When we did our QUASAR trials, initially we were looking at control vs fluoropyrimidine chemotherapy. Although there was an overall impact on survival of the whole trial group (the 5000 patients in our study), when we looked by decile, there was a significant diminution of benefit even to fluoropyrimidine therapy in our trial in patients aged 70 or above. I think this careful meta-analysis must make us question the use of oxaliplatin in elderly patients.

What could the explanation be? Why could the well-known and described benefits of oxaliplatin, particularly for stage III disease, attenuate in older people? It may be to do with reduction in dose intensity. Older people have more side effects; therefore, the chemotherapy isn’t completed as planned. Although, increasingly these days, we tend only to be giving 3 months of treatment.

Is there something biologically in terms of the biology or the somatic mutational landscape of the tumor in older people? I don’t think so. Certainly, in terms of their capacity, in terms of stem cell reserve to be as resistant to the side effects of chemotherapy as younger people, we know that does attenuate with age.

Food for thought: The majority of patients I see in the clinic for the adjuvant treatment are elderly. The majority are coming these days with high-risk stage II or stage III disease. There is a real question mark about whether we should be using oxaliplatin at all.

Clearly, one would say that we need more trials of chemotherapy in older folk to see if the addition of drugs like oxaliplatin to a fluoropyrimidine backbone really does make a difference. I’ve said many times before that we, the medical community recommending adjuvant treatment, need to have better risk stratifiers. We need to have better prognostic markers. We need to have better indices that would allow us to perhaps consider these combination treatments in a more focused group of patients who may have a higher risk for recurrence.

Have a look at the paper and see what you think. I think it’s well done. It’s certainly given me pause for thought about the treatment that we will offer our elderly patients.

Have a think about it. Let me know if there are any comments that you’d like to make. For the time being, over and out.

Dr. Kerr is Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford; Professor of Cancer Medicine, Oxford Cancer Centre, Oxford, United Kingdom. He disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer HealthCare Pharmaceuticals, Genomic Health, Merck Serono, and Roche.

A version of this article appeared on Medscape.com.

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