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Is There a Role for GLP-1s in Neurology and Psychiatry?
This transcript has been edited for clarity.
I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.
I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.
These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.
The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.
We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism.
In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
Stroke, Smoking, and Alcohol
A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.
You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.
In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing.
Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.
A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.
There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing.
Parkinson’s Disease
Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease.
Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors.
A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.
The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy.
These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.
If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.
Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases.
Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.
I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.
These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.
The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.
We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism.
In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
Stroke, Smoking, and Alcohol
A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.
You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.
In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing.
Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.
A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.
There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing.
Parkinson’s Disease
Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease.
Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors.
A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.
The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy.
These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.
If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.
Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases.
Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.
I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.
These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.
The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.
We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism.
In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
Stroke, Smoking, and Alcohol
A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.
You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.
In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing.
Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.
A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.
There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing.
Parkinson’s Disease
Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease.
Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors.
A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.
The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy.
These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.
If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.
Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases.
Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FDA Approves Neoadjuvant/Adjuvant Durvalumab for NSCLC
The agency approved durvalumab alongside platinum-containing chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting.
The approval comes shortly after a meeting of FDA’s Oncology Drug Advisory Committee, where agency personnel took AstraZeneca to task for not following its request to include an arm in the approval study, AEGEAN, to clarify whether or not treatment after surgery was necessary.
Even so, advisers at the July 25 meeting voted “yes” to approving the neoadjuvant/adjuvant indication to give patients another immunotherapy option in NSCLC. However, the committee voted unanimously that, going forward, the agency should require — instead of simply request — that companies seeking combined neoadjuvant/adjuvant NSCLC indications show that patients actually need treatment after surgery.
The new approval is durvalumab’s first indication for resectable NSCLC. The agent has been previously approved for unresectable or metastatic disease as well as extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma, and advanced or recurrent endometrial cancer.
AEGEAN included 802 patients with previously untreated and resectable stage IIA-IIIB squamous or nonsquamous NSCLC. Patients were randomly assigned to receive either durvalumab (400 patients) or placebo (402 patients) on a background of platinum-based chemotherapy every 3 weeks for four cycles then, following surgery, durvalumab or placebo once a month for a year.
The pathologic complete response rate was 17% in the durvalumab arm vs 4.3% in the placebo arm. At 12 months, event-free survival was 73.4% with durvalumab vs 64.5% with placebo. Overall survival differences have not been tested for statistical significance, but there was “no clear detriment” with durvalumab, FDA said in a press release.
Adverse reactions in 20% or more of durvalumab recipients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash; 1.7% of durvalumab recipients and 1% of placebo recipients could not have surgery because of side effects during neoadjuvant treatment.
The dosage for patients weighing > 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients who weigh less than that, the recommended dosage is 20 mg/kg.
Durvalumab costs around $1,053 for 120 mg, according to drugs.com.
A version of this article appeared on Medscape.com.
The agency approved durvalumab alongside platinum-containing chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting.
The approval comes shortly after a meeting of FDA’s Oncology Drug Advisory Committee, where agency personnel took AstraZeneca to task for not following its request to include an arm in the approval study, AEGEAN, to clarify whether or not treatment after surgery was necessary.
Even so, advisers at the July 25 meeting voted “yes” to approving the neoadjuvant/adjuvant indication to give patients another immunotherapy option in NSCLC. However, the committee voted unanimously that, going forward, the agency should require — instead of simply request — that companies seeking combined neoadjuvant/adjuvant NSCLC indications show that patients actually need treatment after surgery.
The new approval is durvalumab’s first indication for resectable NSCLC. The agent has been previously approved for unresectable or metastatic disease as well as extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma, and advanced or recurrent endometrial cancer.
AEGEAN included 802 patients with previously untreated and resectable stage IIA-IIIB squamous or nonsquamous NSCLC. Patients were randomly assigned to receive either durvalumab (400 patients) or placebo (402 patients) on a background of platinum-based chemotherapy every 3 weeks for four cycles then, following surgery, durvalumab or placebo once a month for a year.
The pathologic complete response rate was 17% in the durvalumab arm vs 4.3% in the placebo arm. At 12 months, event-free survival was 73.4% with durvalumab vs 64.5% with placebo. Overall survival differences have not been tested for statistical significance, but there was “no clear detriment” with durvalumab, FDA said in a press release.
Adverse reactions in 20% or more of durvalumab recipients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash; 1.7% of durvalumab recipients and 1% of placebo recipients could not have surgery because of side effects during neoadjuvant treatment.
The dosage for patients weighing > 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients who weigh less than that, the recommended dosage is 20 mg/kg.
Durvalumab costs around $1,053 for 120 mg, according to drugs.com.
A version of this article appeared on Medscape.com.
The agency approved durvalumab alongside platinum-containing chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting.
The approval comes shortly after a meeting of FDA’s Oncology Drug Advisory Committee, where agency personnel took AstraZeneca to task for not following its request to include an arm in the approval study, AEGEAN, to clarify whether or not treatment after surgery was necessary.
Even so, advisers at the July 25 meeting voted “yes” to approving the neoadjuvant/adjuvant indication to give patients another immunotherapy option in NSCLC. However, the committee voted unanimously that, going forward, the agency should require — instead of simply request — that companies seeking combined neoadjuvant/adjuvant NSCLC indications show that patients actually need treatment after surgery.
The new approval is durvalumab’s first indication for resectable NSCLC. The agent has been previously approved for unresectable or metastatic disease as well as extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, unresectable hepatocellular carcinoma, and advanced or recurrent endometrial cancer.
AEGEAN included 802 patients with previously untreated and resectable stage IIA-IIIB squamous or nonsquamous NSCLC. Patients were randomly assigned to receive either durvalumab (400 patients) or placebo (402 patients) on a background of platinum-based chemotherapy every 3 weeks for four cycles then, following surgery, durvalumab or placebo once a month for a year.
The pathologic complete response rate was 17% in the durvalumab arm vs 4.3% in the placebo arm. At 12 months, event-free survival was 73.4% with durvalumab vs 64.5% with placebo. Overall survival differences have not been tested for statistical significance, but there was “no clear detriment” with durvalumab, FDA said in a press release.
Adverse reactions in 20% or more of durvalumab recipients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash; 1.7% of durvalumab recipients and 1% of placebo recipients could not have surgery because of side effects during neoadjuvant treatment.
The dosage for patients weighing > 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients who weigh less than that, the recommended dosage is 20 mg/kg.
Durvalumab costs around $1,053 for 120 mg, according to drugs.com.
A version of this article appeared on Medscape.com.
BRCA Mutations in Men: Important but Often Overlooked
BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies.
Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast.
However, men often fly under the radar.
“Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers.
The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.
A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai.
Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said.
BRCA Mutations in Men: What’s the Risk?
Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers.
BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.
For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.
Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%.
When to Test, When to Screen?
Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.
BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization.
For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.
Even for confirmed BRCA carriers, cancer screening guidelines for men vary.
For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family.
Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening.
The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.
The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review.
For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.
And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.
A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”
To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.
Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.
Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
A version of this article first appeared on Medscape.com.
BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies.
Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast.
However, men often fly under the radar.
“Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers.
The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.
A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai.
Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said.
BRCA Mutations in Men: What’s the Risk?
Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers.
BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.
For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.
Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%.
When to Test, When to Screen?
Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.
BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization.
For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.
Even for confirmed BRCA carriers, cancer screening guidelines for men vary.
For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family.
Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening.
The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.
The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review.
For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.
And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.
A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”
To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.
Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.
Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
A version of this article first appeared on Medscape.com.
BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies.
Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast.
However, men often fly under the radar.
“Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers.
The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.
A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai.
Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said.
BRCA Mutations in Men: What’s the Risk?
Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers.
BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.
For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.
Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%.
When to Test, When to Screen?
Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.
BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization.
For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.
Even for confirmed BRCA carriers, cancer screening guidelines for men vary.
For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family.
Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening.
The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.
The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review.
For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.
And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.
A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”
To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.
Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.
Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
A version of this article first appeared on Medscape.com.
FTC Interim Report on Pharmacy Middlemen Is First Step of Many Needed in Addressing Drug Costs, Access
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
PTSD Needs a New Name, Experts Say — Here’s Why
In a bid to reduce stigma and improve treatment rates, for inclusion in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). The APA’s policy is that a rolling name change is available if the current term is determined to be harmful.
Currently led by anesthesiologist Eugene Lipov, MD, clinical assistant professor, University of Illinois Chicago, and chief medical officer of Stella Center, also in Chicago, the formal request for the proposed name change to the APA’s DSM-5-TR Steering Committee in August 2023.
The APA Steering Committee rejected the proposed name change in November 2023, citing a “lack of convincing evidence.” However, Dr. Lipov and colleagues remain undeterred and continue to advocate for the change.
“The word ‘disorder’ is both imprecise and stigmatizing,” Dr. Lipov said. “Because of stigma, many people with PTSD — especially those in the military — don’t get help, which my research has demonstrated.”
Patients are more likely to seek help if their symptoms are framed as manifestations of an injury that is diagnosable and treatable, like a broken leg, Dr. Lipov said. “Stigma can kill in very real ways, since delayed care or lack of care can directly lead to suicides, thus satisfying the reduce harm requirement for the name change.”
Neurobiology of Trauma
Dr. Lipov grew up with a veteran father affected by PTSD and a mother with debilitating depression who eventually took her life. “I understand the impact of trauma very well,” he said.
Although not a psychiatrist, Dr. Lipov pioneered a highly successful treatment for PTSD by adapting an anesthetic technique — the stellate ganglion block (SGB) — to reverse many trauma symptoms through the process of “rebooting.”
This involves reversing the activity of the sympathetic nervous system — the fight-or-flight response — to the pretrauma state by anesthetizing the sympathetic ganglion in the neck. Investigating how SGB can help ameliorate the symptoms of PTSD led him to investigate and describe the neurobiology of PTSD and the mechanism of action of SGB.
The impact of SGD on PTSD was supported by a small neuroimaging study demonstrating that the right amygdala — the area of the brain associated with the fear response — was overactivated in patients with PTSD but that this region was deactivated after the administration of SGB, Dr. Lipov said.
“I believe that psychiatric conditions are actually physiologic brain changes that can be measured by advanced neuroimaging technologies and then physiologically treated,” he stated.
He noted that a growing body of literature suggests that use of the SGB for PTSD can be effective “because PTSD has a neurobiological basis and is essentially caused by an actual injury to the brain.”
A Natural Response, Not a Disorder
Dr. Lipov’s clinical work treating PTSD as a brain injury led him to connect with Frank Ochberg, MD, a founding board member of the International Society for Traumatic Stress Studies, former associate director of the National Institute of Mental Health, and former director of the Michigan Department of Mental Health.
In 2012, Dr. Ochberg teamed up with retired Army General Peter Chiarelli and Jonathan Shay, MD, PhD, author of Achilles in Vietnam: Combat Trauma and the Undoing of Character, to petition the DSM-5 Steering Committee to change the name of PTSD to PTSI in the upcoming DSM-5.
Dr. Ochberg explained that Gen. Chiarelli believed the term “disorder” suggests a preexisting issue prior to enlistment, potentially making an individual appear “weak.” He noted that this stigma is particularly troubling for military personnel, who often avoid seeking so they are not perceived as vulnerable, which can lead to potentially dire consequences, including suicide.
“We received endorsements from many quarters, not only advocates for service members or veterans,” Dr. Ochberg said.
This included feminists like Gloria Steinem, who championed the rights of women who had survived rape, incest, and domestic violence. As one advocate put it: “The natural human reaction to a life-threatening event should not be labeled a disorder.”
The DSM-5 Steering Committee declined to change the name. “Their feeling was that if we change the word ‘disorder’ to something else, we’d have to change every condition in the DSM that’s called a ‘disorder’. And they felt there really was nothing wrong with the word,” said Dr. Ochberg.
However, Dr. Lipov noted that other diagnoses have undergone name changes in the DSM for the sake of accuracy or stigma reduction. For example, the term mental retardation (DSM-IV) was changed to intellectual disability in DSM-5, and gender identity disorder was changed to gender dysphoria.
A decade later, Dr. Lipov decided to try again. To bolster his contention, he conducted a telephone survey of 1025 individuals. Of these, about 50% had a PTSD diagnosis.
Approximately two thirds of respondents agreed that a name change to PTSI would reduce the stigma associated with the term “PTSD.” Over half said it would increase the likelihood they would seek medical help. Those diagnosed with PTSD were most likely to endorse the name change.
Dr. Lipov conducts an ongoing survey of psychiatrists to ascertain their views on the potential name change and hopes to include findings in future research and communication with the DSM-5 Steering Committee. In addition, he has developed a new survey that expands upon his original survey, which specifically looked at individuals with PTSD.
“The new survey includes a wide range of people, many of whom have never been diagnosed. One of the questions we ask is whether they’ve ever heard of PTSD, and then we ask them about their reaction to the term,” he said.
A Barrier to Care
Psychiatrist Marcel Green, MD, director of Hudson Mind in New York City, refers to himself as an “interventional psychiatrist,” as he employs a comprehensive approach that includes not only medication and psychotherapy but also specialized techniques like SBG for severe anxiety-related physical symptoms and certain pain conditions.
Dr. Green, who is not involved in the name change initiative, agrees that the term “disorder” carries more stigma than “injury” for many groups, including those who have experienced childhood trauma, those struggling with substance abuse, or who are from backgrounds or peer groups where seeking mental health care is stigmatized.
Patients like these “are looking to me to give them a language to frame what they’re going through, and I tell them their symptoms are consistent with PTSD,” he said. “But they tell me don’t see themselves as having a disorder, which hinders their pursuit of care.”
Framing the condition as an “injury” also aligns with the approach of using biologic interventions to address the injury. Dr. Green has found SGB helpful in treating substance abuse disorder too, “which is a form of escape from the hyperactivation that accompanies PTSD.” And after the procedure, “they’re more receptive to therapy.”
Unfortunately, said Dr. Lipov, the DSM Steering Committee rejected his proposed name change, stating that the “concept of disorder as a dividing line from, eg, normal reactions to stress, is a core concept in the DSM, and the term has only rarely been removed.”
Moreover, the committee “did not see sufficient evidence ... that the name PTSD is stigmatizing and actually deters people with the disorder from seeking treatment who would not be deterred from doing so by PTSI.”
‘An Avenue for Dignity’
Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness (NAMI), noted that the organization does not have an official position on this issue. However, he shared his own personal perspective.
There may be merit in the proposed name change, said Dr. Duckworth, but more evidence is needed. “If it’s clear, after rigorous studies have been performed and there’s compelling data, that calling it a ‘disorder’ rather than an ‘injury’ is actually preventing people from getting the care they need, then it merits serious attention.”
If so, Dr. Duckworth would be “interested in having a conversation with the policy team at NAMI to start to see if we could activate the DSM Committee.”
Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto in Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit, said the name change initiative is a “really interesting proposal.”
Dr. McIntyre, chairman and executive director of the Brain and Cognition Discovery Foundation, also in Toronto, who is not involved in the initiative, has also heard “many people say that the term ‘disorder’ is stigmatizing and might even come across as pejorative in some ways.”
By contrast, “the word ‘injury’ parallels physical injury, and what we currently call ‘PTSD’ is a psychological or emotional injury no less devastating than torn tissue or broken bones,” added Dr. McIntyre, who is also the chairman of the board of the Depression and Bipolar Support Alliance.
Dr. Ochberg agreed. “In the military, ‘injury’ opens up an avenue for dignity, for a medal. Being injured and learning how to deal with an injury is part of having yet another honorable task that comes from being an honorable person who did an honorable thing.”
While disappointed, Dr. Lipov does not plan to give up on his vision. “I will continue to amass evidence that the word ‘PTSD’ is stigmatizing and indeed does prevent people from seeking care and will resubmit the proposal to the DSM Steering Committee when I have gathered a larger body of compelling evidence.”
Currently, Dr. Lipov is in active discussions with the special operations force of the US Army to obtain more evidence. “This will be the follow-up to bolster the opinion of Peter Chiarelli,” he said. “It is known that suicide and PTSD are highly related. This is especially urgent and relevant because recent data suggest suicide rate of military personnel in the VA may be as high as 44 per day,” Dr. Lipov said.
Dr. Lipov is the chief medical officer and an investor in the Stella Center. Dr. Green performs SGBs as part of his psychiatric practice. Drs. Ochberg, McIntyre, and Duckworth reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
In a bid to reduce stigma and improve treatment rates, for inclusion in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). The APA’s policy is that a rolling name change is available if the current term is determined to be harmful.
Currently led by anesthesiologist Eugene Lipov, MD, clinical assistant professor, University of Illinois Chicago, and chief medical officer of Stella Center, also in Chicago, the formal request for the proposed name change to the APA’s DSM-5-TR Steering Committee in August 2023.
The APA Steering Committee rejected the proposed name change in November 2023, citing a “lack of convincing evidence.” However, Dr. Lipov and colleagues remain undeterred and continue to advocate for the change.
“The word ‘disorder’ is both imprecise and stigmatizing,” Dr. Lipov said. “Because of stigma, many people with PTSD — especially those in the military — don’t get help, which my research has demonstrated.”
Patients are more likely to seek help if their symptoms are framed as manifestations of an injury that is diagnosable and treatable, like a broken leg, Dr. Lipov said. “Stigma can kill in very real ways, since delayed care or lack of care can directly lead to suicides, thus satisfying the reduce harm requirement for the name change.”
Neurobiology of Trauma
Dr. Lipov grew up with a veteran father affected by PTSD and a mother with debilitating depression who eventually took her life. “I understand the impact of trauma very well,” he said.
Although not a psychiatrist, Dr. Lipov pioneered a highly successful treatment for PTSD by adapting an anesthetic technique — the stellate ganglion block (SGB) — to reverse many trauma symptoms through the process of “rebooting.”
This involves reversing the activity of the sympathetic nervous system — the fight-or-flight response — to the pretrauma state by anesthetizing the sympathetic ganglion in the neck. Investigating how SGB can help ameliorate the symptoms of PTSD led him to investigate and describe the neurobiology of PTSD and the mechanism of action of SGB.
The impact of SGD on PTSD was supported by a small neuroimaging study demonstrating that the right amygdala — the area of the brain associated with the fear response — was overactivated in patients with PTSD but that this region was deactivated after the administration of SGB, Dr. Lipov said.
“I believe that psychiatric conditions are actually physiologic brain changes that can be measured by advanced neuroimaging technologies and then physiologically treated,” he stated.
He noted that a growing body of literature suggests that use of the SGB for PTSD can be effective “because PTSD has a neurobiological basis and is essentially caused by an actual injury to the brain.”
A Natural Response, Not a Disorder
Dr. Lipov’s clinical work treating PTSD as a brain injury led him to connect with Frank Ochberg, MD, a founding board member of the International Society for Traumatic Stress Studies, former associate director of the National Institute of Mental Health, and former director of the Michigan Department of Mental Health.
In 2012, Dr. Ochberg teamed up with retired Army General Peter Chiarelli and Jonathan Shay, MD, PhD, author of Achilles in Vietnam: Combat Trauma and the Undoing of Character, to petition the DSM-5 Steering Committee to change the name of PTSD to PTSI in the upcoming DSM-5.
Dr. Ochberg explained that Gen. Chiarelli believed the term “disorder” suggests a preexisting issue prior to enlistment, potentially making an individual appear “weak.” He noted that this stigma is particularly troubling for military personnel, who often avoid seeking so they are not perceived as vulnerable, which can lead to potentially dire consequences, including suicide.
“We received endorsements from many quarters, not only advocates for service members or veterans,” Dr. Ochberg said.
This included feminists like Gloria Steinem, who championed the rights of women who had survived rape, incest, and domestic violence. As one advocate put it: “The natural human reaction to a life-threatening event should not be labeled a disorder.”
The DSM-5 Steering Committee declined to change the name. “Their feeling was that if we change the word ‘disorder’ to something else, we’d have to change every condition in the DSM that’s called a ‘disorder’. And they felt there really was nothing wrong with the word,” said Dr. Ochberg.
However, Dr. Lipov noted that other diagnoses have undergone name changes in the DSM for the sake of accuracy or stigma reduction. For example, the term mental retardation (DSM-IV) was changed to intellectual disability in DSM-5, and gender identity disorder was changed to gender dysphoria.
A decade later, Dr. Lipov decided to try again. To bolster his contention, he conducted a telephone survey of 1025 individuals. Of these, about 50% had a PTSD diagnosis.
Approximately two thirds of respondents agreed that a name change to PTSI would reduce the stigma associated with the term “PTSD.” Over half said it would increase the likelihood they would seek medical help. Those diagnosed with PTSD were most likely to endorse the name change.
Dr. Lipov conducts an ongoing survey of psychiatrists to ascertain their views on the potential name change and hopes to include findings in future research and communication with the DSM-5 Steering Committee. In addition, he has developed a new survey that expands upon his original survey, which specifically looked at individuals with PTSD.
“The new survey includes a wide range of people, many of whom have never been diagnosed. One of the questions we ask is whether they’ve ever heard of PTSD, and then we ask them about their reaction to the term,” he said.
A Barrier to Care
Psychiatrist Marcel Green, MD, director of Hudson Mind in New York City, refers to himself as an “interventional psychiatrist,” as he employs a comprehensive approach that includes not only medication and psychotherapy but also specialized techniques like SBG for severe anxiety-related physical symptoms and certain pain conditions.
Dr. Green, who is not involved in the name change initiative, agrees that the term “disorder” carries more stigma than “injury” for many groups, including those who have experienced childhood trauma, those struggling with substance abuse, or who are from backgrounds or peer groups where seeking mental health care is stigmatized.
Patients like these “are looking to me to give them a language to frame what they’re going through, and I tell them their symptoms are consistent with PTSD,” he said. “But they tell me don’t see themselves as having a disorder, which hinders their pursuit of care.”
Framing the condition as an “injury” also aligns with the approach of using biologic interventions to address the injury. Dr. Green has found SGB helpful in treating substance abuse disorder too, “which is a form of escape from the hyperactivation that accompanies PTSD.” And after the procedure, “they’re more receptive to therapy.”
Unfortunately, said Dr. Lipov, the DSM Steering Committee rejected his proposed name change, stating that the “concept of disorder as a dividing line from, eg, normal reactions to stress, is a core concept in the DSM, and the term has only rarely been removed.”
Moreover, the committee “did not see sufficient evidence ... that the name PTSD is stigmatizing and actually deters people with the disorder from seeking treatment who would not be deterred from doing so by PTSI.”
‘An Avenue for Dignity’
Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness (NAMI), noted that the organization does not have an official position on this issue. However, he shared his own personal perspective.
There may be merit in the proposed name change, said Dr. Duckworth, but more evidence is needed. “If it’s clear, after rigorous studies have been performed and there’s compelling data, that calling it a ‘disorder’ rather than an ‘injury’ is actually preventing people from getting the care they need, then it merits serious attention.”
If so, Dr. Duckworth would be “interested in having a conversation with the policy team at NAMI to start to see if we could activate the DSM Committee.”
Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto in Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit, said the name change initiative is a “really interesting proposal.”
Dr. McIntyre, chairman and executive director of the Brain and Cognition Discovery Foundation, also in Toronto, who is not involved in the initiative, has also heard “many people say that the term ‘disorder’ is stigmatizing and might even come across as pejorative in some ways.”
By contrast, “the word ‘injury’ parallels physical injury, and what we currently call ‘PTSD’ is a psychological or emotional injury no less devastating than torn tissue or broken bones,” added Dr. McIntyre, who is also the chairman of the board of the Depression and Bipolar Support Alliance.
Dr. Ochberg agreed. “In the military, ‘injury’ opens up an avenue for dignity, for a medal. Being injured and learning how to deal with an injury is part of having yet another honorable task that comes from being an honorable person who did an honorable thing.”
While disappointed, Dr. Lipov does not plan to give up on his vision. “I will continue to amass evidence that the word ‘PTSD’ is stigmatizing and indeed does prevent people from seeking care and will resubmit the proposal to the DSM Steering Committee when I have gathered a larger body of compelling evidence.”
Currently, Dr. Lipov is in active discussions with the special operations force of the US Army to obtain more evidence. “This will be the follow-up to bolster the opinion of Peter Chiarelli,” he said. “It is known that suicide and PTSD are highly related. This is especially urgent and relevant because recent data suggest suicide rate of military personnel in the VA may be as high as 44 per day,” Dr. Lipov said.
Dr. Lipov is the chief medical officer and an investor in the Stella Center. Dr. Green performs SGBs as part of his psychiatric practice. Drs. Ochberg, McIntyre, and Duckworth reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
In a bid to reduce stigma and improve treatment rates, for inclusion in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). The APA’s policy is that a rolling name change is available if the current term is determined to be harmful.
Currently led by anesthesiologist Eugene Lipov, MD, clinical assistant professor, University of Illinois Chicago, and chief medical officer of Stella Center, also in Chicago, the formal request for the proposed name change to the APA’s DSM-5-TR Steering Committee in August 2023.
The APA Steering Committee rejected the proposed name change in November 2023, citing a “lack of convincing evidence.” However, Dr. Lipov and colleagues remain undeterred and continue to advocate for the change.
“The word ‘disorder’ is both imprecise and stigmatizing,” Dr. Lipov said. “Because of stigma, many people with PTSD — especially those in the military — don’t get help, which my research has demonstrated.”
Patients are more likely to seek help if their symptoms are framed as manifestations of an injury that is diagnosable and treatable, like a broken leg, Dr. Lipov said. “Stigma can kill in very real ways, since delayed care or lack of care can directly lead to suicides, thus satisfying the reduce harm requirement for the name change.”
Neurobiology of Trauma
Dr. Lipov grew up with a veteran father affected by PTSD and a mother with debilitating depression who eventually took her life. “I understand the impact of trauma very well,” he said.
Although not a psychiatrist, Dr. Lipov pioneered a highly successful treatment for PTSD by adapting an anesthetic technique — the stellate ganglion block (SGB) — to reverse many trauma symptoms through the process of “rebooting.”
This involves reversing the activity of the sympathetic nervous system — the fight-or-flight response — to the pretrauma state by anesthetizing the sympathetic ganglion in the neck. Investigating how SGB can help ameliorate the symptoms of PTSD led him to investigate and describe the neurobiology of PTSD and the mechanism of action of SGB.
The impact of SGD on PTSD was supported by a small neuroimaging study demonstrating that the right amygdala — the area of the brain associated with the fear response — was overactivated in patients with PTSD but that this region was deactivated after the administration of SGB, Dr. Lipov said.
“I believe that psychiatric conditions are actually physiologic brain changes that can be measured by advanced neuroimaging technologies and then physiologically treated,” he stated.
He noted that a growing body of literature suggests that use of the SGB for PTSD can be effective “because PTSD has a neurobiological basis and is essentially caused by an actual injury to the brain.”
A Natural Response, Not a Disorder
Dr. Lipov’s clinical work treating PTSD as a brain injury led him to connect with Frank Ochberg, MD, a founding board member of the International Society for Traumatic Stress Studies, former associate director of the National Institute of Mental Health, and former director of the Michigan Department of Mental Health.
In 2012, Dr. Ochberg teamed up with retired Army General Peter Chiarelli and Jonathan Shay, MD, PhD, author of Achilles in Vietnam: Combat Trauma and the Undoing of Character, to petition the DSM-5 Steering Committee to change the name of PTSD to PTSI in the upcoming DSM-5.
Dr. Ochberg explained that Gen. Chiarelli believed the term “disorder” suggests a preexisting issue prior to enlistment, potentially making an individual appear “weak.” He noted that this stigma is particularly troubling for military personnel, who often avoid seeking so they are not perceived as vulnerable, which can lead to potentially dire consequences, including suicide.
“We received endorsements from many quarters, not only advocates for service members or veterans,” Dr. Ochberg said.
This included feminists like Gloria Steinem, who championed the rights of women who had survived rape, incest, and domestic violence. As one advocate put it: “The natural human reaction to a life-threatening event should not be labeled a disorder.”
The DSM-5 Steering Committee declined to change the name. “Their feeling was that if we change the word ‘disorder’ to something else, we’d have to change every condition in the DSM that’s called a ‘disorder’. And they felt there really was nothing wrong with the word,” said Dr. Ochberg.
However, Dr. Lipov noted that other diagnoses have undergone name changes in the DSM for the sake of accuracy or stigma reduction. For example, the term mental retardation (DSM-IV) was changed to intellectual disability in DSM-5, and gender identity disorder was changed to gender dysphoria.
A decade later, Dr. Lipov decided to try again. To bolster his contention, he conducted a telephone survey of 1025 individuals. Of these, about 50% had a PTSD diagnosis.
Approximately two thirds of respondents agreed that a name change to PTSI would reduce the stigma associated with the term “PTSD.” Over half said it would increase the likelihood they would seek medical help. Those diagnosed with PTSD were most likely to endorse the name change.
Dr. Lipov conducts an ongoing survey of psychiatrists to ascertain their views on the potential name change and hopes to include findings in future research and communication with the DSM-5 Steering Committee. In addition, he has developed a new survey that expands upon his original survey, which specifically looked at individuals with PTSD.
“The new survey includes a wide range of people, many of whom have never been diagnosed. One of the questions we ask is whether they’ve ever heard of PTSD, and then we ask them about their reaction to the term,” he said.
A Barrier to Care
Psychiatrist Marcel Green, MD, director of Hudson Mind in New York City, refers to himself as an “interventional psychiatrist,” as he employs a comprehensive approach that includes not only medication and psychotherapy but also specialized techniques like SBG for severe anxiety-related physical symptoms and certain pain conditions.
Dr. Green, who is not involved in the name change initiative, agrees that the term “disorder” carries more stigma than “injury” for many groups, including those who have experienced childhood trauma, those struggling with substance abuse, or who are from backgrounds or peer groups where seeking mental health care is stigmatized.
Patients like these “are looking to me to give them a language to frame what they’re going through, and I tell them their symptoms are consistent with PTSD,” he said. “But they tell me don’t see themselves as having a disorder, which hinders their pursuit of care.”
Framing the condition as an “injury” also aligns with the approach of using biologic interventions to address the injury. Dr. Green has found SGB helpful in treating substance abuse disorder too, “which is a form of escape from the hyperactivation that accompanies PTSD.” And after the procedure, “they’re more receptive to therapy.”
Unfortunately, said Dr. Lipov, the DSM Steering Committee rejected his proposed name change, stating that the “concept of disorder as a dividing line from, eg, normal reactions to stress, is a core concept in the DSM, and the term has only rarely been removed.”
Moreover, the committee “did not see sufficient evidence ... that the name PTSD is stigmatizing and actually deters people with the disorder from seeking treatment who would not be deterred from doing so by PTSI.”
‘An Avenue for Dignity’
Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness (NAMI), noted that the organization does not have an official position on this issue. However, he shared his own personal perspective.
There may be merit in the proposed name change, said Dr. Duckworth, but more evidence is needed. “If it’s clear, after rigorous studies have been performed and there’s compelling data, that calling it a ‘disorder’ rather than an ‘injury’ is actually preventing people from getting the care they need, then it merits serious attention.”
If so, Dr. Duckworth would be “interested in having a conversation with the policy team at NAMI to start to see if we could activate the DSM Committee.”
Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto in Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit, said the name change initiative is a “really interesting proposal.”
Dr. McIntyre, chairman and executive director of the Brain and Cognition Discovery Foundation, also in Toronto, who is not involved in the initiative, has also heard “many people say that the term ‘disorder’ is stigmatizing and might even come across as pejorative in some ways.”
By contrast, “the word ‘injury’ parallels physical injury, and what we currently call ‘PTSD’ is a psychological or emotional injury no less devastating than torn tissue or broken bones,” added Dr. McIntyre, who is also the chairman of the board of the Depression and Bipolar Support Alliance.
Dr. Ochberg agreed. “In the military, ‘injury’ opens up an avenue for dignity, for a medal. Being injured and learning how to deal with an injury is part of having yet another honorable task that comes from being an honorable person who did an honorable thing.”
While disappointed, Dr. Lipov does not plan to give up on his vision. “I will continue to amass evidence that the word ‘PTSD’ is stigmatizing and indeed does prevent people from seeking care and will resubmit the proposal to the DSM Steering Committee when I have gathered a larger body of compelling evidence.”
Currently, Dr. Lipov is in active discussions with the special operations force of the US Army to obtain more evidence. “This will be the follow-up to bolster the opinion of Peter Chiarelli,” he said. “It is known that suicide and PTSD are highly related. This is especially urgent and relevant because recent data suggest suicide rate of military personnel in the VA may be as high as 44 per day,” Dr. Lipov said.
Dr. Lipov is the chief medical officer and an investor in the Stella Center. Dr. Green performs SGBs as part of his psychiatric practice. Drs. Ochberg, McIntyre, and Duckworth reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
As CGM Benefit Data Accrue, Primary Care Use Expands
ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.
Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.
Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)
This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.
“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.
But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
Informing Food Choice, Treatment Intensification
At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.
At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).
“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.
And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
Diabetes Care and Education Specialists (DCESs) Assist CGM Use
Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.
“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.
Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).
The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.
Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.
Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.
“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.
Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”
Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.
“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
What Predicts Primary Care CGM Prescribing?
Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”
Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.
Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.
More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.
Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.
No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.
For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.
These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.
At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.
In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”
The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.
“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”
Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.
The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.
Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
A version of this article first appeared on Medscape.com.
ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.
Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.
Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)
This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.
“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.
But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
Informing Food Choice, Treatment Intensification
At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.
At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).
“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.
And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
Diabetes Care and Education Specialists (DCESs) Assist CGM Use
Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.
“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.
Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).
The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.
Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.
Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.
“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.
Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”
Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.
“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
What Predicts Primary Care CGM Prescribing?
Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”
Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.
Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.
More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.
Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.
No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.
For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.
These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.
At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.
In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”
The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.
“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”
Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.
The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.
Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
A version of this article first appeared on Medscape.com.
ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.
Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.
Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)
This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.
“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.
But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
Informing Food Choice, Treatment Intensification
At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.
At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).
“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.
And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
Diabetes Care and Education Specialists (DCESs) Assist CGM Use
Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.
“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.
Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).
The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.
Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.
Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.
“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.
Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”
Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.
“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
What Predicts Primary Care CGM Prescribing?
Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”
Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.
Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.
More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.
Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.
No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.
For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.
These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.
At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.
In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”
The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.
“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”
Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.
The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.
Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
A version of this article first appeared on Medscape.com.
FROM ADA 2024
Are We Relying Too Much on BMI to Diagnose Obesity?
Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom.
She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9).
On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk.
This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?
The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening.
The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.
It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.
On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider.
In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines.
Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.
*Patient’s name has been changed
Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom.
She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9).
On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk.
This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?
The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening.
The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.
It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.
On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider.
In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines.
Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.
*Patient’s name has been changed
Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom.
She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9).
On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk.
This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?
The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening.
The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.
It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.
On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider.
In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines.
Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.
*Patient’s name has been changed
Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gastroenterologists Can Play a Critical Role in Obesity Management
according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.
Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.
“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.
Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.
The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.
“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”
Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.
“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
Progress in Pharmacotherapy
In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.
Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.
In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.
Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.
Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
Efficacy of Endobariatrics
For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.
For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).
Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.
Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.
Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.
“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
Monitoring MASLD
Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.
The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.
Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.
“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”
Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.
In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.
“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
Considering the Community Perspective
Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.
Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.
“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”
The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:
- Asking if the patient is ready to talk
- Assessing for factors contributing to obesity
- Advising them of treatment options
- Agreeing on goals based on shared decision-making
- Assisting or Arranging the agreed-on plan.
During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.
During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.
Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.
“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”
according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.
Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.
“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.
Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.
The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.
“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”
Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.
“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
Progress in Pharmacotherapy
In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.
Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.
In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.
Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.
Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
Efficacy of Endobariatrics
For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.
For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).
Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.
Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.
Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.
“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
Monitoring MASLD
Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.
The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.
Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.
“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”
Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.
In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.
“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
Considering the Community Perspective
Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.
Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.
“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”
The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:
- Asking if the patient is ready to talk
- Assessing for factors contributing to obesity
- Advising them of treatment options
- Agreeing on goals based on shared decision-making
- Assisting or Arranging the agreed-on plan.
During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.
During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.
Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.
“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”
according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.
Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.
“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.
Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.
The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.
“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”
Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.
“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
Progress in Pharmacotherapy
In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.
Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.
In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.
Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.
Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
Efficacy of Endobariatrics
For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.
For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).
Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.
Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.
Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.
“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
Monitoring MASLD
Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.
The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.
Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.
“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”
Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.
In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.
“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
Considering the Community Perspective
Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.
Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.
“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”
The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:
- Asking if the patient is ready to talk
- Assessing for factors contributing to obesity
- Advising them of treatment options
- Agreeing on goals based on shared decision-making
- Assisting or Arranging the agreed-on plan.
During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.
During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.
Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.
“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”
Turning Late-Night Advice into Big Business: Two Nurses’ Story
Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.
It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Ms. Hunter and Ms. Walker alternated work-from-home shifts, chatting with many of the practice’s families.
The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families.
“Parents were calling us at 2:00 in the morning with all kinds of things they were worried about, and that’s where Moms on Call was born,” Ms. Walker said.
A few decades later, Ms. Walker and Ms. Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the “instruction manual for babies,” and the two nurses have consulted with more than 10,000 families. Along the way, they’ve sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques.
So how did they do it?
A Folder, a Swaddle, and a Mission
Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.
“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.
The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”
“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.
The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.
Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.
It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
The Ripple Effect
The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”
Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.
One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”
But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
The Gambler Calls
After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.
“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.
Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.
More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
‘They Don’t Teach You That in Nursing School’
The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.
The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.
A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said.
Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”
Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.
Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said.
On Call 24/7 in the Car, in the Checkout Line ...
The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.
“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”
Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.
Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.
“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
Do You Have a Business Idea?
“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.
“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”
In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.
The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.
Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”
A version of this article appeared on Medscape.com.
Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.
It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Ms. Hunter and Ms. Walker alternated work-from-home shifts, chatting with many of the practice’s families.
The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families.
“Parents were calling us at 2:00 in the morning with all kinds of things they were worried about, and that’s where Moms on Call was born,” Ms. Walker said.
A few decades later, Ms. Walker and Ms. Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the “instruction manual for babies,” and the two nurses have consulted with more than 10,000 families. Along the way, they’ve sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques.
So how did they do it?
A Folder, a Swaddle, and a Mission
Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.
“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.
The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”
“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.
The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.
Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.
It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
The Ripple Effect
The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”
Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.
One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”
But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
The Gambler Calls
After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.
“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.
Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.
More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
‘They Don’t Teach You That in Nursing School’
The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.
The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.
A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said.
Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”
Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.
Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said.
On Call 24/7 in the Car, in the Checkout Line ...
The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.
“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”
Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.
Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.
“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
Do You Have a Business Idea?
“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.
“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”
In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.
The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.
Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”
A version of this article appeared on Medscape.com.
Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.
It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Ms. Hunter and Ms. Walker alternated work-from-home shifts, chatting with many of the practice’s families.
The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families.
“Parents were calling us at 2:00 in the morning with all kinds of things they were worried about, and that’s where Moms on Call was born,” Ms. Walker said.
A few decades later, Ms. Walker and Ms. Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the “instruction manual for babies,” and the two nurses have consulted with more than 10,000 families. Along the way, they’ve sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques.
So how did they do it?
A Folder, a Swaddle, and a Mission
Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.
“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.
The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”
“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.
The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.
Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.
It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
The Ripple Effect
The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”
Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.
One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”
But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
The Gambler Calls
After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.
“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.
Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.
More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
‘They Don’t Teach You That in Nursing School’
The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.
The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.
A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said.
Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”
Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.
Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said.
On Call 24/7 in the Car, in the Checkout Line ...
The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.
“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”
Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.
Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.
“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
Do You Have a Business Idea?
“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.
“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”
In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.
The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.
Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”
A version of this article appeared on Medscape.com.
Light Therapy, Phototherapy, Photobiomodulation: New Ways to Heal With Light
A surprising therapy is showing promise for chronic pain, vision loss, and muscle recovery, among other conditions.
It’s not a pill, an injection, or surgery.
It’s light.
Yes, light. The thing that appears when you open the curtains, flip a switch, or strike a match.
Light illuminates our world and helps us see. Early human trials suggest it may help us heal in new ways as well.
“Phototherapy is still in its infancy,” said Mohab Ibrahim, MD, PhD, a professor of anesthesiology at the University of Arizona, Tucson, who studies the effects of light on chronic pain. “There are so many questions, a lot of things we do not understand yet. But that’s where it gets interesting. What we can conclude is that different colors of light can influence different biological functions.”
This growing field goes by several names. Light therapy. Phototherapy. Photobiomodulation.
It leverages known effects of light on human health — such as skin exposure to ultraviolet light producing vitamin D or blue light’s power to regulate human body clocks — to take light as medicine in surprising new directions.
New Science, Old Idea
The science is young, but the concept of using light to restore health is thousands of years old.
Hippocrates prescribed sunbathing to patients at his medical center on the Greek island of Kos in 400 BC. Florence Nightingale promoted sunshine, along with fresh air, as prerequisites for recovery in hospitals during the Civil War. A Danish doctor, Niels Finsen, won the Nobel Prize in 1903 for developing ultraviolet lamps to treat a tuberculosis-related skin condition. And worried parents of the 1930s sat their babies in front of mercury arc lamps, bought at the drugstore, to discourage rickets.
Today, light therapy is widely used in medicine for newborn jaundice, psoriasis, and seasonal affective disorder and in light-activated treatments for cancers of the esophagus and lungs, as well as for actinic keratosis, a skin condition that can lead to cancer.
But researchers are finding that light may be capable of far more, particularly in conditions with few treatment options or where available drugs have unwanted side effects.
How Red Light Could Restore Vision
When 100 midlife and older adults, aged 53-91, with the dry form of age-related macular degeneration (AMD) were treated with an experimental red-light therapy or a sham therapy, the light treatment group showed signs of improved vision, as measured on a standard eye chart.
Volunteers received the therapy three times a week for 3-5 weeks, every 4 months for 2 years. By the study’s end, 67% of those treated with light could read an additional five letters on the chart, and 20% could read 10 or more. About 7% developed geographic atrophy — the most advanced, vision-threatening stage of dry AMD — compared with 24% in the sham group.
The study, called LIGHTSITE III, was conducted at 10 ophthalmology centers across the United States. The device they used — the Valeda Light Delivery System from medical device company LumiThera — is available in Europe and now being reviewed by the Food and Drug Administration (FDA).
Exposure to red light at the wavelengths used in the study likely revitalizes failing mitochondria — the power plants inside cells — so they produce more energy, the researchers say.
“This is the first therapy for dry AMD that’s actually shown a benefit in improving vision,” said study coauthor Richard Rosen, MD, chair of ophthalmology at the Icahn School of Medicine at Mount Sinai and chief of Retinal Services at the New York Eye and Ear Infirmary in New York City. “Supplements called AREDS can reduce progression, and in wet AMD we can improve vision loss with injections. But in dry AMD, none of the treatments studied in the past have improved it.”
AMD develops when the eyes can’t break down natural by-products, which glom together as clumps of protein called drusen. Drusen can lodge under the retina, eventually damaging tissue.
“Retinal epithelial cells, a single layer of cells that cares for the photoreceptors in the eyes, are there for life,” Dr. Rosen said. “They have a tremendous capacity to repair themselves, but things [such as aging and smoking] get in the way.”
“I’m proposing,” Dr. Rosen said, “that by boosting energy levels in cells [with red light], we’re improving normal repair mechanisms.”
Lab studies support this idea.
In a 2017 mouse study from the University College London Institute of Ophthalmology in England, retinal function improved by 25% in old mice exposed to red light. And a 2019 study from the Ophthalmological Research Foundation, Oviedo, Spain, found that exposure to blue light harmed the mitochondria in retina cells, while red light somewhat counteracted the losses.
If cleared by the FDA — which the company anticipated could happen in 2024 — LumiThera’s light delivery device will likely be most useful in the beginning stages of dry AMD, Dr. Rosen said. “I think treatment of early dry AMD will be huge.”
Eventually, light therapy may also be valuable in treating or managing glaucoma and diabetic retinopathy.
For now, Dr. Rosen recommended that clinicians and consumers with AMD skip over-the-counter (OTC) red-light therapy devices currently on the market.
“We don’t know what kind of light the devices produce,” he said. “The wavelengths can vary. The eyes are delicate. Experimenting on your own may be hazardous to your vision.”
Green Light for Pain Relief
On his way to the pharmacy to pick up pain relievers for a headache, Dr. Ibrahim passed Gene C. Reid Park in Tucson. Recalling how his brother eased headaches by sitting in his backyard, Dr. Ibrahim pulled over.
“Reid Park is probably one of the greenest areas of Tucson,” said Dr. Ibrahim, who also serves as medical director of the Comprehensive Center for Pain & Addiction at Banner-University Medical Center Phoenix in Arizona. “I spent a half hour or 40 minutes there, and my headache felt better.”
Being outdoors in a green space may be soothing for lots of reasons, like the quiet or the fresh air. But there’s also sunlight reflected off and shining through greenery. The experience inspired Dr. Ibrahim to take a closer look at the effects of green light on chronic pain.
In his 2021 study of 29 people with migraines, participants reported that, after daily exposure to green light for 10 weeks, the number of days per month when they had headaches fell from 7.9 to 2.4 for those who had episodic migraines and from 22.3 to 9.4 for those with chronic migraines. In another 2021 study, 21 people with fibromyalgia who had green light therapy for 10 weeks said their average, self-reported pain intensity fell from 8.4 to 4.9 on a 10-point scale used at the University of Arizona’s pain clinic.
Volunteers in both studies got their light therapy at home, switching on green LED lights while they listened to music, read a book, relaxed, or exercised for 1 or 2 hours daily. The lights were within their field of vision, but they did not look directly at them.
Dr. Ibrahim now has funding from the Department of Defense and Department of Veterans Affairs to find out why green light alters pain perception.
“What we know is that the visual system is connected to certain areas of the brain that also modulate pain,” he said. “We are trying to understand the connection.”
Padma Gulur, MD, a professor of anesthesiology and population health and director of Pain Management Strategy and Opioid Surveillance at Duke University, Durham, North Carolina, saw similar results in a 2023 study of 45 people with fibromyalgia. But instead of using a light source, volunteers wore glasses with clear, green, or blue lenses for 4 hours a day.
After 2 weeks, 33% in the green lens group reduced their use of opioids by 10% or more, compared with 11% in the blue lens group and 8% who wore clear lenses. Previous studies have found green light affects levels of the feel-good brain chemical serotonin and stimulates the body’s own opioid system, the authors noted.
“Green light helps your body control and reduce pain,” Dr. Gulur said. It “seems to help with pain relief by affecting the body’s natural pain management system. This effect appears to play a crucial role in antinociception — reducing the sensation of pain; antiallodynia — preventing normal, nonpainful stimuli from causing pain; and antihyperalgesia — reducing heightened sensitivity to pain.”
Light therapy could help pain patients reduce their dose of opioids or even forgo the drugs altogether, Dr. Gulur said. “It is our hope this will become a useful adjuvant therapy to manage pain.”
In the University of Arizona studies, some patients on green-light therapy stopped their medications completely. Even if they didn’t, other benefits appeared. “They had improved quality of life, decreased depression and anxiety, and improved sleep,” Dr. Ibrahim said.
But not just any green light or green-tinted glasses will work, both researchers said. “We have found there are specific frequencies of green light that give this benefit,” Dr. Gulur said. “OTC products may not be helpful for that reason.”
While Dr. Ibrahim said it could be possible for healthcare practitioners and consumers to consult his studies and put together an inexpensive green-light device at home while carefully following the protocol participants used in the studies , it would first be a good idea for patients to talk with their family doctor or a pain specialist.
“A headache is not always just a headache,” Dr. Ibrahim said. “It could be some other abnormality that needs diagnosis and treatment. If you have long-lasting pain or pain that’s getting worse, it’s always better to discuss it with your physician.”
Helping Muscles Recover With Red Light
Intense exercise — whether it’s a sprint at the end of a morning run, an extra set of biceps curls, or a weekend of all-day DIY home improvement projects — can temporarily damage muscle, causing soreness, inflammation, and even swelling. Phototherapy with red and near-infrared light is widely used by sports trainers, physical therapists, and athletes to aid in recovery. It may even work better than a trendy plunge in an ice bath, according to a 2019 Texas State University review.
But how does it work? Jamie Ghigiarelli, PhD, professor of Allied Health & Kinesiology at Hofstra University in Hempstead, New York, looked closely at signs of inflammation and muscle damage in 12 athletes to find out.
Study participants overtaxed their muscles with rounds of chin-ups, high-speed sprints, and repeated bench presses. Afterward, they relaxed in a full-body red-light therapy bed or in a similar bed without lights.
The results, published in 2020, showed that blood levels of creatine kinase — an enzyme that’s elevated by muscle damage — were 18% lower 1-3 days after exercising for the light-bed group than for the control group.
“Photobiomodulation seems to help with muscle recovery,” Dr. Ghigiarelli said.
Red light at wavelengths from 650 to 820 nm can enter muscle cells, where it is absorbed by mitochondria and boosts their energy production, he said. At the time of his research, some exercise science researchers and athletes thought using light therapy before an event might also increase athletic performance, but according to Dr. Ghigiarelli, that use has not panned out.
Handheld red light and near-infrared light devices for muscle recovery are widely available, but it’s important to do your homework before buying one.
“You want to choose a device with the right energy production — the right wavelength of light, the right power — to be safe and effective,” he said.
For details, he recommends consulting a 2019 paper in The Brazilian Journal of Physical Therapy called “Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: Current evidence and future directions.”
The paper, from the Laboratory of Phototherapy and Innovative Technologies in Health at the Universidade Nove de Julho in Sao Paulo, Brazil, recommends that for small muscle groups like the biceps or triceps, use red-light lasers or LED devices with a wavelength of 640 nm for red light or 950 nm for infrared light, at a power of 50-200 mW per diode for single-probe device types, at a dose of 20-60 J, given 5-10 minutes after exercise.
A version of this article appeared on Medscape.com.
A surprising therapy is showing promise for chronic pain, vision loss, and muscle recovery, among other conditions.
It’s not a pill, an injection, or surgery.
It’s light.
Yes, light. The thing that appears when you open the curtains, flip a switch, or strike a match.
Light illuminates our world and helps us see. Early human trials suggest it may help us heal in new ways as well.
“Phototherapy is still in its infancy,” said Mohab Ibrahim, MD, PhD, a professor of anesthesiology at the University of Arizona, Tucson, who studies the effects of light on chronic pain. “There are so many questions, a lot of things we do not understand yet. But that’s where it gets interesting. What we can conclude is that different colors of light can influence different biological functions.”
This growing field goes by several names. Light therapy. Phototherapy. Photobiomodulation.
It leverages known effects of light on human health — such as skin exposure to ultraviolet light producing vitamin D or blue light’s power to regulate human body clocks — to take light as medicine in surprising new directions.
New Science, Old Idea
The science is young, but the concept of using light to restore health is thousands of years old.
Hippocrates prescribed sunbathing to patients at his medical center on the Greek island of Kos in 400 BC. Florence Nightingale promoted sunshine, along with fresh air, as prerequisites for recovery in hospitals during the Civil War. A Danish doctor, Niels Finsen, won the Nobel Prize in 1903 for developing ultraviolet lamps to treat a tuberculosis-related skin condition. And worried parents of the 1930s sat their babies in front of mercury arc lamps, bought at the drugstore, to discourage rickets.
Today, light therapy is widely used in medicine for newborn jaundice, psoriasis, and seasonal affective disorder and in light-activated treatments for cancers of the esophagus and lungs, as well as for actinic keratosis, a skin condition that can lead to cancer.
But researchers are finding that light may be capable of far more, particularly in conditions with few treatment options or where available drugs have unwanted side effects.
How Red Light Could Restore Vision
When 100 midlife and older adults, aged 53-91, with the dry form of age-related macular degeneration (AMD) were treated with an experimental red-light therapy or a sham therapy, the light treatment group showed signs of improved vision, as measured on a standard eye chart.
Volunteers received the therapy three times a week for 3-5 weeks, every 4 months for 2 years. By the study’s end, 67% of those treated with light could read an additional five letters on the chart, and 20% could read 10 or more. About 7% developed geographic atrophy — the most advanced, vision-threatening stage of dry AMD — compared with 24% in the sham group.
The study, called LIGHTSITE III, was conducted at 10 ophthalmology centers across the United States. The device they used — the Valeda Light Delivery System from medical device company LumiThera — is available in Europe and now being reviewed by the Food and Drug Administration (FDA).
Exposure to red light at the wavelengths used in the study likely revitalizes failing mitochondria — the power plants inside cells — so they produce more energy, the researchers say.
“This is the first therapy for dry AMD that’s actually shown a benefit in improving vision,” said study coauthor Richard Rosen, MD, chair of ophthalmology at the Icahn School of Medicine at Mount Sinai and chief of Retinal Services at the New York Eye and Ear Infirmary in New York City. “Supplements called AREDS can reduce progression, and in wet AMD we can improve vision loss with injections. But in dry AMD, none of the treatments studied in the past have improved it.”
AMD develops when the eyes can’t break down natural by-products, which glom together as clumps of protein called drusen. Drusen can lodge under the retina, eventually damaging tissue.
“Retinal epithelial cells, a single layer of cells that cares for the photoreceptors in the eyes, are there for life,” Dr. Rosen said. “They have a tremendous capacity to repair themselves, but things [such as aging and smoking] get in the way.”
“I’m proposing,” Dr. Rosen said, “that by boosting energy levels in cells [with red light], we’re improving normal repair mechanisms.”
Lab studies support this idea.
In a 2017 mouse study from the University College London Institute of Ophthalmology in England, retinal function improved by 25% in old mice exposed to red light. And a 2019 study from the Ophthalmological Research Foundation, Oviedo, Spain, found that exposure to blue light harmed the mitochondria in retina cells, while red light somewhat counteracted the losses.
If cleared by the FDA — which the company anticipated could happen in 2024 — LumiThera’s light delivery device will likely be most useful in the beginning stages of dry AMD, Dr. Rosen said. “I think treatment of early dry AMD will be huge.”
Eventually, light therapy may also be valuable in treating or managing glaucoma and diabetic retinopathy.
For now, Dr. Rosen recommended that clinicians and consumers with AMD skip over-the-counter (OTC) red-light therapy devices currently on the market.
“We don’t know what kind of light the devices produce,” he said. “The wavelengths can vary. The eyes are delicate. Experimenting on your own may be hazardous to your vision.”
Green Light for Pain Relief
On his way to the pharmacy to pick up pain relievers for a headache, Dr. Ibrahim passed Gene C. Reid Park in Tucson. Recalling how his brother eased headaches by sitting in his backyard, Dr. Ibrahim pulled over.
“Reid Park is probably one of the greenest areas of Tucson,” said Dr. Ibrahim, who also serves as medical director of the Comprehensive Center for Pain & Addiction at Banner-University Medical Center Phoenix in Arizona. “I spent a half hour or 40 minutes there, and my headache felt better.”
Being outdoors in a green space may be soothing for lots of reasons, like the quiet or the fresh air. But there’s also sunlight reflected off and shining through greenery. The experience inspired Dr. Ibrahim to take a closer look at the effects of green light on chronic pain.
In his 2021 study of 29 people with migraines, participants reported that, after daily exposure to green light for 10 weeks, the number of days per month when they had headaches fell from 7.9 to 2.4 for those who had episodic migraines and from 22.3 to 9.4 for those with chronic migraines. In another 2021 study, 21 people with fibromyalgia who had green light therapy for 10 weeks said their average, self-reported pain intensity fell from 8.4 to 4.9 on a 10-point scale used at the University of Arizona’s pain clinic.
Volunteers in both studies got their light therapy at home, switching on green LED lights while they listened to music, read a book, relaxed, or exercised for 1 or 2 hours daily. The lights were within their field of vision, but they did not look directly at them.
Dr. Ibrahim now has funding from the Department of Defense and Department of Veterans Affairs to find out why green light alters pain perception.
“What we know is that the visual system is connected to certain areas of the brain that also modulate pain,” he said. “We are trying to understand the connection.”
Padma Gulur, MD, a professor of anesthesiology and population health and director of Pain Management Strategy and Opioid Surveillance at Duke University, Durham, North Carolina, saw similar results in a 2023 study of 45 people with fibromyalgia. But instead of using a light source, volunteers wore glasses with clear, green, or blue lenses for 4 hours a day.
After 2 weeks, 33% in the green lens group reduced their use of opioids by 10% or more, compared with 11% in the blue lens group and 8% who wore clear lenses. Previous studies have found green light affects levels of the feel-good brain chemical serotonin and stimulates the body’s own opioid system, the authors noted.
“Green light helps your body control and reduce pain,” Dr. Gulur said. It “seems to help with pain relief by affecting the body’s natural pain management system. This effect appears to play a crucial role in antinociception — reducing the sensation of pain; antiallodynia — preventing normal, nonpainful stimuli from causing pain; and antihyperalgesia — reducing heightened sensitivity to pain.”
Light therapy could help pain patients reduce their dose of opioids or even forgo the drugs altogether, Dr. Gulur said. “It is our hope this will become a useful adjuvant therapy to manage pain.”
In the University of Arizona studies, some patients on green-light therapy stopped their medications completely. Even if they didn’t, other benefits appeared. “They had improved quality of life, decreased depression and anxiety, and improved sleep,” Dr. Ibrahim said.
But not just any green light or green-tinted glasses will work, both researchers said. “We have found there are specific frequencies of green light that give this benefit,” Dr. Gulur said. “OTC products may not be helpful for that reason.”
While Dr. Ibrahim said it could be possible for healthcare practitioners and consumers to consult his studies and put together an inexpensive green-light device at home while carefully following the protocol participants used in the studies , it would first be a good idea for patients to talk with their family doctor or a pain specialist.
“A headache is not always just a headache,” Dr. Ibrahim said. “It could be some other abnormality that needs diagnosis and treatment. If you have long-lasting pain or pain that’s getting worse, it’s always better to discuss it with your physician.”
Helping Muscles Recover With Red Light
Intense exercise — whether it’s a sprint at the end of a morning run, an extra set of biceps curls, or a weekend of all-day DIY home improvement projects — can temporarily damage muscle, causing soreness, inflammation, and even swelling. Phototherapy with red and near-infrared light is widely used by sports trainers, physical therapists, and athletes to aid in recovery. It may even work better than a trendy plunge in an ice bath, according to a 2019 Texas State University review.
But how does it work? Jamie Ghigiarelli, PhD, professor of Allied Health & Kinesiology at Hofstra University in Hempstead, New York, looked closely at signs of inflammation and muscle damage in 12 athletes to find out.
Study participants overtaxed their muscles with rounds of chin-ups, high-speed sprints, and repeated bench presses. Afterward, they relaxed in a full-body red-light therapy bed or in a similar bed without lights.
The results, published in 2020, showed that blood levels of creatine kinase — an enzyme that’s elevated by muscle damage — were 18% lower 1-3 days after exercising for the light-bed group than for the control group.
“Photobiomodulation seems to help with muscle recovery,” Dr. Ghigiarelli said.
Red light at wavelengths from 650 to 820 nm can enter muscle cells, where it is absorbed by mitochondria and boosts their energy production, he said. At the time of his research, some exercise science researchers and athletes thought using light therapy before an event might also increase athletic performance, but according to Dr. Ghigiarelli, that use has not panned out.
Handheld red light and near-infrared light devices for muscle recovery are widely available, but it’s important to do your homework before buying one.
“You want to choose a device with the right energy production — the right wavelength of light, the right power — to be safe and effective,” he said.
For details, he recommends consulting a 2019 paper in The Brazilian Journal of Physical Therapy called “Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: Current evidence and future directions.”
The paper, from the Laboratory of Phototherapy and Innovative Technologies in Health at the Universidade Nove de Julho in Sao Paulo, Brazil, recommends that for small muscle groups like the biceps or triceps, use red-light lasers or LED devices with a wavelength of 640 nm for red light or 950 nm for infrared light, at a power of 50-200 mW per diode for single-probe device types, at a dose of 20-60 J, given 5-10 minutes after exercise.
A version of this article appeared on Medscape.com.
A surprising therapy is showing promise for chronic pain, vision loss, and muscle recovery, among other conditions.
It’s not a pill, an injection, or surgery.
It’s light.
Yes, light. The thing that appears when you open the curtains, flip a switch, or strike a match.
Light illuminates our world and helps us see. Early human trials suggest it may help us heal in new ways as well.
“Phototherapy is still in its infancy,” said Mohab Ibrahim, MD, PhD, a professor of anesthesiology at the University of Arizona, Tucson, who studies the effects of light on chronic pain. “There are so many questions, a lot of things we do not understand yet. But that’s where it gets interesting. What we can conclude is that different colors of light can influence different biological functions.”
This growing field goes by several names. Light therapy. Phototherapy. Photobiomodulation.
It leverages known effects of light on human health — such as skin exposure to ultraviolet light producing vitamin D or blue light’s power to regulate human body clocks — to take light as medicine in surprising new directions.
New Science, Old Idea
The science is young, but the concept of using light to restore health is thousands of years old.
Hippocrates prescribed sunbathing to patients at his medical center on the Greek island of Kos in 400 BC. Florence Nightingale promoted sunshine, along with fresh air, as prerequisites for recovery in hospitals during the Civil War. A Danish doctor, Niels Finsen, won the Nobel Prize in 1903 for developing ultraviolet lamps to treat a tuberculosis-related skin condition. And worried parents of the 1930s sat their babies in front of mercury arc lamps, bought at the drugstore, to discourage rickets.
Today, light therapy is widely used in medicine for newborn jaundice, psoriasis, and seasonal affective disorder and in light-activated treatments for cancers of the esophagus and lungs, as well as for actinic keratosis, a skin condition that can lead to cancer.
But researchers are finding that light may be capable of far more, particularly in conditions with few treatment options or where available drugs have unwanted side effects.
How Red Light Could Restore Vision
When 100 midlife and older adults, aged 53-91, with the dry form of age-related macular degeneration (AMD) were treated with an experimental red-light therapy or a sham therapy, the light treatment group showed signs of improved vision, as measured on a standard eye chart.
Volunteers received the therapy three times a week for 3-5 weeks, every 4 months for 2 years. By the study’s end, 67% of those treated with light could read an additional five letters on the chart, and 20% could read 10 or more. About 7% developed geographic atrophy — the most advanced, vision-threatening stage of dry AMD — compared with 24% in the sham group.
The study, called LIGHTSITE III, was conducted at 10 ophthalmology centers across the United States. The device they used — the Valeda Light Delivery System from medical device company LumiThera — is available in Europe and now being reviewed by the Food and Drug Administration (FDA).
Exposure to red light at the wavelengths used in the study likely revitalizes failing mitochondria — the power plants inside cells — so they produce more energy, the researchers say.
“This is the first therapy for dry AMD that’s actually shown a benefit in improving vision,” said study coauthor Richard Rosen, MD, chair of ophthalmology at the Icahn School of Medicine at Mount Sinai and chief of Retinal Services at the New York Eye and Ear Infirmary in New York City. “Supplements called AREDS can reduce progression, and in wet AMD we can improve vision loss with injections. But in dry AMD, none of the treatments studied in the past have improved it.”
AMD develops when the eyes can’t break down natural by-products, which glom together as clumps of protein called drusen. Drusen can lodge under the retina, eventually damaging tissue.
“Retinal epithelial cells, a single layer of cells that cares for the photoreceptors in the eyes, are there for life,” Dr. Rosen said. “They have a tremendous capacity to repair themselves, but things [such as aging and smoking] get in the way.”
“I’m proposing,” Dr. Rosen said, “that by boosting energy levels in cells [with red light], we’re improving normal repair mechanisms.”
Lab studies support this idea.
In a 2017 mouse study from the University College London Institute of Ophthalmology in England, retinal function improved by 25% in old mice exposed to red light. And a 2019 study from the Ophthalmological Research Foundation, Oviedo, Spain, found that exposure to blue light harmed the mitochondria in retina cells, while red light somewhat counteracted the losses.
If cleared by the FDA — which the company anticipated could happen in 2024 — LumiThera’s light delivery device will likely be most useful in the beginning stages of dry AMD, Dr. Rosen said. “I think treatment of early dry AMD will be huge.”
Eventually, light therapy may also be valuable in treating or managing glaucoma and diabetic retinopathy.
For now, Dr. Rosen recommended that clinicians and consumers with AMD skip over-the-counter (OTC) red-light therapy devices currently on the market.
“We don’t know what kind of light the devices produce,” he said. “The wavelengths can vary. The eyes are delicate. Experimenting on your own may be hazardous to your vision.”
Green Light for Pain Relief
On his way to the pharmacy to pick up pain relievers for a headache, Dr. Ibrahim passed Gene C. Reid Park in Tucson. Recalling how his brother eased headaches by sitting in his backyard, Dr. Ibrahim pulled over.
“Reid Park is probably one of the greenest areas of Tucson,” said Dr. Ibrahim, who also serves as medical director of the Comprehensive Center for Pain & Addiction at Banner-University Medical Center Phoenix in Arizona. “I spent a half hour or 40 minutes there, and my headache felt better.”
Being outdoors in a green space may be soothing for lots of reasons, like the quiet or the fresh air. But there’s also sunlight reflected off and shining through greenery. The experience inspired Dr. Ibrahim to take a closer look at the effects of green light on chronic pain.
In his 2021 study of 29 people with migraines, participants reported that, after daily exposure to green light for 10 weeks, the number of days per month when they had headaches fell from 7.9 to 2.4 for those who had episodic migraines and from 22.3 to 9.4 for those with chronic migraines. In another 2021 study, 21 people with fibromyalgia who had green light therapy for 10 weeks said their average, self-reported pain intensity fell from 8.4 to 4.9 on a 10-point scale used at the University of Arizona’s pain clinic.
Volunteers in both studies got their light therapy at home, switching on green LED lights while they listened to music, read a book, relaxed, or exercised for 1 or 2 hours daily. The lights were within their field of vision, but they did not look directly at them.
Dr. Ibrahim now has funding from the Department of Defense and Department of Veterans Affairs to find out why green light alters pain perception.
“What we know is that the visual system is connected to certain areas of the brain that also modulate pain,” he said. “We are trying to understand the connection.”
Padma Gulur, MD, a professor of anesthesiology and population health and director of Pain Management Strategy and Opioid Surveillance at Duke University, Durham, North Carolina, saw similar results in a 2023 study of 45 people with fibromyalgia. But instead of using a light source, volunteers wore glasses with clear, green, or blue lenses for 4 hours a day.
After 2 weeks, 33% in the green lens group reduced their use of opioids by 10% or more, compared with 11% in the blue lens group and 8% who wore clear lenses. Previous studies have found green light affects levels of the feel-good brain chemical serotonin and stimulates the body’s own opioid system, the authors noted.
“Green light helps your body control and reduce pain,” Dr. Gulur said. It “seems to help with pain relief by affecting the body’s natural pain management system. This effect appears to play a crucial role in antinociception — reducing the sensation of pain; antiallodynia — preventing normal, nonpainful stimuli from causing pain; and antihyperalgesia — reducing heightened sensitivity to pain.”
Light therapy could help pain patients reduce their dose of opioids or even forgo the drugs altogether, Dr. Gulur said. “It is our hope this will become a useful adjuvant therapy to manage pain.”
In the University of Arizona studies, some patients on green-light therapy stopped their medications completely. Even if they didn’t, other benefits appeared. “They had improved quality of life, decreased depression and anxiety, and improved sleep,” Dr. Ibrahim said.
But not just any green light or green-tinted glasses will work, both researchers said. “We have found there are specific frequencies of green light that give this benefit,” Dr. Gulur said. “OTC products may not be helpful for that reason.”
While Dr. Ibrahim said it could be possible for healthcare practitioners and consumers to consult his studies and put together an inexpensive green-light device at home while carefully following the protocol participants used in the studies , it would first be a good idea for patients to talk with their family doctor or a pain specialist.
“A headache is not always just a headache,” Dr. Ibrahim said. “It could be some other abnormality that needs diagnosis and treatment. If you have long-lasting pain or pain that’s getting worse, it’s always better to discuss it with your physician.”
Helping Muscles Recover With Red Light
Intense exercise — whether it’s a sprint at the end of a morning run, an extra set of biceps curls, or a weekend of all-day DIY home improvement projects — can temporarily damage muscle, causing soreness, inflammation, and even swelling. Phototherapy with red and near-infrared light is widely used by sports trainers, physical therapists, and athletes to aid in recovery. It may even work better than a trendy plunge in an ice bath, according to a 2019 Texas State University review.
But how does it work? Jamie Ghigiarelli, PhD, professor of Allied Health & Kinesiology at Hofstra University in Hempstead, New York, looked closely at signs of inflammation and muscle damage in 12 athletes to find out.
Study participants overtaxed their muscles with rounds of chin-ups, high-speed sprints, and repeated bench presses. Afterward, they relaxed in a full-body red-light therapy bed or in a similar bed without lights.
The results, published in 2020, showed that blood levels of creatine kinase — an enzyme that’s elevated by muscle damage — were 18% lower 1-3 days after exercising for the light-bed group than for the control group.
“Photobiomodulation seems to help with muscle recovery,” Dr. Ghigiarelli said.
Red light at wavelengths from 650 to 820 nm can enter muscle cells, where it is absorbed by mitochondria and boosts their energy production, he said. At the time of his research, some exercise science researchers and athletes thought using light therapy before an event might also increase athletic performance, but according to Dr. Ghigiarelli, that use has not panned out.
Handheld red light and near-infrared light devices for muscle recovery are widely available, but it’s important to do your homework before buying one.
“You want to choose a device with the right energy production — the right wavelength of light, the right power — to be safe and effective,” he said.
For details, he recommends consulting a 2019 paper in The Brazilian Journal of Physical Therapy called “Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: Current evidence and future directions.”
The paper, from the Laboratory of Phototherapy and Innovative Technologies in Health at the Universidade Nove de Julho in Sao Paulo, Brazil, recommends that for small muscle groups like the biceps or triceps, use red-light lasers or LED devices with a wavelength of 640 nm for red light or 950 nm for infrared light, at a power of 50-200 mW per diode for single-probe device types, at a dose of 20-60 J, given 5-10 minutes after exercise.
A version of this article appeared on Medscape.com.