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FDA approves IB-Stim device for abdominal pain in adolescents with IBS
The IB-Stim device has been approved to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS), according to the U.S. Food and Drug Administration.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release.
The prescription-only device has a single-use electrical nerve stimulator that is placed behind the patient’s ear. Stimulating nerve bundles in and around the ear is thought to provide pain relief. The battery-powered chip of the device emits low-frequency electrical pulses continuously for 5 days, at which time it is replaced. Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS.
The FDA reviewed data from 50 patients, aged 11-18 years, with IBS; 27 patients were treated with the device and 23 patients received a placebo device. The study measured change from baseline to the end of the third week in worst abdominal pain, usual pain, and Pain Frequency Severity Duration (PFSD) scores. Patients were allowed to continue stable doses of medication to treat chronic abdominal pain.
IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of 3 weeks in 52% of treated patients, compared with 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients, compared with 26% of patients who received the placebo.
The treatment group also had greater changes in composite PFSD scores at the end of three weeks. During the study, six patients reported mild ear discomfort, and three patients reported adhesive allergy at the site of application, according to the press release.
The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris.
The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.
The IB-Stim device has been approved to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS), according to the U.S. Food and Drug Administration.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release.
The prescription-only device has a single-use electrical nerve stimulator that is placed behind the patient’s ear. Stimulating nerve bundles in and around the ear is thought to provide pain relief. The battery-powered chip of the device emits low-frequency electrical pulses continuously for 5 days, at which time it is replaced. Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS.
The FDA reviewed data from 50 patients, aged 11-18 years, with IBS; 27 patients were treated with the device and 23 patients received a placebo device. The study measured change from baseline to the end of the third week in worst abdominal pain, usual pain, and Pain Frequency Severity Duration (PFSD) scores. Patients were allowed to continue stable doses of medication to treat chronic abdominal pain.
IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of 3 weeks in 52% of treated patients, compared with 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients, compared with 26% of patients who received the placebo.
The treatment group also had greater changes in composite PFSD scores at the end of three weeks. During the study, six patients reported mild ear discomfort, and three patients reported adhesive allergy at the site of application, according to the press release.
The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris.
The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.
The IB-Stim device has been approved to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS), according to the U.S. Food and Drug Administration.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release.
The prescription-only device has a single-use electrical nerve stimulator that is placed behind the patient’s ear. Stimulating nerve bundles in and around the ear is thought to provide pain relief. The battery-powered chip of the device emits low-frequency electrical pulses continuously for 5 days, at which time it is replaced. Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS.
The FDA reviewed data from 50 patients, aged 11-18 years, with IBS; 27 patients were treated with the device and 23 patients received a placebo device. The study measured change from baseline to the end of the third week in worst abdominal pain, usual pain, and Pain Frequency Severity Duration (PFSD) scores. Patients were allowed to continue stable doses of medication to treat chronic abdominal pain.
IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of 3 weeks in 52% of treated patients, compared with 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients, compared with 26% of patients who received the placebo.
The treatment group also had greater changes in composite PFSD scores at the end of three weeks. During the study, six patients reported mild ear discomfort, and three patients reported adhesive allergy at the site of application, according to the press release.
The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris.
The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.
Chemo-free Smart Start regimen looks promising in poor-prognosis DLBCL
CHICAGO – A chemotherapy-free regimen has produced promising early response and survival outcomes in patients with a particularly poor-prognosis subtype of diffuse large B-cell lymphoma, an investigator reported at the annual meeting of the American Society of Clinical Oncology.
The overall response rate was 86% after two cycles of combined rituximab, lenalidomide, and ibrutinib – or RLI – in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) of the non–germinal center (non-GCB) subtype, said Jason Westin, MD, of the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center in Houston.
The response rate increased to 96% after subsequent cycles of RLI plus standard chemotherapy, said Dr.Westin, who added that the rates of progression-free and overall survival at 1 year were also 96% in the investigator initiated, single-arm, open-label, phase 2 study, called Smart Start.
That looks quite favorable, compared with what’s been achieved in previous studies in this poor-prognosis group of patients, Dr. Westin said during a podium presentation of Smart Start data, though he cautioned against direct comparison to historical studies and added that further follow-up is needed.
“Our survival outcomes appear excellent with about a year’s worth of follow-up,” he said during his presentation. “I’d say the novel/novel combinations, with and without chemotherapy, are feasible for large cell, and next step studies are warranted.”
Jasmine M. Zain, MD, of City of Hope Comprehensive Cancer Center, said these results so far raise the possibility of an effective chemotherapy-free treatment regimen for aggressive lymphomas.
“This regimen, particularly for non-GCB subtypes, is extremely promising,” Dr. Zain said during a podium discussion of the study. “I think we were all oohing and aahing over the results, and it could possibly even be practice changing.”
Moving to a nonchemotherapy regimen could raise new questions for treatment of non-GCB and possibly also GCB subtypes of DLBCL, such as when the treatments could be stopped, or whether a maintenance approach would be useful, she added.
The Smart Start study enrolled a total of 60 patients with non-GCB DLBCL. The patients received RLI for two 21-day cycles, followed by another six cycles of RLI plus chemotherapy, which was either EPOCH or CHOP, at the investigators’ discretion.
“With a median follow-up of 362 days, we’ve had three progression events,” Dr. Westin said in his discussion of the preliminary efficacy results.
Adverse events were similar to what would be expected for standard chemotherapy, according to Dr. Westin, except for rash, which was seen mainly in cycles one and two.
There were two deaths on study protocol, including one fatal fungal infection that investigators attributed to high dose corticosteroids and RLI. There were no subsequent fungal infections after a protocol amendment prohibiting corticosteroids during the RLI-only cycles, according to the investigators’ report.
The high response rates following the initial lead-in phase made investigators wonder what would happen without subsequent chemotherapy, Dr. Westin told attendees during his oral presentation. In one case, a 74-year-old man did complete the two lead-in cycles of RLI and declined further therapy.
“He’s now nearly 2 years out, without any additional therapy, and has not relapsed to date,” Dr. Westin said. “This is, again, with 6 weeks worth of RLI therapy.”
Final results and minimal residual disease data from the Smart Start study will be presented at a conference later in 2019, Dr. Westin said.
The study received research support and funding from the ASCO Conquer Cancer Foundation. The trial drug and support were provided by Celgene and Janssen. Dr. Westin reported disclosures related to Celgene, Genentech/Abbvie, Kite Pharma, Kite/Gilead, Novartis, ProNAi, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Janssen, and Karyopharm Therapeutics.
SOURCE: Westin J et al. ASCO 2019, Abstract 7508.
CHICAGO – A chemotherapy-free regimen has produced promising early response and survival outcomes in patients with a particularly poor-prognosis subtype of diffuse large B-cell lymphoma, an investigator reported at the annual meeting of the American Society of Clinical Oncology.
The overall response rate was 86% after two cycles of combined rituximab, lenalidomide, and ibrutinib – or RLI – in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) of the non–germinal center (non-GCB) subtype, said Jason Westin, MD, of the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center in Houston.
The response rate increased to 96% after subsequent cycles of RLI plus standard chemotherapy, said Dr.Westin, who added that the rates of progression-free and overall survival at 1 year were also 96% in the investigator initiated, single-arm, open-label, phase 2 study, called Smart Start.
That looks quite favorable, compared with what’s been achieved in previous studies in this poor-prognosis group of patients, Dr. Westin said during a podium presentation of Smart Start data, though he cautioned against direct comparison to historical studies and added that further follow-up is needed.
“Our survival outcomes appear excellent with about a year’s worth of follow-up,” he said during his presentation. “I’d say the novel/novel combinations, with and without chemotherapy, are feasible for large cell, and next step studies are warranted.”
Jasmine M. Zain, MD, of City of Hope Comprehensive Cancer Center, said these results so far raise the possibility of an effective chemotherapy-free treatment regimen for aggressive lymphomas.
“This regimen, particularly for non-GCB subtypes, is extremely promising,” Dr. Zain said during a podium discussion of the study. “I think we were all oohing and aahing over the results, and it could possibly even be practice changing.”
Moving to a nonchemotherapy regimen could raise new questions for treatment of non-GCB and possibly also GCB subtypes of DLBCL, such as when the treatments could be stopped, or whether a maintenance approach would be useful, she added.
The Smart Start study enrolled a total of 60 patients with non-GCB DLBCL. The patients received RLI for two 21-day cycles, followed by another six cycles of RLI plus chemotherapy, which was either EPOCH or CHOP, at the investigators’ discretion.
“With a median follow-up of 362 days, we’ve had three progression events,” Dr. Westin said in his discussion of the preliminary efficacy results.
Adverse events were similar to what would be expected for standard chemotherapy, according to Dr. Westin, except for rash, which was seen mainly in cycles one and two.
There were two deaths on study protocol, including one fatal fungal infection that investigators attributed to high dose corticosteroids and RLI. There were no subsequent fungal infections after a protocol amendment prohibiting corticosteroids during the RLI-only cycles, according to the investigators’ report.
The high response rates following the initial lead-in phase made investigators wonder what would happen without subsequent chemotherapy, Dr. Westin told attendees during his oral presentation. In one case, a 74-year-old man did complete the two lead-in cycles of RLI and declined further therapy.
“He’s now nearly 2 years out, without any additional therapy, and has not relapsed to date,” Dr. Westin said. “This is, again, with 6 weeks worth of RLI therapy.”
Final results and minimal residual disease data from the Smart Start study will be presented at a conference later in 2019, Dr. Westin said.
The study received research support and funding from the ASCO Conquer Cancer Foundation. The trial drug and support were provided by Celgene and Janssen. Dr. Westin reported disclosures related to Celgene, Genentech/Abbvie, Kite Pharma, Kite/Gilead, Novartis, ProNAi, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Janssen, and Karyopharm Therapeutics.
SOURCE: Westin J et al. ASCO 2019, Abstract 7508.
CHICAGO – A chemotherapy-free regimen has produced promising early response and survival outcomes in patients with a particularly poor-prognosis subtype of diffuse large B-cell lymphoma, an investigator reported at the annual meeting of the American Society of Clinical Oncology.
The overall response rate was 86% after two cycles of combined rituximab, lenalidomide, and ibrutinib – or RLI – in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) of the non–germinal center (non-GCB) subtype, said Jason Westin, MD, of the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center in Houston.
The response rate increased to 96% after subsequent cycles of RLI plus standard chemotherapy, said Dr.Westin, who added that the rates of progression-free and overall survival at 1 year were also 96% in the investigator initiated, single-arm, open-label, phase 2 study, called Smart Start.
That looks quite favorable, compared with what’s been achieved in previous studies in this poor-prognosis group of patients, Dr. Westin said during a podium presentation of Smart Start data, though he cautioned against direct comparison to historical studies and added that further follow-up is needed.
“Our survival outcomes appear excellent with about a year’s worth of follow-up,” he said during his presentation. “I’d say the novel/novel combinations, with and without chemotherapy, are feasible for large cell, and next step studies are warranted.”
Jasmine M. Zain, MD, of City of Hope Comprehensive Cancer Center, said these results so far raise the possibility of an effective chemotherapy-free treatment regimen for aggressive lymphomas.
“This regimen, particularly for non-GCB subtypes, is extremely promising,” Dr. Zain said during a podium discussion of the study. “I think we were all oohing and aahing over the results, and it could possibly even be practice changing.”
Moving to a nonchemotherapy regimen could raise new questions for treatment of non-GCB and possibly also GCB subtypes of DLBCL, such as when the treatments could be stopped, or whether a maintenance approach would be useful, she added.
The Smart Start study enrolled a total of 60 patients with non-GCB DLBCL. The patients received RLI for two 21-day cycles, followed by another six cycles of RLI plus chemotherapy, which was either EPOCH or CHOP, at the investigators’ discretion.
“With a median follow-up of 362 days, we’ve had three progression events,” Dr. Westin said in his discussion of the preliminary efficacy results.
Adverse events were similar to what would be expected for standard chemotherapy, according to Dr. Westin, except for rash, which was seen mainly in cycles one and two.
There were two deaths on study protocol, including one fatal fungal infection that investigators attributed to high dose corticosteroids and RLI. There were no subsequent fungal infections after a protocol amendment prohibiting corticosteroids during the RLI-only cycles, according to the investigators’ report.
The high response rates following the initial lead-in phase made investigators wonder what would happen without subsequent chemotherapy, Dr. Westin told attendees during his oral presentation. In one case, a 74-year-old man did complete the two lead-in cycles of RLI and declined further therapy.
“He’s now nearly 2 years out, without any additional therapy, and has not relapsed to date,” Dr. Westin said. “This is, again, with 6 weeks worth of RLI therapy.”
Final results and minimal residual disease data from the Smart Start study will be presented at a conference later in 2019, Dr. Westin said.
The study received research support and funding from the ASCO Conquer Cancer Foundation. The trial drug and support were provided by Celgene and Janssen. Dr. Westin reported disclosures related to Celgene, Genentech/Abbvie, Kite Pharma, Kite/Gilead, Novartis, ProNAi, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Janssen, and Karyopharm Therapeutics.
SOURCE: Westin J et al. ASCO 2019, Abstract 7508.
REPORTING FROM ASCO 2019
The costs of surviving cancer
Cancer survivors have significantly higher out-of-pocket medical costs than those with no history of cancer, and a quarter of those survivors have some type of material hardship related to their diagnosis, according to the Centers for Disease Control and Prevention.
Along with those material financial hardships – the need to borrow money, go into debt, or declare bankruptcy – more than 34% of cancer survivors aged 18-64 years experienced psychological financial hardship, defined as worry about large medical bills, in 2011 and 2016, Donatus U. Ekwueme, PhD, and his associates reported in the Morbidity and Mortality Weekly Report.
Cancer survivors spend 60% more out of pocket than those with no cancer history: $1,000 a year from 2011 to 2016, compared with $622 for adults without a history of cancer. Spending was lowest among younger people (18-39 years) and increased with age, but the prevalence of both material and psychological hardships was highest in the middle age group (40-49 years) and lowest in the oldest group (50-64 years), they said.
Women had higher out-of-pocket costs than men, although the difference was smaller for those with cancer ($1,023 vs. $976) than for those without ($721 vs. $519). Material and psychological hardships were both more common among women, said Dr. Ekwueme of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and his associates.
Mean out-of-pocket spending was much higher for cancer survivors with private health insurance ($1,114) than for survivors with public insurance ($471), but material hardship was much more prevalent among those with public insurance (33.1% vs. 21.9%). Rates of psychological hardship, however, were much closer: 35.9% for those with public insurance and 32.5% for those with private insurance, the investigators said.
“The number of Americans with a history of cancer is projected to increase in the next decade, and the economic burden associated with living with a cancer diagnosis will likely increase as well,” they wrote, and interventions such as “systematic screening for financial hardship at cancer diagnosis and throughout the cancer care trajectory [are needed] to minimize financial hardship for cancer survivors.”
The analysis was based on data for 123,771 adults aged 18-64 years from the Medical Expenditure Panel Survey. Out-of-pocket costs were calculated using data from 2011 to 2016, with all costs adjusted to 2016 dollars, but the hardship calculations involved data from only 2011 and 2016.
SOURCE: Ekwueme DU et al. MMWR 2019 Jun 7;68(22):494-9.
Cancer survivors have significantly higher out-of-pocket medical costs than those with no history of cancer, and a quarter of those survivors have some type of material hardship related to their diagnosis, according to the Centers for Disease Control and Prevention.
Along with those material financial hardships – the need to borrow money, go into debt, or declare bankruptcy – more than 34% of cancer survivors aged 18-64 years experienced psychological financial hardship, defined as worry about large medical bills, in 2011 and 2016, Donatus U. Ekwueme, PhD, and his associates reported in the Morbidity and Mortality Weekly Report.
Cancer survivors spend 60% more out of pocket than those with no cancer history: $1,000 a year from 2011 to 2016, compared with $622 for adults without a history of cancer. Spending was lowest among younger people (18-39 years) and increased with age, but the prevalence of both material and psychological hardships was highest in the middle age group (40-49 years) and lowest in the oldest group (50-64 years), they said.
Women had higher out-of-pocket costs than men, although the difference was smaller for those with cancer ($1,023 vs. $976) than for those without ($721 vs. $519). Material and psychological hardships were both more common among women, said Dr. Ekwueme of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and his associates.
Mean out-of-pocket spending was much higher for cancer survivors with private health insurance ($1,114) than for survivors with public insurance ($471), but material hardship was much more prevalent among those with public insurance (33.1% vs. 21.9%). Rates of psychological hardship, however, were much closer: 35.9% for those with public insurance and 32.5% for those with private insurance, the investigators said.
“The number of Americans with a history of cancer is projected to increase in the next decade, and the economic burden associated with living with a cancer diagnosis will likely increase as well,” they wrote, and interventions such as “systematic screening for financial hardship at cancer diagnosis and throughout the cancer care trajectory [are needed] to minimize financial hardship for cancer survivors.”
The analysis was based on data for 123,771 adults aged 18-64 years from the Medical Expenditure Panel Survey. Out-of-pocket costs were calculated using data from 2011 to 2016, with all costs adjusted to 2016 dollars, but the hardship calculations involved data from only 2011 and 2016.
SOURCE: Ekwueme DU et al. MMWR 2019 Jun 7;68(22):494-9.
Cancer survivors have significantly higher out-of-pocket medical costs than those with no history of cancer, and a quarter of those survivors have some type of material hardship related to their diagnosis, according to the Centers for Disease Control and Prevention.
Along with those material financial hardships – the need to borrow money, go into debt, or declare bankruptcy – more than 34% of cancer survivors aged 18-64 years experienced psychological financial hardship, defined as worry about large medical bills, in 2011 and 2016, Donatus U. Ekwueme, PhD, and his associates reported in the Morbidity and Mortality Weekly Report.
Cancer survivors spend 60% more out of pocket than those with no cancer history: $1,000 a year from 2011 to 2016, compared with $622 for adults without a history of cancer. Spending was lowest among younger people (18-39 years) and increased with age, but the prevalence of both material and psychological hardships was highest in the middle age group (40-49 years) and lowest in the oldest group (50-64 years), they said.
Women had higher out-of-pocket costs than men, although the difference was smaller for those with cancer ($1,023 vs. $976) than for those without ($721 vs. $519). Material and psychological hardships were both more common among women, said Dr. Ekwueme of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and his associates.
Mean out-of-pocket spending was much higher for cancer survivors with private health insurance ($1,114) than for survivors with public insurance ($471), but material hardship was much more prevalent among those with public insurance (33.1% vs. 21.9%). Rates of psychological hardship, however, were much closer: 35.9% for those with public insurance and 32.5% for those with private insurance, the investigators said.
“The number of Americans with a history of cancer is projected to increase in the next decade, and the economic burden associated with living with a cancer diagnosis will likely increase as well,” they wrote, and interventions such as “systematic screening for financial hardship at cancer diagnosis and throughout the cancer care trajectory [are needed] to minimize financial hardship for cancer survivors.”
The analysis was based on data for 123,771 adults aged 18-64 years from the Medical Expenditure Panel Survey. Out-of-pocket costs were calculated using data from 2011 to 2016, with all costs adjusted to 2016 dollars, but the hardship calculations involved data from only 2011 and 2016.
SOURCE: Ekwueme DU et al. MMWR 2019 Jun 7;68(22):494-9.
FROM MMWR
A large employer ‘frames’ the Medicare-for-all debate
EASTON, PA. — Walk into a big-box retailer such as Walmart or Michaels and you’re likely to see MCS Industries’ picture frames, decorative mirrors, or kitschy wall décor.
Adjacent to a dairy farm a few miles west of downtown Easton, MCS is the nation’s largest maker of such household products. But MCS doesn’t actually make anything here anymore. It has moved its manufacturing operations to Mexico and China, with the last manufacturing jobs departing this city along the Delaware River in 2005. MCS now has about 175 U.S. employees and 600 people overseas.
“We were going to lose the business because we were no longer competitive,” CEO Richard Master explained. And one of the biggest impediments to keeping labor costs in line, he said, has been the increasing expense of health coverage in the United States.
Today, he’s at the vanguard of a small but growing group of business executives who are lining up to support a Medicare-for-all national health program.
In February, Master stood with Rep. Pramila Jayapal (D-Wash.) outside the Capitol after she introduced her Medicare-for-all bill. “This bill removes an albatross from the neck of American business, puts more money in consumer products and will boost our economy,” he said.
As health costs continue to grow, straining employer budgets and slowing wage growth, others in the business community are beginning to take the option more seriously.
While the influential U.S. Chamber of Commerce and other large business lobbying groups strongly oppose increased government involvement in health care, the resolve of many in the business community – especially among smaller firms – may be shifting.
“There is growing momentum among employers supporting single-payer,” said Dan Geiger, codirector of the Business Alliance for a Healthy California, which has sought to generate business support for a universal health care program in California. About 300 mostly small employers have signed on.
“Businesses are really angry about the system, and there is a lot of frustration with its rising costs and dysfunction,” he said.
Mr. Geiger acknowledged the effort still lacks support from any Fortune 500 company CEOs. He said large businesses are hesitant to get involved in this political debate and many don’t want to lose the ability to attract workers with generous health benefits. “There is also a lingering distrust of the government, and they think they can offer coverage better than the government,” he said.
In addition, some in the business community are hesitant to sign on to Medicare-for-all with many details missing, such as how much it would increase taxes, said Ellen Kelsay, chief strategy officer for the National Business Group on Health, a leading business group focused on health benefits.
Democrats propel the debate
For decades, a government-run health plan was considered too radical an idea for serious consideration. But Medicare-for-all has been garnering more political support in recent months, especially after a progressive wave helped Democrats take control of the House this year. Several 2020 Democratic presidential candidates, including Sens. Bernie Sanders and Elizabeth Warren, strongly back it.
The labor unions and consumer groups that have long endorsed a single-payer health system hope that the embrace of it by employers such as Mr. Master marks another turning point for the movement.
Supporters of the concept say the health system overall would see savings from a coordinated effort to bring down prices and the elimination of many administrative costs or insurance company profits.
“It’s critical for our success to engage employers, particularly because our current system is hurting employers almost as much as it is patients,” said Melinda St. Louis, campaign director of Medicare-for-all at Public Citizen, a consumer-rights group based in Washington.
Mr. Master, a former Washington lawyer, worked on Democratic Sen. George McGovern’s presidential campaign before returning to Pennsylvania in 1973 to take over his father’s company, which made rigid paper boxes. In 1980, he founded MCS, which pioneered the popular front-loading picture frame and steamless fog-free mirrors for bathrooms. The company has grown into a $250 million corporation.
Mr. Master frequently travels to Washington and around the country to talk with business leaders as he seeks to build political support for a single-payer health system.
In the past 4 years, he has produced several documentary videos on the topic. In 2018, he formed the Business Initiative for Health Policy, a nonprofit group of business leaders, economists, and health policy experts trying to explain the financial benefits of a single-payer system.
Dan Wolf, CEO of Cape Air, a Hyannis, Mass.–based regional airline that employs 800 people calls himself “a free-market guy.” But he also supports Medicare-for-all. He said Mr. Master helps turn the political argument over single-payer into a practical one.
“It’s about good business sense and about caring for his employees and their well-being,” he said, adding that employers should no longer be straddled with the cost and complexity of health care.
“It makes no more sense for an airline to understand health policy for the bulk of its workers than for a health facility to have to supply all the air transportation for its employees,” he said.
Employers also are an important voice in the debate because 156 million Americans get employer-paid health care, making it by far the single-largest form of coverage.
Mr. Master said his company has tried various methods to control costs with little success, including high deductibles, narrow networks of providers and wellness plans that emphasize preventive medicine.
Insurers who are supposed to negotiate lower rates from hospitals and doctors have failed, he added, and too many premium dollars go to covering administrative costs. Only by having the federal government set rates can the United States control costs of drugs, hospitals, and other health services, he said.
“Insurance companies are not watching the store and don’t have incentives to hold down costs in the current system,” he said.
Glad the boss is trying to make a difference
What’s left of MCS in Pennsylvania is a spacious corporate office building housing administrative staff, designers, and a giant distribution center piled high with carton boxes from floor to ceiling.
MCS pays an average of $1,260 per month for each employee’s health care, up from $716 in 2009, the company said. In recent years, the company has reduced out-of-pocket costs for employees by covering most of their deductibles.
Medicare-for-all would require several new taxes to raise money, but Mr. Master said such a plan would mean savings for his company and employees.
MCS employees largely support Mr. Master’s attempt to fix the health system even if they are not all on board with a Medicare-for-all approach, according to interviews with several workers in Easton.
“I think it’s a good idea,” said Faith Wildrick, a shipper at MCS who has worked for the company 26 years. “If the other countries are doing it and it is working for them, why can’t it work for us?”
Ms. Wildrick said that even with insurance her family struggles with health costs as her husband, Bill, a former MCS employee, deals with liver disease and needs many diagnostic tests and prescription medications. Their annual deductible has swung from $4,000 several years ago to $500 this year as the company has worked to lower employees’ out-of-pocket costs.
“I’m really glad someone is fighting for this and trying to make a difference,” said Ms. Wildrick.
Jessica Ehrhardt, the human resources manager at MCS, said the effort to reduce employees’ out-of-pocket health costs means the company must pay higher health costs. That results in less money for salary increases and other benefits, she added.
Asked about Medicare-for-all, Ms. Ehrhardt said, “It’s a drastic solution, but something needs to happen.”
For too long, Mr. Master said, the push for a single-payer health system has been about ideology.
“The movement has been about making health care a human right and that we have a right to universal health care,” he said. “What I am saying is this is prudent for our economy and am trying to make the business and economic case.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
EASTON, PA. — Walk into a big-box retailer such as Walmart or Michaels and you’re likely to see MCS Industries’ picture frames, decorative mirrors, or kitschy wall décor.
Adjacent to a dairy farm a few miles west of downtown Easton, MCS is the nation’s largest maker of such household products. But MCS doesn’t actually make anything here anymore. It has moved its manufacturing operations to Mexico and China, with the last manufacturing jobs departing this city along the Delaware River in 2005. MCS now has about 175 U.S. employees and 600 people overseas.
“We were going to lose the business because we were no longer competitive,” CEO Richard Master explained. And one of the biggest impediments to keeping labor costs in line, he said, has been the increasing expense of health coverage in the United States.
Today, he’s at the vanguard of a small but growing group of business executives who are lining up to support a Medicare-for-all national health program.
In February, Master stood with Rep. Pramila Jayapal (D-Wash.) outside the Capitol after she introduced her Medicare-for-all bill. “This bill removes an albatross from the neck of American business, puts more money in consumer products and will boost our economy,” he said.
As health costs continue to grow, straining employer budgets and slowing wage growth, others in the business community are beginning to take the option more seriously.
While the influential U.S. Chamber of Commerce and other large business lobbying groups strongly oppose increased government involvement in health care, the resolve of many in the business community – especially among smaller firms – may be shifting.
“There is growing momentum among employers supporting single-payer,” said Dan Geiger, codirector of the Business Alliance for a Healthy California, which has sought to generate business support for a universal health care program in California. About 300 mostly small employers have signed on.
“Businesses are really angry about the system, and there is a lot of frustration with its rising costs and dysfunction,” he said.
Mr. Geiger acknowledged the effort still lacks support from any Fortune 500 company CEOs. He said large businesses are hesitant to get involved in this political debate and many don’t want to lose the ability to attract workers with generous health benefits. “There is also a lingering distrust of the government, and they think they can offer coverage better than the government,” he said.
In addition, some in the business community are hesitant to sign on to Medicare-for-all with many details missing, such as how much it would increase taxes, said Ellen Kelsay, chief strategy officer for the National Business Group on Health, a leading business group focused on health benefits.
Democrats propel the debate
For decades, a government-run health plan was considered too radical an idea for serious consideration. But Medicare-for-all has been garnering more political support in recent months, especially after a progressive wave helped Democrats take control of the House this year. Several 2020 Democratic presidential candidates, including Sens. Bernie Sanders and Elizabeth Warren, strongly back it.
The labor unions and consumer groups that have long endorsed a single-payer health system hope that the embrace of it by employers such as Mr. Master marks another turning point for the movement.
Supporters of the concept say the health system overall would see savings from a coordinated effort to bring down prices and the elimination of many administrative costs or insurance company profits.
“It’s critical for our success to engage employers, particularly because our current system is hurting employers almost as much as it is patients,” said Melinda St. Louis, campaign director of Medicare-for-all at Public Citizen, a consumer-rights group based in Washington.
Mr. Master, a former Washington lawyer, worked on Democratic Sen. George McGovern’s presidential campaign before returning to Pennsylvania in 1973 to take over his father’s company, which made rigid paper boxes. In 1980, he founded MCS, which pioneered the popular front-loading picture frame and steamless fog-free mirrors for bathrooms. The company has grown into a $250 million corporation.
Mr. Master frequently travels to Washington and around the country to talk with business leaders as he seeks to build political support for a single-payer health system.
In the past 4 years, he has produced several documentary videos on the topic. In 2018, he formed the Business Initiative for Health Policy, a nonprofit group of business leaders, economists, and health policy experts trying to explain the financial benefits of a single-payer system.
Dan Wolf, CEO of Cape Air, a Hyannis, Mass.–based regional airline that employs 800 people calls himself “a free-market guy.” But he also supports Medicare-for-all. He said Mr. Master helps turn the political argument over single-payer into a practical one.
“It’s about good business sense and about caring for his employees and their well-being,” he said, adding that employers should no longer be straddled with the cost and complexity of health care.
“It makes no more sense for an airline to understand health policy for the bulk of its workers than for a health facility to have to supply all the air transportation for its employees,” he said.
Employers also are an important voice in the debate because 156 million Americans get employer-paid health care, making it by far the single-largest form of coverage.
Mr. Master said his company has tried various methods to control costs with little success, including high deductibles, narrow networks of providers and wellness plans that emphasize preventive medicine.
Insurers who are supposed to negotiate lower rates from hospitals and doctors have failed, he added, and too many premium dollars go to covering administrative costs. Only by having the federal government set rates can the United States control costs of drugs, hospitals, and other health services, he said.
“Insurance companies are not watching the store and don’t have incentives to hold down costs in the current system,” he said.
Glad the boss is trying to make a difference
What’s left of MCS in Pennsylvania is a spacious corporate office building housing administrative staff, designers, and a giant distribution center piled high with carton boxes from floor to ceiling.
MCS pays an average of $1,260 per month for each employee’s health care, up from $716 in 2009, the company said. In recent years, the company has reduced out-of-pocket costs for employees by covering most of their deductibles.
Medicare-for-all would require several new taxes to raise money, but Mr. Master said such a plan would mean savings for his company and employees.
MCS employees largely support Mr. Master’s attempt to fix the health system even if they are not all on board with a Medicare-for-all approach, according to interviews with several workers in Easton.
“I think it’s a good idea,” said Faith Wildrick, a shipper at MCS who has worked for the company 26 years. “If the other countries are doing it and it is working for them, why can’t it work for us?”
Ms. Wildrick said that even with insurance her family struggles with health costs as her husband, Bill, a former MCS employee, deals with liver disease and needs many diagnostic tests and prescription medications. Their annual deductible has swung from $4,000 several years ago to $500 this year as the company has worked to lower employees’ out-of-pocket costs.
“I’m really glad someone is fighting for this and trying to make a difference,” said Ms. Wildrick.
Jessica Ehrhardt, the human resources manager at MCS, said the effort to reduce employees’ out-of-pocket health costs means the company must pay higher health costs. That results in less money for salary increases and other benefits, she added.
Asked about Medicare-for-all, Ms. Ehrhardt said, “It’s a drastic solution, but something needs to happen.”
For too long, Mr. Master said, the push for a single-payer health system has been about ideology.
“The movement has been about making health care a human right and that we have a right to universal health care,” he said. “What I am saying is this is prudent for our economy and am trying to make the business and economic case.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
EASTON, PA. — Walk into a big-box retailer such as Walmart or Michaels and you’re likely to see MCS Industries’ picture frames, decorative mirrors, or kitschy wall décor.
Adjacent to a dairy farm a few miles west of downtown Easton, MCS is the nation’s largest maker of such household products. But MCS doesn’t actually make anything here anymore. It has moved its manufacturing operations to Mexico and China, with the last manufacturing jobs departing this city along the Delaware River in 2005. MCS now has about 175 U.S. employees and 600 people overseas.
“We were going to lose the business because we were no longer competitive,” CEO Richard Master explained. And one of the biggest impediments to keeping labor costs in line, he said, has been the increasing expense of health coverage in the United States.
Today, he’s at the vanguard of a small but growing group of business executives who are lining up to support a Medicare-for-all national health program.
In February, Master stood with Rep. Pramila Jayapal (D-Wash.) outside the Capitol after she introduced her Medicare-for-all bill. “This bill removes an albatross from the neck of American business, puts more money in consumer products and will boost our economy,” he said.
As health costs continue to grow, straining employer budgets and slowing wage growth, others in the business community are beginning to take the option more seriously.
While the influential U.S. Chamber of Commerce and other large business lobbying groups strongly oppose increased government involvement in health care, the resolve of many in the business community – especially among smaller firms – may be shifting.
“There is growing momentum among employers supporting single-payer,” said Dan Geiger, codirector of the Business Alliance for a Healthy California, which has sought to generate business support for a universal health care program in California. About 300 mostly small employers have signed on.
“Businesses are really angry about the system, and there is a lot of frustration with its rising costs and dysfunction,” he said.
Mr. Geiger acknowledged the effort still lacks support from any Fortune 500 company CEOs. He said large businesses are hesitant to get involved in this political debate and many don’t want to lose the ability to attract workers with generous health benefits. “There is also a lingering distrust of the government, and they think they can offer coverage better than the government,” he said.
In addition, some in the business community are hesitant to sign on to Medicare-for-all with many details missing, such as how much it would increase taxes, said Ellen Kelsay, chief strategy officer for the National Business Group on Health, a leading business group focused on health benefits.
Democrats propel the debate
For decades, a government-run health plan was considered too radical an idea for serious consideration. But Medicare-for-all has been garnering more political support in recent months, especially after a progressive wave helped Democrats take control of the House this year. Several 2020 Democratic presidential candidates, including Sens. Bernie Sanders and Elizabeth Warren, strongly back it.
The labor unions and consumer groups that have long endorsed a single-payer health system hope that the embrace of it by employers such as Mr. Master marks another turning point for the movement.
Supporters of the concept say the health system overall would see savings from a coordinated effort to bring down prices and the elimination of many administrative costs or insurance company profits.
“It’s critical for our success to engage employers, particularly because our current system is hurting employers almost as much as it is patients,” said Melinda St. Louis, campaign director of Medicare-for-all at Public Citizen, a consumer-rights group based in Washington.
Mr. Master, a former Washington lawyer, worked on Democratic Sen. George McGovern’s presidential campaign before returning to Pennsylvania in 1973 to take over his father’s company, which made rigid paper boxes. In 1980, he founded MCS, which pioneered the popular front-loading picture frame and steamless fog-free mirrors for bathrooms. The company has grown into a $250 million corporation.
Mr. Master frequently travels to Washington and around the country to talk with business leaders as he seeks to build political support for a single-payer health system.
In the past 4 years, he has produced several documentary videos on the topic. In 2018, he formed the Business Initiative for Health Policy, a nonprofit group of business leaders, economists, and health policy experts trying to explain the financial benefits of a single-payer system.
Dan Wolf, CEO of Cape Air, a Hyannis, Mass.–based regional airline that employs 800 people calls himself “a free-market guy.” But he also supports Medicare-for-all. He said Mr. Master helps turn the political argument over single-payer into a practical one.
“It’s about good business sense and about caring for his employees and their well-being,” he said, adding that employers should no longer be straddled with the cost and complexity of health care.
“It makes no more sense for an airline to understand health policy for the bulk of its workers than for a health facility to have to supply all the air transportation for its employees,” he said.
Employers also are an important voice in the debate because 156 million Americans get employer-paid health care, making it by far the single-largest form of coverage.
Mr. Master said his company has tried various methods to control costs with little success, including high deductibles, narrow networks of providers and wellness plans that emphasize preventive medicine.
Insurers who are supposed to negotiate lower rates from hospitals and doctors have failed, he added, and too many premium dollars go to covering administrative costs. Only by having the federal government set rates can the United States control costs of drugs, hospitals, and other health services, he said.
“Insurance companies are not watching the store and don’t have incentives to hold down costs in the current system,” he said.
Glad the boss is trying to make a difference
What’s left of MCS in Pennsylvania is a spacious corporate office building housing administrative staff, designers, and a giant distribution center piled high with carton boxes from floor to ceiling.
MCS pays an average of $1,260 per month for each employee’s health care, up from $716 in 2009, the company said. In recent years, the company has reduced out-of-pocket costs for employees by covering most of their deductibles.
Medicare-for-all would require several new taxes to raise money, but Mr. Master said such a plan would mean savings for his company and employees.
MCS employees largely support Mr. Master’s attempt to fix the health system even if they are not all on board with a Medicare-for-all approach, according to interviews with several workers in Easton.
“I think it’s a good idea,” said Faith Wildrick, a shipper at MCS who has worked for the company 26 years. “If the other countries are doing it and it is working for them, why can’t it work for us?”
Ms. Wildrick said that even with insurance her family struggles with health costs as her husband, Bill, a former MCS employee, deals with liver disease and needs many diagnostic tests and prescription medications. Their annual deductible has swung from $4,000 several years ago to $500 this year as the company has worked to lower employees’ out-of-pocket costs.
“I’m really glad someone is fighting for this and trying to make a difference,” said Ms. Wildrick.
Jessica Ehrhardt, the human resources manager at MCS, said the effort to reduce employees’ out-of-pocket health costs means the company must pay higher health costs. That results in less money for salary increases and other benefits, she added.
Asked about Medicare-for-all, Ms. Ehrhardt said, “It’s a drastic solution, but something needs to happen.”
For too long, Mr. Master said, the push for a single-payer health system has been about ideology.
“The movement has been about making health care a human right and that we have a right to universal health care,” he said. “What I am saying is this is prudent for our economy and am trying to make the business and economic case.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Swedish OA self-management program earns high marks
TORONTO – A in an observational registry study of 47,035 participants, Therese S. Jönsson reported at the OARSI 2019 World Congress.
“The BOA [Better management of patients with Osteoarthritis] program is feasible and demonstrates positive results in a large clinical context. Our results indicate that offering this intervention as the first-line treatment for patients with hip and knee osteoarthritis may reduce the burden of disease,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.
Indeed, the results of the Swedish BOA program for nonsurgical treatment of OA played an influential role in the new draft of OARSI guidelines for management of knee osteoarthritis. The program could serve as a template for implementation of a similar approach in other health care settings. The BOA program has been rolled out to more than 700 Swedish primary care practice sites, according to Ms. Jönsson, a PhD student at Lund (Sweden) University.
The program was created to meet a defined national goal that, as early as possible in the course of the disease, every Swedish patient with knee or hip OA should receive education about their disease and the importance of exercise as a means of improving their quality of life. The impetus for BOA was a widespread concern that, in Sweden and elsewhere, far too many OA patients were being referred for joint surgery without ever having tried the evidence-based core nonsurgical treatments.
The BOA intervention
Following patient referral by a primary care physician, the Swedish BOA program starts off with individual assessment and biomechanical testing by a physical therapist. This is followed by two small-group education sessions of about 90 minutes led by a physical therapist or occupational therapist. Session one includes information about the pathology of OA, risk factors, symptoms, and the available treatments. Session two focuses on coping skills, self-management strategies to reduce pain and symptoms, the central role of exercise as a core treatment in OA, and ways to incorporate physical activity into daily living.
Then comes a decision point. Having listened to a motivational message extolling the benefits of exercise as a means of empowering self-management of their chronic disease, participants next have three choices: They can attend supervised group exercise classes twice weekly for 6 weeks to kick-start a more physically active lifestyle, they can start an individually adapted home exercise program, or they can decline exercise.
Giving patients a choice in this matter is a strategy rooted in the psychological concept of motivational stages of change, which recognizes that some patients with a chronic illness whose course is modifiable through lifestyle change are initially in a precontemplation stage of change. And pushing them hard at that point is counterproductive. The home exercise option, which permits patients to take a low-and-slow approach to exercise, is based upon the BOA program developers’ stated philosophy that 5 minutes of exercise daily, performed as part of everyday life, has a bigger impact upon function than does a 30-minute exercise program that’s abandoned after a few weeks. The goal of the BOA program is for patients to eventually build up to at least 150 minutes of moderate-intensity exercise per week.
The results
Roughly 15% of patients enrolled in the registry declined the exercise option. Ms. Jönsson’s analysis focused on those who opted to participate in an exercise program, 40% of whom selected the home exercise option. This analysis included 30,682 patients with knee OA and 16,363 with hip OA. They returned to the physical therapist for a face-to-face reassessment after 3 months, and they completed a mailed outcome-oriented questionnaire at 12 months.
The BOA intervention was more effective in reducing pain in the knee OA group than in those with hip OA. A statistically significant reduction in self-assessed pain scores on a 0-10 scale was seen in both the knee and hip OA groups at 3 and 12 months; however, only the knee OA patients achieved a clinically important decrease in pain, defined as at least a 15% drop in pain scores. Their pain scores improved from 5.24 at baseline to 4.07 at 3 months and 4.23 at 12 months. In the hip OA patients, pain scores went from 5.39 at baseline to 4.56 at 3 months and 4.7 at 12 months.
However, at 3 and 12 months, significantly fewer patients in both the hip and knee OA groups reported experiencing pain more than once per week, compared with baseline. They also took fewer pain-killing medications, reported less avoidance behavior involving fear of movement, were less willing to undergo joint surgery, and scored significantly higher on the five-level EQ-5D quality-of-life measure than at baseline. Moreover, fewer patients were on sick leave at the 12-month follow-up than at baseline, an outcome that wasn’t assessed at 3 months.
Adherence to the group exercise classes was “quite low,” according to Ms. Jönsson, and poor adherence was reflected in smaller reductions in pain scores. Only 30% of patients who elected the supervised group exercise option attended 10 of the 12 sessions, she noted.
Ms. Jönsson reported having no financial conflicts regarding her study. The BOA program is funded by the Swedish government.
SOURCE: Jönsson TS et al. Osteoarthritis Cartilage. 2019 Apr;27(suppl 1):S497, Abstract 717.
TORONTO – A in an observational registry study of 47,035 participants, Therese S. Jönsson reported at the OARSI 2019 World Congress.
“The BOA [Better management of patients with Osteoarthritis] program is feasible and demonstrates positive results in a large clinical context. Our results indicate that offering this intervention as the first-line treatment for patients with hip and knee osteoarthritis may reduce the burden of disease,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.
Indeed, the results of the Swedish BOA program for nonsurgical treatment of OA played an influential role in the new draft of OARSI guidelines for management of knee osteoarthritis. The program could serve as a template for implementation of a similar approach in other health care settings. The BOA program has been rolled out to more than 700 Swedish primary care practice sites, according to Ms. Jönsson, a PhD student at Lund (Sweden) University.
The program was created to meet a defined national goal that, as early as possible in the course of the disease, every Swedish patient with knee or hip OA should receive education about their disease and the importance of exercise as a means of improving their quality of life. The impetus for BOA was a widespread concern that, in Sweden and elsewhere, far too many OA patients were being referred for joint surgery without ever having tried the evidence-based core nonsurgical treatments.
The BOA intervention
Following patient referral by a primary care physician, the Swedish BOA program starts off with individual assessment and biomechanical testing by a physical therapist. This is followed by two small-group education sessions of about 90 minutes led by a physical therapist or occupational therapist. Session one includes information about the pathology of OA, risk factors, symptoms, and the available treatments. Session two focuses on coping skills, self-management strategies to reduce pain and symptoms, the central role of exercise as a core treatment in OA, and ways to incorporate physical activity into daily living.
Then comes a decision point. Having listened to a motivational message extolling the benefits of exercise as a means of empowering self-management of their chronic disease, participants next have three choices: They can attend supervised group exercise classes twice weekly for 6 weeks to kick-start a more physically active lifestyle, they can start an individually adapted home exercise program, or they can decline exercise.
Giving patients a choice in this matter is a strategy rooted in the psychological concept of motivational stages of change, which recognizes that some patients with a chronic illness whose course is modifiable through lifestyle change are initially in a precontemplation stage of change. And pushing them hard at that point is counterproductive. The home exercise option, which permits patients to take a low-and-slow approach to exercise, is based upon the BOA program developers’ stated philosophy that 5 minutes of exercise daily, performed as part of everyday life, has a bigger impact upon function than does a 30-minute exercise program that’s abandoned after a few weeks. The goal of the BOA program is for patients to eventually build up to at least 150 minutes of moderate-intensity exercise per week.
The results
Roughly 15% of patients enrolled in the registry declined the exercise option. Ms. Jönsson’s analysis focused on those who opted to participate in an exercise program, 40% of whom selected the home exercise option. This analysis included 30,682 patients with knee OA and 16,363 with hip OA. They returned to the physical therapist for a face-to-face reassessment after 3 months, and they completed a mailed outcome-oriented questionnaire at 12 months.
The BOA intervention was more effective in reducing pain in the knee OA group than in those with hip OA. A statistically significant reduction in self-assessed pain scores on a 0-10 scale was seen in both the knee and hip OA groups at 3 and 12 months; however, only the knee OA patients achieved a clinically important decrease in pain, defined as at least a 15% drop in pain scores. Their pain scores improved from 5.24 at baseline to 4.07 at 3 months and 4.23 at 12 months. In the hip OA patients, pain scores went from 5.39 at baseline to 4.56 at 3 months and 4.7 at 12 months.
However, at 3 and 12 months, significantly fewer patients in both the hip and knee OA groups reported experiencing pain more than once per week, compared with baseline. They also took fewer pain-killing medications, reported less avoidance behavior involving fear of movement, were less willing to undergo joint surgery, and scored significantly higher on the five-level EQ-5D quality-of-life measure than at baseline. Moreover, fewer patients were on sick leave at the 12-month follow-up than at baseline, an outcome that wasn’t assessed at 3 months.
Adherence to the group exercise classes was “quite low,” according to Ms. Jönsson, and poor adherence was reflected in smaller reductions in pain scores. Only 30% of patients who elected the supervised group exercise option attended 10 of the 12 sessions, she noted.
Ms. Jönsson reported having no financial conflicts regarding her study. The BOA program is funded by the Swedish government.
SOURCE: Jönsson TS et al. Osteoarthritis Cartilage. 2019 Apr;27(suppl 1):S497, Abstract 717.
TORONTO – A in an observational registry study of 47,035 participants, Therese S. Jönsson reported at the OARSI 2019 World Congress.
“The BOA [Better management of patients with Osteoarthritis] program is feasible and demonstrates positive results in a large clinical context. Our results indicate that offering this intervention as the first-line treatment for patients with hip and knee osteoarthritis may reduce the burden of disease,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.
Indeed, the results of the Swedish BOA program for nonsurgical treatment of OA played an influential role in the new draft of OARSI guidelines for management of knee osteoarthritis. The program could serve as a template for implementation of a similar approach in other health care settings. The BOA program has been rolled out to more than 700 Swedish primary care practice sites, according to Ms. Jönsson, a PhD student at Lund (Sweden) University.
The program was created to meet a defined national goal that, as early as possible in the course of the disease, every Swedish patient with knee or hip OA should receive education about their disease and the importance of exercise as a means of improving their quality of life. The impetus for BOA was a widespread concern that, in Sweden and elsewhere, far too many OA patients were being referred for joint surgery without ever having tried the evidence-based core nonsurgical treatments.
The BOA intervention
Following patient referral by a primary care physician, the Swedish BOA program starts off with individual assessment and biomechanical testing by a physical therapist. This is followed by two small-group education sessions of about 90 minutes led by a physical therapist or occupational therapist. Session one includes information about the pathology of OA, risk factors, symptoms, and the available treatments. Session two focuses on coping skills, self-management strategies to reduce pain and symptoms, the central role of exercise as a core treatment in OA, and ways to incorporate physical activity into daily living.
Then comes a decision point. Having listened to a motivational message extolling the benefits of exercise as a means of empowering self-management of their chronic disease, participants next have three choices: They can attend supervised group exercise classes twice weekly for 6 weeks to kick-start a more physically active lifestyle, they can start an individually adapted home exercise program, or they can decline exercise.
Giving patients a choice in this matter is a strategy rooted in the psychological concept of motivational stages of change, which recognizes that some patients with a chronic illness whose course is modifiable through lifestyle change are initially in a precontemplation stage of change. And pushing them hard at that point is counterproductive. The home exercise option, which permits patients to take a low-and-slow approach to exercise, is based upon the BOA program developers’ stated philosophy that 5 minutes of exercise daily, performed as part of everyday life, has a bigger impact upon function than does a 30-minute exercise program that’s abandoned after a few weeks. The goal of the BOA program is for patients to eventually build up to at least 150 minutes of moderate-intensity exercise per week.
The results
Roughly 15% of patients enrolled in the registry declined the exercise option. Ms. Jönsson’s analysis focused on those who opted to participate in an exercise program, 40% of whom selected the home exercise option. This analysis included 30,682 patients with knee OA and 16,363 with hip OA. They returned to the physical therapist for a face-to-face reassessment after 3 months, and they completed a mailed outcome-oriented questionnaire at 12 months.
The BOA intervention was more effective in reducing pain in the knee OA group than in those with hip OA. A statistically significant reduction in self-assessed pain scores on a 0-10 scale was seen in both the knee and hip OA groups at 3 and 12 months; however, only the knee OA patients achieved a clinically important decrease in pain, defined as at least a 15% drop in pain scores. Their pain scores improved from 5.24 at baseline to 4.07 at 3 months and 4.23 at 12 months. In the hip OA patients, pain scores went from 5.39 at baseline to 4.56 at 3 months and 4.7 at 12 months.
However, at 3 and 12 months, significantly fewer patients in both the hip and knee OA groups reported experiencing pain more than once per week, compared with baseline. They also took fewer pain-killing medications, reported less avoidance behavior involving fear of movement, were less willing to undergo joint surgery, and scored significantly higher on the five-level EQ-5D quality-of-life measure than at baseline. Moreover, fewer patients were on sick leave at the 12-month follow-up than at baseline, an outcome that wasn’t assessed at 3 months.
Adherence to the group exercise classes was “quite low,” according to Ms. Jönsson, and poor adherence was reflected in smaller reductions in pain scores. Only 30% of patients who elected the supervised group exercise option attended 10 of the 12 sessions, she noted.
Ms. Jönsson reported having no financial conflicts regarding her study. The BOA program is funded by the Swedish government.
SOURCE: Jönsson TS et al. Osteoarthritis Cartilage. 2019 Apr;27(suppl 1):S497, Abstract 717.
REPORTING FROM OARSI 2019
OA is underrepresented in the medical literature
TORONTO – Osteoarthritis research doesn’t get nearly the respect it deserves in the medical literature, Elizabeth M. Badley, PhD, asserted at the OARSI 2019 World Congress.
“Osteoarthritis is by far the most common type of arthritis. There are easily 10 times more people who have osteoarthritis than any other joint disease, but when you look at the literature, the situation is kind of reversed. Osteoarthritis is brushed off by society to a degree,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.
Dr. Bradley and colleagues performed a search of MEDLINE for 2007-2016, which turned up a total of 1,625 publications in 2016 on osteoarthritis, excluding those with an orthopedic surgery focus, compared with 10,904 results regarding the broader topic of joint diseases and 28,932 on musculoskeletal diseases.
The bottom line: “Progress is slow, and at this rate osteoarthritis will not be receiving the attention it deserves in our lifetime,” said Dr. Badley, of the department of epidemiology at the University of Toronto and a senior scientist at the Krembil Research Institute, also in Toronto.
The number of publications per year devoted to OA rose by a robust 88% during 2007-2016, while the number on OA not focused on orthopedic procedures grew by 65%. Both of these increases were greater than those for publications on musculoskeletal diseases and joint diseases overall, which were 41% and 51%, respectively. But the absolute number of OA publications was dwarfed by the numbers of those in the other search categories. For example, the number of publications on OA without an orthopedic surgery thrust was 985 in 2007, compared with 7,204 on joint diseases overall.
Among the striking findings of the investigators’ study of the medical literature was the disconnect between the amount of attention devoted to some of the joint-specific manifestations of OA and the actual prevalence of these conditions in the population. For example, the prevalence of hand OA in people living with OA was 52% according to the 2009 Survey on Living with Chronic Diseases in Canada, conducted by Statistics Canada, yet only 6.5% of the publications on OA in 2016 were devoted to hand/thumb OA. Similarly, the prevalence of spine OA was 52% among Canadians with OA, but only 4.3% of OA publications in 2016 focused on that topic. And while the number of publications devoted to elbow OA soared by a seemingly impressive 233% during the study period, the actual numbers were 3 publications in 2007 and 10 in 2016.
“Also, the average number of affected joints in people with osteoarthritis is four. Yet very, very few papers are about multijoint osteoarthritis. And when they do talk about multijoint osteoarthritis, they’re still only talking about hand/hip/knee. So we’re missing the bigger picture of osteoarthritis as a multijoint disease. We’re missing the spine, largely, as a part of osteoarthritis, and we’re missing the peripheral joints,” she said.
Dr. Badley reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Badley EM et al. Osteoarthritis Cartilage. 2019 Apr;27(Suppl 1):S278, Abstract 393.
TORONTO – Osteoarthritis research doesn’t get nearly the respect it deserves in the medical literature, Elizabeth M. Badley, PhD, asserted at the OARSI 2019 World Congress.
“Osteoarthritis is by far the most common type of arthritis. There are easily 10 times more people who have osteoarthritis than any other joint disease, but when you look at the literature, the situation is kind of reversed. Osteoarthritis is brushed off by society to a degree,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.
Dr. Bradley and colleagues performed a search of MEDLINE for 2007-2016, which turned up a total of 1,625 publications in 2016 on osteoarthritis, excluding those with an orthopedic surgery focus, compared with 10,904 results regarding the broader topic of joint diseases and 28,932 on musculoskeletal diseases.
The bottom line: “Progress is slow, and at this rate osteoarthritis will not be receiving the attention it deserves in our lifetime,” said Dr. Badley, of the department of epidemiology at the University of Toronto and a senior scientist at the Krembil Research Institute, also in Toronto.
The number of publications per year devoted to OA rose by a robust 88% during 2007-2016, while the number on OA not focused on orthopedic procedures grew by 65%. Both of these increases were greater than those for publications on musculoskeletal diseases and joint diseases overall, which were 41% and 51%, respectively. But the absolute number of OA publications was dwarfed by the numbers of those in the other search categories. For example, the number of publications on OA without an orthopedic surgery thrust was 985 in 2007, compared with 7,204 on joint diseases overall.
Among the striking findings of the investigators’ study of the medical literature was the disconnect between the amount of attention devoted to some of the joint-specific manifestations of OA and the actual prevalence of these conditions in the population. For example, the prevalence of hand OA in people living with OA was 52% according to the 2009 Survey on Living with Chronic Diseases in Canada, conducted by Statistics Canada, yet only 6.5% of the publications on OA in 2016 were devoted to hand/thumb OA. Similarly, the prevalence of spine OA was 52% among Canadians with OA, but only 4.3% of OA publications in 2016 focused on that topic. And while the number of publications devoted to elbow OA soared by a seemingly impressive 233% during the study period, the actual numbers were 3 publications in 2007 and 10 in 2016.
“Also, the average number of affected joints in people with osteoarthritis is four. Yet very, very few papers are about multijoint osteoarthritis. And when they do talk about multijoint osteoarthritis, they’re still only talking about hand/hip/knee. So we’re missing the bigger picture of osteoarthritis as a multijoint disease. We’re missing the spine, largely, as a part of osteoarthritis, and we’re missing the peripheral joints,” she said.
Dr. Badley reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Badley EM et al. Osteoarthritis Cartilage. 2019 Apr;27(Suppl 1):S278, Abstract 393.
TORONTO – Osteoarthritis research doesn’t get nearly the respect it deserves in the medical literature, Elizabeth M. Badley, PhD, asserted at the OARSI 2019 World Congress.
“Osteoarthritis is by far the most common type of arthritis. There are easily 10 times more people who have osteoarthritis than any other joint disease, but when you look at the literature, the situation is kind of reversed. Osteoarthritis is brushed off by society to a degree,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.
Dr. Bradley and colleagues performed a search of MEDLINE for 2007-2016, which turned up a total of 1,625 publications in 2016 on osteoarthritis, excluding those with an orthopedic surgery focus, compared with 10,904 results regarding the broader topic of joint diseases and 28,932 on musculoskeletal diseases.
The bottom line: “Progress is slow, and at this rate osteoarthritis will not be receiving the attention it deserves in our lifetime,” said Dr. Badley, of the department of epidemiology at the University of Toronto and a senior scientist at the Krembil Research Institute, also in Toronto.
The number of publications per year devoted to OA rose by a robust 88% during 2007-2016, while the number on OA not focused on orthopedic procedures grew by 65%. Both of these increases were greater than those for publications on musculoskeletal diseases and joint diseases overall, which were 41% and 51%, respectively. But the absolute number of OA publications was dwarfed by the numbers of those in the other search categories. For example, the number of publications on OA without an orthopedic surgery thrust was 985 in 2007, compared with 7,204 on joint diseases overall.
Among the striking findings of the investigators’ study of the medical literature was the disconnect between the amount of attention devoted to some of the joint-specific manifestations of OA and the actual prevalence of these conditions in the population. For example, the prevalence of hand OA in people living with OA was 52% according to the 2009 Survey on Living with Chronic Diseases in Canada, conducted by Statistics Canada, yet only 6.5% of the publications on OA in 2016 were devoted to hand/thumb OA. Similarly, the prevalence of spine OA was 52% among Canadians with OA, but only 4.3% of OA publications in 2016 focused on that topic. And while the number of publications devoted to elbow OA soared by a seemingly impressive 233% during the study period, the actual numbers were 3 publications in 2007 and 10 in 2016.
“Also, the average number of affected joints in people with osteoarthritis is four. Yet very, very few papers are about multijoint osteoarthritis. And when they do talk about multijoint osteoarthritis, they’re still only talking about hand/hip/knee. So we’re missing the bigger picture of osteoarthritis as a multijoint disease. We’re missing the spine, largely, as a part of osteoarthritis, and we’re missing the peripheral joints,” she said.
Dr. Badley reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Badley EM et al. Osteoarthritis Cartilage. 2019 Apr;27(Suppl 1):S278, Abstract 393.
REPORTING FROM OARSI 2019
AMA announces final eight recipients of Reimagining Residency initiative
led by medical schools, residency programs, and health systems.
“After establishing a framework for creating the medical schools of the future, the AMA is now supporting innovation projects that will better align residency training with the evolving needs of patients and communities, as well as the workforce needs of the current and future health care system,” AMA CEO and Executive Vice President James L. Madara, MD, stated in a press release.
The projects include curricular innovations to address workforce shortages and address social determinants of health. Other projects will be developed within the framework of innovations and concepts developed and implemented in medical schools over the past 6 years by the AMA’s consortium. These projects include implementing competency-based programs and incorporating Health Systems Science into residency training.
The projects were chosen through a competitive grant process by an advisory panel made up of leading experts in medical education, and selection was based on how well each program met the goals of the initiative: improving the transition from medical school to residency, ensuring readiness for practice through modifications of residency curricula, and optimizing the learning environment to support well-being.
Each of the following projects will receive $1.8 million over 5 years:
- California Oregon Medical Partnership to Address Disparities in Rural Education and Health – Oregon Health & Science University, Portland, and the University of California, Davis
- Fully Integrated Readiness for Service Training: Enhancing the Continuum from Medical School to Residency to Practice – University of North Carolina at Chapel Hill
- NYU Transition to Residency Advantage – New York University
- Promotion in Place: Enhancing Trainee Well-Being and Patient Care Through Time-Variable Graduate Medical Education – Partners HealthCare System, Massachusetts General Hospital, and Brigham and Women’s Hospital, Boston
- Reimagining Residency: Ensuring Readiness for Practice Through Growing Interprofessional Partnerships to Advance Care and Education – Maine Medical Center, Portland
- Residency Training to Effectively Address Social Determinants of Health: Applying a Curricular Framework Across Four Primary Care Specialties – Montefiore Health System, New York
- The Graduate Medical Training “Laboratory”: An Innovative Program to Generate, Implement, and Evaluate Interventions to Improve Resident Burnout and Clinical Skill – Johns Hopkins University, Baltimore; Stanford (Calif.) University; and the University of Alabama at Birmingham
- The GOL2D Project (Goals of Life and Learning Delineated): Collaboration Across Academic Health Systems to Better Align GME with Learner, Patient, and Societal Needs – Vanderbilt University, Nashville, Tenn., and the University of Mississippi, Jackson
An additional three programs will receive a smaller $50,000 planning grant to expedite further exploration and development.
“As the health care landscape and technology rapidly evolve, the AMA will continue working with its community of innovation to drive the future of medicine by supporting significant redesign in physician training. Our goal is to ensure physicians are prepared to adapt, grow, and thrive at every stage of their training and career. Better prepared physicians will deliver more effective and equitable health care,” said Dr. Madara.
led by medical schools, residency programs, and health systems.
“After establishing a framework for creating the medical schools of the future, the AMA is now supporting innovation projects that will better align residency training with the evolving needs of patients and communities, as well as the workforce needs of the current and future health care system,” AMA CEO and Executive Vice President James L. Madara, MD, stated in a press release.
The projects include curricular innovations to address workforce shortages and address social determinants of health. Other projects will be developed within the framework of innovations and concepts developed and implemented in medical schools over the past 6 years by the AMA’s consortium. These projects include implementing competency-based programs and incorporating Health Systems Science into residency training.
The projects were chosen through a competitive grant process by an advisory panel made up of leading experts in medical education, and selection was based on how well each program met the goals of the initiative: improving the transition from medical school to residency, ensuring readiness for practice through modifications of residency curricula, and optimizing the learning environment to support well-being.
Each of the following projects will receive $1.8 million over 5 years:
- California Oregon Medical Partnership to Address Disparities in Rural Education and Health – Oregon Health & Science University, Portland, and the University of California, Davis
- Fully Integrated Readiness for Service Training: Enhancing the Continuum from Medical School to Residency to Practice – University of North Carolina at Chapel Hill
- NYU Transition to Residency Advantage – New York University
- Promotion in Place: Enhancing Trainee Well-Being and Patient Care Through Time-Variable Graduate Medical Education – Partners HealthCare System, Massachusetts General Hospital, and Brigham and Women’s Hospital, Boston
- Reimagining Residency: Ensuring Readiness for Practice Through Growing Interprofessional Partnerships to Advance Care and Education – Maine Medical Center, Portland
- Residency Training to Effectively Address Social Determinants of Health: Applying a Curricular Framework Across Four Primary Care Specialties – Montefiore Health System, New York
- The Graduate Medical Training “Laboratory”: An Innovative Program to Generate, Implement, and Evaluate Interventions to Improve Resident Burnout and Clinical Skill – Johns Hopkins University, Baltimore; Stanford (Calif.) University; and the University of Alabama at Birmingham
- The GOL2D Project (Goals of Life and Learning Delineated): Collaboration Across Academic Health Systems to Better Align GME with Learner, Patient, and Societal Needs – Vanderbilt University, Nashville, Tenn., and the University of Mississippi, Jackson
An additional three programs will receive a smaller $50,000 planning grant to expedite further exploration and development.
“As the health care landscape and technology rapidly evolve, the AMA will continue working with its community of innovation to drive the future of medicine by supporting significant redesign in physician training. Our goal is to ensure physicians are prepared to adapt, grow, and thrive at every stage of their training and career. Better prepared physicians will deliver more effective and equitable health care,” said Dr. Madara.
led by medical schools, residency programs, and health systems.
“After establishing a framework for creating the medical schools of the future, the AMA is now supporting innovation projects that will better align residency training with the evolving needs of patients and communities, as well as the workforce needs of the current and future health care system,” AMA CEO and Executive Vice President James L. Madara, MD, stated in a press release.
The projects include curricular innovations to address workforce shortages and address social determinants of health. Other projects will be developed within the framework of innovations and concepts developed and implemented in medical schools over the past 6 years by the AMA’s consortium. These projects include implementing competency-based programs and incorporating Health Systems Science into residency training.
The projects were chosen through a competitive grant process by an advisory panel made up of leading experts in medical education, and selection was based on how well each program met the goals of the initiative: improving the transition from medical school to residency, ensuring readiness for practice through modifications of residency curricula, and optimizing the learning environment to support well-being.
Each of the following projects will receive $1.8 million over 5 years:
- California Oregon Medical Partnership to Address Disparities in Rural Education and Health – Oregon Health & Science University, Portland, and the University of California, Davis
- Fully Integrated Readiness for Service Training: Enhancing the Continuum from Medical School to Residency to Practice – University of North Carolina at Chapel Hill
- NYU Transition to Residency Advantage – New York University
- Promotion in Place: Enhancing Trainee Well-Being and Patient Care Through Time-Variable Graduate Medical Education – Partners HealthCare System, Massachusetts General Hospital, and Brigham and Women’s Hospital, Boston
- Reimagining Residency: Ensuring Readiness for Practice Through Growing Interprofessional Partnerships to Advance Care and Education – Maine Medical Center, Portland
- Residency Training to Effectively Address Social Determinants of Health: Applying a Curricular Framework Across Four Primary Care Specialties – Montefiore Health System, New York
- The Graduate Medical Training “Laboratory”: An Innovative Program to Generate, Implement, and Evaluate Interventions to Improve Resident Burnout and Clinical Skill – Johns Hopkins University, Baltimore; Stanford (Calif.) University; and the University of Alabama at Birmingham
- The GOL2D Project (Goals of Life and Learning Delineated): Collaboration Across Academic Health Systems to Better Align GME with Learner, Patient, and Societal Needs – Vanderbilt University, Nashville, Tenn., and the University of Mississippi, Jackson
An additional three programs will receive a smaller $50,000 planning grant to expedite further exploration and development.
“As the health care landscape and technology rapidly evolve, the AMA will continue working with its community of innovation to drive the future of medicine by supporting significant redesign in physician training. Our goal is to ensure physicians are prepared to adapt, grow, and thrive at every stage of their training and career. Better prepared physicians will deliver more effective and equitable health care,” said Dr. Madara.
Mentoring during fellowship to improve career fit, decrease burnout, and optimize career satisfaction among young gastroenterologists
Introduction
Burnout in physicians has received significant attention within the past several years, particularly among trainees and early-career physicians. The subspecialties of gastroenterology and hepatology are not immune to burnout, with multiple studies indicating that early career gastroenterologists may be disproportionately affected, compared with their more-established counterparts.1-4 Although the drivers of depersonalization, emotional exhaustion, and a reduced sense of personal accomplishment among trainees and early-career gastroenterologists are not fully understood, maximizing career fit during the transition from fellowship into the first posttraining position has been promoted as a potential method to decrease burnout in this population.4,5
While most trainees enter gastroenterology fellowships with a set of predefined career goals, mentorship during fellowship can provide critical guidance along with exposure to new areas and career tracks that were not previously considered. In a survey of gastroenterology and transplant hepatology fellows, 94% of participants with a mentor reported that the mentor significantly influenced their career decision.6 Effective mentoring also has been identified as one possible method to decrease burnout among trainees.7,8
Formal mentoring in gastroenterology fellowship programs might decrease burnout through effectively identifying risk factors such as work hour violations or a lack of social support. Additionally, when fellows are being prepared for transition to their first positions as attending gastroenterologists, there is a critical opportunity to improve career fit and decrease burnout rates among early-career gastroenterologists. Making the correct choice of subsequent career path after fellowship might be a source of stress, but this should allow early-career gastroenterologists to maximize the time spent doing those activities they feel are the most rewarding. A formal mentoring system and an accessible career mentor can be invaluable in allowing the mentee to identify and select that position.
Career fit
The concept of career fit has been described as the ability of individuals to focus their effort on the aspect or aspects of their work that they find most meaningful.5 Multiple specialties have recognized the importance of career fit and the need to choose appropriately when selecting a position and career path upon completing fellowship. In one evaluation of faculty members from the department of medicine at a large academic medical center, those individuals who spent less than 20% of their time working on the activity that they found most meaningful were significantly more likely to demonstrate burnout.5
In a relatively short time period, gastroenterology fellows are required to gather multiple new skill sets, including functioning as a consultant, performing endoscopic procedures, and potentially gaining formal training in clinical, basic, or translational research methods. During this same period, an intense phase of self-assessment should begin, with one critical aim of training being to identify those factors most likely to lead to a long, satisfying career. The growth that occurs during fellowship may allow for the identification of a career track that is likely to be the most rewarding, such as a career as a clinical investigator, clinician educator, or in clinical practice. Importantly, the trainee must decide which career track will most likely lead to self-fulfillment, even if the chosen path does not align with a mentor or advisor. Additionally, self-assessment also may aid in the identification of a niche that an individual finds most intellectually stimulating, which may lead to an area of research or clinical expertise.
While the demonstrated relationship between career fit and burnout is only an association without demonstrated causation, this does merit further consideration. For the first time in most trainees’ careers, the position after fellowship represents an opportunity to choose a job as opposed to going through a “match” process. Therefore, the trainee must strongly consider the factors that will ultimately lead to career satisfaction. If a large disconnect is present between self-identified career goals and the actual tasks required within daily workflow, this may lead to burnout relatively early in a career. Perhaps more importantly, if an individual did not perform adequate self-reflection when choosing a career path or did not receive effective guidance from career mentors, this also might lead to decreased career satisfaction, poor career fit, and an increased risk for burnout as an early-career gastroenterologist.
The mentor’s role
Although a structured career mentoring program is in place within many gastroenterology training programs, other fellowships encourage the mentee to select from a pool of potential mentors. In many cases, trainees and early career gastroenterologists will benefit from building a mentorship team, including career mentor or mentors, research mentors, and other advisors.9
While the mentor-mentee relationship can be an extremely rewarding experience for both parties, the effective mentor must meet a high standard. Several qualities have been identified that will maximize the benefit of the mentor-mentee relationship for the trainee, including the mentor taking a selfless approach to the relationship, working to assist the mentee in choosing a career path that will be the most rewarding, and then aiding the mentee in making helpful connections to promote growth along that chosen path.9 A good mentors should inspire a mentees, but also should be willing to provide honest and at times critical feedback to ensure that mentees maximizes their potential and ultimately assume the appropriate career trajectory. Unbiased mentorship, as well as continued reevaluations of strengths, weaknesses, and career goals by the mentor and mentee, will ultimately offer an opportunity to ensure the best combination of career fit,5 work-life balance,10 and satisfaction with career choice.11
The mentor-mentee relationship after training is complete
Once a trainee has completed gastroenterology fellowship, another stressful transition to the role of an attending physician commences. It is critical that early-career gastroenterologists not only have confidence in the guidance that their mentor has provided to ensure appropriate career fit in their new role but also maintain these critical mentor-mentee relationships during this transition. A good mentor does not disappear because one phase of training is complete. The need for effective mentoring at the junior faculty level also is well recognized,12 and early-career gastroenterologists should continue to rely on established mentoring relationships when new decision points are encountered.
Depending on the career track of an early-career gastroenterologist, formal mentoring also may be offered in the new role as a junior faculty member.12 Additionally, external mentoring can exist within foundations or other subspecialty groups. One example of extramural mentoring is the Career Connection Program offered through the Crohn’s & Colitis Foundation’s Rising Educators Academics and Clinicians Helping IBD (REACH-IBD) platform. In this program, early-career gastroenterologists are selected and paired with national opinion leaders for one-on-one mentoring relationships. Such a program offers further opportunities for career growth, establishing connections within a smaller subspecialty of gastroenterology, and maximizing career fit.
Conclusion
In an era where the toll of burnout and other influences on early-career gastroenterologists are increasingly being recognized, the importance of career fit during the transition into the role of an attending should not be underestimated. In conjunction with appropriate self-reflection, unbiased and critical mentorship during fellowship can promote significant growth among trainees and allow for the ultimate selection of a career track or career path that will promote happiness, work-life balance, and long-term success as defined by the mentee.
Edward L. Barnes, MD, MPH, is with the Multidisciplinary Center for Inflammatory Bowel Diseases and the Center for Gastrointestinal Biology and Disease in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. Dr. Barnes reports no relevant disclosures.
References
1. Keswani RN et al. Am J Gastroenterol. 2011;106(10):1734-40.
2. Burke C et al. Am J Gastroenterol. 2017;112:S593-4.
3. DeCross AJ. AGA Perspectives. 2017.
4. Barnes EL et al. Dig Dis Sci. 2019;64(2):302-6.
5. Shanafelt TD et al. Arch Intern Med. 2009;169(10):990-5.
6. Ordway SM et al. Hepatol Commun. 2017;1(4):347-53.
7. Janko MR, Smeds MR. J Vasc Surg. 2019;69(4):1233-42.
8. Eckleberry-Hunt J et al. Acad Med. 2009;84(2):269-77.
9. Lieberman D. Gastroenterology. 2016;151(1):17-9.
10. Shanafelt TD et al. Mayo Clin Proc. 2015;90(12):1600-13.
11. Shanafelt TD et al. Ann Surg. 2009;250(3):463-71.
12. Shaheen NJ, Sandler RS. Gastroenterology. 2018;155(5):1293-7.
Introduction
Burnout in physicians has received significant attention within the past several years, particularly among trainees and early-career physicians. The subspecialties of gastroenterology and hepatology are not immune to burnout, with multiple studies indicating that early career gastroenterologists may be disproportionately affected, compared with their more-established counterparts.1-4 Although the drivers of depersonalization, emotional exhaustion, and a reduced sense of personal accomplishment among trainees and early-career gastroenterologists are not fully understood, maximizing career fit during the transition from fellowship into the first posttraining position has been promoted as a potential method to decrease burnout in this population.4,5
While most trainees enter gastroenterology fellowships with a set of predefined career goals, mentorship during fellowship can provide critical guidance along with exposure to new areas and career tracks that were not previously considered. In a survey of gastroenterology and transplant hepatology fellows, 94% of participants with a mentor reported that the mentor significantly influenced their career decision.6 Effective mentoring also has been identified as one possible method to decrease burnout among trainees.7,8
Formal mentoring in gastroenterology fellowship programs might decrease burnout through effectively identifying risk factors such as work hour violations or a lack of social support. Additionally, when fellows are being prepared for transition to their first positions as attending gastroenterologists, there is a critical opportunity to improve career fit and decrease burnout rates among early-career gastroenterologists. Making the correct choice of subsequent career path after fellowship might be a source of stress, but this should allow early-career gastroenterologists to maximize the time spent doing those activities they feel are the most rewarding. A formal mentoring system and an accessible career mentor can be invaluable in allowing the mentee to identify and select that position.
Career fit
The concept of career fit has been described as the ability of individuals to focus their effort on the aspect or aspects of their work that they find most meaningful.5 Multiple specialties have recognized the importance of career fit and the need to choose appropriately when selecting a position and career path upon completing fellowship. In one evaluation of faculty members from the department of medicine at a large academic medical center, those individuals who spent less than 20% of their time working on the activity that they found most meaningful were significantly more likely to demonstrate burnout.5
In a relatively short time period, gastroenterology fellows are required to gather multiple new skill sets, including functioning as a consultant, performing endoscopic procedures, and potentially gaining formal training in clinical, basic, or translational research methods. During this same period, an intense phase of self-assessment should begin, with one critical aim of training being to identify those factors most likely to lead to a long, satisfying career. The growth that occurs during fellowship may allow for the identification of a career track that is likely to be the most rewarding, such as a career as a clinical investigator, clinician educator, or in clinical practice. Importantly, the trainee must decide which career track will most likely lead to self-fulfillment, even if the chosen path does not align with a mentor or advisor. Additionally, self-assessment also may aid in the identification of a niche that an individual finds most intellectually stimulating, which may lead to an area of research or clinical expertise.
While the demonstrated relationship between career fit and burnout is only an association without demonstrated causation, this does merit further consideration. For the first time in most trainees’ careers, the position after fellowship represents an opportunity to choose a job as opposed to going through a “match” process. Therefore, the trainee must strongly consider the factors that will ultimately lead to career satisfaction. If a large disconnect is present between self-identified career goals and the actual tasks required within daily workflow, this may lead to burnout relatively early in a career. Perhaps more importantly, if an individual did not perform adequate self-reflection when choosing a career path or did not receive effective guidance from career mentors, this also might lead to decreased career satisfaction, poor career fit, and an increased risk for burnout as an early-career gastroenterologist.
The mentor’s role
Although a structured career mentoring program is in place within many gastroenterology training programs, other fellowships encourage the mentee to select from a pool of potential mentors. In many cases, trainees and early career gastroenterologists will benefit from building a mentorship team, including career mentor or mentors, research mentors, and other advisors.9
While the mentor-mentee relationship can be an extremely rewarding experience for both parties, the effective mentor must meet a high standard. Several qualities have been identified that will maximize the benefit of the mentor-mentee relationship for the trainee, including the mentor taking a selfless approach to the relationship, working to assist the mentee in choosing a career path that will be the most rewarding, and then aiding the mentee in making helpful connections to promote growth along that chosen path.9 A good mentors should inspire a mentees, but also should be willing to provide honest and at times critical feedback to ensure that mentees maximizes their potential and ultimately assume the appropriate career trajectory. Unbiased mentorship, as well as continued reevaluations of strengths, weaknesses, and career goals by the mentor and mentee, will ultimately offer an opportunity to ensure the best combination of career fit,5 work-life balance,10 and satisfaction with career choice.11
The mentor-mentee relationship after training is complete
Once a trainee has completed gastroenterology fellowship, another stressful transition to the role of an attending physician commences. It is critical that early-career gastroenterologists not only have confidence in the guidance that their mentor has provided to ensure appropriate career fit in their new role but also maintain these critical mentor-mentee relationships during this transition. A good mentor does not disappear because one phase of training is complete. The need for effective mentoring at the junior faculty level also is well recognized,12 and early-career gastroenterologists should continue to rely on established mentoring relationships when new decision points are encountered.
Depending on the career track of an early-career gastroenterologist, formal mentoring also may be offered in the new role as a junior faculty member.12 Additionally, external mentoring can exist within foundations or other subspecialty groups. One example of extramural mentoring is the Career Connection Program offered through the Crohn’s & Colitis Foundation’s Rising Educators Academics and Clinicians Helping IBD (REACH-IBD) platform. In this program, early-career gastroenterologists are selected and paired with national opinion leaders for one-on-one mentoring relationships. Such a program offers further opportunities for career growth, establishing connections within a smaller subspecialty of gastroenterology, and maximizing career fit.
Conclusion
In an era where the toll of burnout and other influences on early-career gastroenterologists are increasingly being recognized, the importance of career fit during the transition into the role of an attending should not be underestimated. In conjunction with appropriate self-reflection, unbiased and critical mentorship during fellowship can promote significant growth among trainees and allow for the ultimate selection of a career track or career path that will promote happiness, work-life balance, and long-term success as defined by the mentee.
Edward L. Barnes, MD, MPH, is with the Multidisciplinary Center for Inflammatory Bowel Diseases and the Center for Gastrointestinal Biology and Disease in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. Dr. Barnes reports no relevant disclosures.
References
1. Keswani RN et al. Am J Gastroenterol. 2011;106(10):1734-40.
2. Burke C et al. Am J Gastroenterol. 2017;112:S593-4.
3. DeCross AJ. AGA Perspectives. 2017.
4. Barnes EL et al. Dig Dis Sci. 2019;64(2):302-6.
5. Shanafelt TD et al. Arch Intern Med. 2009;169(10):990-5.
6. Ordway SM et al. Hepatol Commun. 2017;1(4):347-53.
7. Janko MR, Smeds MR. J Vasc Surg. 2019;69(4):1233-42.
8. Eckleberry-Hunt J et al. Acad Med. 2009;84(2):269-77.
9. Lieberman D. Gastroenterology. 2016;151(1):17-9.
10. Shanafelt TD et al. Mayo Clin Proc. 2015;90(12):1600-13.
11. Shanafelt TD et al. Ann Surg. 2009;250(3):463-71.
12. Shaheen NJ, Sandler RS. Gastroenterology. 2018;155(5):1293-7.
Introduction
Burnout in physicians has received significant attention within the past several years, particularly among trainees and early-career physicians. The subspecialties of gastroenterology and hepatology are not immune to burnout, with multiple studies indicating that early career gastroenterologists may be disproportionately affected, compared with their more-established counterparts.1-4 Although the drivers of depersonalization, emotional exhaustion, and a reduced sense of personal accomplishment among trainees and early-career gastroenterologists are not fully understood, maximizing career fit during the transition from fellowship into the first posttraining position has been promoted as a potential method to decrease burnout in this population.4,5
While most trainees enter gastroenterology fellowships with a set of predefined career goals, mentorship during fellowship can provide critical guidance along with exposure to new areas and career tracks that were not previously considered. In a survey of gastroenterology and transplant hepatology fellows, 94% of participants with a mentor reported that the mentor significantly influenced their career decision.6 Effective mentoring also has been identified as one possible method to decrease burnout among trainees.7,8
Formal mentoring in gastroenterology fellowship programs might decrease burnout through effectively identifying risk factors such as work hour violations or a lack of social support. Additionally, when fellows are being prepared for transition to their first positions as attending gastroenterologists, there is a critical opportunity to improve career fit and decrease burnout rates among early-career gastroenterologists. Making the correct choice of subsequent career path after fellowship might be a source of stress, but this should allow early-career gastroenterologists to maximize the time spent doing those activities they feel are the most rewarding. A formal mentoring system and an accessible career mentor can be invaluable in allowing the mentee to identify and select that position.
Career fit
The concept of career fit has been described as the ability of individuals to focus their effort on the aspect or aspects of their work that they find most meaningful.5 Multiple specialties have recognized the importance of career fit and the need to choose appropriately when selecting a position and career path upon completing fellowship. In one evaluation of faculty members from the department of medicine at a large academic medical center, those individuals who spent less than 20% of their time working on the activity that they found most meaningful were significantly more likely to demonstrate burnout.5
In a relatively short time period, gastroenterology fellows are required to gather multiple new skill sets, including functioning as a consultant, performing endoscopic procedures, and potentially gaining formal training in clinical, basic, or translational research methods. During this same period, an intense phase of self-assessment should begin, with one critical aim of training being to identify those factors most likely to lead to a long, satisfying career. The growth that occurs during fellowship may allow for the identification of a career track that is likely to be the most rewarding, such as a career as a clinical investigator, clinician educator, or in clinical practice. Importantly, the trainee must decide which career track will most likely lead to self-fulfillment, even if the chosen path does not align with a mentor or advisor. Additionally, self-assessment also may aid in the identification of a niche that an individual finds most intellectually stimulating, which may lead to an area of research or clinical expertise.
While the demonstrated relationship between career fit and burnout is only an association without demonstrated causation, this does merit further consideration. For the first time in most trainees’ careers, the position after fellowship represents an opportunity to choose a job as opposed to going through a “match” process. Therefore, the trainee must strongly consider the factors that will ultimately lead to career satisfaction. If a large disconnect is present between self-identified career goals and the actual tasks required within daily workflow, this may lead to burnout relatively early in a career. Perhaps more importantly, if an individual did not perform adequate self-reflection when choosing a career path or did not receive effective guidance from career mentors, this also might lead to decreased career satisfaction, poor career fit, and an increased risk for burnout as an early-career gastroenterologist.
The mentor’s role
Although a structured career mentoring program is in place within many gastroenterology training programs, other fellowships encourage the mentee to select from a pool of potential mentors. In many cases, trainees and early career gastroenterologists will benefit from building a mentorship team, including career mentor or mentors, research mentors, and other advisors.9
While the mentor-mentee relationship can be an extremely rewarding experience for both parties, the effective mentor must meet a high standard. Several qualities have been identified that will maximize the benefit of the mentor-mentee relationship for the trainee, including the mentor taking a selfless approach to the relationship, working to assist the mentee in choosing a career path that will be the most rewarding, and then aiding the mentee in making helpful connections to promote growth along that chosen path.9 A good mentors should inspire a mentees, but also should be willing to provide honest and at times critical feedback to ensure that mentees maximizes their potential and ultimately assume the appropriate career trajectory. Unbiased mentorship, as well as continued reevaluations of strengths, weaknesses, and career goals by the mentor and mentee, will ultimately offer an opportunity to ensure the best combination of career fit,5 work-life balance,10 and satisfaction with career choice.11
The mentor-mentee relationship after training is complete
Once a trainee has completed gastroenterology fellowship, another stressful transition to the role of an attending physician commences. It is critical that early-career gastroenterologists not only have confidence in the guidance that their mentor has provided to ensure appropriate career fit in their new role but also maintain these critical mentor-mentee relationships during this transition. A good mentor does not disappear because one phase of training is complete. The need for effective mentoring at the junior faculty level also is well recognized,12 and early-career gastroenterologists should continue to rely on established mentoring relationships when new decision points are encountered.
Depending on the career track of an early-career gastroenterologist, formal mentoring also may be offered in the new role as a junior faculty member.12 Additionally, external mentoring can exist within foundations or other subspecialty groups. One example of extramural mentoring is the Career Connection Program offered through the Crohn’s & Colitis Foundation’s Rising Educators Academics and Clinicians Helping IBD (REACH-IBD) platform. In this program, early-career gastroenterologists are selected and paired with national opinion leaders for one-on-one mentoring relationships. Such a program offers further opportunities for career growth, establishing connections within a smaller subspecialty of gastroenterology, and maximizing career fit.
Conclusion
In an era where the toll of burnout and other influences on early-career gastroenterologists are increasingly being recognized, the importance of career fit during the transition into the role of an attending should not be underestimated. In conjunction with appropriate self-reflection, unbiased and critical mentorship during fellowship can promote significant growth among trainees and allow for the ultimate selection of a career track or career path that will promote happiness, work-life balance, and long-term success as defined by the mentee.
Edward L. Barnes, MD, MPH, is with the Multidisciplinary Center for Inflammatory Bowel Diseases and the Center for Gastrointestinal Biology and Disease in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. Dr. Barnes reports no relevant disclosures.
References
1. Keswani RN et al. Am J Gastroenterol. 2011;106(10):1734-40.
2. Burke C et al. Am J Gastroenterol. 2017;112:S593-4.
3. DeCross AJ. AGA Perspectives. 2017.
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5. Shanafelt TD et al. Arch Intern Med. 2009;169(10):990-5.
6. Ordway SM et al. Hepatol Commun. 2017;1(4):347-53.
7. Janko MR, Smeds MR. J Vasc Surg. 2019;69(4):1233-42.
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Opioid prescriptions declined 33% over 5 years
Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.
Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.
The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.
A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.
Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).
In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.
More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.
While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.
The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.
A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.
“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”
Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”
Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.
Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.
The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.
A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.
Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).
In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.
More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.
While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.
The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.
A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.
“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”
Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”
Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.
Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.
The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.
A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.
Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).
In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.
More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.
While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.
The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.
A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.
“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”
Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”
New help for peanut allergies
Breakthrough therapy holds potential
When it comes to anaphylaxis episodes leading to pediatric intensive care–unit stays, peanuts are the most common culprit. Now the results of a recent clinical trial may lead to approval of the first oral medication to ameliorate reactions in children with severe peanut allergies.
After 6 months of treatment and 6 months of maintenance therapy, two-thirds of the 372 children who received this treatment could ingest the equivalent of two peanuts without allergic symptoms. Just 4% of the 124 children given a placebo powder were able to consume that amount of peanut without reacting. The treatment was not effective for the small number of adults in the study.
This trial of the drug, called AR101 and developed by Aimmune Therapeutics, was published in Nov. 2018 in the New England Journal of Medicine. The company has submitted a biologics license application to the U.S. Food and Drug Administration, and because the drug has been designated a breakthrough therapy, it will go through an accelerated approval process. It could be on the market by the end of 2019.
Reference
1. Rabin RC. New Peanut Allergy Drug Shows ‘Lifesaving’ Potential. New York Times. Nov. 18, 2018. https://www.nytimes.com/2018/11/18/well/live/new-peanut-allergy-drug-shows-lifesaving-potential.html. Accessed Nov. 26, 2018.
Breakthrough therapy holds potential
Breakthrough therapy holds potential
When it comes to anaphylaxis episodes leading to pediatric intensive care–unit stays, peanuts are the most common culprit. Now the results of a recent clinical trial may lead to approval of the first oral medication to ameliorate reactions in children with severe peanut allergies.
After 6 months of treatment and 6 months of maintenance therapy, two-thirds of the 372 children who received this treatment could ingest the equivalent of two peanuts without allergic symptoms. Just 4% of the 124 children given a placebo powder were able to consume that amount of peanut without reacting. The treatment was not effective for the small number of adults in the study.
This trial of the drug, called AR101 and developed by Aimmune Therapeutics, was published in Nov. 2018 in the New England Journal of Medicine. The company has submitted a biologics license application to the U.S. Food and Drug Administration, and because the drug has been designated a breakthrough therapy, it will go through an accelerated approval process. It could be on the market by the end of 2019.
Reference
1. Rabin RC. New Peanut Allergy Drug Shows ‘Lifesaving’ Potential. New York Times. Nov. 18, 2018. https://www.nytimes.com/2018/11/18/well/live/new-peanut-allergy-drug-shows-lifesaving-potential.html. Accessed Nov. 26, 2018.
When it comes to anaphylaxis episodes leading to pediatric intensive care–unit stays, peanuts are the most common culprit. Now the results of a recent clinical trial may lead to approval of the first oral medication to ameliorate reactions in children with severe peanut allergies.
After 6 months of treatment and 6 months of maintenance therapy, two-thirds of the 372 children who received this treatment could ingest the equivalent of two peanuts without allergic symptoms. Just 4% of the 124 children given a placebo powder were able to consume that amount of peanut without reacting. The treatment was not effective for the small number of adults in the study.
This trial of the drug, called AR101 and developed by Aimmune Therapeutics, was published in Nov. 2018 in the New England Journal of Medicine. The company has submitted a biologics license application to the U.S. Food and Drug Administration, and because the drug has been designated a breakthrough therapy, it will go through an accelerated approval process. It could be on the market by the end of 2019.
Reference
1. Rabin RC. New Peanut Allergy Drug Shows ‘Lifesaving’ Potential. New York Times. Nov. 18, 2018. https://www.nytimes.com/2018/11/18/well/live/new-peanut-allergy-drug-shows-lifesaving-potential.html. Accessed Nov. 26, 2018.