According to a new survey report released by The Physicians Foundation, 80% of physicians across all specialties report being at full capacity or overextended, and 78% reported sometimes, often, or always experiencing feelings of burnout.

Sixty-two percent of U.S. doctors are pessimistic about the future of medicine, and 49% wouldn’t recommend medicine as a career to their children. This paints a pretty grim picture of medical practice in the United States in 2018.

The survey is conducted every other year by The Physicians Foundation with the assistance of Merritt Hawkins, and I wrote a blog post about the 2016 survey results, which showed alarming levels of disengagement and burnout. So, I thought it would be worthwhile looking over the 2018 report to see if anything has improved.

It appears that things haven’t changed much for doctors since 2016 regarding their attitudes toward their work. The biggest take-away from this year’s survey is that doctors overall are working fewer hours and seeing fewer patients but still struggling with morale and burnout. One important trend that was highlighted is the move toward employment by hospitals or integrated delivery systems; only 31% of physicians are independent practice owners or partners, vs. 49% in the first such survey conducted in 2012. Interestingly, employed doctors tend to work longer hours but see fewer patients compared with their practice-owner colleagues.

The 39-question survey is sent out via e-mail to more than 700,000 physicians (everyone the AMA or Merritt Hawkins has in their databases), and this year 8,774 physicians responded; the statistics geniuses at the University of Tennessee say the survey results have a margin of error of +/– 1.057%. Interestingly, that’s less than half of the 17,236 physicians who responded to the survey in 2016, and I wonder if the reduction in response rate itself indicates an increased level of disengagement among doctors.

Doctors expressed similar frustrations with specific aspects of their work this year, compared with 2016. The single biggest frustration cited by doctors was EHRs (39% this year vs. 27% in 2016), followed by regulatory/insurance requirements (down to 38% from 58% in 2016) and loss of clinical autonomy (37% vs. 32% in 2016). Survey respondents reported working an average of 51.4 hours per week, of which 11.4 hours (22%) are spent on nonclinical (paperwork) duties.

Read the full post at hospitalleader.org.
 

Also on The Hospital Leader

• I don’t want someone like you caring for me by Gopi Astik, MD
• CMS added care transition codes a few years back. How’s that goin’? by Brad Flansbaum, DO, MPH, MHM
• Sleepless in the hospital no more: Lessons learned during the SIESTA Study by Vineet Arora, MD, MAPP, MHM
• Are you committing malpractice by not treating opioid use disorder in the hospital? by Chris Moriates, MD

According to a new survey report released by The Physicians Foundation, 80% of physicians across all specialties report being at full capacity or overextended, and 78% reported sometimes, often, or always experiencing feelings of burnout.

Sixty-two percent of U.S. doctors are pessimistic about the future of medicine, and 49% wouldn’t recommend medicine as a career to their children. This paints a pretty grim picture of medical practice in the United States in 2018.

The survey is conducted every other year by The Physicians Foundation with the assistance of Merritt Hawkins, and I wrote a blog post about the 2016 survey results, which showed alarming levels of disengagement and burnout. So, I thought it would be worthwhile looking over the 2018 report to see if anything has improved.

It appears that things haven’t changed much for doctors since 2016 regarding their attitudes toward their work. The biggest take-away from this year’s survey is that doctors overall are working fewer hours and seeing fewer patients but still struggling with morale and burnout. One important trend that was highlighted is the move toward employment by hospitals or integrated delivery systems; only 31% of physicians are independent practice owners or partners, vs. 49% in the first such survey conducted in 2012. Interestingly, employed doctors tend to work longer hours but see fewer patients compared with their practice-owner colleagues.

The 39-question survey is sent out via e-mail to more than 700,000 physicians (everyone the AMA or Merritt Hawkins has in their databases), and this year 8,774 physicians responded; the statistics geniuses at the University of Tennessee say the survey results have a margin of error of +/– 1.057%. Interestingly, that’s less than half of the 17,236 physicians who responded to the survey in 2016, and I wonder if the reduction in response rate itself indicates an increased level of disengagement among doctors.

Doctors expressed similar frustrations with specific aspects of their work this year, compared with 2016. The single biggest frustration cited by doctors was EHRs (39% this year vs. 27% in 2016), followed by regulatory/insurance requirements (down to 38% from 58% in 2016) and loss of clinical autonomy (37% vs. 32% in 2016). Survey respondents reported working an average of 51.4 hours per week, of which 11.4 hours (22%) are spent on nonclinical (paperwork) duties.

Read the full post at hospitalleader.org.
 

Also on The Hospital Leader

• I don’t want someone like you caring for me by Gopi Astik, MD
• CMS added care transition codes a few years back. How’s that goin’? by Brad Flansbaum, DO, MPH, MHM
• Sleepless in the hospital no more: Lessons learned during the SIESTA Study by Vineet Arora, MD, MAPP, MHM
• Are you committing malpractice by not treating opioid use disorder in the hospital? by Chris Moriates, MD

According to a new survey report released by The Physicians Foundation, 80% of physicians across all specialties report being at full capacity or overextended, and 78% reported sometimes, often, or always experiencing feelings of burnout.

Sixty-two percent of U.S. doctors are pessimistic about the future of medicine, and 49% wouldn’t recommend medicine as a career to their children. This paints a pretty grim picture of medical practice in the United States in 2018.

The survey is conducted every other year by The Physicians Foundation with the assistance of Merritt Hawkins, and I wrote a blog post about the 2016 survey results, which showed alarming levels of disengagement and burnout. So, I thought it would be worthwhile looking over the 2018 report to see if anything has improved.

It appears that things haven’t changed much for doctors since 2016 regarding their attitudes toward their work. The biggest take-away from this year’s survey is that doctors overall are working fewer hours and seeing fewer patients but still struggling with morale and burnout. One important trend that was highlighted is the move toward employment by hospitals or integrated delivery systems; only 31% of physicians are independent practice owners or partners, vs. 49% in the first such survey conducted in 2012. Interestingly, employed doctors tend to work longer hours but see fewer patients compared with their practice-owner colleagues.

The 39-question survey is sent out via e-mail to more than 700,000 physicians (everyone the AMA or Merritt Hawkins has in their databases), and this year 8,774 physicians responded; the statistics geniuses at the University of Tennessee say the survey results have a margin of error of +/– 1.057%. Interestingly, that’s less than half of the 17,236 physicians who responded to the survey in 2016, and I wonder if the reduction in response rate itself indicates an increased level of disengagement among doctors.

Doctors expressed similar frustrations with specific aspects of their work this year, compared with 2016. The single biggest frustration cited by doctors was EHRs (39% this year vs. 27% in 2016), followed by regulatory/insurance requirements (down to 38% from 58% in 2016) and loss of clinical autonomy (37% vs. 32% in 2016). Survey respondents reported working an average of 51.4 hours per week, of which 11.4 hours (22%) are spent on nonclinical (paperwork) duties.

Read the full post at hospitalleader.org.
 

Also on The Hospital Leader

• I don’t want someone like you caring for me by Gopi Astik, MD
• CMS added care transition codes a few years back. How’s that goin’? by Brad Flansbaum, DO, MPH, MHM
• Sleepless in the hospital no more: Lessons learned during the SIESTA Study by Vineet Arora, MD, MAPP, MHM
• Are you committing malpractice by not treating opioid use disorder in the hospital? by Chris Moriates, MD

When Erin Gilmer filled her insulin prescription at a Denver-area Walgreens in January, she paid $8.50. U.S. taxpayers paid another $280.51.

iStock/ThinkStock

“It eats at me to know that taxpayer money is being wasted,” said Gilmer, who has Medicare and was diagnosed with type 1 diabetes while a sophomore at the University of Colorado in 2002.

The diagnosis meant that for the rest of her life she’d require daily insulin shots to stay alive. But the price of that insulin is skyrocketing.

Between 2009 and 2017 the wholesale price of a single vial of Humalog, the Eli Lilly and Co.–manufactured insulin Gilmer uses, nearly tripled – rising from $92.70 to $274.70, according to data from IBM Watson Health.

Six years ago, Gilmer qualified for Social Security Disability Insurance – and thus, Medicare – because of a range of health issues. At the time, the insulin she needed cost $167.70 per vial, according to IBM Watson Health.

“When it’s taxpayer money paying for medication for someone like me, it makes it a national issue, not just a diabetic issue,” Gilmer said.

Stories about people with type 1 diabetes dying when they couldn’t afford insulin have made headlines. Patient activists like Gilmer have protested high prices outside Lilly’s headquarters in Indianapolis.

Last October in Minnesota, State Attorney General Lori Swanson sued insulin manufacturers, alleging price gouging. Pharmaceutical executives were grilled about high drug prices by the Senate Finance Committee on Feb. 26.

This is the backdrop for Lilly’s announcement March 4 that it is rolling out a half-priced, generic version of Humalog called “insulin lispro.” The list price: $137.35 per vial.

“Patients, doctors and policymakers are demanding lower list prices for medicines and lower patient costs at the pharmacy counter,” Eli Lilly CEO David Ricks wrote in a blog post about the move. “You might be surprised to hear that we agree – it’s time for change in our system and for consumer prices to come down.”
 

No panacea

When Lilly’s Humalog, the first short-acting insulin, came to market in 1996, the list price was about $21 per vial. The price didn’t reach $275 overnight, but yearly price increases added up.

In February 2009, for example, the wholesale price was $92.70, according to IBM Watson Health. It rose to $99.65 in December 2009, then to $107.60 in September 2010, $115.70 in May 2011, and so on.

“There’s no justification for why prices should keep increasing at an average rate of 10% every year,” said Inmaculada Hernandez of the University of Pittsburgh School of Pharmacy, who was lead author of a January report in Health Affairs attributing the skyrocketing cost of prescription drugs to accumulated yearly price hikes.

“The public perception that we have in general is that drugs are so expensive because we need to pay for research and development, and that’s true,” Hernandez said. “However, usually research and development is paid for in the first years of life of a drug.”

At $137.35 per vial, Lilly’s generic insulin is priced at about the same level as Humalog was in 2012, 16 years after it came to market.

“We want to recognize that this is not a panacea,” said company spokesman Greg Kueterman. “This is an option that we hope can help people in the current system that we work with.”

It’s worth noting that Humalog is a rapid-acting insulin, but that’s only one of the two types of insulin most people with type 1 diabetes use every day. The second kind is long-lasting. Lilly makes one called Basaglar. The most popular long-lasting insulin is Lantus, produced by Sanofi. Neither has a lower-cost alternative.

Still, Lilly’s move on Humalog could put pressure on the other two big makers of insulin to act.

Novo Nordisk called Lilly’s lower-priced generic insulin “an important development,” in an emailed statement.

“Bringing affordable insulin to the market requires ideas from all stakeholders,” Novo Nordisk’s Ken Inchausti said in an email, which also listed steps the company has taken, such as a patient assistance program. The statement didn’t say whether Novo Nordisk is considering offering a lower-priced version of its popular insulin Novolog, a rival of Humalog.

A statement from Sanofi, the third major insulin maker, also didn’t say whether the company would offer lower-priced versions of its insulins.

“Sanofi supports any actions that increase access to insulins for patients living with diabetes at an affordable price,” spokeswoman Ashleigh Koss said in the email, which also touted the company’s patient assistance program.
 

A different kind of generic

One twist in this story is that Lilly’s new insulin is just a repackaged version of Humalog, minus the brand name. It’s called an “authorized generic.”

“Whoever came up with the term ‘authorized generic’?” Dr. Vincent Rajkumar said, laughing. Rajkumar is a hematologist at the Mayo Clinic in Rochester, Minn.

“It’s the same exact drug” as the brand name, he continued.

Typically, Rajkumar said, authorized generics are introduced by brand-name drugmakers to compete with generic versions of their drugs made by rival companies.

But in the case of Humalog and other insulins, there are no generics made by competitors, as there are for, say, the cholesterol medicine Lipitor or even other diabetes drugs, such as metformin.

So when Lilly’s authorized generic comes to market, the company will have both Humalog insulin and the authorized generic version of that medicine on the market.

Rajkumar said it’s a public relations move.

“There’s outrage over the price of insulin that is being discussed in Congress and elsewhere. And so the company basically says, ‘Hey, we will make the identical product available at half price.’ On the surface that sounds great,” Rajkumar said.

“But you look at the problems and you think, ‘OK, how crazy is this that someone is actually going to be buying the brand-name drug?’ ”

In fact, it’s possible that Lilly could break even or profit off its authorized generic compared to the name-brand Humalog, according to University of Pittsburgh’s Hernandez.

The profit margin would depend on the rebates paid by the company to insurers and pharmacy benefit managers. Rebates are getting a lot of attention these days as one factor that pushes drug prices higher. They’re usually not disclosed and increase as a drug’s price increases, providing an incentive to some companies to raise prices.

“Doing an authorized generic is nothing else than giving insurers two options,” Hernandez said: Pay the full list price for a brand-name drug and receive a higher rebate, or pay the lower price for the authorized generic and receive a presumably smaller rebate.

“What we really need to get insulin prices down is to get generics into the market, and we need more than one,” Hernandez said, adding that previous research has shown that prices begin to go down when two or three generics are competing in the marketplace.

Even so, Lillly’s Kueterman said the authorized generic insulin “is going to help hopefully move the system toward a more sustainable model.”

“I can guarantee you the reason that we’re doing this is to help people,” Kueterman said, noting the company’s Diabetes Solution Center has also helped “10,000 people each month pay significantly less for their insulin” since it opened in August.

For Erin Gilmer, the news about an authorized generic insulin from Lilly has left her mildly encouraged.

“It sounds really good, and it will help some people, which is great,” Gilmer said. “It’s Eli Lilly and pharma starting to understand that grassroots activism has to be taken seriously, and we are at a tipping point.”
 

This story is part of a partnership that includes NPR and Kaiser Health News. 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.

When Erin Gilmer filled her insulin prescription at a Denver-area Walgreens in January, she paid $8.50. U.S. taxpayers paid another $280.51.

iStock/ThinkStock

“It eats at me to know that taxpayer money is being wasted,” said Gilmer, who has Medicare and was diagnosed with type 1 diabetes while a sophomore at the University of Colorado in 2002.

The diagnosis meant that for the rest of her life she’d require daily insulin shots to stay alive. But the price of that insulin is skyrocketing.

Between 2009 and 2017 the wholesale price of a single vial of Humalog, the Eli Lilly and Co.–manufactured insulin Gilmer uses, nearly tripled – rising from $92.70 to $274.70, according to data from IBM Watson Health.

Six years ago, Gilmer qualified for Social Security Disability Insurance – and thus, Medicare – because of a range of health issues. At the time, the insulin she needed cost $167.70 per vial, according to IBM Watson Health.

“When it’s taxpayer money paying for medication for someone like me, it makes it a national issue, not just a diabetic issue,” Gilmer said.

Stories about people with type 1 diabetes dying when they couldn’t afford insulin have made headlines. Patient activists like Gilmer have protested high prices outside Lilly’s headquarters in Indianapolis.

Last October in Minnesota, State Attorney General Lori Swanson sued insulin manufacturers, alleging price gouging. Pharmaceutical executives were grilled about high drug prices by the Senate Finance Committee on Feb. 26.

This is the backdrop for Lilly’s announcement March 4 that it is rolling out a half-priced, generic version of Humalog called “insulin lispro.” The list price: $137.35 per vial.

“Patients, doctors and policymakers are demanding lower list prices for medicines and lower patient costs at the pharmacy counter,” Eli Lilly CEO David Ricks wrote in a blog post about the move. “You might be surprised to hear that we agree – it’s time for change in our system and for consumer prices to come down.”
 

No panacea

When Lilly’s Humalog, the first short-acting insulin, came to market in 1996, the list price was about $21 per vial. The price didn’t reach $275 overnight, but yearly price increases added up.

In February 2009, for example, the wholesale price was $92.70, according to IBM Watson Health. It rose to $99.65 in December 2009, then to $107.60 in September 2010, $115.70 in May 2011, and so on.

“There’s no justification for why prices should keep increasing at an average rate of 10% every year,” said Inmaculada Hernandez of the University of Pittsburgh School of Pharmacy, who was lead author of a January report in Health Affairs attributing the skyrocketing cost of prescription drugs to accumulated yearly price hikes.

“The public perception that we have in general is that drugs are so expensive because we need to pay for research and development, and that’s true,” Hernandez said. “However, usually research and development is paid for in the first years of life of a drug.”

At $137.35 per vial, Lilly’s generic insulin is priced at about the same level as Humalog was in 2012, 16 years after it came to market.

“We want to recognize that this is not a panacea,” said company spokesman Greg Kueterman. “This is an option that we hope can help people in the current system that we work with.”

It’s worth noting that Humalog is a rapid-acting insulin, but that’s only one of the two types of insulin most people with type 1 diabetes use every day. The second kind is long-lasting. Lilly makes one called Basaglar. The most popular long-lasting insulin is Lantus, produced by Sanofi. Neither has a lower-cost alternative.

Still, Lilly’s move on Humalog could put pressure on the other two big makers of insulin to act.

Novo Nordisk called Lilly’s lower-priced generic insulin “an important development,” in an emailed statement.

“Bringing affordable insulin to the market requires ideas from all stakeholders,” Novo Nordisk’s Ken Inchausti said in an email, which also listed steps the company has taken, such as a patient assistance program. The statement didn’t say whether Novo Nordisk is considering offering a lower-priced version of its popular insulin Novolog, a rival of Humalog.

A statement from Sanofi, the third major insulin maker, also didn’t say whether the company would offer lower-priced versions of its insulins.

“Sanofi supports any actions that increase access to insulins for patients living with diabetes at an affordable price,” spokeswoman Ashleigh Koss said in the email, which also touted the company’s patient assistance program.
 

A different kind of generic

One twist in this story is that Lilly’s new insulin is just a repackaged version of Humalog, minus the brand name. It’s called an “authorized generic.”

“Whoever came up with the term ‘authorized generic’?” Dr. Vincent Rajkumar said, laughing. Rajkumar is a hematologist at the Mayo Clinic in Rochester, Minn.

“It’s the same exact drug” as the brand name, he continued.

Typically, Rajkumar said, authorized generics are introduced by brand-name drugmakers to compete with generic versions of their drugs made by rival companies.

But in the case of Humalog and other insulins, there are no generics made by competitors, as there are for, say, the cholesterol medicine Lipitor or even other diabetes drugs, such as metformin.

So when Lilly’s authorized generic comes to market, the company will have both Humalog insulin and the authorized generic version of that medicine on the market.

Rajkumar said it’s a public relations move.

“There’s outrage over the price of insulin that is being discussed in Congress and elsewhere. And so the company basically says, ‘Hey, we will make the identical product available at half price.’ On the surface that sounds great,” Rajkumar said.

“But you look at the problems and you think, ‘OK, how crazy is this that someone is actually going to be buying the brand-name drug?’ ”

In fact, it’s possible that Lilly could break even or profit off its authorized generic compared to the name-brand Humalog, according to University of Pittsburgh’s Hernandez.

The profit margin would depend on the rebates paid by the company to insurers and pharmacy benefit managers. Rebates are getting a lot of attention these days as one factor that pushes drug prices higher. They’re usually not disclosed and increase as a drug’s price increases, providing an incentive to some companies to raise prices.

“Doing an authorized generic is nothing else than giving insurers two options,” Hernandez said: Pay the full list price for a brand-name drug and receive a higher rebate, or pay the lower price for the authorized generic and receive a presumably smaller rebate.

“What we really need to get insulin prices down is to get generics into the market, and we need more than one,” Hernandez said, adding that previous research has shown that prices begin to go down when two or three generics are competing in the marketplace.

Even so, Lillly’s Kueterman said the authorized generic insulin “is going to help hopefully move the system toward a more sustainable model.”

“I can guarantee you the reason that we’re doing this is to help people,” Kueterman said, noting the company’s Diabetes Solution Center has also helped “10,000 people each month pay significantly less for their insulin” since it opened in August.

For Erin Gilmer, the news about an authorized generic insulin from Lilly has left her mildly encouraged.

“It sounds really good, and it will help some people, which is great,” Gilmer said. “It’s Eli Lilly and pharma starting to understand that grassroots activism has to be taken seriously, and we are at a tipping point.”
 

This story is part of a partnership that includes NPR and Kaiser Health News. 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.

When Erin Gilmer filled her insulin prescription at a Denver-area Walgreens in January, she paid $8.50. U.S. taxpayers paid another $280.51.

iStock/ThinkStock

“It eats at me to know that taxpayer money is being wasted,” said Gilmer, who has Medicare and was diagnosed with type 1 diabetes while a sophomore at the University of Colorado in 2002.

The diagnosis meant that for the rest of her life she’d require daily insulin shots to stay alive. But the price of that insulin is skyrocketing.

Between 2009 and 2017 the wholesale price of a single vial of Humalog, the Eli Lilly and Co.–manufactured insulin Gilmer uses, nearly tripled – rising from $92.70 to $274.70, according to data from IBM Watson Health.

Six years ago, Gilmer qualified for Social Security Disability Insurance – and thus, Medicare – because of a range of health issues. At the time, the insulin she needed cost $167.70 per vial, according to IBM Watson Health.

“When it’s taxpayer money paying for medication for someone like me, it makes it a national issue, not just a diabetic issue,” Gilmer said.

Stories about people with type 1 diabetes dying when they couldn’t afford insulin have made headlines. Patient activists like Gilmer have protested high prices outside Lilly’s headquarters in Indianapolis.

Last October in Minnesota, State Attorney General Lori Swanson sued insulin manufacturers, alleging price gouging. Pharmaceutical executives were grilled about high drug prices by the Senate Finance Committee on Feb. 26.

This is the backdrop for Lilly’s announcement March 4 that it is rolling out a half-priced, generic version of Humalog called “insulin lispro.” The list price: $137.35 per vial.

“Patients, doctors and policymakers are demanding lower list prices for medicines and lower patient costs at the pharmacy counter,” Eli Lilly CEO David Ricks wrote in a blog post about the move. “You might be surprised to hear that we agree – it’s time for change in our system and for consumer prices to come down.”
 

No panacea

When Lilly’s Humalog, the first short-acting insulin, came to market in 1996, the list price was about $21 per vial. The price didn’t reach $275 overnight, but yearly price increases added up.

In February 2009, for example, the wholesale price was $92.70, according to IBM Watson Health. It rose to $99.65 in December 2009, then to $107.60 in September 2010, $115.70 in May 2011, and so on.

“There’s no justification for why prices should keep increasing at an average rate of 10% every year,” said Inmaculada Hernandez of the University of Pittsburgh School of Pharmacy, who was lead author of a January report in Health Affairs attributing the skyrocketing cost of prescription drugs to accumulated yearly price hikes.

“The public perception that we have in general is that drugs are so expensive because we need to pay for research and development, and that’s true,” Hernandez said. “However, usually research and development is paid for in the first years of life of a drug.”

At $137.35 per vial, Lilly’s generic insulin is priced at about the same level as Humalog was in 2012, 16 years after it came to market.

“We want to recognize that this is not a panacea,” said company spokesman Greg Kueterman. “This is an option that we hope can help people in the current system that we work with.”

It’s worth noting that Humalog is a rapid-acting insulin, but that’s only one of the two types of insulin most people with type 1 diabetes use every day. The second kind is long-lasting. Lilly makes one called Basaglar. The most popular long-lasting insulin is Lantus, produced by Sanofi. Neither has a lower-cost alternative.

Still, Lilly’s move on Humalog could put pressure on the other two big makers of insulin to act.

Novo Nordisk called Lilly’s lower-priced generic insulin “an important development,” in an emailed statement.

“Bringing affordable insulin to the market requires ideas from all stakeholders,” Novo Nordisk’s Ken Inchausti said in an email, which also listed steps the company has taken, such as a patient assistance program. The statement didn’t say whether Novo Nordisk is considering offering a lower-priced version of its popular insulin Novolog, a rival of Humalog.

A statement from Sanofi, the third major insulin maker, also didn’t say whether the company would offer lower-priced versions of its insulins.

“Sanofi supports any actions that increase access to insulins for patients living with diabetes at an affordable price,” spokeswoman Ashleigh Koss said in the email, which also touted the company’s patient assistance program.
 

A different kind of generic

One twist in this story is that Lilly’s new insulin is just a repackaged version of Humalog, minus the brand name. It’s called an “authorized generic.”

“Whoever came up with the term ‘authorized generic’?” Dr. Vincent Rajkumar said, laughing. Rajkumar is a hematologist at the Mayo Clinic in Rochester, Minn.

“It’s the same exact drug” as the brand name, he continued.

Typically, Rajkumar said, authorized generics are introduced by brand-name drugmakers to compete with generic versions of their drugs made by rival companies.

But in the case of Humalog and other insulins, there are no generics made by competitors, as there are for, say, the cholesterol medicine Lipitor or even other diabetes drugs, such as metformin.

So when Lilly’s authorized generic comes to market, the company will have both Humalog insulin and the authorized generic version of that medicine on the market.

Rajkumar said it’s a public relations move.

“There’s outrage over the price of insulin that is being discussed in Congress and elsewhere. And so the company basically says, ‘Hey, we will make the identical product available at half price.’ On the surface that sounds great,” Rajkumar said.

“But you look at the problems and you think, ‘OK, how crazy is this that someone is actually going to be buying the brand-name drug?’ ”

In fact, it’s possible that Lilly could break even or profit off its authorized generic compared to the name-brand Humalog, according to University of Pittsburgh’s Hernandez.

The profit margin would depend on the rebates paid by the company to insurers and pharmacy benefit managers. Rebates are getting a lot of attention these days as one factor that pushes drug prices higher. They’re usually not disclosed and increase as a drug’s price increases, providing an incentive to some companies to raise prices.

“Doing an authorized generic is nothing else than giving insurers two options,” Hernandez said: Pay the full list price for a brand-name drug and receive a higher rebate, or pay the lower price for the authorized generic and receive a presumably smaller rebate.

“What we really need to get insulin prices down is to get generics into the market, and we need more than one,” Hernandez said, adding that previous research has shown that prices begin to go down when two or three generics are competing in the marketplace.

Even so, Lillly’s Kueterman said the authorized generic insulin “is going to help hopefully move the system toward a more sustainable model.”

“I can guarantee you the reason that we’re doing this is to help people,” Kueterman said, noting the company’s Diabetes Solution Center has also helped “10,000 people each month pay significantly less for their insulin” since it opened in August.

For Erin Gilmer, the news about an authorized generic insulin from Lilly has left her mildly encouraged.

“It sounds really good, and it will help some people, which is great,” Gilmer said. “It’s Eli Lilly and pharma starting to understand that grassroots activism has to be taken seriously, and we are at a tipping point.”
 

This story is part of a partnership that includes NPR and Kaiser Health News. 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.

Tramadol appears to be associated with higher mortality risk among older patients with osteoarthritis when compared against common NSAIDs, according to findings from a study published online March 12 in JAMA.

KatarzynaBialasiewicz/Thinkstock

The findings from the retrospective cohort study are worth noting despite their susceptibility to confounding by indication because “tramadol is a weak opioid agonist and has been considered a potential alternative to NSAIDs and traditional opioids because of its assumed relatively lower risk of serious cardiovascular and gastrointestinal adverse effects than NSAIDs, as well as a lower risk of addiction and respiratory depression compared with other opioids,” wrote Chao Zeng, MD, PhD, of Xiangya Hospital of Central South University, Changsha, China, and his coauthors.

The investigators analyzed data from a combined total of 88,902 individuals aged 50 years and older with knee, hip, or hand osteoarthritis who were seen during 2000-2015 and had visits recorded in the United Kingdom’s The Health Improvement Network (THIN) electronic medical records database. Participants were matched on sociodemographic and lifestyle factors, as well as osteoarthritis duration, comorbidities, other prescriptions, and health care utilization prior to the index date of the study.

Over 1 year of follow-up, researchers saw a 71% higher risk of all-cause mortality in patients taking tramadol than that in seen in those taking naproxen, 88% higher than in those taking diclofenac, 70% higher than in those taking celecoxib, and about twice as high as in patients taking etoricoxib.

However, there was no significant difference in risk of all-cause mortality between tramadol and codeine, the researchers found.

The authors suggested that tramadol may have adverse effects on the neurologic system by inhibiting central serotonin and norepinephrine uptake, which could potentially lead to serotonin syndrome. They also speculated that it could increase the risk of postoperative delirium, cause fatal poisoning or respiratory depression if taken in conjunction with alcohol or other drugs, or increase the risk of hypoglycemia, hyponatremia, fractures, or falls.

The numbers of deaths from cardiovascular, gastrointestinal, infection, cancer, and respiratory diseases were all higher in the tramadol group, compared with patients taking NSAIDs, but the differences were not statistically significant because of the relatively small number of deaths, the authors said.

Overall, 44,451 patients were taking tramadol, 12,397 were taking naproxen, 6,512 were taking diclofenac, 5,674 were taking celecoxib, 2,946 were taking etoricoxib, and 16,922 were taking codeine.

Patients in the tramadol cohort were generally older, with higher body mass index, a longer duration of osteoarthritis, and had a higher prevalence of comorbidities, higher health care utilization, and more prescriptions of other medications.

The authors noted that, while the patients from each medication cohort were matched on propensity score, the results were still susceptible to confounding by indication and should be interpreted with caution.

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Natural Science Foundation of China. One author declared funding from the National Institute on Drug Abuse during the conduct of the study and grants from Optum Labs outside the study. No other conflicts of interest were declared.

SOURCE: Zeng C et al. JAMA. 2019;321:969-82.

Tramadol appears to be associated with higher mortality risk among older patients with osteoarthritis when compared against common NSAIDs, according to findings from a study published online March 12 in JAMA.

KatarzynaBialasiewicz/Thinkstock

The findings from the retrospective cohort study are worth noting despite their susceptibility to confounding by indication because “tramadol is a weak opioid agonist and has been considered a potential alternative to NSAIDs and traditional opioids because of its assumed relatively lower risk of serious cardiovascular and gastrointestinal adverse effects than NSAIDs, as well as a lower risk of addiction and respiratory depression compared with other opioids,” wrote Chao Zeng, MD, PhD, of Xiangya Hospital of Central South University, Changsha, China, and his coauthors.

The investigators analyzed data from a combined total of 88,902 individuals aged 50 years and older with knee, hip, or hand osteoarthritis who were seen during 2000-2015 and had visits recorded in the United Kingdom’s The Health Improvement Network (THIN) electronic medical records database. Participants were matched on sociodemographic and lifestyle factors, as well as osteoarthritis duration, comorbidities, other prescriptions, and health care utilization prior to the index date of the study.

Over 1 year of follow-up, researchers saw a 71% higher risk of all-cause mortality in patients taking tramadol than that in seen in those taking naproxen, 88% higher than in those taking diclofenac, 70% higher than in those taking celecoxib, and about twice as high as in patients taking etoricoxib.

However, there was no significant difference in risk of all-cause mortality between tramadol and codeine, the researchers found.

The authors suggested that tramadol may have adverse effects on the neurologic system by inhibiting central serotonin and norepinephrine uptake, which could potentially lead to serotonin syndrome. They also speculated that it could increase the risk of postoperative delirium, cause fatal poisoning or respiratory depression if taken in conjunction with alcohol or other drugs, or increase the risk of hypoglycemia, hyponatremia, fractures, or falls.

The numbers of deaths from cardiovascular, gastrointestinal, infection, cancer, and respiratory diseases were all higher in the tramadol group, compared with patients taking NSAIDs, but the differences were not statistically significant because of the relatively small number of deaths, the authors said.

Overall, 44,451 patients were taking tramadol, 12,397 were taking naproxen, 6,512 were taking diclofenac, 5,674 were taking celecoxib, 2,946 were taking etoricoxib, and 16,922 were taking codeine.

Patients in the tramadol cohort were generally older, with higher body mass index, a longer duration of osteoarthritis, and had a higher prevalence of comorbidities, higher health care utilization, and more prescriptions of other medications.

The authors noted that, while the patients from each medication cohort were matched on propensity score, the results were still susceptible to confounding by indication and should be interpreted with caution.

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Natural Science Foundation of China. One author declared funding from the National Institute on Drug Abuse during the conduct of the study and grants from Optum Labs outside the study. No other conflicts of interest were declared.

SOURCE: Zeng C et al. JAMA. 2019;321:969-82.

Tramadol appears to be associated with higher mortality risk among older patients with osteoarthritis when compared against common NSAIDs, according to findings from a study published online March 12 in JAMA.

KatarzynaBialasiewicz/Thinkstock

The findings from the retrospective cohort study are worth noting despite their susceptibility to confounding by indication because “tramadol is a weak opioid agonist and has been considered a potential alternative to NSAIDs and traditional opioids because of its assumed relatively lower risk of serious cardiovascular and gastrointestinal adverse effects than NSAIDs, as well as a lower risk of addiction and respiratory depression compared with other opioids,” wrote Chao Zeng, MD, PhD, of Xiangya Hospital of Central South University, Changsha, China, and his coauthors.

The investigators analyzed data from a combined total of 88,902 individuals aged 50 years and older with knee, hip, or hand osteoarthritis who were seen during 2000-2015 and had visits recorded in the United Kingdom’s The Health Improvement Network (THIN) electronic medical records database. Participants were matched on sociodemographic and lifestyle factors, as well as osteoarthritis duration, comorbidities, other prescriptions, and health care utilization prior to the index date of the study.

Over 1 year of follow-up, researchers saw a 71% higher risk of all-cause mortality in patients taking tramadol than that in seen in those taking naproxen, 88% higher than in those taking diclofenac, 70% higher than in those taking celecoxib, and about twice as high as in patients taking etoricoxib.

However, there was no significant difference in risk of all-cause mortality between tramadol and codeine, the researchers found.

The authors suggested that tramadol may have adverse effects on the neurologic system by inhibiting central serotonin and norepinephrine uptake, which could potentially lead to serotonin syndrome. They also speculated that it could increase the risk of postoperative delirium, cause fatal poisoning or respiratory depression if taken in conjunction with alcohol or other drugs, or increase the risk of hypoglycemia, hyponatremia, fractures, or falls.

The numbers of deaths from cardiovascular, gastrointestinal, infection, cancer, and respiratory diseases were all higher in the tramadol group, compared with patients taking NSAIDs, but the differences were not statistically significant because of the relatively small number of deaths, the authors said.

Overall, 44,451 patients were taking tramadol, 12,397 were taking naproxen, 6,512 were taking diclofenac, 5,674 were taking celecoxib, 2,946 were taking etoricoxib, and 16,922 were taking codeine.

Patients in the tramadol cohort were generally older, with higher body mass index, a longer duration of osteoarthritis, and had a higher prevalence of comorbidities, higher health care utilization, and more prescriptions of other medications.

The authors noted that, while the patients from each medication cohort were matched on propensity score, the results were still susceptible to confounding by indication and should be interpreted with caution.

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Natural Science Foundation of China. One author declared funding from the National Institute on Drug Abuse during the conduct of the study and grants from Optum Labs outside the study. No other conflicts of interest were declared.

SOURCE: Zeng C et al. JAMA. 2019;321:969-82.

DALLAS – When it comes to family planning and pregnancy-related decisions such as breastfeeding and medication management, patients with multiple sclerosis (MS) receive a wide variety of advice, guidance, and engagement from their health care providers, results from a single-center survey demonstrated.

Doug Brunk/MDedge News

“We want our patients to feel comfortable when they come to us in their 20s or 30s and they get diagnosed, they’re scared, and it’s all new to them,” one of the study authors, Casey E. Engel said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We want them to know that family planning is something to consider and that they can proceed with having a family with our help and guidance.”

In an effort to collect patient-experience data around family planning, pregnancy, and breastfeeding post-MS diagnosis, Ms. Engel and senior author Myla D. Goldman, MD, mailed a survey to 1,000 women with confirmed MS diagnosis who had received care at the University of Virginia Medical Center in Charlottesville. The researchers reported findings from 173 respondents, of whom 70% were receiving specialty care for MS. Most of the survey participants (137) did not become pregnant following their diagnosis, while 36 did.

Of the 137 respondents who did not become pregnant following diagnosis, 22 (16%) indicated that their decision was driven by MS-related concerns, including MS worsening with pregnancy (64%), ability to care for child secondary to MS (46%), lack of knowledge about options for pregnancy and MS (18%), passing MS onto child (18%), and stopping disease-modifying therapy (DMT) to attempt pregnancy (9%).

Of the 36 women who had a pregnancy following diagnosis, 20% reported postpartum depression or anxiety, higher than the national average of 10%-15%. In addition, 79% reported not being on DMT at the time of conception, 9% were on either glatiramer acetate injection or interferon beta-1a at time of conception, and 3% were on fingolimod (Gilenya) at time of conception. The majority reported receiving inconsistent advice about when to discontinue DMT before attempting pregnancy (a range from 0 to 6 months).

“It’s also noteworthy that 20% took a year to achieve pregnancy,” said Dr. Goldman, a neurologist who directs the university’s MS clinic. “If these women stop [their DMT] 6 months in advance and they take a year to achieve pregnancy, that’s 18 months without therapeutic coverage. That’s a concern to bring to light.”

Breastfeeding was reported in 71% of mothers in postdiagnosis pregnancy with a range between 1 week and 10 months, driven in part by variable guidelines regarding DMT reinitiation. In the meantime, respondents who did not breastfeed made this decision due to fear of relapse, glucocorticoids, or desire to reinitiate medication.

“Though our study was limited by low survey response, we hope that our work may highlight the difficulty our patients face and foster discussions within the MS community around these issues to improve the individual patient experience,” the researchers wrote in their poster.

Ms. Engel worked on the study while an undergraduate at the University of Virginia. The study was supported by the ziMS Foundation.

dbrunk@mdedge.com

SOURCE: Engel CE et al. ACTRIMS Forum 2019, Poster 307.

DALLAS – When it comes to family planning and pregnancy-related decisions such as breastfeeding and medication management, patients with multiple sclerosis (MS) receive a wide variety of advice, guidance, and engagement from their health care providers, results from a single-center survey demonstrated.

Doug Brunk/MDedge News

“We want our patients to feel comfortable when they come to us in their 20s or 30s and they get diagnosed, they’re scared, and it’s all new to them,” one of the study authors, Casey E. Engel said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We want them to know that family planning is something to consider and that they can proceed with having a family with our help and guidance.”

In an effort to collect patient-experience data around family planning, pregnancy, and breastfeeding post-MS diagnosis, Ms. Engel and senior author Myla D. Goldman, MD, mailed a survey to 1,000 women with confirmed MS diagnosis who had received care at the University of Virginia Medical Center in Charlottesville. The researchers reported findings from 173 respondents, of whom 70% were receiving specialty care for MS. Most of the survey participants (137) did not become pregnant following their diagnosis, while 36 did.

Of the 137 respondents who did not become pregnant following diagnosis, 22 (16%) indicated that their decision was driven by MS-related concerns, including MS worsening with pregnancy (64%), ability to care for child secondary to MS (46%), lack of knowledge about options for pregnancy and MS (18%), passing MS onto child (18%), and stopping disease-modifying therapy (DMT) to attempt pregnancy (9%).

Of the 36 women who had a pregnancy following diagnosis, 20% reported postpartum depression or anxiety, higher than the national average of 10%-15%. In addition, 79% reported not being on DMT at the time of conception, 9% were on either glatiramer acetate injection or interferon beta-1a at time of conception, and 3% were on fingolimod (Gilenya) at time of conception. The majority reported receiving inconsistent advice about when to discontinue DMT before attempting pregnancy (a range from 0 to 6 months).

“It’s also noteworthy that 20% took a year to achieve pregnancy,” said Dr. Goldman, a neurologist who directs the university’s MS clinic. “If these women stop [their DMT] 6 months in advance and they take a year to achieve pregnancy, that’s 18 months without therapeutic coverage. That’s a concern to bring to light.”

Breastfeeding was reported in 71% of mothers in postdiagnosis pregnancy with a range between 1 week and 10 months, driven in part by variable guidelines regarding DMT reinitiation. In the meantime, respondents who did not breastfeed made this decision due to fear of relapse, glucocorticoids, or desire to reinitiate medication.

“Though our study was limited by low survey response, we hope that our work may highlight the difficulty our patients face and foster discussions within the MS community around these issues to improve the individual patient experience,” the researchers wrote in their poster.

Ms. Engel worked on the study while an undergraduate at the University of Virginia. The study was supported by the ziMS Foundation.

dbrunk@mdedge.com

SOURCE: Engel CE et al. ACTRIMS Forum 2019, Poster 307.

DALLAS – When it comes to family planning and pregnancy-related decisions such as breastfeeding and medication management, patients with multiple sclerosis (MS) receive a wide variety of advice, guidance, and engagement from their health care providers, results from a single-center survey demonstrated.

Doug Brunk/MDedge News

“We want our patients to feel comfortable when they come to us in their 20s or 30s and they get diagnosed, they’re scared, and it’s all new to them,” one of the study authors, Casey E. Engel said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We want them to know that family planning is something to consider and that they can proceed with having a family with our help and guidance.”

In an effort to collect patient-experience data around family planning, pregnancy, and breastfeeding post-MS diagnosis, Ms. Engel and senior author Myla D. Goldman, MD, mailed a survey to 1,000 women with confirmed MS diagnosis who had received care at the University of Virginia Medical Center in Charlottesville. The researchers reported findings from 173 respondents, of whom 70% were receiving specialty care for MS. Most of the survey participants (137) did not become pregnant following their diagnosis, while 36 did.

Of the 137 respondents who did not become pregnant following diagnosis, 22 (16%) indicated that their decision was driven by MS-related concerns, including MS worsening with pregnancy (64%), ability to care for child secondary to MS (46%), lack of knowledge about options for pregnancy and MS (18%), passing MS onto child (18%), and stopping disease-modifying therapy (DMT) to attempt pregnancy (9%).

Of the 36 women who had a pregnancy following diagnosis, 20% reported postpartum depression or anxiety, higher than the national average of 10%-15%. In addition, 79% reported not being on DMT at the time of conception, 9% were on either glatiramer acetate injection or interferon beta-1a at time of conception, and 3% were on fingolimod (Gilenya) at time of conception. The majority reported receiving inconsistent advice about when to discontinue DMT before attempting pregnancy (a range from 0 to 6 months).

“It’s also noteworthy that 20% took a year to achieve pregnancy,” said Dr. Goldman, a neurologist who directs the university’s MS clinic. “If these women stop [their DMT] 6 months in advance and they take a year to achieve pregnancy, that’s 18 months without therapeutic coverage. That’s a concern to bring to light.”

Breastfeeding was reported in 71% of mothers in postdiagnosis pregnancy with a range between 1 week and 10 months, driven in part by variable guidelines regarding DMT reinitiation. In the meantime, respondents who did not breastfeed made this decision due to fear of relapse, glucocorticoids, or desire to reinitiate medication.

“Though our study was limited by low survey response, we hope that our work may highlight the difficulty our patients face and foster discussions within the MS community around these issues to improve the individual patient experience,” the researchers wrote in their poster.

Ms. Engel worked on the study while an undergraduate at the University of Virginia. The study was supported by the ziMS Foundation.

dbrunk@mdedge.com

SOURCE: Engel CE et al. ACTRIMS Forum 2019, Poster 307.

Resection of a brain area implicated in seizure modulation improves the odds of being seizure free in patients with temporal lobe epilepsy, according to results of a recent multicenter analysis.

Patients with long-term postoperative freedom from seizures had a larger proportion of the piriform cortex resected versus patients who were not seizure free. Removing at least half the piriform cortex was associated with a 1500% increase in odds of seizure freedom, first author Marian Galovic, MD, of the department of clinical and experimental epilepsy at the University College London’s Queen Square Institute of Neurology and his colleagues reported in JAMA Neurology.

“If confirmed in prospective interventional trials, these findings will have practical implications for guiding neurosurgeons about the extent of the surgical resection,” Dr. Galovic and his coinvestigators wrote.

The area tempestas in the piriform cortex has been identified as an epileptic trigger zone in animal studies, but to date, evidence of a human epileptic trigger zone in this area remain limited, according to the investigators.

To evaluate the impact of resection in this area, Dr. Galovic and his colleagues evaluated 107 patients with temporal lobe epilepsy from an ongoing, single-center, prospective study, and validated their findings with 31 patients from two other independent cohorts.

Of the 107 patients in the main cohort, 46% were completely seizure free for a median of 5 years after epilepsy surgery, with results of voxel-based morphometry showing that those patients had a more pronounced loss of gray matter in the ipsilateral piriform, compared with non–seizure-free patients.

The seizure-free patients had a median of 83% of the piriform cortex resected, compared with 52% for the non–seizure-free patients (P less than .001), results of a volumetric analysis confirmed.

Anxiety or psychosis outcomes were not influenced by the extent of piriform cortex resection, the investigators wrote, adding that poor verbal memory outcome was linked to the extent of resection of other brain regions, but not the piriform cortex.

The investigators confirmed these findings in the 31 patients of the validation cohort, with significant associations between extent of piriform cortex resection and postsurgical outcomes.

Resecting at least half of the region increased odds of being seizure free by a factor of 16 (95% CI, 5-47; P less than .001), Dr. Galovic and his colleagues added.

“Our results provide evidence suggesting that the human piriform cortex has a role in the generation of seizures that involve the temporal lobe,” they wrote in a discussion of their results.

The findings, if confirmed, could have implications not only for surgical practice, they wrote, but also for the understanding of the mechanisms underlying epileptic networks, which could lead to new drug and nondrug interventions to mitigate seizure activity.

Dr. Galovic reported receiving a grant from the Medical Research Council. His coauthors reported disclosures with the Medical Research Council, Wellcome Trust, Medtronic, Neuropace, Nevro, Eisai, UCB, and Mallinckrodt, among other entities.

SOURCE: Galovic M et al. JAMA Neurol. 2019 Mar 11. doi: 10.1001/jamaneurol.2019.0204.

Resection of a brain area implicated in seizure modulation improves the odds of being seizure free in patients with temporal lobe epilepsy, according to results of a recent multicenter analysis.

Patients with long-term postoperative freedom from seizures had a larger proportion of the piriform cortex resected versus patients who were not seizure free. Removing at least half the piriform cortex was associated with a 1500% increase in odds of seizure freedom, first author Marian Galovic, MD, of the department of clinical and experimental epilepsy at the University College London’s Queen Square Institute of Neurology and his colleagues reported in JAMA Neurology.

“If confirmed in prospective interventional trials, these findings will have practical implications for guiding neurosurgeons about the extent of the surgical resection,” Dr. Galovic and his coinvestigators wrote.

The area tempestas in the piriform cortex has been identified as an epileptic trigger zone in animal studies, but to date, evidence of a human epileptic trigger zone in this area remain limited, according to the investigators.

To evaluate the impact of resection in this area, Dr. Galovic and his colleagues evaluated 107 patients with temporal lobe epilepsy from an ongoing, single-center, prospective study, and validated their findings with 31 patients from two other independent cohorts.

Of the 107 patients in the main cohort, 46% were completely seizure free for a median of 5 years after epilepsy surgery, with results of voxel-based morphometry showing that those patients had a more pronounced loss of gray matter in the ipsilateral piriform, compared with non–seizure-free patients.

The seizure-free patients had a median of 83% of the piriform cortex resected, compared with 52% for the non–seizure-free patients (P less than .001), results of a volumetric analysis confirmed.

Anxiety or psychosis outcomes were not influenced by the extent of piriform cortex resection, the investigators wrote, adding that poor verbal memory outcome was linked to the extent of resection of other brain regions, but not the piriform cortex.

The investigators confirmed these findings in the 31 patients of the validation cohort, with significant associations between extent of piriform cortex resection and postsurgical outcomes.

Resecting at least half of the region increased odds of being seizure free by a factor of 16 (95% CI, 5-47; P less than .001), Dr. Galovic and his colleagues added.

“Our results provide evidence suggesting that the human piriform cortex has a role in the generation of seizures that involve the temporal lobe,” they wrote in a discussion of their results.

The findings, if confirmed, could have implications not only for surgical practice, they wrote, but also for the understanding of the mechanisms underlying epileptic networks, which could lead to new drug and nondrug interventions to mitigate seizure activity.

Dr. Galovic reported receiving a grant from the Medical Research Council. His coauthors reported disclosures with the Medical Research Council, Wellcome Trust, Medtronic, Neuropace, Nevro, Eisai, UCB, and Mallinckrodt, among other entities.

SOURCE: Galovic M et al. JAMA Neurol. 2019 Mar 11. doi: 10.1001/jamaneurol.2019.0204.

Resection of a brain area implicated in seizure modulation improves the odds of being seizure free in patients with temporal lobe epilepsy, according to results of a recent multicenter analysis.

Patients with long-term postoperative freedom from seizures had a larger proportion of the piriform cortex resected versus patients who were not seizure free. Removing at least half the piriform cortex was associated with a 1500% increase in odds of seizure freedom, first author Marian Galovic, MD, of the department of clinical and experimental epilepsy at the University College London’s Queen Square Institute of Neurology and his colleagues reported in JAMA Neurology.

“If confirmed in prospective interventional trials, these findings will have practical implications for guiding neurosurgeons about the extent of the surgical resection,” Dr. Galovic and his coinvestigators wrote.

The area tempestas in the piriform cortex has been identified as an epileptic trigger zone in animal studies, but to date, evidence of a human epileptic trigger zone in this area remain limited, according to the investigators.

To evaluate the impact of resection in this area, Dr. Galovic and his colleagues evaluated 107 patients with temporal lobe epilepsy from an ongoing, single-center, prospective study, and validated their findings with 31 patients from two other independent cohorts.

Of the 107 patients in the main cohort, 46% were completely seizure free for a median of 5 years after epilepsy surgery, with results of voxel-based morphometry showing that those patients had a more pronounced loss of gray matter in the ipsilateral piriform, compared with non–seizure-free patients.

The seizure-free patients had a median of 83% of the piriform cortex resected, compared with 52% for the non–seizure-free patients (P less than .001), results of a volumetric analysis confirmed.

Anxiety or psychosis outcomes were not influenced by the extent of piriform cortex resection, the investigators wrote, adding that poor verbal memory outcome was linked to the extent of resection of other brain regions, but not the piriform cortex.

The investigators confirmed these findings in the 31 patients of the validation cohort, with significant associations between extent of piriform cortex resection and postsurgical outcomes.

Resecting at least half of the region increased odds of being seizure free by a factor of 16 (95% CI, 5-47; P less than .001), Dr. Galovic and his colleagues added.

“Our results provide evidence suggesting that the human piriform cortex has a role in the generation of seizures that involve the temporal lobe,” they wrote in a discussion of their results.

The findings, if confirmed, could have implications not only for surgical practice, they wrote, but also for the understanding of the mechanisms underlying epileptic networks, which could lead to new drug and nondrug interventions to mitigate seizure activity.

Dr. Galovic reported receiving a grant from the Medical Research Council. His coauthors reported disclosures with the Medical Research Council, Wellcome Trust, Medtronic, Neuropace, Nevro, Eisai, UCB, and Mallinckrodt, among other entities.

SOURCE: Galovic M et al. JAMA Neurol. 2019 Mar 11. doi: 10.1001/jamaneurol.2019.0204.

DALLAS – Low or undetectable levels of teriflunomide (Aubagio) occur in women who are sexually active with men taking the drug for relapsing multiple sclerosis, results from a small study demonstrated.

Doug Brunk/MDedge News

“One of the issues with this particular drug is that it carries a strong pregnancy warning because in animal studies the drug has been teratogenic,” Joseph B. Guarnaccia, MD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other issue is that it remains detectable in the body for some time. The issue of females taking this drug and conception are well known. There are strong warnings that, if a woman wants to become pregnant, the drug should be removed quickly from the system. But if their male partner is on the drug, does that pose a risk to their female partner? That question has never been addressed in a human study.”

The Food and Drug Administration prescribing information recommends that men wishing to father a child should discontinue use of teriflunomide and undergo the accelerated elimination procedure. It also recommends that female partners wishing to become pregnant should discontinue the drug and undergo an accelerated elimination procedure to verify that the plasma teriflunomide concentration is less than 0.020 mcg/mL.

In an effort to test the risk of female exposure to potentially teratogenic levels of teriflunomide through sexual intercourse, Dr. Guarnaccia, a neurologist with the Multiple Sclerosis Treatment Center at Griffin Hospital in Derby, Conn., and his colleagues recruited 10 couples and compared serum levels of teriflunomide in men with relapsing multiple sclerosis with those of their female partners. Enrollment criteria for men included a diagnosis of relapsing multiple sclerosis, age between 18 and 55 years, treatment with teriflunomide for at least 2 months prior to study entry, and frequency of sexual intercourse with their female partners at least twice a month. Pregnancy was excluded in females, and couples could not use barrier or withdrawal methods of contraception. The couples completed a brief questionnaire and underwent a one-time blood draw for teriflunomide levels either at the investigator’s office or at a LabCorp facility.

The mean age of study participants was 47 years and the mean frequency of intercourse was seven episodes per month. The mean teriflunomide concentration in men was 42.30 mcg/mL (ranged from 10.07 to 142.84 mcg/mL). Six women had teriflunomide below detection levels (0.020 mcg/mL). However, four women had detectable levels that averaged 0.045 mcg/mL (ranging from 0.022 to 0.077 mcg/mL).

“This small study demonstrates that low or undetectable levels of teriflunomide occur in females who are sexually active with males taking teriflunomide for relapsing multiple sclerosis,” the researchers wrote in their poster. They found that women who had low detectable levels of teriflunomide, compared with women with undetectable levels, did not engage in more frequent sexual intercourse nor were their levels associated with higher levels of teriflunomide in their male partners.

“Indeed, one might have expected a positive correlation between serum levels of teriflunomide in females and the frequency or concentration of inoculation in semen from their partners,” the researchers wrote. “While semen levels of teriflunomide were not measured in this study, it might be assumed that serum and semen concentrations of small molecules like teriflunomide are similar.”

The study was supported by a investigator-sponsored research grant from Sanofi-Genzyme. Dr. Guarnaccia reported that he has received speaking honoraria and educational grants from Sanofi-Genzyme, Biogen, Teva, Acorda Therapeutics, Bayer, EMD Serono, and Genentech.

dbrunk@mdedge.com

SOURCE: Guarnaccia JB et al. ACTRIMS Forum 2019, Poster 115.

DALLAS – Low or undetectable levels of teriflunomide (Aubagio) occur in women who are sexually active with men taking the drug for relapsing multiple sclerosis, results from a small study demonstrated.

Doug Brunk/MDedge News

“One of the issues with this particular drug is that it carries a strong pregnancy warning because in animal studies the drug has been teratogenic,” Joseph B. Guarnaccia, MD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other issue is that it remains detectable in the body for some time. The issue of females taking this drug and conception are well known. There are strong warnings that, if a woman wants to become pregnant, the drug should be removed quickly from the system. But if their male partner is on the drug, does that pose a risk to their female partner? That question has never been addressed in a human study.”

The Food and Drug Administration prescribing information recommends that men wishing to father a child should discontinue use of teriflunomide and undergo the accelerated elimination procedure. It also recommends that female partners wishing to become pregnant should discontinue the drug and undergo an accelerated elimination procedure to verify that the plasma teriflunomide concentration is less than 0.020 mcg/mL.

In an effort to test the risk of female exposure to potentially teratogenic levels of teriflunomide through sexual intercourse, Dr. Guarnaccia, a neurologist with the Multiple Sclerosis Treatment Center at Griffin Hospital in Derby, Conn., and his colleagues recruited 10 couples and compared serum levels of teriflunomide in men with relapsing multiple sclerosis with those of their female partners. Enrollment criteria for men included a diagnosis of relapsing multiple sclerosis, age between 18 and 55 years, treatment with teriflunomide for at least 2 months prior to study entry, and frequency of sexual intercourse with their female partners at least twice a month. Pregnancy was excluded in females, and couples could not use barrier or withdrawal methods of contraception. The couples completed a brief questionnaire and underwent a one-time blood draw for teriflunomide levels either at the investigator’s office or at a LabCorp facility.

The mean age of study participants was 47 years and the mean frequency of intercourse was seven episodes per month. The mean teriflunomide concentration in men was 42.30 mcg/mL (ranged from 10.07 to 142.84 mcg/mL). Six women had teriflunomide below detection levels (0.020 mcg/mL). However, four women had detectable levels that averaged 0.045 mcg/mL (ranging from 0.022 to 0.077 mcg/mL).

“This small study demonstrates that low or undetectable levels of teriflunomide occur in females who are sexually active with males taking teriflunomide for relapsing multiple sclerosis,” the researchers wrote in their poster. They found that women who had low detectable levels of teriflunomide, compared with women with undetectable levels, did not engage in more frequent sexual intercourse nor were their levels associated with higher levels of teriflunomide in their male partners.

“Indeed, one might have expected a positive correlation between serum levels of teriflunomide in females and the frequency or concentration of inoculation in semen from their partners,” the researchers wrote. “While semen levels of teriflunomide were not measured in this study, it might be assumed that serum and semen concentrations of small molecules like teriflunomide are similar.”

The study was supported by a investigator-sponsored research grant from Sanofi-Genzyme. Dr. Guarnaccia reported that he has received speaking honoraria and educational grants from Sanofi-Genzyme, Biogen, Teva, Acorda Therapeutics, Bayer, EMD Serono, and Genentech.

dbrunk@mdedge.com

SOURCE: Guarnaccia JB et al. ACTRIMS Forum 2019, Poster 115.

DALLAS – Low or undetectable levels of teriflunomide (Aubagio) occur in women who are sexually active with men taking the drug for relapsing multiple sclerosis, results from a small study demonstrated.

Doug Brunk/MDedge News

“One of the issues with this particular drug is that it carries a strong pregnancy warning because in animal studies the drug has been teratogenic,” Joseph B. Guarnaccia, MD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other issue is that it remains detectable in the body for some time. The issue of females taking this drug and conception are well known. There are strong warnings that, if a woman wants to become pregnant, the drug should be removed quickly from the system. But if their male partner is on the drug, does that pose a risk to their female partner? That question has never been addressed in a human study.”

The Food and Drug Administration prescribing information recommends that men wishing to father a child should discontinue use of teriflunomide and undergo the accelerated elimination procedure. It also recommends that female partners wishing to become pregnant should discontinue the drug and undergo an accelerated elimination procedure to verify that the plasma teriflunomide concentration is less than 0.020 mcg/mL.

In an effort to test the risk of female exposure to potentially teratogenic levels of teriflunomide through sexual intercourse, Dr. Guarnaccia, a neurologist with the Multiple Sclerosis Treatment Center at Griffin Hospital in Derby, Conn., and his colleagues recruited 10 couples and compared serum levels of teriflunomide in men with relapsing multiple sclerosis with those of their female partners. Enrollment criteria for men included a diagnosis of relapsing multiple sclerosis, age between 18 and 55 years, treatment with teriflunomide for at least 2 months prior to study entry, and frequency of sexual intercourse with their female partners at least twice a month. Pregnancy was excluded in females, and couples could not use barrier or withdrawal methods of contraception. The couples completed a brief questionnaire and underwent a one-time blood draw for teriflunomide levels either at the investigator’s office or at a LabCorp facility.

The mean age of study participants was 47 years and the mean frequency of intercourse was seven episodes per month. The mean teriflunomide concentration in men was 42.30 mcg/mL (ranged from 10.07 to 142.84 mcg/mL). Six women had teriflunomide below detection levels (0.020 mcg/mL). However, four women had detectable levels that averaged 0.045 mcg/mL (ranging from 0.022 to 0.077 mcg/mL).

“This small study demonstrates that low or undetectable levels of teriflunomide occur in females who are sexually active with males taking teriflunomide for relapsing multiple sclerosis,” the researchers wrote in their poster. They found that women who had low detectable levels of teriflunomide, compared with women with undetectable levels, did not engage in more frequent sexual intercourse nor were their levels associated with higher levels of teriflunomide in their male partners.

“Indeed, one might have expected a positive correlation between serum levels of teriflunomide in females and the frequency or concentration of inoculation in semen from their partners,” the researchers wrote. “While semen levels of teriflunomide were not measured in this study, it might be assumed that serum and semen concentrations of small molecules like teriflunomide are similar.”

The study was supported by a investigator-sponsored research grant from Sanofi-Genzyme. Dr. Guarnaccia reported that he has received speaking honoraria and educational grants from Sanofi-Genzyme, Biogen, Teva, Acorda Therapeutics, Bayer, EMD Serono, and Genentech.

dbrunk@mdedge.com

SOURCE: Guarnaccia JB et al. ACTRIMS Forum 2019, Poster 115.

Endoscopic full-thickness resection (EFTR) may be an effective treatment strategy for patients with early colorectal cancer, according to results from a study published in Gastrointestinal Endoscopy.

“EFTR is an emerging technique for removal of nonlifting colorectal lesions but data on resection of malignant tumors are limited,” wrote Armin Kuellmer, MD, of the University of Freiburg (Germany), along with his colleagues.

The researchers retrospectively studied a cohort of 156 patients with histologically confirmed adenocarcinoma from 2015 to 2018 included in a German endoscopy registry. The most common indication for the procedure was removal of nonlifting lesions (n = 92), followed by resection of malignant polyps (n = 64). Dr. Kuellmer and his colleagues examined the efficacy, safety, and clinical significance of this novel technique.

The primary outcomes measured were technical success and R0 resection, which were defined as the macroscopic complete removal of the lesion and complete histologic removal with no evidence of malignant tissue in a tissue sample, respectively.

“Low-risk versus high-risk lesions are difficult to discriminate before resection as criteria are based on histological features,” the researchers wrote. “The study underlines the potential of EFTR to exactly discriminate between high-risk versus low-risk tumors to aid decision[s] for the optimal individual treatment strategy.”

After analysis, the investigators reported a technical success rate of 92.3% in patients who underwent the procedure and that the R0 resection rate was 71.8% in the same group.

“Reported technical success rates of EFTR for other indications [mainly nonlifting adenomas] range from 75% to 100% and are in line with our data,” they explained.

In a subgroup analysis, Dr. Kuellmer and his colleagues saw a higher R0 resection rate in patients who underwent the procedure for removal of malignant polyps (group 1) versus nonlifting lesions (group 2) (87.5% vs. 60.9%; P less than .001).

“This [difference] may be due to the fact that group 1 mainly consisted of low-risk tumors and small resection scars whereas the majority of lesions in group 2 proved to be more advanced tumors,” they added.

With respect to safety, 21 treatment-related adverse events were seen in the cohort, which were classified as either mild, moderate, or severe. Of these events, six were severe, defined as possibly life-threatening or requiring surgical intervention to resolve.

“The rate of major [adverse events] including perforation is in line with reported data on EFTR for other indications [0%-5%],” they wrote.

The authors acknowledged that a key limitation of the study was the retrospective cohort design. As a result, specific treatment strategies and procedural expertise could have varied across the participating centers. “We therefore cannot provide data on how much patients in total have been evaluated for EFTR,” they wrote.

Moving forward, the researchers highlighted the importance of conducting prospective studies to assess whether EFTR is a viable, safe, and effective treatment option for patients with early colorectal cancer.

“For patients with high-risk lesions unfit for surgery, [EFTR] might as well be a valuable option for local endoscopic treatment,” they concluded.

Funding sources and conflicts of interests were not reported.

SOURCE: Kuellmer A et al. Gastrointest Endosc. 2019 Jan 14. doi: 10.1016/j.gie.2018.12.025.

Endoscopic full-thickness resection (EFTR) may be an effective treatment strategy for patients with early colorectal cancer, according to results from a study published in Gastrointestinal Endoscopy.

“EFTR is an emerging technique for removal of nonlifting colorectal lesions but data on resection of malignant tumors are limited,” wrote Armin Kuellmer, MD, of the University of Freiburg (Germany), along with his colleagues.

The researchers retrospectively studied a cohort of 156 patients with histologically confirmed adenocarcinoma from 2015 to 2018 included in a German endoscopy registry. The most common indication for the procedure was removal of nonlifting lesions (n = 92), followed by resection of malignant polyps (n = 64). Dr. Kuellmer and his colleagues examined the efficacy, safety, and clinical significance of this novel technique.

The primary outcomes measured were technical success and R0 resection, which were defined as the macroscopic complete removal of the lesion and complete histologic removal with no evidence of malignant tissue in a tissue sample, respectively.

“Low-risk versus high-risk lesions are difficult to discriminate before resection as criteria are based on histological features,” the researchers wrote. “The study underlines the potential of EFTR to exactly discriminate between high-risk versus low-risk tumors to aid decision[s] for the optimal individual treatment strategy.”

After analysis, the investigators reported a technical success rate of 92.3% in patients who underwent the procedure and that the R0 resection rate was 71.8% in the same group.

“Reported technical success rates of EFTR for other indications [mainly nonlifting adenomas] range from 75% to 100% and are in line with our data,” they explained.

In a subgroup analysis, Dr. Kuellmer and his colleagues saw a higher R0 resection rate in patients who underwent the procedure for removal of malignant polyps (group 1) versus nonlifting lesions (group 2) (87.5% vs. 60.9%; P less than .001).

“This [difference] may be due to the fact that group 1 mainly consisted of low-risk tumors and small resection scars whereas the majority of lesions in group 2 proved to be more advanced tumors,” they added.

With respect to safety, 21 treatment-related adverse events were seen in the cohort, which were classified as either mild, moderate, or severe. Of these events, six were severe, defined as possibly life-threatening or requiring surgical intervention to resolve.

“The rate of major [adverse events] including perforation is in line with reported data on EFTR for other indications [0%-5%],” they wrote.

The authors acknowledged that a key limitation of the study was the retrospective cohort design. As a result, specific treatment strategies and procedural expertise could have varied across the participating centers. “We therefore cannot provide data on how much patients in total have been evaluated for EFTR,” they wrote.

Moving forward, the researchers highlighted the importance of conducting prospective studies to assess whether EFTR is a viable, safe, and effective treatment option for patients with early colorectal cancer.

“For patients with high-risk lesions unfit for surgery, [EFTR] might as well be a valuable option for local endoscopic treatment,” they concluded.

Funding sources and conflicts of interests were not reported.

SOURCE: Kuellmer A et al. Gastrointest Endosc. 2019 Jan 14. doi: 10.1016/j.gie.2018.12.025.

Endoscopic full-thickness resection (EFTR) may be an effective treatment strategy for patients with early colorectal cancer, according to results from a study published in Gastrointestinal Endoscopy.

“EFTR is an emerging technique for removal of nonlifting colorectal lesions but data on resection of malignant tumors are limited,” wrote Armin Kuellmer, MD, of the University of Freiburg (Germany), along with his colleagues.

The researchers retrospectively studied a cohort of 156 patients with histologically confirmed adenocarcinoma from 2015 to 2018 included in a German endoscopy registry. The most common indication for the procedure was removal of nonlifting lesions (n = 92), followed by resection of malignant polyps (n = 64). Dr. Kuellmer and his colleagues examined the efficacy, safety, and clinical significance of this novel technique.

The primary outcomes measured were technical success and R0 resection, which were defined as the macroscopic complete removal of the lesion and complete histologic removal with no evidence of malignant tissue in a tissue sample, respectively.

“Low-risk versus high-risk lesions are difficult to discriminate before resection as criteria are based on histological features,” the researchers wrote. “The study underlines the potential of EFTR to exactly discriminate between high-risk versus low-risk tumors to aid decision[s] for the optimal individual treatment strategy.”

After analysis, the investigators reported a technical success rate of 92.3% in patients who underwent the procedure and that the R0 resection rate was 71.8% in the same group.

“Reported technical success rates of EFTR for other indications [mainly nonlifting adenomas] range from 75% to 100% and are in line with our data,” they explained.

In a subgroup analysis, Dr. Kuellmer and his colleagues saw a higher R0 resection rate in patients who underwent the procedure for removal of malignant polyps (group 1) versus nonlifting lesions (group 2) (87.5% vs. 60.9%; P less than .001).

“This [difference] may be due to the fact that group 1 mainly consisted of low-risk tumors and small resection scars whereas the majority of lesions in group 2 proved to be more advanced tumors,” they added.

With respect to safety, 21 treatment-related adverse events were seen in the cohort, which were classified as either mild, moderate, or severe. Of these events, six were severe, defined as possibly life-threatening or requiring surgical intervention to resolve.

“The rate of major [adverse events] including perforation is in line with reported data on EFTR for other indications [0%-5%],” they wrote.

The authors acknowledged that a key limitation of the study was the retrospective cohort design. As a result, specific treatment strategies and procedural expertise could have varied across the participating centers. “We therefore cannot provide data on how much patients in total have been evaluated for EFTR,” they wrote.

Moving forward, the researchers highlighted the importance of conducting prospective studies to assess whether EFTR is a viable, safe, and effective treatment option for patients with early colorectal cancer.

“For patients with high-risk lesions unfit for surgery, [EFTR] might as well be a valuable option for local endoscopic treatment,” they concluded.

Funding sources and conflicts of interests were not reported.

SOURCE: Kuellmer A et al. Gastrointest Endosc. 2019 Jan 14. doi: 10.1016/j.gie.2018.12.025.

Physicians continue to be the major drivers of hospital revenue, and invasive cardiologists were among the top revenue-generating specialists in 2018, according to a new survey by physician search firm Merritt Hawkins.

“The value of physician care is not only related to the quality of patient outcomes,” Travis Singleton, the company’s executive vice president, wrote in a statement. “Physicians continue to drive the financial health and viability of hospitals, even in a health care system that is evolving towards value-based payments.”

Invasive cardiologists generated an average of $3.48 million for their affiliated hospitals last year, second only to cardiovascular surgeons’ $3.70 million among the 19 specialties included in the survey. Average revenue generated by noninvasive cardiologists in 2018 came in at $2.31 million – that’s an 83% increase over the 3 years since the survey was last conducted, compared with the 42% rise seen by the invasive cardiologists over that time, Merritt Hawkins reported.


Specialist physicians as a group averaged over $2.45 million in revenue in 2018, compared with $2.13 million for primary care physicians, which “suggests that emerging value-based delivery models have yet to inhibit the revenue generating power of physician specialists,” the report said. Average revenue for all physicians in the survey was almost $2.38 million, an increase of 52% since Merritt Hawkins’ last survey.

The survey was conducted from October to December 2018 and is based on responses from 62 chief financial officers or other financial managers who represented 93 hospitals. Responses from smaller hospitals (0-99 beds) were “somewhat overrepresented in the survey” relative to their number nationwide, Merritt Hawkins said.

rfranki@mdedge.com

Physicians continue to be the major drivers of hospital revenue, and invasive cardiologists were among the top revenue-generating specialists in 2018, according to a new survey by physician search firm Merritt Hawkins.

“The value of physician care is not only related to the quality of patient outcomes,” Travis Singleton, the company’s executive vice president, wrote in a statement. “Physicians continue to drive the financial health and viability of hospitals, even in a health care system that is evolving towards value-based payments.”

Invasive cardiologists generated an average of $3.48 million for their affiliated hospitals last year, second only to cardiovascular surgeons’ $3.70 million among the 19 specialties included in the survey. Average revenue generated by noninvasive cardiologists in 2018 came in at $2.31 million – that’s an 83% increase over the 3 years since the survey was last conducted, compared with the 42% rise seen by the invasive cardiologists over that time, Merritt Hawkins reported.


Specialist physicians as a group averaged over $2.45 million in revenue in 2018, compared with $2.13 million for primary care physicians, which “suggests that emerging value-based delivery models have yet to inhibit the revenue generating power of physician specialists,” the report said. Average revenue for all physicians in the survey was almost $2.38 million, an increase of 52% since Merritt Hawkins’ last survey.

The survey was conducted from October to December 2018 and is based on responses from 62 chief financial officers or other financial managers who represented 93 hospitals. Responses from smaller hospitals (0-99 beds) were “somewhat overrepresented in the survey” relative to their number nationwide, Merritt Hawkins said.

rfranki@mdedge.com

Physicians continue to be the major drivers of hospital revenue, and invasive cardiologists were among the top revenue-generating specialists in 2018, according to a new survey by physician search firm Merritt Hawkins.

“The value of physician care is not only related to the quality of patient outcomes,” Travis Singleton, the company’s executive vice president, wrote in a statement. “Physicians continue to drive the financial health and viability of hospitals, even in a health care system that is evolving towards value-based payments.”

Invasive cardiologists generated an average of $3.48 million for their affiliated hospitals last year, second only to cardiovascular surgeons’ $3.70 million among the 19 specialties included in the survey. Average revenue generated by noninvasive cardiologists in 2018 came in at $2.31 million – that’s an 83% increase over the 3 years since the survey was last conducted, compared with the 42% rise seen by the invasive cardiologists over that time, Merritt Hawkins reported.


Specialist physicians as a group averaged over $2.45 million in revenue in 2018, compared with $2.13 million for primary care physicians, which “suggests that emerging value-based delivery models have yet to inhibit the revenue generating power of physician specialists,” the report said. Average revenue for all physicians in the survey was almost $2.38 million, an increase of 52% since Merritt Hawkins’ last survey.

The survey was conducted from October to December 2018 and is based on responses from 62 chief financial officers or other financial managers who represented 93 hospitals. Responses from smaller hospitals (0-99 beds) were “somewhat overrepresented in the survey” relative to their number nationwide, Merritt Hawkins said.

rfranki@mdedge.com

A proposed clinical scoring system using readily available laboratory data, rather than complex formulas, can be used to predict risk for overall survival and help with clinical decision making for patients with multiple myeloma who are ineligible for stem cell transplants, the system’s creators claim.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

When applied to data from two clinical trials that enrolled patients with transplant-ineligible multiple myeloma, the UK Myeloma Research Alliance Risk Profile (MRP) was shown to accurately group patients into low-, medium- and high-risk categories and was prognostic of overall survival, reported Gordon Cook, PhD, of the University of Leeds, England, and his colleagues.

“The ability of clinical scoring systems, such as that proposed here, to predict whether a patient is likely to stop treatment early because of treatment intolerability, could enable preemptive, upfront dose adjustments in patients with multiple myeloma, preventing toxicity and potentially enabling patients to stay on therapy for longer,” they wrote in the Lancet Haematology.

The investigators used data on 1,852 newly diagnosed patients recruited to the non–intensive treatment pathway of the UK’s National Cancer Research Institute Myeloma XI study (NCRI-XI, ISRCTN49407852) for a training dataset and internal validation dataset, and 520 patients recruited into the Medical Research Council Myeloma IX study (MRC-IX, ISRCTN68454111) for the test dataset.

Patient characteristics, biochemical measurements, and hematological data were plugged into univariate and multivariate models to determine their potential as prognostic variables.

The final model for the test and validation datasets included World Health Organization performance status, the multiple myeloma International Staging System, patient age, and C-reactive protein concentrations.

As noted before, the scoring algorithm groups patients into low-, medium- and high-risk categories, with each of the prognostic variables increasing in severity across the three groups in both clinical trials.

In the NCRI-XI trial, median overall survival for patients in the MRP low-risk group was 60 months, compared with 44 months in the medium-risk group, and 25 months in the high-risk group.

Similarly, in the MRC-IX trial, the respective median overall survival was 49, 34, and 20 months.

The risk groups also were associated with progression-free survival in each trial, although not as robustly as the association with overall survival.

The investigators also found that, the higher the risk group, the greater the likelihood that the median percentage of protocol dose delivered would be lower, and both a decrease in protocol dose delivered and quality of life at baseline were associated with increased risk.

The MRP categories were prognostic in patients treated with various therapeutic regimens and in patients with high-risk cytogenetics.

“None of the risk scoring systems previously developed in myeloma are dynamic, making them unable to accommodate changes in disease-related frailty that might be minimized by effective anti-myeloma therapy. There is therefore scope to improve clinical risk scores by the addition of a suitable frailty biomarker, which is currently still in developmental stages,” Dr. Cook and his colleagues wrote.

The study was funded by the Medical Research Council, Novartis, Schering Health Care, Chugai, Pharmion, Celgene, Ortho Biotech, Cancer Research UK, Celgene, Merck Sharp & Dohme, and Amgen. Dr. Cook reported grants and nonfinancial support from Celgene, Amgen, and Merck Sharp & Dohme, during the conduct of the study and personal fees from other companies outside the submitted work.

SOURCE: Cook G et al. Lancet Haematol. 2019 Mar;6(3):e154-66.

A proposed clinical scoring system using readily available laboratory data, rather than complex formulas, can be used to predict risk for overall survival and help with clinical decision making for patients with multiple myeloma who are ineligible for stem cell transplants, the system’s creators claim.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

When applied to data from two clinical trials that enrolled patients with transplant-ineligible multiple myeloma, the UK Myeloma Research Alliance Risk Profile (MRP) was shown to accurately group patients into low-, medium- and high-risk categories and was prognostic of overall survival, reported Gordon Cook, PhD, of the University of Leeds, England, and his colleagues.

“The ability of clinical scoring systems, such as that proposed here, to predict whether a patient is likely to stop treatment early because of treatment intolerability, could enable preemptive, upfront dose adjustments in patients with multiple myeloma, preventing toxicity and potentially enabling patients to stay on therapy for longer,” they wrote in the Lancet Haematology.

The investigators used data on 1,852 newly diagnosed patients recruited to the non–intensive treatment pathway of the UK’s National Cancer Research Institute Myeloma XI study (NCRI-XI, ISRCTN49407852) for a training dataset and internal validation dataset, and 520 patients recruited into the Medical Research Council Myeloma IX study (MRC-IX, ISRCTN68454111) for the test dataset.

Patient characteristics, biochemical measurements, and hematological data were plugged into univariate and multivariate models to determine their potential as prognostic variables.

The final model for the test and validation datasets included World Health Organization performance status, the multiple myeloma International Staging System, patient age, and C-reactive protein concentrations.

As noted before, the scoring algorithm groups patients into low-, medium- and high-risk categories, with each of the prognostic variables increasing in severity across the three groups in both clinical trials.

In the NCRI-XI trial, median overall survival for patients in the MRP low-risk group was 60 months, compared with 44 months in the medium-risk group, and 25 months in the high-risk group.

Similarly, in the MRC-IX trial, the respective median overall survival was 49, 34, and 20 months.

The risk groups also were associated with progression-free survival in each trial, although not as robustly as the association with overall survival.

The investigators also found that, the higher the risk group, the greater the likelihood that the median percentage of protocol dose delivered would be lower, and both a decrease in protocol dose delivered and quality of life at baseline were associated with increased risk.

The MRP categories were prognostic in patients treated with various therapeutic regimens and in patients with high-risk cytogenetics.

“None of the risk scoring systems previously developed in myeloma are dynamic, making them unable to accommodate changes in disease-related frailty that might be minimized by effective anti-myeloma therapy. There is therefore scope to improve clinical risk scores by the addition of a suitable frailty biomarker, which is currently still in developmental stages,” Dr. Cook and his colleagues wrote.

The study was funded by the Medical Research Council, Novartis, Schering Health Care, Chugai, Pharmion, Celgene, Ortho Biotech, Cancer Research UK, Celgene, Merck Sharp & Dohme, and Amgen. Dr. Cook reported grants and nonfinancial support from Celgene, Amgen, and Merck Sharp & Dohme, during the conduct of the study and personal fees from other companies outside the submitted work.

SOURCE: Cook G et al. Lancet Haematol. 2019 Mar;6(3):e154-66.

A proposed clinical scoring system using readily available laboratory data, rather than complex formulas, can be used to predict risk for overall survival and help with clinical decision making for patients with multiple myeloma who are ineligible for stem cell transplants, the system’s creators claim.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

When applied to data from two clinical trials that enrolled patients with transplant-ineligible multiple myeloma, the UK Myeloma Research Alliance Risk Profile (MRP) was shown to accurately group patients into low-, medium- and high-risk categories and was prognostic of overall survival, reported Gordon Cook, PhD, of the University of Leeds, England, and his colleagues.

“The ability of clinical scoring systems, such as that proposed here, to predict whether a patient is likely to stop treatment early because of treatment intolerability, could enable preemptive, upfront dose adjustments in patients with multiple myeloma, preventing toxicity and potentially enabling patients to stay on therapy for longer,” they wrote in the Lancet Haematology.

The investigators used data on 1,852 newly diagnosed patients recruited to the non–intensive treatment pathway of the UK’s National Cancer Research Institute Myeloma XI study (NCRI-XI, ISRCTN49407852) for a training dataset and internal validation dataset, and 520 patients recruited into the Medical Research Council Myeloma IX study (MRC-IX, ISRCTN68454111) for the test dataset.

Patient characteristics, biochemical measurements, and hematological data were plugged into univariate and multivariate models to determine their potential as prognostic variables.

The final model for the test and validation datasets included World Health Organization performance status, the multiple myeloma International Staging System, patient age, and C-reactive protein concentrations.

As noted before, the scoring algorithm groups patients into low-, medium- and high-risk categories, with each of the prognostic variables increasing in severity across the three groups in both clinical trials.

In the NCRI-XI trial, median overall survival for patients in the MRP low-risk group was 60 months, compared with 44 months in the medium-risk group, and 25 months in the high-risk group.

Similarly, in the MRC-IX trial, the respective median overall survival was 49, 34, and 20 months.

The risk groups also were associated with progression-free survival in each trial, although not as robustly as the association with overall survival.

The investigators also found that, the higher the risk group, the greater the likelihood that the median percentage of protocol dose delivered would be lower, and both a decrease in protocol dose delivered and quality of life at baseline were associated with increased risk.

The MRP categories were prognostic in patients treated with various therapeutic regimens and in patients with high-risk cytogenetics.

“None of the risk scoring systems previously developed in myeloma are dynamic, making them unable to accommodate changes in disease-related frailty that might be minimized by effective anti-myeloma therapy. There is therefore scope to improve clinical risk scores by the addition of a suitable frailty biomarker, which is currently still in developmental stages,” Dr. Cook and his colleagues wrote.

The study was funded by the Medical Research Council, Novartis, Schering Health Care, Chugai, Pharmion, Celgene, Ortho Biotech, Cancer Research UK, Celgene, Merck Sharp & Dohme, and Amgen. Dr. Cook reported grants and nonfinancial support from Celgene, Amgen, and Merck Sharp & Dohme, during the conduct of the study and personal fees from other companies outside the submitted work.

SOURCE: Cook G et al. Lancet Haematol. 2019 Mar;6(3):e154-66.

Children whose mothers experienced any type of infection during pregnancy were nearly 80 times more likely to be diagnosed with autism, compared with those whose mothers did not have infections. Also today, for FPs, 2018 was a big year for generating hospital revenue, prenatal betamethasone is not linked to later adverse neurocognitive problems, and heart-harming toxins may hurt hookah smokers.

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Apple Podcasts

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Spotify
 

Children whose mothers experienced any type of infection during pregnancy were nearly 80 times more likely to be diagnosed with autism, compared with those whose mothers did not have infections. Also today, for FPs, 2018 was a big year for generating hospital revenue, prenatal betamethasone is not linked to later adverse neurocognitive problems, and heart-harming toxins may hurt hookah smokers.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Children whose mothers experienced any type of infection during pregnancy were nearly 80 times more likely to be diagnosed with autism, compared with those whose mothers did not have infections. Also today, for FPs, 2018 was a big year for generating hospital revenue, prenatal betamethasone is not linked to later adverse neurocognitive problems, and heart-harming toxins may hurt hookah smokers.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify