Patients with an acute transient immune response that is directed against small nerve fibers can display features similar to those of Guillain-Barré syndrome, according to Nobuhiro Yuki, PhD, and associates.

The investigators described three Chinese patients with severe pain in their extremities weeks after infectious illness. Pain greatly improved in two of the patients within days (up to 1 week) of treatment with intravenous immunoglobulin. One patient who refused intravenous immunoglobulin gradually improved with 3 weeks of prednisolone treatment but did not improve as much as the other two.

The investigators found that intrathecal injections of the sera from the acute phase of these patients’ illnesses into nociceptive thermal mouse models induced a transient thermal hypersensitivity, whereas sera from 25 patients with Charcot-Marie-Tooth disease and 25 patients with chronic inflammatory demyelinating polyneuropathy who served as disease controls did not. The intrathecal injections of sera from a healthy donor or from the first two of the three described patients after recovery did not affect thermal sensitivity.

Also, patients’ sera in the acute phase strongly and widely stained small nerve fibers in the dermis of the foot pads of the mice and colocalized with a nerve marker. The sera did not react against myelinated fibers from mouse sciatic nerves. Serum IgG antibodies immunostained the dorsal horn of the lumber spinal cord during the acute phase in all patients, but none of the patients showed reactivity in the convalescent phase.

Patients’ IgG antibodies reacted against surface antigens from the neuron cell body and axon from patients’ sera, but none of the patients with Charcot-Marie-Tooth or chronic inflammatory demyelinating polyneuropathy presented a similar reaction against dorsal root ganglion neurons.

“Our case series and the cases identified in the literature suggest that an acute immune response can be directed against small fibers and exhibit similarities to Guillain-Barré syndrome, including acute preceding infectious illness, a monophasic course, and albuminocytologic dissociation,” the researchers concluded. “It is also worth pointing out that patients with ‘acute small fiber sensory neuropathy’ subsequent to infection or vaccination do not always complain of pain, suggesting a different disease entity.”

Read the full study in Muscle & Nerve (2017. doi: 10.1002/mus.25738).

[email protected]

Patients with an acute transient immune response that is directed against small nerve fibers can display features similar to those of Guillain-Barré syndrome, according to Nobuhiro Yuki, PhD, and associates.

The investigators described three Chinese patients with severe pain in their extremities weeks after infectious illness. Pain greatly improved in two of the patients within days (up to 1 week) of treatment with intravenous immunoglobulin. One patient who refused intravenous immunoglobulin gradually improved with 3 weeks of prednisolone treatment but did not improve as much as the other two.

The investigators found that intrathecal injections of the sera from the acute phase of these patients’ illnesses into nociceptive thermal mouse models induced a transient thermal hypersensitivity, whereas sera from 25 patients with Charcot-Marie-Tooth disease and 25 patients with chronic inflammatory demyelinating polyneuropathy who served as disease controls did not. The intrathecal injections of sera from a healthy donor or from the first two of the three described patients after recovery did not affect thermal sensitivity.

Also, patients’ sera in the acute phase strongly and widely stained small nerve fibers in the dermis of the foot pads of the mice and colocalized with a nerve marker. The sera did not react against myelinated fibers from mouse sciatic nerves. Serum IgG antibodies immunostained the dorsal horn of the lumber spinal cord during the acute phase in all patients, but none of the patients showed reactivity in the convalescent phase.

Patients’ IgG antibodies reacted against surface antigens from the neuron cell body and axon from patients’ sera, but none of the patients with Charcot-Marie-Tooth or chronic inflammatory demyelinating polyneuropathy presented a similar reaction against dorsal root ganglion neurons.

“Our case series and the cases identified in the literature suggest that an acute immune response can be directed against small fibers and exhibit similarities to Guillain-Barré syndrome, including acute preceding infectious illness, a monophasic course, and albuminocytologic dissociation,” the researchers concluded. “It is also worth pointing out that patients with ‘acute small fiber sensory neuropathy’ subsequent to infection or vaccination do not always complain of pain, suggesting a different disease entity.”

Read the full study in Muscle & Nerve (2017. doi: 10.1002/mus.25738).

[email protected]

Patients with an acute transient immune response that is directed against small nerve fibers can display features similar to those of Guillain-Barré syndrome, according to Nobuhiro Yuki, PhD, and associates.

The investigators described three Chinese patients with severe pain in their extremities weeks after infectious illness. Pain greatly improved in two of the patients within days (up to 1 week) of treatment with intravenous immunoglobulin. One patient who refused intravenous immunoglobulin gradually improved with 3 weeks of prednisolone treatment but did not improve as much as the other two.

The investigators found that intrathecal injections of the sera from the acute phase of these patients’ illnesses into nociceptive thermal mouse models induced a transient thermal hypersensitivity, whereas sera from 25 patients with Charcot-Marie-Tooth disease and 25 patients with chronic inflammatory demyelinating polyneuropathy who served as disease controls did not. The intrathecal injections of sera from a healthy donor or from the first two of the three described patients after recovery did not affect thermal sensitivity.

Also, patients’ sera in the acute phase strongly and widely stained small nerve fibers in the dermis of the foot pads of the mice and colocalized with a nerve marker. The sera did not react against myelinated fibers from mouse sciatic nerves. Serum IgG antibodies immunostained the dorsal horn of the lumber spinal cord during the acute phase in all patients, but none of the patients showed reactivity in the convalescent phase.

Patients’ IgG antibodies reacted against surface antigens from the neuron cell body and axon from patients’ sera, but none of the patients with Charcot-Marie-Tooth or chronic inflammatory demyelinating polyneuropathy presented a similar reaction against dorsal root ganglion neurons.

“Our case series and the cases identified in the literature suggest that an acute immune response can be directed against small fibers and exhibit similarities to Guillain-Barré syndrome, including acute preceding infectious illness, a monophasic course, and albuminocytologic dissociation,” the researchers concluded. “It is also worth pointing out that patients with ‘acute small fiber sensory neuropathy’ subsequent to infection or vaccination do not always complain of pain, suggesting a different disease entity.”

Read the full study in Muscle & Nerve (2017. doi: 10.1002/mus.25738).

[email protected]

President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.

He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.

In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.

Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

‘Cost-sharing reductions’

Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.

Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.

The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.

Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.

The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.

Weaken the mandate

The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.

Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.

For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.

But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.

If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.

Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.

But even with the mandate in effect, the efforts to defang it bring confusion.

“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.

As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.

“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”

Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.

A bare market

Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.

Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”

And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.

“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.

All quiet on the enrollment front

The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.

That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.

Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.

The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.

Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.

Again, Mr. Jost said, that affects insurer participation.

“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.

Word of (bad) mouth

HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.

If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.

Perceived hostility also has an effect on insurers, steering them away from marketplace participation.

“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.

He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.

In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.

Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

‘Cost-sharing reductions’

Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.

Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.

The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.

Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.

The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.

Weaken the mandate

The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.

Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.

For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.

But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.

If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.

Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.

But even with the mandate in effect, the efforts to defang it bring confusion.

“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.

As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.

“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”

Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.

A bare market

Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.

Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”

And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.

“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.

All quiet on the enrollment front

The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.

That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.

Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.

The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.

Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.

Again, Mr. Jost said, that affects insurer participation.

“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.

Word of (bad) mouth

HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.

If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.

Perceived hostility also has an effect on insurers, steering them away from marketplace participation.

“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.

He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.

In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.

Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

‘Cost-sharing reductions’

Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.

Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.

The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.

Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.

The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.

Weaken the mandate

The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.

Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.

For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.

But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.

If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.

Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.

But even with the mandate in effect, the efforts to defang it bring confusion.

“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.

As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.

“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”

Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.

A bare market

Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.

Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”

And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.

“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.

All quiet on the enrollment front

The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.

That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.

Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.

The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.

Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.

Again, Mr. Jost said, that affects insurer participation.

“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.

Word of (bad) mouth

HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.

If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.

Perceived hostility also has an effect on insurers, steering them away from marketplace participation.

“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Photo by Graham Colm

Quest Diagnostics has announced the US launch of QHerit™, a genetic screening service that helps people of multiple ethnicities identify their risk of passing on heritable disorders to their offspring.

The QHerit Pan-Ethnic Expanded Carrier Screen is a panel of tests for the 22 heritable diseases cited in new screening guidelines from the American College of Gynecology (ACOG).

Among the diseases are alpha-thalassemia, Fanconi anemia, and beta-hemoglobinopathies, including sickle cell disease (SCD).

Traditionally, genetic carrier screening has been used for at-risk populations based on specific ancestry assumptions and focused on only a few likely disorders with higher prevalence associated with that ethnicity.

In its new guidelines, ACOG recommends offering pan-ethnic, expanded carrier, and ethnic-specific screening for all women considering pregnancy. The guidelines also state that the partner of a woman who tests positive may be a candidate for screening.

QHerit screens women and men for clinically relevant variants of genes for disorders that could have potentially devastating consequences, result in early death, or create a need for significant early intervention.

The disorders covered by QHerit include:

QHerit is now available for order by US physicians. For more information, visit www.QHerit.com.

Photo by Graham Colm

Quest Diagnostics has announced the US launch of QHerit™, a genetic screening service that helps people of multiple ethnicities identify their risk of passing on heritable disorders to their offspring.

The QHerit Pan-Ethnic Expanded Carrier Screen is a panel of tests for the 22 heritable diseases cited in new screening guidelines from the American College of Gynecology (ACOG).

Among the diseases are alpha-thalassemia, Fanconi anemia, and beta-hemoglobinopathies, including sickle cell disease (SCD).

Traditionally, genetic carrier screening has been used for at-risk populations based on specific ancestry assumptions and focused on only a few likely disorders with higher prevalence associated with that ethnicity.

In its new guidelines, ACOG recommends offering pan-ethnic, expanded carrier, and ethnic-specific screening for all women considering pregnancy. The guidelines also state that the partner of a woman who tests positive may be a candidate for screening.

QHerit screens women and men for clinically relevant variants of genes for disorders that could have potentially devastating consequences, result in early death, or create a need for significant early intervention.

The disorders covered by QHerit include:

QHerit is now available for order by US physicians. For more information, visit www.QHerit.com.

Photo by Graham Colm

Quest Diagnostics has announced the US launch of QHerit™, a genetic screening service that helps people of multiple ethnicities identify their risk of passing on heritable disorders to their offspring.

The QHerit Pan-Ethnic Expanded Carrier Screen is a panel of tests for the 22 heritable diseases cited in new screening guidelines from the American College of Gynecology (ACOG).

Among the diseases are alpha-thalassemia, Fanconi anemia, and beta-hemoglobinopathies, including sickle cell disease (SCD).

Traditionally, genetic carrier screening has been used for at-risk populations based on specific ancestry assumptions and focused on only a few likely disorders with higher prevalence associated with that ethnicity.

In its new guidelines, ACOG recommends offering pan-ethnic, expanded carrier, and ethnic-specific screening for all women considering pregnancy. The guidelines also state that the partner of a woman who tests positive may be a candidate for screening.

QHerit screens women and men for clinically relevant variants of genes for disorders that could have potentially devastating consequences, result in early death, or create a need for significant early intervention.

The disorders covered by QHerit include:

QHerit is now available for order by US physicians. For more information, visit www.QHerit.com.

Title: Variation in physician spending not associated with patient outcomes

Clinical Question: Is there a variation in spending between physicians in the same hospital, and does it have an effect on patient outcomes?

Background: Not much is known about the presence of variations in individual physician spending within the same hospital and it is not known if higher-spending physicians have better patient outcomes compared to peers within the same institution.

Dr. Rankin is a hospitalist and director of the family medicine residency inpatient service at the University of New Mexico.

Title: Variation in physician spending not associated with patient outcomes

Clinical Question: Is there a variation in spending between physicians in the same hospital, and does it have an effect on patient outcomes?

Background: Not much is known about the presence of variations in individual physician spending within the same hospital and it is not known if higher-spending physicians have better patient outcomes compared to peers within the same institution.

Dr. Rankin is a hospitalist and director of the family medicine residency inpatient service at the University of New Mexico.

Title: Variation in physician spending not associated with patient outcomes

Clinical Question: Is there a variation in spending between physicians in the same hospital, and does it have an effect on patient outcomes?

Background: Not much is known about the presence of variations in individual physician spending within the same hospital and it is not known if higher-spending physicians have better patient outcomes compared to peers within the same institution.

Dr. Rankin is a hospitalist and director of the family medicine residency inpatient service at the University of New Mexico.

Photo courtesy of Novartis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending approval for midostaurin (Rydapt®) as a treatment for acute myeloid leukemia (AML) and systemic mastocytosis (SM).

If approved by the European Commission, midostaurin would be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation—followed by midostaurin maintenance for patients in complete response—in adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-mutation-positive.

Midostaurin would also be approved to treat adults with aggressive SM, SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

If approved, midostaurin would be the first targeted treatment available in the European Union for newly diagnosed FLT3+ AML patients and advanced SM patients.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation. The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

Midostaurin in AML

The CHMP’s recommendation for midostaurin in AML is based on results from the phase 3 RATIFY trial, which were recently published in NEJM.

In RATIFY, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in 717 adults younger than age 60 who had FLT3-mutated AML.

The median overall survival was significantly longer in the midostaurin arm than the placebo arm—74.7 months and 25.6 months, respectively (hazard ratio=0.77, P=0.016).

And the median event-free survival was significantly longer in the midostaurin arm than the placebo arm—8.2 months and 3.0 months, respectively (hazard ratio=0.78, P=0.004).

The most frequent adverse events (AEs) in the midostaurin arm (occurring in at least 20% of patients) were febrile neutropenia, nausea, vomiting, mucositis, headache, musculoskeletal pain, petechiae, device-related infection, epistaxis, hyperglycemia, and upper respiratory tract infections.

The most frequent grade 3/4 AEs (occurring in at least 10% of patients) were febrile neutropenia, device-related infection, and mucositis. Nine percent of patients in the midostaurin arm stopped treatment due to AEs, as did 6% in the placebo arm.

Midostaurin in advanced SM

The CHMP’s recommendation for midostaurin in advanced SM was based on results from a pair of phase 2, single-arm studies, hereafter referred to as Study 2 and Study 3.

Data from Study 2 were published in NEJM in June 2016, and data from Study 3 were presented at the 2010 ASH Annual Meeting.

Study 2 included 116 patients, 115 of whom were evaluable for response.

The overall response rate (ORR) was 17% in the entire cohort, 31% among patients with ASM, 11% among patients with SM-AHN, and 19% among patients with MCL. The complete response rates were 2%, 6%, 0%, and 5%, respectively.

Study 3 included 26 patients with advanced SM. In 3 of the patients, the subtype of SM was unconfirmed.

Among the 17 patients with SM-AHN, there were 10 responses (ORR=59%), including 1 partial response and 9 major responses. In the 6 patients with MCL, there were 2 responses (ORR=33%), which included 1 partial response and 1 major response.

In both studies combined, there were 142 adults with ASM, SM-AHN, or MCL.

The most frequent AEs (excluding laboratory abnormalities) that occurred in at least 20% of these patients were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

The most frequent grade 3 or higher AEs (excluding laboratory abnormalities) that occurred in at least 5% of patients were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain, and renal insufficiency.

Serious AEs occurred in 68% of patients, most commonly infections and gastrointestinal disorders. Twenty-one percent of patients discontinued treatment due to AEs, the most frequent of which were infection, nausea or vomiting, QT prolongation, and gastrointestinal hemorrhage.

Photo courtesy of Novartis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending approval for midostaurin (Rydapt®) as a treatment for acute myeloid leukemia (AML) and systemic mastocytosis (SM).

If approved by the European Commission, midostaurin would be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation—followed by midostaurin maintenance for patients in complete response—in adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-mutation-positive.

Midostaurin would also be approved to treat adults with aggressive SM, SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

If approved, midostaurin would be the first targeted treatment available in the European Union for newly diagnosed FLT3+ AML patients and advanced SM patients.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation. The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

Midostaurin in AML

The CHMP’s recommendation for midostaurin in AML is based on results from the phase 3 RATIFY trial, which were recently published in NEJM.

In RATIFY, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in 717 adults younger than age 60 who had FLT3-mutated AML.

The median overall survival was significantly longer in the midostaurin arm than the placebo arm—74.7 months and 25.6 months, respectively (hazard ratio=0.77, P=0.016).

And the median event-free survival was significantly longer in the midostaurin arm than the placebo arm—8.2 months and 3.0 months, respectively (hazard ratio=0.78, P=0.004).

The most frequent adverse events (AEs) in the midostaurin arm (occurring in at least 20% of patients) were febrile neutropenia, nausea, vomiting, mucositis, headache, musculoskeletal pain, petechiae, device-related infection, epistaxis, hyperglycemia, and upper respiratory tract infections.

The most frequent grade 3/4 AEs (occurring in at least 10% of patients) were febrile neutropenia, device-related infection, and mucositis. Nine percent of patients in the midostaurin arm stopped treatment due to AEs, as did 6% in the placebo arm.

Midostaurin in advanced SM

The CHMP’s recommendation for midostaurin in advanced SM was based on results from a pair of phase 2, single-arm studies, hereafter referred to as Study 2 and Study 3.

Data from Study 2 were published in NEJM in June 2016, and data from Study 3 were presented at the 2010 ASH Annual Meeting.

Study 2 included 116 patients, 115 of whom were evaluable for response.

The overall response rate (ORR) was 17% in the entire cohort, 31% among patients with ASM, 11% among patients with SM-AHN, and 19% among patients with MCL. The complete response rates were 2%, 6%, 0%, and 5%, respectively.

Study 3 included 26 patients with advanced SM. In 3 of the patients, the subtype of SM was unconfirmed.

Among the 17 patients with SM-AHN, there were 10 responses (ORR=59%), including 1 partial response and 9 major responses. In the 6 patients with MCL, there were 2 responses (ORR=33%), which included 1 partial response and 1 major response.

In both studies combined, there were 142 adults with ASM, SM-AHN, or MCL.

The most frequent AEs (excluding laboratory abnormalities) that occurred in at least 20% of these patients were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

The most frequent grade 3 or higher AEs (excluding laboratory abnormalities) that occurred in at least 5% of patients were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain, and renal insufficiency.

Serious AEs occurred in 68% of patients, most commonly infections and gastrointestinal disorders. Twenty-one percent of patients discontinued treatment due to AEs, the most frequent of which were infection, nausea or vomiting, QT prolongation, and gastrointestinal hemorrhage.

Photo courtesy of Novartis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending approval for midostaurin (Rydapt®) as a treatment for acute myeloid leukemia (AML) and systemic mastocytosis (SM).

If approved by the European Commission, midostaurin would be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation—followed by midostaurin maintenance for patients in complete response—in adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-mutation-positive.

Midostaurin would also be approved to treat adults with aggressive SM, SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

If approved, midostaurin would be the first targeted treatment available in the European Union for newly diagnosed FLT3+ AML patients and advanced SM patients.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation. The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

Midostaurin in AML

The CHMP’s recommendation for midostaurin in AML is based on results from the phase 3 RATIFY trial, which were recently published in NEJM.

In RATIFY, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in 717 adults younger than age 60 who had FLT3-mutated AML.

The median overall survival was significantly longer in the midostaurin arm than the placebo arm—74.7 months and 25.6 months, respectively (hazard ratio=0.77, P=0.016).

And the median event-free survival was significantly longer in the midostaurin arm than the placebo arm—8.2 months and 3.0 months, respectively (hazard ratio=0.78, P=0.004).

The most frequent adverse events (AEs) in the midostaurin arm (occurring in at least 20% of patients) were febrile neutropenia, nausea, vomiting, mucositis, headache, musculoskeletal pain, petechiae, device-related infection, epistaxis, hyperglycemia, and upper respiratory tract infections.

The most frequent grade 3/4 AEs (occurring in at least 10% of patients) were febrile neutropenia, device-related infection, and mucositis. Nine percent of patients in the midostaurin arm stopped treatment due to AEs, as did 6% in the placebo arm.

Midostaurin in advanced SM

The CHMP’s recommendation for midostaurin in advanced SM was based on results from a pair of phase 2, single-arm studies, hereafter referred to as Study 2 and Study 3.

Data from Study 2 were published in NEJM in June 2016, and data from Study 3 were presented at the 2010 ASH Annual Meeting.

Study 2 included 116 patients, 115 of whom were evaluable for response.

The overall response rate (ORR) was 17% in the entire cohort, 31% among patients with ASM, 11% among patients with SM-AHN, and 19% among patients with MCL. The complete response rates were 2%, 6%, 0%, and 5%, respectively.

Study 3 included 26 patients with advanced SM. In 3 of the patients, the subtype of SM was unconfirmed.

Among the 17 patients with SM-AHN, there were 10 responses (ORR=59%), including 1 partial response and 9 major responses. In the 6 patients with MCL, there were 2 responses (ORR=33%), which included 1 partial response and 1 major response.

In both studies combined, there were 142 adults with ASM, SM-AHN, or MCL.

The most frequent AEs (excluding laboratory abnormalities) that occurred in at least 20% of these patients were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

The most frequent grade 3 or higher AEs (excluding laboratory abnormalities) that occurred in at least 5% of patients were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain, and renal insufficiency.

Serious AEs occurred in 68% of patients, most commonly infections and gastrointestinal disorders. Twenty-one percent of patients discontinued treatment due to AEs, the most frequent of which were infection, nausea or vomiting, QT prolongation, and gastrointestinal hemorrhage.

Micrograph showing FL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for obinutuzumab (Gazyvaro).

The new proposed indication is for obinutuzumab in combination with chemotherapy for patients with previously untreated, advanced follicular lymphoma (FL). This would be followed by obinutuzumab maintenance in patients who achieved a response.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation.

The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

If approved for this new indication, obinutuzumab will be authorized for use in the European Economic Area as follows:

• In combination with chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukemia and comorbidities making them unsuitable for full-dose fludarabine-based therapy.
• In combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with FL who did not respond to, or who progressed during or up to 6 months after, treatment with rituximab or a rituximab-containing regimen.
• In combination with chemotherapy, followed by obinutuzumab maintenance in responders, for the treatment of patients with previously untreated, advanced FL.

GALLIUM trial

The CHMP’s recommendation is based on results of the phase 3 GALLIUM trial, which were presented at the 2016 ASH Annual Meeting.

The study enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Micrograph showing FL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for obinutuzumab (Gazyvaro).

The new proposed indication is for obinutuzumab in combination with chemotherapy for patients with previously untreated, advanced follicular lymphoma (FL). This would be followed by obinutuzumab maintenance in patients who achieved a response.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation.

The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

If approved for this new indication, obinutuzumab will be authorized for use in the European Economic Area as follows:

• In combination with chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukemia and comorbidities making them unsuitable for full-dose fludarabine-based therapy.
• In combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with FL who did not respond to, or who progressed during or up to 6 months after, treatment with rituximab or a rituximab-containing regimen.
• In combination with chemotherapy, followed by obinutuzumab maintenance in responders, for the treatment of patients with previously untreated, advanced FL.

GALLIUM trial

The CHMP’s recommendation is based on results of the phase 3 GALLIUM trial, which were presented at the 2016 ASH Annual Meeting.

The study enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Micrograph showing FL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for obinutuzumab (Gazyvaro).

The new proposed indication is for obinutuzumab in combination with chemotherapy for patients with previously untreated, advanced follicular lymphoma (FL). This would be followed by obinutuzumab maintenance in patients who achieved a response.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation.

The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

If approved for this new indication, obinutuzumab will be authorized for use in the European Economic Area as follows:

• In combination with chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukemia and comorbidities making them unsuitable for full-dose fludarabine-based therapy.
• In combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with FL who did not respond to, or who progressed during or up to 6 months after, treatment with rituximab or a rituximab-containing regimen.
• In combination with chemotherapy, followed by obinutuzumab maintenance in responders, for the treatment of patients with previously untreated, advanced FL.

GALLIUM trial

The CHMP’s recommendation is based on results of the phase 3 GALLIUM trial, which were presented at the 2016 ASH Annual Meeting.

The study enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

In the almost 30 years since I started surgical residency, the attention to ethical issues in surgery has dramatically changed. Although surgeons still faced ethical dilemmas decades ago, there was little specific attention paid to highlighting these ethical issues in the past. Today, for many reasons, specific attention to the ethical issues in the care of surgical patients is a widespread phenomenon. We see articles in surgical journals about ethical issues and it is commonplace to find sessions devoted to various surgical ethics topics at many surgical society meetings. The American College of Surgeons is even publishing a textbook of surgical ethics in the upcoming months.

This contemporary attention to ethics in surgery seems to be a recent phenomenon. One of my senior colleagues, in commenting on how much more specific attention we pay to ethical issues today, once jokingly stated that he had trained in surgery “before there was ethics.” Although we laughed at the idea that there was a time before ethics, my own experience and my discussions with many retired surgeons, including my father, have led me to believe that things are very different today than several decades ago. I thought that although there were certainly ethically challenging cases in the past that demanded surgeons to make tough choices, such cases I thought were unlikely to be called out as ethics cases.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

In the almost 30 years since I started surgical residency, the attention to ethical issues in surgery has dramatically changed. Although surgeons still faced ethical dilemmas decades ago, there was little specific attention paid to highlighting these ethical issues in the past. Today, for many reasons, specific attention to the ethical issues in the care of surgical patients is a widespread phenomenon. We see articles in surgical journals about ethical issues and it is commonplace to find sessions devoted to various surgical ethics topics at many surgical society meetings. The American College of Surgeons is even publishing a textbook of surgical ethics in the upcoming months.

This contemporary attention to ethics in surgery seems to be a recent phenomenon. One of my senior colleagues, in commenting on how much more specific attention we pay to ethical issues today, once jokingly stated that he had trained in surgery “before there was ethics.” Although we laughed at the idea that there was a time before ethics, my own experience and my discussions with many retired surgeons, including my father, have led me to believe that things are very different today than several decades ago. I thought that although there were certainly ethically challenging cases in the past that demanded surgeons to make tough choices, such cases I thought were unlikely to be called out as ethics cases.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

In the almost 30 years since I started surgical residency, the attention to ethical issues in surgery has dramatically changed. Although surgeons still faced ethical dilemmas decades ago, there was little specific attention paid to highlighting these ethical issues in the past. Today, for many reasons, specific attention to the ethical issues in the care of surgical patients is a widespread phenomenon. We see articles in surgical journals about ethical issues and it is commonplace to find sessions devoted to various surgical ethics topics at many surgical society meetings. The American College of Surgeons is even publishing a textbook of surgical ethics in the upcoming months.

This contemporary attention to ethics in surgery seems to be a recent phenomenon. One of my senior colleagues, in commenting on how much more specific attention we pay to ethical issues today, once jokingly stated that he had trained in surgery “before there was ethics.” Although we laughed at the idea that there was a time before ethics, my own experience and my discussions with many retired surgeons, including my father, have led me to believe that things are very different today than several decades ago. I thought that although there were certainly ethically challenging cases in the past that demanded surgeons to make tough choices, such cases I thought were unlikely to be called out as ethics cases.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.