Pain is common in patients with cirrhosis, and its management presents significant challenges to health care providers, such as worries about GI bleeding, renal injury, falls, and hepatic encephalopathy.

To address those issues, researchers at the University of Michigan, Ann Arbor, authored a review, published in Hepatology, that describes the pain syndromes experienced by patients, as well as pharmaceutical and nonpharmaceutical treatment options.

“I think it’s a very pragmatic approach to a very common problem. Health care providers are concerned about prescribing analgesia for people with cirrhosis for a number of different reasons. One of them is acetaminophen can be toxic to the liver, but generally only in pretty large doses. It’s actually a pretty good option in a dose of less than about 2 g/day because it doesn’t have some of the side effects that other painkillers such as the NSAIDs have. It doesn’t irritate the stomach, and it doesn’t affect kidney function,” said Paul Martin, MD, who was asked to comment on the review. He is chief of digestive health and liver diseases at the University of Miami.

He appreciated the discussion of both pharmacologic and nonpharmacologic interventions, including diet and psychological interventions. “And I think it provides a useful overview of the pharmacological agents we can use in patients with cirrhosis, so I think it’s a very useful contribution to the literature,” said Dr. Martin.

An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of life. The authors noted that, although recent practice guidance had recommended involving palliative care providers, psychiatry, and physical therapy in for patients with decompensated cirrhosis, this is not always feasible. The authors also pointed out that there are different pain phenotypes in cirrhosis, and these require different management strategies.

They described three mechanistic categories of chronic pain: Nociceptive pain involves tissue damage and inflammation; neuropathic pain results from nerve damage; and nociplastic pain describes situations in which there is no evidence of tissue or nerve damage, but clinical or psychophysical signs suggest changes to nociception.

The different pain types are best assessed using different tools: The 2016 Fibromyalgia Survey Criteria is useful for nociplastic pain, the Neuropathic Pain Questionnaire and painDETECT can be useful for neuropathic pain, and a physical examination can pinpoint nociceptive pain.

When managing chronic pain, the initial patient workup should include a complete evaluation of the location, quality, and severity of pain, along with any functional interference or associated symptoms like fatigue, mood disturbance, or sensory sensitivity. One option is to use a body map to assess how widespread the pain is. Multisite pain is often a signal that it could be nociplastic. Any comorbid psychiatric disorders should be identified and treated.

The first treatment option for any pain should be self-directed, nonpharmacologic interventions. This is because most analgesics are only modestly effective in the treatment of chronic pain, leading to improvement in only about one in three cases, the authors noted. Opioids have poor efficacy against chronic pain, particularly nociplastic pain, which may even be worsened by opioid use.

Mladen Zivkovic/iStock/Getty Images

Although there is evidence that patients are motivated to seek out nonpharmacologic pain treatment, they have reported frustration by a dearth of simple, evidence-based therapies. The authors noted that digital self-management tools for pain have been developed, including their own PainGuide, which focuses on exercise and behavioral interventions for chronic pain. Other nonpharmacologic approaches include diet modification and sleep hygiene. Patients should be allowed to choose the approach that interests them most, with the physician emphasizing the importance of self-directed management.

Pharmacologic therapy may be added to these approaches, but they have limited utility and are associated with adverse effects. For nociceptive pain, topical NSAIDs like diclofenac gel can be used, as can acetaminophen (500 mg every 6 hours, maximum dose of 2 g/day). Opioids can be employed for short-term treatment of acute pain (for example: hydromorphone 1 mg every 6 hours as needed, oxycodone 2.5 mg by mouth every 6-8 hours as needed, or fentanyl patch in select patients). Tricyclic antidepressants may be used for multiple symptoms or neuropathic pain, but with caution. Neuropathic pain, as well as associated depression or fatigue, can be treated with low-dose serotonin and norepinephrine reuptake inhibitors, though there is a small risk of hepatotoxicity. Neuropathic pain, sleep difficulties, or anxiety can be treated with gabapentin at low starting doses (for example, 300 mg/day) or pregabalin (for example, 50 mg twice a day). Lidocaine patches are an option for peripheral neuropathic pain or postherpetic neuralgia, and topical capsaicin may be used for peripheral neuropathic pain.

“Since all pain types can co-occur, interventions to address nociplastic pain may be broadly therapeutic,” the authors concluded. “The treatment of nociplastic pain emphasizes nonpharmacologic management, including self-management techniques addressing mood, cognitions, behaviors, sleep, and environment. Future research should continue to explore methods of pain phenotyping, as well as self-management therapies, including implementation tools.”

The authors and Dr. Martin reported no relevant conflicts of interest.

Pain is common in patients with cirrhosis, and its management presents significant challenges to health care providers, such as worries about GI bleeding, renal injury, falls, and hepatic encephalopathy.

To address those issues, researchers at the University of Michigan, Ann Arbor, authored a review, published in Hepatology, that describes the pain syndromes experienced by patients, as well as pharmaceutical and nonpharmaceutical treatment options.

“I think it’s a very pragmatic approach to a very common problem. Health care providers are concerned about prescribing analgesia for people with cirrhosis for a number of different reasons. One of them is acetaminophen can be toxic to the liver, but generally only in pretty large doses. It’s actually a pretty good option in a dose of less than about 2 g/day because it doesn’t have some of the side effects that other painkillers such as the NSAIDs have. It doesn’t irritate the stomach, and it doesn’t affect kidney function,” said Paul Martin, MD, who was asked to comment on the review. He is chief of digestive health and liver diseases at the University of Miami.

He appreciated the discussion of both pharmacologic and nonpharmacologic interventions, including diet and psychological interventions. “And I think it provides a useful overview of the pharmacological agents we can use in patients with cirrhosis, so I think it’s a very useful contribution to the literature,” said Dr. Martin.

An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of life. The authors noted that, although recent practice guidance had recommended involving palliative care providers, psychiatry, and physical therapy in for patients with decompensated cirrhosis, this is not always feasible. The authors also pointed out that there are different pain phenotypes in cirrhosis, and these require different management strategies.

They described three mechanistic categories of chronic pain: Nociceptive pain involves tissue damage and inflammation; neuropathic pain results from nerve damage; and nociplastic pain describes situations in which there is no evidence of tissue or nerve damage, but clinical or psychophysical signs suggest changes to nociception.

The different pain types are best assessed using different tools: The 2016 Fibromyalgia Survey Criteria is useful for nociplastic pain, the Neuropathic Pain Questionnaire and painDETECT can be useful for neuropathic pain, and a physical examination can pinpoint nociceptive pain.

When managing chronic pain, the initial patient workup should include a complete evaluation of the location, quality, and severity of pain, along with any functional interference or associated symptoms like fatigue, mood disturbance, or sensory sensitivity. One option is to use a body map to assess how widespread the pain is. Multisite pain is often a signal that it could be nociplastic. Any comorbid psychiatric disorders should be identified and treated.

The first treatment option for any pain should be self-directed, nonpharmacologic interventions. This is because most analgesics are only modestly effective in the treatment of chronic pain, leading to improvement in only about one in three cases, the authors noted. Opioids have poor efficacy against chronic pain, particularly nociplastic pain, which may even be worsened by opioid use.

Mladen Zivkovic/iStock/Getty Images

Although there is evidence that patients are motivated to seek out nonpharmacologic pain treatment, they have reported frustration by a dearth of simple, evidence-based therapies. The authors noted that digital self-management tools for pain have been developed, including their own PainGuide, which focuses on exercise and behavioral interventions for chronic pain. Other nonpharmacologic approaches include diet modification and sleep hygiene. Patients should be allowed to choose the approach that interests them most, with the physician emphasizing the importance of self-directed management.

Pharmacologic therapy may be added to these approaches, but they have limited utility and are associated with adverse effects. For nociceptive pain, topical NSAIDs like diclofenac gel can be used, as can acetaminophen (500 mg every 6 hours, maximum dose of 2 g/day). Opioids can be employed for short-term treatment of acute pain (for example: hydromorphone 1 mg every 6 hours as needed, oxycodone 2.5 mg by mouth every 6-8 hours as needed, or fentanyl patch in select patients). Tricyclic antidepressants may be used for multiple symptoms or neuropathic pain, but with caution. Neuropathic pain, as well as associated depression or fatigue, can be treated with low-dose serotonin and norepinephrine reuptake inhibitors, though there is a small risk of hepatotoxicity. Neuropathic pain, sleep difficulties, or anxiety can be treated with gabapentin at low starting doses (for example, 300 mg/day) or pregabalin (for example, 50 mg twice a day). Lidocaine patches are an option for peripheral neuropathic pain or postherpetic neuralgia, and topical capsaicin may be used for peripheral neuropathic pain.

“Since all pain types can co-occur, interventions to address nociplastic pain may be broadly therapeutic,” the authors concluded. “The treatment of nociplastic pain emphasizes nonpharmacologic management, including self-management techniques addressing mood, cognitions, behaviors, sleep, and environment. Future research should continue to explore methods of pain phenotyping, as well as self-management therapies, including implementation tools.”

The authors and Dr. Martin reported no relevant conflicts of interest.

Pain is common in patients with cirrhosis, and its management presents significant challenges to health care providers, such as worries about GI bleeding, renal injury, falls, and hepatic encephalopathy.

To address those issues, researchers at the University of Michigan, Ann Arbor, authored a review, published in Hepatology, that describes the pain syndromes experienced by patients, as well as pharmaceutical and nonpharmaceutical treatment options.

“I think it’s a very pragmatic approach to a very common problem. Health care providers are concerned about prescribing analgesia for people with cirrhosis for a number of different reasons. One of them is acetaminophen can be toxic to the liver, but generally only in pretty large doses. It’s actually a pretty good option in a dose of less than about 2 g/day because it doesn’t have some of the side effects that other painkillers such as the NSAIDs have. It doesn’t irritate the stomach, and it doesn’t affect kidney function,” said Paul Martin, MD, who was asked to comment on the review. He is chief of digestive health and liver diseases at the University of Miami.

He appreciated the discussion of both pharmacologic and nonpharmacologic interventions, including diet and psychological interventions. “And I think it provides a useful overview of the pharmacological agents we can use in patients with cirrhosis, so I think it’s a very useful contribution to the literature,” said Dr. Martin.

An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of life. The authors noted that, although recent practice guidance had recommended involving palliative care providers, psychiatry, and physical therapy in for patients with decompensated cirrhosis, this is not always feasible. The authors also pointed out that there are different pain phenotypes in cirrhosis, and these require different management strategies.

They described three mechanistic categories of chronic pain: Nociceptive pain involves tissue damage and inflammation; neuropathic pain results from nerve damage; and nociplastic pain describes situations in which there is no evidence of tissue or nerve damage, but clinical or psychophysical signs suggest changes to nociception.

The different pain types are best assessed using different tools: The 2016 Fibromyalgia Survey Criteria is useful for nociplastic pain, the Neuropathic Pain Questionnaire and painDETECT can be useful for neuropathic pain, and a physical examination can pinpoint nociceptive pain.

When managing chronic pain, the initial patient workup should include a complete evaluation of the location, quality, and severity of pain, along with any functional interference or associated symptoms like fatigue, mood disturbance, or sensory sensitivity. One option is to use a body map to assess how widespread the pain is. Multisite pain is often a signal that it could be nociplastic. Any comorbid psychiatric disorders should be identified and treated.

The first treatment option for any pain should be self-directed, nonpharmacologic interventions. This is because most analgesics are only modestly effective in the treatment of chronic pain, leading to improvement in only about one in three cases, the authors noted. Opioids have poor efficacy against chronic pain, particularly nociplastic pain, which may even be worsened by opioid use.

Mladen Zivkovic/iStock/Getty Images

Although there is evidence that patients are motivated to seek out nonpharmacologic pain treatment, they have reported frustration by a dearth of simple, evidence-based therapies. The authors noted that digital self-management tools for pain have been developed, including their own PainGuide, which focuses on exercise and behavioral interventions for chronic pain. Other nonpharmacologic approaches include diet modification and sleep hygiene. Patients should be allowed to choose the approach that interests them most, with the physician emphasizing the importance of self-directed management.

Pharmacologic therapy may be added to these approaches, but they have limited utility and are associated with adverse effects. For nociceptive pain, topical NSAIDs like diclofenac gel can be used, as can acetaminophen (500 mg every 6 hours, maximum dose of 2 g/day). Opioids can be employed for short-term treatment of acute pain (for example: hydromorphone 1 mg every 6 hours as needed, oxycodone 2.5 mg by mouth every 6-8 hours as needed, or fentanyl patch in select patients). Tricyclic antidepressants may be used for multiple symptoms or neuropathic pain, but with caution. Neuropathic pain, as well as associated depression or fatigue, can be treated with low-dose serotonin and norepinephrine reuptake inhibitors, though there is a small risk of hepatotoxicity. Neuropathic pain, sleep difficulties, or anxiety can be treated with gabapentin at low starting doses (for example, 300 mg/day) or pregabalin (for example, 50 mg twice a day). Lidocaine patches are an option for peripheral neuropathic pain or postherpetic neuralgia, and topical capsaicin may be used for peripheral neuropathic pain.

“Since all pain types can co-occur, interventions to address nociplastic pain may be broadly therapeutic,” the authors concluded. “The treatment of nociplastic pain emphasizes nonpharmacologic management, including self-management techniques addressing mood, cognitions, behaviors, sleep, and environment. Future research should continue to explore methods of pain phenotyping, as well as self-management therapies, including implementation tools.”

The authors and Dr. Martin reported no relevant conflicts of interest.

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

A version of this article first appeared on Medscape.com.

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

A version of this article first appeared on Medscape.com.

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

A version of this article first appeared on Medscape.com.

One of the most common procedures in gastroenterology – esophagogastroduodenoscopy (EGD) – needs to consistently meet quality measures, but data on interventions to improve them is lacking, according to a recent review.

Researchers, led by Fateh Bazerbachi, MD, with CentraCare, Interventional Endoscopy Program, at St. Cloud (Minn.) Hospital performed a systematic review of the literature to identify which interventions and measures have improved the performance of EGD quality indicators previously identified by the American Society for Gastrointestinal Endoscopy. They also looked for demonstrations of improving compliance with the prioritized indicators. The review appeared in Gastrointestinal Endoscopy.

The authors pointed out that more than 6.1 million EGDs are performed every year in the United States. Although gastroenterologists perform most of them, other providers also perform them, including primary care physicians, surgeons, and sometimes advanced practice providers. Therefore, establishing well-defined quality measures is critical for consistent outcomes.

Daniel C. Buckles, MD, associate professor of gastroenterology, hepatology & motility at the University of Kansas Medical Center in Kansas City, who was not part of the review, said high-quality EGDs are critical for many reasons, including avoiding overuse when results of the procedure are not likely to change a patient’s treatment but add risk to the patient and increase costs to the health care system.

“Lack of training to recognize important GI pathology seen on an EGD and lack of standardized reporting of GI abnormalities using validated classification systems can lead to suboptimal treatment and follow-up for patients,” he noted.

Testing provider adherence to guidelines years after publication helps providers understand what works and can improve outcomes, Dr. Buckles said.  

One of the most common procedures in gastroenterology – esophagogastroduodenoscopy (EGD) – needs to consistently meet quality measures, but data on interventions to improve them is lacking, according to a recent review.

Researchers, led by Fateh Bazerbachi, MD, with CentraCare, Interventional Endoscopy Program, at St. Cloud (Minn.) Hospital performed a systematic review of the literature to identify which interventions and measures have improved the performance of EGD quality indicators previously identified by the American Society for Gastrointestinal Endoscopy. They also looked for demonstrations of improving compliance with the prioritized indicators. The review appeared in Gastrointestinal Endoscopy.

The authors pointed out that more than 6.1 million EGDs are performed every year in the United States. Although gastroenterologists perform most of them, other providers also perform them, including primary care physicians, surgeons, and sometimes advanced practice providers. Therefore, establishing well-defined quality measures is critical for consistent outcomes.

Daniel C. Buckles, MD, associate professor of gastroenterology, hepatology & motility at the University of Kansas Medical Center in Kansas City, who was not part of the review, said high-quality EGDs are critical for many reasons, including avoiding overuse when results of the procedure are not likely to change a patient’s treatment but add risk to the patient and increase costs to the health care system.

“Lack of training to recognize important GI pathology seen on an EGD and lack of standardized reporting of GI abnormalities using validated classification systems can lead to suboptimal treatment and follow-up for patients,” he noted.

Testing provider adherence to guidelines years after publication helps providers understand what works and can improve outcomes, Dr. Buckles said.  

One of the most common procedures in gastroenterology – esophagogastroduodenoscopy (EGD) – needs to consistently meet quality measures, but data on interventions to improve them is lacking, according to a recent review.

Researchers, led by Fateh Bazerbachi, MD, with CentraCare, Interventional Endoscopy Program, at St. Cloud (Minn.) Hospital performed a systematic review of the literature to identify which interventions and measures have improved the performance of EGD quality indicators previously identified by the American Society for Gastrointestinal Endoscopy. They also looked for demonstrations of improving compliance with the prioritized indicators. The review appeared in Gastrointestinal Endoscopy.

The authors pointed out that more than 6.1 million EGDs are performed every year in the United States. Although gastroenterologists perform most of them, other providers also perform them, including primary care physicians, surgeons, and sometimes advanced practice providers. Therefore, establishing well-defined quality measures is critical for consistent outcomes.

Daniel C. Buckles, MD, associate professor of gastroenterology, hepatology & motility at the University of Kansas Medical Center in Kansas City, who was not part of the review, said high-quality EGDs are critical for many reasons, including avoiding overuse when results of the procedure are not likely to change a patient’s treatment but add risk to the patient and increase costs to the health care system.

“Lack of training to recognize important GI pathology seen on an EGD and lack of standardized reporting of GI abnormalities using validated classification systems can lead to suboptimal treatment and follow-up for patients,” he noted.

Testing provider adherence to guidelines years after publication helps providers understand what works and can improve outcomes, Dr. Buckles said.  

Planned giving provides an opportunity for all who have benefited from digestive disease research to give back to the field in a unique and lasting way.

Your investment in the AGA Research Foundation will enable the foundation to continue our investment in the future of gastroenterological research and innovation. With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment, and cure of digestive diseases.

If you make a contribution, it will be because you believe in what we do and because you want to help make a difference in the lives of others. But we’d also like to make sure you benefit from making a gift to the AGA Research Foundation.
 

Your giving options

There are several gift arrangements to choose from. The chart below summarizes the benefits of some of the main types of charitable gifts. Just think of what you want to accomplish with your gift, and there’s probably a way to do it!

Planned giving provides an opportunity for all who have benefited from digestive disease research to give back to the field in a unique and lasting way.

Your investment in the AGA Research Foundation will enable the foundation to continue our investment in the future of gastroenterological research and innovation. With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment, and cure of digestive diseases.

If you make a contribution, it will be because you believe in what we do and because you want to help make a difference in the lives of others. But we’d also like to make sure you benefit from making a gift to the AGA Research Foundation.
 

Your giving options

There are several gift arrangements to choose from. The chart below summarizes the benefits of some of the main types of charitable gifts. Just think of what you want to accomplish with your gift, and there’s probably a way to do it!

Planned giving provides an opportunity for all who have benefited from digestive disease research to give back to the field in a unique and lasting way.

Your investment in the AGA Research Foundation will enable the foundation to continue our investment in the future of gastroenterological research and innovation. With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment, and cure of digestive diseases.

If you make a contribution, it will be because you believe in what we do and because you want to help make a difference in the lives of others. But we’d also like to make sure you benefit from making a gift to the AGA Research Foundation.
 

Your giving options

There are several gift arrangements to choose from. The chart below summarizes the benefits of some of the main types of charitable gifts. Just think of what you want to accomplish with your gift, and there’s probably a way to do it!

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

Women for whom an intrauterine device is inserted from 4 days to 6 weeks after giving birth, as well as those who are breastfeeding, are at higher risk of the contraceptive device puncturing their uterus, new research shows.

The risk of perforation was nearly seven times higher for patients who received an IUD within that window than for those with an IUD who’d never given birth or who were more than a year out from delivery, the researchers found. Health care providers should make patients aware of the heightened risk and should monitor these patients more closely, according to Susan Reed, MD, an ob.gyn. at the University of Washington, Seattle, lead author of the new study.

“I’m a surgeon, and I like to be able to give people good information and good data about risks and benefits for their choices,” Dr. Reed told this news organization. “Uterine perforations related to IUDs are exceedingly rare, and to get good data or known risk factors, you need huge studies. This was the largest study done that really provided accurate information for patients and providers.” The new study, which appears in a recent issue of The Lancet, also found that the risk of uterine perforation was lower if an IUD had been inserted immediately after delivery.

Dr. Reed and colleagues analyzed data from the health records of 326,658 women younger than 50 years for whom an IUD was inserted between 2001 and 2018 at four health care systems. Nearly 30% of these patients received an IUD after giving birth.

The researchers identified a total of 1,008 uterine perforations, for a cumulative incidence at 5 years of 0.6%. The cumulative incidence of uterine perforations was lowest in the group of women who were considered “nonpostpartum”; these women either received an IUD a full year after giving birth or had not given birth during the study period (0.29%; 95% confidence interval, 0.26-0.34).

Women who received an IUD during the 3 days after delivery had a nearly threefold increased risk of an IUD perforation over nonpostpartum women.

In addition, the cumulative incidence of perforation was almost double among breastfeeding women, compared with women who were not breastfeeding. However, Dr. Reed and coauthors noted that breastfeeding is highly beneficial for babies and that the risk of IUD perforation is relatively small.

Among the women who received an IUD following birth, Dr. Reed’s group found that 673 uterine perforations – of which 62% were complete – occurred in breastfeeding individuals, 37% more than for those who did not breastfeed.

Dr. Reed said the study provided some clarity on previous notions that women who’d never given birth were possibly at higher risk for uterine perforation because of smaller uteruses.

“We used to be concerned that women who had never had a pregnancy at all might be at higher risk because their uterus was smaller, the cervix was tighter, and therefore perhaps they might have greater risks,” Dr. Reed said in an interview. “As a clinician and as a provider, it’s pretty exciting to me to be able to tell our younger women who have never had a pregnancy that indeed their risk is lower than anybody else’s.”

The findings help women to make informed decisions, but overall, the benefits of IUDs outweigh the risks, said Monica V. Dragoman, MD, assistant professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York.

“The likelihood of anyone experiencing these types of complications of that population level remains really low,” Dr. Dragoman said.

The findings also provide guidance for providers as to which patients should come in for additional follow-up visits following insertion, Dr. Reed said.

“These are small risks, but it does tell us where we need to consider if there’s a challenging insertion,” Dr. Reed said. “You’re going to look with the ultrasound and make sure the placement looks right. You’re going to give instructions that if the woman has pain or a change in her bleeding pattern, you want to see her back.”

Patients should be aware of the symptoms of uterine perforation – an abrupt change in bleeding pattern and pelvic pain. Perforation correction typically consists of a minimally invasive surgical procedure.

The study was conducted as a result of an order from the Food and Drug Administration to Bayer Pharmaceuticals to evaluate risks of uterine perforation for women who’d received the company’s Mirena IUD. The findings led the company to update the language on the packaging of the device so as to specify the main symptoms of uterine perforations.

The study authors received research funding from Bayer. Multiple authors are employees of Bayer. One study author has in the past received funding from CooperSurgical, Bayer Healthcare Pharmaceutical, and Merck. Bayer was provided the opportunity to review the manuscript before submission, and comments were advisory only.

A version of this article first appeared on Medscape.com.

Women for whom an intrauterine device is inserted from 4 days to 6 weeks after giving birth, as well as those who are breastfeeding, are at higher risk of the contraceptive device puncturing their uterus, new research shows.

The risk of perforation was nearly seven times higher for patients who received an IUD within that window than for those with an IUD who’d never given birth or who were more than a year out from delivery, the researchers found. Health care providers should make patients aware of the heightened risk and should monitor these patients more closely, according to Susan Reed, MD, an ob.gyn. at the University of Washington, Seattle, lead author of the new study.

“I’m a surgeon, and I like to be able to give people good information and good data about risks and benefits for their choices,” Dr. Reed told this news organization. “Uterine perforations related to IUDs are exceedingly rare, and to get good data or known risk factors, you need huge studies. This was the largest study done that really provided accurate information for patients and providers.” The new study, which appears in a recent issue of The Lancet, also found that the risk of uterine perforation was lower if an IUD had been inserted immediately after delivery.

Dr. Reed and colleagues analyzed data from the health records of 326,658 women younger than 50 years for whom an IUD was inserted between 2001 and 2018 at four health care systems. Nearly 30% of these patients received an IUD after giving birth.

The researchers identified a total of 1,008 uterine perforations, for a cumulative incidence at 5 years of 0.6%. The cumulative incidence of uterine perforations was lowest in the group of women who were considered “nonpostpartum”; these women either received an IUD a full year after giving birth or had not given birth during the study period (0.29%; 95% confidence interval, 0.26-0.34).

Women who received an IUD during the 3 days after delivery had a nearly threefold increased risk of an IUD perforation over nonpostpartum women.

In addition, the cumulative incidence of perforation was almost double among breastfeeding women, compared with women who were not breastfeeding. However, Dr. Reed and coauthors noted that breastfeeding is highly beneficial for babies and that the risk of IUD perforation is relatively small.

Among the women who received an IUD following birth, Dr. Reed’s group found that 673 uterine perforations – of which 62% were complete – occurred in breastfeeding individuals, 37% more than for those who did not breastfeed.

Dr. Reed said the study provided some clarity on previous notions that women who’d never given birth were possibly at higher risk for uterine perforation because of smaller uteruses.

“We used to be concerned that women who had never had a pregnancy at all might be at higher risk because their uterus was smaller, the cervix was tighter, and therefore perhaps they might have greater risks,” Dr. Reed said in an interview. “As a clinician and as a provider, it’s pretty exciting to me to be able to tell our younger women who have never had a pregnancy that indeed their risk is lower than anybody else’s.”

The findings help women to make informed decisions, but overall, the benefits of IUDs outweigh the risks, said Monica V. Dragoman, MD, assistant professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York.

“The likelihood of anyone experiencing these types of complications of that population level remains really low,” Dr. Dragoman said.

The findings also provide guidance for providers as to which patients should come in for additional follow-up visits following insertion, Dr. Reed said.

“These are small risks, but it does tell us where we need to consider if there’s a challenging insertion,” Dr. Reed said. “You’re going to look with the ultrasound and make sure the placement looks right. You’re going to give instructions that if the woman has pain or a change in her bleeding pattern, you want to see her back.”

Patients should be aware of the symptoms of uterine perforation – an abrupt change in bleeding pattern and pelvic pain. Perforation correction typically consists of a minimally invasive surgical procedure.

The study was conducted as a result of an order from the Food and Drug Administration to Bayer Pharmaceuticals to evaluate risks of uterine perforation for women who’d received the company’s Mirena IUD. The findings led the company to update the language on the packaging of the device so as to specify the main symptoms of uterine perforations.

The study authors received research funding from Bayer. Multiple authors are employees of Bayer. One study author has in the past received funding from CooperSurgical, Bayer Healthcare Pharmaceutical, and Merck. Bayer was provided the opportunity to review the manuscript before submission, and comments were advisory only.

A version of this article first appeared on Medscape.com.

Women for whom an intrauterine device is inserted from 4 days to 6 weeks after giving birth, as well as those who are breastfeeding, are at higher risk of the contraceptive device puncturing their uterus, new research shows.

The risk of perforation was nearly seven times higher for patients who received an IUD within that window than for those with an IUD who’d never given birth or who were more than a year out from delivery, the researchers found. Health care providers should make patients aware of the heightened risk and should monitor these patients more closely, according to Susan Reed, MD, an ob.gyn. at the University of Washington, Seattle, lead author of the new study.

“I’m a surgeon, and I like to be able to give people good information and good data about risks and benefits for their choices,” Dr. Reed told this news organization. “Uterine perforations related to IUDs are exceedingly rare, and to get good data or known risk factors, you need huge studies. This was the largest study done that really provided accurate information for patients and providers.” The new study, which appears in a recent issue of The Lancet, also found that the risk of uterine perforation was lower if an IUD had been inserted immediately after delivery.

Dr. Reed and colleagues analyzed data from the health records of 326,658 women younger than 50 years for whom an IUD was inserted between 2001 and 2018 at four health care systems. Nearly 30% of these patients received an IUD after giving birth.

The researchers identified a total of 1,008 uterine perforations, for a cumulative incidence at 5 years of 0.6%. The cumulative incidence of uterine perforations was lowest in the group of women who were considered “nonpostpartum”; these women either received an IUD a full year after giving birth or had not given birth during the study period (0.29%; 95% confidence interval, 0.26-0.34).

Women who received an IUD during the 3 days after delivery had a nearly threefold increased risk of an IUD perforation over nonpostpartum women.

In addition, the cumulative incidence of perforation was almost double among breastfeeding women, compared with women who were not breastfeeding. However, Dr. Reed and coauthors noted that breastfeeding is highly beneficial for babies and that the risk of IUD perforation is relatively small.

Among the women who received an IUD following birth, Dr. Reed’s group found that 673 uterine perforations – of which 62% were complete – occurred in breastfeeding individuals, 37% more than for those who did not breastfeed.

Dr. Reed said the study provided some clarity on previous notions that women who’d never given birth were possibly at higher risk for uterine perforation because of smaller uteruses.

“We used to be concerned that women who had never had a pregnancy at all might be at higher risk because their uterus was smaller, the cervix was tighter, and therefore perhaps they might have greater risks,” Dr. Reed said in an interview. “As a clinician and as a provider, it’s pretty exciting to me to be able to tell our younger women who have never had a pregnancy that indeed their risk is lower than anybody else’s.”

The findings help women to make informed decisions, but overall, the benefits of IUDs outweigh the risks, said Monica V. Dragoman, MD, assistant professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York.

“The likelihood of anyone experiencing these types of complications of that population level remains really low,” Dr. Dragoman said.

The findings also provide guidance for providers as to which patients should come in for additional follow-up visits following insertion, Dr. Reed said.

“These are small risks, but it does tell us where we need to consider if there’s a challenging insertion,” Dr. Reed said. “You’re going to look with the ultrasound and make sure the placement looks right. You’re going to give instructions that if the woman has pain or a change in her bleeding pattern, you want to see her back.”

Patients should be aware of the symptoms of uterine perforation – an abrupt change in bleeding pattern and pelvic pain. Perforation correction typically consists of a minimally invasive surgical procedure.

The study was conducted as a result of an order from the Food and Drug Administration to Bayer Pharmaceuticals to evaluate risks of uterine perforation for women who’d received the company’s Mirena IUD. The findings led the company to update the language on the packaging of the device so as to specify the main symptoms of uterine perforations.

The study authors received research funding from Bayer. Multiple authors are employees of Bayer. One study author has in the past received funding from CooperSurgical, Bayer Healthcare Pharmaceutical, and Merck. Bayer was provided the opportunity to review the manuscript before submission, and comments were advisory only.

A version of this article first appeared on Medscape.com.

Three billion dollars: It’s enough to finance the annual out-of-pocket costs for 1 in 7 patients with cancer. It would cover almost half of the National Cancer Institute’s annual budget. And it could fund President Biden’s entire Cancer Moonshot program, with more than a billion to spare.

It’s also how much the United States spends on unused cancer drugs each year, some experts estimate.

Every year in the United States, hospitals and practices discard substantial quantities of expensive oncology drugs.

The reason boils down to inefficient drug packaging. Drug companies typically sell infused drugs in one or two single-dose vial sizes, but patients don’t come in such neat packages. A patient may need 300 mg of a drug that is only sold as 200 mg vials, which means half of a vial will go to waste.

Although most oncology drugs don’t incur substantial waste, even small volumes can translate to millions of dollars a year.

But can this money be saved or reallocated, if only we delivered drugs more efficiently?

Some experts don’t believe that’s possible.

“Attempts to recoup money for discarded drugs wouldn’t happen in a vacuum,” said Robin Yabroff, PhD, MBA, an epidemiologist and scientific vice president of Health Services Research at the American Cancer Society, who was part of a committee commissioned to evaluate the costs associated with discarded drugs.

The potential catch of any widespread effort to seek repayment or reduce the amount of discarded drugs, Dr. Yabroff and colleagues note, is that manufacturers would “simply increase the price of the vial.”

In other words, attempting to fix one problem may lead to another — essentially a whack-a-mole of cancer costs, which are projected to balloon to $246 billion by 2030.  

What this means is without sweeping policies to rein in cancer care costs, oncologists can only do so much. And every little bit counts.

“We are left chipping away at this monster of cancer care costs,” said Adam Binder, MD, a medical oncologist at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.
 

Millions spent on “reasonable amount” of waste

Michal Sarfaty, MD, was excited when enfortumab vedotin came on the market to treat advanced urothelial cancer in late 2019.

The cost of the drug, however, tempered her enthusiasm.

Enfortumab vedotin is a “great drug,” said Dr. Sarfaty, an oncologist at the Sheba Medical Center, Ramat Gan, Israel. But it can cost upwards of $500,000 a year for an average-weight man.

Given the expense, Dr. Sarfaty wanted to understand how much of the drug gets thrown away. During a fellowship at Memorial Sloan Kettering (MSK) Cancer Center in New York, Dr. Sarfaty explored the amount of unused enfortumab vedotin among the 64 patients who received the drug in 2020. She, along with a team at MSK, calculated the price tag of that waste and extrapolated those estimates for patients across the country.

Although waste occurred in almost half of administered doses (367 of 793), only a small volume got discarded — 2.9% per dose, on average.

Multiplying unused milligrams by the cost per milligram, Dr. Sarfaty and colleagues estimated that, for each patient, $3,127 of the drug got discarded. When calculated over the year, the cost came to just over $200,000 at MSK, and nearly $15 million when projected across the approved patient population in the United States.

“Ultimately, we did not see a lot of waste with this specific drug,” Dr. Sarfaty said. “Under 2.9% is considered a reasonable amount, below the 3% threshold Peter Bach, MD, and colleagues recommend. But even with this small amount of waste, the cost per patient and to the system remains notable.”
 

The problem with recouping drug waste

Estimates from the Centers for Medicare & Medicaid Services (CMS), which tracks costs associated with discarded weight-based drugs covered under Medicare Part B, support the notion that small quantities of discarded drugs can still translate to big bucks.

Since 2017, CMS has required healthcare providers to report the volume of drugs discarded from a single-dose vial using a code, known as the JW modifier. The JW modifier means that providers can be reimbursed for the entire vial amount, not just the quantity the patient used.

In 2019, claims data from Medicare Part B showed that 1.85% of discarded rituximab came to $33.3 million. For infliximab, the 1.55% of discarded liquid translated to $15 million, and just 0.36% of discarded pembrolizumab reached $10 million.

However, experts question whether the JW modifier accurately reflects the quantity of drugs discarded.

According to the 2021 report from the National Academies of Sciences, Engineering, and Medicine (NASEM), most physicians don’t use the JW modifier. Among Medicare claims, 16.2% included the JW modifier in 2017 and 16.9% did in 2018.

The rate was significantly lower for private insurance. Of more than 4 million private insurance claims on 77 drugs made in 2017 and 2018, only 3.6% included the JW modifier; 15 of these drugs had no JW claims.

“Although we found that most physicians don’t use the JW modifier, even those who do, don’t use it consistently, even for the same patient,” said Dr. Yabroff, a co-author on the report.

Going a step further, Dr. Yabroff and colleagues argue that even if everyone used the JW modifier as intended, manufacturers would probably increase the price of drugs to compensate for any loss, potentially eliminating savings for payers.

That’s because, in the United States, manufacturers typically base drug prices on a patient and payers’ “willingness to pay for better health,” not on the volume of liquid used. Take a patient who pays $2,000 to receive the dose they need. If that dose is 600 mg but requires using two vials of 400 mg, then “to the patient, the 600-mg dose is worth $2,000, and the remainder has no value whatsoever,” the NASEM authors argue.

The authors parallel this scenario to purchasing a designer coat or dress. If that item requires alterations that remove a section of material, “the customer does not typically get a rebate because all the fabric was not needed,” the NASEM team writes.

But there’s a flaw in this rationale, argues Daniel Goldstein, MD, a medical oncologist at the Rabin Medical Center, Petah Tikva, Israel. A person’s willingness to pay for better health assumes that the price of a drug is based on proper market forces, where a drug’s cost and its effectiveness are in harmony.

“The problem is we’re operating in a broken market where the prices of oncology drugs have no real bearing on their efficacy,” said Dr. Goldstein.

And, as Dr. Bach noted in a 2021 Health Affairs piece, willingness to pay also requires that consumers know what they’re paying and allows them to walk away from an excessively high price.

But neither is a reality.

For one, Dr. Bach explains, companies may lowball the monthly price of a drug. In 2020, GlaxoSmithKline (GSK) announced that its new drug Blenrep would carry a list price of $8,277 per vial, or about $23,900 per month for an average 79 kg (175 lb) patient. That price accounts for two vials of the drug. But, according to Dr. Bach, “what GSK left out is that 44% of U.S. adults weigh more than 80 kg, and above that weight, three vials are needed per dose.” That would raise the average monthly cost to $30,479.

Perhaps more importantly, consumers can’t easily walk away.

“Medicare can’t negotiate prices and is forced to pay what a drug company says,” Dr. Goldstein said. “This is very different to when I buy a coat. If the price is too high, I can walk away.”
 

Fixed dosing: A solution or a new problem?

Efforts to reduce the financial impact of discarded cancer drugs can blow back on physicians, patients, and payers in other unanticipated ways. Take fixed dosing. Although chemotherapy dosing remains weight-based, many targeted therapies — such as nivolumab and pembrolizumab — recently transitioned to a fixed dosing regimen.

Administering a fixed, instead of weight-based, dose eliminates waste but can create new problems.

“Patients with cancer not only tend to get too high a dose of the drug, but costs go up significantly,” said Dr. Goldstein. In a 2017 analysis, Dr. Goldstein and colleagues compared dosing strategies in patients with metastatic non–small cell lung cancer who received pembrolizumab. The team found that the total annual cost of weight-based dosing was $2.6 billion, whereas the cost of the fixed dosing strategy was $3.44 billion — 24% more. In other words, personalized weight-based dosing would save more than $825 million dollars in the United States each year.

A 2020 analysis based in France found a similar cost increase of 26% for fixed dosing of pembrolizumab as well as nivolumab.

“I’ve argued we should go back to weight-based dosing,” Dr. Goldstein said. “Why should we give a higher dose with the same efficacy when that dose will cost significantly more and has the potential to increase adverse events?”
 

Does dose rounding work?

Rose DiMarco, PharmD, BCPS, BCOP, keeps a tight watch on patients being treated at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.

Dr. DiMarco educates patients about their treatment plan, reviews their lab results, and monitors them for side effects and drug interactions.

She also thinks a lot about costs.

“We spend about $100,000 a day on oncology drugs, and we want to make sure we’re not being wasteful,” Dr. DiMarco said in an interview.

One major initiative to curb waste and reduce costs at Jefferson has centered on dose rounding, which calculates whether a specific dose can be altered slightly to conserve vials and prevent waste. According to the Hematology/Oncology Pharmacy Association, a patient can receive up to 10% more or less of a weight-based dose without impacting treatment efficacy.

If, for instance, a patient requires 380 mg, but two vials come to 400 mg, rounding up that dose by approximately 5% means eliminating 20 mg that would go unused. But if that patient requires 420 mg, rounding down about 5% means substantial savings from not opening a new vial.

At Jefferson, Dr. DiMarco and her pharmacy colleagues map out dose ranges for all patients. Anyone who falls inside the 10% may be eligible for dose rounding. Anyone who doesn’t will receive the usual dose.

Although it is a challenge to implement, dose rounding has become standard of care at many cancer centers across the United States and is linked to substantial savings.

A 2018 analysis projected annual savings of $865,000 associated with rounding down eight monoclonal antibodies for patients with metastatic disease at a community cancer center. A more recent analysis from the Mayo Clinic found that dose rounding saved a total of 9,814 drug vials — 4485 of which were cancer drugs and 5329 of which were biologics — and resulted in $7.3 million in savings over 6 months in 2019 — $1.56 million from oncology agents and $5.7 from biologics.

And in a small 2019 analysis, researchers at Jefferson showed dose rounding of one monoclonal antibody saved approximately $30,000 in just 3 months, Dr. DiMarco noted.

“Not only does this process reduce costs and waste, but it also standardizes the preparation of hazardous medications, which can help prevent medication errors,” Dr. DiMarco said.
 

Nibbling around the edges

Despite estimates that scale into the billions of dollars, “drug wastage is just a small part of overall cancer costs,” Dr. Sarfaty said.

Fumiko Chino, MD, a radiation oncologist at MSK, agrees. “When we talk about affordability and cost, we can nibble around the edges of what’s really important,” Dr. Chino said. “Discarded drugs may cost a lot when you consider them in aggregate, but they are not as important as negotiated drug prices, which could substantially reduce overall costs.”

And until drug prices are addressed on a broader policy level, the cost of cancer care likely won’t improve in a meaningful way.

“But for the patient sitting in front of me, my focus will always be to provide the best care possible,” Dr. Binder said.

A version of this article first appeared on Medscape.com.

Three billion dollars: It’s enough to finance the annual out-of-pocket costs for 1 in 7 patients with cancer. It would cover almost half of the National Cancer Institute’s annual budget. And it could fund President Biden’s entire Cancer Moonshot program, with more than a billion to spare.

It’s also how much the United States spends on unused cancer drugs each year, some experts estimate.

Every year in the United States, hospitals and practices discard substantial quantities of expensive oncology drugs.

The reason boils down to inefficient drug packaging. Drug companies typically sell infused drugs in one or two single-dose vial sizes, but patients don’t come in such neat packages. A patient may need 300 mg of a drug that is only sold as 200 mg vials, which means half of a vial will go to waste.

Although most oncology drugs don’t incur substantial waste, even small volumes can translate to millions of dollars a year.

But can this money be saved or reallocated, if only we delivered drugs more efficiently?

Some experts don’t believe that’s possible.

“Attempts to recoup money for discarded drugs wouldn’t happen in a vacuum,” said Robin Yabroff, PhD, MBA, an epidemiologist and scientific vice president of Health Services Research at the American Cancer Society, who was part of a committee commissioned to evaluate the costs associated with discarded drugs.

The potential catch of any widespread effort to seek repayment or reduce the amount of discarded drugs, Dr. Yabroff and colleagues note, is that manufacturers would “simply increase the price of the vial.”

In other words, attempting to fix one problem may lead to another — essentially a whack-a-mole of cancer costs, which are projected to balloon to $246 billion by 2030.  

What this means is without sweeping policies to rein in cancer care costs, oncologists can only do so much. And every little bit counts.

“We are left chipping away at this monster of cancer care costs,” said Adam Binder, MD, a medical oncologist at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.
 

Millions spent on “reasonable amount” of waste

Michal Sarfaty, MD, was excited when enfortumab vedotin came on the market to treat advanced urothelial cancer in late 2019.

The cost of the drug, however, tempered her enthusiasm.

Enfortumab vedotin is a “great drug,” said Dr. Sarfaty, an oncologist at the Sheba Medical Center, Ramat Gan, Israel. But it can cost upwards of $500,000 a year for an average-weight man.

Given the expense, Dr. Sarfaty wanted to understand how much of the drug gets thrown away. During a fellowship at Memorial Sloan Kettering (MSK) Cancer Center in New York, Dr. Sarfaty explored the amount of unused enfortumab vedotin among the 64 patients who received the drug in 2020. She, along with a team at MSK, calculated the price tag of that waste and extrapolated those estimates for patients across the country.

Although waste occurred in almost half of administered doses (367 of 793), only a small volume got discarded — 2.9% per dose, on average.

Multiplying unused milligrams by the cost per milligram, Dr. Sarfaty and colleagues estimated that, for each patient, $3,127 of the drug got discarded. When calculated over the year, the cost came to just over $200,000 at MSK, and nearly $15 million when projected across the approved patient population in the United States.

“Ultimately, we did not see a lot of waste with this specific drug,” Dr. Sarfaty said. “Under 2.9% is considered a reasonable amount, below the 3% threshold Peter Bach, MD, and colleagues recommend. But even with this small amount of waste, the cost per patient and to the system remains notable.”
 

The problem with recouping drug waste

Estimates from the Centers for Medicare & Medicaid Services (CMS), which tracks costs associated with discarded weight-based drugs covered under Medicare Part B, support the notion that small quantities of discarded drugs can still translate to big bucks.

Since 2017, CMS has required healthcare providers to report the volume of drugs discarded from a single-dose vial using a code, known as the JW modifier. The JW modifier means that providers can be reimbursed for the entire vial amount, not just the quantity the patient used.

In 2019, claims data from Medicare Part B showed that 1.85% of discarded rituximab came to $33.3 million. For infliximab, the 1.55% of discarded liquid translated to $15 million, and just 0.36% of discarded pembrolizumab reached $10 million.

However, experts question whether the JW modifier accurately reflects the quantity of drugs discarded.

According to the 2021 report from the National Academies of Sciences, Engineering, and Medicine (NASEM), most physicians don’t use the JW modifier. Among Medicare claims, 16.2% included the JW modifier in 2017 and 16.9% did in 2018.

The rate was significantly lower for private insurance. Of more than 4 million private insurance claims on 77 drugs made in 2017 and 2018, only 3.6% included the JW modifier; 15 of these drugs had no JW claims.

“Although we found that most physicians don’t use the JW modifier, even those who do, don’t use it consistently, even for the same patient,” said Dr. Yabroff, a co-author on the report.

Going a step further, Dr. Yabroff and colleagues argue that even if everyone used the JW modifier as intended, manufacturers would probably increase the price of drugs to compensate for any loss, potentially eliminating savings for payers.

That’s because, in the United States, manufacturers typically base drug prices on a patient and payers’ “willingness to pay for better health,” not on the volume of liquid used. Take a patient who pays $2,000 to receive the dose they need. If that dose is 600 mg but requires using two vials of 400 mg, then “to the patient, the 600-mg dose is worth $2,000, and the remainder has no value whatsoever,” the NASEM authors argue.

The authors parallel this scenario to purchasing a designer coat or dress. If that item requires alterations that remove a section of material, “the customer does not typically get a rebate because all the fabric was not needed,” the NASEM team writes.

But there’s a flaw in this rationale, argues Daniel Goldstein, MD, a medical oncologist at the Rabin Medical Center, Petah Tikva, Israel. A person’s willingness to pay for better health assumes that the price of a drug is based on proper market forces, where a drug’s cost and its effectiveness are in harmony.

“The problem is we’re operating in a broken market where the prices of oncology drugs have no real bearing on their efficacy,” said Dr. Goldstein.

And, as Dr. Bach noted in a 2021 Health Affairs piece, willingness to pay also requires that consumers know what they’re paying and allows them to walk away from an excessively high price.

But neither is a reality.

For one, Dr. Bach explains, companies may lowball the monthly price of a drug. In 2020, GlaxoSmithKline (GSK) announced that its new drug Blenrep would carry a list price of $8,277 per vial, or about $23,900 per month for an average 79 kg (175 lb) patient. That price accounts for two vials of the drug. But, according to Dr. Bach, “what GSK left out is that 44% of U.S. adults weigh more than 80 kg, and above that weight, three vials are needed per dose.” That would raise the average monthly cost to $30,479.

Perhaps more importantly, consumers can’t easily walk away.

“Medicare can’t negotiate prices and is forced to pay what a drug company says,” Dr. Goldstein said. “This is very different to when I buy a coat. If the price is too high, I can walk away.”
 

Fixed dosing: A solution or a new problem?

Efforts to reduce the financial impact of discarded cancer drugs can blow back on physicians, patients, and payers in other unanticipated ways. Take fixed dosing. Although chemotherapy dosing remains weight-based, many targeted therapies — such as nivolumab and pembrolizumab — recently transitioned to a fixed dosing regimen.

Administering a fixed, instead of weight-based, dose eliminates waste but can create new problems.

“Patients with cancer not only tend to get too high a dose of the drug, but costs go up significantly,” said Dr. Goldstein. In a 2017 analysis, Dr. Goldstein and colleagues compared dosing strategies in patients with metastatic non–small cell lung cancer who received pembrolizumab. The team found that the total annual cost of weight-based dosing was $2.6 billion, whereas the cost of the fixed dosing strategy was $3.44 billion — 24% more. In other words, personalized weight-based dosing would save more than $825 million dollars in the United States each year.

A 2020 analysis based in France found a similar cost increase of 26% for fixed dosing of pembrolizumab as well as nivolumab.

“I’ve argued we should go back to weight-based dosing,” Dr. Goldstein said. “Why should we give a higher dose with the same efficacy when that dose will cost significantly more and has the potential to increase adverse events?”
 

Does dose rounding work?

Rose DiMarco, PharmD, BCPS, BCOP, keeps a tight watch on patients being treated at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.

Dr. DiMarco educates patients about their treatment plan, reviews their lab results, and monitors them for side effects and drug interactions.

She also thinks a lot about costs.

“We spend about $100,000 a day on oncology drugs, and we want to make sure we’re not being wasteful,” Dr. DiMarco said in an interview.

One major initiative to curb waste and reduce costs at Jefferson has centered on dose rounding, which calculates whether a specific dose can be altered slightly to conserve vials and prevent waste. According to the Hematology/Oncology Pharmacy Association, a patient can receive up to 10% more or less of a weight-based dose without impacting treatment efficacy.

If, for instance, a patient requires 380 mg, but two vials come to 400 mg, rounding up that dose by approximately 5% means eliminating 20 mg that would go unused. But if that patient requires 420 mg, rounding down about 5% means substantial savings from not opening a new vial.

At Jefferson, Dr. DiMarco and her pharmacy colleagues map out dose ranges for all patients. Anyone who falls inside the 10% may be eligible for dose rounding. Anyone who doesn’t will receive the usual dose.

Although it is a challenge to implement, dose rounding has become standard of care at many cancer centers across the United States and is linked to substantial savings.

A 2018 analysis projected annual savings of $865,000 associated with rounding down eight monoclonal antibodies for patients with metastatic disease at a community cancer center. A more recent analysis from the Mayo Clinic found that dose rounding saved a total of 9,814 drug vials — 4485 of which were cancer drugs and 5329 of which were biologics — and resulted in $7.3 million in savings over 6 months in 2019 — $1.56 million from oncology agents and $5.7 from biologics.

And in a small 2019 analysis, researchers at Jefferson showed dose rounding of one monoclonal antibody saved approximately $30,000 in just 3 months, Dr. DiMarco noted.

“Not only does this process reduce costs and waste, but it also standardizes the preparation of hazardous medications, which can help prevent medication errors,” Dr. DiMarco said.
 

Nibbling around the edges

Despite estimates that scale into the billions of dollars, “drug wastage is just a small part of overall cancer costs,” Dr. Sarfaty said.

Fumiko Chino, MD, a radiation oncologist at MSK, agrees. “When we talk about affordability and cost, we can nibble around the edges of what’s really important,” Dr. Chino said. “Discarded drugs may cost a lot when you consider them in aggregate, but they are not as important as negotiated drug prices, which could substantially reduce overall costs.”

And until drug prices are addressed on a broader policy level, the cost of cancer care likely won’t improve in a meaningful way.

“But for the patient sitting in front of me, my focus will always be to provide the best care possible,” Dr. Binder said.

A version of this article first appeared on Medscape.com.

Three billion dollars: It’s enough to finance the annual out-of-pocket costs for 1 in 7 patients with cancer. It would cover almost half of the National Cancer Institute’s annual budget. And it could fund President Biden’s entire Cancer Moonshot program, with more than a billion to spare.

It’s also how much the United States spends on unused cancer drugs each year, some experts estimate.

Every year in the United States, hospitals and practices discard substantial quantities of expensive oncology drugs.

The reason boils down to inefficient drug packaging. Drug companies typically sell infused drugs in one or two single-dose vial sizes, but patients don’t come in such neat packages. A patient may need 300 mg of a drug that is only sold as 200 mg vials, which means half of a vial will go to waste.

Although most oncology drugs don’t incur substantial waste, even small volumes can translate to millions of dollars a year.

But can this money be saved or reallocated, if only we delivered drugs more efficiently?

Some experts don’t believe that’s possible.

“Attempts to recoup money for discarded drugs wouldn’t happen in a vacuum,” said Robin Yabroff, PhD, MBA, an epidemiologist and scientific vice president of Health Services Research at the American Cancer Society, who was part of a committee commissioned to evaluate the costs associated with discarded drugs.

The potential catch of any widespread effort to seek repayment or reduce the amount of discarded drugs, Dr. Yabroff and colleagues note, is that manufacturers would “simply increase the price of the vial.”

In other words, attempting to fix one problem may lead to another — essentially a whack-a-mole of cancer costs, which are projected to balloon to $246 billion by 2030.  

What this means is without sweeping policies to rein in cancer care costs, oncologists can only do so much. And every little bit counts.

“We are left chipping away at this monster of cancer care costs,” said Adam Binder, MD, a medical oncologist at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.
 

Millions spent on “reasonable amount” of waste

Michal Sarfaty, MD, was excited when enfortumab vedotin came on the market to treat advanced urothelial cancer in late 2019.

The cost of the drug, however, tempered her enthusiasm.

Enfortumab vedotin is a “great drug,” said Dr. Sarfaty, an oncologist at the Sheba Medical Center, Ramat Gan, Israel. But it can cost upwards of $500,000 a year for an average-weight man.

Given the expense, Dr. Sarfaty wanted to understand how much of the drug gets thrown away. During a fellowship at Memorial Sloan Kettering (MSK) Cancer Center in New York, Dr. Sarfaty explored the amount of unused enfortumab vedotin among the 64 patients who received the drug in 2020. She, along with a team at MSK, calculated the price tag of that waste and extrapolated those estimates for patients across the country.

Although waste occurred in almost half of administered doses (367 of 793), only a small volume got discarded — 2.9% per dose, on average.

Multiplying unused milligrams by the cost per milligram, Dr. Sarfaty and colleagues estimated that, for each patient, $3,127 of the drug got discarded. When calculated over the year, the cost came to just over $200,000 at MSK, and nearly $15 million when projected across the approved patient population in the United States.

“Ultimately, we did not see a lot of waste with this specific drug,” Dr. Sarfaty said. “Under 2.9% is considered a reasonable amount, below the 3% threshold Peter Bach, MD, and colleagues recommend. But even with this small amount of waste, the cost per patient and to the system remains notable.”
 

The problem with recouping drug waste

Estimates from the Centers for Medicare & Medicaid Services (CMS), which tracks costs associated with discarded weight-based drugs covered under Medicare Part B, support the notion that small quantities of discarded drugs can still translate to big bucks.

Since 2017, CMS has required healthcare providers to report the volume of drugs discarded from a single-dose vial using a code, known as the JW modifier. The JW modifier means that providers can be reimbursed for the entire vial amount, not just the quantity the patient used.

In 2019, claims data from Medicare Part B showed that 1.85% of discarded rituximab came to $33.3 million. For infliximab, the 1.55% of discarded liquid translated to $15 million, and just 0.36% of discarded pembrolizumab reached $10 million.

However, experts question whether the JW modifier accurately reflects the quantity of drugs discarded.

According to the 2021 report from the National Academies of Sciences, Engineering, and Medicine (NASEM), most physicians don’t use the JW modifier. Among Medicare claims, 16.2% included the JW modifier in 2017 and 16.9% did in 2018.

The rate was significantly lower for private insurance. Of more than 4 million private insurance claims on 77 drugs made in 2017 and 2018, only 3.6% included the JW modifier; 15 of these drugs had no JW claims.

“Although we found that most physicians don’t use the JW modifier, even those who do, don’t use it consistently, even for the same patient,” said Dr. Yabroff, a co-author on the report.

Going a step further, Dr. Yabroff and colleagues argue that even if everyone used the JW modifier as intended, manufacturers would probably increase the price of drugs to compensate for any loss, potentially eliminating savings for payers.

That’s because, in the United States, manufacturers typically base drug prices on a patient and payers’ “willingness to pay for better health,” not on the volume of liquid used. Take a patient who pays $2,000 to receive the dose they need. If that dose is 600 mg but requires using two vials of 400 mg, then “to the patient, the 600-mg dose is worth $2,000, and the remainder has no value whatsoever,” the NASEM authors argue.

The authors parallel this scenario to purchasing a designer coat or dress. If that item requires alterations that remove a section of material, “the customer does not typically get a rebate because all the fabric was not needed,” the NASEM team writes.

But there’s a flaw in this rationale, argues Daniel Goldstein, MD, a medical oncologist at the Rabin Medical Center, Petah Tikva, Israel. A person’s willingness to pay for better health assumes that the price of a drug is based on proper market forces, where a drug’s cost and its effectiveness are in harmony.

“The problem is we’re operating in a broken market where the prices of oncology drugs have no real bearing on their efficacy,” said Dr. Goldstein.

And, as Dr. Bach noted in a 2021 Health Affairs piece, willingness to pay also requires that consumers know what they’re paying and allows them to walk away from an excessively high price.

But neither is a reality.

For one, Dr. Bach explains, companies may lowball the monthly price of a drug. In 2020, GlaxoSmithKline (GSK) announced that its new drug Blenrep would carry a list price of $8,277 per vial, or about $23,900 per month for an average 79 kg (175 lb) patient. That price accounts for two vials of the drug. But, according to Dr. Bach, “what GSK left out is that 44% of U.S. adults weigh more than 80 kg, and above that weight, three vials are needed per dose.” That would raise the average monthly cost to $30,479.

Perhaps more importantly, consumers can’t easily walk away.

“Medicare can’t negotiate prices and is forced to pay what a drug company says,” Dr. Goldstein said. “This is very different to when I buy a coat. If the price is too high, I can walk away.”
 

Fixed dosing: A solution or a new problem?

Efforts to reduce the financial impact of discarded cancer drugs can blow back on physicians, patients, and payers in other unanticipated ways. Take fixed dosing. Although chemotherapy dosing remains weight-based, many targeted therapies — such as nivolumab and pembrolizumab — recently transitioned to a fixed dosing regimen.

Administering a fixed, instead of weight-based, dose eliminates waste but can create new problems.

“Patients with cancer not only tend to get too high a dose of the drug, but costs go up significantly,” said Dr. Goldstein. In a 2017 analysis, Dr. Goldstein and colleagues compared dosing strategies in patients with metastatic non–small cell lung cancer who received pembrolizumab. The team found that the total annual cost of weight-based dosing was $2.6 billion, whereas the cost of the fixed dosing strategy was $3.44 billion — 24% more. In other words, personalized weight-based dosing would save more than $825 million dollars in the United States each year.

A 2020 analysis based in France found a similar cost increase of 26% for fixed dosing of pembrolizumab as well as nivolumab.

“I’ve argued we should go back to weight-based dosing,” Dr. Goldstein said. “Why should we give a higher dose with the same efficacy when that dose will cost significantly more and has the potential to increase adverse events?”
 

Does dose rounding work?

Rose DiMarco, PharmD, BCPS, BCOP, keeps a tight watch on patients being treated at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.

Dr. DiMarco educates patients about their treatment plan, reviews their lab results, and monitors them for side effects and drug interactions.

She also thinks a lot about costs.

“We spend about $100,000 a day on oncology drugs, and we want to make sure we’re not being wasteful,” Dr. DiMarco said in an interview.

One major initiative to curb waste and reduce costs at Jefferson has centered on dose rounding, which calculates whether a specific dose can be altered slightly to conserve vials and prevent waste. According to the Hematology/Oncology Pharmacy Association, a patient can receive up to 10% more or less of a weight-based dose without impacting treatment efficacy.

If, for instance, a patient requires 380 mg, but two vials come to 400 mg, rounding up that dose by approximately 5% means eliminating 20 mg that would go unused. But if that patient requires 420 mg, rounding down about 5% means substantial savings from not opening a new vial.

At Jefferson, Dr. DiMarco and her pharmacy colleagues map out dose ranges for all patients. Anyone who falls inside the 10% may be eligible for dose rounding. Anyone who doesn’t will receive the usual dose.

Although it is a challenge to implement, dose rounding has become standard of care at many cancer centers across the United States and is linked to substantial savings.

A 2018 analysis projected annual savings of $865,000 associated with rounding down eight monoclonal antibodies for patients with metastatic disease at a community cancer center. A more recent analysis from the Mayo Clinic found that dose rounding saved a total of 9,814 drug vials — 4485 of which were cancer drugs and 5329 of which were biologics — and resulted in $7.3 million in savings over 6 months in 2019 — $1.56 million from oncology agents and $5.7 from biologics.

And in a small 2019 analysis, researchers at Jefferson showed dose rounding of one monoclonal antibody saved approximately $30,000 in just 3 months, Dr. DiMarco noted.

“Not only does this process reduce costs and waste, but it also standardizes the preparation of hazardous medications, which can help prevent medication errors,” Dr. DiMarco said.
 

Nibbling around the edges

Despite estimates that scale into the billions of dollars, “drug wastage is just a small part of overall cancer costs,” Dr. Sarfaty said.

Fumiko Chino, MD, a radiation oncologist at MSK, agrees. “When we talk about affordability and cost, we can nibble around the edges of what’s really important,” Dr. Chino said. “Discarded drugs may cost a lot when you consider them in aggregate, but they are not as important as negotiated drug prices, which could substantially reduce overall costs.”

And until drug prices are addressed on a broader policy level, the cost of cancer care likely won’t improve in a meaningful way.

“But for the patient sitting in front of me, my focus will always be to provide the best care possible,” Dr. Binder said.

A version of this article first appeared on Medscape.com.

Endometrial cancer (EC) is the most common gynecologic malignancy and is the fourth most common cancer seen in U.S. women. It is the only major cancer that has continued to see a rise in incidence and mortality for the past 2 decades, and it is anticipated that nearly 66,000 new cases of EC will be diagnosed this year with 12,550 deaths.¹ Given that the well-established risk factors for developing EC including obesity, diabetes, and insulin resistance, the obesity epidemic is indisputably playing a significant role in the increasing incidence.

Historically, White women were thought to have the highest incidence of EC; however, this incidence rate did not account for hysterectomy prevalence, which can vary widely by numerous factors including age, race, ethnicity, and geographic region. When correcting EC incidence rates for prevalence of hysterectomy, Black women have had the highest incidence of EC since 2007, and rates continue to climb.² In fact, the average annual percent change (APC) in EC incidence from 2000 to 2015 was stable for White women at 0.2% while Black women had a near order of magnitude greater APC at 2.1%.²

Differing incidence rates of EC can also be seen by histologic subtype. Endometrioid EC is the more common and less lethal histology of EC that often coincides with the type I classification of EC. These tumors are estrogen driven; therefore, they are associated with conditions resulting in excess estrogen (for example, anovulation, obesity, and hyperlipidemia). Nonendometrioid histologies, primarily composed of serous tumors, are more rare, are typically more aggressive, are not estrogen driven, and are commonly classified as type II tumors. Racial differences between type I and type II tumors are seen with White women more commonly being diagnosed with type I tumors while Black women more typically have type II tumors. White women have the greatest incidence rate of endometrioid EC with an APC that remained relatively unchanged from 2000 to 2015. Black women’s APC in incidence rate of endometrioid EC has increased during this same period at 1.3%. For nonendometrioid tumors, an increasing incidence is seen in all races and ethnicities; however, Black women have a much higher incidence of these tumors, with a rate that continues to increase at an APC of 3.2%.²

EC incidence is increasing with a particularly concerning rise in those who report Black race, but are these same disparities being seen in EC mortality? Unfortunately, drastic disparities are seen in survival data for Black women afflicted with EC. Black patients are more likely to be diagnosed with advanced or metastatic EC and less likely to be diagnosed with localized tumors. While being diagnosed with a more advanced stage of disease does affect survival in EC, Black patients have worse survival regardless of stage of disease at the time of diagnosis.¹ As discussed earlier, the more aggressive type II tumors are composed of nonendometrioid histologies and are more common in Black women. This could lead to the false assumption that these higher-risk tumors are why Black women are disproportionately dying from EC; however, when examining survival by histologic subtype, Black women are more frequently dying from the lower-risk endometrioid EC regardless of stage of disease. The same disparate survival outcomes are also seen in nonendometrioid histologies.² Thus, Black patients have the lowest survival rates irrespective of stage at diagnosis or histologic subtype.

The disparities seen in EC mortality are not new. They can be seen in data for over 30 years and are only widening. While there has been an increase in mortality rates from EC across all races and ethnicities from 2015 to 2019 compared with 1990 to 1994, the mortality rate ratio for Black women compared with White women has increased from 1.83 in 1990-1994 to 1.98 in 2015-2019.³ In the early 1990s, the risk of death from ovarian cancer was twice that of EC. The mortality of EC is now similar to that of ovarian cancer. This threshold in mortality ratio of EC to ovarian cancer has already been seen in Black women, who have experienced greater mortality in EC compared with ovarian cancer since 2005. In fact, the EC mortality of Black women in 2019 was similar to the mortality of White women with ovarian cancer nearly 30 years ago.³

Decades of data have demonstrated the glaring racial disparities seen in EC, and yet, no significant progress has been made in addressing this inequity. Oncology research is now beginning to move beyond describing these differences to a strategy of achieving equitable cancer care. While the study frameworks and novel investigations aimed at addressing the disparities in EC is outside the scope of this article, disparities in clinical trial enrollment continue to exist.

A recent example can be seen in the practice-changing KEYNOTE-775 trial, which led to the Food and Drug Administration approval of lenvatinib plus pembrolizumab in EC treatment.⁴ A total of 827 patients with EC that progressed or recurred following treatment with platinum-based chemotherapy were enrolled in this multinational, multicenter trial. Thirty-one (3.7%) of the patients enrolled were Black. Of those who were enrolled in the United States, 14% were Black. The authors report that this proportion of Black patients in the United States is consistent with 2020 census data, which reported 13.4% of people identified as Black. However, using census data as a benchmark for equitable enrollment is inappropriate. Certain demographic groups are historically more difficult to count, and the COVID-19 pandemic exacerbated the challenge in obtaining an accurate count through job loss, government distrust, and access restrictions resulting in an estimated net undercount of 2.45% in those who report Black race.⁵ Composition of trial enrollment should mirror the population that will be affected by the study results. As advanced EC disproportionately affects Black patients, their enrollment must be higher in these pivotal trials. How else are we to know if these novel therapeutics will work in the population that is most afflicted by EC?

Future studies must account for socioeconomic factors while acknowledging the role of social determinants of health. It is imperative that we use the knowledge that race is a social construct created to control access to power and that there are biologic responses to environmental stresses, including that of racism, affecting health and disease. Changes at every level, from individual practitioners up to federal policies, will need to be enacted or else the unacceptable status quo will continue.
 

Dr. Burkett is a clinical fellow in the division of gynecologic oncology, department of obstetrics and gynecology, at the University of North Carolina at Chapel Hill.

References

1. Siegel RL et al. CA Cancer J Clin. 2022;72:7-33.

2. Clarke MA et al. J Clin Oncol. 2019;37:1895-908.

3. Giaquinto AN et al. Obstet Gynecol. 2022;139:440-2.

4. Makker V et al. N Engl J Med. 2022;386:437-48.

5. Elliott D et al. Simulating the 2020 Census: Miscounts and the fairness of outcomes. Urban Institute; 2021.

Endometrial cancer (EC) is the most common gynecologic malignancy and is the fourth most common cancer seen in U.S. women. It is the only major cancer that has continued to see a rise in incidence and mortality for the past 2 decades, and it is anticipated that nearly 66,000 new cases of EC will be diagnosed this year with 12,550 deaths.¹ Given that the well-established risk factors for developing EC including obesity, diabetes, and insulin resistance, the obesity epidemic is indisputably playing a significant role in the increasing incidence.

Historically, White women were thought to have the highest incidence of EC; however, this incidence rate did not account for hysterectomy prevalence, which can vary widely by numerous factors including age, race, ethnicity, and geographic region. When correcting EC incidence rates for prevalence of hysterectomy, Black women have had the highest incidence of EC since 2007, and rates continue to climb.² In fact, the average annual percent change (APC) in EC incidence from 2000 to 2015 was stable for White women at 0.2% while Black women had a near order of magnitude greater APC at 2.1%.²

Differing incidence rates of EC can also be seen by histologic subtype. Endometrioid EC is the more common and less lethal histology of EC that often coincides with the type I classification of EC. These tumors are estrogen driven; therefore, they are associated with conditions resulting in excess estrogen (for example, anovulation, obesity, and hyperlipidemia). Nonendometrioid histologies, primarily composed of serous tumors, are more rare, are typically more aggressive, are not estrogen driven, and are commonly classified as type II tumors. Racial differences between type I and type II tumors are seen with White women more commonly being diagnosed with type I tumors while Black women more typically have type II tumors. White women have the greatest incidence rate of endometrioid EC with an APC that remained relatively unchanged from 2000 to 2015. Black women’s APC in incidence rate of endometrioid EC has increased during this same period at 1.3%. For nonendometrioid tumors, an increasing incidence is seen in all races and ethnicities; however, Black women have a much higher incidence of these tumors, with a rate that continues to increase at an APC of 3.2%.²

EC incidence is increasing with a particularly concerning rise in those who report Black race, but are these same disparities being seen in EC mortality? Unfortunately, drastic disparities are seen in survival data for Black women afflicted with EC. Black patients are more likely to be diagnosed with advanced or metastatic EC and less likely to be diagnosed with localized tumors. While being diagnosed with a more advanced stage of disease does affect survival in EC, Black patients have worse survival regardless of stage of disease at the time of diagnosis.¹ As discussed earlier, the more aggressive type II tumors are composed of nonendometrioid histologies and are more common in Black women. This could lead to the false assumption that these higher-risk tumors are why Black women are disproportionately dying from EC; however, when examining survival by histologic subtype, Black women are more frequently dying from the lower-risk endometrioid EC regardless of stage of disease. The same disparate survival outcomes are also seen in nonendometrioid histologies.² Thus, Black patients have the lowest survival rates irrespective of stage at diagnosis or histologic subtype.

The disparities seen in EC mortality are not new. They can be seen in data for over 30 years and are only widening. While there has been an increase in mortality rates from EC across all races and ethnicities from 2015 to 2019 compared with 1990 to 1994, the mortality rate ratio for Black women compared with White women has increased from 1.83 in 1990-1994 to 1.98 in 2015-2019.³ In the early 1990s, the risk of death from ovarian cancer was twice that of EC. The mortality of EC is now similar to that of ovarian cancer. This threshold in mortality ratio of EC to ovarian cancer has already been seen in Black women, who have experienced greater mortality in EC compared with ovarian cancer since 2005. In fact, the EC mortality of Black women in 2019 was similar to the mortality of White women with ovarian cancer nearly 30 years ago.³

Decades of data have demonstrated the glaring racial disparities seen in EC, and yet, no significant progress has been made in addressing this inequity. Oncology research is now beginning to move beyond describing these differences to a strategy of achieving equitable cancer care. While the study frameworks and novel investigations aimed at addressing the disparities in EC is outside the scope of this article, disparities in clinical trial enrollment continue to exist.

A recent example can be seen in the practice-changing KEYNOTE-775 trial, which led to the Food and Drug Administration approval of lenvatinib plus pembrolizumab in EC treatment.⁴ A total of 827 patients with EC that progressed or recurred following treatment with platinum-based chemotherapy were enrolled in this multinational, multicenter trial. Thirty-one (3.7%) of the patients enrolled were Black. Of those who were enrolled in the United States, 14% were Black. The authors report that this proportion of Black patients in the United States is consistent with 2020 census data, which reported 13.4% of people identified as Black. However, using census data as a benchmark for equitable enrollment is inappropriate. Certain demographic groups are historically more difficult to count, and the COVID-19 pandemic exacerbated the challenge in obtaining an accurate count through job loss, government distrust, and access restrictions resulting in an estimated net undercount of 2.45% in those who report Black race.⁵ Composition of trial enrollment should mirror the population that will be affected by the study results. As advanced EC disproportionately affects Black patients, their enrollment must be higher in these pivotal trials. How else are we to know if these novel therapeutics will work in the population that is most afflicted by EC?

Future studies must account for socioeconomic factors while acknowledging the role of social determinants of health. It is imperative that we use the knowledge that race is a social construct created to control access to power and that there are biologic responses to environmental stresses, including that of racism, affecting health and disease. Changes at every level, from individual practitioners up to federal policies, will need to be enacted or else the unacceptable status quo will continue.
 

Dr. Burkett is a clinical fellow in the division of gynecologic oncology, department of obstetrics and gynecology, at the University of North Carolina at Chapel Hill.

References

1. Siegel RL et al. CA Cancer J Clin. 2022;72:7-33.

2. Clarke MA et al. J Clin Oncol. 2019;37:1895-908.

3. Giaquinto AN et al. Obstet Gynecol. 2022;139:440-2.

4. Makker V et al. N Engl J Med. 2022;386:437-48.

5. Elliott D et al. Simulating the 2020 Census: Miscounts and the fairness of outcomes. Urban Institute; 2021.

Endometrial cancer (EC) is the most common gynecologic malignancy and is the fourth most common cancer seen in U.S. women. It is the only major cancer that has continued to see a rise in incidence and mortality for the past 2 decades, and it is anticipated that nearly 66,000 new cases of EC will be diagnosed this year with 12,550 deaths.¹ Given that the well-established risk factors for developing EC including obesity, diabetes, and insulin resistance, the obesity epidemic is indisputably playing a significant role in the increasing incidence.

Historically, White women were thought to have the highest incidence of EC; however, this incidence rate did not account for hysterectomy prevalence, which can vary widely by numerous factors including age, race, ethnicity, and geographic region. When correcting EC incidence rates for prevalence of hysterectomy, Black women have had the highest incidence of EC since 2007, and rates continue to climb.² In fact, the average annual percent change (APC) in EC incidence from 2000 to 2015 was stable for White women at 0.2% while Black women had a near order of magnitude greater APC at 2.1%.²

Differing incidence rates of EC can also be seen by histologic subtype. Endometrioid EC is the more common and less lethal histology of EC that often coincides with the type I classification of EC. These tumors are estrogen driven; therefore, they are associated with conditions resulting in excess estrogen (for example, anovulation, obesity, and hyperlipidemia). Nonendometrioid histologies, primarily composed of serous tumors, are more rare, are typically more aggressive, are not estrogen driven, and are commonly classified as type II tumors. Racial differences between type I and type II tumors are seen with White women more commonly being diagnosed with type I tumors while Black women more typically have type II tumors. White women have the greatest incidence rate of endometrioid EC with an APC that remained relatively unchanged from 2000 to 2015. Black women’s APC in incidence rate of endometrioid EC has increased during this same period at 1.3%. For nonendometrioid tumors, an increasing incidence is seen in all races and ethnicities; however, Black women have a much higher incidence of these tumors, with a rate that continues to increase at an APC of 3.2%.²

EC incidence is increasing with a particularly concerning rise in those who report Black race, but are these same disparities being seen in EC mortality? Unfortunately, drastic disparities are seen in survival data for Black women afflicted with EC. Black patients are more likely to be diagnosed with advanced or metastatic EC and less likely to be diagnosed with localized tumors. While being diagnosed with a more advanced stage of disease does affect survival in EC, Black patients have worse survival regardless of stage of disease at the time of diagnosis.¹ As discussed earlier, the more aggressive type II tumors are composed of nonendometrioid histologies and are more common in Black women. This could lead to the false assumption that these higher-risk tumors are why Black women are disproportionately dying from EC; however, when examining survival by histologic subtype, Black women are more frequently dying from the lower-risk endometrioid EC regardless of stage of disease. The same disparate survival outcomes are also seen in nonendometrioid histologies.² Thus, Black patients have the lowest survival rates irrespective of stage at diagnosis or histologic subtype.

The disparities seen in EC mortality are not new. They can be seen in data for over 30 years and are only widening. While there has been an increase in mortality rates from EC across all races and ethnicities from 2015 to 2019 compared with 1990 to 1994, the mortality rate ratio for Black women compared with White women has increased from 1.83 in 1990-1994 to 1.98 in 2015-2019.³ In the early 1990s, the risk of death from ovarian cancer was twice that of EC. The mortality of EC is now similar to that of ovarian cancer. This threshold in mortality ratio of EC to ovarian cancer has already been seen in Black women, who have experienced greater mortality in EC compared with ovarian cancer since 2005. In fact, the EC mortality of Black women in 2019 was similar to the mortality of White women with ovarian cancer nearly 30 years ago.³

Decades of data have demonstrated the glaring racial disparities seen in EC, and yet, no significant progress has been made in addressing this inequity. Oncology research is now beginning to move beyond describing these differences to a strategy of achieving equitable cancer care. While the study frameworks and novel investigations aimed at addressing the disparities in EC is outside the scope of this article, disparities in clinical trial enrollment continue to exist.

A recent example can be seen in the practice-changing KEYNOTE-775 trial, which led to the Food and Drug Administration approval of lenvatinib plus pembrolizumab in EC treatment.⁴ A total of 827 patients with EC that progressed or recurred following treatment with platinum-based chemotherapy were enrolled in this multinational, multicenter trial. Thirty-one (3.7%) of the patients enrolled were Black. Of those who were enrolled in the United States, 14% were Black. The authors report that this proportion of Black patients in the United States is consistent with 2020 census data, which reported 13.4% of people identified as Black. However, using census data as a benchmark for equitable enrollment is inappropriate. Certain demographic groups are historically more difficult to count, and the COVID-19 pandemic exacerbated the challenge in obtaining an accurate count through job loss, government distrust, and access restrictions resulting in an estimated net undercount of 2.45% in those who report Black race.⁵ Composition of trial enrollment should mirror the population that will be affected by the study results. As advanced EC disproportionately affects Black patients, their enrollment must be higher in these pivotal trials. How else are we to know if these novel therapeutics will work in the population that is most afflicted by EC?

Future studies must account for socioeconomic factors while acknowledging the role of social determinants of health. It is imperative that we use the knowledge that race is a social construct created to control access to power and that there are biologic responses to environmental stresses, including that of racism, affecting health and disease. Changes at every level, from individual practitioners up to federal policies, will need to be enacted or else the unacceptable status quo will continue.
 

Dr. Burkett is a clinical fellow in the division of gynecologic oncology, department of obstetrics and gynecology, at the University of North Carolina at Chapel Hill.

References

1. Siegel RL et al. CA Cancer J Clin. 2022;72:7-33.

2. Clarke MA et al. J Clin Oncol. 2019;37:1895-908.

3. Giaquinto AN et al. Obstet Gynecol. 2022;139:440-2.

4. Makker V et al. N Engl J Med. 2022;386:437-48.

5. Elliott D et al. Simulating the 2020 Census: Miscounts and the fairness of outcomes. Urban Institute; 2021.

Almost a third of patients with migraine have experienced some form of stigma, new research shows. Results from the OVERCOME population-based survey study, which included more than 59,000 respondents, showed about 32% reported experiencing migraine-related stigma “often” or “very often.”

Even those experiencing only a few headaches per month said they experienced negative attitudes from others about migraine.

“We have been utterly blind to the burden people with migraine experience in terms of how their disease is appreciated by others. It’s time to get busy and address this very stubborn social phenomenon,” said the study’s coinvestigator, Robert E. Shapiro, MD, PhD, professor emeritus, department of neurological sciences, Larner College of Medicine, University of Vermont, Burlington.

Population-based research

Stigma is defined as the discounting or discrediting of an individual with a trait that deviates from social norms. To date, there have been no significant population-based studies of how these attitudes affect individuals with migraine.

OVERCOME is a cross-sectional, longitudinal, prospective, web-based survey conducted in a representative sample of the United States population. For this new analysis, researchers pooled data from surveys conducted in 2018, 2019, and 2020.

The analysis included 59,004 respondents (mean age, 41.3 years; 75% women; 70% White) who reported one or more headache or migraine attacks during the previous 12 months and who met criteria for migraine from the International Classification of Headache Disorders. Among the patients, 35% had a college degree, and 89% suffered episodic-type headaches.

Researchers used the following four patient-reported outcome measures:

• Migraine Disability Assessment, which quantifies number of days missed at work, home, or social events over the previous 3 months
• Migraine Interictal Burden Scale–4, which measures burden of migraine between attacks over the previous 4 weeks
• Migraine-Specific Quality of Life Role-Function Restrictive, which assesses the functional effect of migraine on social and work-related activities over the previous 4 weeks
• Migraine-Related Stigma

For the latter, the investigators used two measures – the degree to which others think migraine is used to acquire secondary gain, such as avoiding commitments, and the degree to which others minimize the burden of migraine.
 

One of the most stigmatizing disorders

Results showed that 31.7% of participants reported experiencing stigmatization from one or both migraine-related stigma categories often or very often – a result Dr. Shapiro characterized as “pretty shocking.”

Participants with chronic headaches, defined as having 15 or more headache days per month, made up 11% of the sample. About 47% of these respondents felt stigma often or very often.

However, even 25% of participants with three or fewer headache days per month reported stigma.

“This is a fundamental tip that we are not really understanding the concerns that drive burden for people living with this disabling disease,” Dr. Shapiro said.

Some previous studies that compared levels of stigmatizing attitudes regarding various diseases showed that migraine is more stigmatized than even epilepsy, a condition “equated with demonic possession in biblical times,” he noted.

One study used machine learning to measure the number of pejorative or negative terms associated with various diseases. “Shockingly, migraine was one of the most stigmatized diseases,” said Dr. Shapiro. “It was as stigmatized as gonorrhea by certain measures.”

Results from the new study showed that, irrespective of the number of headache days experienced per month, there was a threefold increase in interictal burden among those reporting stigma often or very often, compared with those who didn’t report stigma.
 

Large impact on QoL

“Stigma is a social concept, so maybe it’s not surprising that it would be present whether or not someone is experiencing other symptoms of migraine,” said Dr. Shapiro.

Across all monthly headache days, experiencing more migraine-related stigma was associated with increased disability and decreased quality of life.

Dr. Shapiro noted that when it comes to migraine-specific quality of life, stigma appears to have more of an effect than number of headache days. “That means there are big gaps in our appreciation for what drives the burdens in the patient experience of living with this disabling disease,” he said.

He added that headache’s place within the migraine sphere needs to be reconsidered. “Its singular emphasis has limited our full appreciation of this disease and how we should be paying attention to the things that are important to patients,” he said.

Dr. Shapiro predicts that future clinical trials will include migraine-related stigma as a measure to guide trial enrollment.

In addition, researchers are now digging deeper to try to understand what factors are most likely to drive stigma. “We need to understand why those attitudes are held and who is more likely to hold those attitudes, and that may allow us to develop mitigating strategies to reduce those attitudes,” said Dr. Shapiro.
 

‘Worrisome’ findings

Commenting on the findings, Deborah Friedman, MD, professor, departments of neurology and of ophthalmology, UT Southwestern Medical Center, Dallas, said the data on stigma were “worrisome.”

Missing social occasions and lost productivity may make migraine more visible to others so perhaps may “provoke stigma or stigmatizing comments or stigmatizing attitudes,” said Dr. Friedman, who was not involved with the research.

She noted that patients with migraine might also have trouble functioning in the workplace. “They may not be able to tolerate the computer screen or smells of perfume at the office and not get accommodation for that,” she said.

In addition to external stigma, which was investigated in the study, individuals with migraine may also experience internal stigma – blaming themselves for their disease, which may make it less likely they will seek care, said Dr. Friedman.

“That’s a huge problem,” she added.

The OVERCOME study is funded by Lilly. Dr. Shapiro has been compensated by Lilly as a research consultant and as a member of the data monitoring committee for clinical trials for galcanezumab, a Lilly pharmaceutical. Dr. Friedman has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Almost a third of patients with migraine have experienced some form of stigma, new research shows. Results from the OVERCOME population-based survey study, which included more than 59,000 respondents, showed about 32% reported experiencing migraine-related stigma “often” or “very often.”

Even those experiencing only a few headaches per month said they experienced negative attitudes from others about migraine.

“We have been utterly blind to the burden people with migraine experience in terms of how their disease is appreciated by others. It’s time to get busy and address this very stubborn social phenomenon,” said the study’s coinvestigator, Robert E. Shapiro, MD, PhD, professor emeritus, department of neurological sciences, Larner College of Medicine, University of Vermont, Burlington.

Population-based research

Stigma is defined as the discounting or discrediting of an individual with a trait that deviates from social norms. To date, there have been no significant population-based studies of how these attitudes affect individuals with migraine.

OVERCOME is a cross-sectional, longitudinal, prospective, web-based survey conducted in a representative sample of the United States population. For this new analysis, researchers pooled data from surveys conducted in 2018, 2019, and 2020.

The analysis included 59,004 respondents (mean age, 41.3 years; 75% women; 70% White) who reported one or more headache or migraine attacks during the previous 12 months and who met criteria for migraine from the International Classification of Headache Disorders. Among the patients, 35% had a college degree, and 89% suffered episodic-type headaches.

Researchers used the following four patient-reported outcome measures:

• Migraine Disability Assessment, which quantifies number of days missed at work, home, or social events over the previous 3 months
• Migraine Interictal Burden Scale–4, which measures burden of migraine between attacks over the previous 4 weeks
• Migraine-Specific Quality of Life Role-Function Restrictive, which assesses the functional effect of migraine on social and work-related activities over the previous 4 weeks
• Migraine-Related Stigma

For the latter, the investigators used two measures – the degree to which others think migraine is used to acquire secondary gain, such as avoiding commitments, and the degree to which others minimize the burden of migraine.
 

One of the most stigmatizing disorders

Results showed that 31.7% of participants reported experiencing stigmatization from one or both migraine-related stigma categories often or very often – a result Dr. Shapiro characterized as “pretty shocking.”

Participants with chronic headaches, defined as having 15 or more headache days per month, made up 11% of the sample. About 47% of these respondents felt stigma often or very often.

However, even 25% of participants with three or fewer headache days per month reported stigma.

“This is a fundamental tip that we are not really understanding the concerns that drive burden for people living with this disabling disease,” Dr. Shapiro said.

Some previous studies that compared levels of stigmatizing attitudes regarding various diseases showed that migraine is more stigmatized than even epilepsy, a condition “equated with demonic possession in biblical times,” he noted.

One study used machine learning to measure the number of pejorative or negative terms associated with various diseases. “Shockingly, migraine was one of the most stigmatized diseases,” said Dr. Shapiro. “It was as stigmatized as gonorrhea by certain measures.”

Results from the new study showed that, irrespective of the number of headache days experienced per month, there was a threefold increase in interictal burden among those reporting stigma often or very often, compared with those who didn’t report stigma.
 

Large impact on QoL

“Stigma is a social concept, so maybe it’s not surprising that it would be present whether or not someone is experiencing other symptoms of migraine,” said Dr. Shapiro.

Across all monthly headache days, experiencing more migraine-related stigma was associated with increased disability and decreased quality of life.

Dr. Shapiro noted that when it comes to migraine-specific quality of life, stigma appears to have more of an effect than number of headache days. “That means there are big gaps in our appreciation for what drives the burdens in the patient experience of living with this disabling disease,” he said.

He added that headache’s place within the migraine sphere needs to be reconsidered. “Its singular emphasis has limited our full appreciation of this disease and how we should be paying attention to the things that are important to patients,” he said.

Dr. Shapiro predicts that future clinical trials will include migraine-related stigma as a measure to guide trial enrollment.

In addition, researchers are now digging deeper to try to understand what factors are most likely to drive stigma. “We need to understand why those attitudes are held and who is more likely to hold those attitudes, and that may allow us to develop mitigating strategies to reduce those attitudes,” said Dr. Shapiro.
 

‘Worrisome’ findings

Commenting on the findings, Deborah Friedman, MD, professor, departments of neurology and of ophthalmology, UT Southwestern Medical Center, Dallas, said the data on stigma were “worrisome.”

Missing social occasions and lost productivity may make migraine more visible to others so perhaps may “provoke stigma or stigmatizing comments or stigmatizing attitudes,” said Dr. Friedman, who was not involved with the research.

She noted that patients with migraine might also have trouble functioning in the workplace. “They may not be able to tolerate the computer screen or smells of perfume at the office and not get accommodation for that,” she said.

In addition to external stigma, which was investigated in the study, individuals with migraine may also experience internal stigma – blaming themselves for their disease, which may make it less likely they will seek care, said Dr. Friedman.

“That’s a huge problem,” she added.

The OVERCOME study is funded by Lilly. Dr. Shapiro has been compensated by Lilly as a research consultant and as a member of the data monitoring committee for clinical trials for galcanezumab, a Lilly pharmaceutical. Dr. Friedman has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Almost a third of patients with migraine have experienced some form of stigma, new research shows. Results from the OVERCOME population-based survey study, which included more than 59,000 respondents, showed about 32% reported experiencing migraine-related stigma “often” or “very often.”

Even those experiencing only a few headaches per month said they experienced negative attitudes from others about migraine.

“We have been utterly blind to the burden people with migraine experience in terms of how their disease is appreciated by others. It’s time to get busy and address this very stubborn social phenomenon,” said the study’s coinvestigator, Robert E. Shapiro, MD, PhD, professor emeritus, department of neurological sciences, Larner College of Medicine, University of Vermont, Burlington.

Population-based research

Stigma is defined as the discounting or discrediting of an individual with a trait that deviates from social norms. To date, there have been no significant population-based studies of how these attitudes affect individuals with migraine.

OVERCOME is a cross-sectional, longitudinal, prospective, web-based survey conducted in a representative sample of the United States population. For this new analysis, researchers pooled data from surveys conducted in 2018, 2019, and 2020.

The analysis included 59,004 respondents (mean age, 41.3 years; 75% women; 70% White) who reported one or more headache or migraine attacks during the previous 12 months and who met criteria for migraine from the International Classification of Headache Disorders. Among the patients, 35% had a college degree, and 89% suffered episodic-type headaches.

Researchers used the following four patient-reported outcome measures:

• Migraine Disability Assessment, which quantifies number of days missed at work, home, or social events over the previous 3 months
• Migraine Interictal Burden Scale–4, which measures burden of migraine between attacks over the previous 4 weeks
• Migraine-Specific Quality of Life Role-Function Restrictive, which assesses the functional effect of migraine on social and work-related activities over the previous 4 weeks
• Migraine-Related Stigma

For the latter, the investigators used two measures – the degree to which others think migraine is used to acquire secondary gain, such as avoiding commitments, and the degree to which others minimize the burden of migraine.
 

One of the most stigmatizing disorders

Results showed that 31.7% of participants reported experiencing stigmatization from one or both migraine-related stigma categories often or very often – a result Dr. Shapiro characterized as “pretty shocking.”

Participants with chronic headaches, defined as having 15 or more headache days per month, made up 11% of the sample. About 47% of these respondents felt stigma often or very often.

However, even 25% of participants with three or fewer headache days per month reported stigma.

“This is a fundamental tip that we are not really understanding the concerns that drive burden for people living with this disabling disease,” Dr. Shapiro said.

Some previous studies that compared levels of stigmatizing attitudes regarding various diseases showed that migraine is more stigmatized than even epilepsy, a condition “equated with demonic possession in biblical times,” he noted.

One study used machine learning to measure the number of pejorative or negative terms associated with various diseases. “Shockingly, migraine was one of the most stigmatized diseases,” said Dr. Shapiro. “It was as stigmatized as gonorrhea by certain measures.”

Results from the new study showed that, irrespective of the number of headache days experienced per month, there was a threefold increase in interictal burden among those reporting stigma often or very often, compared with those who didn’t report stigma.
 

Large impact on QoL

“Stigma is a social concept, so maybe it’s not surprising that it would be present whether or not someone is experiencing other symptoms of migraine,” said Dr. Shapiro.

Across all monthly headache days, experiencing more migraine-related stigma was associated with increased disability and decreased quality of life.

Dr. Shapiro noted that when it comes to migraine-specific quality of life, stigma appears to have more of an effect than number of headache days. “That means there are big gaps in our appreciation for what drives the burdens in the patient experience of living with this disabling disease,” he said.

He added that headache’s place within the migraine sphere needs to be reconsidered. “Its singular emphasis has limited our full appreciation of this disease and how we should be paying attention to the things that are important to patients,” he said.

Dr. Shapiro predicts that future clinical trials will include migraine-related stigma as a measure to guide trial enrollment.

In addition, researchers are now digging deeper to try to understand what factors are most likely to drive stigma. “We need to understand why those attitudes are held and who is more likely to hold those attitudes, and that may allow us to develop mitigating strategies to reduce those attitudes,” said Dr. Shapiro.
 

‘Worrisome’ findings

Commenting on the findings, Deborah Friedman, MD, professor, departments of neurology and of ophthalmology, UT Southwestern Medical Center, Dallas, said the data on stigma were “worrisome.”

Missing social occasions and lost productivity may make migraine more visible to others so perhaps may “provoke stigma or stigmatizing comments or stigmatizing attitudes,” said Dr. Friedman, who was not involved with the research.

She noted that patients with migraine might also have trouble functioning in the workplace. “They may not be able to tolerate the computer screen or smells of perfume at the office and not get accommodation for that,” she said.

In addition to external stigma, which was investigated in the study, individuals with migraine may also experience internal stigma – blaming themselves for their disease, which may make it less likely they will seek care, said Dr. Friedman.

“That’s a huge problem,” she added.

The OVERCOME study is funded by Lilly. Dr. Shapiro has been compensated by Lilly as a research consultant and as a member of the data monitoring committee for clinical trials for galcanezumab, a Lilly pharmaceutical. Dr. Friedman has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.

“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”

The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.

To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.

Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.

In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.

The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.

The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.

The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.

But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).

Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
 

Findings can help providers advise patients and their families about tonsillectomy risks

Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.

“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.

“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.

Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.

She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.

“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”

The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.

A version of this article first appeared on Medscape.com.

It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.

“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”

The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.

To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.

Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.

In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.

The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.

The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.

The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.

But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).

Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
 

Findings can help providers advise patients and their families about tonsillectomy risks

Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.

“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.

“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.

Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.

She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.

“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”

The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.

A version of this article first appeared on Medscape.com.

It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.

“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”

The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.

To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.

Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.

In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.

The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.

The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.

The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.

But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).

Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
 

Findings can help providers advise patients and their families about tonsillectomy risks

Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.

“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.

“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.

Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.

She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.

“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”

The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.

A version of this article first appeared on Medscape.com.