Roe v. Wade: Medical groups react to Supreme Court decision

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Roe v. Wade: Medical groups react to Supreme Court decision

The country’s top medical organizations condemned the overturning of Roe v. Wade, saying the removal of federal protections for women to access abortion services marks a “dark day.”

“It is unfathomable. It is unfair. It is wrong,” said the President of the American College of Obstetricians and Gynecologists (ACOG) Iffath Abbasi Hoskins, MD.

“Today is a very dark day in health care. It is a dark day, indeed, for the tens of millions of patients who have suddenly and unfairly lost access to safe legal and evidence-based abortion care,” Dr. Hoskins said at a press conference June 24 sponsored by ACOG. 

“It is dark for the thousands of clinicians who now, instead of focusing on providing health care to their patients, have to live with the threats of legal, civil, and even professional penalties,” Dr. Hoskins added.

ACOG has 62,000 members and is the leading group of doctors that provides obstetric and gynecologic care.
 

Dilemma for some doctors?

“I’d like to take a moment to talk about the future of the medical profession,” said ACOG Chief Executive Officer Maureen G. Phipps, MD, MPH. “[The] decision is, as Dr. Hoskins clearly said, a tragic one for our patients in states across the country, but the harm does not end there.”

Dr. Phipps described overturning Roe v. Wade as “the boldest act of legislative interference that we have seen in this country. It will allow state legislators to tell physicians what care they can and cannot provide to their patients.”

“It will leave physicians looking over our shoulders, wondering if a patient is in enough of a crisis to permit an exception to a law,” Dr. Phipps added. “This is an affront to all that drew my colleagues and me into medicine.”

Although the impact on doctor training remains to be seen, she said 44% of ob.gyn. residents are trained in states now empowered to ban abortions.

The effect of the Supreme Court decision on miscarriage management is another unknown.

“It’s going to be very difficult for us, the clinicians, to manage miscarriage,” Dr. Hoskins said. “Many miscarriages could be what we call ‘incomplete’ in the beginning,” where there is still a heartbeat and the patient is cramping and/or bleeding.

In that instance, Dr. Hoskins said, clinicians may be thinking that they have to wait.

“They may be needing to get additional opinions, whether it’s a legal opinion ... or another medical opinion.”

“It’s going to have a devastating effect on every aspect of a woman’s health care, including if she is spontaneously miscarrying,” Dr. Hoskins predicted.

 

 

Physician protect thyself?

To what extent doctors can shield themselves from potential prosecution “is a hard question to answer,” Molly Meegan, JD, ACOG’s chief legal officer and general counsel, said.

Ms. Meegan recommended members speak to the risk managers at their individual institutions for guidance.

“It is a real patchwork [of laws] out there, she said. “And that patchwork itself is a danger to people as they seek essential reproductive health care.”

Also, she added, “If a doctor can’t tell what the law is at the time they’re trying to provide the care, it has a terribly chilling effect on medical care.”

Another potential threat to doctors in states that still allow abortion services is action from a neighboring state.

“We are going to be advocating very strongly that states do not have extra-territorial jurisdiction to reach beyond the edges of their state.”

The worry is if a doctor in New Mexico, where abortion is legal, performs an abortion for a person from Texas, where it will soon be illegal, is then prosecuted by Texas, for example.
 

Medication abortion

Asked about any potential effects on medication abortions, ACOG’s Jen Villavicencio, MD, said it remains to be seen.

“Certainly many of the laws that we have seen, including trigger ban laws, encompass medication abortion,” she said. Several states have these so-called trigger laws, which put into effect laws passed to ban abortion in case Roe was overturned.

This means, she said, that any abortion option, whether it’s procedural or medication, could be and will be banned in some of these states.

Ms. Meegan added that ACOG will continue to support access to medication abortion and that it should be decided by the U.S. Food and Drug Administration and not individual states.
 

Maternal mortality may rise

“Maternal mortality in and of itself is a very difficult topic,” Dr. Hoskins said, but [the] decision amplifies the implications. “I think of the patients who will have to manage severe complications and mental health challenges while they are carrying a pregnancy that they are forced to carry.”

“I also think of the patients who need to end their pregnancies in order to save their own lives,” Dr. Hoskins added.

Dr. Hoskins said the United States already has a high maternal mortality rate. This new law, she added, could force women into higher-risk situations if they experience high blood pressure, preeclampsia, or bleeding after the birth of the baby.
 

Growing inequality possible?

“The grievous inequities that exist in this country will grow and expand unchecked without safe access to legal abortion,” Dr. Phipps said.

She noted that women, based on location, will continue “to have protected access to safe evidence-based abortion. Others will have the means and resources and opportunities to secure the care.”

But the same may not be true for women in underserved or disadvantaged communities, Dr. Phipps added.
 

American Medical Association

ACOG was not the only group to react. “The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half century of precedent protecting patients’ right to critical reproductive health care,” President Jack Resneck Jr., MD, said in a statement.

The decision represents “an egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services.”

 

 

American Academy of Family Physicians

“The American Academy of Family Physicians is disappointed and disheartened by the Supreme Court’s decision to strike down longstanding protections afforded by Roe v. Wade and Planned Parenthood v. Casey,” President Sterling N. Ransone Jr., MD, said in a statement.

The organization has 127,600 physician and medical student members.

“This decision negatively impacts our practices and our patients by undermining the patient-physician relationship and potentially criminalizing evidence-based medical care,” added Dr. Ransone.
 

American College of Physicians

“A patient’s decision about whether to continue a pregnancy should be a private decision made in consultation with a physician or other health care professional, without interference from the government,” President Ryan D. Mire, MD, said in a statement. “We strongly oppose medically unnecessary government restrictions on any health care services,” added Dr. Mire on behalf of the group’s 161,000 members.

 

American Academy of Pediatrics

“This decision carries grave consequences for our adolescent patients, who already face many more barriers than adults in accessing comprehensive reproductive health care services and abortion care,” President Moira Szilagyi, MD, PhD, said in a statement. 

“In the wake of this ruling, the American Academy of Pediatrics will continue to support our chapters as states consider policies affecting access to abortion care, and pediatricians will continue to support our patients,” Dr. Szilagyi added.
 

American Public Health Association

The court’s decision “is a catastrophic judicial failure that will reverberate differently in each state and portends to jeopardize the health and lives of all Americans,” Executive Director Georges C. Benjamin, MD, said in a statement.

American Urogynecologic Society

“The American Urogynecologic Society opposes any ruling that restricts a person’s access to health care and criminalizes the practice of medicine,” the group said in a statement. “This ruling ultimately poses a serious threat to the patient-provider relationship and subsequent decisionmaking necessary to ensure optimal outcomes for patients. As practitioners, we should be free to provide what is in the best interest of our patients.”

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

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The country’s top medical organizations condemned the overturning of Roe v. Wade, saying the removal of federal protections for women to access abortion services marks a “dark day.”

“It is unfathomable. It is unfair. It is wrong,” said the President of the American College of Obstetricians and Gynecologists (ACOG) Iffath Abbasi Hoskins, MD.

“Today is a very dark day in health care. It is a dark day, indeed, for the tens of millions of patients who have suddenly and unfairly lost access to safe legal and evidence-based abortion care,” Dr. Hoskins said at a press conference June 24 sponsored by ACOG. 

“It is dark for the thousands of clinicians who now, instead of focusing on providing health care to their patients, have to live with the threats of legal, civil, and even professional penalties,” Dr. Hoskins added.

ACOG has 62,000 members and is the leading group of doctors that provides obstetric and gynecologic care.
 

Dilemma for some doctors?

“I’d like to take a moment to talk about the future of the medical profession,” said ACOG Chief Executive Officer Maureen G. Phipps, MD, MPH. “[The] decision is, as Dr. Hoskins clearly said, a tragic one for our patients in states across the country, but the harm does not end there.”

Dr. Phipps described overturning Roe v. Wade as “the boldest act of legislative interference that we have seen in this country. It will allow state legislators to tell physicians what care they can and cannot provide to their patients.”

“It will leave physicians looking over our shoulders, wondering if a patient is in enough of a crisis to permit an exception to a law,” Dr. Phipps added. “This is an affront to all that drew my colleagues and me into medicine.”

Although the impact on doctor training remains to be seen, she said 44% of ob.gyn. residents are trained in states now empowered to ban abortions.

The effect of the Supreme Court decision on miscarriage management is another unknown.

“It’s going to be very difficult for us, the clinicians, to manage miscarriage,” Dr. Hoskins said. “Many miscarriages could be what we call ‘incomplete’ in the beginning,” where there is still a heartbeat and the patient is cramping and/or bleeding.

In that instance, Dr. Hoskins said, clinicians may be thinking that they have to wait.

“They may be needing to get additional opinions, whether it’s a legal opinion ... or another medical opinion.”

“It’s going to have a devastating effect on every aspect of a woman’s health care, including if she is spontaneously miscarrying,” Dr. Hoskins predicted.

 

 

Physician protect thyself?

To what extent doctors can shield themselves from potential prosecution “is a hard question to answer,” Molly Meegan, JD, ACOG’s chief legal officer and general counsel, said.

Ms. Meegan recommended members speak to the risk managers at their individual institutions for guidance.

“It is a real patchwork [of laws] out there, she said. “And that patchwork itself is a danger to people as they seek essential reproductive health care.”

Also, she added, “If a doctor can’t tell what the law is at the time they’re trying to provide the care, it has a terribly chilling effect on medical care.”

Another potential threat to doctors in states that still allow abortion services is action from a neighboring state.

“We are going to be advocating very strongly that states do not have extra-territorial jurisdiction to reach beyond the edges of their state.”

The worry is if a doctor in New Mexico, where abortion is legal, performs an abortion for a person from Texas, where it will soon be illegal, is then prosecuted by Texas, for example.
 

Medication abortion

Asked about any potential effects on medication abortions, ACOG’s Jen Villavicencio, MD, said it remains to be seen.

“Certainly many of the laws that we have seen, including trigger ban laws, encompass medication abortion,” she said. Several states have these so-called trigger laws, which put into effect laws passed to ban abortion in case Roe was overturned.

This means, she said, that any abortion option, whether it’s procedural or medication, could be and will be banned in some of these states.

Ms. Meegan added that ACOG will continue to support access to medication abortion and that it should be decided by the U.S. Food and Drug Administration and not individual states.
 

Maternal mortality may rise

“Maternal mortality in and of itself is a very difficult topic,” Dr. Hoskins said, but [the] decision amplifies the implications. “I think of the patients who will have to manage severe complications and mental health challenges while they are carrying a pregnancy that they are forced to carry.”

“I also think of the patients who need to end their pregnancies in order to save their own lives,” Dr. Hoskins added.

Dr. Hoskins said the United States already has a high maternal mortality rate. This new law, she added, could force women into higher-risk situations if they experience high blood pressure, preeclampsia, or bleeding after the birth of the baby.
 

Growing inequality possible?

“The grievous inequities that exist in this country will grow and expand unchecked without safe access to legal abortion,” Dr. Phipps said.

She noted that women, based on location, will continue “to have protected access to safe evidence-based abortion. Others will have the means and resources and opportunities to secure the care.”

But the same may not be true for women in underserved or disadvantaged communities, Dr. Phipps added.
 

American Medical Association

ACOG was not the only group to react. “The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half century of precedent protecting patients’ right to critical reproductive health care,” President Jack Resneck Jr., MD, said in a statement.

The decision represents “an egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services.”

 

 

American Academy of Family Physicians

“The American Academy of Family Physicians is disappointed and disheartened by the Supreme Court’s decision to strike down longstanding protections afforded by Roe v. Wade and Planned Parenthood v. Casey,” President Sterling N. Ransone Jr., MD, said in a statement.

The organization has 127,600 physician and medical student members.

“This decision negatively impacts our practices and our patients by undermining the patient-physician relationship and potentially criminalizing evidence-based medical care,” added Dr. Ransone.
 

American College of Physicians

“A patient’s decision about whether to continue a pregnancy should be a private decision made in consultation with a physician or other health care professional, without interference from the government,” President Ryan D. Mire, MD, said in a statement. “We strongly oppose medically unnecessary government restrictions on any health care services,” added Dr. Mire on behalf of the group’s 161,000 members.

 

American Academy of Pediatrics

“This decision carries grave consequences for our adolescent patients, who already face many more barriers than adults in accessing comprehensive reproductive health care services and abortion care,” President Moira Szilagyi, MD, PhD, said in a statement. 

“In the wake of this ruling, the American Academy of Pediatrics will continue to support our chapters as states consider policies affecting access to abortion care, and pediatricians will continue to support our patients,” Dr. Szilagyi added.
 

American Public Health Association

The court’s decision “is a catastrophic judicial failure that will reverberate differently in each state and portends to jeopardize the health and lives of all Americans,” Executive Director Georges C. Benjamin, MD, said in a statement.

American Urogynecologic Society

“The American Urogynecologic Society opposes any ruling that restricts a person’s access to health care and criminalizes the practice of medicine,” the group said in a statement. “This ruling ultimately poses a serious threat to the patient-provider relationship and subsequent decisionmaking necessary to ensure optimal outcomes for patients. As practitioners, we should be free to provide what is in the best interest of our patients.”

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

The country’s top medical organizations condemned the overturning of Roe v. Wade, saying the removal of federal protections for women to access abortion services marks a “dark day.”

“It is unfathomable. It is unfair. It is wrong,” said the President of the American College of Obstetricians and Gynecologists (ACOG) Iffath Abbasi Hoskins, MD.

“Today is a very dark day in health care. It is a dark day, indeed, for the tens of millions of patients who have suddenly and unfairly lost access to safe legal and evidence-based abortion care,” Dr. Hoskins said at a press conference June 24 sponsored by ACOG. 

“It is dark for the thousands of clinicians who now, instead of focusing on providing health care to their patients, have to live with the threats of legal, civil, and even professional penalties,” Dr. Hoskins added.

ACOG has 62,000 members and is the leading group of doctors that provides obstetric and gynecologic care.
 

Dilemma for some doctors?

“I’d like to take a moment to talk about the future of the medical profession,” said ACOG Chief Executive Officer Maureen G. Phipps, MD, MPH. “[The] decision is, as Dr. Hoskins clearly said, a tragic one for our patients in states across the country, but the harm does not end there.”

Dr. Phipps described overturning Roe v. Wade as “the boldest act of legislative interference that we have seen in this country. It will allow state legislators to tell physicians what care they can and cannot provide to their patients.”

“It will leave physicians looking over our shoulders, wondering if a patient is in enough of a crisis to permit an exception to a law,” Dr. Phipps added. “This is an affront to all that drew my colleagues and me into medicine.”

Although the impact on doctor training remains to be seen, she said 44% of ob.gyn. residents are trained in states now empowered to ban abortions.

The effect of the Supreme Court decision on miscarriage management is another unknown.

“It’s going to be very difficult for us, the clinicians, to manage miscarriage,” Dr. Hoskins said. “Many miscarriages could be what we call ‘incomplete’ in the beginning,” where there is still a heartbeat and the patient is cramping and/or bleeding.

In that instance, Dr. Hoskins said, clinicians may be thinking that they have to wait.

“They may be needing to get additional opinions, whether it’s a legal opinion ... or another medical opinion.”

“It’s going to have a devastating effect on every aspect of a woman’s health care, including if she is spontaneously miscarrying,” Dr. Hoskins predicted.

 

 

Physician protect thyself?

To what extent doctors can shield themselves from potential prosecution “is a hard question to answer,” Molly Meegan, JD, ACOG’s chief legal officer and general counsel, said.

Ms. Meegan recommended members speak to the risk managers at their individual institutions for guidance.

“It is a real patchwork [of laws] out there, she said. “And that patchwork itself is a danger to people as they seek essential reproductive health care.”

Also, she added, “If a doctor can’t tell what the law is at the time they’re trying to provide the care, it has a terribly chilling effect on medical care.”

Another potential threat to doctors in states that still allow abortion services is action from a neighboring state.

“We are going to be advocating very strongly that states do not have extra-territorial jurisdiction to reach beyond the edges of their state.”

The worry is if a doctor in New Mexico, where abortion is legal, performs an abortion for a person from Texas, where it will soon be illegal, is then prosecuted by Texas, for example.
 

Medication abortion

Asked about any potential effects on medication abortions, ACOG’s Jen Villavicencio, MD, said it remains to be seen.

“Certainly many of the laws that we have seen, including trigger ban laws, encompass medication abortion,” she said. Several states have these so-called trigger laws, which put into effect laws passed to ban abortion in case Roe was overturned.

This means, she said, that any abortion option, whether it’s procedural or medication, could be and will be banned in some of these states.

Ms. Meegan added that ACOG will continue to support access to medication abortion and that it should be decided by the U.S. Food and Drug Administration and not individual states.
 

Maternal mortality may rise

“Maternal mortality in and of itself is a very difficult topic,” Dr. Hoskins said, but [the] decision amplifies the implications. “I think of the patients who will have to manage severe complications and mental health challenges while they are carrying a pregnancy that they are forced to carry.”

“I also think of the patients who need to end their pregnancies in order to save their own lives,” Dr. Hoskins added.

Dr. Hoskins said the United States already has a high maternal mortality rate. This new law, she added, could force women into higher-risk situations if they experience high blood pressure, preeclampsia, or bleeding after the birth of the baby.
 

Growing inequality possible?

“The grievous inequities that exist in this country will grow and expand unchecked without safe access to legal abortion,” Dr. Phipps said.

She noted that women, based on location, will continue “to have protected access to safe evidence-based abortion. Others will have the means and resources and opportunities to secure the care.”

But the same may not be true for women in underserved or disadvantaged communities, Dr. Phipps added.
 

American Medical Association

ACOG was not the only group to react. “The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half century of precedent protecting patients’ right to critical reproductive health care,” President Jack Resneck Jr., MD, said in a statement.

The decision represents “an egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services.”

 

 

American Academy of Family Physicians

“The American Academy of Family Physicians is disappointed and disheartened by the Supreme Court’s decision to strike down longstanding protections afforded by Roe v. Wade and Planned Parenthood v. Casey,” President Sterling N. Ransone Jr., MD, said in a statement.

The organization has 127,600 physician and medical student members.

“This decision negatively impacts our practices and our patients by undermining the patient-physician relationship and potentially criminalizing evidence-based medical care,” added Dr. Ransone.
 

American College of Physicians

“A patient’s decision about whether to continue a pregnancy should be a private decision made in consultation with a physician or other health care professional, without interference from the government,” President Ryan D. Mire, MD, said in a statement. “We strongly oppose medically unnecessary government restrictions on any health care services,” added Dr. Mire on behalf of the group’s 161,000 members.

 

American Academy of Pediatrics

“This decision carries grave consequences for our adolescent patients, who already face many more barriers than adults in accessing comprehensive reproductive health care services and abortion care,” President Moira Szilagyi, MD, PhD, said in a statement. 

“In the wake of this ruling, the American Academy of Pediatrics will continue to support our chapters as states consider policies affecting access to abortion care, and pediatricians will continue to support our patients,” Dr. Szilagyi added.
 

American Public Health Association

The court’s decision “is a catastrophic judicial failure that will reverberate differently in each state and portends to jeopardize the health and lives of all Americans,” Executive Director Georges C. Benjamin, MD, said in a statement.

American Urogynecologic Society

“The American Urogynecologic Society opposes any ruling that restricts a person’s access to health care and criminalizes the practice of medicine,” the group said in a statement. “This ruling ultimately poses a serious threat to the patient-provider relationship and subsequent decisionmaking necessary to ensure optimal outcomes for patients. As practitioners, we should be free to provide what is in the best interest of our patients.”

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

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FDA authorizes COVID vaccines in kids as young as 6 months

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Fri, 06/17/2022 - 12:56

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

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The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

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Biden boosts LGBTQIA+ protections, bans conversion therapy

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Fri, 06/17/2022 - 16:05

President Joe Biden issued an executive order on June 15 banning conversion therapy and offering other LBGTQIA+ protections as part of White House efforts to advance equality during Pride Month.

“My order will use the full force of the federal government to end inhumane practices of conversion therapy,” President Biden said in a speech before signing the order. “This is the first time the federal government is making a coordinated effort against this dangerous and discredited practice.”

Conversion therapy is any emotional or physical therapy used to “cure” or “repair” a person’s attraction to the same sex, or their gender identity and expression. Providers claim these therapies can make someone heterosexual or “straight.” But there’s no evidence to support this.

Medical and mental health experts have rejected conversion therapy practices as dangerous and discriminatory for decades.

The executive order also addresses:

  • The LGBTQIA+ youth mental health crisis, in part by expanding suicide prevention resources for that at-risk population.
  • Discrimination within the foster care system against LGBTQIA+ children and parents.
  • Discrimination, poverty and isolation challenges faced by LGBTQIA+ seniors.
  • Efforts to strengthen federal data collection in this population to counter homelessness, housing insecurity and barriers to health care access.

Enforcement of executive order will rely on legal experts, including the Justice Department.

President Biden’s order comes at a time when multiple states are promoting or passing anti-LGBTQIA+ laws.

“I don’t have to tell you about the ultra-MAGA agenda attacking our freedoms. There are more than 300 discriminatory bills introduced in states across this country,” President Biden said. “In Texas, they are knocking on front doors to investigate parents who are raising transgender children, and in Florida they are going after Mickey Mouse for God’s sake.”

First Lady Jill Biden, PhD, said the order will not solve all problems. “Prejudice and discrimination still lurk. We will not let the progress we fought for slip away. Pride is a celebration of the courage it takes to stand up for what’s right.”

The American Psychiatric Association applauded President Biden’s action. This executive order will “protect the mental health of LGBTQ+ people, particularly children. APA has long condemned the practice of so-called ‘conversion therapy’ and we welcome the federal government’s efforts to raise public awareness about its harms, alongside other practices that will help to end it.”

The goal of the order is to “improve the health, wellbeing, and safety of countless families across the country,” senior White House administration officials said in a June 15 media call. “And they will send a powerful signal from the president of the United States to LGBTQIA+ kids across the country – who may be feeling scared and hopeless – that their president has their back.”

Biden also called on Congress to pass the Equality Act “to enshrine the long overdue civil rights to protect all Americans.”

The event was held in the East Room of the White House at a Pride event attended by Vice President Kamala Harris and her husband, the first lady, Transportation Secretary Pete Buttigieg, and hundreds of LGBTQIA+ leaders.
 

 

 

Guidance on starting transgender treatment

In other LGBTQIA+-related news, an international group focusing on transgender health lowered the minimum ages they recommend for starting hormone therapy or surgery for transgender youth.

The World Professional Association for Transgender Health said that hormones could be started at 14, 2 years earlier than the group’s previous advice. The association also said some surgeries can be performed at age 15 or 17, a year or so earlier than their previous recommendations.

The group acknowledged potential risks but said it is unethical and harmful to withhold early treatment, according to a report from The Associated Press.

Transgender treatment for teens has been a controversial issue, with experts disagreeing about whether teenagers can fully understand the ramifications of such life-altering decisions.

During the White House background media call, senior administration officials pointed to existing policy regarding transgender care. “We’ve already put out guidance through HHS about civil rights protections and making clear that the denial of medical care based on someone’s gender identity is discriminatory and have invited the members of the public to file complaints with the Office of Civil Rights.”

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

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President Joe Biden issued an executive order on June 15 banning conversion therapy and offering other LBGTQIA+ protections as part of White House efforts to advance equality during Pride Month.

“My order will use the full force of the federal government to end inhumane practices of conversion therapy,” President Biden said in a speech before signing the order. “This is the first time the federal government is making a coordinated effort against this dangerous and discredited practice.”

Conversion therapy is any emotional or physical therapy used to “cure” or “repair” a person’s attraction to the same sex, or their gender identity and expression. Providers claim these therapies can make someone heterosexual or “straight.” But there’s no evidence to support this.

Medical and mental health experts have rejected conversion therapy practices as dangerous and discriminatory for decades.

The executive order also addresses:

  • The LGBTQIA+ youth mental health crisis, in part by expanding suicide prevention resources for that at-risk population.
  • Discrimination within the foster care system against LGBTQIA+ children and parents.
  • Discrimination, poverty and isolation challenges faced by LGBTQIA+ seniors.
  • Efforts to strengthen federal data collection in this population to counter homelessness, housing insecurity and barriers to health care access.

Enforcement of executive order will rely on legal experts, including the Justice Department.

President Biden’s order comes at a time when multiple states are promoting or passing anti-LGBTQIA+ laws.

“I don’t have to tell you about the ultra-MAGA agenda attacking our freedoms. There are more than 300 discriminatory bills introduced in states across this country,” President Biden said. “In Texas, they are knocking on front doors to investigate parents who are raising transgender children, and in Florida they are going after Mickey Mouse for God’s sake.”

First Lady Jill Biden, PhD, said the order will not solve all problems. “Prejudice and discrimination still lurk. We will not let the progress we fought for slip away. Pride is a celebration of the courage it takes to stand up for what’s right.”

The American Psychiatric Association applauded President Biden’s action. This executive order will “protect the mental health of LGBTQ+ people, particularly children. APA has long condemned the practice of so-called ‘conversion therapy’ and we welcome the federal government’s efforts to raise public awareness about its harms, alongside other practices that will help to end it.”

The goal of the order is to “improve the health, wellbeing, and safety of countless families across the country,” senior White House administration officials said in a June 15 media call. “And they will send a powerful signal from the president of the United States to LGBTQIA+ kids across the country – who may be feeling scared and hopeless – that their president has their back.”

Biden also called on Congress to pass the Equality Act “to enshrine the long overdue civil rights to protect all Americans.”

The event was held in the East Room of the White House at a Pride event attended by Vice President Kamala Harris and her husband, the first lady, Transportation Secretary Pete Buttigieg, and hundreds of LGBTQIA+ leaders.
 

 

 

Guidance on starting transgender treatment

In other LGBTQIA+-related news, an international group focusing on transgender health lowered the minimum ages they recommend for starting hormone therapy or surgery for transgender youth.

The World Professional Association for Transgender Health said that hormones could be started at 14, 2 years earlier than the group’s previous advice. The association also said some surgeries can be performed at age 15 or 17, a year or so earlier than their previous recommendations.

The group acknowledged potential risks but said it is unethical and harmful to withhold early treatment, according to a report from The Associated Press.

Transgender treatment for teens has been a controversial issue, with experts disagreeing about whether teenagers can fully understand the ramifications of such life-altering decisions.

During the White House background media call, senior administration officials pointed to existing policy regarding transgender care. “We’ve already put out guidance through HHS about civil rights protections and making clear that the denial of medical care based on someone’s gender identity is discriminatory and have invited the members of the public to file complaints with the Office of Civil Rights.”

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

President Joe Biden issued an executive order on June 15 banning conversion therapy and offering other LBGTQIA+ protections as part of White House efforts to advance equality during Pride Month.

“My order will use the full force of the federal government to end inhumane practices of conversion therapy,” President Biden said in a speech before signing the order. “This is the first time the federal government is making a coordinated effort against this dangerous and discredited practice.”

Conversion therapy is any emotional or physical therapy used to “cure” or “repair” a person’s attraction to the same sex, or their gender identity and expression. Providers claim these therapies can make someone heterosexual or “straight.” But there’s no evidence to support this.

Medical and mental health experts have rejected conversion therapy practices as dangerous and discriminatory for decades.

The executive order also addresses:

  • The LGBTQIA+ youth mental health crisis, in part by expanding suicide prevention resources for that at-risk population.
  • Discrimination within the foster care system against LGBTQIA+ children and parents.
  • Discrimination, poverty and isolation challenges faced by LGBTQIA+ seniors.
  • Efforts to strengthen federal data collection in this population to counter homelessness, housing insecurity and barriers to health care access.

Enforcement of executive order will rely on legal experts, including the Justice Department.

President Biden’s order comes at a time when multiple states are promoting or passing anti-LGBTQIA+ laws.

“I don’t have to tell you about the ultra-MAGA agenda attacking our freedoms. There are more than 300 discriminatory bills introduced in states across this country,” President Biden said. “In Texas, they are knocking on front doors to investigate parents who are raising transgender children, and in Florida they are going after Mickey Mouse for God’s sake.”

First Lady Jill Biden, PhD, said the order will not solve all problems. “Prejudice and discrimination still lurk. We will not let the progress we fought for slip away. Pride is a celebration of the courage it takes to stand up for what’s right.”

The American Psychiatric Association applauded President Biden’s action. This executive order will “protect the mental health of LGBTQ+ people, particularly children. APA has long condemned the practice of so-called ‘conversion therapy’ and we welcome the federal government’s efforts to raise public awareness about its harms, alongside other practices that will help to end it.”

The goal of the order is to “improve the health, wellbeing, and safety of countless families across the country,” senior White House administration officials said in a June 15 media call. “And they will send a powerful signal from the president of the United States to LGBTQIA+ kids across the country – who may be feeling scared and hopeless – that their president has their back.”

Biden also called on Congress to pass the Equality Act “to enshrine the long overdue civil rights to protect all Americans.”

The event was held in the East Room of the White House at a Pride event attended by Vice President Kamala Harris and her husband, the first lady, Transportation Secretary Pete Buttigieg, and hundreds of LGBTQIA+ leaders.
 

 

 

Guidance on starting transgender treatment

In other LGBTQIA+-related news, an international group focusing on transgender health lowered the minimum ages they recommend for starting hormone therapy or surgery for transgender youth.

The World Professional Association for Transgender Health said that hormones could be started at 14, 2 years earlier than the group’s previous advice. The association also said some surgeries can be performed at age 15 or 17, a year or so earlier than their previous recommendations.

The group acknowledged potential risks but said it is unethical and harmful to withhold early treatment, according to a report from The Associated Press.

Transgender treatment for teens has been a controversial issue, with experts disagreeing about whether teenagers can fully understand the ramifications of such life-altering decisions.

During the White House background media call, senior administration officials pointed to existing policy regarding transgender care. “We’ve already put out guidance through HHS about civil rights protections and making clear that the denial of medical care based on someone’s gender identity is discriminatory and have invited the members of the public to file complaints with the Office of Civil Rights.”

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

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Blood test aims to measure COVID immunity

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Thu, 06/23/2022 - 17:01

A small blood sample and 24 hours might be all that’s needed to find out how strong the immune system is against a first or repeat coronavirus infections.

Scientists created a test that indirectly measures T-cell response – an important, long-term component of immunity that can last long after antibody levels fall off – to a challenge by the virus in whole blood.

The test mimics what can be done in a formal laboratory now but avoids some complicated steps and specialized training for lab personnel. This test, researchers said, is faster, can scale up to test many more people, and can be adapted to detect viral mutations as they emerge in the future.

The study explaining how all this works was published online in Nature Biotechnology.

The test, called dqTACT, could help predict the likelihood of “breakthrough” infections in people who are fully vaccinated and could help determine how frequently people who are immunocompromised might need to be revaccinated, the authors noted.

Infection with the coronavirus and other viruses can trigger a one-two punch from the immunity system – a fast antibody response followed by longer-lasting cellular immunity, including T cells, which “remember” the virus. Cellular immunity can trigger a quick response if the same virus ever shows up again.

The new test adds synthetic viral peptides – strings of amino acids that make up proteins – from the coronavirus to a blood sample. If there is no T-cell reaction within 24 hours, the test is negative. If the peptides trigger T cells, the test can measure the strength of the immune response.

The researchers validated the new test against traditional laboratory testing in 91 people, about half of whom never had COVID-19 and another half who were infected and recovered. The results matched well.

They also found the test predicted immune strength up to 8 months following a second dose of COVID-19 vaccine. Furthermore, T-cell response was greater among people who received two doses of a vaccine versus others who received only one immunization.

Studies are ongoing and designed to meet authorization requirements as part of future licensing from the Food and Drug Administration.

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

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A small blood sample and 24 hours might be all that’s needed to find out how strong the immune system is against a first or repeat coronavirus infections.

Scientists created a test that indirectly measures T-cell response – an important, long-term component of immunity that can last long after antibody levels fall off – to a challenge by the virus in whole blood.

The test mimics what can be done in a formal laboratory now but avoids some complicated steps and specialized training for lab personnel. This test, researchers said, is faster, can scale up to test many more people, and can be adapted to detect viral mutations as they emerge in the future.

The study explaining how all this works was published online in Nature Biotechnology.

The test, called dqTACT, could help predict the likelihood of “breakthrough” infections in people who are fully vaccinated and could help determine how frequently people who are immunocompromised might need to be revaccinated, the authors noted.

Infection with the coronavirus and other viruses can trigger a one-two punch from the immunity system – a fast antibody response followed by longer-lasting cellular immunity, including T cells, which “remember” the virus. Cellular immunity can trigger a quick response if the same virus ever shows up again.

The new test adds synthetic viral peptides – strings of amino acids that make up proteins – from the coronavirus to a blood sample. If there is no T-cell reaction within 24 hours, the test is negative. If the peptides trigger T cells, the test can measure the strength of the immune response.

The researchers validated the new test against traditional laboratory testing in 91 people, about half of whom never had COVID-19 and another half who were infected and recovered. The results matched well.

They also found the test predicted immune strength up to 8 months following a second dose of COVID-19 vaccine. Furthermore, T-cell response was greater among people who received two doses of a vaccine versus others who received only one immunization.

Studies are ongoing and designed to meet authorization requirements as part of future licensing from the Food and Drug Administration.

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

A small blood sample and 24 hours might be all that’s needed to find out how strong the immune system is against a first or repeat coronavirus infections.

Scientists created a test that indirectly measures T-cell response – an important, long-term component of immunity that can last long after antibody levels fall off – to a challenge by the virus in whole blood.

The test mimics what can be done in a formal laboratory now but avoids some complicated steps and specialized training for lab personnel. This test, researchers said, is faster, can scale up to test many more people, and can be adapted to detect viral mutations as they emerge in the future.

The study explaining how all this works was published online in Nature Biotechnology.

The test, called dqTACT, could help predict the likelihood of “breakthrough” infections in people who are fully vaccinated and could help determine how frequently people who are immunocompromised might need to be revaccinated, the authors noted.

Infection with the coronavirus and other viruses can trigger a one-two punch from the immunity system – a fast antibody response followed by longer-lasting cellular immunity, including T cells, which “remember” the virus. Cellular immunity can trigger a quick response if the same virus ever shows up again.

The new test adds synthetic viral peptides – strings of amino acids that make up proteins – from the coronavirus to a blood sample. If there is no T-cell reaction within 24 hours, the test is negative. If the peptides trigger T cells, the test can measure the strength of the immune response.

The researchers validated the new test against traditional laboratory testing in 91 people, about half of whom never had COVID-19 and another half who were infected and recovered. The results matched well.

They also found the test predicted immune strength up to 8 months following a second dose of COVID-19 vaccine. Furthermore, T-cell response was greater among people who received two doses of a vaccine versus others who received only one immunization.

Studies are ongoing and designed to meet authorization requirements as part of future licensing from the Food and Drug Administration.

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

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At-home colorectal cancer testing and follow-up vary by ethnicity

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Wed, 06/08/2022 - 09:36

Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.

Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.

Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.

Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”

Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week® (DDW), held in person in San Diego and virtually.
 

Breakdown by physician specialty

“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.

Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.

Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P <  .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).

Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).

Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
 

Ongoing and future research

Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.

When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.

Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.

The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.

“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
 

 

 

Some unanswered questions

“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”

“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”

Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?

“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”

“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.

According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.

“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”

“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”

“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.

The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.

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

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Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.

Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.

Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.

Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”

Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week® (DDW), held in person in San Diego and virtually.
 

Breakdown by physician specialty

“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.

Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.

Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P <  .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).

Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).

Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
 

Ongoing and future research

Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.

When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.

Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.

The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.

“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
 

 

 

Some unanswered questions

“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”

“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”

Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?

“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”

“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.

According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.

“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”

“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”

“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.

The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.

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

Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.

Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.

Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.

Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”

Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week® (DDW), held in person in San Diego and virtually.
 

Breakdown by physician specialty

“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.

Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.

Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P <  .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).

Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).

Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
 

Ongoing and future research

Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.

When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.

Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.

The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.

“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
 

 

 

Some unanswered questions

“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”

“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”

Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?

“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”

“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.

According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.

“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”

“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”

“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.

The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.

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

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Dogs can be protective, even against Crohn’s disease

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Sorry, cat people and only children: Having a dog as a toddler and growing up in a large family are two things linked to a significantly lower chance of getting Crohn’s disease later in life, according to a new study.

Children who lived with a dog between the ages of 2 years and 4 years were 37% less likely to have Crohn’s disease, the study says. And those who lived with at least three other family members during the first year of life were 64% less likely to have this form of inflammatory bowel disease (IBD).

“In this study, we’re interested in environmental exposures and which ones are associated with Crohn’s disease onset,” Williams Turpin, PhD, said in a media interview May 23 at the annual Digestive Disease Week® (DDW).

Dr. Turpin and colleagues looked at other things in the environment – including living on a farm, drinking unpasteurized milk or well water, and growing up with a cat – but they did not have a significant link to a higher risk.

Two other things were associated with a slight increase in risk: having a sibling with Crohn’s disease and living with a bird at time of the study. But the number of bird owners was small; only a few people in the study had a pet bird when they enrolled.

The link to living with a dog as a toddler “was more robust,” said Dr. Turpin, a project manager at Mount Sinai Hospital in Toronto.

The study included 4,289 healthy first-degree relatives of people diagnosed with Crohn’s disease. They provided urine, blood, and stool samples and did surveys about environmental exposures at different stages of life.

Investigators followed them an average of 5.6 years, during which time 86 people got Crohn’s disease.
 

Gut instinct

Living with a dog early in life likely means more exposure to different microbes, boosting the strength of a person’s immune system against later challenges. This theory was supported in the study comparing the gut microbiome in people who did and not have a dog in the home early in life.

Dr. Turpin and colleagues genetically sequenced the gut microbiome of the people in the study and found differences in bacteria between groups.

“Our study also shows that just by living with a dog, it impacts your gut microbiome composition, which may have an impact on the immune response later in life,” Dr. Turpin said.

The researchers also looked at the health of the gut by measuring certain factors in the urine. One factor was higher in people who did not live with a dog at any point.
 

Mediated by the microbiome?

Living with a dog between the ages of 2 and 4 years and a large family size (more than three people) in the first year were significantly associated with a lower risk of Crohn’s disease onset.

It is unknown if the results apply to other populations; the researchers studied first-degree relatives of people with Crohn’s disease.

“The study needs to be replicated and validated,” Dr. Turpin said.

Future research could evaluate people who never had a dog and look for changes in their microbiome after they get one.
 

‘Well-crafted’ study

“It’s a really interesting study from a good group. It’s novel in terms of getting at what really drives environmental risk factors,” said Brigid Boland, MD, a gastroenterologist at UC San Diego Health, who was not affiliated with the study.

Autoimmune diseases are really complicated, in part because the risk of getting an autoimmune disease is low, and you’re going back in time to look at what put people at risk.

“The study was well crafted in choosing siblings and family members of people with IBD,” Dr. Boland said, agreeing with Dr. Turpin that more research is needed to understand this.

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

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Sorry, cat people and only children: Having a dog as a toddler and growing up in a large family are two things linked to a significantly lower chance of getting Crohn’s disease later in life, according to a new study.

Children who lived with a dog between the ages of 2 years and 4 years were 37% less likely to have Crohn’s disease, the study says. And those who lived with at least three other family members during the first year of life were 64% less likely to have this form of inflammatory bowel disease (IBD).

“In this study, we’re interested in environmental exposures and which ones are associated with Crohn’s disease onset,” Williams Turpin, PhD, said in a media interview May 23 at the annual Digestive Disease Week® (DDW).

Dr. Turpin and colleagues looked at other things in the environment – including living on a farm, drinking unpasteurized milk or well water, and growing up with a cat – but they did not have a significant link to a higher risk.

Two other things were associated with a slight increase in risk: having a sibling with Crohn’s disease and living with a bird at time of the study. But the number of bird owners was small; only a few people in the study had a pet bird when they enrolled.

The link to living with a dog as a toddler “was more robust,” said Dr. Turpin, a project manager at Mount Sinai Hospital in Toronto.

The study included 4,289 healthy first-degree relatives of people diagnosed with Crohn’s disease. They provided urine, blood, and stool samples and did surveys about environmental exposures at different stages of life.

Investigators followed them an average of 5.6 years, during which time 86 people got Crohn’s disease.
 

Gut instinct

Living with a dog early in life likely means more exposure to different microbes, boosting the strength of a person’s immune system against later challenges. This theory was supported in the study comparing the gut microbiome in people who did and not have a dog in the home early in life.

Dr. Turpin and colleagues genetically sequenced the gut microbiome of the people in the study and found differences in bacteria between groups.

“Our study also shows that just by living with a dog, it impacts your gut microbiome composition, which may have an impact on the immune response later in life,” Dr. Turpin said.

The researchers also looked at the health of the gut by measuring certain factors in the urine. One factor was higher in people who did not live with a dog at any point.
 

Mediated by the microbiome?

Living with a dog between the ages of 2 and 4 years and a large family size (more than three people) in the first year were significantly associated with a lower risk of Crohn’s disease onset.

It is unknown if the results apply to other populations; the researchers studied first-degree relatives of people with Crohn’s disease.

“The study needs to be replicated and validated,” Dr. Turpin said.

Future research could evaluate people who never had a dog and look for changes in their microbiome after they get one.
 

‘Well-crafted’ study

“It’s a really interesting study from a good group. It’s novel in terms of getting at what really drives environmental risk factors,” said Brigid Boland, MD, a gastroenterologist at UC San Diego Health, who was not affiliated with the study.

Autoimmune diseases are really complicated, in part because the risk of getting an autoimmune disease is low, and you’re going back in time to look at what put people at risk.

“The study was well crafted in choosing siblings and family members of people with IBD,” Dr. Boland said, agreeing with Dr. Turpin that more research is needed to understand this.

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

Sorry, cat people and only children: Having a dog as a toddler and growing up in a large family are two things linked to a significantly lower chance of getting Crohn’s disease later in life, according to a new study.

Children who lived with a dog between the ages of 2 years and 4 years were 37% less likely to have Crohn’s disease, the study says. And those who lived with at least three other family members during the first year of life were 64% less likely to have this form of inflammatory bowel disease (IBD).

“In this study, we’re interested in environmental exposures and which ones are associated with Crohn’s disease onset,” Williams Turpin, PhD, said in a media interview May 23 at the annual Digestive Disease Week® (DDW).

Dr. Turpin and colleagues looked at other things in the environment – including living on a farm, drinking unpasteurized milk or well water, and growing up with a cat – but they did not have a significant link to a higher risk.

Two other things were associated with a slight increase in risk: having a sibling with Crohn’s disease and living with a bird at time of the study. But the number of bird owners was small; only a few people in the study had a pet bird when they enrolled.

The link to living with a dog as a toddler “was more robust,” said Dr. Turpin, a project manager at Mount Sinai Hospital in Toronto.

The study included 4,289 healthy first-degree relatives of people diagnosed with Crohn’s disease. They provided urine, blood, and stool samples and did surveys about environmental exposures at different stages of life.

Investigators followed them an average of 5.6 years, during which time 86 people got Crohn’s disease.
 

Gut instinct

Living with a dog early in life likely means more exposure to different microbes, boosting the strength of a person’s immune system against later challenges. This theory was supported in the study comparing the gut microbiome in people who did and not have a dog in the home early in life.

Dr. Turpin and colleagues genetically sequenced the gut microbiome of the people in the study and found differences in bacteria between groups.

“Our study also shows that just by living with a dog, it impacts your gut microbiome composition, which may have an impact on the immune response later in life,” Dr. Turpin said.

The researchers also looked at the health of the gut by measuring certain factors in the urine. One factor was higher in people who did not live with a dog at any point.
 

Mediated by the microbiome?

Living with a dog between the ages of 2 and 4 years and a large family size (more than three people) in the first year were significantly associated with a lower risk of Crohn’s disease onset.

It is unknown if the results apply to other populations; the researchers studied first-degree relatives of people with Crohn’s disease.

“The study needs to be replicated and validated,” Dr. Turpin said.

Future research could evaluate people who never had a dog and look for changes in their microbiome after they get one.
 

‘Well-crafted’ study

“It’s a really interesting study from a good group. It’s novel in terms of getting at what really drives environmental risk factors,” said Brigid Boland, MD, a gastroenterologist at UC San Diego Health, who was not affiliated with the study.

Autoimmune diseases are really complicated, in part because the risk of getting an autoimmune disease is low, and you’re going back in time to look at what put people at risk.

“The study was well crafted in choosing siblings and family members of people with IBD,” Dr. Boland said, agreeing with Dr. Turpin that more research is needed to understand this.

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

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Fidaxomicin favored over vancomycin in real-world C. diff study

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Thu, 05/26/2022 - 10:53
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Fidaxomicin favored over vancomycin in real-world C. diff study

Fidaxomicin (Fificid) emerged favorable to vancomycin for the treatment of both initial and recurrent Clostridioides difficile infections in a Medicare population, according to a new retrospective study.

Although fidaxomicin was about 14% more effective than vancomycin in treating the initial infection, a larger difference of 30% was found among people with recurrent C. diff. infections.

Lead investigator Erik Dubberke, MD, professor of infectious diseases at the University of Washington, St. Louis, and colleagues noted that this real-world evidence of the two agents used to treat C. diff. was “strikingly similar” to clinical trial data.

They said that their findings support the 2021 change in clinical guidelines from the Infectious Diseases Society of America recommending fidaxomicin over vancomycin.

The study was presented at Digestive Disease Week® (DDW) 2022, which was held virtually and in San Diego.
 

Evaluating a high-risk population

Because few real-world data exist that compare these two agents for C. diff., “particularly in a high-risk, high-prevalence population like Medicare,” the researchers evaluated Medicare Parts A, B, and D claims from 2016 to 2018 and included patients who had received fidaxomicin or vancomycin for an initial episode of C. diff. and for any recurrent episodes.

The researchers compared sustained response and recurrence of C. diff. within 4 weeks and 8 weeks after initial treatment with fidaxomicin or vancomycin. Treatment was considered successful if clinical resolution occurred 1 day after finishing therapy and there was no evidence of C. diff. recurrence.

Recurrence of C. diff. was defined as any evidence of new treatment or hospitalization for the infection within 4 or 8 weeks of when a patient filled the prescription for fidaxomicin or vancomycin.

The treatment groups were similar in age and race. However, the fidaxomicin group was at higher risk for recurrence, owing to risk factors such as history of C. diff. infection and compromised immunity. To reduce bias in comparing the groups, Dr. Dubberke and colleagues used propensity score matching. This approach yielded 190 matched pairs in the initial C. diff. episode sample and 67 matched pairs in the recurrent episode sample.

Among patients with their first C. diff. infection, fidaxomicin had a 13.5% higher rate of 4-week sustained response, compared with vancomycin (71.7% vs. 58.2%; P = .0058). There was also a 13.2% higher rate for 8-week sustained response with fidaxomicin (63.2% vs. 50.0%; P = .0114).

Sustained response at 4 weeks and 8 weeks among the patients who experienced a recurrent episode of C. diff. favored fidaxomicin over vancomycin by 30.1% (P = .0002) and 27.6% (P = .0012), respectively.

The rates of C. diff. recurrence in patients who experienced their first C. diff. infection or who experienced a recurrent bout were lower with fidaxomicin than vancomycin, but the differences were not statistically significant.
 

A costly edge

When asked to comment, Colleen Kelly, MD, a gastroenterologist and associate professor of medicine at Brown University, Providence, R.I., said that the study was “worthwhile” and added that “Eric Dubberke has done a lot of work in this area.”

The study “gives more evidence that fidaxomicin does have a bit of an edge in people who have already had a bout of C. diff.,” she said.

Dr. Kelly added that the cost needs to be considered. Fidaxomicin “is about 30 times more expensive than vancomycin,” she said.

In part because of the cost difference, the American College of Gastroenterology (ACG) 2021 guidelines, which Dr. Kelly helped create, recommend that fidaxomicin be held as a second-line agent. The ACG guidance reserved fidaxomicin for people with C. diff. for whom initial treatment with vancomycin failed.

“The fidaxomicin question is going to get a lot easier once the cost of the drug comes down,” Dr. Kelly said.

The study was funded by Merck. Dr. Dubberke is a consultant for Merck. Dr. Kelly reports no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff

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

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Fidaxomicin (Fificid) emerged favorable to vancomycin for the treatment of both initial and recurrent Clostridioides difficile infections in a Medicare population, according to a new retrospective study.

Although fidaxomicin was about 14% more effective than vancomycin in treating the initial infection, a larger difference of 30% was found among people with recurrent C. diff. infections.

Lead investigator Erik Dubberke, MD, professor of infectious diseases at the University of Washington, St. Louis, and colleagues noted that this real-world evidence of the two agents used to treat C. diff. was “strikingly similar” to clinical trial data.

They said that their findings support the 2021 change in clinical guidelines from the Infectious Diseases Society of America recommending fidaxomicin over vancomycin.

The study was presented at Digestive Disease Week® (DDW) 2022, which was held virtually and in San Diego.
 

Evaluating a high-risk population

Because few real-world data exist that compare these two agents for C. diff., “particularly in a high-risk, high-prevalence population like Medicare,” the researchers evaluated Medicare Parts A, B, and D claims from 2016 to 2018 and included patients who had received fidaxomicin or vancomycin for an initial episode of C. diff. and for any recurrent episodes.

The researchers compared sustained response and recurrence of C. diff. within 4 weeks and 8 weeks after initial treatment with fidaxomicin or vancomycin. Treatment was considered successful if clinical resolution occurred 1 day after finishing therapy and there was no evidence of C. diff. recurrence.

Recurrence of C. diff. was defined as any evidence of new treatment or hospitalization for the infection within 4 or 8 weeks of when a patient filled the prescription for fidaxomicin or vancomycin.

The treatment groups were similar in age and race. However, the fidaxomicin group was at higher risk for recurrence, owing to risk factors such as history of C. diff. infection and compromised immunity. To reduce bias in comparing the groups, Dr. Dubberke and colleagues used propensity score matching. This approach yielded 190 matched pairs in the initial C. diff. episode sample and 67 matched pairs in the recurrent episode sample.

Among patients with their first C. diff. infection, fidaxomicin had a 13.5% higher rate of 4-week sustained response, compared with vancomycin (71.7% vs. 58.2%; P = .0058). There was also a 13.2% higher rate for 8-week sustained response with fidaxomicin (63.2% vs. 50.0%; P = .0114).

Sustained response at 4 weeks and 8 weeks among the patients who experienced a recurrent episode of C. diff. favored fidaxomicin over vancomycin by 30.1% (P = .0002) and 27.6% (P = .0012), respectively.

The rates of C. diff. recurrence in patients who experienced their first C. diff. infection or who experienced a recurrent bout were lower with fidaxomicin than vancomycin, but the differences were not statistically significant.
 

A costly edge

When asked to comment, Colleen Kelly, MD, a gastroenterologist and associate professor of medicine at Brown University, Providence, R.I., said that the study was “worthwhile” and added that “Eric Dubberke has done a lot of work in this area.”

The study “gives more evidence that fidaxomicin does have a bit of an edge in people who have already had a bout of C. diff.,” she said.

Dr. Kelly added that the cost needs to be considered. Fidaxomicin “is about 30 times more expensive than vancomycin,” she said.

In part because of the cost difference, the American College of Gastroenterology (ACG) 2021 guidelines, which Dr. Kelly helped create, recommend that fidaxomicin be held as a second-line agent. The ACG guidance reserved fidaxomicin for people with C. diff. for whom initial treatment with vancomycin failed.

“The fidaxomicin question is going to get a lot easier once the cost of the drug comes down,” Dr. Kelly said.

The study was funded by Merck. Dr. Dubberke is a consultant for Merck. Dr. Kelly reports no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff

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

Fidaxomicin (Fificid) emerged favorable to vancomycin for the treatment of both initial and recurrent Clostridioides difficile infections in a Medicare population, according to a new retrospective study.

Although fidaxomicin was about 14% more effective than vancomycin in treating the initial infection, a larger difference of 30% was found among people with recurrent C. diff. infections.

Lead investigator Erik Dubberke, MD, professor of infectious diseases at the University of Washington, St. Louis, and colleagues noted that this real-world evidence of the two agents used to treat C. diff. was “strikingly similar” to clinical trial data.

They said that their findings support the 2021 change in clinical guidelines from the Infectious Diseases Society of America recommending fidaxomicin over vancomycin.

The study was presented at Digestive Disease Week® (DDW) 2022, which was held virtually and in San Diego.
 

Evaluating a high-risk population

Because few real-world data exist that compare these two agents for C. diff., “particularly in a high-risk, high-prevalence population like Medicare,” the researchers evaluated Medicare Parts A, B, and D claims from 2016 to 2018 and included patients who had received fidaxomicin or vancomycin for an initial episode of C. diff. and for any recurrent episodes.

The researchers compared sustained response and recurrence of C. diff. within 4 weeks and 8 weeks after initial treatment with fidaxomicin or vancomycin. Treatment was considered successful if clinical resolution occurred 1 day after finishing therapy and there was no evidence of C. diff. recurrence.

Recurrence of C. diff. was defined as any evidence of new treatment or hospitalization for the infection within 4 or 8 weeks of when a patient filled the prescription for fidaxomicin or vancomycin.

The treatment groups were similar in age and race. However, the fidaxomicin group was at higher risk for recurrence, owing to risk factors such as history of C. diff. infection and compromised immunity. To reduce bias in comparing the groups, Dr. Dubberke and colleagues used propensity score matching. This approach yielded 190 matched pairs in the initial C. diff. episode sample and 67 matched pairs in the recurrent episode sample.

Among patients with their first C. diff. infection, fidaxomicin had a 13.5% higher rate of 4-week sustained response, compared with vancomycin (71.7% vs. 58.2%; P = .0058). There was also a 13.2% higher rate for 8-week sustained response with fidaxomicin (63.2% vs. 50.0%; P = .0114).

Sustained response at 4 weeks and 8 weeks among the patients who experienced a recurrent episode of C. diff. favored fidaxomicin over vancomycin by 30.1% (P = .0002) and 27.6% (P = .0012), respectively.

The rates of C. diff. recurrence in patients who experienced their first C. diff. infection or who experienced a recurrent bout were lower with fidaxomicin than vancomycin, but the differences were not statistically significant.
 

A costly edge

When asked to comment, Colleen Kelly, MD, a gastroenterologist and associate professor of medicine at Brown University, Providence, R.I., said that the study was “worthwhile” and added that “Eric Dubberke has done a lot of work in this area.”

The study “gives more evidence that fidaxomicin does have a bit of an edge in people who have already had a bout of C. diff.,” she said.

Dr. Kelly added that the cost needs to be considered. Fidaxomicin “is about 30 times more expensive than vancomycin,” she said.

In part because of the cost difference, the American College of Gastroenterology (ACG) 2021 guidelines, which Dr. Kelly helped create, recommend that fidaxomicin be held as a second-line agent. The ACG guidance reserved fidaxomicin for people with C. diff. for whom initial treatment with vancomycin failed.

“The fidaxomicin question is going to get a lot easier once the cost of the drug comes down,” Dr. Kelly said.

The study was funded by Merck. Dr. Dubberke is a consultant for Merck. Dr. Kelly reports no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff

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

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Fidaxomicin favored over vancomycin in real-world C. diff study

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Thu, 05/26/2022 - 10:45
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Fidaxomicin favored over vancomycin in real-world C. diff study

Fidaxomicin (Fificid) emerged favorable to vancomycin for the treatment of both initial and recurrent Clostridioides difficile infections in a Medicare population, according to a new retrospective study.

Although fidaxomicin was about 14% more effective than vancomycin in treating the initial infection, a larger difference of 30% was found among people with recurrent C. diff. infections.

Lead investigator Erik Dubberke, MD, professor of infectious diseases at the University of Washington, St. Louis, and colleagues noted that this real-world evidence of the two agents used to treat C. diff. was “strikingly similar” to clinical trial data.

They said that their findings support the 2021 change in clinical guidelines from the Infectious Diseases Society of America recommending fidaxomicin over vancomycin.

The study was presented at Digestive Disease Week® (DDW) 2022, which was held virtually and in San Diego.
 

Evaluating a high-risk population

Because few real-world data exist that compare these two agents for C. diff., “particularly in a high-risk, high-prevalence population like Medicare,” the researchers evaluated Medicare Parts A, B, and D claims from 2016 to 2018 and included patients who had received fidaxomicin or vancomycin for an initial episode of C. diff. and for any recurrent episodes.

The researchers compared sustained response and recurrence of C. diff. within 4 weeks and 8 weeks after initial treatment with fidaxomicin or vancomycin. Treatment was considered successful if clinical resolution occurred 1 day after finishing therapy and there was no evidence of C. diff. recurrence.

Recurrence of C. diff. was defined as any evidence of new treatment or hospitalization for the infection within 4 or 8 weeks of when a patient filled the prescription for fidaxomicin or vancomycin.

The treatment groups were similar in age and race. However, the fidaxomicin group was at higher risk for recurrence, owing to risk factors such as history of C. diff. infection and compromised immunity. To reduce bias in comparing the groups, Dr. Dubberke and colleagues used propensity score matching. This approach yielded 190 matched pairs in the initial C. diff. episode sample and 67 matched pairs in the recurrent episode sample.

Among patients with their first C. diff. infection, fidaxomicin had a 13.5% higher rate of 4-week sustained response, compared with vancomycin (71.7% vs. 58.2%; P = .0058). There was also a 13.2% higher rate for 8-week sustained response with fidaxomicin (63.2% vs. 50.0%; P = .0114).

Sustained response at 4 weeks and 8 weeks among the patients who experienced a recurrent episode of C. diff. favored fidaxomicin over vancomycin by 30.1% (P = .0002) and 27.6% (P = .0012), respectively.

The rates of C. diff. recurrence in patients who experienced their first C. diff. infection or who experienced a recurrent bout were lower with fidaxomicin than vancomycin, but the differences were not statistically significant.
 

A costly edge

When asked to comment, Colleen Kelly, MD, a gastroenterologist and associate professor of medicine at Brown University, Providence, R.I., said that the study was “worthwhile” and added that “Eric Dubberke has done a lot of work in this area.”

The study “gives more evidence that fidaxomicin does have a bit of an edge in people who have already had a bout of C. diff.,” she said.

Dr. Kelly added that the cost needs to be considered. Fidaxomicin “is about 30 times more expensive than vancomycin,” she said.

In part because of the cost difference, the American College of Gastroenterology (ACG) 2021 guidelines, which Dr. Kelly helped create, recommend that fidaxomicin be held as a second-line agent. The ACG guidance reserved fidaxomicin for people with C. diff. for whom initial treatment with vancomycin failed.

“The fidaxomicin question is going to get a lot easier once the cost of the drug comes down,” Dr. Kelly said.

The study was funded by Merck. Dr. Dubberke is a consultant for Merck. Dr. Kelly reports no relevant financial relationships.

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

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Fidaxomicin (Fificid) emerged favorable to vancomycin for the treatment of both initial and recurrent Clostridioides difficile infections in a Medicare population, according to a new retrospective study.

Although fidaxomicin was about 14% more effective than vancomycin in treating the initial infection, a larger difference of 30% was found among people with recurrent C. diff. infections.

Lead investigator Erik Dubberke, MD, professor of infectious diseases at the University of Washington, St. Louis, and colleagues noted that this real-world evidence of the two agents used to treat C. diff. was “strikingly similar” to clinical trial data.

They said that their findings support the 2021 change in clinical guidelines from the Infectious Diseases Society of America recommending fidaxomicin over vancomycin.

The study was presented at Digestive Disease Week® (DDW) 2022, which was held virtually and in San Diego.
 

Evaluating a high-risk population

Because few real-world data exist that compare these two agents for C. diff., “particularly in a high-risk, high-prevalence population like Medicare,” the researchers evaluated Medicare Parts A, B, and D claims from 2016 to 2018 and included patients who had received fidaxomicin or vancomycin for an initial episode of C. diff. and for any recurrent episodes.

The researchers compared sustained response and recurrence of C. diff. within 4 weeks and 8 weeks after initial treatment with fidaxomicin or vancomycin. Treatment was considered successful if clinical resolution occurred 1 day after finishing therapy and there was no evidence of C. diff. recurrence.

Recurrence of C. diff. was defined as any evidence of new treatment or hospitalization for the infection within 4 or 8 weeks of when a patient filled the prescription for fidaxomicin or vancomycin.

The treatment groups were similar in age and race. However, the fidaxomicin group was at higher risk for recurrence, owing to risk factors such as history of C. diff. infection and compromised immunity. To reduce bias in comparing the groups, Dr. Dubberke and colleagues used propensity score matching. This approach yielded 190 matched pairs in the initial C. diff. episode sample and 67 matched pairs in the recurrent episode sample.

Among patients with their first C. diff. infection, fidaxomicin had a 13.5% higher rate of 4-week sustained response, compared with vancomycin (71.7% vs. 58.2%; P = .0058). There was also a 13.2% higher rate for 8-week sustained response with fidaxomicin (63.2% vs. 50.0%; P = .0114).

Sustained response at 4 weeks and 8 weeks among the patients who experienced a recurrent episode of C. diff. favored fidaxomicin over vancomycin by 30.1% (P = .0002) and 27.6% (P = .0012), respectively.

The rates of C. diff. recurrence in patients who experienced their first C. diff. infection or who experienced a recurrent bout were lower with fidaxomicin than vancomycin, but the differences were not statistically significant.
 

A costly edge

When asked to comment, Colleen Kelly, MD, a gastroenterologist and associate professor of medicine at Brown University, Providence, R.I., said that the study was “worthwhile” and added that “Eric Dubberke has done a lot of work in this area.”

The study “gives more evidence that fidaxomicin does have a bit of an edge in people who have already had a bout of C. diff.,” she said.

Dr. Kelly added that the cost needs to be considered. Fidaxomicin “is about 30 times more expensive than vancomycin,” she said.

In part because of the cost difference, the American College of Gastroenterology (ACG) 2021 guidelines, which Dr. Kelly helped create, recommend that fidaxomicin be held as a second-line agent. The ACG guidance reserved fidaxomicin for people with C. diff. for whom initial treatment with vancomycin failed.

“The fidaxomicin question is going to get a lot easier once the cost of the drug comes down,” Dr. Kelly said.

The study was funded by Merck. Dr. Dubberke is a consultant for Merck. Dr. Kelly reports no relevant financial relationships.

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

Fidaxomicin (Fificid) emerged favorable to vancomycin for the treatment of both initial and recurrent Clostridioides difficile infections in a Medicare population, according to a new retrospective study.

Although fidaxomicin was about 14% more effective than vancomycin in treating the initial infection, a larger difference of 30% was found among people with recurrent C. diff. infections.

Lead investigator Erik Dubberke, MD, professor of infectious diseases at the University of Washington, St. Louis, and colleagues noted that this real-world evidence of the two agents used to treat C. diff. was “strikingly similar” to clinical trial data.

They said that their findings support the 2021 change in clinical guidelines from the Infectious Diseases Society of America recommending fidaxomicin over vancomycin.

The study was presented at Digestive Disease Week® (DDW) 2022, which was held virtually and in San Diego.
 

Evaluating a high-risk population

Because few real-world data exist that compare these two agents for C. diff., “particularly in a high-risk, high-prevalence population like Medicare,” the researchers evaluated Medicare Parts A, B, and D claims from 2016 to 2018 and included patients who had received fidaxomicin or vancomycin for an initial episode of C. diff. and for any recurrent episodes.

The researchers compared sustained response and recurrence of C. diff. within 4 weeks and 8 weeks after initial treatment with fidaxomicin or vancomycin. Treatment was considered successful if clinical resolution occurred 1 day after finishing therapy and there was no evidence of C. diff. recurrence.

Recurrence of C. diff. was defined as any evidence of new treatment or hospitalization for the infection within 4 or 8 weeks of when a patient filled the prescription for fidaxomicin or vancomycin.

The treatment groups were similar in age and race. However, the fidaxomicin group was at higher risk for recurrence, owing to risk factors such as history of C. diff. infection and compromised immunity. To reduce bias in comparing the groups, Dr. Dubberke and colleagues used propensity score matching. This approach yielded 190 matched pairs in the initial C. diff. episode sample and 67 matched pairs in the recurrent episode sample.

Among patients with their first C. diff. infection, fidaxomicin had a 13.5% higher rate of 4-week sustained response, compared with vancomycin (71.7% vs. 58.2%; P = .0058). There was also a 13.2% higher rate for 8-week sustained response with fidaxomicin (63.2% vs. 50.0%; P = .0114).

Sustained response at 4 weeks and 8 weeks among the patients who experienced a recurrent episode of C. diff. favored fidaxomicin over vancomycin by 30.1% (P = .0002) and 27.6% (P = .0012), respectively.

The rates of C. diff. recurrence in patients who experienced their first C. diff. infection or who experienced a recurrent bout were lower with fidaxomicin than vancomycin, but the differences were not statistically significant.
 

A costly edge

When asked to comment, Colleen Kelly, MD, a gastroenterologist and associate professor of medicine at Brown University, Providence, R.I., said that the study was “worthwhile” and added that “Eric Dubberke has done a lot of work in this area.”

The study “gives more evidence that fidaxomicin does have a bit of an edge in people who have already had a bout of C. diff.,” she said.

Dr. Kelly added that the cost needs to be considered. Fidaxomicin “is about 30 times more expensive than vancomycin,” she said.

In part because of the cost difference, the American College of Gastroenterology (ACG) 2021 guidelines, which Dr. Kelly helped create, recommend that fidaxomicin be held as a second-line agent. The ACG guidance reserved fidaxomicin for people with C. diff. for whom initial treatment with vancomycin failed.

“The fidaxomicin question is going to get a lot easier once the cost of the drug comes down,” Dr. Kelly said.

The study was funded by Merck. Dr. Dubberke is a consultant for Merck. Dr. Kelly reports no relevant financial relationships.

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

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More evidence dementia not linked to PPI use in older people

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Tue, 05/31/2022 - 13:33

Controversy regarding the purported link between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonists (H2RAs) and risk for dementia continues.

Adding to the “no link” column comes new evidence from a study presented at the annual Digestive Disease Week® (DDW) .

Among almost 19,000 people, no association was found between the use of these agents and a greater likelihood of incident dementia, Alzheimer’s disease, or cognitive decline in people older than 65 years.

“We found that baseline PPI or H2RA use in older adults was not associated with dementia, with mild cognitive impairment, or declines in cognitive scores over time,” said lead author Raaj Shishir Mehta, MD, a gastroenterology fellow at Massachusetts General Hospital in Boston.

“While deprescribing efforts are important, especially when medications are not indicated, these data provide reassurance about the cognitive impacts of long-term use of PPIs in older adults,” he added.
 

Growing use, growing concern

As PPI use has increased worldwide, so too have concerns over the adverse effects from their long-term use, Dr. Mehta said.

“One particular area of concern, especially among older adults, is the link between long-term PPI use and risk for dementia,” he said.

Igniting the controversy was a February 2016 study published in JAMA Neurology that showed a positive association between PPI use and dementia in residents of Germany aged 75 years and older. Researchers linked PPI use to a 44% increased risk of dementia over 5 years.

The 2016 study was based on claims data, which can introduce “inaccuracy or bias in defining dementia cases,” Dr. Mehta said. He noted that it and other previous studies also were limited by an inability to account for concomitant medications or comorbidities.

To overcome these limitations in their study, Dr. Mehta and colleagues analyzed medication data collected during in-person visits and asked experts to confirm dementia outcomes. The research data come from ASPREE, a large aspirin study of 18,846 people older than 65 years in the United States and Australia. Participants were enrolled from 2010 to 2014. A total of 566 people developed incident dementia during follow-up.

The researchers had data on alcohol consumption and other lifestyle factors, as well as information on comorbidities, hospitalizations, and overall well-being.

“Perhaps the biggest strength of our study is our rigorous neurocognitive assessments,” Dr. Mehta said.

They assessed cognition at baseline and at years 1, 3, 5, and 7 using a battery of tests. An expert panel of neurologists, neuropsychologists, and geriatricians adjudicated cases of dementia, in accordance with DSM-IV criteria. If the diagnosis was unclear, they referred people for additional workup, including neuroimaging.

Cox proportional hazards, regression, and/or mixed effects modeling were used to relate medication use with cognitive scores.

All analyses were adjusted for age, sex, body mass index, alcohol use, family history of dementia, medications, and other medical comorbidities.

At baseline, PPI users were more likely to be White, have fewer years of education, and have higher rates of hypertension, diabetes, and kidney disease. This group also was more likely to be taking five or more medications.
 

 

 

Key points

During 80,976 person-years of follow-up, there were 566 incident cases of dementia, including 235 probable cases of Alzheimer’s disease and 331 other dementias.

Baseline PPI use, in comparison with nonuse, was not associated with incident dementia (hazard ratio, 0.86; 95% confidence interval, 0.70-1.05).

“Similarly, when we look specifically at Alzheimer’s disease or mixed types of dementia, we find no association between baseline PPI use and dementia,” Dr. Mehta said.

When they excluded people already taking PPIs at baseline, they found no association between starting PPIs and developing dementia over time.

Secondary aims of the study included looking for a link between PPI use and mild cognitive impairment or significant changes in cognition over time. In both cases, no association emerged. PPI use at baseline also was not associated with cognitive impairment/no dementia (also known as mild cognitive impairment) or with changes in overall cognitive test scores over time.

To determine whether any association could be a class effect of acid suppression medication, they assessed use of H2RA medications and development of incident dementia. Again, the researchers found no link.

A diverse multinational population from urban and rural areas was a strength of the study, as was the “very rigorous cognitive testing with expert adjudication of our endpoints,” Dr. Mehta said. In addition, fewer than 5% of patients were lost to follow-up.

In terms of limitations, this was an observational study “so residual confounding is always possible,” he added. “But I’ll emphasize that we are among the largest studies to date with wealth of covariates.”
 

Why the different findings?

The study was “really well done,” session moderator Paul Moayyedi, MD, said during the Q&A session at DDW 2022.

Dr. Moayyedi, a professor of medicine at McMaster University, Hamilton, Ont., asked Dr. Mehta why he “found absolutely no signal, whereas the German study did.”

“It’s a good question,” Dr. Mehta responded. “If you look across the board, there have been conflicting results.”

The disparity could be related to how researchers conducting claims data studies classify dementia, he noted.

“If you look at the nitty-gritty details over 5 years, almost 40% of participants [in those studies] end up with a diagnosis of dementia, which is quite high,” Dr. Mehta said. “That raises questions about whether the diagnosis of dementia is truly accurate.”

Dr. Mehta and Dr. Moayyedi reported no relevant financial relationships.

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

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Controversy regarding the purported link between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonists (H2RAs) and risk for dementia continues.

Adding to the “no link” column comes new evidence from a study presented at the annual Digestive Disease Week® (DDW) .

Among almost 19,000 people, no association was found between the use of these agents and a greater likelihood of incident dementia, Alzheimer’s disease, or cognitive decline in people older than 65 years.

“We found that baseline PPI or H2RA use in older adults was not associated with dementia, with mild cognitive impairment, or declines in cognitive scores over time,” said lead author Raaj Shishir Mehta, MD, a gastroenterology fellow at Massachusetts General Hospital in Boston.

“While deprescribing efforts are important, especially when medications are not indicated, these data provide reassurance about the cognitive impacts of long-term use of PPIs in older adults,” he added.
 

Growing use, growing concern

As PPI use has increased worldwide, so too have concerns over the adverse effects from their long-term use, Dr. Mehta said.

“One particular area of concern, especially among older adults, is the link between long-term PPI use and risk for dementia,” he said.

Igniting the controversy was a February 2016 study published in JAMA Neurology that showed a positive association between PPI use and dementia in residents of Germany aged 75 years and older. Researchers linked PPI use to a 44% increased risk of dementia over 5 years.

The 2016 study was based on claims data, which can introduce “inaccuracy or bias in defining dementia cases,” Dr. Mehta said. He noted that it and other previous studies also were limited by an inability to account for concomitant medications or comorbidities.

To overcome these limitations in their study, Dr. Mehta and colleagues analyzed medication data collected during in-person visits and asked experts to confirm dementia outcomes. The research data come from ASPREE, a large aspirin study of 18,846 people older than 65 years in the United States and Australia. Participants were enrolled from 2010 to 2014. A total of 566 people developed incident dementia during follow-up.

The researchers had data on alcohol consumption and other lifestyle factors, as well as information on comorbidities, hospitalizations, and overall well-being.

“Perhaps the biggest strength of our study is our rigorous neurocognitive assessments,” Dr. Mehta said.

They assessed cognition at baseline and at years 1, 3, 5, and 7 using a battery of tests. An expert panel of neurologists, neuropsychologists, and geriatricians adjudicated cases of dementia, in accordance with DSM-IV criteria. If the diagnosis was unclear, they referred people for additional workup, including neuroimaging.

Cox proportional hazards, regression, and/or mixed effects modeling were used to relate medication use with cognitive scores.

All analyses were adjusted for age, sex, body mass index, alcohol use, family history of dementia, medications, and other medical comorbidities.

At baseline, PPI users were more likely to be White, have fewer years of education, and have higher rates of hypertension, diabetes, and kidney disease. This group also was more likely to be taking five or more medications.
 

 

 

Key points

During 80,976 person-years of follow-up, there were 566 incident cases of dementia, including 235 probable cases of Alzheimer’s disease and 331 other dementias.

Baseline PPI use, in comparison with nonuse, was not associated with incident dementia (hazard ratio, 0.86; 95% confidence interval, 0.70-1.05).

“Similarly, when we look specifically at Alzheimer’s disease or mixed types of dementia, we find no association between baseline PPI use and dementia,” Dr. Mehta said.

When they excluded people already taking PPIs at baseline, they found no association between starting PPIs and developing dementia over time.

Secondary aims of the study included looking for a link between PPI use and mild cognitive impairment or significant changes in cognition over time. In both cases, no association emerged. PPI use at baseline also was not associated with cognitive impairment/no dementia (also known as mild cognitive impairment) or with changes in overall cognitive test scores over time.

To determine whether any association could be a class effect of acid suppression medication, they assessed use of H2RA medications and development of incident dementia. Again, the researchers found no link.

A diverse multinational population from urban and rural areas was a strength of the study, as was the “very rigorous cognitive testing with expert adjudication of our endpoints,” Dr. Mehta said. In addition, fewer than 5% of patients were lost to follow-up.

In terms of limitations, this was an observational study “so residual confounding is always possible,” he added. “But I’ll emphasize that we are among the largest studies to date with wealth of covariates.”
 

Why the different findings?

The study was “really well done,” session moderator Paul Moayyedi, MD, said during the Q&A session at DDW 2022.

Dr. Moayyedi, a professor of medicine at McMaster University, Hamilton, Ont., asked Dr. Mehta why he “found absolutely no signal, whereas the German study did.”

“It’s a good question,” Dr. Mehta responded. “If you look across the board, there have been conflicting results.”

The disparity could be related to how researchers conducting claims data studies classify dementia, he noted.

“If you look at the nitty-gritty details over 5 years, almost 40% of participants [in those studies] end up with a diagnosis of dementia, which is quite high,” Dr. Mehta said. “That raises questions about whether the diagnosis of dementia is truly accurate.”

Dr. Mehta and Dr. Moayyedi reported no relevant financial relationships.

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

Controversy regarding the purported link between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonists (H2RAs) and risk for dementia continues.

Adding to the “no link” column comes new evidence from a study presented at the annual Digestive Disease Week® (DDW) .

Among almost 19,000 people, no association was found between the use of these agents and a greater likelihood of incident dementia, Alzheimer’s disease, or cognitive decline in people older than 65 years.

“We found that baseline PPI or H2RA use in older adults was not associated with dementia, with mild cognitive impairment, or declines in cognitive scores over time,” said lead author Raaj Shishir Mehta, MD, a gastroenterology fellow at Massachusetts General Hospital in Boston.

“While deprescribing efforts are important, especially when medications are not indicated, these data provide reassurance about the cognitive impacts of long-term use of PPIs in older adults,” he added.
 

Growing use, growing concern

As PPI use has increased worldwide, so too have concerns over the adverse effects from their long-term use, Dr. Mehta said.

“One particular area of concern, especially among older adults, is the link between long-term PPI use and risk for dementia,” he said.

Igniting the controversy was a February 2016 study published in JAMA Neurology that showed a positive association between PPI use and dementia in residents of Germany aged 75 years and older. Researchers linked PPI use to a 44% increased risk of dementia over 5 years.

The 2016 study was based on claims data, which can introduce “inaccuracy or bias in defining dementia cases,” Dr. Mehta said. He noted that it and other previous studies also were limited by an inability to account for concomitant medications or comorbidities.

To overcome these limitations in their study, Dr. Mehta and colleagues analyzed medication data collected during in-person visits and asked experts to confirm dementia outcomes. The research data come from ASPREE, a large aspirin study of 18,846 people older than 65 years in the United States and Australia. Participants were enrolled from 2010 to 2014. A total of 566 people developed incident dementia during follow-up.

The researchers had data on alcohol consumption and other lifestyle factors, as well as information on comorbidities, hospitalizations, and overall well-being.

“Perhaps the biggest strength of our study is our rigorous neurocognitive assessments,” Dr. Mehta said.

They assessed cognition at baseline and at years 1, 3, 5, and 7 using a battery of tests. An expert panel of neurologists, neuropsychologists, and geriatricians adjudicated cases of dementia, in accordance with DSM-IV criteria. If the diagnosis was unclear, they referred people for additional workup, including neuroimaging.

Cox proportional hazards, regression, and/or mixed effects modeling were used to relate medication use with cognitive scores.

All analyses were adjusted for age, sex, body mass index, alcohol use, family history of dementia, medications, and other medical comorbidities.

At baseline, PPI users were more likely to be White, have fewer years of education, and have higher rates of hypertension, diabetes, and kidney disease. This group also was more likely to be taking five or more medications.
 

 

 

Key points

During 80,976 person-years of follow-up, there were 566 incident cases of dementia, including 235 probable cases of Alzheimer’s disease and 331 other dementias.

Baseline PPI use, in comparison with nonuse, was not associated with incident dementia (hazard ratio, 0.86; 95% confidence interval, 0.70-1.05).

“Similarly, when we look specifically at Alzheimer’s disease or mixed types of dementia, we find no association between baseline PPI use and dementia,” Dr. Mehta said.

When they excluded people already taking PPIs at baseline, they found no association between starting PPIs and developing dementia over time.

Secondary aims of the study included looking for a link between PPI use and mild cognitive impairment or significant changes in cognition over time. In both cases, no association emerged. PPI use at baseline also was not associated with cognitive impairment/no dementia (also known as mild cognitive impairment) or with changes in overall cognitive test scores over time.

To determine whether any association could be a class effect of acid suppression medication, they assessed use of H2RA medications and development of incident dementia. Again, the researchers found no link.

A diverse multinational population from urban and rural areas was a strength of the study, as was the “very rigorous cognitive testing with expert adjudication of our endpoints,” Dr. Mehta said. In addition, fewer than 5% of patients were lost to follow-up.

In terms of limitations, this was an observational study “so residual confounding is always possible,” he added. “But I’ll emphasize that we are among the largest studies to date with wealth of covariates.”
 

Why the different findings?

The study was “really well done,” session moderator Paul Moayyedi, MD, said during the Q&A session at DDW 2022.

Dr. Moayyedi, a professor of medicine at McMaster University, Hamilton, Ont., asked Dr. Mehta why he “found absolutely no signal, whereas the German study did.”

“It’s a good question,” Dr. Mehta responded. “If you look across the board, there have been conflicting results.”

The disparity could be related to how researchers conducting claims data studies classify dementia, he noted.

“If you look at the nitty-gritty details over 5 years, almost 40% of participants [in those studies] end up with a diagnosis of dementia, which is quite high,” Dr. Mehta said. “That raises questions about whether the diagnosis of dementia is truly accurate.”

Dr. Mehta and Dr. Moayyedi reported no relevant financial relationships.

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

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IBD after age 60: More evidence antibiotics play a role

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Mon, 05/23/2022 - 10:08

Something different appears to be going on when an older adult develops inflammatory bowel disease (IBD), and now researchers offer more evidence that antibiotics could be playing a role.

Most studies to date have assessed a link between antibiotics and IBD in younger patients, lead researcher Adam S. Faye, MD, said during a media briefing that previewed select research for the annual Digestive Disease Week® (DDW).

The impact of antibiotic use on the incidence of IBD in older adults is really unknown, he added.

In contrast to younger people with IBD, who tend to have a strong family history or genetic predisposition to developing Crohn’s disease or ulcerative colitis, the cause is likely different in older populations.

“There’s clearly something in the environment that’s driving this new older-onset IBD,” said Dr. Faye, who is an assistant professor of medicine and population health at New York University.
 

Antibiotics as a contributing link

Dr. Faye and colleagues took a closer look at antibiotics as contributing to this link. They studied 2.3 million patient records in Denmark’s national medical registry from 2000 to 2018. They identified people aged 60 years and older who were newly diagnosed with IBD, and they then assessed the number, frequency, and timing of any antibiotic prescriptions.

They found that IBD was 27% more likely in this age group if the patients had received any antibiotic prescription.

They also found that the chance of developing IBD was higher as the number of antibiotic prescriptions increased. For example, IBD was 55% more likely if a person had received two prescriptions, and it was 96% more likely with four prescriptions. The risk really jumped with five or more antibiotic prescriptions – a person with this many prescriptions was more than 2.3 times (236%) more likely to be diagnosed with IBD than those who had not been prescribed antibiotics in the prior 5 years.

Not all antibiotics were equal, however. For example, the investigators found no link with nitrofurantoin, an antibiotic commonly prescribed for urinary tract infections. In contrast, all other antibiotic agents that were evaluated, and especially fluoroquinolones, nitroimidazoles, and macrolides, were associated with IBD.

Timing made some difference.

“The risk was highest if antibiotics were prescribed within the 1- to 2-year period before diagnosis, and it declined as you go farther out. But the risks persist,” Dr. Faye said. He noted that they even found that risk was elevated 10 years out.

The investigators also considered whether the antibiotic agent or infection was behind the association.

Dr. Faye cited previous research, again in younger people with IBD, that revealed that “infections plus antibiotics substantially increase the odds or risk of developing IBD more than the infection alone.

“So there really does seem to be something that the antibiotics are doing here,” Dr. Faye said.

A leading theory is that antibiotics disrupt the gut microbiota and increase the risk for developing IBD. “But, obviously, it’s quite complicated,” he said.
 

Clinical implications

The findings suggest that older people who may have IBD should be screened for prior antibiotic use, Dr. Faye said.

“This is a result that really has important implications for diagnosing older adults with new gastrointestinal symptoms,” he said. “Inflammatory bowel disease often can be overlooked in older adults because there’s a lot of different diagnoses you’re thinking of.”

IBD “should be considered, especially if you have a patient who’s reporting multiple courses of antibiotics in the last few years,” he added.

The results suggest another reason that antimicrobial stewardship programs should promote judicial use of these agents beyond concerns about resistance.

“We think of antibiotic stewardship to prevent the development of multidrug-resistant organisms, but we should be thinking about it to also prevent the development of inflammatory bowel disease,” Dr. Faye said.

Although this study adds to the evidence implicating antibiotics and expands the concept to an older population, “we really don’t have a great handle on what all of the environmental and other factors are,” he said.

Some researchers point to smoking and diet, among other factors, but the interplay remains unknown, Dr. Faye added.

The study is important because the incidence of IBD is increasing within the older population, “and this is one of the first studies to look at it,” he said.

Dr. Faye and colleagues plan to start a new study to evaluate other environmental factors.

“Hopefully, we’ll have more within the next few years to report,” he said.
 

Shedding more light on older-onset IBD worldwide

“It’s a well-done study,” Aline Charabaty, MD, said in a comment. “We are seeing that there’s an increase of incidence of IBD in the entire population, but even more so in the elderly.”

IBD is likely caused by a combination of factors, including genetics, environmental influences, and dysfunction of the gut immune system, agreed Dr. Charabaty, who is an assistant clinical professor in the division of gastroenterology at Johns Hopkins University, Baltimore.

The research “goes along with other studies that we’ve done in the pediatric and adult populations that show antibiotics exposure increases the risk of developing inflammatory bowel disease,” she said.

For a broader perspective of the study’s findings, Dr. Faye was asked during the media briefing if the results of this Danish registry study would be generalizable to the U.S. population.

“The simplest answer is we’ll need to redo this study within the U.S. to make absolutely sure,” Dr. Faye said. She noted that prior studies in the United States and elsewhere have found a risk associated with antibiotics, although again these studies focused on younger patients.

Dr. Charabaty was more certain that the findings were meaningful outside of Denmark.

“I definitely think this will apply to our U.S. population,” added Dr. Charabaty, who is also the clinical director of the IBD Center at Johns Hopkins–Sibley Memorial Hospital, Washington. “We have very similar practices in terms of how we approach antibiotic use.

“This could be one of the risk factors that’s promoting an increase in IBD everywhere,” she added.

The study was conducted in partnership with the Danish National Center of Excellence PREDICT Program. Dr. Faye and Dr. Charabaty did not report any conflicts of interest related to this study.

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

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Something different appears to be going on when an older adult develops inflammatory bowel disease (IBD), and now researchers offer more evidence that antibiotics could be playing a role.

Most studies to date have assessed a link between antibiotics and IBD in younger patients, lead researcher Adam S. Faye, MD, said during a media briefing that previewed select research for the annual Digestive Disease Week® (DDW).

The impact of antibiotic use on the incidence of IBD in older adults is really unknown, he added.

In contrast to younger people with IBD, who tend to have a strong family history or genetic predisposition to developing Crohn’s disease or ulcerative colitis, the cause is likely different in older populations.

“There’s clearly something in the environment that’s driving this new older-onset IBD,” said Dr. Faye, who is an assistant professor of medicine and population health at New York University.
 

Antibiotics as a contributing link

Dr. Faye and colleagues took a closer look at antibiotics as contributing to this link. They studied 2.3 million patient records in Denmark’s national medical registry from 2000 to 2018. They identified people aged 60 years and older who were newly diagnosed with IBD, and they then assessed the number, frequency, and timing of any antibiotic prescriptions.

They found that IBD was 27% more likely in this age group if the patients had received any antibiotic prescription.

They also found that the chance of developing IBD was higher as the number of antibiotic prescriptions increased. For example, IBD was 55% more likely if a person had received two prescriptions, and it was 96% more likely with four prescriptions. The risk really jumped with five or more antibiotic prescriptions – a person with this many prescriptions was more than 2.3 times (236%) more likely to be diagnosed with IBD than those who had not been prescribed antibiotics in the prior 5 years.

Not all antibiotics were equal, however. For example, the investigators found no link with nitrofurantoin, an antibiotic commonly prescribed for urinary tract infections. In contrast, all other antibiotic agents that were evaluated, and especially fluoroquinolones, nitroimidazoles, and macrolides, were associated with IBD.

Timing made some difference.

“The risk was highest if antibiotics were prescribed within the 1- to 2-year period before diagnosis, and it declined as you go farther out. But the risks persist,” Dr. Faye said. He noted that they even found that risk was elevated 10 years out.

The investigators also considered whether the antibiotic agent or infection was behind the association.

Dr. Faye cited previous research, again in younger people with IBD, that revealed that “infections plus antibiotics substantially increase the odds or risk of developing IBD more than the infection alone.

“So there really does seem to be something that the antibiotics are doing here,” Dr. Faye said.

A leading theory is that antibiotics disrupt the gut microbiota and increase the risk for developing IBD. “But, obviously, it’s quite complicated,” he said.
 

Clinical implications

The findings suggest that older people who may have IBD should be screened for prior antibiotic use, Dr. Faye said.

“This is a result that really has important implications for diagnosing older adults with new gastrointestinal symptoms,” he said. “Inflammatory bowel disease often can be overlooked in older adults because there’s a lot of different diagnoses you’re thinking of.”

IBD “should be considered, especially if you have a patient who’s reporting multiple courses of antibiotics in the last few years,” he added.

The results suggest another reason that antimicrobial stewardship programs should promote judicial use of these agents beyond concerns about resistance.

“We think of antibiotic stewardship to prevent the development of multidrug-resistant organisms, but we should be thinking about it to also prevent the development of inflammatory bowel disease,” Dr. Faye said.

Although this study adds to the evidence implicating antibiotics and expands the concept to an older population, “we really don’t have a great handle on what all of the environmental and other factors are,” he said.

Some researchers point to smoking and diet, among other factors, but the interplay remains unknown, Dr. Faye added.

The study is important because the incidence of IBD is increasing within the older population, “and this is one of the first studies to look at it,” he said.

Dr. Faye and colleagues plan to start a new study to evaluate other environmental factors.

“Hopefully, we’ll have more within the next few years to report,” he said.
 

Shedding more light on older-onset IBD worldwide

“It’s a well-done study,” Aline Charabaty, MD, said in a comment. “We are seeing that there’s an increase of incidence of IBD in the entire population, but even more so in the elderly.”

IBD is likely caused by a combination of factors, including genetics, environmental influences, and dysfunction of the gut immune system, agreed Dr. Charabaty, who is an assistant clinical professor in the division of gastroenterology at Johns Hopkins University, Baltimore.

The research “goes along with other studies that we’ve done in the pediatric and adult populations that show antibiotics exposure increases the risk of developing inflammatory bowel disease,” she said.

For a broader perspective of the study’s findings, Dr. Faye was asked during the media briefing if the results of this Danish registry study would be generalizable to the U.S. population.

“The simplest answer is we’ll need to redo this study within the U.S. to make absolutely sure,” Dr. Faye said. She noted that prior studies in the United States and elsewhere have found a risk associated with antibiotics, although again these studies focused on younger patients.

Dr. Charabaty was more certain that the findings were meaningful outside of Denmark.

“I definitely think this will apply to our U.S. population,” added Dr. Charabaty, who is also the clinical director of the IBD Center at Johns Hopkins–Sibley Memorial Hospital, Washington. “We have very similar practices in terms of how we approach antibiotic use.

“This could be one of the risk factors that’s promoting an increase in IBD everywhere,” she added.

The study was conducted in partnership with the Danish National Center of Excellence PREDICT Program. Dr. Faye and Dr. Charabaty did not report any conflicts of interest related to this study.

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

Something different appears to be going on when an older adult develops inflammatory bowel disease (IBD), and now researchers offer more evidence that antibiotics could be playing a role.

Most studies to date have assessed a link between antibiotics and IBD in younger patients, lead researcher Adam S. Faye, MD, said during a media briefing that previewed select research for the annual Digestive Disease Week® (DDW).

The impact of antibiotic use on the incidence of IBD in older adults is really unknown, he added.

In contrast to younger people with IBD, who tend to have a strong family history or genetic predisposition to developing Crohn’s disease or ulcerative colitis, the cause is likely different in older populations.

“There’s clearly something in the environment that’s driving this new older-onset IBD,” said Dr. Faye, who is an assistant professor of medicine and population health at New York University.
 

Antibiotics as a contributing link

Dr. Faye and colleagues took a closer look at antibiotics as contributing to this link. They studied 2.3 million patient records in Denmark’s national medical registry from 2000 to 2018. They identified people aged 60 years and older who were newly diagnosed with IBD, and they then assessed the number, frequency, and timing of any antibiotic prescriptions.

They found that IBD was 27% more likely in this age group if the patients had received any antibiotic prescription.

They also found that the chance of developing IBD was higher as the number of antibiotic prescriptions increased. For example, IBD was 55% more likely if a person had received two prescriptions, and it was 96% more likely with four prescriptions. The risk really jumped with five or more antibiotic prescriptions – a person with this many prescriptions was more than 2.3 times (236%) more likely to be diagnosed with IBD than those who had not been prescribed antibiotics in the prior 5 years.

Not all antibiotics were equal, however. For example, the investigators found no link with nitrofurantoin, an antibiotic commonly prescribed for urinary tract infections. In contrast, all other antibiotic agents that were evaluated, and especially fluoroquinolones, nitroimidazoles, and macrolides, were associated with IBD.

Timing made some difference.

“The risk was highest if antibiotics were prescribed within the 1- to 2-year period before diagnosis, and it declined as you go farther out. But the risks persist,” Dr. Faye said. He noted that they even found that risk was elevated 10 years out.

The investigators also considered whether the antibiotic agent or infection was behind the association.

Dr. Faye cited previous research, again in younger people with IBD, that revealed that “infections plus antibiotics substantially increase the odds or risk of developing IBD more than the infection alone.

“So there really does seem to be something that the antibiotics are doing here,” Dr. Faye said.

A leading theory is that antibiotics disrupt the gut microbiota and increase the risk for developing IBD. “But, obviously, it’s quite complicated,” he said.
 

Clinical implications

The findings suggest that older people who may have IBD should be screened for prior antibiotic use, Dr. Faye said.

“This is a result that really has important implications for diagnosing older adults with new gastrointestinal symptoms,” he said. “Inflammatory bowel disease often can be overlooked in older adults because there’s a lot of different diagnoses you’re thinking of.”

IBD “should be considered, especially if you have a patient who’s reporting multiple courses of antibiotics in the last few years,” he added.

The results suggest another reason that antimicrobial stewardship programs should promote judicial use of these agents beyond concerns about resistance.

“We think of antibiotic stewardship to prevent the development of multidrug-resistant organisms, but we should be thinking about it to also prevent the development of inflammatory bowel disease,” Dr. Faye said.

Although this study adds to the evidence implicating antibiotics and expands the concept to an older population, “we really don’t have a great handle on what all of the environmental and other factors are,” he said.

Some researchers point to smoking and diet, among other factors, but the interplay remains unknown, Dr. Faye added.

The study is important because the incidence of IBD is increasing within the older population, “and this is one of the first studies to look at it,” he said.

Dr. Faye and colleagues plan to start a new study to evaluate other environmental factors.

“Hopefully, we’ll have more within the next few years to report,” he said.
 

Shedding more light on older-onset IBD worldwide

“It’s a well-done study,” Aline Charabaty, MD, said in a comment. “We are seeing that there’s an increase of incidence of IBD in the entire population, but even more so in the elderly.”

IBD is likely caused by a combination of factors, including genetics, environmental influences, and dysfunction of the gut immune system, agreed Dr. Charabaty, who is an assistant clinical professor in the division of gastroenterology at Johns Hopkins University, Baltimore.

The research “goes along with other studies that we’ve done in the pediatric and adult populations that show antibiotics exposure increases the risk of developing inflammatory bowel disease,” she said.

For a broader perspective of the study’s findings, Dr. Faye was asked during the media briefing if the results of this Danish registry study would be generalizable to the U.S. population.

“The simplest answer is we’ll need to redo this study within the U.S. to make absolutely sure,” Dr. Faye said. She noted that prior studies in the United States and elsewhere have found a risk associated with antibiotics, although again these studies focused on younger patients.

Dr. Charabaty was more certain that the findings were meaningful outside of Denmark.

“I definitely think this will apply to our U.S. population,” added Dr. Charabaty, who is also the clinical director of the IBD Center at Johns Hopkins–Sibley Memorial Hospital, Washington. “We have very similar practices in terms of how we approach antibiotic use.

“This could be one of the risk factors that’s promoting an increase in IBD everywhere,” she added.

The study was conducted in partnership with the Danish National Center of Excellence PREDICT Program. Dr. Faye and Dr. Charabaty did not report any conflicts of interest related to this study.

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

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