Dermatology News

ORLANDO – Dermatologists may have to contend with some of mankind’s oldest diseases – from group A streptococcus to measles – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1_UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.

“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”

Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”

2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.

“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.

In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.

“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”

One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.

“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”

Dr. Finch reported no relevant conflicts of interest.

ORLANDO – Dermatologists may have to contend with some of mankind’s oldest diseases – from group A streptococcus to measles – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1_UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.

“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”

Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”

2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.

“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.

In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.

“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”

One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.

“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”

Dr. Finch reported no relevant conflicts of interest.

ORLANDO – Dermatologists may have to contend with some of mankind’s oldest diseases – from group A streptococcus to measles – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1_UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.

“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”

Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”

2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.

“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.

In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.

“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”

One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.

“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”

Dr. Finch reported no relevant conflicts of interest.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

LONDON – Treatment with the antihypertensive drug losartan raised no safety concerns in the treatment of children with epidermolysis bullosa (EB) and reduced signs of fibrosis in an early clinical study.

In the ongoing phase 1/2 REFLECT (Recessive dystrophic EB: Mechanisms of fibrosis and its prevention with Losartan in vivo) trial, involving 29 children, no severe complications have been noted so far, according to one of the study investigators, Dimitra Kiritsi, MD, of the University of Freiburg, Germany. At the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA), she presented interim data on 18 patients in the trial, emphasizing that the primary aim of the trial was to evaluate the safety of this treatment approach.

Over the 2 years the trial has been underway, 65 adverse events have been reported, of which 4 have been severe. Two of these were bacterial infections that required hospital treatment and the other two were a reduction in the general health condition of the child.

Losartan is an angiotensin-II receptor blocker (ARB) that has been in clinical use for more than 25 years in adults and 15 years in children over the age of 6 years.

The drug may be used for treating recessive dystrophic EB (RDEB) in the future, Dr. Kiritsi said, because it attenuates tumor necrosis factor–beta (TGF-beta) signaling, which is thought to be involved in the fibrotic process. So while it may not target the genetic defect, it could help ameliorate the effects of the disease.

The precursor to REFLECT was a study performed in a mouse disease model of EB (EMBO Mol Med. 2015;7:1211-28) where a reduction in fibrotic scarring was seen with losartan with “remarkable effects” on “mitten” deformity, Dr. Kiritsi said. The results of that study suggested that the earlier treatment with losartan was started in the course of the disease, the better the effect, she added. (Mitten deformity is the result of fused skin between the fingers or toes, and the subsequent buildup of fibrotic tissue causes the hand or foot to contract.)

REFLECT is an investigator-initiated trial that started in 2017 and is being funded by DEBRA International. It is a dual-center, nonrandomized, single-arm study in which children aged 3-16 years with RDEB are treated with losartan for 10 months, with follow-up at 3 months.

Various secondary endpoints were included to look for the first signs of any efficacy: the Physician’s Global Assessment (PGA), the Birmingham Epidermolysis Bullosa Severity Score (BEBS), the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), the Itch Assessment Scale for the Pediatric Burn Patients, and two quality of life indices: the Quality of Life in EB (QOLEB) questionnaire and the Children’s Dermatology Life Quality Index (CDLQI).

Dr. Kiritsi highlighted a few of the secondary endpoint findings, saying that reduced BEBS scores showed there was “amelioration of the patients’ phenotype” and that EBDASI scores also decreased, with “nearly 60% of the patients having significant improvement of their skin disease.” Importantly, itch improved in most of the patients, she said. Reductions in CDLQI were observed, “meaning that quality of life was significantly better at the end of the trial.” There were also decreases in inflammatory markers, such as C-reactive protein, interleukin-6, and TNF-alpha.

Although there is no validated tool available to assess hand function, Dr. Kiritsi and her team used their own morphometric scoring instrument to measure how far the hand could stretch; their evaluations suggested that this measure improved – or at least did not worsen – with losartan treatment, she noted.

A larger, randomized trial is needed to confirm if there is any benefit of losartan, but first, a new, easy-to-swallow losartan formulation needs to be developed specifically for EB in the pediatric population, Dr. Kiritsi said. Although a pediatric suspension of losartan was previously available, it is no longer on the market, so the next step is to develop a formulation that could be used in a pivotal clinical trial, she noted.

“Losartan faces fewer technical hurdles compared to other novel treatments as it is an established medicine,” Dr. Kiritsi and associates observed in a poster presentation. There are still economic hurdles, however, since “with losartan patents expired, companies cannot expect to recoup an investment into clinical studies” and alternative funding sources are needed.

In 2019, losartan was granted an orphan drug designation for the treatment of EB from both the Food and Drug Administration and the European Medicines Agency, but its use remains off label in children. “We decided to treat children,” Dr. Kiritsi said, “because we wanted to start as early as possible. If you already have mitten deformities, these cannot be reversed.”

DEBRA International funded the study. Dr. Kiritsi received research support from Rheacell GmbH and honoraria or consultation fees from Amryt Pharma and Rheacell GmbH. She has received other support from DEBRA International, EB Research Partnership, Fritz Thyssen Stiftung, German Research Foundation (funding of research projects), and 3R Pharma Consulting and Midas Pharma GmbH (consultation for losartan new drug formulation).

SOURCE: Kiritsi D et al. EB 2020. Poster 47.
 

LONDON – Treatment with the antihypertensive drug losartan raised no safety concerns in the treatment of children with epidermolysis bullosa (EB) and reduced signs of fibrosis in an early clinical study.

In the ongoing phase 1/2 REFLECT (Recessive dystrophic EB: Mechanisms of fibrosis and its prevention with Losartan in vivo) trial, involving 29 children, no severe complications have been noted so far, according to one of the study investigators, Dimitra Kiritsi, MD, of the University of Freiburg, Germany. At the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA), she presented interim data on 18 patients in the trial, emphasizing that the primary aim of the trial was to evaluate the safety of this treatment approach.

Over the 2 years the trial has been underway, 65 adverse events have been reported, of which 4 have been severe. Two of these were bacterial infections that required hospital treatment and the other two were a reduction in the general health condition of the child.

Losartan is an angiotensin-II receptor blocker (ARB) that has been in clinical use for more than 25 years in adults and 15 years in children over the age of 6 years.

The drug may be used for treating recessive dystrophic EB (RDEB) in the future, Dr. Kiritsi said, because it attenuates tumor necrosis factor–beta (TGF-beta) signaling, which is thought to be involved in the fibrotic process. So while it may not target the genetic defect, it could help ameliorate the effects of the disease.

The precursor to REFLECT was a study performed in a mouse disease model of EB (EMBO Mol Med. 2015;7:1211-28) where a reduction in fibrotic scarring was seen with losartan with “remarkable effects” on “mitten” deformity, Dr. Kiritsi said. The results of that study suggested that the earlier treatment with losartan was started in the course of the disease, the better the effect, she added. (Mitten deformity is the result of fused skin between the fingers or toes, and the subsequent buildup of fibrotic tissue causes the hand or foot to contract.)

REFLECT is an investigator-initiated trial that started in 2017 and is being funded by DEBRA International. It is a dual-center, nonrandomized, single-arm study in which children aged 3-16 years with RDEB are treated with losartan for 10 months, with follow-up at 3 months.

Various secondary endpoints were included to look for the first signs of any efficacy: the Physician’s Global Assessment (PGA), the Birmingham Epidermolysis Bullosa Severity Score (BEBS), the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), the Itch Assessment Scale for the Pediatric Burn Patients, and two quality of life indices: the Quality of Life in EB (QOLEB) questionnaire and the Children’s Dermatology Life Quality Index (CDLQI).

Dr. Kiritsi highlighted a few of the secondary endpoint findings, saying that reduced BEBS scores showed there was “amelioration of the patients’ phenotype” and that EBDASI scores also decreased, with “nearly 60% of the patients having significant improvement of their skin disease.” Importantly, itch improved in most of the patients, she said. Reductions in CDLQI were observed, “meaning that quality of life was significantly better at the end of the trial.” There were also decreases in inflammatory markers, such as C-reactive protein, interleukin-6, and TNF-alpha.

Although there is no validated tool available to assess hand function, Dr. Kiritsi and her team used their own morphometric scoring instrument to measure how far the hand could stretch; their evaluations suggested that this measure improved – or at least did not worsen – with losartan treatment, she noted.

A larger, randomized trial is needed to confirm if there is any benefit of losartan, but first, a new, easy-to-swallow losartan formulation needs to be developed specifically for EB in the pediatric population, Dr. Kiritsi said. Although a pediatric suspension of losartan was previously available, it is no longer on the market, so the next step is to develop a formulation that could be used in a pivotal clinical trial, she noted.

“Losartan faces fewer technical hurdles compared to other novel treatments as it is an established medicine,” Dr. Kiritsi and associates observed in a poster presentation. There are still economic hurdles, however, since “with losartan patents expired, companies cannot expect to recoup an investment into clinical studies” and alternative funding sources are needed.

In 2019, losartan was granted an orphan drug designation for the treatment of EB from both the Food and Drug Administration and the European Medicines Agency, but its use remains off label in children. “We decided to treat children,” Dr. Kiritsi said, “because we wanted to start as early as possible. If you already have mitten deformities, these cannot be reversed.”

DEBRA International funded the study. Dr. Kiritsi received research support from Rheacell GmbH and honoraria or consultation fees from Amryt Pharma and Rheacell GmbH. She has received other support from DEBRA International, EB Research Partnership, Fritz Thyssen Stiftung, German Research Foundation (funding of research projects), and 3R Pharma Consulting and Midas Pharma GmbH (consultation for losartan new drug formulation).

SOURCE: Kiritsi D et al. EB 2020. Poster 47.
 

LONDON – Treatment with the antihypertensive drug losartan raised no safety concerns in the treatment of children with epidermolysis bullosa (EB) and reduced signs of fibrosis in an early clinical study.

In the ongoing phase 1/2 REFLECT (Recessive dystrophic EB: Mechanisms of fibrosis and its prevention with Losartan in vivo) trial, involving 29 children, no severe complications have been noted so far, according to one of the study investigators, Dimitra Kiritsi, MD, of the University of Freiburg, Germany. At the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA), she presented interim data on 18 patients in the trial, emphasizing that the primary aim of the trial was to evaluate the safety of this treatment approach.

Over the 2 years the trial has been underway, 65 adverse events have been reported, of which 4 have been severe. Two of these were bacterial infections that required hospital treatment and the other two were a reduction in the general health condition of the child.

Losartan is an angiotensin-II receptor blocker (ARB) that has been in clinical use for more than 25 years in adults and 15 years in children over the age of 6 years.

The drug may be used for treating recessive dystrophic EB (RDEB) in the future, Dr. Kiritsi said, because it attenuates tumor necrosis factor–beta (TGF-beta) signaling, which is thought to be involved in the fibrotic process. So while it may not target the genetic defect, it could help ameliorate the effects of the disease.

The precursor to REFLECT was a study performed in a mouse disease model of EB (EMBO Mol Med. 2015;7:1211-28) where a reduction in fibrotic scarring was seen with losartan with “remarkable effects” on “mitten” deformity, Dr. Kiritsi said. The results of that study suggested that the earlier treatment with losartan was started in the course of the disease, the better the effect, she added. (Mitten deformity is the result of fused skin between the fingers or toes, and the subsequent buildup of fibrotic tissue causes the hand or foot to contract.)

REFLECT is an investigator-initiated trial that started in 2017 and is being funded by DEBRA International. It is a dual-center, nonrandomized, single-arm study in which children aged 3-16 years with RDEB are treated with losartan for 10 months, with follow-up at 3 months.

Various secondary endpoints were included to look for the first signs of any efficacy: the Physician’s Global Assessment (PGA), the Birmingham Epidermolysis Bullosa Severity Score (BEBS), the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), the Itch Assessment Scale for the Pediatric Burn Patients, and two quality of life indices: the Quality of Life in EB (QOLEB) questionnaire and the Children’s Dermatology Life Quality Index (CDLQI).

Dr. Kiritsi highlighted a few of the secondary endpoint findings, saying that reduced BEBS scores showed there was “amelioration of the patients’ phenotype” and that EBDASI scores also decreased, with “nearly 60% of the patients having significant improvement of their skin disease.” Importantly, itch improved in most of the patients, she said. Reductions in CDLQI were observed, “meaning that quality of life was significantly better at the end of the trial.” There were also decreases in inflammatory markers, such as C-reactive protein, interleukin-6, and TNF-alpha.

Although there is no validated tool available to assess hand function, Dr. Kiritsi and her team used their own morphometric scoring instrument to measure how far the hand could stretch; their evaluations suggested that this measure improved – or at least did not worsen – with losartan treatment, she noted.

A larger, randomized trial is needed to confirm if there is any benefit of losartan, but first, a new, easy-to-swallow losartan formulation needs to be developed specifically for EB in the pediatric population, Dr. Kiritsi said. Although a pediatric suspension of losartan was previously available, it is no longer on the market, so the next step is to develop a formulation that could be used in a pivotal clinical trial, she noted.

“Losartan faces fewer technical hurdles compared to other novel treatments as it is an established medicine,” Dr. Kiritsi and associates observed in a poster presentation. There are still economic hurdles, however, since “with losartan patents expired, companies cannot expect to recoup an investment into clinical studies” and alternative funding sources are needed.

In 2019, losartan was granted an orphan drug designation for the treatment of EB from both the Food and Drug Administration and the European Medicines Agency, but its use remains off label in children. “We decided to treat children,” Dr. Kiritsi said, “because we wanted to start as early as possible. If you already have mitten deformities, these cannot be reversed.”

DEBRA International funded the study. Dr. Kiritsi received research support from Rheacell GmbH and honoraria or consultation fees from Amryt Pharma and Rheacell GmbH. She has received other support from DEBRA International, EB Research Partnership, Fritz Thyssen Stiftung, German Research Foundation (funding of research projects), and 3R Pharma Consulting and Midas Pharma GmbH (consultation for losartan new drug formulation).

SOURCE: Kiritsi D et al. EB 2020. Poster 47.
 

The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.

The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.

Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.

For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.

“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.

Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.

All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*

HPV

The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.

“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”

“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.

Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.

Influenza, hepatitis A and B

For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.

Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.

For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.

Meningitis B

Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.

Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.

Td/Tdap, varicella

The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.

Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.

Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”

In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.

Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.

As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.

The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.

The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine. 

The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.

The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.

Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.

For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.

“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.

Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.

All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*

HPV

The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.

“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”

“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.

Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.

Influenza, hepatitis A and B

For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.

Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.

For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.

Meningitis B

Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.

Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.

Td/Tdap, varicella

The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.

Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.

Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”

In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.

Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.

As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.

The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.

The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine. 

The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.

The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.

Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.

For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.

“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.

Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.

All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*

HPV

The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.

“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”

“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.

Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.

Influenza, hepatitis A and B

For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.

Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.

For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.

Meningitis B

Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.

Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.

Td/Tdap, varicella

The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.

Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.

Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”

In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.

Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.

As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.

The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.

The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine. 

A new line of Barbie dolls unveiled by Mattel earlier this month includes one with vitiligo, much to the delight of clinicians who treat children and adolescents with the condition.

Mattel, Inc.

“When I see young children and adolescents with vitiligo, it is very common for me to feel their emotional suffering from their skin condition,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center in Dallas said in an interview. “Kids can be cruel. Name calling, social ostracizing, [and] effects on self-esteem are all things I have seen amongst my patients and their families in their own struggles with vitiligo.”

According to a brand communications representative from toymaker Mattel, which began manufacturing Barbie dolls in 1959, the company worked with a board-certified dermatologist to include a doll with vitiligo in its 2020 “Fashionistas” line. “As we continue to redefine what it means to be a ‘Barbie’ or look like Barbie, offering a doll with vitiligo in our main doll line allows kids to play out even more stories they see in the world around them,” the representative wrote in an email message. Other dolls debuting as part of the lineup include one with no hair, one with a darker skin tone that uses a gold prosthetic limb, and a Ken doll with long rooted hair (think Jeff Spicoli in “Fast Times at Ridgemont High,” but about six inches longer).

Such efforts to celebrate diversity and inclusiveness go far in helping children and young adults to embrace their skin and their own identities, said Dr. Desai, the immediate past president of the Skin of Color Society and a member of the American Academy of Dermatology board of directors. “One nuance, perhaps even more important, is that the Barbie can help to break down barriers, create awareness, and potentially even reduce bullying, stigma, and lack of knowledge about vitiligo amongst the general public who don’t understand vitiligo,” he said. “I hope the public and social media will embrace this new Barbie. Who knows? Pretty soon, vitiligo may no longer be a ‘thing’ that causes ‘stares’ and ‘glares.’ ”

Referring to the Barbie with no hair in the new line of dolls, the Mattel statement said, “ if a girl is experiencing hair loss for any reason, she can see herself reflected in the line.”

Mattel, Inc.

In 2019, Mattel introduced a lineup of Barbie dolls reflecting permanent disabilities, including one with a prosthetic limb. For that effort, the company collaborated with then-12-year-old Jordan Reeves, the “Born Just Right” coauthor “who is on a mission to build creative solutions that help kids with disabilities, to create a play experience that is as representative as possible,” the Mattel representative wrote.

[email protected]

A new line of Barbie dolls unveiled by Mattel earlier this month includes one with vitiligo, much to the delight of clinicians who treat children and adolescents with the condition.

Mattel, Inc.

“When I see young children and adolescents with vitiligo, it is very common for me to feel their emotional suffering from their skin condition,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center in Dallas said in an interview. “Kids can be cruel. Name calling, social ostracizing, [and] effects on self-esteem are all things I have seen amongst my patients and their families in their own struggles with vitiligo.”

According to a brand communications representative from toymaker Mattel, which began manufacturing Barbie dolls in 1959, the company worked with a board-certified dermatologist to include a doll with vitiligo in its 2020 “Fashionistas” line. “As we continue to redefine what it means to be a ‘Barbie’ or look like Barbie, offering a doll with vitiligo in our main doll line allows kids to play out even more stories they see in the world around them,” the representative wrote in an email message. Other dolls debuting as part of the lineup include one with no hair, one with a darker skin tone that uses a gold prosthetic limb, and a Ken doll with long rooted hair (think Jeff Spicoli in “Fast Times at Ridgemont High,” but about six inches longer).

Such efforts to celebrate diversity and inclusiveness go far in helping children and young adults to embrace their skin and their own identities, said Dr. Desai, the immediate past president of the Skin of Color Society and a member of the American Academy of Dermatology board of directors. “One nuance, perhaps even more important, is that the Barbie can help to break down barriers, create awareness, and potentially even reduce bullying, stigma, and lack of knowledge about vitiligo amongst the general public who don’t understand vitiligo,” he said. “I hope the public and social media will embrace this new Barbie. Who knows? Pretty soon, vitiligo may no longer be a ‘thing’ that causes ‘stares’ and ‘glares.’ ”

Referring to the Barbie with no hair in the new line of dolls, the Mattel statement said, “ if a girl is experiencing hair loss for any reason, she can see herself reflected in the line.”

Mattel, Inc.

In 2019, Mattel introduced a lineup of Barbie dolls reflecting permanent disabilities, including one with a prosthetic limb. For that effort, the company collaborated with then-12-year-old Jordan Reeves, the “Born Just Right” coauthor “who is on a mission to build creative solutions that help kids with disabilities, to create a play experience that is as representative as possible,” the Mattel representative wrote.

[email protected]

A new line of Barbie dolls unveiled by Mattel earlier this month includes one with vitiligo, much to the delight of clinicians who treat children and adolescents with the condition.

Mattel, Inc.

“When I see young children and adolescents with vitiligo, it is very common for me to feel their emotional suffering from their skin condition,” Seemal R. Desai, MD, a dermatologist at the University of Texas Southwestern Medical Center in Dallas said in an interview. “Kids can be cruel. Name calling, social ostracizing, [and] effects on self-esteem are all things I have seen amongst my patients and their families in their own struggles with vitiligo.”

According to a brand communications representative from toymaker Mattel, which began manufacturing Barbie dolls in 1959, the company worked with a board-certified dermatologist to include a doll with vitiligo in its 2020 “Fashionistas” line. “As we continue to redefine what it means to be a ‘Barbie’ or look like Barbie, offering a doll with vitiligo in our main doll line allows kids to play out even more stories they see in the world around them,” the representative wrote in an email message. Other dolls debuting as part of the lineup include one with no hair, one with a darker skin tone that uses a gold prosthetic limb, and a Ken doll with long rooted hair (think Jeff Spicoli in “Fast Times at Ridgemont High,” but about six inches longer).

Such efforts to celebrate diversity and inclusiveness go far in helping children and young adults to embrace their skin and their own identities, said Dr. Desai, the immediate past president of the Skin of Color Society and a member of the American Academy of Dermatology board of directors. “One nuance, perhaps even more important, is that the Barbie can help to break down barriers, create awareness, and potentially even reduce bullying, stigma, and lack of knowledge about vitiligo amongst the general public who don’t understand vitiligo,” he said. “I hope the public and social media will embrace this new Barbie. Who knows? Pretty soon, vitiligo may no longer be a ‘thing’ that causes ‘stares’ and ‘glares.’ ”

Referring to the Barbie with no hair in the new line of dolls, the Mattel statement said, “ if a girl is experiencing hair loss for any reason, she can see herself reflected in the line.”

Mattel, Inc.

In 2019, Mattel introduced a lineup of Barbie dolls reflecting permanent disabilities, including one with a prosthetic limb. For that effort, the company collaborated with then-12-year-old Jordan Reeves, the “Born Just Right” coauthor “who is on a mission to build creative solutions that help kids with disabilities, to create a play experience that is as representative as possible,” the Mattel representative wrote.

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

LONDON – More than £2.8 million (almost $3.7 million) was spent every year on wound dressings and bandages for treatment in a group of 60 people with recessive dystrophic epidermolysis bullosa (RDEB), according to a report at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA).

Results from the Prospective Epidermolysis Bullosa Longitudinal Evaluation Study (PEBLES), which is looking at the natural history of RDEB, showed that wound dressing and bandage costs were highest for study participants with the generalized severe (RDEB-GS) subtype, at just over £85,156 (about $112,450) per patient annually. Respective yearly costs for the generalized intermediate (RDEB-GI) and inversa (RDEB-INV) subtypes were £10,112 (about $13,350) and £1,699 (about $2,240) per patient.

Looking at the costs associated with EB is important, said one of the lead investigators for PEBLES, Jemima Mellerio, MD, FRCP, consultant dermatologist at St John’s Institute of Dermatology, at Guy’s & St. Thomas’ NHS Foundation Trust, London.

“If we are going to justify the kind of expenditure [associated with new treatments], we need to know that what we are treating is already a significant burden on our health care systems,” Dr. Mellerio said.

PEBLES is an ongoing London-based registry study that is enrolling patients with all subtypes of RDEB. Data are collected via a tablet device and include demographic data, information on clinical features, results of skin biopsies and genetic tests, and laboratory findings, as well as objective disease severity and subjective patient-orientated outcome scores.

So far, 60 patients – 49 adults and 11 children – have been enrolled in PEBLES since November 2014: 26 with RDEB-GS, 23 with RDEB-GI, 9 with RDEB-INV, and 2 with the pruriginosa RDEB subtype (RDEB-PR).

Most of the participants (71%) changed all their wound dressings at one time, patching up when required. Fourteen of 49 participants had paid people to help them change their dressings and when the total cost of combined wound dressings and paid care was taken into consideration, the mean annual cost per patient was around £2,500 (about $3,300) for RDEB-INV, £10,375 (about $13,700) per patient for RDEB-GS, and a staggering £98,000 (about $129,000) per patient for RDEB-GS. The total annual cost of dressings and associated care was an estimated £3,184,229 (about $4.2 million).

In addition to data on the cost of wound dressings, data on itch and pain and quality of life were presented at the EB World Congress and discussed by Dr. Mellerio.

A total of 42 participants older than 8 years of age had itch measured via the Leuven Itch Scale, she reported, noting that itch was a consistent symptom across all subtypes of RDEB. Itch is important as it not only causes problems with skin lesions and healing, but also significantly affects sleep and has a negative impact on patients’ mood, she emphasized.

xtrekx/iStock/Getty Images Plus

SOURCE: Mellerio JE et al. EB 2020. Pillay EI et al. Poster 77; Jeffs E et al. Poster 74; Jeffs et al. Poster 75. https://ebworldcongress.org/.

LONDON – More than £2.8 million (almost $3.7 million) was spent every year on wound dressings and bandages for treatment in a group of 60 people with recessive dystrophic epidermolysis bullosa (RDEB), according to a report at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA).

Results from the Prospective Epidermolysis Bullosa Longitudinal Evaluation Study (PEBLES), which is looking at the natural history of RDEB, showed that wound dressing and bandage costs were highest for study participants with the generalized severe (RDEB-GS) subtype, at just over £85,156 (about $112,450) per patient annually. Respective yearly costs for the generalized intermediate (RDEB-GI) and inversa (RDEB-INV) subtypes were £10,112 (about $13,350) and £1,699 (about $2,240) per patient.

Looking at the costs associated with EB is important, said one of the lead investigators for PEBLES, Jemima Mellerio, MD, FRCP, consultant dermatologist at St John’s Institute of Dermatology, at Guy’s & St. Thomas’ NHS Foundation Trust, London.

“If we are going to justify the kind of expenditure [associated with new treatments], we need to know that what we are treating is already a significant burden on our health care systems,” Dr. Mellerio said.

PEBLES is an ongoing London-based registry study that is enrolling patients with all subtypes of RDEB. Data are collected via a tablet device and include demographic data, information on clinical features, results of skin biopsies and genetic tests, and laboratory findings, as well as objective disease severity and subjective patient-orientated outcome scores.

So far, 60 patients – 49 adults and 11 children – have been enrolled in PEBLES since November 2014: 26 with RDEB-GS, 23 with RDEB-GI, 9 with RDEB-INV, and 2 with the pruriginosa RDEB subtype (RDEB-PR).

Most of the participants (71%) changed all their wound dressings at one time, patching up when required. Fourteen of 49 participants had paid people to help them change their dressings and when the total cost of combined wound dressings and paid care was taken into consideration, the mean annual cost per patient was around £2,500 (about $3,300) for RDEB-INV, £10,375 (about $13,700) per patient for RDEB-GS, and a staggering £98,000 (about $129,000) per patient for RDEB-GS. The total annual cost of dressings and associated care was an estimated £3,184,229 (about $4.2 million).

In addition to data on the cost of wound dressings, data on itch and pain and quality of life were presented at the EB World Congress and discussed by Dr. Mellerio.

A total of 42 participants older than 8 years of age had itch measured via the Leuven Itch Scale, she reported, noting that itch was a consistent symptom across all subtypes of RDEB. Itch is important as it not only causes problems with skin lesions and healing, but also significantly affects sleep and has a negative impact on patients’ mood, she emphasized.

xtrekx/iStock/Getty Images Plus

SOURCE: Mellerio JE et al. EB 2020. Pillay EI et al. Poster 77; Jeffs E et al. Poster 74; Jeffs et al. Poster 75. https://ebworldcongress.org/.

LONDON – More than £2.8 million (almost $3.7 million) was spent every year on wound dressings and bandages for treatment in a group of 60 people with recessive dystrophic epidermolysis bullosa (RDEB), according to a report at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA).

Results from the Prospective Epidermolysis Bullosa Longitudinal Evaluation Study (PEBLES), which is looking at the natural history of RDEB, showed that wound dressing and bandage costs were highest for study participants with the generalized severe (RDEB-GS) subtype, at just over £85,156 (about $112,450) per patient annually. Respective yearly costs for the generalized intermediate (RDEB-GI) and inversa (RDEB-INV) subtypes were £10,112 (about $13,350) and £1,699 (about $2,240) per patient.

Looking at the costs associated with EB is important, said one of the lead investigators for PEBLES, Jemima Mellerio, MD, FRCP, consultant dermatologist at St John’s Institute of Dermatology, at Guy’s & St. Thomas’ NHS Foundation Trust, London.

“If we are going to justify the kind of expenditure [associated with new treatments], we need to know that what we are treating is already a significant burden on our health care systems,” Dr. Mellerio said.

PEBLES is an ongoing London-based registry study that is enrolling patients with all subtypes of RDEB. Data are collected via a tablet device and include demographic data, information on clinical features, results of skin biopsies and genetic tests, and laboratory findings, as well as objective disease severity and subjective patient-orientated outcome scores.

So far, 60 patients – 49 adults and 11 children – have been enrolled in PEBLES since November 2014: 26 with RDEB-GS, 23 with RDEB-GI, 9 with RDEB-INV, and 2 with the pruriginosa RDEB subtype (RDEB-PR).

Most of the participants (71%) changed all their wound dressings at one time, patching up when required. Fourteen of 49 participants had paid people to help them change their dressings and when the total cost of combined wound dressings and paid care was taken into consideration, the mean annual cost per patient was around £2,500 (about $3,300) for RDEB-INV, £10,375 (about $13,700) per patient for RDEB-GS, and a staggering £98,000 (about $129,000) per patient for RDEB-GS. The total annual cost of dressings and associated care was an estimated £3,184,229 (about $4.2 million).

In addition to data on the cost of wound dressings, data on itch and pain and quality of life were presented at the EB World Congress and discussed by Dr. Mellerio.

A total of 42 participants older than 8 years of age had itch measured via the Leuven Itch Scale, she reported, noting that itch was a consistent symptom across all subtypes of RDEB. Itch is important as it not only causes problems with skin lesions and healing, but also significantly affects sleep and has a negative impact on patients’ mood, she emphasized.

xtrekx/iStock/Getty Images Plus

SOURCE: Mellerio JE et al. EB 2020. Pillay EI et al. Poster 77; Jeffs E et al. Poster 74; Jeffs et al. Poster 75. https://ebworldcongress.org/.

A small survey suggests many patients consult social media for advice on acne treatment and follow recommendations that don’t align with clinical guidelines.

llhedgehogll/Thinkstock

Of the 130 patients surveyed, 45% consulted social media for advice on acne treatment, and 52% of those patients followed recommendations that don’t correspond to American Academy of Dermatology (AAD) guidelines. Most patients reported no improvement (40%) or minimal improvement (53%) in their acne after following advice from social media.

“These results suggest that dermatologists should inquire about social media acne treatment advice and directly address misinformation,” wrote Ahmed Yousaf, of West Virginia University, Morgantown, W.Va., and colleagues. Their report is in Pediatric Dermatology.

They conducted the survey of 130 patients treated for acne at West Virginia University. Most patients were female (60%), and a majority were adolescents (54%) or adults (44%). About half of the patients (51%) said their acne was moderate, 38% said it was severe, and 11% said it was mild.

Most patients said they consulted a medical professional for their first acne treatment (58%). However, 16% of patients said they first went to social media for advice, 26% said they consulted family or friends, and 10% took “other” steps as their first approach to acne treatment.

In all, 45% of patients consulted social media for acne treatment advice at some point. This includes 54% of women, 31% of men, 41% of adolescents, and 51% of adults. Social media consultation was more common among patients with severe acne (54%) than among those with mild (36%) or moderate (39%) acne.

The most common social media platforms used were YouTube and Instagram (58% each), followed by Pinterest (31%), Facebook (19%), Twitter (9%), Snapchat (7%), and Tumblr (3%). (Patients could select more than one social media platform.)

Roughly half (52%) of patients who consulted social media followed advice that does not align with AAD guidelines, 31% made changes that are recommended by the AAD, and 17% did not provide information on recommendations they followed.

The social media advice patients followed included using over-the-counter products (81%), making dietary changes (40%), using self-made products (19%), taking supplements (16%), and making changes in exercise routines (7%). (Patients could select more than one treatment approach.)

Among the patients who followed social media advice, 40% said they saw no change in their acne, and 53% reported minimal improvement.

“Only 7% of social media users reported significant improvement in their acne,” Mr. Yousaf and colleagues wrote. “This may be due to less accurate content found on social media compared to other health care sources.”

The authors acknowledged that the patients surveyed were recruited from a dermatology clinic. Therefore, these results “likely underestimate the percentage of patients who improve from social media acne treatment advice and do not consult a medical professional.”

Mr. Yousaf and colleagues did not disclose any conflicts of interest.

[email protected]

SOURCE: Yousaf A et al. Pediatr Dermatol. 2020 Jan 15. doi: 10.1111/pde.14091.

A small survey suggests many patients consult social media for advice on acne treatment and follow recommendations that don’t align with clinical guidelines.

llhedgehogll/Thinkstock

Of the 130 patients surveyed, 45% consulted social media for advice on acne treatment, and 52% of those patients followed recommendations that don’t correspond to American Academy of Dermatology (AAD) guidelines. Most patients reported no improvement (40%) or minimal improvement (53%) in their acne after following advice from social media.

“These results suggest that dermatologists should inquire about social media acne treatment advice and directly address misinformation,” wrote Ahmed Yousaf, of West Virginia University, Morgantown, W.Va., and colleagues. Their report is in Pediatric Dermatology.

They conducted the survey of 130 patients treated for acne at West Virginia University. Most patients were female (60%), and a majority were adolescents (54%) or adults (44%). About half of the patients (51%) said their acne was moderate, 38% said it was severe, and 11% said it was mild.

Most patients said they consulted a medical professional for their first acne treatment (58%). However, 16% of patients said they first went to social media for advice, 26% said they consulted family or friends, and 10% took “other” steps as their first approach to acne treatment.

In all, 45% of patients consulted social media for acne treatment advice at some point. This includes 54% of women, 31% of men, 41% of adolescents, and 51% of adults. Social media consultation was more common among patients with severe acne (54%) than among those with mild (36%) or moderate (39%) acne.

The most common social media platforms used were YouTube and Instagram (58% each), followed by Pinterest (31%), Facebook (19%), Twitter (9%), Snapchat (7%), and Tumblr (3%). (Patients could select more than one social media platform.)

Roughly half (52%) of patients who consulted social media followed advice that does not align with AAD guidelines, 31% made changes that are recommended by the AAD, and 17% did not provide information on recommendations they followed.

The social media advice patients followed included using over-the-counter products (81%), making dietary changes (40%), using self-made products (19%), taking supplements (16%), and making changes in exercise routines (7%). (Patients could select more than one treatment approach.)

Among the patients who followed social media advice, 40% said they saw no change in their acne, and 53% reported minimal improvement.

“Only 7% of social media users reported significant improvement in their acne,” Mr. Yousaf and colleagues wrote. “This may be due to less accurate content found on social media compared to other health care sources.”

The authors acknowledged that the patients surveyed were recruited from a dermatology clinic. Therefore, these results “likely underestimate the percentage of patients who improve from social media acne treatment advice and do not consult a medical professional.”

Mr. Yousaf and colleagues did not disclose any conflicts of interest.

[email protected]

SOURCE: Yousaf A et al. Pediatr Dermatol. 2020 Jan 15. doi: 10.1111/pde.14091.

A small survey suggests many patients consult social media for advice on acne treatment and follow recommendations that don’t align with clinical guidelines.

llhedgehogll/Thinkstock

Of the 130 patients surveyed, 45% consulted social media for advice on acne treatment, and 52% of those patients followed recommendations that don’t correspond to American Academy of Dermatology (AAD) guidelines. Most patients reported no improvement (40%) or minimal improvement (53%) in their acne after following advice from social media.

“These results suggest that dermatologists should inquire about social media acne treatment advice and directly address misinformation,” wrote Ahmed Yousaf, of West Virginia University, Morgantown, W.Va., and colleagues. Their report is in Pediatric Dermatology.

They conducted the survey of 130 patients treated for acne at West Virginia University. Most patients were female (60%), and a majority were adolescents (54%) or adults (44%). About half of the patients (51%) said their acne was moderate, 38% said it was severe, and 11% said it was mild.

Most patients said they consulted a medical professional for their first acne treatment (58%). However, 16% of patients said they first went to social media for advice, 26% said they consulted family or friends, and 10% took “other” steps as their first approach to acne treatment.

In all, 45% of patients consulted social media for acne treatment advice at some point. This includes 54% of women, 31% of men, 41% of adolescents, and 51% of adults. Social media consultation was more common among patients with severe acne (54%) than among those with mild (36%) or moderate (39%) acne.

The most common social media platforms used were YouTube and Instagram (58% each), followed by Pinterest (31%), Facebook (19%), Twitter (9%), Snapchat (7%), and Tumblr (3%). (Patients could select more than one social media platform.)

Roughly half (52%) of patients who consulted social media followed advice that does not align with AAD guidelines, 31% made changes that are recommended by the AAD, and 17% did not provide information on recommendations they followed.

The social media advice patients followed included using over-the-counter products (81%), making dietary changes (40%), using self-made products (19%), taking supplements (16%), and making changes in exercise routines (7%). (Patients could select more than one treatment approach.)

Among the patients who followed social media advice, 40% said they saw no change in their acne, and 53% reported minimal improvement.

“Only 7% of social media users reported significant improvement in their acne,” Mr. Yousaf and colleagues wrote. “This may be due to less accurate content found on social media compared to other health care sources.”

The authors acknowledged that the patients surveyed were recruited from a dermatology clinic. Therefore, these results “likely underestimate the percentage of patients who improve from social media acne treatment advice and do not consult a medical professional.”

Mr. Yousaf and colleagues did not disclose any conflicts of interest.

[email protected]

SOURCE: Yousaf A et al. Pediatr Dermatol. 2020 Jan 15. doi: 10.1111/pde.14091.

Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.

Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.

In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.

Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.

The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.

A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.

“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.

“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.

The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.

SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.

Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.

Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.

In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.

Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.

The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.

A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.

“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.

“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.

The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.

SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.

Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.

Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.

In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.

Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.

The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.

A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.

“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.

“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.

The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.

SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.

Enrichment next-generation sequencing (NGS) provides a more cost-efficient and sensitive method for detecting and sequencing novel coronaviruses from wild bat populations, according to a study reported in mSphere, an open-access journal from the American Society for Microbiology.

Wikimedia Commons/Mickey Samuni-Blank

With the appearance of the new zoonotic Wuhan coronavirus, the importance of monitoring the likelihood of new virus risks in wildlife reservoirs has been heightened. Bats in particular have been found to be the most common reservoir of coronaviruses, including being a probable source or mixing vessel for two previous modern epidemic coronaviruses: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).

“We should be alert and vigilant with the knowledge that bat CoVs [coronaviruses] are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to Bei Li, MD, of the Wuhan (China) Institute of Virology, and colleagues.

“We previously provided serological evidence that [HKU8-related] CoV had jumped over from bats to camels and recombined with MERS-CoV, alerting other researchers that the CoV species could be dangerous. ... Genome-level comparison is needed to monitor the risk of alterations in species tropism and pathogenesis,” according to study authors. They performed a study to develop a more effective and cost efficient method for detecting and sequencing novel coronaviruses in the bat population.

The taxonomy of coronaviruses is particularly complex and may be too narrowly defined, given the high level of genetic plasticity found. There are four genera (Alpha-, Beta-, Gamma-, and Deltacoronavirus) consisting of 38 unique species in the CoV subfamily Orthocoronavirinae, and the number is increasing. Viral taxomists rely on the open reading frame 1b (ORF1b) gene for classification, but viruses in the same species may show great diversity in regions outside ORF1b, confounding the species designation. In particular, bat CoVs classed as the same species can differ significantly in terms of receptor usage or virus-host interaction, as observed in bat SARS-related CoVs, according to the researchers.

The researchers obtained RNA from previous bat CoV surveillance projects, which used bat rectal swabs. Libraries for NGS were constructed from total RNA and processed to generate RNA fragments larger than 300 nucleotides. Following first- and second-strand cDNA synthesis, double-stranded cDNA was purified and the library was amplified by polymerase chain reaction (PCR) technology.

Targeted CoV genome enrichment was achieved using 4,303 customized biotinylated 120-mer baits. These baits were designed from 90 representative CoV genomes, and in silico analysis determined that these baits should target the known CoV species tested. These baits were added and hybridized to the libraries. To capture virus-specific library fragments, streptavidin magnetic beads (which bind to biotin) were added to the hybridization reaction mixture. The beads were then washed to remove unbound DNA. The postcapture virus-specific library fragments were then amplified using a subsequent round of PCR.

The enrichment NGS were retrospectively complemented with unbiased NGS and/or additional Sanger sequencing to obtain full-length genomes. The study showed that enrichment NGS not only decreased the amount of data requiring analysis but produced full-length genome coverage in both laboratory and clinical samples.

Using this technology, the researchers “effectively reduced sequencing costs by increasing the sensitivity of detection. We discovered nine full genomes of bat CoVs in this study and revealed great genetic diversity for eight of them.” In addition, they noted that using standard targeted PCR, which is common practice for many surveillance studies, would not have discovered this diversity.

“We should be alert and vigilant with the knowledge that bat CoVs are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to the researchers.

“We have provided a cost-effective methodology for bat CoV surveillance. The high genetic diversity observed in our newly sequenced samples suggests further work is needed to characterize these bat CoVs prior to or in the early stages of spillover to humans,” the authors concluded.

This study was supported by the Chinese government. The authors reported that they had no conflicts.

Viral genome data for new CoVs from this study are available in GenBank under accession numbers MN611517 to MN611525.

[email protected]

SOURCE: Li B et al. mSphere 2020 Jan 29;5:e00807-19.

Enrichment next-generation sequencing (NGS) provides a more cost-efficient and sensitive method for detecting and sequencing novel coronaviruses from wild bat populations, according to a study reported in mSphere, an open-access journal from the American Society for Microbiology.

Wikimedia Commons/Mickey Samuni-Blank

With the appearance of the new zoonotic Wuhan coronavirus, the importance of monitoring the likelihood of new virus risks in wildlife reservoirs has been heightened. Bats in particular have been found to be the most common reservoir of coronaviruses, including being a probable source or mixing vessel for two previous modern epidemic coronaviruses: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).

“We should be alert and vigilant with the knowledge that bat CoVs [coronaviruses] are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to Bei Li, MD, of the Wuhan (China) Institute of Virology, and colleagues.

“We previously provided serological evidence that [HKU8-related] CoV had jumped over from bats to camels and recombined with MERS-CoV, alerting other researchers that the CoV species could be dangerous. ... Genome-level comparison is needed to monitor the risk of alterations in species tropism and pathogenesis,” according to study authors. They performed a study to develop a more effective and cost efficient method for detecting and sequencing novel coronaviruses in the bat population.

The taxonomy of coronaviruses is particularly complex and may be too narrowly defined, given the high level of genetic plasticity found. There are four genera (Alpha-, Beta-, Gamma-, and Deltacoronavirus) consisting of 38 unique species in the CoV subfamily Orthocoronavirinae, and the number is increasing. Viral taxomists rely on the open reading frame 1b (ORF1b) gene for classification, but viruses in the same species may show great diversity in regions outside ORF1b, confounding the species designation. In particular, bat CoVs classed as the same species can differ significantly in terms of receptor usage or virus-host interaction, as observed in bat SARS-related CoVs, according to the researchers.

The researchers obtained RNA from previous bat CoV surveillance projects, which used bat rectal swabs. Libraries for NGS were constructed from total RNA and processed to generate RNA fragments larger than 300 nucleotides. Following first- and second-strand cDNA synthesis, double-stranded cDNA was purified and the library was amplified by polymerase chain reaction (PCR) technology.

Targeted CoV genome enrichment was achieved using 4,303 customized biotinylated 120-mer baits. These baits were designed from 90 representative CoV genomes, and in silico analysis determined that these baits should target the known CoV species tested. These baits were added and hybridized to the libraries. To capture virus-specific library fragments, streptavidin magnetic beads (which bind to biotin) were added to the hybridization reaction mixture. The beads were then washed to remove unbound DNA. The postcapture virus-specific library fragments were then amplified using a subsequent round of PCR.

The enrichment NGS were retrospectively complemented with unbiased NGS and/or additional Sanger sequencing to obtain full-length genomes. The study showed that enrichment NGS not only decreased the amount of data requiring analysis but produced full-length genome coverage in both laboratory and clinical samples.

Using this technology, the researchers “effectively reduced sequencing costs by increasing the sensitivity of detection. We discovered nine full genomes of bat CoVs in this study and revealed great genetic diversity for eight of them.” In addition, they noted that using standard targeted PCR, which is common practice for many surveillance studies, would not have discovered this diversity.

“We should be alert and vigilant with the knowledge that bat CoVs are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to the researchers.

“We have provided a cost-effective methodology for bat CoV surveillance. The high genetic diversity observed in our newly sequenced samples suggests further work is needed to characterize these bat CoVs prior to or in the early stages of spillover to humans,” the authors concluded.

This study was supported by the Chinese government. The authors reported that they had no conflicts.

Viral genome data for new CoVs from this study are available in GenBank under accession numbers MN611517 to MN611525.

[email protected]

SOURCE: Li B et al. mSphere 2020 Jan 29;5:e00807-19.

Enrichment next-generation sequencing (NGS) provides a more cost-efficient and sensitive method for detecting and sequencing novel coronaviruses from wild bat populations, according to a study reported in mSphere, an open-access journal from the American Society for Microbiology.

Wikimedia Commons/Mickey Samuni-Blank

With the appearance of the new zoonotic Wuhan coronavirus, the importance of monitoring the likelihood of new virus risks in wildlife reservoirs has been heightened. Bats in particular have been found to be the most common reservoir of coronaviruses, including being a probable source or mixing vessel for two previous modern epidemic coronaviruses: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).

“We should be alert and vigilant with the knowledge that bat CoVs [coronaviruses] are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to Bei Li, MD, of the Wuhan (China) Institute of Virology, and colleagues.

“We previously provided serological evidence that [HKU8-related] CoV had jumped over from bats to camels and recombined with MERS-CoV, alerting other researchers that the CoV species could be dangerous. ... Genome-level comparison is needed to monitor the risk of alterations in species tropism and pathogenesis,” according to study authors. They performed a study to develop a more effective and cost efficient method for detecting and sequencing novel coronaviruses in the bat population.

The taxonomy of coronaviruses is particularly complex and may be too narrowly defined, given the high level of genetic plasticity found. There are four genera (Alpha-, Beta-, Gamma-, and Deltacoronavirus) consisting of 38 unique species in the CoV subfamily Orthocoronavirinae, and the number is increasing. Viral taxomists rely on the open reading frame 1b (ORF1b) gene for classification, but viruses in the same species may show great diversity in regions outside ORF1b, confounding the species designation. In particular, bat CoVs classed as the same species can differ significantly in terms of receptor usage or virus-host interaction, as observed in bat SARS-related CoVs, according to the researchers.

The researchers obtained RNA from previous bat CoV surveillance projects, which used bat rectal swabs. Libraries for NGS were constructed from total RNA and processed to generate RNA fragments larger than 300 nucleotides. Following first- and second-strand cDNA synthesis, double-stranded cDNA was purified and the library was amplified by polymerase chain reaction (PCR) technology.

Targeted CoV genome enrichment was achieved using 4,303 customized biotinylated 120-mer baits. These baits were designed from 90 representative CoV genomes, and in silico analysis determined that these baits should target the known CoV species tested. These baits were added and hybridized to the libraries. To capture virus-specific library fragments, streptavidin magnetic beads (which bind to biotin) were added to the hybridization reaction mixture. The beads were then washed to remove unbound DNA. The postcapture virus-specific library fragments were then amplified using a subsequent round of PCR.

The enrichment NGS were retrospectively complemented with unbiased NGS and/or additional Sanger sequencing to obtain full-length genomes. The study showed that enrichment NGS not only decreased the amount of data requiring analysis but produced full-length genome coverage in both laboratory and clinical samples.

Using this technology, the researchers “effectively reduced sequencing costs by increasing the sensitivity of detection. We discovered nine full genomes of bat CoVs in this study and revealed great genetic diversity for eight of them.” In addition, they noted that using standard targeted PCR, which is common practice for many surveillance studies, would not have discovered this diversity.

“We should be alert and vigilant with the knowledge that bat CoVs are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to the researchers.

“We have provided a cost-effective methodology for bat CoV surveillance. The high genetic diversity observed in our newly sequenced samples suggests further work is needed to characterize these bat CoVs prior to or in the early stages of spillover to humans,” the authors concluded.

This study was supported by the Chinese government. The authors reported that they had no conflicts.

Viral genome data for new CoVs from this study are available in GenBank under accession numbers MN611517 to MN611525.

[email protected]

SOURCE: Li B et al. mSphere 2020 Jan 29;5:e00807-19.