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Government Accuses Health System of Paying Docs Outrageous Salaries for Patient Referrals
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
SUNY Downstate Emergency Medicine Doc Charged With $1.5M Fraud
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
Maternal Obesity Linked to Sudden Infant Death
More than 5% of cases of sudden infant death may be linked to maternal obesity, new research showed.
“When a parent has a child that dies of sudden unexplained infant death [SUID], it’s extremely devastating,” said Jan-Marino Ramirez, PhD, the Zain Nadella Endowed Chair in Pediatric Neurosciences at the University of Washington, Seattle, and director of the Center for Integrative Brain Research at Seattle Children’s Hospital. “And the most devastating problem is that there’s no clear answer. Understanding the mechanisms will help parents understand.”
The study was published online in JAMA Pediatrics.
In the United States, approximately 3500 cases of SUID are reported yearly. After educational campaigns in the 1990s demonstrating safe infant sleep positions, rates of these fatalities dropped but have since plateaued.
Maternal Obesity During Pregnancy
Rates of maternal obesity are increasing globally, and more than half of women of reproductive age are overweight or obese.
“Maternal obesity before pregnancy affects placental development, gene expression, and has long-term implications,” said Patrick Catalano, MD, a professor in residence at the Departments of Reproductive Endocrinology and Obstetrics and Gynecology at Massachusetts General Hospital and Harvard Medical School in Boston.
Maternal obesity is a well-documented risk factor for adverse outcomes of pregnancy including stillbirth, preterm birth, and admission to the neonatal intensive care unit. Swedish researchers in 2014 reported maternal obesity was linked to an increase in infant mortality that increased with body mass index (BMI), but that study did not look specifically at SUID.
For their new study, Dr. Ramirez and colleagues looked at data from all live births in the United States from 2015 to 2019 recorded by the Centers for Disease Control and Prevention and the National Center for Health Statistics. Of the 18,857,694 live births occurring at 28 weeks of gestation or later, 16,545 infants died of a sudden, unexplained cause.
Rates of SUID in babies born to mothers with obesity increased in a statistically significant, dose-dependent manner relative to normal weight mothers. The unadjusted absolute risks for SUID were 0.74 cases per 1000 births for normal weight mothers, 0.99 cases at BMIs between 30 and 35, 1.17 cases at BMIs between 35 and 40, and 1.47 instances at BMI ≥ 40.
After adjustment for maternal age, race, ethnicity, and level of education, the adjusted odds ratio for a case of SUID was 1.39 among women with the highest levels of obesity (95% CI, 1.31-1.47), according to the researchers.
While the study revealed an association between maternal obesity and SUID, the basis for this connection remains unknown, the investigators noted. One possibility for the link is that obesity increases the risk for obstructive sleep apnea, which can result in intermittent hypoxia. That, in turn, causes oxidative stress, which may possibly have effects on the fetus causing effects that eventually lead to SUID in the infant.
An accompanying editorial by Jacqueline Maya, MD; Marie-France Hivert, MD, MMSc; and Lydia Shook, MD, from the Massachusetts General Hospital and Harvard Medical School, suggested that the SUID is unlikely directly influenced by high maternal BMI but rather by the metabolic concerns related to obesity such as inflammation, insulin resistance, and abnormal lipid metabolism. Epigenetics may also play a role.
“We believe the evidence for this study of an association between prepregnancy obesity and SUID is a call to action for the scientific and medical community to better understand the complex interplay of biological, social, and behavioral factors that may lead to SUID, a devastating complication that no family should experience,” the authors of the editorial wrote.
Dr. Ramirez stressed the importance of not initiating guilt because there are many factors in SUID such as genetics that cannot be controlled.
“We are far from saying a baby died because you were obese; that’s an important message to parents,” he said. What he sees as important, rather, is using this new research to elucidate further mechanisms that may allow for more targeted interventions: “If we discover that it’s due to, for example, sleep apnea, that’s something we can prevent.”
The researchers reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
More than 5% of cases of sudden infant death may be linked to maternal obesity, new research showed.
“When a parent has a child that dies of sudden unexplained infant death [SUID], it’s extremely devastating,” said Jan-Marino Ramirez, PhD, the Zain Nadella Endowed Chair in Pediatric Neurosciences at the University of Washington, Seattle, and director of the Center for Integrative Brain Research at Seattle Children’s Hospital. “And the most devastating problem is that there’s no clear answer. Understanding the mechanisms will help parents understand.”
The study was published online in JAMA Pediatrics.
In the United States, approximately 3500 cases of SUID are reported yearly. After educational campaigns in the 1990s demonstrating safe infant sleep positions, rates of these fatalities dropped but have since plateaued.
Maternal Obesity During Pregnancy
Rates of maternal obesity are increasing globally, and more than half of women of reproductive age are overweight or obese.
“Maternal obesity before pregnancy affects placental development, gene expression, and has long-term implications,” said Patrick Catalano, MD, a professor in residence at the Departments of Reproductive Endocrinology and Obstetrics and Gynecology at Massachusetts General Hospital and Harvard Medical School in Boston.
Maternal obesity is a well-documented risk factor for adverse outcomes of pregnancy including stillbirth, preterm birth, and admission to the neonatal intensive care unit. Swedish researchers in 2014 reported maternal obesity was linked to an increase in infant mortality that increased with body mass index (BMI), but that study did not look specifically at SUID.
For their new study, Dr. Ramirez and colleagues looked at data from all live births in the United States from 2015 to 2019 recorded by the Centers for Disease Control and Prevention and the National Center for Health Statistics. Of the 18,857,694 live births occurring at 28 weeks of gestation or later, 16,545 infants died of a sudden, unexplained cause.
Rates of SUID in babies born to mothers with obesity increased in a statistically significant, dose-dependent manner relative to normal weight mothers. The unadjusted absolute risks for SUID were 0.74 cases per 1000 births for normal weight mothers, 0.99 cases at BMIs between 30 and 35, 1.17 cases at BMIs between 35 and 40, and 1.47 instances at BMI ≥ 40.
After adjustment for maternal age, race, ethnicity, and level of education, the adjusted odds ratio for a case of SUID was 1.39 among women with the highest levels of obesity (95% CI, 1.31-1.47), according to the researchers.
While the study revealed an association between maternal obesity and SUID, the basis for this connection remains unknown, the investigators noted. One possibility for the link is that obesity increases the risk for obstructive sleep apnea, which can result in intermittent hypoxia. That, in turn, causes oxidative stress, which may possibly have effects on the fetus causing effects that eventually lead to SUID in the infant.
An accompanying editorial by Jacqueline Maya, MD; Marie-France Hivert, MD, MMSc; and Lydia Shook, MD, from the Massachusetts General Hospital and Harvard Medical School, suggested that the SUID is unlikely directly influenced by high maternal BMI but rather by the metabolic concerns related to obesity such as inflammation, insulin resistance, and abnormal lipid metabolism. Epigenetics may also play a role.
“We believe the evidence for this study of an association between prepregnancy obesity and SUID is a call to action for the scientific and medical community to better understand the complex interplay of biological, social, and behavioral factors that may lead to SUID, a devastating complication that no family should experience,” the authors of the editorial wrote.
Dr. Ramirez stressed the importance of not initiating guilt because there are many factors in SUID such as genetics that cannot be controlled.
“We are far from saying a baby died because you were obese; that’s an important message to parents,” he said. What he sees as important, rather, is using this new research to elucidate further mechanisms that may allow for more targeted interventions: “If we discover that it’s due to, for example, sleep apnea, that’s something we can prevent.”
The researchers reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
More than 5% of cases of sudden infant death may be linked to maternal obesity, new research showed.
“When a parent has a child that dies of sudden unexplained infant death [SUID], it’s extremely devastating,” said Jan-Marino Ramirez, PhD, the Zain Nadella Endowed Chair in Pediatric Neurosciences at the University of Washington, Seattle, and director of the Center for Integrative Brain Research at Seattle Children’s Hospital. “And the most devastating problem is that there’s no clear answer. Understanding the mechanisms will help parents understand.”
The study was published online in JAMA Pediatrics.
In the United States, approximately 3500 cases of SUID are reported yearly. After educational campaigns in the 1990s demonstrating safe infant sleep positions, rates of these fatalities dropped but have since plateaued.
Maternal Obesity During Pregnancy
Rates of maternal obesity are increasing globally, and more than half of women of reproductive age are overweight or obese.
“Maternal obesity before pregnancy affects placental development, gene expression, and has long-term implications,” said Patrick Catalano, MD, a professor in residence at the Departments of Reproductive Endocrinology and Obstetrics and Gynecology at Massachusetts General Hospital and Harvard Medical School in Boston.
Maternal obesity is a well-documented risk factor for adverse outcomes of pregnancy including stillbirth, preterm birth, and admission to the neonatal intensive care unit. Swedish researchers in 2014 reported maternal obesity was linked to an increase in infant mortality that increased with body mass index (BMI), but that study did not look specifically at SUID.
For their new study, Dr. Ramirez and colleagues looked at data from all live births in the United States from 2015 to 2019 recorded by the Centers for Disease Control and Prevention and the National Center for Health Statistics. Of the 18,857,694 live births occurring at 28 weeks of gestation or later, 16,545 infants died of a sudden, unexplained cause.
Rates of SUID in babies born to mothers with obesity increased in a statistically significant, dose-dependent manner relative to normal weight mothers. The unadjusted absolute risks for SUID were 0.74 cases per 1000 births for normal weight mothers, 0.99 cases at BMIs between 30 and 35, 1.17 cases at BMIs between 35 and 40, and 1.47 instances at BMI ≥ 40.
After adjustment for maternal age, race, ethnicity, and level of education, the adjusted odds ratio for a case of SUID was 1.39 among women with the highest levels of obesity (95% CI, 1.31-1.47), according to the researchers.
While the study revealed an association between maternal obesity and SUID, the basis for this connection remains unknown, the investigators noted. One possibility for the link is that obesity increases the risk for obstructive sleep apnea, which can result in intermittent hypoxia. That, in turn, causes oxidative stress, which may possibly have effects on the fetus causing effects that eventually lead to SUID in the infant.
An accompanying editorial by Jacqueline Maya, MD; Marie-France Hivert, MD, MMSc; and Lydia Shook, MD, from the Massachusetts General Hospital and Harvard Medical School, suggested that the SUID is unlikely directly influenced by high maternal BMI but rather by the metabolic concerns related to obesity such as inflammation, insulin resistance, and abnormal lipid metabolism. Epigenetics may also play a role.
“We believe the evidence for this study of an association between prepregnancy obesity and SUID is a call to action for the scientific and medical community to better understand the complex interplay of biological, social, and behavioral factors that may lead to SUID, a devastating complication that no family should experience,” the authors of the editorial wrote.
Dr. Ramirez stressed the importance of not initiating guilt because there are many factors in SUID such as genetics that cannot be controlled.
“We are far from saying a baby died because you were obese; that’s an important message to parents,” he said. What he sees as important, rather, is using this new research to elucidate further mechanisms that may allow for more targeted interventions: “If we discover that it’s due to, for example, sleep apnea, that’s something we can prevent.”
The researchers reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA PEDIATRICS
Ancient Viruses in Our DNA Hold Clues to Cancer Treatment
according to a fascinating new study in Science Advances. Targeting these viral remnants still lingering in our DNA could lead to more effective cancer treatment with fewer side effects, the researchers said.
The study “gives a better understanding of how gene regulation can be impacted by these ancient retroviral sequences,” said Dixie Mager, PhD, scientist emeritus at the Terry Fox Laboratory at the British Columbia Cancer Research Institute, Vancouver, British Columbia, Canada. (Mager was not involved in the study.)
Long thought to be “junk” DNA with no biologic function, “endogenous retroviruses,” which have mutated over time and lost their ability to create the virus, are now known to regulate genes — allowing some genes to turn on and off. Research in recent years suggests they may play a role in diseases like cancer.
But scientists weren’t exactly sure what that role was, said senior study author Edward Chuong, PhD, a genome biologist at the University of Colorado Boulder.
Most studies have looked at whether endogenous retroviruses code for proteins that influence cancer. But these ancient viral strands usually don’t code for proteins at all.
Dr. Chuong took a different approach. Inspired by scientists who’ve studied how viral remnants regulate positive processes (immunity, brain development, or placenta development), he and his team explored whether some might regulate genes that, once activated, help cancer thrive.
Borrowing from epigenomic analysis data (data on molecules that alter gene expression) for 21 cancers mapped by the Cancer Genome Atlas, the researchers identified 19 virus-derived DNA sequences that bind to regulatory proteins more in cancer cells than in healthy cells. All of these could potentially act as gene regulators that promote cancer.
The researchers homed in on one sequence, called LTR10, because it showed especially high activity in several cancers, including lung and colorectal cancer. This DNA segment comes from a virus that entered our ancestors’ genome 30 million years ago, and it’s activated in a third of colorectal cancers.
Using the gene editing technology clustered regularly interspaced short palindromic repeats (CRISPR), Dr. Chuong’s team silenced LTR10 in colorectal cancer cells, altering the gene sequence so it couldn’t bind to regulatory proteins. Doing so dampened the activity of nearby cancer-promoting genes.
“They still behaved like cancer cells,” Dr. Chuong said. But “it made the cancer cells more susceptible to radiation. That would imply that the presence of that viral ‘switch’ actually helped those cancer cells survive radiation therapy.”
Previously, two studies had found that viral regulators play a role in promoting two types of cancer: Leukemia and prostate cancer. The new study shows these two cases weren’t flukes. All 21 cancers they looked at had at least one of those 19 viral elements, presumably working as cancer enhancers.
The study also identified what activates LTR10 to make it promote cancer. The culprit is a regulator protein called mitogen-activated protein (MAP) kinase, which is overactivated in about 40% of all human cancers.
Some cancer drugs — MAP kinase inhibitors — already target MAP kinase, and they’re often the first ones prescribed when a patient is diagnosed with cancer, Dr. Chuong said. As with many cancer treatments, doctors don’t know why they work, just that they do.
“By understanding the mechanisms in the cell, we might be able to make them work better or further optimize their treatment,” he said.
“MAP kinase inhibitors are really like a sledgehammer to the cell,” Dr. Chuong said — meaning they affect many cellular processes, not just those related to cancer.
“If we’re able to say that these viral switches are what’s important, then that could potentially help us develop a more targeted therapy that uses something like CRISPR to silence these viral elements,” he said. Or it could help providers choose a MAP kinase inhibitor from among the dozens available best suited to treat an individual patient and avoid side effects.
Still, whether the findings translate to real cancer patients remains to be seen. “It’s very, very hard to go the final step of showing in a patient that these actually make a difference in the cancer,” Dr. Mager said.
More lab research, human trials, and at least a few years will be needed before this discovery could help treat cancer. “Directly targeting these elements as a therapy would be at least 5 years out,” Dr. Chuong said, “partly because that application would rely on CRISPR epigenome editing technology that is still being developed for clinical use.”
A version of this article first appeared on Medscape.com.
according to a fascinating new study in Science Advances. Targeting these viral remnants still lingering in our DNA could lead to more effective cancer treatment with fewer side effects, the researchers said.
The study “gives a better understanding of how gene regulation can be impacted by these ancient retroviral sequences,” said Dixie Mager, PhD, scientist emeritus at the Terry Fox Laboratory at the British Columbia Cancer Research Institute, Vancouver, British Columbia, Canada. (Mager was not involved in the study.)
Long thought to be “junk” DNA with no biologic function, “endogenous retroviruses,” which have mutated over time and lost their ability to create the virus, are now known to regulate genes — allowing some genes to turn on and off. Research in recent years suggests they may play a role in diseases like cancer.
But scientists weren’t exactly sure what that role was, said senior study author Edward Chuong, PhD, a genome biologist at the University of Colorado Boulder.
Most studies have looked at whether endogenous retroviruses code for proteins that influence cancer. But these ancient viral strands usually don’t code for proteins at all.
Dr. Chuong took a different approach. Inspired by scientists who’ve studied how viral remnants regulate positive processes (immunity, brain development, or placenta development), he and his team explored whether some might regulate genes that, once activated, help cancer thrive.
Borrowing from epigenomic analysis data (data on molecules that alter gene expression) for 21 cancers mapped by the Cancer Genome Atlas, the researchers identified 19 virus-derived DNA sequences that bind to regulatory proteins more in cancer cells than in healthy cells. All of these could potentially act as gene regulators that promote cancer.
The researchers homed in on one sequence, called LTR10, because it showed especially high activity in several cancers, including lung and colorectal cancer. This DNA segment comes from a virus that entered our ancestors’ genome 30 million years ago, and it’s activated in a third of colorectal cancers.
Using the gene editing technology clustered regularly interspaced short palindromic repeats (CRISPR), Dr. Chuong’s team silenced LTR10 in colorectal cancer cells, altering the gene sequence so it couldn’t bind to regulatory proteins. Doing so dampened the activity of nearby cancer-promoting genes.
“They still behaved like cancer cells,” Dr. Chuong said. But “it made the cancer cells more susceptible to radiation. That would imply that the presence of that viral ‘switch’ actually helped those cancer cells survive radiation therapy.”
Previously, two studies had found that viral regulators play a role in promoting two types of cancer: Leukemia and prostate cancer. The new study shows these two cases weren’t flukes. All 21 cancers they looked at had at least one of those 19 viral elements, presumably working as cancer enhancers.
The study also identified what activates LTR10 to make it promote cancer. The culprit is a regulator protein called mitogen-activated protein (MAP) kinase, which is overactivated in about 40% of all human cancers.
Some cancer drugs — MAP kinase inhibitors — already target MAP kinase, and they’re often the first ones prescribed when a patient is diagnosed with cancer, Dr. Chuong said. As with many cancer treatments, doctors don’t know why they work, just that they do.
“By understanding the mechanisms in the cell, we might be able to make them work better or further optimize their treatment,” he said.
“MAP kinase inhibitors are really like a sledgehammer to the cell,” Dr. Chuong said — meaning they affect many cellular processes, not just those related to cancer.
“If we’re able to say that these viral switches are what’s important, then that could potentially help us develop a more targeted therapy that uses something like CRISPR to silence these viral elements,” he said. Or it could help providers choose a MAP kinase inhibitor from among the dozens available best suited to treat an individual patient and avoid side effects.
Still, whether the findings translate to real cancer patients remains to be seen. “It’s very, very hard to go the final step of showing in a patient that these actually make a difference in the cancer,” Dr. Mager said.
More lab research, human trials, and at least a few years will be needed before this discovery could help treat cancer. “Directly targeting these elements as a therapy would be at least 5 years out,” Dr. Chuong said, “partly because that application would rely on CRISPR epigenome editing technology that is still being developed for clinical use.”
A version of this article first appeared on Medscape.com.
according to a fascinating new study in Science Advances. Targeting these viral remnants still lingering in our DNA could lead to more effective cancer treatment with fewer side effects, the researchers said.
The study “gives a better understanding of how gene regulation can be impacted by these ancient retroviral sequences,” said Dixie Mager, PhD, scientist emeritus at the Terry Fox Laboratory at the British Columbia Cancer Research Institute, Vancouver, British Columbia, Canada. (Mager was not involved in the study.)
Long thought to be “junk” DNA with no biologic function, “endogenous retroviruses,” which have mutated over time and lost their ability to create the virus, are now known to regulate genes — allowing some genes to turn on and off. Research in recent years suggests they may play a role in diseases like cancer.
But scientists weren’t exactly sure what that role was, said senior study author Edward Chuong, PhD, a genome biologist at the University of Colorado Boulder.
Most studies have looked at whether endogenous retroviruses code for proteins that influence cancer. But these ancient viral strands usually don’t code for proteins at all.
Dr. Chuong took a different approach. Inspired by scientists who’ve studied how viral remnants regulate positive processes (immunity, brain development, or placenta development), he and his team explored whether some might regulate genes that, once activated, help cancer thrive.
Borrowing from epigenomic analysis data (data on molecules that alter gene expression) for 21 cancers mapped by the Cancer Genome Atlas, the researchers identified 19 virus-derived DNA sequences that bind to regulatory proteins more in cancer cells than in healthy cells. All of these could potentially act as gene regulators that promote cancer.
The researchers homed in on one sequence, called LTR10, because it showed especially high activity in several cancers, including lung and colorectal cancer. This DNA segment comes from a virus that entered our ancestors’ genome 30 million years ago, and it’s activated in a third of colorectal cancers.
Using the gene editing technology clustered regularly interspaced short palindromic repeats (CRISPR), Dr. Chuong’s team silenced LTR10 in colorectal cancer cells, altering the gene sequence so it couldn’t bind to regulatory proteins. Doing so dampened the activity of nearby cancer-promoting genes.
“They still behaved like cancer cells,” Dr. Chuong said. But “it made the cancer cells more susceptible to radiation. That would imply that the presence of that viral ‘switch’ actually helped those cancer cells survive radiation therapy.”
Previously, two studies had found that viral regulators play a role in promoting two types of cancer: Leukemia and prostate cancer. The new study shows these two cases weren’t flukes. All 21 cancers they looked at had at least one of those 19 viral elements, presumably working as cancer enhancers.
The study also identified what activates LTR10 to make it promote cancer. The culprit is a regulator protein called mitogen-activated protein (MAP) kinase, which is overactivated in about 40% of all human cancers.
Some cancer drugs — MAP kinase inhibitors — already target MAP kinase, and they’re often the first ones prescribed when a patient is diagnosed with cancer, Dr. Chuong said. As with many cancer treatments, doctors don’t know why they work, just that they do.
“By understanding the mechanisms in the cell, we might be able to make them work better or further optimize their treatment,” he said.
“MAP kinase inhibitors are really like a sledgehammer to the cell,” Dr. Chuong said — meaning they affect many cellular processes, not just those related to cancer.
“If we’re able to say that these viral switches are what’s important, then that could potentially help us develop a more targeted therapy that uses something like CRISPR to silence these viral elements,” he said. Or it could help providers choose a MAP kinase inhibitor from among the dozens available best suited to treat an individual patient and avoid side effects.
Still, whether the findings translate to real cancer patients remains to be seen. “It’s very, very hard to go the final step of showing in a patient that these actually make a difference in the cancer,” Dr. Mager said.
More lab research, human trials, and at least a few years will be needed before this discovery could help treat cancer. “Directly targeting these elements as a therapy would be at least 5 years out,” Dr. Chuong said, “partly because that application would rely on CRISPR epigenome editing technology that is still being developed for clinical use.”
A version of this article first appeared on Medscape.com.
FROM SCIENCE ADVANCES
Consider Risks, Toxicity of Some Topical Ingredients in Infants, Young Children
TORONTO — Lawrence A. Schachner, MD, would like pediatric dermatologists to adopt a “toxic agent of the year” to raise awareness about the potential harm related to certain topical treatments in babies and young children.
Dr. Schachner, director of the Division of Pediatric Dermatology in the Department of Dermatology & Cutaneous Surgery at the University of Miami, Coral Gables, Florida, said he got the idea from the American Contact Dermatitis Society, which annually names the “Allergen of the Year.”
, said Dr. Schachner, professor of pediatrics and dermatology at the University of Miami.
“Any one of those would be excellent toxic substances of the year” that could be the focus of an educational campaign, he told this news organization following his presentation on “Toxicology of Topical Ingredients in Pediatric Dermatology” at the annual meeting of the Society for Pediatric Dermatology on July 14.
Benzene might also be a good candidate for the list, although the jury seems to be still out on its toxicity, said Dr. Schachner.
He talked about the “four Ps” of poisoning — the physician, pharmacy, parents, and pharmaceutical manufacturing — which all have some responsibility for errors that lead to adverse outcomes but can also take steps to prevent them.
During his presentation, Dr. Schachner discussed how babies are especially sensitive to topical therapies, noting that a baby’s skin is thinner and more permeable than that of an adult. And children have a greater body surface-to-weight ratio, so they absorb more substances through their skin.
He also noted that babies lack natural moisturizing factors, and their skin barrier isn’t mature until about age 3-5 years, stressing the need for extreme care when applying a topical agent to a baby’s skin.
Tragic Stories
Dr. Schachner pointed to some instances of mishaps related to toxic topical substances in children. There was the outbreak in the early 1980s of accidental hexachlorophene poisoning among children in France exposed to talc “baby powder.” Of the 204 affected children, 36 died.
The cause was a manufacturing error; the product contained 6.3% hexachlorophene, as opposed to the 0.1% limit recommended by the US Food and Drug Administration (FDA).
Local anesthetics, including lidocaine, dibucaine, and prilocaine, can cause local anesthetic systemic toxicity, a syndrome with symptoms that include central nervous system depression, seizures, and cardiotoxicity. Dr. Schachner described the case of a 3-year-old who developed methemoglobinemia, with seizures, after treatment with an excessive amount of eutectic mixture of local anesthetics (EMLA) cream, which contains both lidocaine and prilocaine.
EMLA shouldn’t be used with methemoglobinemia-inducing agents, such as some antimalarials, analgesics, anesthetics, and antineoplastic agents. It’s not recommended in neonates or for those under 12 months if receiving methemoglobinemia-inducing agents, “and I would keep an eye on it after 12 months of age,” said Dr. Schachner.
He cited a retrospective review of topical lidocaine toxicity in pediatric patients reported to the National Poison Data System from 2000 to 2020. It found 37 cases of toxicity, the most common from application prior to dermatologic procedures (37.5%), which led to two deaths.
Not Benign Agents
“These are not benign agents; we have to use them correctly,” Dr. Schachner stressed. When discussing alcohols and antiseptics, he noted that phenol is found in a variety of household disinfectants, gargling products, ointments, and lip balms. Phenol can be used as a chemical peel and is the antiseptic component of Castellani paint. He also referred to cases of alcohol intoxication linked to umbilical care in newborns.
Benzene at elevated levels has been found in some topical benzoyl peroxide acne products and in some sunscreens. There have been suggestions, not strongly substantiated, that benzene may increase the risk for cancer, especially leukemias.
But there is sparse data on the absorption and toxicity of benzene exposure with sunscreen use. The data, he said, include an analysis of National Health and Nutrition Examination Survey data, which found that people who regularly used sunscreens were less likely to have elevated benzene levels compared with those who didn’t use sunscreens.
Turning to insecticides, Dr. Schachner discussed N,N-diethyl-m-toluamide (DEET), the active ingredient in many insect repellents. It helps avoid “some terrible diseases,” including mosquito-borne illnesses such as malaria and tick-borne conditions such as Lyme disease, and is available in several convenient formulations, he said.
When used on children, the American Academy of Pediatrics (AAP) recommends products with no more than 30% DEET. And insect repellents are not recommended for children younger than 2 months, or under clothing or damaged skin, he said.
Dr. Schachner referred to a case series of 18 children who developed DEET-induced encephalopathy; 13 (72%) involved dermal exposure. Three of those with cutaneous exposure died, mostly from neurologic, respiratory, and cardiac issues. “What’s very striking is that 55% of the kids were exposed to DEET of 20% or less, even though the AAP approves DEET at 30%, so maybe that’s something we have to look at,” he said.
Medication Patches
With medication patches, especially fentanyl transdermal patches, much can go wrong when it comes to children. This was highlighted by the cases Schachner cited, including an infant who developed acute cytotoxic cerebellar edema from fentanyl patch intoxication.
In another case, emergency room staff found a fentanyl patch stuck to the back of a 3-year-old girl. A CT scan showed global cerebral edema, and the patient progressed to brain death. “This is not a unique case; there have been over 10 such cases in the United States,” said Dr. Schachner. “We should be doing better with fentanyl.”
Nicotine patches can also be dangerous to children, he added. As for other topical agents, there have been reports of toxicity and deaths linked to salicylic acid, commonly used by dermatologists because of its bacteriostatic, fungicidal, keratolytic, and photoprotective properties.
Dr. Schachner cited the case of a 2-month-old where the pediatrician prescribed 50% salicylic acid for seborrheic dermatitis of the scalp, under occlusion. “It’s amazing this child survived; that’s clearly a physician error,” he said.
Henna, a reddish-brown dye derived from the crushed leaves of Lawsonia alba, is used cosmetically for the hair, skin, and nails. Many henna products are mixed with additives, including para-phenylenediamine, which has been associated with dermatitis, asthma, renal failure, and permanent vision loss.
Asked to comment on the presentation, Sheilagh Maguiness, MD, professor of dermatology and pediatrics and chair of pediatric dermatology at the University of Minnesota, Minneapolis, recalled a particularly concerning story in 2008, when the FDA issued a warning about Mommy’s Bliss, a cream containing chlorphenesin and phenoxyethanol as preservatives, promoted to nursing mothers for soothing cracked nipples. There were reports of the cream causing respiratory distress, vomiting, and diarrhea in nursing infants.
Dr. Schachner is chair of Stiefel Laboratories and is an investigator with: Astellas, Berg Pharma, Celgene, Ferndale Labs, Lilly, Medimetriks Pharmaceuticals, Novartis, Organogenesis, Pfizer, Sciton; is a consultant for: Alphyn, Amryt Pharma, Beiersdorf, Brickell, Cutanea, Hoth, Lexington, Mustela, TopMD, Noble Pharma; a speaker for: Novartis, Sanofi-Regeneron, CeraVe; is on the advisory boards of: Almirall, Alphyn, Apogee, Aslan, Biofrontera, CeraVe, Krystal Biotech, Mustela, Noble Pharma, Pfizer, Pierre Fabre, Sanofi-Regeneron; and owns stocks in: TopMD and Alphyn. Dr. Maguiness had no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
TORONTO — Lawrence A. Schachner, MD, would like pediatric dermatologists to adopt a “toxic agent of the year” to raise awareness about the potential harm related to certain topical treatments in babies and young children.
Dr. Schachner, director of the Division of Pediatric Dermatology in the Department of Dermatology & Cutaneous Surgery at the University of Miami, Coral Gables, Florida, said he got the idea from the American Contact Dermatitis Society, which annually names the “Allergen of the Year.”
, said Dr. Schachner, professor of pediatrics and dermatology at the University of Miami.
“Any one of those would be excellent toxic substances of the year” that could be the focus of an educational campaign, he told this news organization following his presentation on “Toxicology of Topical Ingredients in Pediatric Dermatology” at the annual meeting of the Society for Pediatric Dermatology on July 14.
Benzene might also be a good candidate for the list, although the jury seems to be still out on its toxicity, said Dr. Schachner.
He talked about the “four Ps” of poisoning — the physician, pharmacy, parents, and pharmaceutical manufacturing — which all have some responsibility for errors that lead to adverse outcomes but can also take steps to prevent them.
During his presentation, Dr. Schachner discussed how babies are especially sensitive to topical therapies, noting that a baby’s skin is thinner and more permeable than that of an adult. And children have a greater body surface-to-weight ratio, so they absorb more substances through their skin.
He also noted that babies lack natural moisturizing factors, and their skin barrier isn’t mature until about age 3-5 years, stressing the need for extreme care when applying a topical agent to a baby’s skin.
Tragic Stories
Dr. Schachner pointed to some instances of mishaps related to toxic topical substances in children. There was the outbreak in the early 1980s of accidental hexachlorophene poisoning among children in France exposed to talc “baby powder.” Of the 204 affected children, 36 died.
The cause was a manufacturing error; the product contained 6.3% hexachlorophene, as opposed to the 0.1% limit recommended by the US Food and Drug Administration (FDA).
Local anesthetics, including lidocaine, dibucaine, and prilocaine, can cause local anesthetic systemic toxicity, a syndrome with symptoms that include central nervous system depression, seizures, and cardiotoxicity. Dr. Schachner described the case of a 3-year-old who developed methemoglobinemia, with seizures, after treatment with an excessive amount of eutectic mixture of local anesthetics (EMLA) cream, which contains both lidocaine and prilocaine.
EMLA shouldn’t be used with methemoglobinemia-inducing agents, such as some antimalarials, analgesics, anesthetics, and antineoplastic agents. It’s not recommended in neonates or for those under 12 months if receiving methemoglobinemia-inducing agents, “and I would keep an eye on it after 12 months of age,” said Dr. Schachner.
He cited a retrospective review of topical lidocaine toxicity in pediatric patients reported to the National Poison Data System from 2000 to 2020. It found 37 cases of toxicity, the most common from application prior to dermatologic procedures (37.5%), which led to two deaths.
Not Benign Agents
“These are not benign agents; we have to use them correctly,” Dr. Schachner stressed. When discussing alcohols and antiseptics, he noted that phenol is found in a variety of household disinfectants, gargling products, ointments, and lip balms. Phenol can be used as a chemical peel and is the antiseptic component of Castellani paint. He also referred to cases of alcohol intoxication linked to umbilical care in newborns.
Benzene at elevated levels has been found in some topical benzoyl peroxide acne products and in some sunscreens. There have been suggestions, not strongly substantiated, that benzene may increase the risk for cancer, especially leukemias.
But there is sparse data on the absorption and toxicity of benzene exposure with sunscreen use. The data, he said, include an analysis of National Health and Nutrition Examination Survey data, which found that people who regularly used sunscreens were less likely to have elevated benzene levels compared with those who didn’t use sunscreens.
Turning to insecticides, Dr. Schachner discussed N,N-diethyl-m-toluamide (DEET), the active ingredient in many insect repellents. It helps avoid “some terrible diseases,” including mosquito-borne illnesses such as malaria and tick-borne conditions such as Lyme disease, and is available in several convenient formulations, he said.
When used on children, the American Academy of Pediatrics (AAP) recommends products with no more than 30% DEET. And insect repellents are not recommended for children younger than 2 months, or under clothing or damaged skin, he said.
Dr. Schachner referred to a case series of 18 children who developed DEET-induced encephalopathy; 13 (72%) involved dermal exposure. Three of those with cutaneous exposure died, mostly from neurologic, respiratory, and cardiac issues. “What’s very striking is that 55% of the kids were exposed to DEET of 20% or less, even though the AAP approves DEET at 30%, so maybe that’s something we have to look at,” he said.
Medication Patches
With medication patches, especially fentanyl transdermal patches, much can go wrong when it comes to children. This was highlighted by the cases Schachner cited, including an infant who developed acute cytotoxic cerebellar edema from fentanyl patch intoxication.
In another case, emergency room staff found a fentanyl patch stuck to the back of a 3-year-old girl. A CT scan showed global cerebral edema, and the patient progressed to brain death. “This is not a unique case; there have been over 10 such cases in the United States,” said Dr. Schachner. “We should be doing better with fentanyl.”
Nicotine patches can also be dangerous to children, he added. As for other topical agents, there have been reports of toxicity and deaths linked to salicylic acid, commonly used by dermatologists because of its bacteriostatic, fungicidal, keratolytic, and photoprotective properties.
Dr. Schachner cited the case of a 2-month-old where the pediatrician prescribed 50% salicylic acid for seborrheic dermatitis of the scalp, under occlusion. “It’s amazing this child survived; that’s clearly a physician error,” he said.
Henna, a reddish-brown dye derived from the crushed leaves of Lawsonia alba, is used cosmetically for the hair, skin, and nails. Many henna products are mixed with additives, including para-phenylenediamine, which has been associated with dermatitis, asthma, renal failure, and permanent vision loss.
Asked to comment on the presentation, Sheilagh Maguiness, MD, professor of dermatology and pediatrics and chair of pediatric dermatology at the University of Minnesota, Minneapolis, recalled a particularly concerning story in 2008, when the FDA issued a warning about Mommy’s Bliss, a cream containing chlorphenesin and phenoxyethanol as preservatives, promoted to nursing mothers for soothing cracked nipples. There were reports of the cream causing respiratory distress, vomiting, and diarrhea in nursing infants.
Dr. Schachner is chair of Stiefel Laboratories and is an investigator with: Astellas, Berg Pharma, Celgene, Ferndale Labs, Lilly, Medimetriks Pharmaceuticals, Novartis, Organogenesis, Pfizer, Sciton; is a consultant for: Alphyn, Amryt Pharma, Beiersdorf, Brickell, Cutanea, Hoth, Lexington, Mustela, TopMD, Noble Pharma; a speaker for: Novartis, Sanofi-Regeneron, CeraVe; is on the advisory boards of: Almirall, Alphyn, Apogee, Aslan, Biofrontera, CeraVe, Krystal Biotech, Mustela, Noble Pharma, Pfizer, Pierre Fabre, Sanofi-Regeneron; and owns stocks in: TopMD and Alphyn. Dr. Maguiness had no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
TORONTO — Lawrence A. Schachner, MD, would like pediatric dermatologists to adopt a “toxic agent of the year” to raise awareness about the potential harm related to certain topical treatments in babies and young children.
Dr. Schachner, director of the Division of Pediatric Dermatology in the Department of Dermatology & Cutaneous Surgery at the University of Miami, Coral Gables, Florida, said he got the idea from the American Contact Dermatitis Society, which annually names the “Allergen of the Year.”
, said Dr. Schachner, professor of pediatrics and dermatology at the University of Miami.
“Any one of those would be excellent toxic substances of the year” that could be the focus of an educational campaign, he told this news organization following his presentation on “Toxicology of Topical Ingredients in Pediatric Dermatology” at the annual meeting of the Society for Pediatric Dermatology on July 14.
Benzene might also be a good candidate for the list, although the jury seems to be still out on its toxicity, said Dr. Schachner.
He talked about the “four Ps” of poisoning — the physician, pharmacy, parents, and pharmaceutical manufacturing — which all have some responsibility for errors that lead to adverse outcomes but can also take steps to prevent them.
During his presentation, Dr. Schachner discussed how babies are especially sensitive to topical therapies, noting that a baby’s skin is thinner and more permeable than that of an adult. And children have a greater body surface-to-weight ratio, so they absorb more substances through their skin.
He also noted that babies lack natural moisturizing factors, and their skin barrier isn’t mature until about age 3-5 years, stressing the need for extreme care when applying a topical agent to a baby’s skin.
Tragic Stories
Dr. Schachner pointed to some instances of mishaps related to toxic topical substances in children. There was the outbreak in the early 1980s of accidental hexachlorophene poisoning among children in France exposed to talc “baby powder.” Of the 204 affected children, 36 died.
The cause was a manufacturing error; the product contained 6.3% hexachlorophene, as opposed to the 0.1% limit recommended by the US Food and Drug Administration (FDA).
Local anesthetics, including lidocaine, dibucaine, and prilocaine, can cause local anesthetic systemic toxicity, a syndrome with symptoms that include central nervous system depression, seizures, and cardiotoxicity. Dr. Schachner described the case of a 3-year-old who developed methemoglobinemia, with seizures, after treatment with an excessive amount of eutectic mixture of local anesthetics (EMLA) cream, which contains both lidocaine and prilocaine.
EMLA shouldn’t be used with methemoglobinemia-inducing agents, such as some antimalarials, analgesics, anesthetics, and antineoplastic agents. It’s not recommended in neonates or for those under 12 months if receiving methemoglobinemia-inducing agents, “and I would keep an eye on it after 12 months of age,” said Dr. Schachner.
He cited a retrospective review of topical lidocaine toxicity in pediatric patients reported to the National Poison Data System from 2000 to 2020. It found 37 cases of toxicity, the most common from application prior to dermatologic procedures (37.5%), which led to two deaths.
Not Benign Agents
“These are not benign agents; we have to use them correctly,” Dr. Schachner stressed. When discussing alcohols and antiseptics, he noted that phenol is found in a variety of household disinfectants, gargling products, ointments, and lip balms. Phenol can be used as a chemical peel and is the antiseptic component of Castellani paint. He also referred to cases of alcohol intoxication linked to umbilical care in newborns.
Benzene at elevated levels has been found in some topical benzoyl peroxide acne products and in some sunscreens. There have been suggestions, not strongly substantiated, that benzene may increase the risk for cancer, especially leukemias.
But there is sparse data on the absorption and toxicity of benzene exposure with sunscreen use. The data, he said, include an analysis of National Health and Nutrition Examination Survey data, which found that people who regularly used sunscreens were less likely to have elevated benzene levels compared with those who didn’t use sunscreens.
Turning to insecticides, Dr. Schachner discussed N,N-diethyl-m-toluamide (DEET), the active ingredient in many insect repellents. It helps avoid “some terrible diseases,” including mosquito-borne illnesses such as malaria and tick-borne conditions such as Lyme disease, and is available in several convenient formulations, he said.
When used on children, the American Academy of Pediatrics (AAP) recommends products with no more than 30% DEET. And insect repellents are not recommended for children younger than 2 months, or under clothing or damaged skin, he said.
Dr. Schachner referred to a case series of 18 children who developed DEET-induced encephalopathy; 13 (72%) involved dermal exposure. Three of those with cutaneous exposure died, mostly from neurologic, respiratory, and cardiac issues. “What’s very striking is that 55% of the kids were exposed to DEET of 20% or less, even though the AAP approves DEET at 30%, so maybe that’s something we have to look at,” he said.
Medication Patches
With medication patches, especially fentanyl transdermal patches, much can go wrong when it comes to children. This was highlighted by the cases Schachner cited, including an infant who developed acute cytotoxic cerebellar edema from fentanyl patch intoxication.
In another case, emergency room staff found a fentanyl patch stuck to the back of a 3-year-old girl. A CT scan showed global cerebral edema, and the patient progressed to brain death. “This is not a unique case; there have been over 10 such cases in the United States,” said Dr. Schachner. “We should be doing better with fentanyl.”
Nicotine patches can also be dangerous to children, he added. As for other topical agents, there have been reports of toxicity and deaths linked to salicylic acid, commonly used by dermatologists because of its bacteriostatic, fungicidal, keratolytic, and photoprotective properties.
Dr. Schachner cited the case of a 2-month-old where the pediatrician prescribed 50% salicylic acid for seborrheic dermatitis of the scalp, under occlusion. “It’s amazing this child survived; that’s clearly a physician error,” he said.
Henna, a reddish-brown dye derived from the crushed leaves of Lawsonia alba, is used cosmetically for the hair, skin, and nails. Many henna products are mixed with additives, including para-phenylenediamine, which has been associated with dermatitis, asthma, renal failure, and permanent vision loss.
Asked to comment on the presentation, Sheilagh Maguiness, MD, professor of dermatology and pediatrics and chair of pediatric dermatology at the University of Minnesota, Minneapolis, recalled a particularly concerning story in 2008, when the FDA issued a warning about Mommy’s Bliss, a cream containing chlorphenesin and phenoxyethanol as preservatives, promoted to nursing mothers for soothing cracked nipples. There were reports of the cream causing respiratory distress, vomiting, and diarrhea in nursing infants.
Dr. Schachner is chair of Stiefel Laboratories and is an investigator with: Astellas, Berg Pharma, Celgene, Ferndale Labs, Lilly, Medimetriks Pharmaceuticals, Novartis, Organogenesis, Pfizer, Sciton; is a consultant for: Alphyn, Amryt Pharma, Beiersdorf, Brickell, Cutanea, Hoth, Lexington, Mustela, TopMD, Noble Pharma; a speaker for: Novartis, Sanofi-Regeneron, CeraVe; is on the advisory boards of: Almirall, Alphyn, Apogee, Aslan, Biofrontera, CeraVe, Krystal Biotech, Mustela, Noble Pharma, Pfizer, Pierre Fabre, Sanofi-Regeneron; and owns stocks in: TopMD and Alphyn. Dr. Maguiness had no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
FROM SPD 2024
Insurers’ Rules and AI for Preauthorization: ‘Ethically Nuts,’ Says Ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City.
There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.
I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.
Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. or somebody saying, this is the standard of care and this is what ought to happen.
We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine.
We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.
We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.
If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review?
Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.
Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.
This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.
There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.
This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.
I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.
Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City.
There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.
I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.
Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. or somebody saying, this is the standard of care and this is what ought to happen.
We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine.
We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.
We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.
If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review?
Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.
Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.
This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.
There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.
This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.
I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.
Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City.
There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.
I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.
Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. or somebody saying, this is the standard of care and this is what ought to happen.
We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine.
We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.
We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.
If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review?
Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.
Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.
This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.
There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.
This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.
I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.
Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.
A version of this article first appeared on Medscape.com.
Is Parenthood Losing Its Appeal?
A recent survey by the Pew Research Center has found that among adults younger than 50, the percentage who say they are unlikely to have children rose from 37% to 47%. With this trend freshly etched in my consciousness, I stumbled across an interview with Anastasia Berg, an assistant professor of philosophy at the University of California, Irvine. Professor Berg and Rachel Wiseman have just published What Are Children For? On Ambivalence and Choice. How could a pediatrician with time on his hands ignore a provocative title like that?
I was immediately drawn to Professor Berg’s observations about the “concerns, anxieties, and lines of reasoning people encounter when considering whether or not they should have children.” Prior to the 1960s, motherhood seemed to just be a natural progression from marriage. That’s the way my wife and I approached it when we had our first child while I was in my last year of medical school in 1971. There was no discussion of the pros and cons, except maybe that financially waiting until the eve of my first professional paycheck seemed to make sense.
However, as Professor Berg points out, from the 1960s up until well into the 1980s, as feminist thought gained a higher profile, there were anti-motherhood factions. There were others who wanted to see motherhood reformed and adapted so it “could once again be a legitimate source of meaning and value in life.” However, both camps agreed that the choice to have children was a decision that “women should make completely on their own.”
Now, well into the new millennium, we are looking at a completely different landscape. In the past, having children was woven into the fabric of human life in which we had a past, a present, and a role in creating the future. Professor Berg observes that currently, having children is often considered a project, not unlike our other projects such as “career choice or travel plans.” What are the pluses and minuses?
The Pew Survey found that 60% of adults younger than 50 who don’t have children said that not having children made it less difficult to be successful and have an active social life. Many felt that being a parent would improve the chances of having someone to care for you as you aged.
When my wife and I considered the financial costs of motherhood more than 50 years ago, our calculation was primarily about the timing. The decision to have a second child focused our concern around our ability to balance our attention between two siblings. A third child just sorta happened without any discussion.
Professor Berg echoes the Pew findings when she observes that currently woman are considering the cost in terms of their identities. Will motherhood transform me? Will there be a cost not only to my career but also to all the associations, interests, and activities I have accumulated? These costs are likely to be greater the longer the decision to have a child is put off. She adds that viewing motherhood as a transformation can make the decision to have children scarier than it needs to be. My wife and I, at age 26 and 27, were still in the early stages of building our identities. My wife had a 2-year college degree and no career plans on the horizon. Having a child was one of those things that was built into who we became.
But to compare our experiences in the 1970s to the realities of the first quarter of the 21st century ignores the concerns facing today’s adults who are facing the cloud of uncertainty hanging over all of us. Despite their claims to fix the situation, both sides of the political spectrum are leveraging fear to gain our support. Even climate change skeptics must have some concern in the spate of natural disasters we are experiencing. Not to mention the pandemic. Anxiety in this country is at an all time high. Optimism doesn’t seem to fit into today’s journalists’ lexicon, as they chose to focus on conflict instead of cooperation. It’s hard to question any adult who harbors serious doubts on taking on the challenge of parenthood and bringing a child into a world that feels unsettled.
However, based on her research and her own experience as a parent, Professor Berg offers some advice. She encourages people to think and discuss the decision to have children earlier in their life trajectory, before they have made decisions that may eventually limit their options. Second, she discourages making a list of pros and cons. Finally, she advises taking a long view and ask yourself whether you “choose to take a direct part in ushering in the next generation.”
Sounds like advice that will optimize the chances of making the good decision about having a child. I’m just thankful to have lived at time and in a situation when having child was just the thing most married couples did.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
A recent survey by the Pew Research Center has found that among adults younger than 50, the percentage who say they are unlikely to have children rose from 37% to 47%. With this trend freshly etched in my consciousness, I stumbled across an interview with Anastasia Berg, an assistant professor of philosophy at the University of California, Irvine. Professor Berg and Rachel Wiseman have just published What Are Children For? On Ambivalence and Choice. How could a pediatrician with time on his hands ignore a provocative title like that?
I was immediately drawn to Professor Berg’s observations about the “concerns, anxieties, and lines of reasoning people encounter when considering whether or not they should have children.” Prior to the 1960s, motherhood seemed to just be a natural progression from marriage. That’s the way my wife and I approached it when we had our first child while I was in my last year of medical school in 1971. There was no discussion of the pros and cons, except maybe that financially waiting until the eve of my first professional paycheck seemed to make sense.
However, as Professor Berg points out, from the 1960s up until well into the 1980s, as feminist thought gained a higher profile, there were anti-motherhood factions. There were others who wanted to see motherhood reformed and adapted so it “could once again be a legitimate source of meaning and value in life.” However, both camps agreed that the choice to have children was a decision that “women should make completely on their own.”
Now, well into the new millennium, we are looking at a completely different landscape. In the past, having children was woven into the fabric of human life in which we had a past, a present, and a role in creating the future. Professor Berg observes that currently, having children is often considered a project, not unlike our other projects such as “career choice or travel plans.” What are the pluses and minuses?
The Pew Survey found that 60% of adults younger than 50 who don’t have children said that not having children made it less difficult to be successful and have an active social life. Many felt that being a parent would improve the chances of having someone to care for you as you aged.
When my wife and I considered the financial costs of motherhood more than 50 years ago, our calculation was primarily about the timing. The decision to have a second child focused our concern around our ability to balance our attention between two siblings. A third child just sorta happened without any discussion.
Professor Berg echoes the Pew findings when she observes that currently woman are considering the cost in terms of their identities. Will motherhood transform me? Will there be a cost not only to my career but also to all the associations, interests, and activities I have accumulated? These costs are likely to be greater the longer the decision to have a child is put off. She adds that viewing motherhood as a transformation can make the decision to have children scarier than it needs to be. My wife and I, at age 26 and 27, were still in the early stages of building our identities. My wife had a 2-year college degree and no career plans on the horizon. Having a child was one of those things that was built into who we became.
But to compare our experiences in the 1970s to the realities of the first quarter of the 21st century ignores the concerns facing today’s adults who are facing the cloud of uncertainty hanging over all of us. Despite their claims to fix the situation, both sides of the political spectrum are leveraging fear to gain our support. Even climate change skeptics must have some concern in the spate of natural disasters we are experiencing. Not to mention the pandemic. Anxiety in this country is at an all time high. Optimism doesn’t seem to fit into today’s journalists’ lexicon, as they chose to focus on conflict instead of cooperation. It’s hard to question any adult who harbors serious doubts on taking on the challenge of parenthood and bringing a child into a world that feels unsettled.
However, based on her research and her own experience as a parent, Professor Berg offers some advice. She encourages people to think and discuss the decision to have children earlier in their life trajectory, before they have made decisions that may eventually limit their options. Second, she discourages making a list of pros and cons. Finally, she advises taking a long view and ask yourself whether you “choose to take a direct part in ushering in the next generation.”
Sounds like advice that will optimize the chances of making the good decision about having a child. I’m just thankful to have lived at time and in a situation when having child was just the thing most married couples did.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
A recent survey by the Pew Research Center has found that among adults younger than 50, the percentage who say they are unlikely to have children rose from 37% to 47%. With this trend freshly etched in my consciousness, I stumbled across an interview with Anastasia Berg, an assistant professor of philosophy at the University of California, Irvine. Professor Berg and Rachel Wiseman have just published What Are Children For? On Ambivalence and Choice. How could a pediatrician with time on his hands ignore a provocative title like that?
I was immediately drawn to Professor Berg’s observations about the “concerns, anxieties, and lines of reasoning people encounter when considering whether or not they should have children.” Prior to the 1960s, motherhood seemed to just be a natural progression from marriage. That’s the way my wife and I approached it when we had our first child while I was in my last year of medical school in 1971. There was no discussion of the pros and cons, except maybe that financially waiting until the eve of my first professional paycheck seemed to make sense.
However, as Professor Berg points out, from the 1960s up until well into the 1980s, as feminist thought gained a higher profile, there were anti-motherhood factions. There were others who wanted to see motherhood reformed and adapted so it “could once again be a legitimate source of meaning and value in life.” However, both camps agreed that the choice to have children was a decision that “women should make completely on their own.”
Now, well into the new millennium, we are looking at a completely different landscape. In the past, having children was woven into the fabric of human life in which we had a past, a present, and a role in creating the future. Professor Berg observes that currently, having children is often considered a project, not unlike our other projects such as “career choice or travel plans.” What are the pluses and minuses?
The Pew Survey found that 60% of adults younger than 50 who don’t have children said that not having children made it less difficult to be successful and have an active social life. Many felt that being a parent would improve the chances of having someone to care for you as you aged.
When my wife and I considered the financial costs of motherhood more than 50 years ago, our calculation was primarily about the timing. The decision to have a second child focused our concern around our ability to balance our attention between two siblings. A third child just sorta happened without any discussion.
Professor Berg echoes the Pew findings when she observes that currently woman are considering the cost in terms of their identities. Will motherhood transform me? Will there be a cost not only to my career but also to all the associations, interests, and activities I have accumulated? These costs are likely to be greater the longer the decision to have a child is put off. She adds that viewing motherhood as a transformation can make the decision to have children scarier than it needs to be. My wife and I, at age 26 and 27, were still in the early stages of building our identities. My wife had a 2-year college degree and no career plans on the horizon. Having a child was one of those things that was built into who we became.
But to compare our experiences in the 1970s to the realities of the first quarter of the 21st century ignores the concerns facing today’s adults who are facing the cloud of uncertainty hanging over all of us. Despite their claims to fix the situation, both sides of the political spectrum are leveraging fear to gain our support. Even climate change skeptics must have some concern in the spate of natural disasters we are experiencing. Not to mention the pandemic. Anxiety in this country is at an all time high. Optimism doesn’t seem to fit into today’s journalists’ lexicon, as they chose to focus on conflict instead of cooperation. It’s hard to question any adult who harbors serious doubts on taking on the challenge of parenthood and bringing a child into a world that feels unsettled.
However, based on her research and her own experience as a parent, Professor Berg offers some advice. She encourages people to think and discuss the decision to have children earlier in their life trajectory, before they have made decisions that may eventually limit their options. Second, she discourages making a list of pros and cons. Finally, she advises taking a long view and ask yourself whether you “choose to take a direct part in ushering in the next generation.”
Sounds like advice that will optimize the chances of making the good decision about having a child. I’m just thankful to have lived at time and in a situation when having child was just the thing most married couples did.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Identifying, Treating Lyme Disease in Primary Care
Geographic spread of the ticks that most often cause Lyme disease in the United States and a rise in incidence of bites, resulting in 476,000 new US cases a year, have increased the chances that physicians who have never encountered a patient with Lyme disease will see their first cases.
“It’s increasing in areas where it was not seen before,” Steven E. Schutzer, MD, with the Department of Medicine, Rutgers New Jersey Medical School, Newark, said in an interview. Dr. Schutzer coauthored a report on diagnosing and treating Lyme disease with Patricia K. Coyle, MD, Department of Neurology, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.
The report, a Curbside Consult published in New England Journal of Medicine Evidence, comes amid high season for Lyme disease. Bites from an ixodid (hard shield) tick — almost always the source of the disease in the United States — are most common from April through October.
Identifying the Bite
About 70%-90% of the time, Lyme disease will be signaled by erythema migrans (EM) or lesion expanding from the tick bite site, the authors wrote. The “classic” presentation looks like a bullseye, but most of the time the skin will show a variation of that, the authors noted.
“The presence of EM is considered the best clinical diagnostic marker for Lyme disease,” they wrote.
Other dermatologic conditions, however, can complicate diagnosis: “EM mimickers include contact dermatitis, other arthropod bites, fixed drug eruptions, granuloma annulare, cellulitis, dermatophytosis, and systemic lupus erythematosus,” they wrote.
Testing Steps
“The current recommendation is to do two-step testing almost simultaneously,” Dr. Schutzer said in an interview. The first, he said, is an ELISA (enzyme-linked immunosorbent assay)-type test and the second one, used for years, has been a pictoral view of a Western immunoblot showing which antigens of the Lyme bacteria, Borrelia burgdorferi, the antibodies are reacting to.
However, the pictoral view is subjective and some of the antigens could be cross-reactive. So the U.S. Food and Drug Administration (FDA) “has been allowing newer substitutes like a second ELISA-like assay that often uses more recombinant, less cross-reactive antigen targets,” he said. The authors advised that, “The second-tier test should not be performed alone without the first tier.”
Dr. Schutzer advised physicians to check with the lab they plan to use before sending samples.
“If you’re a practicing physician and you know you’re using a particular laboratory, you should familiarize yourself with them, talking to one of the clinical pathologists involved in advance to know what the limitations are.” Take the time to talk with the person overseeing the test and get tips on how they want the sample transported and how the cases should be reported, he said.
If the patient has neurological symptoms, he said, before treating talk with a neurologist who can advise whether, for instance, a spinal tap is in order or whether an emergency department visit is appropriate.
“If you just start proceeding you may mess up the diagnostic signs that could show up in a lab test. Don’t be hesitant to ask for extra input from colleagues,” Dr. Schutzer said.
Suspicion in Endemic Areas
On Long Island, New York, where Lyme disease is endemic, internist Ian Storch, DO, said he sees “a few cases a season.
“We have a lot of people over the summer going to the Hamptons and areas out east for the weekend and tick bites are not uncommon,” he said. “People panic.”
He said one thing it’s important to tell patients is that the tick has to be on the skin for 48-72 hours to transmit the disease. If individuals were in a wooded area and were fine before they got there and the tick was attached for less than 2 days, “they’re usually fine.”
Another issue, Dr. Storch said, is patients sometimes want to get tested for Lyme disease immediately after a tick bite. But the antibody test doesn’t turn positive for weeks, he noted, and you can get a false-negative result. “If you’re worried and you really want to test, you need to wait 6 weeks to do the blood test.”
In his region, he said that although a tick bite is a red flag, he may also suspect Lyme disease when a patient presents with otherwise unexplained joint pain, weakness, lethargy, or fever. “In our area, those are things that would make you test for Lyme.”
He also urged consideration of Lyme in this new age of long COVID. Weakness, fatigue, and lethargy are also classic symptoms of long COVID, he noted. “Keep Lyme disease in your differential because there is a lot of overlap with chronic Lyme disease,” Dr. Storch said.
Discerning Lyme from Southern Tick–Associated Rash Illness
Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic in Texas, where Lyme disease is not endemic, said Lyme disease “will not and should not be on the initial differential diagnosis for those residing in nonendemic areas unless a history of travel to an endemic area is obtained.”
She noted the typical EM rash may not be as distinct or easy to discern on black and brown skin. In addition, she said, EM may have many variations in presentation, such as a crusted center or faint borders, which could lead to a delay in diagnosis and treatment. She suggested consulting the CDC guidance on Lyme disease rashes.
Another challenge in diagnosis, she said, is the patient who presents with what appears to be a classic EM lesion but does not live in a Lyme-endemic area. In Texas, Southern Tick–Associated Rash Illness (STARI) may present with a similar lesion, she said.
“It is transmitted by the Lone Star Tick, which is found in the southeast and south-central US,” Dr. Word said. “However, its habitat is moving northward and westerly,” she said.
Adding Lyme disease to the differential diagnosis is reasonable, she said, if a patient presents with neurologic symptoms “such as a facial palsy, meningitis, radiculitis, and carditis if in addition to their symptoms there is evidence of an epidemiologic link to a Lyme-endemic region.”
She noted that a detailed travel history is important as “Lyme is also endemic in Eastern Canada, Europe, states of the former Soviet Union, China, Mongolia, and Japan.”
Primary care physicians play a critical role in evaluating, diagnosing, and treating most cases of early Lyme disease, thus limiting the number of people who will develop disseminated or late Lyme disease, she said. “The two latter manifestations are most often treated by infectious disease, neurology, or rheumatology specialists.”
Treatment*
Treatment is tailored to the clinical situation, Dr. Schutzer and Dr. Coyle write. A watch-and-wait approach may be appropriate in an asymptomatic but concerned person, even in an endemic area if the person has no known tick bite and no EM lesion.
If there is high risk of an infected ixodid tick bite in a high-incidence area and the tick was attached for at least 36 hours but less than 72 hours, one dose of doxycycline has been recommended as prophylaxis.
When a diagnosis of early nondisseminated Lyme disease is made after observation of an EM lesion, oral antibiotics are typically used to treat for 10 to 14 days. Suggested oral antibiotics and doses are 100 mg of doxycycline twice a day, 500 mg of amoxicillin three times a day, or 500 mg of cefuroxime twice a day, the authors write.
Dr. Schutzer said he hopes the paper serves as a refresher for those physicians who regularly see Lyme disease cases and also helps those newly included in the disease’s spreading regions.
“The earlier you diagnose it, the earlier you can treat it and the better the chance for a favorable outcome,” he said.
Dr. Schutzer, Dr. Coyle, Dr. Storch, and Dr. Word reported no relevant financial relationships.
*This story was updated on August, 2, 2024.
Geographic spread of the ticks that most often cause Lyme disease in the United States and a rise in incidence of bites, resulting in 476,000 new US cases a year, have increased the chances that physicians who have never encountered a patient with Lyme disease will see their first cases.
“It’s increasing in areas where it was not seen before,” Steven E. Schutzer, MD, with the Department of Medicine, Rutgers New Jersey Medical School, Newark, said in an interview. Dr. Schutzer coauthored a report on diagnosing and treating Lyme disease with Patricia K. Coyle, MD, Department of Neurology, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.
The report, a Curbside Consult published in New England Journal of Medicine Evidence, comes amid high season for Lyme disease. Bites from an ixodid (hard shield) tick — almost always the source of the disease in the United States — are most common from April through October.
Identifying the Bite
About 70%-90% of the time, Lyme disease will be signaled by erythema migrans (EM) or lesion expanding from the tick bite site, the authors wrote. The “classic” presentation looks like a bullseye, but most of the time the skin will show a variation of that, the authors noted.
“The presence of EM is considered the best clinical diagnostic marker for Lyme disease,” they wrote.
Other dermatologic conditions, however, can complicate diagnosis: “EM mimickers include contact dermatitis, other arthropod bites, fixed drug eruptions, granuloma annulare, cellulitis, dermatophytosis, and systemic lupus erythematosus,” they wrote.
Testing Steps
“The current recommendation is to do two-step testing almost simultaneously,” Dr. Schutzer said in an interview. The first, he said, is an ELISA (enzyme-linked immunosorbent assay)-type test and the second one, used for years, has been a pictoral view of a Western immunoblot showing which antigens of the Lyme bacteria, Borrelia burgdorferi, the antibodies are reacting to.
However, the pictoral view is subjective and some of the antigens could be cross-reactive. So the U.S. Food and Drug Administration (FDA) “has been allowing newer substitutes like a second ELISA-like assay that often uses more recombinant, less cross-reactive antigen targets,” he said. The authors advised that, “The second-tier test should not be performed alone without the first tier.”
Dr. Schutzer advised physicians to check with the lab they plan to use before sending samples.
“If you’re a practicing physician and you know you’re using a particular laboratory, you should familiarize yourself with them, talking to one of the clinical pathologists involved in advance to know what the limitations are.” Take the time to talk with the person overseeing the test and get tips on how they want the sample transported and how the cases should be reported, he said.
If the patient has neurological symptoms, he said, before treating talk with a neurologist who can advise whether, for instance, a spinal tap is in order or whether an emergency department visit is appropriate.
“If you just start proceeding you may mess up the diagnostic signs that could show up in a lab test. Don’t be hesitant to ask for extra input from colleagues,” Dr. Schutzer said.
Suspicion in Endemic Areas
On Long Island, New York, where Lyme disease is endemic, internist Ian Storch, DO, said he sees “a few cases a season.
“We have a lot of people over the summer going to the Hamptons and areas out east for the weekend and tick bites are not uncommon,” he said. “People panic.”
He said one thing it’s important to tell patients is that the tick has to be on the skin for 48-72 hours to transmit the disease. If individuals were in a wooded area and were fine before they got there and the tick was attached for less than 2 days, “they’re usually fine.”
Another issue, Dr. Storch said, is patients sometimes want to get tested for Lyme disease immediately after a tick bite. But the antibody test doesn’t turn positive for weeks, he noted, and you can get a false-negative result. “If you’re worried and you really want to test, you need to wait 6 weeks to do the blood test.”
In his region, he said that although a tick bite is a red flag, he may also suspect Lyme disease when a patient presents with otherwise unexplained joint pain, weakness, lethargy, or fever. “In our area, those are things that would make you test for Lyme.”
He also urged consideration of Lyme in this new age of long COVID. Weakness, fatigue, and lethargy are also classic symptoms of long COVID, he noted. “Keep Lyme disease in your differential because there is a lot of overlap with chronic Lyme disease,” Dr. Storch said.
Discerning Lyme from Southern Tick–Associated Rash Illness
Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic in Texas, where Lyme disease is not endemic, said Lyme disease “will not and should not be on the initial differential diagnosis for those residing in nonendemic areas unless a history of travel to an endemic area is obtained.”
She noted the typical EM rash may not be as distinct or easy to discern on black and brown skin. In addition, she said, EM may have many variations in presentation, such as a crusted center or faint borders, which could lead to a delay in diagnosis and treatment. She suggested consulting the CDC guidance on Lyme disease rashes.
Another challenge in diagnosis, she said, is the patient who presents with what appears to be a classic EM lesion but does not live in a Lyme-endemic area. In Texas, Southern Tick–Associated Rash Illness (STARI) may present with a similar lesion, she said.
“It is transmitted by the Lone Star Tick, which is found in the southeast and south-central US,” Dr. Word said. “However, its habitat is moving northward and westerly,” she said.
Adding Lyme disease to the differential diagnosis is reasonable, she said, if a patient presents with neurologic symptoms “such as a facial palsy, meningitis, radiculitis, and carditis if in addition to their symptoms there is evidence of an epidemiologic link to a Lyme-endemic region.”
She noted that a detailed travel history is important as “Lyme is also endemic in Eastern Canada, Europe, states of the former Soviet Union, China, Mongolia, and Japan.”
Primary care physicians play a critical role in evaluating, diagnosing, and treating most cases of early Lyme disease, thus limiting the number of people who will develop disseminated or late Lyme disease, she said. “The two latter manifestations are most often treated by infectious disease, neurology, or rheumatology specialists.”
Treatment*
Treatment is tailored to the clinical situation, Dr. Schutzer and Dr. Coyle write. A watch-and-wait approach may be appropriate in an asymptomatic but concerned person, even in an endemic area if the person has no known tick bite and no EM lesion.
If there is high risk of an infected ixodid tick bite in a high-incidence area and the tick was attached for at least 36 hours but less than 72 hours, one dose of doxycycline has been recommended as prophylaxis.
When a diagnosis of early nondisseminated Lyme disease is made after observation of an EM lesion, oral antibiotics are typically used to treat for 10 to 14 days. Suggested oral antibiotics and doses are 100 mg of doxycycline twice a day, 500 mg of amoxicillin three times a day, or 500 mg of cefuroxime twice a day, the authors write.
Dr. Schutzer said he hopes the paper serves as a refresher for those physicians who regularly see Lyme disease cases and also helps those newly included in the disease’s spreading regions.
“The earlier you diagnose it, the earlier you can treat it and the better the chance for a favorable outcome,” he said.
Dr. Schutzer, Dr. Coyle, Dr. Storch, and Dr. Word reported no relevant financial relationships.
*This story was updated on August, 2, 2024.
Geographic spread of the ticks that most often cause Lyme disease in the United States and a rise in incidence of bites, resulting in 476,000 new US cases a year, have increased the chances that physicians who have never encountered a patient with Lyme disease will see their first cases.
“It’s increasing in areas where it was not seen before,” Steven E. Schutzer, MD, with the Department of Medicine, Rutgers New Jersey Medical School, Newark, said in an interview. Dr. Schutzer coauthored a report on diagnosing and treating Lyme disease with Patricia K. Coyle, MD, Department of Neurology, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.
The report, a Curbside Consult published in New England Journal of Medicine Evidence, comes amid high season for Lyme disease. Bites from an ixodid (hard shield) tick — almost always the source of the disease in the United States — are most common from April through October.
Identifying the Bite
About 70%-90% of the time, Lyme disease will be signaled by erythema migrans (EM) or lesion expanding from the tick bite site, the authors wrote. The “classic” presentation looks like a bullseye, but most of the time the skin will show a variation of that, the authors noted.
“The presence of EM is considered the best clinical diagnostic marker for Lyme disease,” they wrote.
Other dermatologic conditions, however, can complicate diagnosis: “EM mimickers include contact dermatitis, other arthropod bites, fixed drug eruptions, granuloma annulare, cellulitis, dermatophytosis, and systemic lupus erythematosus,” they wrote.
Testing Steps
“The current recommendation is to do two-step testing almost simultaneously,” Dr. Schutzer said in an interview. The first, he said, is an ELISA (enzyme-linked immunosorbent assay)-type test and the second one, used for years, has been a pictoral view of a Western immunoblot showing which antigens of the Lyme bacteria, Borrelia burgdorferi, the antibodies are reacting to.
However, the pictoral view is subjective and some of the antigens could be cross-reactive. So the U.S. Food and Drug Administration (FDA) “has been allowing newer substitutes like a second ELISA-like assay that often uses more recombinant, less cross-reactive antigen targets,” he said. The authors advised that, “The second-tier test should not be performed alone without the first tier.”
Dr. Schutzer advised physicians to check with the lab they plan to use before sending samples.
“If you’re a practicing physician and you know you’re using a particular laboratory, you should familiarize yourself with them, talking to one of the clinical pathologists involved in advance to know what the limitations are.” Take the time to talk with the person overseeing the test and get tips on how they want the sample transported and how the cases should be reported, he said.
If the patient has neurological symptoms, he said, before treating talk with a neurologist who can advise whether, for instance, a spinal tap is in order or whether an emergency department visit is appropriate.
“If you just start proceeding you may mess up the diagnostic signs that could show up in a lab test. Don’t be hesitant to ask for extra input from colleagues,” Dr. Schutzer said.
Suspicion in Endemic Areas
On Long Island, New York, where Lyme disease is endemic, internist Ian Storch, DO, said he sees “a few cases a season.
“We have a lot of people over the summer going to the Hamptons and areas out east for the weekend and tick bites are not uncommon,” he said. “People panic.”
He said one thing it’s important to tell patients is that the tick has to be on the skin for 48-72 hours to transmit the disease. If individuals were in a wooded area and were fine before they got there and the tick was attached for less than 2 days, “they’re usually fine.”
Another issue, Dr. Storch said, is patients sometimes want to get tested for Lyme disease immediately after a tick bite. But the antibody test doesn’t turn positive for weeks, he noted, and you can get a false-negative result. “If you’re worried and you really want to test, you need to wait 6 weeks to do the blood test.”
In his region, he said that although a tick bite is a red flag, he may also suspect Lyme disease when a patient presents with otherwise unexplained joint pain, weakness, lethargy, or fever. “In our area, those are things that would make you test for Lyme.”
He also urged consideration of Lyme in this new age of long COVID. Weakness, fatigue, and lethargy are also classic symptoms of long COVID, he noted. “Keep Lyme disease in your differential because there is a lot of overlap with chronic Lyme disease,” Dr. Storch said.
Discerning Lyme from Southern Tick–Associated Rash Illness
Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic in Texas, where Lyme disease is not endemic, said Lyme disease “will not and should not be on the initial differential diagnosis for those residing in nonendemic areas unless a history of travel to an endemic area is obtained.”
She noted the typical EM rash may not be as distinct or easy to discern on black and brown skin. In addition, she said, EM may have many variations in presentation, such as a crusted center or faint borders, which could lead to a delay in diagnosis and treatment. She suggested consulting the CDC guidance on Lyme disease rashes.
Another challenge in diagnosis, she said, is the patient who presents with what appears to be a classic EM lesion but does not live in a Lyme-endemic area. In Texas, Southern Tick–Associated Rash Illness (STARI) may present with a similar lesion, she said.
“It is transmitted by the Lone Star Tick, which is found in the southeast and south-central US,” Dr. Word said. “However, its habitat is moving northward and westerly,” she said.
Adding Lyme disease to the differential diagnosis is reasonable, she said, if a patient presents with neurologic symptoms “such as a facial palsy, meningitis, radiculitis, and carditis if in addition to their symptoms there is evidence of an epidemiologic link to a Lyme-endemic region.”
She noted that a detailed travel history is important as “Lyme is also endemic in Eastern Canada, Europe, states of the former Soviet Union, China, Mongolia, and Japan.”
Primary care physicians play a critical role in evaluating, diagnosing, and treating most cases of early Lyme disease, thus limiting the number of people who will develop disseminated or late Lyme disease, she said. “The two latter manifestations are most often treated by infectious disease, neurology, or rheumatology specialists.”
Treatment*
Treatment is tailored to the clinical situation, Dr. Schutzer and Dr. Coyle write. A watch-and-wait approach may be appropriate in an asymptomatic but concerned person, even in an endemic area if the person has no known tick bite and no EM lesion.
If there is high risk of an infected ixodid tick bite in a high-incidence area and the tick was attached for at least 36 hours but less than 72 hours, one dose of doxycycline has been recommended as prophylaxis.
When a diagnosis of early nondisseminated Lyme disease is made after observation of an EM lesion, oral antibiotics are typically used to treat for 10 to 14 days. Suggested oral antibiotics and doses are 100 mg of doxycycline twice a day, 500 mg of amoxicillin three times a day, or 500 mg of cefuroxime twice a day, the authors write.
Dr. Schutzer said he hopes the paper serves as a refresher for those physicians who regularly see Lyme disease cases and also helps those newly included in the disease’s spreading regions.
“The earlier you diagnose it, the earlier you can treat it and the better the chance for a favorable outcome,” he said.
Dr. Schutzer, Dr. Coyle, Dr. Storch, and Dr. Word reported no relevant financial relationships.
*This story was updated on August, 2, 2024.
Study Quantifies Benefit of Newborn Screening for Vitamin B12 Deficiency
Newborn screening for neonatal vitamin B12 deficiency may lead to a fourfold reduction in chances of developing symptomatic vitamin B12 in the first year of life compared with infants without newborn screening, a hospital-based surveillance study in Germany indicates.
Vitamin B12 deficiency can impede development in infants, but the true impact of newborn screening versus no screening had not been known in Germany. Early treatment had been shown to be linked with normal development in infants who got newborn screening, but left unclear was how many who had newborn screening would have progressed to symptomatic vitamin B12 deficiency without treatment. Thus formal evidence for the benefit of the screening was lacking.
The nationwide surveillance study, led by Ulrike Mütze, MD, with the Heidelberg University Center for Child and Adolescent Medicine, was published online in Pediatrics. It used prospectively collected data from incident cases of infants under 12 months of age with vitamin B12 deficiency from 2021 to 2022.
The researchers analyzed 61 cases of vitamin B12 deficiency reported to the German Pediatric Surveillance Unit. They were either identified by newborn screening (n = 31) or diagnosed after the onset of suggestive symptoms (non-newborn screening; n = 30).
At a median 4 months of age, the great majority (90%) of the infants identified by newborn screening were still asymptomatic, while the non-newborn screening cohort presented with muscular hypotonia (68%), anemia (58%), developmental delay (44%), microcephalia (30%), and seizures (12%).
Symptomatically diagnosed vitamin B12 deficiency in the baby’s first year was reported four times more frequently in infants who did not receive newborn screening for neonatal vitamin B12 deficiency compared with those screened for vitamin B12 as newborns (Fisher’s Exact Test; odds ratio, 4.12 [95% confidence interval, 1.29-17.18], P = .008).
Clinical presentation of vitamin B12 deficiency in infants usually starts in the first months and reportedly includes, in addition to developmental delay, feeding difficulties, muscular hypotonia and weakness, severe failure to thrive, irritability, lethargy, and (as late symptoms) megaloblastic anemia and brain atrophy.
The current study confirmed these reports and highlighted that the most common presentations in symptomatic infantile vitamin B12 deficiency were muscular hypotonia, anemia, developmental delay, malnutrition or failure to thrive, and microcephalia, brain atrophy, or delayed myelination.
Stephen Walker, MD, a pediatric neurologist at University of Alabama, Birmingham, who was not involved with the study, said newborn screening for vitamin B12 deficiency is routine in the United States.
“In Alabama, we’re generally the last to adopt any of these newborn screenings ... and we’ve been doing it for several years,” he said. Vitamin B12 deficiency is one of 59 conditions included in the state’s newborn blood spot screening. In the United States, he added, when deficiencies are identified, cases are quickly referred to genetic or nutritional specialists.
In the Mütze et al. study, the authors conclude, “The incidence of symptomatic vitamin B12 deficiency accounts for about half of the estimated incidence of the vitamin B12 deficiency identified by newborn screening [NBS]. This supports the notion that not all newborns identified will develop a symptomatic infantile vitamin B12 deficiency but at the same time [this study demonstrates] the high beneficial potential of NBS for vitamin B12 deficiency.”
Dr. Mütze received a research grant from the Medical Faculty of Heidelberg University, Germany. Dr. Kölker, Dr. Hoffmann, and Dr. Mütze received research grants for their work on newborn screening from the Dietmar Hopp Foundation, St. Leon-Rot, Germany. Dr. Hoffmann, Dr. Janzen, and Dr. Röschinger are principal investigators for newborn screening pilot studies including neonatal vitamin B12 deficiency. The other authors have no relevant disclosures. Dr. Walker reports no relevant financial relationships.
Newborn screening for neonatal vitamin B12 deficiency may lead to a fourfold reduction in chances of developing symptomatic vitamin B12 in the first year of life compared with infants without newborn screening, a hospital-based surveillance study in Germany indicates.
Vitamin B12 deficiency can impede development in infants, but the true impact of newborn screening versus no screening had not been known in Germany. Early treatment had been shown to be linked with normal development in infants who got newborn screening, but left unclear was how many who had newborn screening would have progressed to symptomatic vitamin B12 deficiency without treatment. Thus formal evidence for the benefit of the screening was lacking.
The nationwide surveillance study, led by Ulrike Mütze, MD, with the Heidelberg University Center for Child and Adolescent Medicine, was published online in Pediatrics. It used prospectively collected data from incident cases of infants under 12 months of age with vitamin B12 deficiency from 2021 to 2022.
The researchers analyzed 61 cases of vitamin B12 deficiency reported to the German Pediatric Surveillance Unit. They were either identified by newborn screening (n = 31) or diagnosed after the onset of suggestive symptoms (non-newborn screening; n = 30).
At a median 4 months of age, the great majority (90%) of the infants identified by newborn screening were still asymptomatic, while the non-newborn screening cohort presented with muscular hypotonia (68%), anemia (58%), developmental delay (44%), microcephalia (30%), and seizures (12%).
Symptomatically diagnosed vitamin B12 deficiency in the baby’s first year was reported four times more frequently in infants who did not receive newborn screening for neonatal vitamin B12 deficiency compared with those screened for vitamin B12 as newborns (Fisher’s Exact Test; odds ratio, 4.12 [95% confidence interval, 1.29-17.18], P = .008).
Clinical presentation of vitamin B12 deficiency in infants usually starts in the first months and reportedly includes, in addition to developmental delay, feeding difficulties, muscular hypotonia and weakness, severe failure to thrive, irritability, lethargy, and (as late symptoms) megaloblastic anemia and brain atrophy.
The current study confirmed these reports and highlighted that the most common presentations in symptomatic infantile vitamin B12 deficiency were muscular hypotonia, anemia, developmental delay, malnutrition or failure to thrive, and microcephalia, brain atrophy, or delayed myelination.
Stephen Walker, MD, a pediatric neurologist at University of Alabama, Birmingham, who was not involved with the study, said newborn screening for vitamin B12 deficiency is routine in the United States.
“In Alabama, we’re generally the last to adopt any of these newborn screenings ... and we’ve been doing it for several years,” he said. Vitamin B12 deficiency is one of 59 conditions included in the state’s newborn blood spot screening. In the United States, he added, when deficiencies are identified, cases are quickly referred to genetic or nutritional specialists.
In the Mütze et al. study, the authors conclude, “The incidence of symptomatic vitamin B12 deficiency accounts for about half of the estimated incidence of the vitamin B12 deficiency identified by newborn screening [NBS]. This supports the notion that not all newborns identified will develop a symptomatic infantile vitamin B12 deficiency but at the same time [this study demonstrates] the high beneficial potential of NBS for vitamin B12 deficiency.”
Dr. Mütze received a research grant from the Medical Faculty of Heidelberg University, Germany. Dr. Kölker, Dr. Hoffmann, and Dr. Mütze received research grants for their work on newborn screening from the Dietmar Hopp Foundation, St. Leon-Rot, Germany. Dr. Hoffmann, Dr. Janzen, and Dr. Röschinger are principal investigators for newborn screening pilot studies including neonatal vitamin B12 deficiency. The other authors have no relevant disclosures. Dr. Walker reports no relevant financial relationships.
Newborn screening for neonatal vitamin B12 deficiency may lead to a fourfold reduction in chances of developing symptomatic vitamin B12 in the first year of life compared with infants without newborn screening, a hospital-based surveillance study in Germany indicates.
Vitamin B12 deficiency can impede development in infants, but the true impact of newborn screening versus no screening had not been known in Germany. Early treatment had been shown to be linked with normal development in infants who got newborn screening, but left unclear was how many who had newborn screening would have progressed to symptomatic vitamin B12 deficiency without treatment. Thus formal evidence for the benefit of the screening was lacking.
The nationwide surveillance study, led by Ulrike Mütze, MD, with the Heidelberg University Center for Child and Adolescent Medicine, was published online in Pediatrics. It used prospectively collected data from incident cases of infants under 12 months of age with vitamin B12 deficiency from 2021 to 2022.
The researchers analyzed 61 cases of vitamin B12 deficiency reported to the German Pediatric Surveillance Unit. They were either identified by newborn screening (n = 31) or diagnosed after the onset of suggestive symptoms (non-newborn screening; n = 30).
At a median 4 months of age, the great majority (90%) of the infants identified by newborn screening were still asymptomatic, while the non-newborn screening cohort presented with muscular hypotonia (68%), anemia (58%), developmental delay (44%), microcephalia (30%), and seizures (12%).
Symptomatically diagnosed vitamin B12 deficiency in the baby’s first year was reported four times more frequently in infants who did not receive newborn screening for neonatal vitamin B12 deficiency compared with those screened for vitamin B12 as newborns (Fisher’s Exact Test; odds ratio, 4.12 [95% confidence interval, 1.29-17.18], P = .008).
Clinical presentation of vitamin B12 deficiency in infants usually starts in the first months and reportedly includes, in addition to developmental delay, feeding difficulties, muscular hypotonia and weakness, severe failure to thrive, irritability, lethargy, and (as late symptoms) megaloblastic anemia and brain atrophy.
The current study confirmed these reports and highlighted that the most common presentations in symptomatic infantile vitamin B12 deficiency were muscular hypotonia, anemia, developmental delay, malnutrition or failure to thrive, and microcephalia, brain atrophy, or delayed myelination.
Stephen Walker, MD, a pediatric neurologist at University of Alabama, Birmingham, who was not involved with the study, said newborn screening for vitamin B12 deficiency is routine in the United States.
“In Alabama, we’re generally the last to adopt any of these newborn screenings ... and we’ve been doing it for several years,” he said. Vitamin B12 deficiency is one of 59 conditions included in the state’s newborn blood spot screening. In the United States, he added, when deficiencies are identified, cases are quickly referred to genetic or nutritional specialists.
In the Mütze et al. study, the authors conclude, “The incidence of symptomatic vitamin B12 deficiency accounts for about half of the estimated incidence of the vitamin B12 deficiency identified by newborn screening [NBS]. This supports the notion that not all newborns identified will develop a symptomatic infantile vitamin B12 deficiency but at the same time [this study demonstrates] the high beneficial potential of NBS for vitamin B12 deficiency.”
Dr. Mütze received a research grant from the Medical Faculty of Heidelberg University, Germany. Dr. Kölker, Dr. Hoffmann, and Dr. Mütze received research grants for their work on newborn screening from the Dietmar Hopp Foundation, St. Leon-Rot, Germany. Dr. Hoffmann, Dr. Janzen, and Dr. Röschinger are principal investigators for newborn screening pilot studies including neonatal vitamin B12 deficiency. The other authors have no relevant disclosures. Dr. Walker reports no relevant financial relationships.
FROM PEDIATRICS
Advantages of a Pediatric Rheumatology/Dermatology Clinic Evaluated
results from a retrospective cohort study showed.
“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”
To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.
In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.
Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).
Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.
The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.
“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”
In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.
“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”
The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
results from a retrospective cohort study showed.
“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”
To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.
In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.
Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).
Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.
The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.
“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”
In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.
“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”
The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
results from a retrospective cohort study showed.
“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”
To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.
In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.
Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).
Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.
The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.
“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”
In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.
“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”
The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM SPD 2024