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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.
Plastic Surgeon to Pay $5 Million for Restriction of Negative Reviews, Directing Fake Reviews
A Seattle plastic surgeon who illegally restricted patients from posting negative reviews about his practice and directed his staff to post fake positive reviews will pay $5 million for violating Washington state’s consumer protection law.
According to a July 1 consent decree, Javad Sajan, MD, and his practice Allure Esthetic must pay $1.5 million in restitution to 21,000 patients and $3.5 million to the state for manipulation of patient ratings.
In an April decision, US District Judge Ricardo S. Martinez sided with the state, ruling that Allure Esthetic’s actions violated the federal Consumer Review Fairness Act (CRFA).
“Writing a truthful review about a business should not subject you to threats or intimidation,” Mr. Ferguson said in a July 2 statement. “Consumers rely on reviews when determining who to trust, especially services that affect their health and safety. This resolution holds Allure accountable for brazenly violating that trust — and the law — and ensures the clinic stops its harmful conduct.”
In court documents, Dr. Sajan’s attorneys had argued that the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them.
The surgeon’s practice is “pleased to have resolved its case with the Attorney General’s Office,” according to a statement provided by Dr. Sajan’s attorney. “The cooperative settlement, while not admitting fault and resolving claims asserted by both sides, allows Allure Esthetic to continue to focus on its core mission of providing compassionate care to patients and serving the community. The decision to settle was not an easy one, but it was necessary to allocate time and resources where they matter most — the patients.”
The dispute stemmed from NDAs that Dr. Sajan’s practice required patients to sign starting in 2017, according to Mr. Ferguson’s complaint. The terms instructed patients to contact the business directly if they had concerns rather than post a negative review.
If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the lawsuit. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.
In addition, Mr. Ferguson accused Dr. Sajan of creating fake positive accounts of patient experiences and buying fake followers on social media. State investigators found Dr. Sajan directed Allure Esthetic’s employees to create fake Gmail accounts to post the false reviews, many of which are still online today, according to the state’s complaint.
Mr. Ferguson also claimed Dr. Sajan and his practice manipulated social media to appear more popular by purchasing followers through an online vendor. The practice also allegedly used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media.
After filing the lawsuit, Mr. Ferguson’s office uncovered further evidence of Dr. Sajan’s efforts to influence his professional reputation through fabrication, according to the July 2 release. Allure Esthetic “rigged” “best doctor” competitions hosted by local media outlets by paying staff and contractors to vote for Dr. Sajan as “best plastic surgeon” in the region, according to the release. The staff cast as many votes as websites allowed, despite not being patients of Allure Esthetic.
The practice also allegedly edited before-and-after photos of patients to make their results appear better and kept tens of thousands of dollars in rebates intended for its patients.
In addition to paying $5 million, the consent decree requires Dr. Sajan and his practice also:
- Stop posting or influencing consumer reviews; perform a full audit of all public reviews on Google, Yelp, and other third-party review platforms; and request removal of every review Allure Esthetic was involved in creating, posting, or shaping in any manner.
- Remove all misleading “before-and-after” photographs of plastic surgery procedures from its website and social media and stop altering photographs of future procedures.
- Cease use of and attempts to enforce all illegal NDAs and notify patients who previously signed them that they are released from the terms of those NDAs.
- Pay a third-party forensic accounting firm to perform a full, independent audit of Allure Esthetic’s consumer rebate program to identify consumers who are owed rebates that were unlawfully claimed by Allure Esthetic.
Additionally, the attorney general’s office will continue to monitor Allure Esthetic, and upon request, the practice must provide information that demonstrates its compliance with the consent decree for the next 10 years.
The practice must also develop internal policies and implement a training program to educate staff about nondeceptive advertising and compliance with consumer protection laws.
Dr. Sajan and his practice agreed to the terms of the consent decree, and the settlement is not considered an admission of liability.
A version of this article first appeared on Medscape.com.
A Seattle plastic surgeon who illegally restricted patients from posting negative reviews about his practice and directed his staff to post fake positive reviews will pay $5 million for violating Washington state’s consumer protection law.
According to a July 1 consent decree, Javad Sajan, MD, and his practice Allure Esthetic must pay $1.5 million in restitution to 21,000 patients and $3.5 million to the state for manipulation of patient ratings.
In an April decision, US District Judge Ricardo S. Martinez sided with the state, ruling that Allure Esthetic’s actions violated the federal Consumer Review Fairness Act (CRFA).
“Writing a truthful review about a business should not subject you to threats or intimidation,” Mr. Ferguson said in a July 2 statement. “Consumers rely on reviews when determining who to trust, especially services that affect their health and safety. This resolution holds Allure accountable for brazenly violating that trust — and the law — and ensures the clinic stops its harmful conduct.”
In court documents, Dr. Sajan’s attorneys had argued that the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them.
The surgeon’s practice is “pleased to have resolved its case with the Attorney General’s Office,” according to a statement provided by Dr. Sajan’s attorney. “The cooperative settlement, while not admitting fault and resolving claims asserted by both sides, allows Allure Esthetic to continue to focus on its core mission of providing compassionate care to patients and serving the community. The decision to settle was not an easy one, but it was necessary to allocate time and resources where they matter most — the patients.”
The dispute stemmed from NDAs that Dr. Sajan’s practice required patients to sign starting in 2017, according to Mr. Ferguson’s complaint. The terms instructed patients to contact the business directly if they had concerns rather than post a negative review.
If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the lawsuit. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.
In addition, Mr. Ferguson accused Dr. Sajan of creating fake positive accounts of patient experiences and buying fake followers on social media. State investigators found Dr. Sajan directed Allure Esthetic’s employees to create fake Gmail accounts to post the false reviews, many of which are still online today, according to the state’s complaint.
Mr. Ferguson also claimed Dr. Sajan and his practice manipulated social media to appear more popular by purchasing followers through an online vendor. The practice also allegedly used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media.
After filing the lawsuit, Mr. Ferguson’s office uncovered further evidence of Dr. Sajan’s efforts to influence his professional reputation through fabrication, according to the July 2 release. Allure Esthetic “rigged” “best doctor” competitions hosted by local media outlets by paying staff and contractors to vote for Dr. Sajan as “best plastic surgeon” in the region, according to the release. The staff cast as many votes as websites allowed, despite not being patients of Allure Esthetic.
The practice also allegedly edited before-and-after photos of patients to make their results appear better and kept tens of thousands of dollars in rebates intended for its patients.
In addition to paying $5 million, the consent decree requires Dr. Sajan and his practice also:
- Stop posting or influencing consumer reviews; perform a full audit of all public reviews on Google, Yelp, and other third-party review platforms; and request removal of every review Allure Esthetic was involved in creating, posting, or shaping in any manner.
- Remove all misleading “before-and-after” photographs of plastic surgery procedures from its website and social media and stop altering photographs of future procedures.
- Cease use of and attempts to enforce all illegal NDAs and notify patients who previously signed them that they are released from the terms of those NDAs.
- Pay a third-party forensic accounting firm to perform a full, independent audit of Allure Esthetic’s consumer rebate program to identify consumers who are owed rebates that were unlawfully claimed by Allure Esthetic.
Additionally, the attorney general’s office will continue to monitor Allure Esthetic, and upon request, the practice must provide information that demonstrates its compliance with the consent decree for the next 10 years.
The practice must also develop internal policies and implement a training program to educate staff about nondeceptive advertising and compliance with consumer protection laws.
Dr. Sajan and his practice agreed to the terms of the consent decree, and the settlement is not considered an admission of liability.
A version of this article first appeared on Medscape.com.
A Seattle plastic surgeon who illegally restricted patients from posting negative reviews about his practice and directed his staff to post fake positive reviews will pay $5 million for violating Washington state’s consumer protection law.
According to a July 1 consent decree, Javad Sajan, MD, and his practice Allure Esthetic must pay $1.5 million in restitution to 21,000 patients and $3.5 million to the state for manipulation of patient ratings.
In an April decision, US District Judge Ricardo S. Martinez sided with the state, ruling that Allure Esthetic’s actions violated the federal Consumer Review Fairness Act (CRFA).
“Writing a truthful review about a business should not subject you to threats or intimidation,” Mr. Ferguson said in a July 2 statement. “Consumers rely on reviews when determining who to trust, especially services that affect their health and safety. This resolution holds Allure accountable for brazenly violating that trust — and the law — and ensures the clinic stops its harmful conduct.”
In court documents, Dr. Sajan’s attorneys had argued that the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them.
The surgeon’s practice is “pleased to have resolved its case with the Attorney General’s Office,” according to a statement provided by Dr. Sajan’s attorney. “The cooperative settlement, while not admitting fault and resolving claims asserted by both sides, allows Allure Esthetic to continue to focus on its core mission of providing compassionate care to patients and serving the community. The decision to settle was not an easy one, but it was necessary to allocate time and resources where they matter most — the patients.”
The dispute stemmed from NDAs that Dr. Sajan’s practice required patients to sign starting in 2017, according to Mr. Ferguson’s complaint. The terms instructed patients to contact the business directly if they had concerns rather than post a negative review.
If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the lawsuit. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.
In addition, Mr. Ferguson accused Dr. Sajan of creating fake positive accounts of patient experiences and buying fake followers on social media. State investigators found Dr. Sajan directed Allure Esthetic’s employees to create fake Gmail accounts to post the false reviews, many of which are still online today, according to the state’s complaint.
Mr. Ferguson also claimed Dr. Sajan and his practice manipulated social media to appear more popular by purchasing followers through an online vendor. The practice also allegedly used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media.
After filing the lawsuit, Mr. Ferguson’s office uncovered further evidence of Dr. Sajan’s efforts to influence his professional reputation through fabrication, according to the July 2 release. Allure Esthetic “rigged” “best doctor” competitions hosted by local media outlets by paying staff and contractors to vote for Dr. Sajan as “best plastic surgeon” in the region, according to the release. The staff cast as many votes as websites allowed, despite not being patients of Allure Esthetic.
The practice also allegedly edited before-and-after photos of patients to make their results appear better and kept tens of thousands of dollars in rebates intended for its patients.
In addition to paying $5 million, the consent decree requires Dr. Sajan and his practice also:
- Stop posting or influencing consumer reviews; perform a full audit of all public reviews on Google, Yelp, and other third-party review platforms; and request removal of every review Allure Esthetic was involved in creating, posting, or shaping in any manner.
- Remove all misleading “before-and-after” photographs of plastic surgery procedures from its website and social media and stop altering photographs of future procedures.
- Cease use of and attempts to enforce all illegal NDAs and notify patients who previously signed them that they are released from the terms of those NDAs.
- Pay a third-party forensic accounting firm to perform a full, independent audit of Allure Esthetic’s consumer rebate program to identify consumers who are owed rebates that were unlawfully claimed by Allure Esthetic.
Additionally, the attorney general’s office will continue to monitor Allure Esthetic, and upon request, the practice must provide information that demonstrates its compliance with the consent decree for the next 10 years.
The practice must also develop internal policies and implement a training program to educate staff about nondeceptive advertising and compliance with consumer protection laws.
Dr. Sajan and his practice agreed to the terms of the consent decree, and the settlement is not considered an admission of liability.
A version of this article first appeared on Medscape.com.
Feds May End Hospital System’s Noncompete Contract for Part-Time Docs
Mount Sinai Health System in New York City is forcing part-time physicians to sign employment contracts that violate their labor rights, according to a June 2024 complaint by the National Labor Relations Board (NLRB).
The complaint stems from no-poaching and confidentiality clauses in the agreements required as a condition of employment, NLRB officials alleged.
according to a copy of the terms included in NLRB’s June 18 complaint.
By requiring the agreements, NLRB officials claimed, Mount Sinai is “interfering with, restraining, and coercing employees” in violation of the National Labor Relations Act. The health system’s “unfair labor practices” affects commerce as outlined under the law, according to the NLRB. The Act bans employers from burdening or obstructing commerce or the free flow of commerce.
Mount Sinai did not respond to requests for comment.
The NLRB’s complaint follows a landmark decision by the Federal Trade Commission (FTC) to ban noncompete agreements nationwide. In April 2024, the FTC voted to prohibit noncompetes indefinitely in an effort to protect workers.
“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8500 new startups that would be created a year once noncompetes are banned,” FTC Chair Lina M. Khan said in a statement. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”
Business groups and agencies have since sued to challenge against the ban, including the Chamber of Commerce. The Chamber and other business groups argue that noncompete agreements are important for companies to protect trade secrets, shield recruiting investments, and hide confidential information. The lawsuits are ongoing.
A Physician Blows the Whistle
An anonymous physician first alerted the NLRB to the contract language in November 2023. The doctor was required the sign the hospital system’s agreement for part-time physicians. The complaint does not say if the employee is still employed by the hospital system.
To remedy the unfair labor practices alleged, the NLRB seeks an order requiring the health system to rescind the contract language, stop any actions against current or former employees to enforce the provisions, and make whole any employees who suffered financial losses related to the contract terms.
The allegation against Mount Sinai is among a rising number of grievances filed with the NLRB that claim unfair labor practices. During the first 6 months of fiscal year 2024, unfair labor practice charges filed across the NLRB’s field offices increased 7% — from 9612 in 2023 to 10,278 in 2024, according to a news release.
NLRB, meanwhile has been cracking down on anticompetitive labor practices and confidentiality provisions that prevent employees from speaking out.
In a February 2023 decision for instance, NLRB ruled that an employer violates the National Labor Relations Act by offering severance agreements to workers that include restrictive confidentiality and nondisparagement terms. In 2022, the NLRB and the Federal Trade Commission forged a partnership to more widely combat unfair, anticompetitive, and deceptive business practices.
“Noncompete provisions reasonably tend to chill employees in the exercise of Section 7 rights when the provisions could reasonably be construed by employees to deny them the ability to quit or change jobs by cutting off their access to other employment opportunities that they are qualified for,” NLRB General Counsel Jennifer Abruzzo said in a 2023 release.
Ms. Abruzzo stressed in a memo that NLR Act is committed to an interagency approach to restrictions on the exercise of employee rights, “including limits to workers’ job mobility, information sharing, and referrals to other agencies.”
Mount Sinai Health System must respond to the NLRB’s complaint by July 16, and an administrative law judge is scheduled to hear the case on September 24.
A version of this article first appeared on Medscape.com.
Mount Sinai Health System in New York City is forcing part-time physicians to sign employment contracts that violate their labor rights, according to a June 2024 complaint by the National Labor Relations Board (NLRB).
The complaint stems from no-poaching and confidentiality clauses in the agreements required as a condition of employment, NLRB officials alleged.
according to a copy of the terms included in NLRB’s June 18 complaint.
By requiring the agreements, NLRB officials claimed, Mount Sinai is “interfering with, restraining, and coercing employees” in violation of the National Labor Relations Act. The health system’s “unfair labor practices” affects commerce as outlined under the law, according to the NLRB. The Act bans employers from burdening or obstructing commerce or the free flow of commerce.
Mount Sinai did not respond to requests for comment.
The NLRB’s complaint follows a landmark decision by the Federal Trade Commission (FTC) to ban noncompete agreements nationwide. In April 2024, the FTC voted to prohibit noncompetes indefinitely in an effort to protect workers.
“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8500 new startups that would be created a year once noncompetes are banned,” FTC Chair Lina M. Khan said in a statement. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”
Business groups and agencies have since sued to challenge against the ban, including the Chamber of Commerce. The Chamber and other business groups argue that noncompete agreements are important for companies to protect trade secrets, shield recruiting investments, and hide confidential information. The lawsuits are ongoing.
A Physician Blows the Whistle
An anonymous physician first alerted the NLRB to the contract language in November 2023. The doctor was required the sign the hospital system’s agreement for part-time physicians. The complaint does not say if the employee is still employed by the hospital system.
To remedy the unfair labor practices alleged, the NLRB seeks an order requiring the health system to rescind the contract language, stop any actions against current or former employees to enforce the provisions, and make whole any employees who suffered financial losses related to the contract terms.
The allegation against Mount Sinai is among a rising number of grievances filed with the NLRB that claim unfair labor practices. During the first 6 months of fiscal year 2024, unfair labor practice charges filed across the NLRB’s field offices increased 7% — from 9612 in 2023 to 10,278 in 2024, according to a news release.
NLRB, meanwhile has been cracking down on anticompetitive labor practices and confidentiality provisions that prevent employees from speaking out.
In a February 2023 decision for instance, NLRB ruled that an employer violates the National Labor Relations Act by offering severance agreements to workers that include restrictive confidentiality and nondisparagement terms. In 2022, the NLRB and the Federal Trade Commission forged a partnership to more widely combat unfair, anticompetitive, and deceptive business practices.
“Noncompete provisions reasonably tend to chill employees in the exercise of Section 7 rights when the provisions could reasonably be construed by employees to deny them the ability to quit or change jobs by cutting off their access to other employment opportunities that they are qualified for,” NLRB General Counsel Jennifer Abruzzo said in a 2023 release.
Ms. Abruzzo stressed in a memo that NLR Act is committed to an interagency approach to restrictions on the exercise of employee rights, “including limits to workers’ job mobility, information sharing, and referrals to other agencies.”
Mount Sinai Health System must respond to the NLRB’s complaint by July 16, and an administrative law judge is scheduled to hear the case on September 24.
A version of this article first appeared on Medscape.com.
Mount Sinai Health System in New York City is forcing part-time physicians to sign employment contracts that violate their labor rights, according to a June 2024 complaint by the National Labor Relations Board (NLRB).
The complaint stems from no-poaching and confidentiality clauses in the agreements required as a condition of employment, NLRB officials alleged.
according to a copy of the terms included in NLRB’s June 18 complaint.
By requiring the agreements, NLRB officials claimed, Mount Sinai is “interfering with, restraining, and coercing employees” in violation of the National Labor Relations Act. The health system’s “unfair labor practices” affects commerce as outlined under the law, according to the NLRB. The Act bans employers from burdening or obstructing commerce or the free flow of commerce.
Mount Sinai did not respond to requests for comment.
The NLRB’s complaint follows a landmark decision by the Federal Trade Commission (FTC) to ban noncompete agreements nationwide. In April 2024, the FTC voted to prohibit noncompetes indefinitely in an effort to protect workers.
“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8500 new startups that would be created a year once noncompetes are banned,” FTC Chair Lina M. Khan said in a statement. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”
Business groups and agencies have since sued to challenge against the ban, including the Chamber of Commerce. The Chamber and other business groups argue that noncompete agreements are important for companies to protect trade secrets, shield recruiting investments, and hide confidential information. The lawsuits are ongoing.
A Physician Blows the Whistle
An anonymous physician first alerted the NLRB to the contract language in November 2023. The doctor was required the sign the hospital system’s agreement for part-time physicians. The complaint does not say if the employee is still employed by the hospital system.
To remedy the unfair labor practices alleged, the NLRB seeks an order requiring the health system to rescind the contract language, stop any actions against current or former employees to enforce the provisions, and make whole any employees who suffered financial losses related to the contract terms.
The allegation against Mount Sinai is among a rising number of grievances filed with the NLRB that claim unfair labor practices. During the first 6 months of fiscal year 2024, unfair labor practice charges filed across the NLRB’s field offices increased 7% — from 9612 in 2023 to 10,278 in 2024, according to a news release.
NLRB, meanwhile has been cracking down on anticompetitive labor practices and confidentiality provisions that prevent employees from speaking out.
In a February 2023 decision for instance, NLRB ruled that an employer violates the National Labor Relations Act by offering severance agreements to workers that include restrictive confidentiality and nondisparagement terms. In 2022, the NLRB and the Federal Trade Commission forged a partnership to more widely combat unfair, anticompetitive, and deceptive business practices.
“Noncompete provisions reasonably tend to chill employees in the exercise of Section 7 rights when the provisions could reasonably be construed by employees to deny them the ability to quit or change jobs by cutting off their access to other employment opportunities that they are qualified for,” NLRB General Counsel Jennifer Abruzzo said in a 2023 release.
Ms. Abruzzo stressed in a memo that NLR Act is committed to an interagency approach to restrictions on the exercise of employee rights, “including limits to workers’ job mobility, information sharing, and referrals to other agencies.”
Mount Sinai Health System must respond to the NLRB’s complaint by July 16, and an administrative law judge is scheduled to hear the case on September 24.
A version of this article first appeared on Medscape.com.
Time Warp: Fax Machines Still Common in Oncology Practice. Why?
One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine.
“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”
Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers.
According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found.
Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained.
“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.”
If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.
Or is it?
Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently.
“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”
And when information is lost, patient care can be compromised.
Slower Workflows, Care Concerns
Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum.
Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices.
“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.”
Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said.
Insurers and third-party laboratories often send test results back by fax as well.
“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.
“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”
Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened.
As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added.
“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.”
Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients.
Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend.
“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said.
Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said.
“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”
Broader Health Policy Impacts
The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say.
Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.
Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.
Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always.
“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said.
Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said.
“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”
But, she said, “we didn’t have the level of systems in place to do it well.”
Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said.
Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.
“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’”
Slow, but Steady, Improvements
Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.
Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.
According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data.
The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.
Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape.
Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care.
EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said.
“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”
Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology.
But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.”
“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
A version of this article appeared on Medscape.com.
One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine.
“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”
Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers.
According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found.
Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained.
“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.”
If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.
Or is it?
Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently.
“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”
And when information is lost, patient care can be compromised.
Slower Workflows, Care Concerns
Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum.
Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices.
“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.”
Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said.
Insurers and third-party laboratories often send test results back by fax as well.
“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.
“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”
Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened.
As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added.
“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.”
Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients.
Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend.
“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said.
Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said.
“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”
Broader Health Policy Impacts
The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say.
Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.
Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.
Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always.
“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said.
Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said.
“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”
But, she said, “we didn’t have the level of systems in place to do it well.”
Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said.
Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.
“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’”
Slow, but Steady, Improvements
Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.
Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.
According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data.
The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.
Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape.
Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care.
EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said.
“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”
Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology.
But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.”
“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
A version of this article appeared on Medscape.com.
One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine.
“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”
Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers.
According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found.
Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained.
“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.”
If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.
Or is it?
Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently.
“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”
And when information is lost, patient care can be compromised.
Slower Workflows, Care Concerns
Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum.
Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices.
“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.”
Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said.
Insurers and third-party laboratories often send test results back by fax as well.
“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.
“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”
Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened.
As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added.
“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.”
Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients.
Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend.
“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said.
Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said.
“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”
Broader Health Policy Impacts
The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say.
Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.
Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.
Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always.
“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said.
Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said.
“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”
But, she said, “we didn’t have the level of systems in place to do it well.”
Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said.
Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.
“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’”
Slow, but Steady, Improvements
Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.
Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.
According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data.
The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.
Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape.
Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care.
EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said.
“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”
Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology.
But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.”
“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
A version of this article appeared on Medscape.com.
Engineering Mind Helps Investigator Develop New Cancer Therapies
Dr. Kopetz received the AACR-Waun Ki Hong Award in April. The American Association for Cancer Research (AACR) granted Dr. Kopetz this award to recognize his leadership in the development of novel therapies for patients with BRAF-mutated metastatic colon cancer with poor prognoses, according to a statement from the AACR.
Using molecular profiling and patient-derived xenografts, Dr. Kopetz discovered resistance mechanisms and helped develop approaches to overcome such resistant pathways. His clinical studies analyzing vemurafenib, cetuximab, and irinotecan resulted in new additions to National Comprehensive Cancer Network guidelines and led to the FDA approval of encorafenib plus cetuximab for adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation after prior therapy.
In an interview, Dr. Kopetz shared his unique road to research, how his engineering background influences his work, and why his recent award’s namesake holds special significance to him.
What led to your medical career? Growing up, did you always want to be a doctor?
Dr. Kopetz: My interest initially was in engineering. I grew up in Tennessee from a family of engineers and doctors. In college, I completed a degree in biomedical engineering and electrical engineering.
I had the opportunity to spend one summer at the National Institutes of Health, where I did some research on the structure of the HIV integrase enzyme. It was fundamental basic research with some engineering overlay and required spending 4 days a week working in the dark in a laser lab to analyze the structure of this protein.
One day a week, I was at Georgetown in the HIV/AIDS Clinic, where I collected blood samples and saw HIV/AIDS patients. At the end of the summer, I reflected and realized that I really enjoyed that 1 day out of the week, much more than the other 4. I enjoyed working with patients and interacting with people and thought I’d enjoy the more direct way to help patients, so made a pivot into medicine.
Was the rest of your medical training more traditional?
Dr. Kopetz: My path was a little atypical for a physician scientist. I pursued a medical degree at Johns Hopkins, did internal medicine training at Duke, and then came down to MD Anderson Cancer Center [in Houston, Texas] to do a fellowship in medical oncology, and also obtained a PhD in cancer biology, where I explored mechanisms of resistance to colorectal cancer treatment.
While a traditional physician scientist typically obtains a PhD training in the middle of their medical school, I completed my medical training and then went back to get a PhD. It was a different, nontraditional route.
What is your current role, and what is most inspiring about your work?
Dr. Kopetz: I’ve been at MD Anderson now for 20 years in GI medical oncology. I recently stepped into a new role of helping facilitate translational research at the institution and am now Associate VP for translational research.
I’m excited about where we are in cancer research. I think we’re moving into an era where the amount of information that we can get out of patients and the rapidity in which we can move discoveries is much greater than it has ever been.
Our ability to extract information out of patient biopsies, surgical samples, or even minimally invasive techniques to sample the tumors, such as liquid biopsy, has provided tremendous insights into how tumors are evolving and adapting to therapies and [provides us] opportunities for novel interventions. This opens up ways where I think as a field, we can more readily accelerate our understanding of cancer.
The second component is seeing the rapidity in which we’re now able to execute ideas in the drug development space compared to years before. The pace of new drug development has increased and the innovations in the chemistries have opened up new opportunities and new targets that in the past were considered undruggable. For example, the mutated oncogene, KRAS, was once an extremely challenging therapeutic target and considered undruggable. Mutations in the p53 gene, a tumor suppressor gene, were similarly challenging. I think the convergence of these two trends are going to more rapidly accelerate the advances for our patients. I’m optimistic about the future.
Tell us more about the novel therapies for patients with BRAF-mutated metastatic colon cancer for which you were a lead researcher.
Dr. Kopetz: A lot of [my] work goes back over 10 years, where my [research colleagues and I] were targeting the BRAF V600E oncogene in colorectal cancer melanoma and identified that this worked well in melanoma but was relatively inactive in colorectal cancer despite the same drugs and the same mutations. This led to a recognition of optimal combination drugs that really blocked some of the adaptive feedback that we saw in colorectal cancer. This was a key recognition that these tumors, after you block one node of signaling, rapidly adapt and reactivate the signaling through alternate nodes. This finding really resonated with me with my engineering background, thinking about the networks, signaling networks, and the concepts of feedback regulation of complex systems.
The strategy of blocking the primary oncogene and then blocking the feedback mechanisms that the tumors were utilizing was adopted in colorectal cancer through this work. It took us 10 years to get to an FDA approval with this strategy, but it’s really encouraging that we’re now using this strategy and applying it to the new wave of KRAS inhibitors, where the exact same feedback pathway appears to be at play.
Does your engineering background impact your work today?
Dr. Kopetz: Yes, I’ve found that my engineering training has provided me with complementary skills that can significantly contribute to the development of innovative technologies, computational approaches, and interdisciplinary strategies for advancing cancer research.
Today, I do a lot of work understanding and recognizing complex networks of signaling, and it’s the same network theories that we learned and developed in engineering.
These same theories are now being applied to biology. For example, we are very interested in how tumors adapt over the longer term, over multiple lines of therapy, where there is both clonal selection and clonal evolution occurring with our various standard-of-care therapies. Our hope is that application of engineering principles can help uncover new vulnerabilities in cancer that weren’t evident when we were thinking about CRC as a static tumor.
I understand your recently awarded AACR-Waun Ki Hong Award for Outstanding Achievement in Translational and Clinical Cancer Research has special significance to you. Can you explain why that is?
Dr. Kopetz: This holds a special meaning for me, because Dr. Hong provided a lot of guidance [to me] over the years. He was the division head for cancer medicine at MD Anderson for many years and was instrumental in helping advocate [for me] and advance my career as well as the careers of so many others in and outside of the institution. I considered him a key mentor and sponsor. He helped provide me with guidance early in my oncology career, helping me identify high-value projects and critically evaluate research directions to pursue. He also helped me think about how to balance my research portfolio and provided guidance about how to work well within a team.
It’s really humbling to have a reward bearing his name as somebody who I so deeply respected, and I’m so grateful for the impact he had on my life.
Dr. Kopetz received the AACR-Waun Ki Hong Award in April. The American Association for Cancer Research (AACR) granted Dr. Kopetz this award to recognize his leadership in the development of novel therapies for patients with BRAF-mutated metastatic colon cancer with poor prognoses, according to a statement from the AACR.
Using molecular profiling and patient-derived xenografts, Dr. Kopetz discovered resistance mechanisms and helped develop approaches to overcome such resistant pathways. His clinical studies analyzing vemurafenib, cetuximab, and irinotecan resulted in new additions to National Comprehensive Cancer Network guidelines and led to the FDA approval of encorafenib plus cetuximab for adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation after prior therapy.
In an interview, Dr. Kopetz shared his unique road to research, how his engineering background influences his work, and why his recent award’s namesake holds special significance to him.
What led to your medical career? Growing up, did you always want to be a doctor?
Dr. Kopetz: My interest initially was in engineering. I grew up in Tennessee from a family of engineers and doctors. In college, I completed a degree in biomedical engineering and electrical engineering.
I had the opportunity to spend one summer at the National Institutes of Health, where I did some research on the structure of the HIV integrase enzyme. It was fundamental basic research with some engineering overlay and required spending 4 days a week working in the dark in a laser lab to analyze the structure of this protein.
One day a week, I was at Georgetown in the HIV/AIDS Clinic, where I collected blood samples and saw HIV/AIDS patients. At the end of the summer, I reflected and realized that I really enjoyed that 1 day out of the week, much more than the other 4. I enjoyed working with patients and interacting with people and thought I’d enjoy the more direct way to help patients, so made a pivot into medicine.
Was the rest of your medical training more traditional?
Dr. Kopetz: My path was a little atypical for a physician scientist. I pursued a medical degree at Johns Hopkins, did internal medicine training at Duke, and then came down to MD Anderson Cancer Center [in Houston, Texas] to do a fellowship in medical oncology, and also obtained a PhD in cancer biology, where I explored mechanisms of resistance to colorectal cancer treatment.
While a traditional physician scientist typically obtains a PhD training in the middle of their medical school, I completed my medical training and then went back to get a PhD. It was a different, nontraditional route.
What is your current role, and what is most inspiring about your work?
Dr. Kopetz: I’ve been at MD Anderson now for 20 years in GI medical oncology. I recently stepped into a new role of helping facilitate translational research at the institution and am now Associate VP for translational research.
I’m excited about where we are in cancer research. I think we’re moving into an era where the amount of information that we can get out of patients and the rapidity in which we can move discoveries is much greater than it has ever been.
Our ability to extract information out of patient biopsies, surgical samples, or even minimally invasive techniques to sample the tumors, such as liquid biopsy, has provided tremendous insights into how tumors are evolving and adapting to therapies and [provides us] opportunities for novel interventions. This opens up ways where I think as a field, we can more readily accelerate our understanding of cancer.
The second component is seeing the rapidity in which we’re now able to execute ideas in the drug development space compared to years before. The pace of new drug development has increased and the innovations in the chemistries have opened up new opportunities and new targets that in the past were considered undruggable. For example, the mutated oncogene, KRAS, was once an extremely challenging therapeutic target and considered undruggable. Mutations in the p53 gene, a tumor suppressor gene, were similarly challenging. I think the convergence of these two trends are going to more rapidly accelerate the advances for our patients. I’m optimistic about the future.
Tell us more about the novel therapies for patients with BRAF-mutated metastatic colon cancer for which you were a lead researcher.
Dr. Kopetz: A lot of [my] work goes back over 10 years, where my [research colleagues and I] were targeting the BRAF V600E oncogene in colorectal cancer melanoma and identified that this worked well in melanoma but was relatively inactive in colorectal cancer despite the same drugs and the same mutations. This led to a recognition of optimal combination drugs that really blocked some of the adaptive feedback that we saw in colorectal cancer. This was a key recognition that these tumors, after you block one node of signaling, rapidly adapt and reactivate the signaling through alternate nodes. This finding really resonated with me with my engineering background, thinking about the networks, signaling networks, and the concepts of feedback regulation of complex systems.
The strategy of blocking the primary oncogene and then blocking the feedback mechanisms that the tumors were utilizing was adopted in colorectal cancer through this work. It took us 10 years to get to an FDA approval with this strategy, but it’s really encouraging that we’re now using this strategy and applying it to the new wave of KRAS inhibitors, where the exact same feedback pathway appears to be at play.
Does your engineering background impact your work today?
Dr. Kopetz: Yes, I’ve found that my engineering training has provided me with complementary skills that can significantly contribute to the development of innovative technologies, computational approaches, and interdisciplinary strategies for advancing cancer research.
Today, I do a lot of work understanding and recognizing complex networks of signaling, and it’s the same network theories that we learned and developed in engineering.
These same theories are now being applied to biology. For example, we are very interested in how tumors adapt over the longer term, over multiple lines of therapy, where there is both clonal selection and clonal evolution occurring with our various standard-of-care therapies. Our hope is that application of engineering principles can help uncover new vulnerabilities in cancer that weren’t evident when we were thinking about CRC as a static tumor.
I understand your recently awarded AACR-Waun Ki Hong Award for Outstanding Achievement in Translational and Clinical Cancer Research has special significance to you. Can you explain why that is?
Dr. Kopetz: This holds a special meaning for me, because Dr. Hong provided a lot of guidance [to me] over the years. He was the division head for cancer medicine at MD Anderson for many years and was instrumental in helping advocate [for me] and advance my career as well as the careers of so many others in and outside of the institution. I considered him a key mentor and sponsor. He helped provide me with guidance early in my oncology career, helping me identify high-value projects and critically evaluate research directions to pursue. He also helped me think about how to balance my research portfolio and provided guidance about how to work well within a team.
It’s really humbling to have a reward bearing his name as somebody who I so deeply respected, and I’m so grateful for the impact he had on my life.
Dr. Kopetz received the AACR-Waun Ki Hong Award in April. The American Association for Cancer Research (AACR) granted Dr. Kopetz this award to recognize his leadership in the development of novel therapies for patients with BRAF-mutated metastatic colon cancer with poor prognoses, according to a statement from the AACR.
Using molecular profiling and patient-derived xenografts, Dr. Kopetz discovered resistance mechanisms and helped develop approaches to overcome such resistant pathways. His clinical studies analyzing vemurafenib, cetuximab, and irinotecan resulted in new additions to National Comprehensive Cancer Network guidelines and led to the FDA approval of encorafenib plus cetuximab for adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation after prior therapy.
In an interview, Dr. Kopetz shared his unique road to research, how his engineering background influences his work, and why his recent award’s namesake holds special significance to him.
What led to your medical career? Growing up, did you always want to be a doctor?
Dr. Kopetz: My interest initially was in engineering. I grew up in Tennessee from a family of engineers and doctors. In college, I completed a degree in biomedical engineering and electrical engineering.
I had the opportunity to spend one summer at the National Institutes of Health, where I did some research on the structure of the HIV integrase enzyme. It was fundamental basic research with some engineering overlay and required spending 4 days a week working in the dark in a laser lab to analyze the structure of this protein.
One day a week, I was at Georgetown in the HIV/AIDS Clinic, where I collected blood samples and saw HIV/AIDS patients. At the end of the summer, I reflected and realized that I really enjoyed that 1 day out of the week, much more than the other 4. I enjoyed working with patients and interacting with people and thought I’d enjoy the more direct way to help patients, so made a pivot into medicine.
Was the rest of your medical training more traditional?
Dr. Kopetz: My path was a little atypical for a physician scientist. I pursued a medical degree at Johns Hopkins, did internal medicine training at Duke, and then came down to MD Anderson Cancer Center [in Houston, Texas] to do a fellowship in medical oncology, and also obtained a PhD in cancer biology, where I explored mechanisms of resistance to colorectal cancer treatment.
While a traditional physician scientist typically obtains a PhD training in the middle of their medical school, I completed my medical training and then went back to get a PhD. It was a different, nontraditional route.
What is your current role, and what is most inspiring about your work?
Dr. Kopetz: I’ve been at MD Anderson now for 20 years in GI medical oncology. I recently stepped into a new role of helping facilitate translational research at the institution and am now Associate VP for translational research.
I’m excited about where we are in cancer research. I think we’re moving into an era where the amount of information that we can get out of patients and the rapidity in which we can move discoveries is much greater than it has ever been.
Our ability to extract information out of patient biopsies, surgical samples, or even minimally invasive techniques to sample the tumors, such as liquid biopsy, has provided tremendous insights into how tumors are evolving and adapting to therapies and [provides us] opportunities for novel interventions. This opens up ways where I think as a field, we can more readily accelerate our understanding of cancer.
The second component is seeing the rapidity in which we’re now able to execute ideas in the drug development space compared to years before. The pace of new drug development has increased and the innovations in the chemistries have opened up new opportunities and new targets that in the past were considered undruggable. For example, the mutated oncogene, KRAS, was once an extremely challenging therapeutic target and considered undruggable. Mutations in the p53 gene, a tumor suppressor gene, were similarly challenging. I think the convergence of these two trends are going to more rapidly accelerate the advances for our patients. I’m optimistic about the future.
Tell us more about the novel therapies for patients with BRAF-mutated metastatic colon cancer for which you were a lead researcher.
Dr. Kopetz: A lot of [my] work goes back over 10 years, where my [research colleagues and I] were targeting the BRAF V600E oncogene in colorectal cancer melanoma and identified that this worked well in melanoma but was relatively inactive in colorectal cancer despite the same drugs and the same mutations. This led to a recognition of optimal combination drugs that really blocked some of the adaptive feedback that we saw in colorectal cancer. This was a key recognition that these tumors, after you block one node of signaling, rapidly adapt and reactivate the signaling through alternate nodes. This finding really resonated with me with my engineering background, thinking about the networks, signaling networks, and the concepts of feedback regulation of complex systems.
The strategy of blocking the primary oncogene and then blocking the feedback mechanisms that the tumors were utilizing was adopted in colorectal cancer through this work. It took us 10 years to get to an FDA approval with this strategy, but it’s really encouraging that we’re now using this strategy and applying it to the new wave of KRAS inhibitors, where the exact same feedback pathway appears to be at play.
Does your engineering background impact your work today?
Dr. Kopetz: Yes, I’ve found that my engineering training has provided me with complementary skills that can significantly contribute to the development of innovative technologies, computational approaches, and interdisciplinary strategies for advancing cancer research.
Today, I do a lot of work understanding and recognizing complex networks of signaling, and it’s the same network theories that we learned and developed in engineering.
These same theories are now being applied to biology. For example, we are very interested in how tumors adapt over the longer term, over multiple lines of therapy, where there is both clonal selection and clonal evolution occurring with our various standard-of-care therapies. Our hope is that application of engineering principles can help uncover new vulnerabilities in cancer that weren’t evident when we were thinking about CRC as a static tumor.
I understand your recently awarded AACR-Waun Ki Hong Award for Outstanding Achievement in Translational and Clinical Cancer Research has special significance to you. Can you explain why that is?
Dr. Kopetz: This holds a special meaning for me, because Dr. Hong provided a lot of guidance [to me] over the years. He was the division head for cancer medicine at MD Anderson for many years and was instrumental in helping advocate [for me] and advance my career as well as the careers of so many others in and outside of the institution. I considered him a key mentor and sponsor. He helped provide me with guidance early in my oncology career, helping me identify high-value projects and critically evaluate research directions to pursue. He also helped me think about how to balance my research portfolio and provided guidance about how to work well within a team.
It’s really humbling to have a reward bearing his name as somebody who I so deeply respected, and I’m so grateful for the impact he had on my life.
Plastic Surgeon Illegally Restricted Negative Reviews, Judge Rules
A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.
Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses.
Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial.
This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response.
The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal.
Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson.
“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”
If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.
In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records.
But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.
The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says
Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative.
Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents.
Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents.
In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media.
At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends.
Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson.
The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents.
In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.
All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson.
Surgeon Claims Competitor Behind Allegations
Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong.
The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show.
“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.
The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation.
Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents.
The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024.
A version of this article appeared on Medscape.com.
A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.
Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses.
Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial.
This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response.
The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal.
Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson.
“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”
If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.
In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records.
But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.
The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says
Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative.
Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents.
Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents.
In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media.
At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends.
Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson.
The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents.
In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.
All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson.
Surgeon Claims Competitor Behind Allegations
Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong.
The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show.
“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.
The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation.
Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents.
The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024.
A version of this article appeared on Medscape.com.
A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.
Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses.
Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial.
This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response.
The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal.
Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson.
“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”
If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.
In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records.
But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.
The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says
Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative.
Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents.
Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents.
In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media.
At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends.
Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson.
The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents.
In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.
All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson.
Surgeon Claims Competitor Behind Allegations
Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong.
The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show.
“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.
The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation.
Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents.
The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024.
A version of this article appeared on Medscape.com.
What’s Driving the Higher Breast Cancer Death Rate in Black Women?
More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.
However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.
Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.
In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.
“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.
The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.
Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
SDH and Screening Rates Differences By Race
A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.
Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.
Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.
Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.
“You’ve got people who are working a job or three jobs, just to make ends meet for their family and can’t necessarily take time off to get that done,” she said. “Nor is it prioritized in their head because they’ve got to put a meal on the table.”
But the racial disparities between Black and White women, at least, are not clearly explained by differences between the screening rates..
Of patients who received mammograms 76% were White and 79% were Black, according to another recent study coauthored by Dr. Islami. While Black women appear to have the highest breast cancer screening rates, some data suggest such rates are being overreported.
Lower screening rates were seen in American Indian/Alaska Native (59%), Asian (67%), and Hispanic women (74%).
Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes
Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.
Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.
Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.
DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.
“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”
The study found that many of the proteins associated with endocrine resistance and poor outcomes in breast cancer patients are differently regulated in Black women compared with White woman. These differences contribute to resistance to standard endocrine therapy, Dr. Haricharan said.
“Because we never studied the biology in Black woman, it was just assumed that across all demographics, it must be the same,” she said. “We are not even accounting for the possibility there are likely intrinsic differences for how you will respond to an endocrine treatment.”
Testing and treatment may also be playing a role in worse breast cancer outcomes for Black women.
In an analysis of 73,363 women with early-stage, estrogen receptor–positive breast cancer, investigators found that a common test used to decide the treatment course for patients may be leading to bad recommendations for Black women.
The test, known as the 21-gene breast recurrence score, is the most commonly ordered biomarker test used to guide doctor’s recommendations for patients with estrogen receptor–positive breast cancer, the most common form of cancer in Black women, representing about 70%-80% of cases.
The test helps physicians identify which patients are good candidates for chemo, but the test may underestimate the benefit of chemo for Black women. It ranks some Black women as unlikely to benefit from chemo, when they actually would have benefited, according to the January 2024 study, published in the Journal of the National Comprehensive Cancer Network.
The test gives a score of zero to 100, explains Kent Hoskins, MD, oncology service line medical director at the University of Illinois (UI) Health and director of the Familial Breast Cancer Clinic at UI Health, both in Chicago. The higher the score, the higher the risk and the greater the benefit of chemotherapy. A patient is either above the cut-off score and receives chemo, or is below the cut-off score and does not. In the analysis, investigators found that Black women start improving with chemo at a lower score than White women do.
Dr. Hoskins said the results raise questions about whether the biomarker test should be modified to be more applicable to Black women, whether other tests should be used, or if physicians should judge cut-off scores differently, depending on race.
How Neighborhood Impacts Breast Cancer, Death Rates
Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.
Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)
Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).
Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.
Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).
Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.
“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.
Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.
Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.
Dr. Miller-Kleinhenz and her colleagues analyzed a cohort of 1764 women diagnosed with breast cancer between January 2010 and December 2017, who were followed up through December 2019. Investigators accessed the cohort based on three exposures: historic redlining (HRL), contemporary mortgage discrimination (CMD), and persistent mortgage discrimination (PMD). Contemporary mortgage discrimination refers to current-day discriminatory mortgage practices and persistent mortgage discrimination refers to neighborhoods that have experienced both HRL and CMD.
Findings showed that Black women living in historical redlined areas had increased odds of being diagnosed with aggressive forms of breast cancer, while White women in redlined areas had increased odds of late-stage diagnosis.
White women exposed to persistent mortgage discrimination were twice as likely to die of breast cancer, compared with their White counterparts living in areas without historical redlining or contemporary mortgage discrimination, the study found.
That is not to say that Black women did not have an increased risk of breast cancer mortality, Dr. Miller-Kleinhenz explained. Black women had a more than threefold elevated risk of breast cancer mortality compared with White women no matter where they lived, according to the findings.
“These results were surprising because it is showing that while neighborhood conditions might be a major driver of breast cancer mortality in White women, there are factors beyond the neighborhood that are additional drivers that are contributing to poor outcomes in Black women,” she said.
Hope for Improved Outcomes, Higher Survival Rates
Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.
Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.
There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.
“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.
The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.
Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”
More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.
However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.
Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.
In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.
“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.
The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.
Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
SDH and Screening Rates Differences By Race
A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.
Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.
Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.
Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.
“You’ve got people who are working a job or three jobs, just to make ends meet for their family and can’t necessarily take time off to get that done,” she said. “Nor is it prioritized in their head because they’ve got to put a meal on the table.”
But the racial disparities between Black and White women, at least, are not clearly explained by differences between the screening rates..
Of patients who received mammograms 76% were White and 79% were Black, according to another recent study coauthored by Dr. Islami. While Black women appear to have the highest breast cancer screening rates, some data suggest such rates are being overreported.
Lower screening rates were seen in American Indian/Alaska Native (59%), Asian (67%), and Hispanic women (74%).
Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes
Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.
Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.
Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.
DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.
“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”
The study found that many of the proteins associated with endocrine resistance and poor outcomes in breast cancer patients are differently regulated in Black women compared with White woman. These differences contribute to resistance to standard endocrine therapy, Dr. Haricharan said.
“Because we never studied the biology in Black woman, it was just assumed that across all demographics, it must be the same,” she said. “We are not even accounting for the possibility there are likely intrinsic differences for how you will respond to an endocrine treatment.”
Testing and treatment may also be playing a role in worse breast cancer outcomes for Black women.
In an analysis of 73,363 women with early-stage, estrogen receptor–positive breast cancer, investigators found that a common test used to decide the treatment course for patients may be leading to bad recommendations for Black women.
The test, known as the 21-gene breast recurrence score, is the most commonly ordered biomarker test used to guide doctor’s recommendations for patients with estrogen receptor–positive breast cancer, the most common form of cancer in Black women, representing about 70%-80% of cases.
The test helps physicians identify which patients are good candidates for chemo, but the test may underestimate the benefit of chemo for Black women. It ranks some Black women as unlikely to benefit from chemo, when they actually would have benefited, according to the January 2024 study, published in the Journal of the National Comprehensive Cancer Network.
The test gives a score of zero to 100, explains Kent Hoskins, MD, oncology service line medical director at the University of Illinois (UI) Health and director of the Familial Breast Cancer Clinic at UI Health, both in Chicago. The higher the score, the higher the risk and the greater the benefit of chemotherapy. A patient is either above the cut-off score and receives chemo, or is below the cut-off score and does not. In the analysis, investigators found that Black women start improving with chemo at a lower score than White women do.
Dr. Hoskins said the results raise questions about whether the biomarker test should be modified to be more applicable to Black women, whether other tests should be used, or if physicians should judge cut-off scores differently, depending on race.
How Neighborhood Impacts Breast Cancer, Death Rates
Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.
Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)
Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).
Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.
Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).
Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.
“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.
Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.
Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.
Dr. Miller-Kleinhenz and her colleagues analyzed a cohort of 1764 women diagnosed with breast cancer between January 2010 and December 2017, who were followed up through December 2019. Investigators accessed the cohort based on three exposures: historic redlining (HRL), contemporary mortgage discrimination (CMD), and persistent mortgage discrimination (PMD). Contemporary mortgage discrimination refers to current-day discriminatory mortgage practices and persistent mortgage discrimination refers to neighborhoods that have experienced both HRL and CMD.
Findings showed that Black women living in historical redlined areas had increased odds of being diagnosed with aggressive forms of breast cancer, while White women in redlined areas had increased odds of late-stage diagnosis.
White women exposed to persistent mortgage discrimination were twice as likely to die of breast cancer, compared with their White counterparts living in areas without historical redlining or contemporary mortgage discrimination, the study found.
That is not to say that Black women did not have an increased risk of breast cancer mortality, Dr. Miller-Kleinhenz explained. Black women had a more than threefold elevated risk of breast cancer mortality compared with White women no matter where they lived, according to the findings.
“These results were surprising because it is showing that while neighborhood conditions might be a major driver of breast cancer mortality in White women, there are factors beyond the neighborhood that are additional drivers that are contributing to poor outcomes in Black women,” she said.
Hope for Improved Outcomes, Higher Survival Rates
Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.
Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.
There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.
“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.
The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.
Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”
More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.
However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.
Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.
In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.
“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.
The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.
Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
SDH and Screening Rates Differences By Race
A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.
Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.
Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.
Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.
“You’ve got people who are working a job or three jobs, just to make ends meet for their family and can’t necessarily take time off to get that done,” she said. “Nor is it prioritized in their head because they’ve got to put a meal on the table.”
But the racial disparities between Black and White women, at least, are not clearly explained by differences between the screening rates..
Of patients who received mammograms 76% were White and 79% were Black, according to another recent study coauthored by Dr. Islami. While Black women appear to have the highest breast cancer screening rates, some data suggest such rates are being overreported.
Lower screening rates were seen in American Indian/Alaska Native (59%), Asian (67%), and Hispanic women (74%).
Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes
Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.
Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.
Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.
DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.
“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”
The study found that many of the proteins associated with endocrine resistance and poor outcomes in breast cancer patients are differently regulated in Black women compared with White woman. These differences contribute to resistance to standard endocrine therapy, Dr. Haricharan said.
“Because we never studied the biology in Black woman, it was just assumed that across all demographics, it must be the same,” she said. “We are not even accounting for the possibility there are likely intrinsic differences for how you will respond to an endocrine treatment.”
Testing and treatment may also be playing a role in worse breast cancer outcomes for Black women.
In an analysis of 73,363 women with early-stage, estrogen receptor–positive breast cancer, investigators found that a common test used to decide the treatment course for patients may be leading to bad recommendations for Black women.
The test, known as the 21-gene breast recurrence score, is the most commonly ordered biomarker test used to guide doctor’s recommendations for patients with estrogen receptor–positive breast cancer, the most common form of cancer in Black women, representing about 70%-80% of cases.
The test helps physicians identify which patients are good candidates for chemo, but the test may underestimate the benefit of chemo for Black women. It ranks some Black women as unlikely to benefit from chemo, when they actually would have benefited, according to the January 2024 study, published in the Journal of the National Comprehensive Cancer Network.
The test gives a score of zero to 100, explains Kent Hoskins, MD, oncology service line medical director at the University of Illinois (UI) Health and director of the Familial Breast Cancer Clinic at UI Health, both in Chicago. The higher the score, the higher the risk and the greater the benefit of chemotherapy. A patient is either above the cut-off score and receives chemo, or is below the cut-off score and does not. In the analysis, investigators found that Black women start improving with chemo at a lower score than White women do.
Dr. Hoskins said the results raise questions about whether the biomarker test should be modified to be more applicable to Black women, whether other tests should be used, or if physicians should judge cut-off scores differently, depending on race.
How Neighborhood Impacts Breast Cancer, Death Rates
Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.
Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)
Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).
Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.
Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).
Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.
“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.
Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.
Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.
Dr. Miller-Kleinhenz and her colleagues analyzed a cohort of 1764 women diagnosed with breast cancer between January 2010 and December 2017, who were followed up through December 2019. Investigators accessed the cohort based on three exposures: historic redlining (HRL), contemporary mortgage discrimination (CMD), and persistent mortgage discrimination (PMD). Contemporary mortgage discrimination refers to current-day discriminatory mortgage practices and persistent mortgage discrimination refers to neighborhoods that have experienced both HRL and CMD.
Findings showed that Black women living in historical redlined areas had increased odds of being diagnosed with aggressive forms of breast cancer, while White women in redlined areas had increased odds of late-stage diagnosis.
White women exposed to persistent mortgage discrimination were twice as likely to die of breast cancer, compared with their White counterparts living in areas without historical redlining or contemporary mortgage discrimination, the study found.
That is not to say that Black women did not have an increased risk of breast cancer mortality, Dr. Miller-Kleinhenz explained. Black women had a more than threefold elevated risk of breast cancer mortality compared with White women no matter where they lived, according to the findings.
“These results were surprising because it is showing that while neighborhood conditions might be a major driver of breast cancer mortality in White women, there are factors beyond the neighborhood that are additional drivers that are contributing to poor outcomes in Black women,” she said.
Hope for Improved Outcomes, Higher Survival Rates
Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.
Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.
There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.
“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.
The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.
Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”
Surgeon Claims Colleague Made False Board Complaints to Get Him Fired
A longtime Kaiser Permanente surgeon is suing a fellow physician for allegedly submitting false medical board complaints against him in an attempt to get him fired.
Dr. Stalfire, a board-certified ob.gyn., has worked for Kaiser Permanente in western Oregon for more than 20 years, including several years as a regional chief surgical officer.
Dr. Stalfire is accusing Dr. Hsieh of defamation and intentional emotional distress, according to the March 25 lawsuit filed in Marion County Circuit Court. Northwest Permanente P.C., a Kaiser subsidiary, is also named as a defendant.
Dr. Stalfire is asking for $1.2 million in economic damages and $300,000 in noneconomic damages. Dr. Hsieh has not yet responded to the legal complaint.
Dr. Stalfire’s attorney did not respond to a message seeking comment. Dr. Hsieh is representing himself, according to court records. A Kaiser Permanente spokeswoman told this news organization that Kaiser does not comment on pending litigation.
The conflict began in February 2023, after Dr. Stalfire underwent surgery to correct issues stemming from severe injuries when a tree fell on his leg, according to court records.
Dr. Hsieh, a Kaiser ob.gyn., senior physician, and quality assurance lead, allegedly contacted Dr. Stalfire after the surgery and demanded he return to work earlier than medically recommended. Dr. Stalfire claims Dr. Hsieh questioned his retirement plans and his ability to continue working to pressure him into quitting.
Dr. Stalfire reported Dr. Hsieh’s conduct to Kaiser’s human resources department. However, the complaint contends Dr. Hsieh’s actions only escalated after the report was made. According to the complaint, Dr. Hsieh began telling coworkers Dr. Stalfire was “lying” about his injuries. Dr. Hsieh also allegedly contacted administrators and schedulers to ask about Dr. Stalfire’s injuries and suggested that he was not “legitimately recovering from serious injuries.” The complaint claims that Dr. Hsieh told Dr. Stalfire’s colleagues that he was a “con man,” a “criminal,” and “despicable.”
According to Dr. Stalfire’s complaint, in August 2023, Dr. Hsieh submitted numerous anonymous complaints about Dr. Stalfire to the Washington Medical Commission, the Oregon Medical Board, and other governmental agencies. Dr. Stalfire defended himself against the complaints, and they were dismissed. The lawsuit does not specify the nature of the complaints.
Dr. Stalfire later made public record requests for the complaints and discovered Dr. Hsieh had used his deceased mother-in-law’s phone number as his contact information, according to the lawsuit.
Despite multiple reports about Dr. Hsieh’s conduct, Dr. Stalfire claims Kaiser retained Dr. Hsieh as an employee and took no action to prevent him from making false statements about Dr. Stalfire.
He claims Dr. Hsieh’s harassment and Kaiser’s inaction harmed his professional reputation, caused lost work time, and resulted in severe emotional distress that required mental health treatment. The harm caused continues to impact his ability to work, the suit contends.
A version of this article appeared on Medscape.com.
A longtime Kaiser Permanente surgeon is suing a fellow physician for allegedly submitting false medical board complaints against him in an attempt to get him fired.
Dr. Stalfire, a board-certified ob.gyn., has worked for Kaiser Permanente in western Oregon for more than 20 years, including several years as a regional chief surgical officer.
Dr. Stalfire is accusing Dr. Hsieh of defamation and intentional emotional distress, according to the March 25 lawsuit filed in Marion County Circuit Court. Northwest Permanente P.C., a Kaiser subsidiary, is also named as a defendant.
Dr. Stalfire is asking for $1.2 million in economic damages and $300,000 in noneconomic damages. Dr. Hsieh has not yet responded to the legal complaint.
Dr. Stalfire’s attorney did not respond to a message seeking comment. Dr. Hsieh is representing himself, according to court records. A Kaiser Permanente spokeswoman told this news organization that Kaiser does not comment on pending litigation.
The conflict began in February 2023, after Dr. Stalfire underwent surgery to correct issues stemming from severe injuries when a tree fell on his leg, according to court records.
Dr. Hsieh, a Kaiser ob.gyn., senior physician, and quality assurance lead, allegedly contacted Dr. Stalfire after the surgery and demanded he return to work earlier than medically recommended. Dr. Stalfire claims Dr. Hsieh questioned his retirement plans and his ability to continue working to pressure him into quitting.
Dr. Stalfire reported Dr. Hsieh’s conduct to Kaiser’s human resources department. However, the complaint contends Dr. Hsieh’s actions only escalated after the report was made. According to the complaint, Dr. Hsieh began telling coworkers Dr. Stalfire was “lying” about his injuries. Dr. Hsieh also allegedly contacted administrators and schedulers to ask about Dr. Stalfire’s injuries and suggested that he was not “legitimately recovering from serious injuries.” The complaint claims that Dr. Hsieh told Dr. Stalfire’s colleagues that he was a “con man,” a “criminal,” and “despicable.”
According to Dr. Stalfire’s complaint, in August 2023, Dr. Hsieh submitted numerous anonymous complaints about Dr. Stalfire to the Washington Medical Commission, the Oregon Medical Board, and other governmental agencies. Dr. Stalfire defended himself against the complaints, and they were dismissed. The lawsuit does not specify the nature of the complaints.
Dr. Stalfire later made public record requests for the complaints and discovered Dr. Hsieh had used his deceased mother-in-law’s phone number as his contact information, according to the lawsuit.
Despite multiple reports about Dr. Hsieh’s conduct, Dr. Stalfire claims Kaiser retained Dr. Hsieh as an employee and took no action to prevent him from making false statements about Dr. Stalfire.
He claims Dr. Hsieh’s harassment and Kaiser’s inaction harmed his professional reputation, caused lost work time, and resulted in severe emotional distress that required mental health treatment. The harm caused continues to impact his ability to work, the suit contends.
A version of this article appeared on Medscape.com.
A longtime Kaiser Permanente surgeon is suing a fellow physician for allegedly submitting false medical board complaints against him in an attempt to get him fired.
Dr. Stalfire, a board-certified ob.gyn., has worked for Kaiser Permanente in western Oregon for more than 20 years, including several years as a regional chief surgical officer.
Dr. Stalfire is accusing Dr. Hsieh of defamation and intentional emotional distress, according to the March 25 lawsuit filed in Marion County Circuit Court. Northwest Permanente P.C., a Kaiser subsidiary, is also named as a defendant.
Dr. Stalfire is asking for $1.2 million in economic damages and $300,000 in noneconomic damages. Dr. Hsieh has not yet responded to the legal complaint.
Dr. Stalfire’s attorney did not respond to a message seeking comment. Dr. Hsieh is representing himself, according to court records. A Kaiser Permanente spokeswoman told this news organization that Kaiser does not comment on pending litigation.
The conflict began in February 2023, after Dr. Stalfire underwent surgery to correct issues stemming from severe injuries when a tree fell on his leg, according to court records.
Dr. Hsieh, a Kaiser ob.gyn., senior physician, and quality assurance lead, allegedly contacted Dr. Stalfire after the surgery and demanded he return to work earlier than medically recommended. Dr. Stalfire claims Dr. Hsieh questioned his retirement plans and his ability to continue working to pressure him into quitting.
Dr. Stalfire reported Dr. Hsieh’s conduct to Kaiser’s human resources department. However, the complaint contends Dr. Hsieh’s actions only escalated after the report was made. According to the complaint, Dr. Hsieh began telling coworkers Dr. Stalfire was “lying” about his injuries. Dr. Hsieh also allegedly contacted administrators and schedulers to ask about Dr. Stalfire’s injuries and suggested that he was not “legitimately recovering from serious injuries.” The complaint claims that Dr. Hsieh told Dr. Stalfire’s colleagues that he was a “con man,” a “criminal,” and “despicable.”
According to Dr. Stalfire’s complaint, in August 2023, Dr. Hsieh submitted numerous anonymous complaints about Dr. Stalfire to the Washington Medical Commission, the Oregon Medical Board, and other governmental agencies. Dr. Stalfire defended himself against the complaints, and they were dismissed. The lawsuit does not specify the nature of the complaints.
Dr. Stalfire later made public record requests for the complaints and discovered Dr. Hsieh had used his deceased mother-in-law’s phone number as his contact information, according to the lawsuit.
Despite multiple reports about Dr. Hsieh’s conduct, Dr. Stalfire claims Kaiser retained Dr. Hsieh as an employee and took no action to prevent him from making false statements about Dr. Stalfire.
He claims Dr. Hsieh’s harassment and Kaiser’s inaction harmed his professional reputation, caused lost work time, and resulted in severe emotional distress that required mental health treatment. The harm caused continues to impact his ability to work, the suit contends.
A version of this article appeared on Medscape.com.
Older, Breastfeeding Mothers Face Differing Advice About Mammograms
When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.
Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.
Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.
Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.
But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.
“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”
Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.
When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.
“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”
Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.
Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.
Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.
“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
Differing Guidelines, Case-by-Case Considerations
The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.
The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.
“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”
In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”
The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.
“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.
Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.
Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.
Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.
“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
How to Clear Up Confusion, Promote Consistency
After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.
The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.
“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”
Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.
“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”
On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.
“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.
Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”
Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.
“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”
When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.
Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.
Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.
Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.
But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.
“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”
Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.
When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.
“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”
Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.
Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.
Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.
“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
Differing Guidelines, Case-by-Case Considerations
The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.
The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.
“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”
In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”
The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.
“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.
Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.
Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.
Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.
“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
How to Clear Up Confusion, Promote Consistency
After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.
The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.
“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”
Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.
“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”
On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.
“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.
Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”
Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.
“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”
When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.
Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.
Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.
Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.
But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.
“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”
Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.
When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.
“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”
Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.
Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.
Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.
“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
Differing Guidelines, Case-by-Case Considerations
The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.
The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.
“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”
In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”
The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.
“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.
Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.
Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.
Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.
“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
How to Clear Up Confusion, Promote Consistency
After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.
The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.
“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”
Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.
“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”
On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.
“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.
Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”
Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.
“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”
Extraordinary Patients Inspired Father of Cancer Immunotherapy
His pioneering research established interleukin-2 (IL-2) as the first U.S. Food and Drug Administration–approved cancer immunotherapy in 1992.
To recognize his trailblazing work and other achievements, the American Association for Cancer Research (AACR) will award Dr. Rosenberg with the 2024 AACR Award for Lifetime Achievement in Cancer Research at its annual meeting in April.
Dr. Rosenberg, a senior investigator for the Center for Cancer Research at the National Cancer Institute (NCI), and chief of the NCI Surgery Branch, shared the history behind his novel research and the patient stories that inspired his discoveries, during an interview.
Tell us a little about yourself and where you grew up.
Dr. Rosenberg: I grew up in the Bronx. My parents both immigrated to the United States from Poland as teenagers.
As a young boy, did you always want to become a doctor?
Dr. Rosenberg: I think some defining moments on why I decided to go into medicine occurred when I was 6 or 7 years old. The second world war was over, and many of the horrors of the Holocaust became apparent to me. I was brought up as an Orthodox Jew. My parents were quite religious, and I remember postcards coming in one after another about relatives that had died in the death camps. That had a profound influence on me.
How did that experience impact your aspirations?
Dr. Rosenberg: It was an example to me of how evil certain people and groups can be toward one another. I decided at that point, that I wanted to do something good for people, and medicine seemed the most likely way to do that. But also, I was developing a broad scientific interest. I ended up at the Bronx High School of Science and knew that I not only wanted to practice the medicine of today, but I wanted to play a role in helping develop the medicine.
What led to your interest in cancer treatment?
Dr. Rosenberg: Well, as a medical student and resident, it became clear that the field of cancer needed major improvement. We had three major ways to treat cancer: surgery, radiation therapy, and chemotherapy. That could cure about half of the people [who] had cancer. But despite the best application of those three specialties, there were over 600,000 deaths from cancer each year in the United States alone. It was clear to me that new approaches were needed, and I became very interested in taking advantage of the body’s immune system as a source of information to try to make progress.
Were there patients who inspired your research?
Dr. Rosenberg: There were two patients that I saw early in my career that impressed me a great deal. One was a patient that I saw when working in the emergency ward as a resident. A patient came in with right upper quadrant pain that looked like a gallbladder attack. That’s what it was. But when I went through his chart, I saw that he had been at that hospital 12 years earlier with a metastatic gastric cancer. The surgeons had operated. They saw tumor had spread to the liver and could not be removed. They closed the belly, not expecting him to survive. Yet he kept showing up for follow-up visits.
Here he was 12 years later. When I helped operate to take out his gallbladder, there was no evidence of any cancer. The cancer had disappeared in the absence of any external treatment. One of the rarest events in medicine, the spontaneous regression of a cancer. Somehow his body had learned how to destroy the tumor.
Was the second patient’s case as impressive?
Dr. Rosenberg: This patient had received a kidney transplant from a gentleman who died in an auto accident. [The donor’s] kidney contained a cancer deposit, a kidney cancer, unbeknownst to the transplant surgeons. [When the kidney was transplanted], the recipient developed widespread metastatic kidney cancer.
[The recipient] was on immunosuppressive drugs, and so the drugs had to be stopped. [When the immunosuppressive drugs were stopped], the patient’s body rejected the kidney and his cancer disappeared.
That showed me that, in fact, if you could stimulate a strong enough immune reaction, in this case, an [allogeneic] reaction, against foreign tissues from a different individual, that you could make large vascularized, invasive cancers disappear based on immune reactivities. Those were clues that led me toward studying the immune system’s impact on cancer.
From there, how did your work evolve?
Dr. Rosenberg: As chief of the surgery branch at NIH, I began doing research. It was very difficult to manipulate immune cells in the laboratory. They wouldn’t stay alive. But I tried to study immune reactions in patients with cancer to see if there was such a thing as an immune reaction against the cancer. There was no such thing known at the time. There were no cancer antigens and no known immune reactions against the disease in the human.
Around this time, investigators were publishing studies about interleukin-2 (IL-2), or white blood cells known as leukocytes. How did interleukin-2 further your research?
Dr. Rosenberg: The advent of interleukin-2 enabled scientists to grow lymphocytes outside the body. [This] enabled us to grow t-lymphocytes, which are some of the major warriors of the immune system against foreign tissue. After [studying] 66 patients in which we studied interleukin-2 and cells that would develop from it, we finally saw a disappearance of melanoma in a patient that received interleukin-2. And we went on to treat hundreds of patients with that hormone, interleukin-2. In fact, interleukin-2 became the first immunotherapy ever approved by the Food and Drug Administration for the treatment of cancer in humans.
How did this finding impact your future discoveries?
Dr. Rosenberg: [It] led to studies of the mechanism of action of interleukin-2 and to do that, we identified a kind of cell called a tumor infiltrating lymphocyte. What better place, intuitively to look for cells doing battle against the cancer than within the cancer itself?
In 1988, we demonstrated for the first time that transfer of lymphocytes with antitumor activity could cause the regression of melanoma. This was a living drug obtained from melanoma deposits that could be grown outside the body and then readministered to the patient under suitable conditions. Interestingly, [in February the FDA approved that drug as treatment for patients with melanoma]. A company developed it to the point where in multi-institutional studies, they reproduced our results.
And we’ve now emphasized the value of using T cell therapy, t cell transfer, for the treatment of patients with the common solid cancers, the cancers that start anywhere from the colon up through the intestine, the stomach, the pancreas, and the esophagus. Solid tumors such as ovarian cancer, uterine cancer and so on, are also potentially susceptible to this T cell therapy.
We’ve published several papers showing in isolated patients that you could cause major regressions, if not complete regressions, of these solid cancers in the liver, in the breast, the cervix, the colon. That’s a major aspect of what we’re doing now.
I think immunotherapy has come to be recognized as a major fourth arm that can be used to attack cancers, adding to surgery, radiation, and chemotherapy.
What guidance would you have for other physician-investigators or young doctors who want to follow in your path?
Dr. Rosenberg: You have to have a broad base of knowledge. You have to be willing to immerse yourself in a problem so that your mind is working on it when you’re doing things where you can only think. [When] you’re taking a shower, [or] waiting at a red light, your mind is working on this problem because you’re immersed in trying to understand it.
You need to have a laser focus on the goals that you have and not get sidetracked by issues that may be interesting but not directly related to the goals that you’re attempting to achieve.
His pioneering research established interleukin-2 (IL-2) as the first U.S. Food and Drug Administration–approved cancer immunotherapy in 1992.
To recognize his trailblazing work and other achievements, the American Association for Cancer Research (AACR) will award Dr. Rosenberg with the 2024 AACR Award for Lifetime Achievement in Cancer Research at its annual meeting in April.
Dr. Rosenberg, a senior investigator for the Center for Cancer Research at the National Cancer Institute (NCI), and chief of the NCI Surgery Branch, shared the history behind his novel research and the patient stories that inspired his discoveries, during an interview.
Tell us a little about yourself and where you grew up.
Dr. Rosenberg: I grew up in the Bronx. My parents both immigrated to the United States from Poland as teenagers.
As a young boy, did you always want to become a doctor?
Dr. Rosenberg: I think some defining moments on why I decided to go into medicine occurred when I was 6 or 7 years old. The second world war was over, and many of the horrors of the Holocaust became apparent to me. I was brought up as an Orthodox Jew. My parents were quite religious, and I remember postcards coming in one after another about relatives that had died in the death camps. That had a profound influence on me.
How did that experience impact your aspirations?
Dr. Rosenberg: It was an example to me of how evil certain people and groups can be toward one another. I decided at that point, that I wanted to do something good for people, and medicine seemed the most likely way to do that. But also, I was developing a broad scientific interest. I ended up at the Bronx High School of Science and knew that I not only wanted to practice the medicine of today, but I wanted to play a role in helping develop the medicine.
What led to your interest in cancer treatment?
Dr. Rosenberg: Well, as a medical student and resident, it became clear that the field of cancer needed major improvement. We had three major ways to treat cancer: surgery, radiation therapy, and chemotherapy. That could cure about half of the people [who] had cancer. But despite the best application of those three specialties, there were over 600,000 deaths from cancer each year in the United States alone. It was clear to me that new approaches were needed, and I became very interested in taking advantage of the body’s immune system as a source of information to try to make progress.
Were there patients who inspired your research?
Dr. Rosenberg: There were two patients that I saw early in my career that impressed me a great deal. One was a patient that I saw when working in the emergency ward as a resident. A patient came in with right upper quadrant pain that looked like a gallbladder attack. That’s what it was. But when I went through his chart, I saw that he had been at that hospital 12 years earlier with a metastatic gastric cancer. The surgeons had operated. They saw tumor had spread to the liver and could not be removed. They closed the belly, not expecting him to survive. Yet he kept showing up for follow-up visits.
Here he was 12 years later. When I helped operate to take out his gallbladder, there was no evidence of any cancer. The cancer had disappeared in the absence of any external treatment. One of the rarest events in medicine, the spontaneous regression of a cancer. Somehow his body had learned how to destroy the tumor.
Was the second patient’s case as impressive?
Dr. Rosenberg: This patient had received a kidney transplant from a gentleman who died in an auto accident. [The donor’s] kidney contained a cancer deposit, a kidney cancer, unbeknownst to the transplant surgeons. [When the kidney was transplanted], the recipient developed widespread metastatic kidney cancer.
[The recipient] was on immunosuppressive drugs, and so the drugs had to be stopped. [When the immunosuppressive drugs were stopped], the patient’s body rejected the kidney and his cancer disappeared.
That showed me that, in fact, if you could stimulate a strong enough immune reaction, in this case, an [allogeneic] reaction, against foreign tissues from a different individual, that you could make large vascularized, invasive cancers disappear based on immune reactivities. Those were clues that led me toward studying the immune system’s impact on cancer.
From there, how did your work evolve?
Dr. Rosenberg: As chief of the surgery branch at NIH, I began doing research. It was very difficult to manipulate immune cells in the laboratory. They wouldn’t stay alive. But I tried to study immune reactions in patients with cancer to see if there was such a thing as an immune reaction against the cancer. There was no such thing known at the time. There were no cancer antigens and no known immune reactions against the disease in the human.
Around this time, investigators were publishing studies about interleukin-2 (IL-2), or white blood cells known as leukocytes. How did interleukin-2 further your research?
Dr. Rosenberg: The advent of interleukin-2 enabled scientists to grow lymphocytes outside the body. [This] enabled us to grow t-lymphocytes, which are some of the major warriors of the immune system against foreign tissue. After [studying] 66 patients in which we studied interleukin-2 and cells that would develop from it, we finally saw a disappearance of melanoma in a patient that received interleukin-2. And we went on to treat hundreds of patients with that hormone, interleukin-2. In fact, interleukin-2 became the first immunotherapy ever approved by the Food and Drug Administration for the treatment of cancer in humans.
How did this finding impact your future discoveries?
Dr. Rosenberg: [It] led to studies of the mechanism of action of interleukin-2 and to do that, we identified a kind of cell called a tumor infiltrating lymphocyte. What better place, intuitively to look for cells doing battle against the cancer than within the cancer itself?
In 1988, we demonstrated for the first time that transfer of lymphocytes with antitumor activity could cause the regression of melanoma. This was a living drug obtained from melanoma deposits that could be grown outside the body and then readministered to the patient under suitable conditions. Interestingly, [in February the FDA approved that drug as treatment for patients with melanoma]. A company developed it to the point where in multi-institutional studies, they reproduced our results.
And we’ve now emphasized the value of using T cell therapy, t cell transfer, for the treatment of patients with the common solid cancers, the cancers that start anywhere from the colon up through the intestine, the stomach, the pancreas, and the esophagus. Solid tumors such as ovarian cancer, uterine cancer and so on, are also potentially susceptible to this T cell therapy.
We’ve published several papers showing in isolated patients that you could cause major regressions, if not complete regressions, of these solid cancers in the liver, in the breast, the cervix, the colon. That’s a major aspect of what we’re doing now.
I think immunotherapy has come to be recognized as a major fourth arm that can be used to attack cancers, adding to surgery, radiation, and chemotherapy.
What guidance would you have for other physician-investigators or young doctors who want to follow in your path?
Dr. Rosenberg: You have to have a broad base of knowledge. You have to be willing to immerse yourself in a problem so that your mind is working on it when you’re doing things where you can only think. [When] you’re taking a shower, [or] waiting at a red light, your mind is working on this problem because you’re immersed in trying to understand it.
You need to have a laser focus on the goals that you have and not get sidetracked by issues that may be interesting but not directly related to the goals that you’re attempting to achieve.
His pioneering research established interleukin-2 (IL-2) as the first U.S. Food and Drug Administration–approved cancer immunotherapy in 1992.
To recognize his trailblazing work and other achievements, the American Association for Cancer Research (AACR) will award Dr. Rosenberg with the 2024 AACR Award for Lifetime Achievement in Cancer Research at its annual meeting in April.
Dr. Rosenberg, a senior investigator for the Center for Cancer Research at the National Cancer Institute (NCI), and chief of the NCI Surgery Branch, shared the history behind his novel research and the patient stories that inspired his discoveries, during an interview.
Tell us a little about yourself and where you grew up.
Dr. Rosenberg: I grew up in the Bronx. My parents both immigrated to the United States from Poland as teenagers.
As a young boy, did you always want to become a doctor?
Dr. Rosenberg: I think some defining moments on why I decided to go into medicine occurred when I was 6 or 7 years old. The second world war was over, and many of the horrors of the Holocaust became apparent to me. I was brought up as an Orthodox Jew. My parents were quite religious, and I remember postcards coming in one after another about relatives that had died in the death camps. That had a profound influence on me.
How did that experience impact your aspirations?
Dr. Rosenberg: It was an example to me of how evil certain people and groups can be toward one another. I decided at that point, that I wanted to do something good for people, and medicine seemed the most likely way to do that. But also, I was developing a broad scientific interest. I ended up at the Bronx High School of Science and knew that I not only wanted to practice the medicine of today, but I wanted to play a role in helping develop the medicine.
What led to your interest in cancer treatment?
Dr. Rosenberg: Well, as a medical student and resident, it became clear that the field of cancer needed major improvement. We had three major ways to treat cancer: surgery, radiation therapy, and chemotherapy. That could cure about half of the people [who] had cancer. But despite the best application of those three specialties, there were over 600,000 deaths from cancer each year in the United States alone. It was clear to me that new approaches were needed, and I became very interested in taking advantage of the body’s immune system as a source of information to try to make progress.
Were there patients who inspired your research?
Dr. Rosenberg: There were two patients that I saw early in my career that impressed me a great deal. One was a patient that I saw when working in the emergency ward as a resident. A patient came in with right upper quadrant pain that looked like a gallbladder attack. That’s what it was. But when I went through his chart, I saw that he had been at that hospital 12 years earlier with a metastatic gastric cancer. The surgeons had operated. They saw tumor had spread to the liver and could not be removed. They closed the belly, not expecting him to survive. Yet he kept showing up for follow-up visits.
Here he was 12 years later. When I helped operate to take out his gallbladder, there was no evidence of any cancer. The cancer had disappeared in the absence of any external treatment. One of the rarest events in medicine, the spontaneous regression of a cancer. Somehow his body had learned how to destroy the tumor.
Was the second patient’s case as impressive?
Dr. Rosenberg: This patient had received a kidney transplant from a gentleman who died in an auto accident. [The donor’s] kidney contained a cancer deposit, a kidney cancer, unbeknownst to the transplant surgeons. [When the kidney was transplanted], the recipient developed widespread metastatic kidney cancer.
[The recipient] was on immunosuppressive drugs, and so the drugs had to be stopped. [When the immunosuppressive drugs were stopped], the patient’s body rejected the kidney and his cancer disappeared.
That showed me that, in fact, if you could stimulate a strong enough immune reaction, in this case, an [allogeneic] reaction, against foreign tissues from a different individual, that you could make large vascularized, invasive cancers disappear based on immune reactivities. Those were clues that led me toward studying the immune system’s impact on cancer.
From there, how did your work evolve?
Dr. Rosenberg: As chief of the surgery branch at NIH, I began doing research. It was very difficult to manipulate immune cells in the laboratory. They wouldn’t stay alive. But I tried to study immune reactions in patients with cancer to see if there was such a thing as an immune reaction against the cancer. There was no such thing known at the time. There were no cancer antigens and no known immune reactions against the disease in the human.
Around this time, investigators were publishing studies about interleukin-2 (IL-2), or white blood cells known as leukocytes. How did interleukin-2 further your research?
Dr. Rosenberg: The advent of interleukin-2 enabled scientists to grow lymphocytes outside the body. [This] enabled us to grow t-lymphocytes, which are some of the major warriors of the immune system against foreign tissue. After [studying] 66 patients in which we studied interleukin-2 and cells that would develop from it, we finally saw a disappearance of melanoma in a patient that received interleukin-2. And we went on to treat hundreds of patients with that hormone, interleukin-2. In fact, interleukin-2 became the first immunotherapy ever approved by the Food and Drug Administration for the treatment of cancer in humans.
How did this finding impact your future discoveries?
Dr. Rosenberg: [It] led to studies of the mechanism of action of interleukin-2 and to do that, we identified a kind of cell called a tumor infiltrating lymphocyte. What better place, intuitively to look for cells doing battle against the cancer than within the cancer itself?
In 1988, we demonstrated for the first time that transfer of lymphocytes with antitumor activity could cause the regression of melanoma. This was a living drug obtained from melanoma deposits that could be grown outside the body and then readministered to the patient under suitable conditions. Interestingly, [in February the FDA approved that drug as treatment for patients with melanoma]. A company developed it to the point where in multi-institutional studies, they reproduced our results.
And we’ve now emphasized the value of using T cell therapy, t cell transfer, for the treatment of patients with the common solid cancers, the cancers that start anywhere from the colon up through the intestine, the stomach, the pancreas, and the esophagus. Solid tumors such as ovarian cancer, uterine cancer and so on, are also potentially susceptible to this T cell therapy.
We’ve published several papers showing in isolated patients that you could cause major regressions, if not complete regressions, of these solid cancers in the liver, in the breast, the cervix, the colon. That’s a major aspect of what we’re doing now.
I think immunotherapy has come to be recognized as a major fourth arm that can be used to attack cancers, adding to surgery, radiation, and chemotherapy.
What guidance would you have for other physician-investigators or young doctors who want to follow in your path?
Dr. Rosenberg: You have to have a broad base of knowledge. You have to be willing to immerse yourself in a problem so that your mind is working on it when you’re doing things where you can only think. [When] you’re taking a shower, [or] waiting at a red light, your mind is working on this problem because you’re immersed in trying to understand it.
You need to have a laser focus on the goals that you have and not get sidetracked by issues that may be interesting but not directly related to the goals that you’re attempting to achieve.