Business of Medicine

TOPLINE: 

Despite experiencing higher rates of positive margins and pathologic node involvement, patients with early-stage breast cancer who undergo nipple-sparing mastectomy are less likely to receive adjuvant radiation therapy than are those who have breast-conserving surgery. 

METHODOLOGY:

• Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
• Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
• The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
• The team also compared overall survival outcomes in patients with positive margins and node involvement.

TAKEAWAY: 

• Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
• Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
• Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
• In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).

IN PRACTICE:

The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.

SOURCE:

The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology. 

LIMITATIONS: 

Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes. 

DISCLOSURES:

The study did not receive any funding support. The authors disclosed no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Despite experiencing higher rates of positive margins and pathologic node involvement, patients with early-stage breast cancer who undergo nipple-sparing mastectomy are less likely to receive adjuvant radiation therapy than are those who have breast-conserving surgery. 

METHODOLOGY:

• Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
• Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
• The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
• The team also compared overall survival outcomes in patients with positive margins and node involvement.

TAKEAWAY: 

• Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
• Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
• Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
• In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).

IN PRACTICE:

The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.

SOURCE:

The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology. 

LIMITATIONS: 

Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes. 

DISCLOSURES:

The study did not receive any funding support. The authors disclosed no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Despite experiencing higher rates of positive margins and pathologic node involvement, patients with early-stage breast cancer who undergo nipple-sparing mastectomy are less likely to receive adjuvant radiation therapy than are those who have breast-conserving surgery. 

METHODOLOGY:

• Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
• Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
• The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
• The team also compared overall survival outcomes in patients with positive margins and node involvement.

TAKEAWAY: 

• Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
• Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
• Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
• In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).

IN PRACTICE:

The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.

SOURCE:

The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology. 

LIMITATIONS: 

Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes. 

DISCLOSURES:

The study did not receive any funding support. The authors disclosed no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

Many, many years ago there was a Thanksgiving when as I was just beginning to earn a reputation in my wife’s family. There were no place cards on the table and the usual hovering and jockeying seats was well underway. From behind me I heard one of my young nieces pipe up: “I want to sit next to Doctor I-don’t-know.”

After a few words of negotiation we were all settled in our places and ready to enjoy our meal. It took only a few seconds of introspection for me to grasp how I had received that moniker, which some physicians might consider disrespectful.

I was the only physician within several generations of that family and, as such, my in-laws thought it only appropriate to ask me medical questions. They courteously seemed to avoid personal questions about their own health and were particularly careful not to roll up their sleeves or unbutton their shirts to show me a lesion or a recently acquired surgical scar. No, my wife’s family members were curious. They wanted answers to deeper questions, the hard science so to speak. “How does aspirin work?” was a typical and painful example. Maybe pharmacologists today have better answers but 40 years ago I’m not so sure; I certainly didn’t know back then and would reply, “I don’t know.” Probably for the third or fourth time that day.

Usually I genuinely didn’t know the answer. However, sometimes my answer was going to be so different from the beliefs and biases of my inquisitor that, in the interest of expediency, “I don’t know” seemed the most appropriate response.

If you were reading Letters from Maine 25 years ago, that scenario might sound familiar. I have chosen to pull it out of the archives as a jumping-off point for a consideration of the unfortunate example some of us set when the COVID pandemic threw a tsunami of unknowns at us. Too many physician-“experts” were afraid to say, “I don’t know.” Instead, and maybe because, they themselves were afraid that the patients couldn’t handle the truth that none of us in the profession knew the correct answers. When so many initial pronouncements proved incorrect, it was too late to undo the damage that had been done to the community’s trust in the rest of us.

It turns out that my in-laws were not the only folks who thought of me as Doctor I-don’t-know. One of the perks of remaining in the same community after one retires is that encounters with former patients and their parents happen frequently. On more than one occasion a parent has thanked me for admitting my ignorance. Some have even claimed that my candid approach was what they remembered most fondly. And, that quality increased their trust when I finally provided an answer.

There is an art to delivering “I don’t know.” Thirty years ago I would excuse myself and tell the family I was going to my office to pull a book off the shelf or call a previous mentor. Now one only needs to ask Dr. Google. No need to leave the room. If appropriate, the provider can swing the computer screen so that the patient can share in the search for the answer.

That strategy only works when the provider merely needs to update or expand his/her knowledge. However, there are those difficult situations when no one could know the answer given the current parameters of the patient’s situation. More lab work might be needed. It may be too early in the trajectory of the patient’s illness for the illnesses signs and symptoms to declare themselves.

In these situations “I don’t know” must be followed by a “but.” It is what comes after that “but” and how it is delivered that can convert the provider’s admission of ignorance into a demonstration of his or her character. Is he/she a caring person trying to understand the patient’s concerns? Willing to enter into a cooperative relationship as together they search for the cause and hopefully for a cure for the patient’s currently mysterious illness?

I recently read about a physician who is encouraging medical educators to incorporate more discussions of “humility” and its role in patient care into the medical school and postgraduate training curricula. He feels, as do I, that if more physicians learned to say “I don’t know” early in their careers, the quality of care we are delivering as a profession will improve, as will the trust bestowed by our patients.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Many, many years ago there was a Thanksgiving when as I was just beginning to earn a reputation in my wife’s family. There were no place cards on the table and the usual hovering and jockeying seats was well underway. From behind me I heard one of my young nieces pipe up: “I want to sit next to Doctor I-don’t-know.”

After a few words of negotiation we were all settled in our places and ready to enjoy our meal. It took only a few seconds of introspection for me to grasp how I had received that moniker, which some physicians might consider disrespectful.

I was the only physician within several generations of that family and, as such, my in-laws thought it only appropriate to ask me medical questions. They courteously seemed to avoid personal questions about their own health and were particularly careful not to roll up their sleeves or unbutton their shirts to show me a lesion or a recently acquired surgical scar. No, my wife’s family members were curious. They wanted answers to deeper questions, the hard science so to speak. “How does aspirin work?” was a typical and painful example. Maybe pharmacologists today have better answers but 40 years ago I’m not so sure; I certainly didn’t know back then and would reply, “I don’t know.” Probably for the third or fourth time that day.

Usually I genuinely didn’t know the answer. However, sometimes my answer was going to be so different from the beliefs and biases of my inquisitor that, in the interest of expediency, “I don’t know” seemed the most appropriate response.

If you were reading Letters from Maine 25 years ago, that scenario might sound familiar. I have chosen to pull it out of the archives as a jumping-off point for a consideration of the unfortunate example some of us set when the COVID pandemic threw a tsunami of unknowns at us. Too many physician-“experts” were afraid to say, “I don’t know.” Instead, and maybe because, they themselves were afraid that the patients couldn’t handle the truth that none of us in the profession knew the correct answers. When so many initial pronouncements proved incorrect, it was too late to undo the damage that had been done to the community’s trust in the rest of us.

It turns out that my in-laws were not the only folks who thought of me as Doctor I-don’t-know. One of the perks of remaining in the same community after one retires is that encounters with former patients and their parents happen frequently. On more than one occasion a parent has thanked me for admitting my ignorance. Some have even claimed that my candid approach was what they remembered most fondly. And, that quality increased their trust when I finally provided an answer.

There is an art to delivering “I don’t know.” Thirty years ago I would excuse myself and tell the family I was going to my office to pull a book off the shelf or call a previous mentor. Now one only needs to ask Dr. Google. No need to leave the room. If appropriate, the provider can swing the computer screen so that the patient can share in the search for the answer.

That strategy only works when the provider merely needs to update or expand his/her knowledge. However, there are those difficult situations when no one could know the answer given the current parameters of the patient’s situation. More lab work might be needed. It may be too early in the trajectory of the patient’s illness for the illnesses signs and symptoms to declare themselves.

In these situations “I don’t know” must be followed by a “but.” It is what comes after that “but” and how it is delivered that can convert the provider’s admission of ignorance into a demonstration of his or her character. Is he/she a caring person trying to understand the patient’s concerns? Willing to enter into a cooperative relationship as together they search for the cause and hopefully for a cure for the patient’s currently mysterious illness?

I recently read about a physician who is encouraging medical educators to incorporate more discussions of “humility” and its role in patient care into the medical school and postgraduate training curricula. He feels, as do I, that if more physicians learned to say “I don’t know” early in their careers, the quality of care we are delivering as a profession will improve, as will the trust bestowed by our patients.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Many, many years ago there was a Thanksgiving when as I was just beginning to earn a reputation in my wife’s family. There were no place cards on the table and the usual hovering and jockeying seats was well underway. From behind me I heard one of my young nieces pipe up: “I want to sit next to Doctor I-don’t-know.”

After a few words of negotiation we were all settled in our places and ready to enjoy our meal. It took only a few seconds of introspection for me to grasp how I had received that moniker, which some physicians might consider disrespectful.

I was the only physician within several generations of that family and, as such, my in-laws thought it only appropriate to ask me medical questions. They courteously seemed to avoid personal questions about their own health and were particularly careful not to roll up their sleeves or unbutton their shirts to show me a lesion or a recently acquired surgical scar. No, my wife’s family members were curious. They wanted answers to deeper questions, the hard science so to speak. “How does aspirin work?” was a typical and painful example. Maybe pharmacologists today have better answers but 40 years ago I’m not so sure; I certainly didn’t know back then and would reply, “I don’t know.” Probably for the third or fourth time that day.

Usually I genuinely didn’t know the answer. However, sometimes my answer was going to be so different from the beliefs and biases of my inquisitor that, in the interest of expediency, “I don’t know” seemed the most appropriate response.

If you were reading Letters from Maine 25 years ago, that scenario might sound familiar. I have chosen to pull it out of the archives as a jumping-off point for a consideration of the unfortunate example some of us set when the COVID pandemic threw a tsunami of unknowns at us. Too many physician-“experts” were afraid to say, “I don’t know.” Instead, and maybe because, they themselves were afraid that the patients couldn’t handle the truth that none of us in the profession knew the correct answers. When so many initial pronouncements proved incorrect, it was too late to undo the damage that had been done to the community’s trust in the rest of us.

It turns out that my in-laws were not the only folks who thought of me as Doctor I-don’t-know. One of the perks of remaining in the same community after one retires is that encounters with former patients and their parents happen frequently. On more than one occasion a parent has thanked me for admitting my ignorance. Some have even claimed that my candid approach was what they remembered most fondly. And, that quality increased their trust when I finally provided an answer.

There is an art to delivering “I don’t know.” Thirty years ago I would excuse myself and tell the family I was going to my office to pull a book off the shelf or call a previous mentor. Now one only needs to ask Dr. Google. No need to leave the room. If appropriate, the provider can swing the computer screen so that the patient can share in the search for the answer.

That strategy only works when the provider merely needs to update or expand his/her knowledge. However, there are those difficult situations when no one could know the answer given the current parameters of the patient’s situation. More lab work might be needed. It may be too early in the trajectory of the patient’s illness for the illnesses signs and symptoms to declare themselves.

In these situations “I don’t know” must be followed by a “but.” It is what comes after that “but” and how it is delivered that can convert the provider’s admission of ignorance into a demonstration of his or her character. Is he/she a caring person trying to understand the patient’s concerns? Willing to enter into a cooperative relationship as together they search for the cause and hopefully for a cure for the patient’s currently mysterious illness?

I recently read about a physician who is encouraging medical educators to incorporate more discussions of “humility” and its role in patient care into the medical school and postgraduate training curricula. He feels, as do I, that if more physicians learned to say “I don’t know” early in their careers, the quality of care we are delivering as a profession will improve, as will the trust bestowed by our patients.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

On July 19, what was supposed to be a harmless software upgrade brought down a huge chunk of the health care, banking, flight, and travel systems.

While my dinky little practice wasn’t affected, several of my patients were in other ways. Tests that had to be rescheduled, flights canceled ... inconveniences, but not life altering.

Things are allegedly fixed (at least until next time) but there may be fallout down the road. People who had delayed medical procedures could have a different prognosis depending on what the results showed when they were done. Hopefully this won’t happen.

But it’s a reminder of how vulnerable our whole world is to disruption of the internet, not to mention the power grid and software systems. Paper is time consuming, and takes up a lot of space, but as long as you have a decent pen and enough light to read it you’re fine.

I’m not saying we should go back to paper. It’s more expensive in the long run, takes up shelf and closet space, kills trees, has to be shredded after a time, and turns yellow around the edges. It also makes it a pain to copy and transfer records. With paper I wouldn’t be able to take all my charts with me to refer to when I leave town on a busman’s holiday. The benefits of digital far outstrip paper or we wouldn’t have switched in the first place.

But it’s still kind of scary to realize how much we depend on software to keep things running smoothly. The events of July 19 were unintentional. Someone looking to cause real trouble could do worse — and there are plenty out there who would love to — and we’re putting our faith in companies like CrowdStrike to protect us from them.

But, on the flip side, we’re asking others to do the same. We often use the phrase “trust me, I’m a doctor,” in jest, but the point is there. People come to us because we have knowledge and training they don’t, and they’re hoping we can help them. We spent a lot of time getting to the point where we can hang up a sign that says so. And we, like everyone else, are not infallible.

We’re individuals, not machines. Both are fallible, though in different ways. In CrowdStrike’s case the machines didn’t fail, they just did what the humans told them to do. Which didn’t work.

The bottom line is that even the most well-meaning will make mistakes.

But it’s still pretty scary because, even unintentionally, there will be a next time. And between now and then our world will become even more dependent on these systems. None of us want to go back to the preconnected era, it’s too much a part of our daily lives.

Like the long list of potential side effects on any drug we prescribe, it’s a trade-off that we’ve accepted. And at this point we aren’t going back.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

On July 19, what was supposed to be a harmless software upgrade brought down a huge chunk of the health care, banking, flight, and travel systems.

While my dinky little practice wasn’t affected, several of my patients were in other ways. Tests that had to be rescheduled, flights canceled ... inconveniences, but not life altering.

Things are allegedly fixed (at least until next time) but there may be fallout down the road. People who had delayed medical procedures could have a different prognosis depending on what the results showed when they were done. Hopefully this won’t happen.

But it’s a reminder of how vulnerable our whole world is to disruption of the internet, not to mention the power grid and software systems. Paper is time consuming, and takes up a lot of space, but as long as you have a decent pen and enough light to read it you’re fine.

I’m not saying we should go back to paper. It’s more expensive in the long run, takes up shelf and closet space, kills trees, has to be shredded after a time, and turns yellow around the edges. It also makes it a pain to copy and transfer records. With paper I wouldn’t be able to take all my charts with me to refer to when I leave town on a busman’s holiday. The benefits of digital far outstrip paper or we wouldn’t have switched in the first place.

But it’s still kind of scary to realize how much we depend on software to keep things running smoothly. The events of July 19 were unintentional. Someone looking to cause real trouble could do worse — and there are plenty out there who would love to — and we’re putting our faith in companies like CrowdStrike to protect us from them.

But, on the flip side, we’re asking others to do the same. We often use the phrase “trust me, I’m a doctor,” in jest, but the point is there. People come to us because we have knowledge and training they don’t, and they’re hoping we can help them. We spent a lot of time getting to the point where we can hang up a sign that says so. And we, like everyone else, are not infallible.

We’re individuals, not machines. Both are fallible, though in different ways. In CrowdStrike’s case the machines didn’t fail, they just did what the humans told them to do. Which didn’t work.

The bottom line is that even the most well-meaning will make mistakes.

But it’s still pretty scary because, even unintentionally, there will be a next time. And between now and then our world will become even more dependent on these systems. None of us want to go back to the preconnected era, it’s too much a part of our daily lives.

Like the long list of potential side effects on any drug we prescribe, it’s a trade-off that we’ve accepted. And at this point we aren’t going back.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

On July 19, what was supposed to be a harmless software upgrade brought down a huge chunk of the health care, banking, flight, and travel systems.

While my dinky little practice wasn’t affected, several of my patients were in other ways. Tests that had to be rescheduled, flights canceled ... inconveniences, but not life altering.

Things are allegedly fixed (at least until next time) but there may be fallout down the road. People who had delayed medical procedures could have a different prognosis depending on what the results showed when they were done. Hopefully this won’t happen.

But it’s a reminder of how vulnerable our whole world is to disruption of the internet, not to mention the power grid and software systems. Paper is time consuming, and takes up a lot of space, but as long as you have a decent pen and enough light to read it you’re fine.

I’m not saying we should go back to paper. It’s more expensive in the long run, takes up shelf and closet space, kills trees, has to be shredded after a time, and turns yellow around the edges. It also makes it a pain to copy and transfer records. With paper I wouldn’t be able to take all my charts with me to refer to when I leave town on a busman’s holiday. The benefits of digital far outstrip paper or we wouldn’t have switched in the first place.

But it’s still kind of scary to realize how much we depend on software to keep things running smoothly. The events of July 19 were unintentional. Someone looking to cause real trouble could do worse — and there are plenty out there who would love to — and we’re putting our faith in companies like CrowdStrike to protect us from them.

But, on the flip side, we’re asking others to do the same. We often use the phrase “trust me, I’m a doctor,” in jest, but the point is there. People come to us because we have knowledge and training they don’t, and they’re hoping we can help them. We spent a lot of time getting to the point where we can hang up a sign that says so. And we, like everyone else, are not infallible.

We’re individuals, not machines. Both are fallible, though in different ways. In CrowdStrike’s case the machines didn’t fail, they just did what the humans told them to do. Which didn’t work.

The bottom line is that even the most well-meaning will make mistakes.

But it’s still pretty scary because, even unintentionally, there will be a next time. And between now and then our world will become even more dependent on these systems. None of us want to go back to the preconnected era, it’s too much a part of our daily lives.

Like the long list of potential side effects on any drug we prescribe, it’s a trade-off that we’ve accepted. And at this point we aren’t going back.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

TORONTO — When it comes to using artificial intelligence (AI) in your practice, pediatric dermatologist Albert Yan, MD, professor of pediatrics and dermatology at the University of Pennsylvania, Philadelphia, suggests that dermatologists “just jump in” and become familiar with the various AI models.

He reminds doctors that many of their colleagues and patients and their families are already using these systems, “and you don’t want to be left behind.”

In an interview following his presentation on AI at the annual meeting of the Society for Pediatric Dermatology (SPD), Dr. Yan discussed his tips for using AI.
 

Changing Fast 

From the outset, most generative AI systems have been very good at processing language — for example, generating letters of medical necessity and summarizing disease processes into lay terms. But now they’re becoming “truly multimodal,” said Dr. Yan. “You can enter images; you could have it process audio; you can even start to have it refine video.”

To get started, he recommends signing up for a free account with ChatGPT, Gemini, Perplexity, Claude, and/or Microsoft Copilot. “To make the best choice, you have to try them out yourself because they each have their own kind of flavor and strengths and weaknesses,” said Dr. Yan.

Personally, he finds that ChatGPT is the most versatile, Gemini perhaps a little better in terms of image generation, and Perplexity probably the best at references because it was designed as an online library.

Once you figure out which platforms you prefer, consider signing up for a premium subscription, which is typically month to month and can be canceled at any time, Dr. Yan said. “This will allow you to get the most out of the AI model.”

As these AI systems are based on large language models, they are excellent at text, Dr. Yan noted. He suggests asking one to generate a letter or patient instruction sheet. “If you have a premium model, give it a PDF to summarize an article or take a photo of something that you want its opinion on.”

Privacy Critical

Always pay attention to privacy issues and avoid entering any private health information that would violate the Health Insurance Portability and Accountability Act (HIPAA), he said.

“We have to be very careful about how we interact with AI,” said Dr. Yan. “We can’t be posting private patient health information into these systems, no matter how useful these systems are.” Many academic institutions are creating “walled gardens” — private areas of AI access that don’t allow patient information to “leak out,” he said. “These AI models may have HIPAA protections in place and come with specific guidelines of use.”

The AI “scribe,” which helps with electronic health record documentation, is one of the most useful tools for clinicians, he said. He referred to a recent study showing that an AI scribe saved users an average of 1 hour at the keyboard every day, and a small patient survey showing 71% reported that it led to spending more time with their physician.

When entering requests into a prompt line with an AI system, Dr. Yan stressed that these prompts need to be clear and concise. For a complicated calculation or multistep problem, try adding the words “let’s do this step by step,” he said. “This is a technique invoking a ‘chain of thought’ that allows the system to enhance its accuracy when solving problems.”

If the response is not satisfactory, try being more detailed in the request, he advised, and consider giving the system examples of what you’re looking for and telling it what you don’t want in the output.

“For instance, if you’re asking for a differential diagnosis of rashes that affect the hands and feet, you can stipulate that you only want rashes that are vesicular or that arise in neonates, so you can get a more focused answer,” said Dr. Yan.

If there are “long-winded verbose” responses, add the phrase “be concise,” and it will shorten the response by about 50%, he added.
 

AI Hallucinations

Dr. Yan broached an issue that occasionally comes up, AI hallucinations, which refer to inaccurate or misleading responses on the basis of incomplete training or intrinsic biases within the model. He pointed to the case of a doctor discussing issues related to a patient’s hands, feet, and mouth, which the AI-generated model summarized as “the patient being diagnosed with hand, foot, and mouth disease.”

Another example he provided was a request to generate a letter of medical necessity for using ustekinumab (Stelara) for treating hidradenitis suppurative in a child that included references for its effectiveness and safety in children. The AI system generated “false references that sounded like they should be real because the authors are often people who have written in that field or on that subject,” said Dr. Yan.

When pressed, the system did acknowledge the references were hypothetical but were meant to illustrate the types of studies that would typically support the use of this drug in pediatric patients with HS. “ It’s well meaning, in the sense that it’s trying to help you achieve your goals using this training system,” said Dr. Yan.

“If you’re skeptical about a response, double-check the answer with a Google search or run the response through another AI [tool] asking it to check if the response is accurate,” he added.

While AI systems won’t replace the clinician, they are continuing to improve and becoming more sophisticated. Dr. Yan advises keeping up with emerging developments and engaging and adapting the most appropriate AI tool for an individual clinician’s work.

Asked to comment on the presentation at the SPD meeting, Sheilagh Maguiness, MD, director of the Division of Pediatric Dermatology at the University of Minnesota, Minneapolis, who, like other doctors, is increasingly testing AI, said she foresees a time when AI scribes fully replace humans for completing tasks during patient interactions.

“The hope is that if the AI scribes get good enough, we can just open our phone, have them translate the interaction, and create the notes for us.”

While she likes the idea of using ChatGPT to help with tasks like letters of recommendation for medications, Dr. Yan’s comments reiterated the importance of “checking and double-checking ChatGPT because it’s not correct all the time.” She particularly welcomed the advice “that we can just go back and ask it again to clarify, and that may improve its answers.”

Dr. Yan’s disclosures included an investment portfolio that includes companies working in the AI space, including Google, Apple, Nvidia, Amazon, Microsoft, and Arm. Dr. Maguiness had no relevant disclosures.

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

TORONTO — When it comes to using artificial intelligence (AI) in your practice, pediatric dermatologist Albert Yan, MD, professor of pediatrics and dermatology at the University of Pennsylvania, Philadelphia, suggests that dermatologists “just jump in” and become familiar with the various AI models.

He reminds doctors that many of their colleagues and patients and their families are already using these systems, “and you don’t want to be left behind.”

In an interview following his presentation on AI at the annual meeting of the Society for Pediatric Dermatology (SPD), Dr. Yan discussed his tips for using AI.
 

Changing Fast 

From the outset, most generative AI systems have been very good at processing language — for example, generating letters of medical necessity and summarizing disease processes into lay terms. But now they’re becoming “truly multimodal,” said Dr. Yan. “You can enter images; you could have it process audio; you can even start to have it refine video.”

To get started, he recommends signing up for a free account with ChatGPT, Gemini, Perplexity, Claude, and/or Microsoft Copilot. “To make the best choice, you have to try them out yourself because they each have their own kind of flavor and strengths and weaknesses,” said Dr. Yan.

Personally, he finds that ChatGPT is the most versatile, Gemini perhaps a little better in terms of image generation, and Perplexity probably the best at references because it was designed as an online library.

Once you figure out which platforms you prefer, consider signing up for a premium subscription, which is typically month to month and can be canceled at any time, Dr. Yan said. “This will allow you to get the most out of the AI model.”

As these AI systems are based on large language models, they are excellent at text, Dr. Yan noted. He suggests asking one to generate a letter or patient instruction sheet. “If you have a premium model, give it a PDF to summarize an article or take a photo of something that you want its opinion on.”

Privacy Critical

Always pay attention to privacy issues and avoid entering any private health information that would violate the Health Insurance Portability and Accountability Act (HIPAA), he said.

“We have to be very careful about how we interact with AI,” said Dr. Yan. “We can’t be posting private patient health information into these systems, no matter how useful these systems are.” Many academic institutions are creating “walled gardens” — private areas of AI access that don’t allow patient information to “leak out,” he said. “These AI models may have HIPAA protections in place and come with specific guidelines of use.”

The AI “scribe,” which helps with electronic health record documentation, is one of the most useful tools for clinicians, he said. He referred to a recent study showing that an AI scribe saved users an average of 1 hour at the keyboard every day, and a small patient survey showing 71% reported that it led to spending more time with their physician.

When entering requests into a prompt line with an AI system, Dr. Yan stressed that these prompts need to be clear and concise. For a complicated calculation or multistep problem, try adding the words “let’s do this step by step,” he said. “This is a technique invoking a ‘chain of thought’ that allows the system to enhance its accuracy when solving problems.”

If the response is not satisfactory, try being more detailed in the request, he advised, and consider giving the system examples of what you’re looking for and telling it what you don’t want in the output.

“For instance, if you’re asking for a differential diagnosis of rashes that affect the hands and feet, you can stipulate that you only want rashes that are vesicular or that arise in neonates, so you can get a more focused answer,” said Dr. Yan.

If there are “long-winded verbose” responses, add the phrase “be concise,” and it will shorten the response by about 50%, he added.
 

AI Hallucinations

Dr. Yan broached an issue that occasionally comes up, AI hallucinations, which refer to inaccurate or misleading responses on the basis of incomplete training or intrinsic biases within the model. He pointed to the case of a doctor discussing issues related to a patient’s hands, feet, and mouth, which the AI-generated model summarized as “the patient being diagnosed with hand, foot, and mouth disease.”

Another example he provided was a request to generate a letter of medical necessity for using ustekinumab (Stelara) for treating hidradenitis suppurative in a child that included references for its effectiveness and safety in children. The AI system generated “false references that sounded like they should be real because the authors are often people who have written in that field or on that subject,” said Dr. Yan.

When pressed, the system did acknowledge the references were hypothetical but were meant to illustrate the types of studies that would typically support the use of this drug in pediatric patients with HS. “ It’s well meaning, in the sense that it’s trying to help you achieve your goals using this training system,” said Dr. Yan.

“If you’re skeptical about a response, double-check the answer with a Google search or run the response through another AI [tool] asking it to check if the response is accurate,” he added.

While AI systems won’t replace the clinician, they are continuing to improve and becoming more sophisticated. Dr. Yan advises keeping up with emerging developments and engaging and adapting the most appropriate AI tool for an individual clinician’s work.

Asked to comment on the presentation at the SPD meeting, Sheilagh Maguiness, MD, director of the Division of Pediatric Dermatology at the University of Minnesota, Minneapolis, who, like other doctors, is increasingly testing AI, said she foresees a time when AI scribes fully replace humans for completing tasks during patient interactions.

“The hope is that if the AI scribes get good enough, we can just open our phone, have them translate the interaction, and create the notes for us.”

While she likes the idea of using ChatGPT to help with tasks like letters of recommendation for medications, Dr. Yan’s comments reiterated the importance of “checking and double-checking ChatGPT because it’s not correct all the time.” She particularly welcomed the advice “that we can just go back and ask it again to clarify, and that may improve its answers.”

Dr. Yan’s disclosures included an investment portfolio that includes companies working in the AI space, including Google, Apple, Nvidia, Amazon, Microsoft, and Arm. Dr. Maguiness had no relevant disclosures.

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

TORONTO — When it comes to using artificial intelligence (AI) in your practice, pediatric dermatologist Albert Yan, MD, professor of pediatrics and dermatology at the University of Pennsylvania, Philadelphia, suggests that dermatologists “just jump in” and become familiar with the various AI models.

He reminds doctors that many of their colleagues and patients and their families are already using these systems, “and you don’t want to be left behind.”

In an interview following his presentation on AI at the annual meeting of the Society for Pediatric Dermatology (SPD), Dr. Yan discussed his tips for using AI.
 

Changing Fast 

From the outset, most generative AI systems have been very good at processing language — for example, generating letters of medical necessity and summarizing disease processes into lay terms. But now they’re becoming “truly multimodal,” said Dr. Yan. “You can enter images; you could have it process audio; you can even start to have it refine video.”

To get started, he recommends signing up for a free account with ChatGPT, Gemini, Perplexity, Claude, and/or Microsoft Copilot. “To make the best choice, you have to try them out yourself because they each have their own kind of flavor and strengths and weaknesses,” said Dr. Yan.

Personally, he finds that ChatGPT is the most versatile, Gemini perhaps a little better in terms of image generation, and Perplexity probably the best at references because it was designed as an online library.

Once you figure out which platforms you prefer, consider signing up for a premium subscription, which is typically month to month and can be canceled at any time, Dr. Yan said. “This will allow you to get the most out of the AI model.”

As these AI systems are based on large language models, they are excellent at text, Dr. Yan noted. He suggests asking one to generate a letter or patient instruction sheet. “If you have a premium model, give it a PDF to summarize an article or take a photo of something that you want its opinion on.”

Privacy Critical

Always pay attention to privacy issues and avoid entering any private health information that would violate the Health Insurance Portability and Accountability Act (HIPAA), he said.

“We have to be very careful about how we interact with AI,” said Dr. Yan. “We can’t be posting private patient health information into these systems, no matter how useful these systems are.” Many academic institutions are creating “walled gardens” — private areas of AI access that don’t allow patient information to “leak out,” he said. “These AI models may have HIPAA protections in place and come with specific guidelines of use.”

The AI “scribe,” which helps with electronic health record documentation, is one of the most useful tools for clinicians, he said. He referred to a recent study showing that an AI scribe saved users an average of 1 hour at the keyboard every day, and a small patient survey showing 71% reported that it led to spending more time with their physician.

When entering requests into a prompt line with an AI system, Dr. Yan stressed that these prompts need to be clear and concise. For a complicated calculation or multistep problem, try adding the words “let’s do this step by step,” he said. “This is a technique invoking a ‘chain of thought’ that allows the system to enhance its accuracy when solving problems.”

If the response is not satisfactory, try being more detailed in the request, he advised, and consider giving the system examples of what you’re looking for and telling it what you don’t want in the output.

“For instance, if you’re asking for a differential diagnosis of rashes that affect the hands and feet, you can stipulate that you only want rashes that are vesicular or that arise in neonates, so you can get a more focused answer,” said Dr. Yan.

If there are “long-winded verbose” responses, add the phrase “be concise,” and it will shorten the response by about 50%, he added.
 

AI Hallucinations

Dr. Yan broached an issue that occasionally comes up, AI hallucinations, which refer to inaccurate or misleading responses on the basis of incomplete training or intrinsic biases within the model. He pointed to the case of a doctor discussing issues related to a patient’s hands, feet, and mouth, which the AI-generated model summarized as “the patient being diagnosed with hand, foot, and mouth disease.”

Another example he provided was a request to generate a letter of medical necessity for using ustekinumab (Stelara) for treating hidradenitis suppurative in a child that included references for its effectiveness and safety in children. The AI system generated “false references that sounded like they should be real because the authors are often people who have written in that field or on that subject,” said Dr. Yan.

When pressed, the system did acknowledge the references were hypothetical but were meant to illustrate the types of studies that would typically support the use of this drug in pediatric patients with HS. “ It’s well meaning, in the sense that it’s trying to help you achieve your goals using this training system,” said Dr. Yan.

“If you’re skeptical about a response, double-check the answer with a Google search or run the response through another AI [tool] asking it to check if the response is accurate,” he added.

While AI systems won’t replace the clinician, they are continuing to improve and becoming more sophisticated. Dr. Yan advises keeping up with emerging developments and engaging and adapting the most appropriate AI tool for an individual clinician’s work.

Asked to comment on the presentation at the SPD meeting, Sheilagh Maguiness, MD, director of the Division of Pediatric Dermatology at the University of Minnesota, Minneapolis, who, like other doctors, is increasingly testing AI, said she foresees a time when AI scribes fully replace humans for completing tasks during patient interactions.

“The hope is that if the AI scribes get good enough, we can just open our phone, have them translate the interaction, and create the notes for us.”

While she likes the idea of using ChatGPT to help with tasks like letters of recommendation for medications, Dr. Yan’s comments reiterated the importance of “checking and double-checking ChatGPT because it’s not correct all the time.” She particularly welcomed the advice “that we can just go back and ask it again to clarify, and that may improve its answers.”

Dr. Yan’s disclosures included an investment portfolio that includes companies working in the AI space, including Google, Apple, Nvidia, Amazon, Microsoft, and Arm. Dr. Maguiness had no relevant disclosures.

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

Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.

A Folder, a Swaddle, and a Mission

Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.

“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.

The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”

“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.

The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.

Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.

It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
 

The Ripple Effect

The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”

Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.

One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”

But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
 

The Gambler Calls

After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.

“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.

Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.

More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
 

‘They Don’t Teach You That in Nursing School’

The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.

The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.

A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said. 

Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”

Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.

Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said. 
 

On Call 24/7 in the Car, in the Checkout Line ...

The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.

“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”

Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.

Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.

“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
 

Do You Have a Business Idea?

“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.

“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”

In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.

The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.

Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”

A version of this article appeared on Medscape.com.

Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.

A Folder, a Swaddle, and a Mission

Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.

“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.

The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”

“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.

The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.

Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.

It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
 

The Ripple Effect

The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”

Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.

One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”

But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
 

The Gambler Calls

After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.

“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.

Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.

More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
 

‘They Don’t Teach You That in Nursing School’

The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.

The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.

A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said. 

Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”

Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.

Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said. 
 

On Call 24/7 in the Car, in the Checkout Line ...

The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.

“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”

Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.

Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.

“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
 

Do You Have a Business Idea?

“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.

“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”

In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.

The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.

Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”

A version of this article appeared on Medscape.com.

Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.

A Folder, a Swaddle, and a Mission

Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.

“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.

The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”

“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.

The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.

Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.

It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
 

The Ripple Effect

The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”

Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.

One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”

But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
 

The Gambler Calls

After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.

“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.

Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.

More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
 

‘They Don’t Teach You That in Nursing School’

The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.

The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.

A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said. 

Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”

Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.

Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said. 
 

On Call 24/7 in the Car, in the Checkout Line ...

The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.

“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”

Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.

Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.

“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
 

Do You Have a Business Idea?

“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.

“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”

In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.

The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.

Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved denileukin diftitox-cxdl (Lymphir, Citius Pharmaceuticals) for adults with relapsed or refractory stage 1-3 cutaneous T-cell lymphoma after at least one prior systemic therapy.

The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021. 

This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.

This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.” 

Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.

The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus. 

Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.

The company expects to launch the agent within 5 months.

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

The Food and Drug Administration has approved denileukin diftitox-cxdl (Lymphir, Citius Pharmaceuticals) for adults with relapsed or refractory stage 1-3 cutaneous T-cell lymphoma after at least one prior systemic therapy.

The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021. 

This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.

This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.” 

Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.

The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus. 

Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.

The company expects to launch the agent within 5 months.

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

The Food and Drug Administration has approved denileukin diftitox-cxdl (Lymphir, Citius Pharmaceuticals) for adults with relapsed or refractory stage 1-3 cutaneous T-cell lymphoma after at least one prior systemic therapy.

The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021. 

This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.

This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.” 

Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.

The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus. 

Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.

The company expects to launch the agent within 5 months.

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

Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.

In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.

The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.

The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.

In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).

In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.

Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.

Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.

In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.

The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.

They called for more measures to mitigate the excess burden of PMADs.

This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.

Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.

In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.

The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.

The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.

In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).

In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.

Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.

Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.

In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.

The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.

They called for more measures to mitigate the excess burden of PMADs.

This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.

Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.

In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.

The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.

The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.

In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).

In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.

Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.

Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.

In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.

The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.

They called for more measures to mitigate the excess burden of PMADs.

This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.