Alicia Ault

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A systematic review of 26 randomized controlled trials (RCTs) finds that, among glucagon-like peptide 1 (GLP-1) receptor agonists and co-agonists on the market or still being investigated, the experimental drug retatrutide (Eli Lilly) produces the greatest weight loss.

The review, conducted by researchers at McGill University, Montreal, Quebec, Canada, examined three commercially available medications in the class and nine that have not yet received regulatory approval.

In healthy adults with overweight or obesity who did not have diabetes, the highest mean reductions in relative and absolute body weight were achieved with once-weekly triple glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 and glucagon receptor agonist retatrutide, followed by the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly) and lastly by the GLP-1 agonist semaglutide (Novo Nordisk), according to the authors.

The use of all the GLP-1s or co-agonist medications “led to decreased body mass index (BMI), waist circumference, SBP (systolic blood pressure), and DBP (diastolic blood pressure),” wrote the authors in Annals of Internal Medicine. All the medications had a similar safety profile.

The researchers did not find any head-to-head studies, so instead examined the results from 26 RCTs that enrolled more than 15,000 patients. Only trials with a treatment duration of at least 16 weeks were included, to ensure that patients had at least a month of a fixed dose.

Not surprisingly, the review found that, except for semaglutide, trials with “dual and triple agonists generally reported numerically greater mean weight losses than single GLP-1 agonists.”

They caution, however, against drawing conclusions about comparative efficacy, as the populations, control groups, and contexts of the various studies might not be directly comparable. All the trial enrollees also received lifestyle modification along with drug therapy or placebo, but the interventions and protocols varied across the studies.

The authors found that individuals on retatrutide (12-mg once-weekly injection) lost 22% of body weight from baseline after 48 weeks. Tirzepatide (15 mg once-weekly injection) recipients lost almost 18% of body weight after 72 weeks, while those on semaglutide (2.4-mg once-weekly injection) lost about 14% after 68 weeks. Both tirzepatide and semaglutide are commercially available.

Patients taking liraglutide (3-mg once-daily injection), also on the market, lost up to 6% of body weight after 26 weeks.

The authors also examined studies of investigational agents and reported that the greatest loss, aside from retatrutide, was with the dual glucagon/GLP-1 agonists survodutide (Boehringer Ingelheim; 6%-15%) and mazdutide (Innovent Biologics; 7%-11%).

Orforglipron (Eli Lilly), a once-daily pill, produced weight loss of 9%-15%, depending on the dose.

The study found that four investigational drugs did not produce as much weight loss: Beinaglutide (0.2-mg injection three times daily, 6%), efpeglenatide (4- to 8-mg injection once weekly, about 7%), exenatide (10-mcg injection twice daily, 5-kg change in weight), and noiiglutide (once-daily injection, 9%).

The most common adverse events for all GLP-1s were gastrointestinal (GI), such as nausea, diarrhea, constipation, and vomiting. Across all agents, 60%-80% of patients taking the medications experienced a GI adverse event, although most were transient, according to the authors. A total of 6%-26% of patients discontinued treatment as a result of a side effect.

The authors said that no serious GI disorders, such as bowel obstruction or gastroparesis, were reported in any of the 26 trials.

The review also shows that it is likely that GLP-1s would have to be used chronically to have the greatest effect, said the authors. They noted that they found that trials “with longer treatment durations demonstrate similar weight loss results to those with shorter follow-up, reinforcing the idea that continuous treatment may be required.”

One coauthor reported receiving payments or honoraria from Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, and Novo Nordisk. The study was carried out independently without any grant or other funding.

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

A systematic review of 26 randomized controlled trials (RCTs) finds that, among glucagon-like peptide 1 (GLP-1) receptor agonists and co-agonists on the market or still being investigated, the experimental drug retatrutide (Eli Lilly) produces the greatest weight loss.

The review, conducted by researchers at McGill University, Montreal, Quebec, Canada, examined three commercially available medications in the class and nine that have not yet received regulatory approval.

In healthy adults with overweight or obesity who did not have diabetes, the highest mean reductions in relative and absolute body weight were achieved with once-weekly triple glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 and glucagon receptor agonist retatrutide, followed by the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly) and lastly by the GLP-1 agonist semaglutide (Novo Nordisk), according to the authors.

The use of all the GLP-1s or co-agonist medications “led to decreased body mass index (BMI), waist circumference, SBP (systolic blood pressure), and DBP (diastolic blood pressure),” wrote the authors in Annals of Internal Medicine. All the medications had a similar safety profile.

The researchers did not find any head-to-head studies, so instead examined the results from 26 RCTs that enrolled more than 15,000 patients. Only trials with a treatment duration of at least 16 weeks were included, to ensure that patients had at least a month of a fixed dose.

Not surprisingly, the review found that, except for semaglutide, trials with “dual and triple agonists generally reported numerically greater mean weight losses than single GLP-1 agonists.”

They caution, however, against drawing conclusions about comparative efficacy, as the populations, control groups, and contexts of the various studies might not be directly comparable. All the trial enrollees also received lifestyle modification along with drug therapy or placebo, but the interventions and protocols varied across the studies.

The authors found that individuals on retatrutide (12-mg once-weekly injection) lost 22% of body weight from baseline after 48 weeks. Tirzepatide (15 mg once-weekly injection) recipients lost almost 18% of body weight after 72 weeks, while those on semaglutide (2.4-mg once-weekly injection) lost about 14% after 68 weeks. Both tirzepatide and semaglutide are commercially available.

Patients taking liraglutide (3-mg once-daily injection), also on the market, lost up to 6% of body weight after 26 weeks.

The authors also examined studies of investigational agents and reported that the greatest loss, aside from retatrutide, was with the dual glucagon/GLP-1 agonists survodutide (Boehringer Ingelheim; 6%-15%) and mazdutide (Innovent Biologics; 7%-11%).

Orforglipron (Eli Lilly), a once-daily pill, produced weight loss of 9%-15%, depending on the dose.

The study found that four investigational drugs did not produce as much weight loss: Beinaglutide (0.2-mg injection three times daily, 6%), efpeglenatide (4- to 8-mg injection once weekly, about 7%), exenatide (10-mcg injection twice daily, 5-kg change in weight), and noiiglutide (once-daily injection, 9%).

The most common adverse events for all GLP-1s were gastrointestinal (GI), such as nausea, diarrhea, constipation, and vomiting. Across all agents, 60%-80% of patients taking the medications experienced a GI adverse event, although most were transient, according to the authors. A total of 6%-26% of patients discontinued treatment as a result of a side effect.

The authors said that no serious GI disorders, such as bowel obstruction or gastroparesis, were reported in any of the 26 trials.

The review also shows that it is likely that GLP-1s would have to be used chronically to have the greatest effect, said the authors. They noted that they found that trials “with longer treatment durations demonstrate similar weight loss results to those with shorter follow-up, reinforcing the idea that continuous treatment may be required.”

One coauthor reported receiving payments or honoraria from Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, and Novo Nordisk. The study was carried out independently without any grant or other funding.

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

A systematic review of 26 randomized controlled trials (RCTs) finds that, among glucagon-like peptide 1 (GLP-1) receptor agonists and co-agonists on the market or still being investigated, the experimental drug retatrutide (Eli Lilly) produces the greatest weight loss.

The review, conducted by researchers at McGill University, Montreal, Quebec, Canada, examined three commercially available medications in the class and nine that have not yet received regulatory approval.

In healthy adults with overweight or obesity who did not have diabetes, the highest mean reductions in relative and absolute body weight were achieved with once-weekly triple glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 and glucagon receptor agonist retatrutide, followed by the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly) and lastly by the GLP-1 agonist semaglutide (Novo Nordisk), according to the authors.

The use of all the GLP-1s or co-agonist medications “led to decreased body mass index (BMI), waist circumference, SBP (systolic blood pressure), and DBP (diastolic blood pressure),” wrote the authors in Annals of Internal Medicine. All the medications had a similar safety profile.

The researchers did not find any head-to-head studies, so instead examined the results from 26 RCTs that enrolled more than 15,000 patients. Only trials with a treatment duration of at least 16 weeks were included, to ensure that patients had at least a month of a fixed dose.

Not surprisingly, the review found that, except for semaglutide, trials with “dual and triple agonists generally reported numerically greater mean weight losses than single GLP-1 agonists.”

They caution, however, against drawing conclusions about comparative efficacy, as the populations, control groups, and contexts of the various studies might not be directly comparable. All the trial enrollees also received lifestyle modification along with drug therapy or placebo, but the interventions and protocols varied across the studies.

The authors found that individuals on retatrutide (12-mg once-weekly injection) lost 22% of body weight from baseline after 48 weeks. Tirzepatide (15 mg once-weekly injection) recipients lost almost 18% of body weight after 72 weeks, while those on semaglutide (2.4-mg once-weekly injection) lost about 14% after 68 weeks. Both tirzepatide and semaglutide are commercially available.

Patients taking liraglutide (3-mg once-daily injection), also on the market, lost up to 6% of body weight after 26 weeks.

The authors also examined studies of investigational agents and reported that the greatest loss, aside from retatrutide, was with the dual glucagon/GLP-1 agonists survodutide (Boehringer Ingelheim; 6%-15%) and mazdutide (Innovent Biologics; 7%-11%).

Orforglipron (Eli Lilly), a once-daily pill, produced weight loss of 9%-15%, depending on the dose.

The study found that four investigational drugs did not produce as much weight loss: Beinaglutide (0.2-mg injection three times daily, 6%), efpeglenatide (4- to 8-mg injection once weekly, about 7%), exenatide (10-mcg injection twice daily, 5-kg change in weight), and noiiglutide (once-daily injection, 9%).

The most common adverse events for all GLP-1s were gastrointestinal (GI), such as nausea, diarrhea, constipation, and vomiting. Across all agents, 60%-80% of patients taking the medications experienced a GI adverse event, although most were transient, according to the authors. A total of 6%-26% of patients discontinued treatment as a result of a side effect.

The authors said that no serious GI disorders, such as bowel obstruction or gastroparesis, were reported in any of the 26 trials.

The review also shows that it is likely that GLP-1s would have to be used chronically to have the greatest effect, said the authors. They noted that they found that trials “with longer treatment durations demonstrate similar weight loss results to those with shorter follow-up, reinforcing the idea that continuous treatment may be required.”

One coauthor reported receiving payments or honoraria from Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, and Novo Nordisk. The study was carried out independently without any grant or other funding.

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

Do patients with early-stage non–small cell lung cancer (NSCLC) benefit from continuing immunotherapy beyond surgery?

The short answer: Oncologists don’t know for sure.

Since October 2023, the US Food and Drug Administration (FDA) has approved three checkpoint inhibitors — pembrolizumab (Keytruda), durvalumab (Imfinzi), and most recently nivolumab (Opdivo) — alongside platinum-containing chemotherapy before surgery and as monotherapy after surgery to treat resectable NSCLC.

But the trials leading to each approval had a major design flaw. The studies failed to distinguish when patients with resectable NSCLC benefited from immunotherapy — before surgery, after surgery, or at both points.

That missing piece has left oncologists without definitive guidance on how best to treat their patients with resectable disease. 

Jamie E. Chaft, MD, a thoracic medical oncologist and attending physician at Memorial Sloan Kettering Cancer Center in New York City, was “surprised” that the FDA had approved the three immunotherapy combination regimens without this clarity. Clinicians are now left with studies that can’t evaluate the contribution of the neoadjuvant and adjuvant phases, she said.

But that may soon change.

In July, an FDA advisory committee met to discuss the pending approval of durvalumab.

During this July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) called out issues with AstraZeneca’s design of the trial, expressing concern that AstraZeneca had not followed the agency’s advice to compare patient outcomes with durvalumab in the neoadjuvant and adjuvant phases.

The ODAC panel ultimately voted unanimously in favor of requiring drug companies to demonstrate that patients need immunotherapy both before and after surgery in resectable NSCLC. Several panelists said this requirement should extend beyond NSCLC to other tumor types.

“We need to understand who needs what therapy when,” Daniel Spratt, MD, chairman of the FDA’s ODAC, told Medscape Medical News.

But even if the FDA does require drug companies to assess the benefit of immunotherapy pre- and post-surgery, will oncologists get the answers they need for their patients with resectable NSCLC? Or will the new costly trial design requirements dead-end progress in this space?

 

Treating Patients Without Clear Evidence

Despite the ODAC’s strong urging to require — not simply request — that drug companies show patients with resectable NSCLC benefit from immunotherapy in both the neoadjuvant and adjuvant settings, the advisory panel did not think durvalumab’s approval should be delayed until the neoadjuvant vs adjuvant question is answered.

A month later, in August, the FDA approved durvalumab for this indication.

Pembrolizumab (Keytruda, Merck) had already been approved 10 months earlier in the neoadjuvant and adjuvant settings in this setting. And most recently, in October, the FDA added nivolumab (Opdivo, Bristol Myers Squibb) to these approvals.

No trial, however, identified when patients benefited from the drug.

Without this understanding, patients may be taking immunotherapy unnecessarily, at significant expense and toxicity risk.

“Toxicities from immunotherapy can occur at any time after initiation,” said Joshua Eric Reuss, MD, a thoracic medical oncologist at Georgetown University’s Lombardi Comprehensive Cancer Center in Washington, DC. And these “risks definitely continue into the adjuvant period.”

So far, the available evidence does suggest that the neoadjuvant phase of immunotherapy confers the greatest benefit, while adjuvant immunotherapy — which can last a year or longer — may expose patients to more costs and toxicities, with no clear benefit.

A 2024 meta-analysis, which included four trials of neoadjuvant-adjuvant immunotherapy and one trial of neoadjuvant immunotherapy in resectable NSCLC, suggested that the addition of adjuvant immunotherapy did not improve event-free survival (hazard ratio [HR], 0.90; P = .59) or overall survival (HR, 1.18; P = .51) compared with neoadjuvant immunotherapy alone.

According to Spratt, “It’s very clear that the neoadjuvant phase is the more important of the two phases.” Given that, “we’re probably overtreating some patients,” said Spratt, also chairman of Radiation Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland.

Chaft agreed that “there’s very little data that we need the postoperative phase, and what data we do have is post hoc and limited.”

This evidence gap “has created considerable dilemmas” for oncologists and patients who are faced with “the challenge of deciding which therapeutic options or approach are best suited for each individual,” experts wrote in recent consensus recommendations from the International Association for the Study of Lung Cancer.

Clinicians may ultimately be left to make decisions about prescribing postoperative immunotherapy based on their experience and comfort level.

When Chaft’s patients have a pathologic complete response with immunotherapy and chemotherapy in the neoadjuvant phase, “I’m comfortable stopping because the data would suggest they’re almost certainly cured,” she said.

For patients who have viable disease after neoadjuvant therapy, continuing an immunotherapy postoperatively when it didn’t work preoperatively “is not going to make a difference,” Chaft explained. In these cases, Chaft would look to enroll them in a clinical trial evaluating a different regimen because of the risk for relapse.

With patients who did well preoperatively but still have tumor left at the time of surgery, she would discuss continuing the immunotherapy or participating in a trial, she said.

All the FDA-approved regimens are covered by insurance, said Chaft. Clinicians are most comfortable with pembrolizumab because it is the most widely used immunotherapy in advanced NSCLC, she said. But, she added, “there’s really no strong differentiating data between any of the studies; all the results look very comparable.”

When assessing whether a patient may benefit from immunotherapy after surgery, Reuss looks at a range of factors, including disease stage, histology, gene mutations, and pathologic response. Reuss also weighs patient preferences. A patient coming from another country might only want a neoadjuvant regimen, for instance, he said.

That “isn’t exactly the kind of the level one evidence that one likes to see when making treatment decisions,” said Reuss. “Without prospective data, all we can do is cross-trial comparisons and assessment of subgroups.”

If a new regimen comes along that improves outcomes or decision-making, “I think we would pivot to that in a heartbeat,” he said.

 

But Will FDA Follow ODAC’s Recommendation?

“ODAC has made their point clear,” said Chaft. “Our patients deserve to know that whatever added risk and cost they’re incurring is merited by a clinical outcome.”

Despite the ODAC’s recommendation, it’s not guaranteed that the FDA will follow it.

An FDA spokesperson did not confirm the agency’s decision on the matter but noted that the FDA is “incorporating the panel’s advice.”

Spratt thinks that, going forward, companies will be held to “a higher bar,” but it’s unclear what that bar will look like.

“Whether this is a mandate or a strong recommendation, I think industry is definitely paying attention,” Spratt said. Companies that do not follow the guidance may risk not having their drug approved, “unless it’s just an absolute huge slam dunk of a major benefit to patients.”

In fact, according to Chaft, drug makers seeking approvals of novel entities in this space “won’t have a choice” but to follow any new trial design requirements from the FDA.

Still, getting answers may be a challenge.

Drug companies with immunotherapies already on the market are unlikely to invest the resources to conduct trials comparing the neoadjuvant and adjuvant settings, said Chaft. “It will take too long and cost too much,” she said.

And it remains unclear whether drug companies will decide to stop pursuing novel agents if approvals will ultimately require more expensive and time-consuming trials.

According to Chaft, oncologists have been discussing protocols that could help fill the knowledge gaps. Such trials will be conducted by the National Cancer Institute’s Cooperative Groups, she noted. But it’s early days.

For the time being, with comparative data from phase 3 trials years away, oncologists will have to work with the limited evidence and individual patients in front of them.

Chaft disclosed ties with AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Genentech/Roche, Guardant Health, Janssen Pharmaceuticals, Eli Lilly, and Merck. Reuss disclosed ties with AstraZeneca, Arcus, AbbVie, Bristol Myers Squibb, CatalYm, Daiichi Sankyo, and Eli Lilly, and that Georgetown has received research funding from Genentech/Roche, Verastem, Nuvalent, LUNGevity Foundation, Exelixis, Arcus, and Revolution Medicines. Spratt disclosed ties with Astellas, AstraZeneca, Bayer, Boston Scientific, Janssen Pharmaceuticals, Novartis, and Pfizer.

A version of this article appeared on Medscape.com.

Do patients with early-stage non–small cell lung cancer (NSCLC) benefit from continuing immunotherapy beyond surgery?

The short answer: Oncologists don’t know for sure.

Since October 2023, the US Food and Drug Administration (FDA) has approved three checkpoint inhibitors — pembrolizumab (Keytruda), durvalumab (Imfinzi), and most recently nivolumab (Opdivo) — alongside platinum-containing chemotherapy before surgery and as monotherapy after surgery to treat resectable NSCLC.

But the trials leading to each approval had a major design flaw. The studies failed to distinguish when patients with resectable NSCLC benefited from immunotherapy — before surgery, after surgery, or at both points.

That missing piece has left oncologists without definitive guidance on how best to treat their patients with resectable disease. 

Jamie E. Chaft, MD, a thoracic medical oncologist and attending physician at Memorial Sloan Kettering Cancer Center in New York City, was “surprised” that the FDA had approved the three immunotherapy combination regimens without this clarity. Clinicians are now left with studies that can’t evaluate the contribution of the neoadjuvant and adjuvant phases, she said.

But that may soon change.

In July, an FDA advisory committee met to discuss the pending approval of durvalumab.

During this July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) called out issues with AstraZeneca’s design of the trial, expressing concern that AstraZeneca had not followed the agency’s advice to compare patient outcomes with durvalumab in the neoadjuvant and adjuvant phases.

The ODAC panel ultimately voted unanimously in favor of requiring drug companies to demonstrate that patients need immunotherapy both before and after surgery in resectable NSCLC. Several panelists said this requirement should extend beyond NSCLC to other tumor types.

“We need to understand who needs what therapy when,” Daniel Spratt, MD, chairman of the FDA’s ODAC, told Medscape Medical News.

But even if the FDA does require drug companies to assess the benefit of immunotherapy pre- and post-surgery, will oncologists get the answers they need for their patients with resectable NSCLC? Or will the new costly trial design requirements dead-end progress in this space?

 

Treating Patients Without Clear Evidence

Despite the ODAC’s strong urging to require — not simply request — that drug companies show patients with resectable NSCLC benefit from immunotherapy in both the neoadjuvant and adjuvant settings, the advisory panel did not think durvalumab’s approval should be delayed until the neoadjuvant vs adjuvant question is answered.

A month later, in August, the FDA approved durvalumab for this indication.

Pembrolizumab (Keytruda, Merck) had already been approved 10 months earlier in the neoadjuvant and adjuvant settings in this setting. And most recently, in October, the FDA added nivolumab (Opdivo, Bristol Myers Squibb) to these approvals.

No trial, however, identified when patients benefited from the drug.

Without this understanding, patients may be taking immunotherapy unnecessarily, at significant expense and toxicity risk.

“Toxicities from immunotherapy can occur at any time after initiation,” said Joshua Eric Reuss, MD, a thoracic medical oncologist at Georgetown University’s Lombardi Comprehensive Cancer Center in Washington, DC. And these “risks definitely continue into the adjuvant period.”

So far, the available evidence does suggest that the neoadjuvant phase of immunotherapy confers the greatest benefit, while adjuvant immunotherapy — which can last a year or longer — may expose patients to more costs and toxicities, with no clear benefit.

A 2024 meta-analysis, which included four trials of neoadjuvant-adjuvant immunotherapy and one trial of neoadjuvant immunotherapy in resectable NSCLC, suggested that the addition of adjuvant immunotherapy did not improve event-free survival (hazard ratio [HR], 0.90; P = .59) or overall survival (HR, 1.18; P = .51) compared with neoadjuvant immunotherapy alone.

According to Spratt, “It’s very clear that the neoadjuvant phase is the more important of the two phases.” Given that, “we’re probably overtreating some patients,” said Spratt, also chairman of Radiation Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland.

Chaft agreed that “there’s very little data that we need the postoperative phase, and what data we do have is post hoc and limited.”

This evidence gap “has created considerable dilemmas” for oncologists and patients who are faced with “the challenge of deciding which therapeutic options or approach are best suited for each individual,” experts wrote in recent consensus recommendations from the International Association for the Study of Lung Cancer.

Clinicians may ultimately be left to make decisions about prescribing postoperative immunotherapy based on their experience and comfort level.

When Chaft’s patients have a pathologic complete response with immunotherapy and chemotherapy in the neoadjuvant phase, “I’m comfortable stopping because the data would suggest they’re almost certainly cured,” she said.

For patients who have viable disease after neoadjuvant therapy, continuing an immunotherapy postoperatively when it didn’t work preoperatively “is not going to make a difference,” Chaft explained. In these cases, Chaft would look to enroll them in a clinical trial evaluating a different regimen because of the risk for relapse.

With patients who did well preoperatively but still have tumor left at the time of surgery, she would discuss continuing the immunotherapy or participating in a trial, she said.

All the FDA-approved regimens are covered by insurance, said Chaft. Clinicians are most comfortable with pembrolizumab because it is the most widely used immunotherapy in advanced NSCLC, she said. But, she added, “there’s really no strong differentiating data between any of the studies; all the results look very comparable.”

When assessing whether a patient may benefit from immunotherapy after surgery, Reuss looks at a range of factors, including disease stage, histology, gene mutations, and pathologic response. Reuss also weighs patient preferences. A patient coming from another country might only want a neoadjuvant regimen, for instance, he said.

That “isn’t exactly the kind of the level one evidence that one likes to see when making treatment decisions,” said Reuss. “Without prospective data, all we can do is cross-trial comparisons and assessment of subgroups.”

If a new regimen comes along that improves outcomes or decision-making, “I think we would pivot to that in a heartbeat,” he said.

 

But Will FDA Follow ODAC’s Recommendation?

“ODAC has made their point clear,” said Chaft. “Our patients deserve to know that whatever added risk and cost they’re incurring is merited by a clinical outcome.”

Despite the ODAC’s recommendation, it’s not guaranteed that the FDA will follow it.

An FDA spokesperson did not confirm the agency’s decision on the matter but noted that the FDA is “incorporating the panel’s advice.”

Spratt thinks that, going forward, companies will be held to “a higher bar,” but it’s unclear what that bar will look like.

“Whether this is a mandate or a strong recommendation, I think industry is definitely paying attention,” Spratt said. Companies that do not follow the guidance may risk not having their drug approved, “unless it’s just an absolute huge slam dunk of a major benefit to patients.”

In fact, according to Chaft, drug makers seeking approvals of novel entities in this space “won’t have a choice” but to follow any new trial design requirements from the FDA.

Still, getting answers may be a challenge.

Drug companies with immunotherapies already on the market are unlikely to invest the resources to conduct trials comparing the neoadjuvant and adjuvant settings, said Chaft. “It will take too long and cost too much,” she said.

And it remains unclear whether drug companies will decide to stop pursuing novel agents if approvals will ultimately require more expensive and time-consuming trials.

According to Chaft, oncologists have been discussing protocols that could help fill the knowledge gaps. Such trials will be conducted by the National Cancer Institute’s Cooperative Groups, she noted. But it’s early days.

For the time being, with comparative data from phase 3 trials years away, oncologists will have to work with the limited evidence and individual patients in front of them.

Chaft disclosed ties with AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Genentech/Roche, Guardant Health, Janssen Pharmaceuticals, Eli Lilly, and Merck. Reuss disclosed ties with AstraZeneca, Arcus, AbbVie, Bristol Myers Squibb, CatalYm, Daiichi Sankyo, and Eli Lilly, and that Georgetown has received research funding from Genentech/Roche, Verastem, Nuvalent, LUNGevity Foundation, Exelixis, Arcus, and Revolution Medicines. Spratt disclosed ties with Astellas, AstraZeneca, Bayer, Boston Scientific, Janssen Pharmaceuticals, Novartis, and Pfizer.

A version of this article appeared on Medscape.com.

Do patients with early-stage non–small cell lung cancer (NSCLC) benefit from continuing immunotherapy beyond surgery?

The short answer: Oncologists don’t know for sure.

Since October 2023, the US Food and Drug Administration (FDA) has approved three checkpoint inhibitors — pembrolizumab (Keytruda), durvalumab (Imfinzi), and most recently nivolumab (Opdivo) — alongside platinum-containing chemotherapy before surgery and as monotherapy after surgery to treat resectable NSCLC.

But the trials leading to each approval had a major design flaw. The studies failed to distinguish when patients with resectable NSCLC benefited from immunotherapy — before surgery, after surgery, or at both points.

That missing piece has left oncologists without definitive guidance on how best to treat their patients with resectable disease. 

Jamie E. Chaft, MD, a thoracic medical oncologist and attending physician at Memorial Sloan Kettering Cancer Center in New York City, was “surprised” that the FDA had approved the three immunotherapy combination regimens without this clarity. Clinicians are now left with studies that can’t evaluate the contribution of the neoadjuvant and adjuvant phases, she said.

But that may soon change.

In July, an FDA advisory committee met to discuss the pending approval of durvalumab.

During this July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) called out issues with AstraZeneca’s design of the trial, expressing concern that AstraZeneca had not followed the agency’s advice to compare patient outcomes with durvalumab in the neoadjuvant and adjuvant phases.

The ODAC panel ultimately voted unanimously in favor of requiring drug companies to demonstrate that patients need immunotherapy both before and after surgery in resectable NSCLC. Several panelists said this requirement should extend beyond NSCLC to other tumor types.

“We need to understand who needs what therapy when,” Daniel Spratt, MD, chairman of the FDA’s ODAC, told Medscape Medical News.

But even if the FDA does require drug companies to assess the benefit of immunotherapy pre- and post-surgery, will oncologists get the answers they need for their patients with resectable NSCLC? Or will the new costly trial design requirements dead-end progress in this space?

 

Treating Patients Without Clear Evidence

Despite the ODAC’s strong urging to require — not simply request — that drug companies show patients with resectable NSCLC benefit from immunotherapy in both the neoadjuvant and adjuvant settings, the advisory panel did not think durvalumab’s approval should be delayed until the neoadjuvant vs adjuvant question is answered.

A month later, in August, the FDA approved durvalumab for this indication.

Pembrolizumab (Keytruda, Merck) had already been approved 10 months earlier in the neoadjuvant and adjuvant settings in this setting. And most recently, in October, the FDA added nivolumab (Opdivo, Bristol Myers Squibb) to these approvals.

No trial, however, identified when patients benefited from the drug.

Without this understanding, patients may be taking immunotherapy unnecessarily, at significant expense and toxicity risk.

“Toxicities from immunotherapy can occur at any time after initiation,” said Joshua Eric Reuss, MD, a thoracic medical oncologist at Georgetown University’s Lombardi Comprehensive Cancer Center in Washington, DC. And these “risks definitely continue into the adjuvant period.”

So far, the available evidence does suggest that the neoadjuvant phase of immunotherapy confers the greatest benefit, while adjuvant immunotherapy — which can last a year or longer — may expose patients to more costs and toxicities, with no clear benefit.

A 2024 meta-analysis, which included four trials of neoadjuvant-adjuvant immunotherapy and one trial of neoadjuvant immunotherapy in resectable NSCLC, suggested that the addition of adjuvant immunotherapy did not improve event-free survival (hazard ratio [HR], 0.90; P = .59) or overall survival (HR, 1.18; P = .51) compared with neoadjuvant immunotherapy alone.

According to Spratt, “It’s very clear that the neoadjuvant phase is the more important of the two phases.” Given that, “we’re probably overtreating some patients,” said Spratt, also chairman of Radiation Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland.

Chaft agreed that “there’s very little data that we need the postoperative phase, and what data we do have is post hoc and limited.”

This evidence gap “has created considerable dilemmas” for oncologists and patients who are faced with “the challenge of deciding which therapeutic options or approach are best suited for each individual,” experts wrote in recent consensus recommendations from the International Association for the Study of Lung Cancer.

Clinicians may ultimately be left to make decisions about prescribing postoperative immunotherapy based on their experience and comfort level.

When Chaft’s patients have a pathologic complete response with immunotherapy and chemotherapy in the neoadjuvant phase, “I’m comfortable stopping because the data would suggest they’re almost certainly cured,” she said.

For patients who have viable disease after neoadjuvant therapy, continuing an immunotherapy postoperatively when it didn’t work preoperatively “is not going to make a difference,” Chaft explained. In these cases, Chaft would look to enroll them in a clinical trial evaluating a different regimen because of the risk for relapse.

With patients who did well preoperatively but still have tumor left at the time of surgery, she would discuss continuing the immunotherapy or participating in a trial, she said.

All the FDA-approved regimens are covered by insurance, said Chaft. Clinicians are most comfortable with pembrolizumab because it is the most widely used immunotherapy in advanced NSCLC, she said. But, she added, “there’s really no strong differentiating data between any of the studies; all the results look very comparable.”

When assessing whether a patient may benefit from immunotherapy after surgery, Reuss looks at a range of factors, including disease stage, histology, gene mutations, and pathologic response. Reuss also weighs patient preferences. A patient coming from another country might only want a neoadjuvant regimen, for instance, he said.

That “isn’t exactly the kind of the level one evidence that one likes to see when making treatment decisions,” said Reuss. “Without prospective data, all we can do is cross-trial comparisons and assessment of subgroups.”

If a new regimen comes along that improves outcomes or decision-making, “I think we would pivot to that in a heartbeat,” he said.

 

But Will FDA Follow ODAC’s Recommendation?

“ODAC has made their point clear,” said Chaft. “Our patients deserve to know that whatever added risk and cost they’re incurring is merited by a clinical outcome.”

Despite the ODAC’s recommendation, it’s not guaranteed that the FDA will follow it.

An FDA spokesperson did not confirm the agency’s decision on the matter but noted that the FDA is “incorporating the panel’s advice.”

Spratt thinks that, going forward, companies will be held to “a higher bar,” but it’s unclear what that bar will look like.

“Whether this is a mandate or a strong recommendation, I think industry is definitely paying attention,” Spratt said. Companies that do not follow the guidance may risk not having their drug approved, “unless it’s just an absolute huge slam dunk of a major benefit to patients.”

In fact, according to Chaft, drug makers seeking approvals of novel entities in this space “won’t have a choice” but to follow any new trial design requirements from the FDA.

Still, getting answers may be a challenge.

Drug companies with immunotherapies already on the market are unlikely to invest the resources to conduct trials comparing the neoadjuvant and adjuvant settings, said Chaft. “It will take too long and cost too much,” she said.

And it remains unclear whether drug companies will decide to stop pursuing novel agents if approvals will ultimately require more expensive and time-consuming trials.

According to Chaft, oncologists have been discussing protocols that could help fill the knowledge gaps. Such trials will be conducted by the National Cancer Institute’s Cooperative Groups, she noted. But it’s early days.

For the time being, with comparative data from phase 3 trials years away, oncologists will have to work with the limited evidence and individual patients in front of them.

Chaft disclosed ties with AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Genentech/Roche, Guardant Health, Janssen Pharmaceuticals, Eli Lilly, and Merck. Reuss disclosed ties with AstraZeneca, Arcus, AbbVie, Bristol Myers Squibb, CatalYm, Daiichi Sankyo, and Eli Lilly, and that Georgetown has received research funding from Genentech/Roche, Verastem, Nuvalent, LUNGevity Foundation, Exelixis, Arcus, and Revolution Medicines. Spratt disclosed ties with Astellas, AstraZeneca, Bayer, Boston Scientific, Janssen Pharmaceuticals, Novartis, and Pfizer.

A version of this article appeared on Medscape.com.

More than two thirds of American counties don’t have an endocrinologist, according to a new analysis by GoodRx, a company that provides discount coupons for medications.

A total of 50 million people who live in the 2168 counties without a practicing endocrinologist are at a higher risk for poor health outcomes, according to the analysis. 

The author reported that individuals who live in endocrinology “deserts” are 12% more likely to die from endocrine-related conditions and have higher rates of diabetes, obesity, and stroke than those who live in counties where there are endocrinologists.

GoodRx’s finely detailed maps show that endocrinologists are clustered on the coasts and around major cities. Many counties have just a single endocrinologist and no pediatric endocrinologists.

Endocrinologists are not flocking to areas with a high type 2 diabetes prevalence — such as southern states, many parts of Texas, and counties with high concentrations of Native Americans or Alaskan Natives.

The maps speak volumes about disparities. In Sabine Parish, Louisiana, which shares a border with east Texas, the adult diabetes prevalence is 14%. The age-adjusted diabetes death rate is 52.6 per 100,000, in a population of 16,936 adults. There are no endocrinologists in that parish and one in a bordering parish.

In the entire state of Alaska, there are a total of two adult endocrinologists — one in Anchorage County and one in Fairbanks County — and two pediatric endocrinologists, both in Anchorage.

Buffalo County, South Dakota, which has no endocrinologists and is dominated by the Crow Creek Reservation, has a diabetes prevalence of 16.6% and a diabetes death rate of 143.3 per 100,000.

Connecticut’s Hartford County, however, has 69 adult endocrinologists and 9 pediatric endocrinologists. The adult diabetes prevalence is 0%, and the death rate is 26.3 per 100,000, in a population of 896,854.

To come up with its maps, GoodRx used population estimates from the 2024 Centers for Disease Control and Prevention (CDC) Places dataset and calculated adult diabetes rates and age-adjusted diabetes-related death rates per 100,000 using the 2024 CDC Places and CDC Wonder datasets. Data on the number of practicing endocrinologists came from HealthLink Dimensions, a company that provides databases for marketing purposes.

Robert Lash, MD, chief medical officer for The Endocrine Society, said that the GoodRx data are not especially new. Endocrinology “deserts” have existed for a decade or more, Lash said.

The GoodRx analysis concluded that a lack of endocrinologists in the “desert” counties directly led to higher death rates in those areas. “This is much more an association that it is causation,” countered Lash, noting that the deserts tend to align with healthcare professional shortage areas.

GoodRx also acknowledged the overlap and said that it could mean less access to primary care. In turn, “many patients may not even receive a diagnosis for endocrine-related conditions, let alone the specialized care they need,” wrote the analyst. “Preventable conditions like diabetes spiral into severe complications.”

Lash said seeking out a primary care doctor is one option for those without access to an endocrinologist. Telemedicine has also helped expand access, said Lash, adding that endocrinologists have been among the more frequent users.

Even so, the shortage of endocrinologists is an ongoing problem, he said. Only about 5000-6000 endocrinologists are actively practicing, estimates The Endocrine Society.

Fewer medical school graduates are choosing endocrinology, in part because of the lack of compensation, said Lash.

The society has begun a push to interest more students. Starting in 2024, The Society awarded grants to 10 medical schools to start endocrinology interest groups. The Medical School Engagement Program also sponsors two students for a VIP-type experience at the annual scientific meeting.

The hope is to boost interest in fellowships, which come after 3 years of internal medicine residency. Currently, there are only about 11 applicants for every 10 fellowship spots, said Lash.

It may be a while before the society’s experiment bears fruit. Those entering medical school in 2024 would not be eligible for fellowship until 2031, noted Lash.

“We’re in this for the long haul,” he said. “We know that this problem is not going to get solved overnight.”

A version of this article appeared on Medscape.com.

More than two thirds of American counties don’t have an endocrinologist, according to a new analysis by GoodRx, a company that provides discount coupons for medications.

A total of 50 million people who live in the 2168 counties without a practicing endocrinologist are at a higher risk for poor health outcomes, according to the analysis. 

The author reported that individuals who live in endocrinology “deserts” are 12% more likely to die from endocrine-related conditions and have higher rates of diabetes, obesity, and stroke than those who live in counties where there are endocrinologists.

GoodRx’s finely detailed maps show that endocrinologists are clustered on the coasts and around major cities. Many counties have just a single endocrinologist and no pediatric endocrinologists.

Endocrinologists are not flocking to areas with a high type 2 diabetes prevalence — such as southern states, many parts of Texas, and counties with high concentrations of Native Americans or Alaskan Natives.

The maps speak volumes about disparities. In Sabine Parish, Louisiana, which shares a border with east Texas, the adult diabetes prevalence is 14%. The age-adjusted diabetes death rate is 52.6 per 100,000, in a population of 16,936 adults. There are no endocrinologists in that parish and one in a bordering parish.

In the entire state of Alaska, there are a total of two adult endocrinologists — one in Anchorage County and one in Fairbanks County — and two pediatric endocrinologists, both in Anchorage.

Buffalo County, South Dakota, which has no endocrinologists and is dominated by the Crow Creek Reservation, has a diabetes prevalence of 16.6% and a diabetes death rate of 143.3 per 100,000.

Connecticut’s Hartford County, however, has 69 adult endocrinologists and 9 pediatric endocrinologists. The adult diabetes prevalence is 0%, and the death rate is 26.3 per 100,000, in a population of 896,854.

To come up with its maps, GoodRx used population estimates from the 2024 Centers for Disease Control and Prevention (CDC) Places dataset and calculated adult diabetes rates and age-adjusted diabetes-related death rates per 100,000 using the 2024 CDC Places and CDC Wonder datasets. Data on the number of practicing endocrinologists came from HealthLink Dimensions, a company that provides databases for marketing purposes.

Robert Lash, MD, chief medical officer for The Endocrine Society, said that the GoodRx data are not especially new. Endocrinology “deserts” have existed for a decade or more, Lash said.

The GoodRx analysis concluded that a lack of endocrinologists in the “desert” counties directly led to higher death rates in those areas. “This is much more an association that it is causation,” countered Lash, noting that the deserts tend to align with healthcare professional shortage areas.

GoodRx also acknowledged the overlap and said that it could mean less access to primary care. In turn, “many patients may not even receive a diagnosis for endocrine-related conditions, let alone the specialized care they need,” wrote the analyst. “Preventable conditions like diabetes spiral into severe complications.”

Lash said seeking out a primary care doctor is one option for those without access to an endocrinologist. Telemedicine has also helped expand access, said Lash, adding that endocrinologists have been among the more frequent users.

Even so, the shortage of endocrinologists is an ongoing problem, he said. Only about 5000-6000 endocrinologists are actively practicing, estimates The Endocrine Society.

Fewer medical school graduates are choosing endocrinology, in part because of the lack of compensation, said Lash.

The society has begun a push to interest more students. Starting in 2024, The Society awarded grants to 10 medical schools to start endocrinology interest groups. The Medical School Engagement Program also sponsors two students for a VIP-type experience at the annual scientific meeting.

The hope is to boost interest in fellowships, which come after 3 years of internal medicine residency. Currently, there are only about 11 applicants for every 10 fellowship spots, said Lash.

It may be a while before the society’s experiment bears fruit. Those entering medical school in 2024 would not be eligible for fellowship until 2031, noted Lash.

“We’re in this for the long haul,” he said. “We know that this problem is not going to get solved overnight.”

A version of this article appeared on Medscape.com.

More than two thirds of American counties don’t have an endocrinologist, according to a new analysis by GoodRx, a company that provides discount coupons for medications.

A total of 50 million people who live in the 2168 counties without a practicing endocrinologist are at a higher risk for poor health outcomes, according to the analysis. 

The author reported that individuals who live in endocrinology “deserts” are 12% more likely to die from endocrine-related conditions and have higher rates of diabetes, obesity, and stroke than those who live in counties where there are endocrinologists.

GoodRx’s finely detailed maps show that endocrinologists are clustered on the coasts and around major cities. Many counties have just a single endocrinologist and no pediatric endocrinologists.

Endocrinologists are not flocking to areas with a high type 2 diabetes prevalence — such as southern states, many parts of Texas, and counties with high concentrations of Native Americans or Alaskan Natives.

The maps speak volumes about disparities. In Sabine Parish, Louisiana, which shares a border with east Texas, the adult diabetes prevalence is 14%. The age-adjusted diabetes death rate is 52.6 per 100,000, in a population of 16,936 adults. There are no endocrinologists in that parish and one in a bordering parish.

In the entire state of Alaska, there are a total of two adult endocrinologists — one in Anchorage County and one in Fairbanks County — and two pediatric endocrinologists, both in Anchorage.

Buffalo County, South Dakota, which has no endocrinologists and is dominated by the Crow Creek Reservation, has a diabetes prevalence of 16.6% and a diabetes death rate of 143.3 per 100,000.

Connecticut’s Hartford County, however, has 69 adult endocrinologists and 9 pediatric endocrinologists. The adult diabetes prevalence is 0%, and the death rate is 26.3 per 100,000, in a population of 896,854.

To come up with its maps, GoodRx used population estimates from the 2024 Centers for Disease Control and Prevention (CDC) Places dataset and calculated adult diabetes rates and age-adjusted diabetes-related death rates per 100,000 using the 2024 CDC Places and CDC Wonder datasets. Data on the number of practicing endocrinologists came from HealthLink Dimensions, a company that provides databases for marketing purposes.

Robert Lash, MD, chief medical officer for The Endocrine Society, said that the GoodRx data are not especially new. Endocrinology “deserts” have existed for a decade or more, Lash said.

The GoodRx analysis concluded that a lack of endocrinologists in the “desert” counties directly led to higher death rates in those areas. “This is much more an association that it is causation,” countered Lash, noting that the deserts tend to align with healthcare professional shortage areas.

GoodRx also acknowledged the overlap and said that it could mean less access to primary care. In turn, “many patients may not even receive a diagnosis for endocrine-related conditions, let alone the specialized care they need,” wrote the analyst. “Preventable conditions like diabetes spiral into severe complications.”

Lash said seeking out a primary care doctor is one option for those without access to an endocrinologist. Telemedicine has also helped expand access, said Lash, adding that endocrinologists have been among the more frequent users.

Even so, the shortage of endocrinologists is an ongoing problem, he said. Only about 5000-6000 endocrinologists are actively practicing, estimates The Endocrine Society.

Fewer medical school graduates are choosing endocrinology, in part because of the lack of compensation, said Lash.

The society has begun a push to interest more students. Starting in 2024, The Society awarded grants to 10 medical schools to start endocrinology interest groups. The Medical School Engagement Program also sponsors two students for a VIP-type experience at the annual scientific meeting.

The hope is to boost interest in fellowships, which come after 3 years of internal medicine residency. Currently, there are only about 11 applicants for every 10 fellowship spots, said Lash.

It may be a while before the society’s experiment bears fruit. Those entering medical school in 2024 would not be eligible for fellowship until 2031, noted Lash.

“We’re in this for the long haul,” he said. “We know that this problem is not going to get solved overnight.”

A version of this article appeared on Medscape.com.

For almost 2 decades, antidepressants have carried boxed warnings linking the medications to an increased risk for suicidal thoughts and behaviors in young people. Paradoxically, and for almost as long, evidence suggests these warnings may have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

With mounting evidence of these negative unintended consequences, some clinicians and researchers are urging the Food and Drug Administration (FDA) to consider revising — or even eliminating — boxed warnings on these medications.

The latest report challenging the utility of the 2005 warnings was particularly sobering. Published in October in Health Affairs, the systematic review of studies from 2003 to 2022 showed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and an abrupt increase in psychotropic drug poisonings and suicides — all after the warnings were added.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, Massachusetts and colleagues wrote. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

While good prospective data on the risks and benefits of antidepressants in youth were limited when the boxed warnings were instituted, there is more information now, said Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine in Ohio. Strawn, whose research on the topic has been cited frequently over the years, said the new evidence suggests it is time for the FDA to reevaluate the warnings.

“I don’t think that they’ve been useful. They’ve actually been harmful,” Strawn told this news organization. “These boxed warnings have decreased physicians’ and other clinicians’ comfort and tendency to prescribe.”

 

Decline in Diagnoses

The FDA issued its first warning about the potential for suicidal thoughts and behavior in children in 2003. After an advisory panel weighed the evidence, the agency added a boxed warning in 2005 to all antidepressants for children younger than 18 years. The warning was expanded in 2007 to include young adults through age 24.

Data suggesting that the warnings have had unintended effects can be found going back to just after they were issued. For instance, in 2009, after rising for years, the rate of new pediatric depression diagnoses fell precipitously after the warning was added, with primary care physicians diagnosing 44% fewer cases.

In 2014, citing evidence of fewer diagnoses and rising psychotropic drug poisonings, Weill Cornell Medicine Professor Richard A. Friedman, MD, called on the FDA in a perspective to remove the boxed warnings.

Strawn and colleagues reported in an often-cited 2014 systematic review and meta-analysis that, in nine trials involving 1673 patients and six medications, antidepressants were superior to placebo, with no increased risk for suicidal thoughts or behavior.

He has also studied adverse effects of the medications, reporting in Pharmacotherapy that suicidality risk might be more likely with some medications, such as paroxetine and venlafaxine, and that it could be influenced by baseline suicidality, among many other factors. A Swedish register study found that risk was highest the month before starting a medication, Strawn and colleagues wrote.

Dara Sakolsky, MD, PhD, associate professor of psychiatry and associate medical director, Services for Teens at Risk at the University of Pittsburgh School of Medicine, Pennsylvania, told this news organization that, because of “these negative unintended consequences,” the FDA should lower the temperature by putting the warnings in labeling.

“It makes sense based on the data that we have at hand now,” said Sakolsky.

 

The Dangers of Untreated Depression

Even with this new information, lingering concerns about earlier studies that pointed to increased suicidality risk may discourage prescribing by primary care physicians and pediatricians, and that worries researchers and psychiatrists.

“My concern is that the risk for suicide and suicidal behavior may be higher in untreated depression than the risk of suicidal thoughts or behaviors from antidepressants,” Jeffrey Bridge, PhD, director of the Center for Suicide Prevention and Research at Nationwide Children’s Hospital, Columbus, Ohio, told this news organization.

Bridge is the lead author of a much-cited 2007 meta-analysis in JAMA that showed that the benefits of antidepressants in children and adolescents appeared to be greater than the risks for suicidality. “The concern about antidepressants must be considered in the context of possible benefit,” wrote Bridge, who also is professor of pediatrics, psychiatry, and behavioral health at Ohio State University College of Medicine, Columbus.

Depression and suicide are a scourge for those younger than 25 years. A 2021 literature review noted that the prevalence of depression — which has been increasing for all Americans — has risen more among adolescents than adults. Depression is “strongly associated with suicide,” the authors wrote.

In 2021, the National Institute of Mental Health reported suicide was the second leading cause of death among 10- to 14-year-olds and the third leading cause of death among those aged 15-24 years.

Suicide kills more kids aged between 10 and 24 years than cancer and all other illnesses combined, John Campo, MD, director of child and adolescent psychiatry at Johns Hopkins University School of Medicine and vice president of psychiatric services at Kennedy Krieger Institute, told this news organization.

Meanwhile, he added, the medications work and clinicians balance risk and benefit in prescribing.

The landmark 2007 Treatment for Adolescents with Depression Study showed that fluoxetine, especially in combination with cognitive-behavioral therapy (CBT), was significantly better than placebo. Since that time, legions of trials have shown the drugs’ effectiveness.

The most effective treatment for teen depression is a combination of CBT and a selective serotonin reuptake inhibitor, said Sakolsky.

“We know that the evidence for that is pretty good,” she said. “On the flip side, we know the risk of having an adverse outcome is pretty low.”

Sakolsky tells patients and families that perhaps 1 in 146 will have a suicidal thought or behavior. “That’s pretty rare when we know how effective these medicines are.” 

Strawn said he always notes that no suicides took place in the trials that led to the warning and stresses that he closely monitors patients. “While the more recent prospective data are reassuring,” the suicidality risk “is something that we still talk about,” he said. He also discusses how some antidepressants seem to increase risk more than others.

For Campo, the discussion is based on his reading of the evidence, not the presence of the FDA warning.

“Based on what we know, I still think it’s fair to proceed with the idea that there is a small, but real risk,” he said. However, “at the same time, the medications might be exceptionally helpful for some kids.”

 

‘What Do We Do Now?’

When the FDA issued its warning in 2005, the agency said it identified the risk for suicidality in a combined analysis of short-term placebo-controlled trials of nine antidepressants. It ultimately included 24 trials involving more than 4400 patients. The risk was highest in the first few months. The average risk for those taking antidepressants was 4%, twice the placebo risk of 2%. There were no suicides in these trials, however.

The trials relied on spontaneous reports of adverse events, not predetermined measures, Campo said. Even so, that 2% difference is “nothing to sneeze at,” he noted.

Bridge’s meta-analysis showed a smaller difference — closer to 0.7%. “But it was still statistically significant,” Campo said. “I have trouble ignoring that.”

The unintended consequences of the warning can’t be studied in a randomized controlled trial. Studies have shown an association but not a direct cause-and-effect relationship between the warning and a decline in treatment and rise in suicides.

But the potential for suicidal thoughts and behavior with antidepressants has been studied prospectively. Some older studies found a significant risk, while more recent trials have not.

While the Health Affairs analysis “certainly makes a strong case,” it is observational data, Campo said.

“The question is, what do we do now in retrospect? Do you say, ‘Never mind. We don’t need the black box warning anymore?’ ” he said. “That would require a pretty careful look.”

The Health Affairs paper “makes me think that there are other areas of research that that need to be completed and done and updated, and then there should be an assessment, a reevaluation from the FDA,” said Bridge. A new meta-analysis “would be very informative,” he said.

 

What’s Next?

When asked about the Health Affairs paper and whether the agency would review the warnings, an FDA spokesperson told this news organization that the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

Sakolsky said the data clearly point to the damage that the warning has done over the past 2 decades, but that things might be improving. Studies conducted more recently might not have captured some changes in practice.

For instance, she noted, in 2022, the US Preventive Services Task Force recommended screening for major depressive disorder in adolescents aged 12-18 years. In turn, she has seen more patients in her office who were referred by pediatricians who had conducted the screening, said Sakolsky.

Strawn said the time for pontificating is long past due. “We’re withholding medications and other treatments that could potentially be effective for disorders that, in and of themselves, are associated with a significant increase in the risk of suicide.” 

After the FDA instituted the warning, “we were all very nervous,” about the potential fallout, said Campo, adding that a part of him wishes that the warnings had been “more mundane and less dramatic.”

Despite the unintended consequences, “it’s going to be hard to put the genie back in the bottle,” he said.

Campo and Sakolsky reported no relevant financial relationships. Strawn disclosed that his institution has received research funding from the National Institute of Child Health and Human Development, the Patient-Centered Outcomes Research Institute (PCORI), and AbbVie. Bridge reported that he received grant support from the National Institute of Mental Health, Centers for Disease Control and Prevention, and PCORI; is a scientific adviser to Clarigent Health; and is on the Scientific Council of the American Foundation for Suicide Prevention.

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

For almost 2 decades, antidepressants have carried boxed warnings linking the medications to an increased risk for suicidal thoughts and behaviors in young people. Paradoxically, and for almost as long, evidence suggests these warnings may have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

With mounting evidence of these negative unintended consequences, some clinicians and researchers are urging the Food and Drug Administration (FDA) to consider revising — or even eliminating — boxed warnings on these medications.

The latest report challenging the utility of the 2005 warnings was particularly sobering. Published in October in Health Affairs, the systematic review of studies from 2003 to 2022 showed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and an abrupt increase in psychotropic drug poisonings and suicides — all after the warnings were added.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, Massachusetts and colleagues wrote. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

While good prospective data on the risks and benefits of antidepressants in youth were limited when the boxed warnings were instituted, there is more information now, said Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine in Ohio. Strawn, whose research on the topic has been cited frequently over the years, said the new evidence suggests it is time for the FDA to reevaluate the warnings.

“I don’t think that they’ve been useful. They’ve actually been harmful,” Strawn told this news organization. “These boxed warnings have decreased physicians’ and other clinicians’ comfort and tendency to prescribe.”

 

Decline in Diagnoses

The FDA issued its first warning about the potential for suicidal thoughts and behavior in children in 2003. After an advisory panel weighed the evidence, the agency added a boxed warning in 2005 to all antidepressants for children younger than 18 years. The warning was expanded in 2007 to include young adults through age 24.

Data suggesting that the warnings have had unintended effects can be found going back to just after they were issued. For instance, in 2009, after rising for years, the rate of new pediatric depression diagnoses fell precipitously after the warning was added, with primary care physicians diagnosing 44% fewer cases.

In 2014, citing evidence of fewer diagnoses and rising psychotropic drug poisonings, Weill Cornell Medicine Professor Richard A. Friedman, MD, called on the FDA in a perspective to remove the boxed warnings.

Strawn and colleagues reported in an often-cited 2014 systematic review and meta-analysis that, in nine trials involving 1673 patients and six medications, antidepressants were superior to placebo, with no increased risk for suicidal thoughts or behavior.

He has also studied adverse effects of the medications, reporting in Pharmacotherapy that suicidality risk might be more likely with some medications, such as paroxetine and venlafaxine, and that it could be influenced by baseline suicidality, among many other factors. A Swedish register study found that risk was highest the month before starting a medication, Strawn and colleagues wrote.

Dara Sakolsky, MD, PhD, associate professor of psychiatry and associate medical director, Services for Teens at Risk at the University of Pittsburgh School of Medicine, Pennsylvania, told this news organization that, because of “these negative unintended consequences,” the FDA should lower the temperature by putting the warnings in labeling.

“It makes sense based on the data that we have at hand now,” said Sakolsky.

 

The Dangers of Untreated Depression

Even with this new information, lingering concerns about earlier studies that pointed to increased suicidality risk may discourage prescribing by primary care physicians and pediatricians, and that worries researchers and psychiatrists.

“My concern is that the risk for suicide and suicidal behavior may be higher in untreated depression than the risk of suicidal thoughts or behaviors from antidepressants,” Jeffrey Bridge, PhD, director of the Center for Suicide Prevention and Research at Nationwide Children’s Hospital, Columbus, Ohio, told this news organization.

Bridge is the lead author of a much-cited 2007 meta-analysis in JAMA that showed that the benefits of antidepressants in children and adolescents appeared to be greater than the risks for suicidality. “The concern about antidepressants must be considered in the context of possible benefit,” wrote Bridge, who also is professor of pediatrics, psychiatry, and behavioral health at Ohio State University College of Medicine, Columbus.

Depression and suicide are a scourge for those younger than 25 years. A 2021 literature review noted that the prevalence of depression — which has been increasing for all Americans — has risen more among adolescents than adults. Depression is “strongly associated with suicide,” the authors wrote.

In 2021, the National Institute of Mental Health reported suicide was the second leading cause of death among 10- to 14-year-olds and the third leading cause of death among those aged 15-24 years.

Suicide kills more kids aged between 10 and 24 years than cancer and all other illnesses combined, John Campo, MD, director of child and adolescent psychiatry at Johns Hopkins University School of Medicine and vice president of psychiatric services at Kennedy Krieger Institute, told this news organization.

Meanwhile, he added, the medications work and clinicians balance risk and benefit in prescribing.

The landmark 2007 Treatment for Adolescents with Depression Study showed that fluoxetine, especially in combination with cognitive-behavioral therapy (CBT), was significantly better than placebo. Since that time, legions of trials have shown the drugs’ effectiveness.

The most effective treatment for teen depression is a combination of CBT and a selective serotonin reuptake inhibitor, said Sakolsky.

“We know that the evidence for that is pretty good,” she said. “On the flip side, we know the risk of having an adverse outcome is pretty low.”

Sakolsky tells patients and families that perhaps 1 in 146 will have a suicidal thought or behavior. “That’s pretty rare when we know how effective these medicines are.” 

Strawn said he always notes that no suicides took place in the trials that led to the warning and stresses that he closely monitors patients. “While the more recent prospective data are reassuring,” the suicidality risk “is something that we still talk about,” he said. He also discusses how some antidepressants seem to increase risk more than others.

For Campo, the discussion is based on his reading of the evidence, not the presence of the FDA warning.

“Based on what we know, I still think it’s fair to proceed with the idea that there is a small, but real risk,” he said. However, “at the same time, the medications might be exceptionally helpful for some kids.”

 

‘What Do We Do Now?’

When the FDA issued its warning in 2005, the agency said it identified the risk for suicidality in a combined analysis of short-term placebo-controlled trials of nine antidepressants. It ultimately included 24 trials involving more than 4400 patients. The risk was highest in the first few months. The average risk for those taking antidepressants was 4%, twice the placebo risk of 2%. There were no suicides in these trials, however.

The trials relied on spontaneous reports of adverse events, not predetermined measures, Campo said. Even so, that 2% difference is “nothing to sneeze at,” he noted.

Bridge’s meta-analysis showed a smaller difference — closer to 0.7%. “But it was still statistically significant,” Campo said. “I have trouble ignoring that.”

The unintended consequences of the warning can’t be studied in a randomized controlled trial. Studies have shown an association but not a direct cause-and-effect relationship between the warning and a decline in treatment and rise in suicides.

But the potential for suicidal thoughts and behavior with antidepressants has been studied prospectively. Some older studies found a significant risk, while more recent trials have not.

While the Health Affairs analysis “certainly makes a strong case,” it is observational data, Campo said.

“The question is, what do we do now in retrospect? Do you say, ‘Never mind. We don’t need the black box warning anymore?’ ” he said. “That would require a pretty careful look.”

The Health Affairs paper “makes me think that there are other areas of research that that need to be completed and done and updated, and then there should be an assessment, a reevaluation from the FDA,” said Bridge. A new meta-analysis “would be very informative,” he said.

 

What’s Next?

When asked about the Health Affairs paper and whether the agency would review the warnings, an FDA spokesperson told this news organization that the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

Sakolsky said the data clearly point to the damage that the warning has done over the past 2 decades, but that things might be improving. Studies conducted more recently might not have captured some changes in practice.

For instance, she noted, in 2022, the US Preventive Services Task Force recommended screening for major depressive disorder in adolescents aged 12-18 years. In turn, she has seen more patients in her office who were referred by pediatricians who had conducted the screening, said Sakolsky.

Strawn said the time for pontificating is long past due. “We’re withholding medications and other treatments that could potentially be effective for disorders that, in and of themselves, are associated with a significant increase in the risk of suicide.” 

After the FDA instituted the warning, “we were all very nervous,” about the potential fallout, said Campo, adding that a part of him wishes that the warnings had been “more mundane and less dramatic.”

Despite the unintended consequences, “it’s going to be hard to put the genie back in the bottle,” he said.

Campo and Sakolsky reported no relevant financial relationships. Strawn disclosed that his institution has received research funding from the National Institute of Child Health and Human Development, the Patient-Centered Outcomes Research Institute (PCORI), and AbbVie. Bridge reported that he received grant support from the National Institute of Mental Health, Centers for Disease Control and Prevention, and PCORI; is a scientific adviser to Clarigent Health; and is on the Scientific Council of the American Foundation for Suicide Prevention.

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

For almost 2 decades, antidepressants have carried boxed warnings linking the medications to an increased risk for suicidal thoughts and behaviors in young people. Paradoxically, and for almost as long, evidence suggests these warnings may have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

With mounting evidence of these negative unintended consequences, some clinicians and researchers are urging the Food and Drug Administration (FDA) to consider revising — or even eliminating — boxed warnings on these medications.

The latest report challenging the utility of the 2005 warnings was particularly sobering. Published in October in Health Affairs, the systematic review of studies from 2003 to 2022 showed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and an abrupt increase in psychotropic drug poisonings and suicides — all after the warnings were added.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, Massachusetts and colleagues wrote. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

While good prospective data on the risks and benefits of antidepressants in youth were limited when the boxed warnings were instituted, there is more information now, said Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine in Ohio. Strawn, whose research on the topic has been cited frequently over the years, said the new evidence suggests it is time for the FDA to reevaluate the warnings.

“I don’t think that they’ve been useful. They’ve actually been harmful,” Strawn told this news organization. “These boxed warnings have decreased physicians’ and other clinicians’ comfort and tendency to prescribe.”

 

Decline in Diagnoses

The FDA issued its first warning about the potential for suicidal thoughts and behavior in children in 2003. After an advisory panel weighed the evidence, the agency added a boxed warning in 2005 to all antidepressants for children younger than 18 years. The warning was expanded in 2007 to include young adults through age 24.

Data suggesting that the warnings have had unintended effects can be found going back to just after they were issued. For instance, in 2009, after rising for years, the rate of new pediatric depression diagnoses fell precipitously after the warning was added, with primary care physicians diagnosing 44% fewer cases.

In 2014, citing evidence of fewer diagnoses and rising psychotropic drug poisonings, Weill Cornell Medicine Professor Richard A. Friedman, MD, called on the FDA in a perspective to remove the boxed warnings.

Strawn and colleagues reported in an often-cited 2014 systematic review and meta-analysis that, in nine trials involving 1673 patients and six medications, antidepressants were superior to placebo, with no increased risk for suicidal thoughts or behavior.

He has also studied adverse effects of the medications, reporting in Pharmacotherapy that suicidality risk might be more likely with some medications, such as paroxetine and venlafaxine, and that it could be influenced by baseline suicidality, among many other factors. A Swedish register study found that risk was highest the month before starting a medication, Strawn and colleagues wrote.

Dara Sakolsky, MD, PhD, associate professor of psychiatry and associate medical director, Services for Teens at Risk at the University of Pittsburgh School of Medicine, Pennsylvania, told this news organization that, because of “these negative unintended consequences,” the FDA should lower the temperature by putting the warnings in labeling.

“It makes sense based on the data that we have at hand now,” said Sakolsky.

 

The Dangers of Untreated Depression

Even with this new information, lingering concerns about earlier studies that pointed to increased suicidality risk may discourage prescribing by primary care physicians and pediatricians, and that worries researchers and psychiatrists.

“My concern is that the risk for suicide and suicidal behavior may be higher in untreated depression than the risk of suicidal thoughts or behaviors from antidepressants,” Jeffrey Bridge, PhD, director of the Center for Suicide Prevention and Research at Nationwide Children’s Hospital, Columbus, Ohio, told this news organization.

Bridge is the lead author of a much-cited 2007 meta-analysis in JAMA that showed that the benefits of antidepressants in children and adolescents appeared to be greater than the risks for suicidality. “The concern about antidepressants must be considered in the context of possible benefit,” wrote Bridge, who also is professor of pediatrics, psychiatry, and behavioral health at Ohio State University College of Medicine, Columbus.

Depression and suicide are a scourge for those younger than 25 years. A 2021 literature review noted that the prevalence of depression — which has been increasing for all Americans — has risen more among adolescents than adults. Depression is “strongly associated with suicide,” the authors wrote.

In 2021, the National Institute of Mental Health reported suicide was the second leading cause of death among 10- to 14-year-olds and the third leading cause of death among those aged 15-24 years.

Suicide kills more kids aged between 10 and 24 years than cancer and all other illnesses combined, John Campo, MD, director of child and adolescent psychiatry at Johns Hopkins University School of Medicine and vice president of psychiatric services at Kennedy Krieger Institute, told this news organization.

Meanwhile, he added, the medications work and clinicians balance risk and benefit in prescribing.

The landmark 2007 Treatment for Adolescents with Depression Study showed that fluoxetine, especially in combination with cognitive-behavioral therapy (CBT), was significantly better than placebo. Since that time, legions of trials have shown the drugs’ effectiveness.

The most effective treatment for teen depression is a combination of CBT and a selective serotonin reuptake inhibitor, said Sakolsky.

“We know that the evidence for that is pretty good,” she said. “On the flip side, we know the risk of having an adverse outcome is pretty low.”

Sakolsky tells patients and families that perhaps 1 in 146 will have a suicidal thought or behavior. “That’s pretty rare when we know how effective these medicines are.” 

Strawn said he always notes that no suicides took place in the trials that led to the warning and stresses that he closely monitors patients. “While the more recent prospective data are reassuring,” the suicidality risk “is something that we still talk about,” he said. He also discusses how some antidepressants seem to increase risk more than others.

For Campo, the discussion is based on his reading of the evidence, not the presence of the FDA warning.

“Based on what we know, I still think it’s fair to proceed with the idea that there is a small, but real risk,” he said. However, “at the same time, the medications might be exceptionally helpful for some kids.”

 

‘What Do We Do Now?’

When the FDA issued its warning in 2005, the agency said it identified the risk for suicidality in a combined analysis of short-term placebo-controlled trials of nine antidepressants. It ultimately included 24 trials involving more than 4400 patients. The risk was highest in the first few months. The average risk for those taking antidepressants was 4%, twice the placebo risk of 2%. There were no suicides in these trials, however.

The trials relied on spontaneous reports of adverse events, not predetermined measures, Campo said. Even so, that 2% difference is “nothing to sneeze at,” he noted.

Bridge’s meta-analysis showed a smaller difference — closer to 0.7%. “But it was still statistically significant,” Campo said. “I have trouble ignoring that.”

The unintended consequences of the warning can’t be studied in a randomized controlled trial. Studies have shown an association but not a direct cause-and-effect relationship between the warning and a decline in treatment and rise in suicides.

But the potential for suicidal thoughts and behavior with antidepressants has been studied prospectively. Some older studies found a significant risk, while more recent trials have not.

While the Health Affairs analysis “certainly makes a strong case,” it is observational data, Campo said.

“The question is, what do we do now in retrospect? Do you say, ‘Never mind. We don’t need the black box warning anymore?’ ” he said. “That would require a pretty careful look.”

The Health Affairs paper “makes me think that there are other areas of research that that need to be completed and done and updated, and then there should be an assessment, a reevaluation from the FDA,” said Bridge. A new meta-analysis “would be very informative,” he said.

 

What’s Next?

When asked about the Health Affairs paper and whether the agency would review the warnings, an FDA spokesperson told this news organization that the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

Sakolsky said the data clearly point to the damage that the warning has done over the past 2 decades, but that things might be improving. Studies conducted more recently might not have captured some changes in practice.

For instance, she noted, in 2022, the US Preventive Services Task Force recommended screening for major depressive disorder in adolescents aged 12-18 years. In turn, she has seen more patients in her office who were referred by pediatricians who had conducted the screening, said Sakolsky.

Strawn said the time for pontificating is long past due. “We’re withholding medications and other treatments that could potentially be effective for disorders that, in and of themselves, are associated with a significant increase in the risk of suicide.” 

After the FDA instituted the warning, “we were all very nervous,” about the potential fallout, said Campo, adding that a part of him wishes that the warnings had been “more mundane and less dramatic.”

Despite the unintended consequences, “it’s going to be hard to put the genie back in the bottle,” he said.

Campo and Sakolsky reported no relevant financial relationships. Strawn disclosed that his institution has received research funding from the National Institute of Child Health and Human Development, the Patient-Centered Outcomes Research Institute (PCORI), and AbbVie. Bridge reported that he received grant support from the National Institute of Mental Health, Centers for Disease Control and Prevention, and PCORI; is a scientific adviser to Clarigent Health; and is on the Scientific Council of the American Foundation for Suicide Prevention.

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

Earlier in 2024, Utah became the seventh state to allow psychologists with the proper training to prescribe psychotropic medications, giving supporters reason to hope that more states might support expanding this scope of practice.

However, the American Psychiatric Association — and some psychologists — oppose granting psychologists this privilege, arguing that the training offered is insufficient and could jeopardize patient safety.

The controversy over whether psychologists should be allowed to prescribe is as old as the so-called RxP movement itself, which began in the early 1990s.

Psychologists have not rushed to become licensed prescribers. After three decades, an estimated 226 psychologists — representing just 0.14% of all those licensed in the United States — have been authorized to prescribe in the six states and one territory where it has been legalized, according to a just-published study in Clinical Psychology.

These are Colorado, Idaho, Illinois, Iowa, Louisiana, New Mexico, and Guam. Data from the study show that only 73 psychologists are prescribing in New Mexico, which authorized it in 2002.

Less is known about the number of psychologists who are prescribing under allowances in the Department of Defense, Indian Health Service and US Public Health Service.

Some psychologists — and the American Psychological Association (APA) — believe that the persistence of the opioid epidemic coupled with a continued lack of access to mental health care for millions of Americans will bring more legislators on-side.

“I feel like we’re on an upswing again,” Deborah Baker, director of legal and regulatory policy for the APA, told Medscape Medical News. “The access issue continues to be a perennial kind of driver.” She noted that at least six states pursued expanding privileges this year.

Robert L. Trestman, MD, chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, said he doesn’t see new momentum. The interest in having psychologists prescribe “continues to trickle based on just the frustration that people have about not getting adequate access to psychiatry,” he told Medscape Medical News.

While states may be trying to increase access to care, granting psychologists privileges is “not a very effective way of doing it,” said Trestman, Chair of Psychiatry and Behavioral Medicine at Virginia Tech Carilion School of Medicine in Roanoke. Psychologists are needed to deliver psychotherapy, he said. “It makes almost no sense to try to make them into pseudo medical professionals,” said Trestman. “It just exposes people to risks.”

William Robiner, PhD — author of Clinical Psychology study — is a long-time opponent of RxP. The psychologist told Medscape Medical News he’s concerned about patient safety and “about some of the disingenuous reasons” that psychologists want to prescribe. Among these are the ability to increase status and income, said Robiner, a professor of medicine at the University of Minnesota Medical School, Minneapolis, and a board member of Psychologists Opposed to Prescription Privileges for Psychologists.

 

Adequate Training?

Only PhD and PsyD psychologists are eligible for RxP training, which entails a master’s in clinical psychopharmacology. After receiving the master’s, they must pass the Psychopharmacology Examination for Psychologists and then are only permitted to prescribe medications for mental health disorders.

They must also obtain a Drug Enforcement Administration license but can’t write prescriptions for schedule 2 medications. In some states, psychologists can prescribe buprenorphine and other opioid use disorder medications.

The APA has developed guidance for master’s programs, which currently number just over a handful in the United States.

At Fairleigh Dickinson University in New Jersey, students enrolled in the master’s program — a distance-learning format — complete 10 courses over five 15-week semesters. The curriculum spans a range of topics, from foundational sciences and legal and ethical considerations to strategies for treating specific disorders.

Derek Phillips, PhD, the program’s executive director, said that when he took the position in 2020, enrollment was capped at 45 students, but “we were not routinely enrolling the maximum.” Now, even with class size increased to 60 “we are consistently full and have a waitlist,” he told Medscape Medical News.

Interest is being driven in part by new laws in Colorado (2023) and Utah, said Phillips. But many are enrolling without intending to write a prescription, he said. The degree gives graduates the ability to better collaborate with other clinicians, teach clinical psychopharmacology, and be expert witnesses in medico-legal cases, he said.

In addition, the training gives students “a balanced and thorough biopsychosocial understanding of our patients,” he said. Students also see the “potential of being able to be a ‘one-stop-stop’ of mental health services,” said Phillips.

The American Board of Professional Psychology is developing a board certification in clinical psychopharmacology.

The APA states on its website that prescribing psychologists have “more training in diagnosing and treating (including prescribing) mental health disorders than primary care physicians.”

However, critics argue that the training falls short. Most psychologists, said Robiner, have not completed the undergraduate prerequisites — such as anatomy, physiology, and chemistry — that are required for other prescribing professionals.

In a 2019 article comparing the training of prescribing professionals, Robiner and colleagues reported that psychiatrists undergo 4- to 6-week rotations during medical school and accumulate 8000 clinical hours focused on psychiatric conditions over the course of their 4-year residencies.

States set requirements for clinical hours for prescribing psychologists, but they are generally elective and completed after individuals receive a master’s degree.

Robiner said psychologists aren’t trained in evaluating drug-related adverse events. “If you show a psychologist a rash, they have no idea whether that rash might be a medication adverse effect or poison ivy,” he said.

Trestman pointed out that many psychotropic medications have black box warnings. “The risk of toxicity is by no means trivial, and the majority of people who are seeking care in psychiatry have multiple comorbidities,” he said. “Giving people the equivalent of more or less 10 weeks of training is just woefully inappropriate,” Trestman said.

 

Increase in Access?

Psychology’s main argument for expanding its scope of practice is that it will increase the number of clinicians available to provide behavioral and mental health care.

Critics said that is a failed experiment, in part because so few psychologists have become prescribers, but also because most psychologists practice in the same areas as psychiatrists. Both specialists tend to cluster in urban regions, which already have high clinician density, said Trestman.

Psychologists are not practicing in underserved rural areas, as even APA data show. A 2018 APA snapshot of the workforce found that the highest density of psychologists was in Washington, DC, Massachusetts, and New York. South Carolina, West Virginia and Mississippi had the fewest number of psychologists per 100,000 people.

The University of Washington Rural Health Research Center reported in 2022 that in 2021, almost half of rural counties did not have a psychologist compared with 15.7% of urban counties.

Psychiatrists also are concentrated on the coasts and New England, according to a study by Ohio State researchers. The highest densities were in Washington, DC (79 per 100,000), Massachusetts (45.3), Rhode Island (42.6), Connecticut (38.6) and Vermont (37.7), whereas the lowest densities were in Idaho (11.8), Mississippi (11.8), Wyoming (12.4), Alabama (13.1), and Indiana (13.5). The study estimated that there were 57,163 psychiatrists responsible for the care of 333,287,557 Americans. “Clinical psychologists, psychotherapists, and counselors can provide alternative forms of intervention, though access to such services is also poor in rural areas,” wrote the authors.

The APA counters with data it says shows that RxP may have increased access. Using the number of psychology practices as a proxy for supply, the authors reported that practices grew in New Mexico, Illinois, Iowa, and Idaho — states that have implemented prescription privileges. Overall, there was an increase of 0.8047 practices per 100,000 residents per county.

However, the access argument “is seriously challenged by the reality of the limited number of psychologists who complete the pathway to prescribing,” Robiner and his colleague Tanya Tompkins countered in Clinical Psychology. They note that in Idaho — a state with shortages of psychologists and psychiatrists — just 10 of the state’s 615 psychologists had prescriptive authority. An estimated 5131 nonpsychologists are prescribers.

Robiner and Tompkins noted that it’s not clear why so few psychologists are pursuing RxP but that many seem to be unaware of the possibility.

 

Do Benefits Outweigh the Harms? 

There is not a large body of literature assessing the harms or benefits of prescribing privileges for psychologists.

Baker shared several studies by Phillip Hughes, PhD, an outcomes researcher at the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. In one study, Hughes found that patients of prescribing psychologists had a 24% lower rate of adverse drug events than patients of psychiatrists. Psychologists’ patients had lower rates of psychotropic polypharmacy but similar rates of emergency room use.

In another paper Hughes suggested that deaths attributable to mental illness had declined in New Mexico after it passed its law. There was no change in Louisiana.

With little evidence of harm — and ongoing provider shortages — making use of nonphysician prescribers is gaining traction with policymakers, claims the psychology association’s Baker, adding that in Utah, the Republican governor was the biggest supporter.

But psychiatrists argue that it’s more important to increase their numbers. Congress agreed in 2021 and 2023 to add 1200 new residency slots — in every specialty — to ease physician shortages. The Centers for Medicare & Medicaid Services recently announced that 70% of the new slots for July 2025 will go to primary care and psychiatry.

“Once those positions are in place, it will be four more years before the first crop of new psychiatrists come out,” noted Trestman. “None of these fixes are quick,” he said.

Baker, Robiner, and Trestman reported no relevant financial relationships.

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

Earlier in 2024, Utah became the seventh state to allow psychologists with the proper training to prescribe psychotropic medications, giving supporters reason to hope that more states might support expanding this scope of practice.

However, the American Psychiatric Association — and some psychologists — oppose granting psychologists this privilege, arguing that the training offered is insufficient and could jeopardize patient safety.

The controversy over whether psychologists should be allowed to prescribe is as old as the so-called RxP movement itself, which began in the early 1990s.

Psychologists have not rushed to become licensed prescribers. After three decades, an estimated 226 psychologists — representing just 0.14% of all those licensed in the United States — have been authorized to prescribe in the six states and one territory where it has been legalized, according to a just-published study in Clinical Psychology.

These are Colorado, Idaho, Illinois, Iowa, Louisiana, New Mexico, and Guam. Data from the study show that only 73 psychologists are prescribing in New Mexico, which authorized it in 2002.

Less is known about the number of psychologists who are prescribing under allowances in the Department of Defense, Indian Health Service and US Public Health Service.

Some psychologists — and the American Psychological Association (APA) — believe that the persistence of the opioid epidemic coupled with a continued lack of access to mental health care for millions of Americans will bring more legislators on-side.

“I feel like we’re on an upswing again,” Deborah Baker, director of legal and regulatory policy for the APA, told Medscape Medical News. “The access issue continues to be a perennial kind of driver.” She noted that at least six states pursued expanding privileges this year.

Robert L. Trestman, MD, chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, said he doesn’t see new momentum. The interest in having psychologists prescribe “continues to trickle based on just the frustration that people have about not getting adequate access to psychiatry,” he told Medscape Medical News.

While states may be trying to increase access to care, granting psychologists privileges is “not a very effective way of doing it,” said Trestman, Chair of Psychiatry and Behavioral Medicine at Virginia Tech Carilion School of Medicine in Roanoke. Psychologists are needed to deliver psychotherapy, he said. “It makes almost no sense to try to make them into pseudo medical professionals,” said Trestman. “It just exposes people to risks.”

William Robiner, PhD — author of Clinical Psychology study — is a long-time opponent of RxP. The psychologist told Medscape Medical News he’s concerned about patient safety and “about some of the disingenuous reasons” that psychologists want to prescribe. Among these are the ability to increase status and income, said Robiner, a professor of medicine at the University of Minnesota Medical School, Minneapolis, and a board member of Psychologists Opposed to Prescription Privileges for Psychologists.

 

Adequate Training?

Only PhD and PsyD psychologists are eligible for RxP training, which entails a master’s in clinical psychopharmacology. After receiving the master’s, they must pass the Psychopharmacology Examination for Psychologists and then are only permitted to prescribe medications for mental health disorders.

They must also obtain a Drug Enforcement Administration license but can’t write prescriptions for schedule 2 medications. In some states, psychologists can prescribe buprenorphine and other opioid use disorder medications.

The APA has developed guidance for master’s programs, which currently number just over a handful in the United States.

At Fairleigh Dickinson University in New Jersey, students enrolled in the master’s program — a distance-learning format — complete 10 courses over five 15-week semesters. The curriculum spans a range of topics, from foundational sciences and legal and ethical considerations to strategies for treating specific disorders.

Derek Phillips, PhD, the program’s executive director, said that when he took the position in 2020, enrollment was capped at 45 students, but “we were not routinely enrolling the maximum.” Now, even with class size increased to 60 “we are consistently full and have a waitlist,” he told Medscape Medical News.

Interest is being driven in part by new laws in Colorado (2023) and Utah, said Phillips. But many are enrolling without intending to write a prescription, he said. The degree gives graduates the ability to better collaborate with other clinicians, teach clinical psychopharmacology, and be expert witnesses in medico-legal cases, he said.

In addition, the training gives students “a balanced and thorough biopsychosocial understanding of our patients,” he said. Students also see the “potential of being able to be a ‘one-stop-stop’ of mental health services,” said Phillips.

The American Board of Professional Psychology is developing a board certification in clinical psychopharmacology.

The APA states on its website that prescribing psychologists have “more training in diagnosing and treating (including prescribing) mental health disorders than primary care physicians.”

However, critics argue that the training falls short. Most psychologists, said Robiner, have not completed the undergraduate prerequisites — such as anatomy, physiology, and chemistry — that are required for other prescribing professionals.

In a 2019 article comparing the training of prescribing professionals, Robiner and colleagues reported that psychiatrists undergo 4- to 6-week rotations during medical school and accumulate 8000 clinical hours focused on psychiatric conditions over the course of their 4-year residencies.

States set requirements for clinical hours for prescribing psychologists, but they are generally elective and completed after individuals receive a master’s degree.

Robiner said psychologists aren’t trained in evaluating drug-related adverse events. “If you show a psychologist a rash, they have no idea whether that rash might be a medication adverse effect or poison ivy,” he said.

Trestman pointed out that many psychotropic medications have black box warnings. “The risk of toxicity is by no means trivial, and the majority of people who are seeking care in psychiatry have multiple comorbidities,” he said. “Giving people the equivalent of more or less 10 weeks of training is just woefully inappropriate,” Trestman said.

 

Increase in Access?

Psychology’s main argument for expanding its scope of practice is that it will increase the number of clinicians available to provide behavioral and mental health care.

Critics said that is a failed experiment, in part because so few psychologists have become prescribers, but also because most psychologists practice in the same areas as psychiatrists. Both specialists tend to cluster in urban regions, which already have high clinician density, said Trestman.

Psychologists are not practicing in underserved rural areas, as even APA data show. A 2018 APA snapshot of the workforce found that the highest density of psychologists was in Washington, DC, Massachusetts, and New York. South Carolina, West Virginia and Mississippi had the fewest number of psychologists per 100,000 people.

The University of Washington Rural Health Research Center reported in 2022 that in 2021, almost half of rural counties did not have a psychologist compared with 15.7% of urban counties.

Psychiatrists also are concentrated on the coasts and New England, according to a study by Ohio State researchers. The highest densities were in Washington, DC (79 per 100,000), Massachusetts (45.3), Rhode Island (42.6), Connecticut (38.6) and Vermont (37.7), whereas the lowest densities were in Idaho (11.8), Mississippi (11.8), Wyoming (12.4), Alabama (13.1), and Indiana (13.5). The study estimated that there were 57,163 psychiatrists responsible for the care of 333,287,557 Americans. “Clinical psychologists, psychotherapists, and counselors can provide alternative forms of intervention, though access to such services is also poor in rural areas,” wrote the authors.

The APA counters with data it says shows that RxP may have increased access. Using the number of psychology practices as a proxy for supply, the authors reported that practices grew in New Mexico, Illinois, Iowa, and Idaho — states that have implemented prescription privileges. Overall, there was an increase of 0.8047 practices per 100,000 residents per county.

However, the access argument “is seriously challenged by the reality of the limited number of psychologists who complete the pathway to prescribing,” Robiner and his colleague Tanya Tompkins countered in Clinical Psychology. They note that in Idaho — a state with shortages of psychologists and psychiatrists — just 10 of the state’s 615 psychologists had prescriptive authority. An estimated 5131 nonpsychologists are prescribers.

Robiner and Tompkins noted that it’s not clear why so few psychologists are pursuing RxP but that many seem to be unaware of the possibility.

 

Do Benefits Outweigh the Harms? 

There is not a large body of literature assessing the harms or benefits of prescribing privileges for psychologists.

Baker shared several studies by Phillip Hughes, PhD, an outcomes researcher at the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. In one study, Hughes found that patients of prescribing psychologists had a 24% lower rate of adverse drug events than patients of psychiatrists. Psychologists’ patients had lower rates of psychotropic polypharmacy but similar rates of emergency room use.

In another paper Hughes suggested that deaths attributable to mental illness had declined in New Mexico after it passed its law. There was no change in Louisiana.

With little evidence of harm — and ongoing provider shortages — making use of nonphysician prescribers is gaining traction with policymakers, claims the psychology association’s Baker, adding that in Utah, the Republican governor was the biggest supporter.

But psychiatrists argue that it’s more important to increase their numbers. Congress agreed in 2021 and 2023 to add 1200 new residency slots — in every specialty — to ease physician shortages. The Centers for Medicare & Medicaid Services recently announced that 70% of the new slots for July 2025 will go to primary care and psychiatry.

“Once those positions are in place, it will be four more years before the first crop of new psychiatrists come out,” noted Trestman. “None of these fixes are quick,” he said.

Baker, Robiner, and Trestman reported no relevant financial relationships.

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

Earlier in 2024, Utah became the seventh state to allow psychologists with the proper training to prescribe psychotropic medications, giving supporters reason to hope that more states might support expanding this scope of practice.

However, the American Psychiatric Association — and some psychologists — oppose granting psychologists this privilege, arguing that the training offered is insufficient and could jeopardize patient safety.

The controversy over whether psychologists should be allowed to prescribe is as old as the so-called RxP movement itself, which began in the early 1990s.

Psychologists have not rushed to become licensed prescribers. After three decades, an estimated 226 psychologists — representing just 0.14% of all those licensed in the United States — have been authorized to prescribe in the six states and one territory where it has been legalized, according to a just-published study in Clinical Psychology.

These are Colorado, Idaho, Illinois, Iowa, Louisiana, New Mexico, and Guam. Data from the study show that only 73 psychologists are prescribing in New Mexico, which authorized it in 2002.

Less is known about the number of psychologists who are prescribing under allowances in the Department of Defense, Indian Health Service and US Public Health Service.

Some psychologists — and the American Psychological Association (APA) — believe that the persistence of the opioid epidemic coupled with a continued lack of access to mental health care for millions of Americans will bring more legislators on-side.

“I feel like we’re on an upswing again,” Deborah Baker, director of legal and regulatory policy for the APA, told Medscape Medical News. “The access issue continues to be a perennial kind of driver.” She noted that at least six states pursued expanding privileges this year.

Robert L. Trestman, MD, chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, said he doesn’t see new momentum. The interest in having psychologists prescribe “continues to trickle based on just the frustration that people have about not getting adequate access to psychiatry,” he told Medscape Medical News.

While states may be trying to increase access to care, granting psychologists privileges is “not a very effective way of doing it,” said Trestman, Chair of Psychiatry and Behavioral Medicine at Virginia Tech Carilion School of Medicine in Roanoke. Psychologists are needed to deliver psychotherapy, he said. “It makes almost no sense to try to make them into pseudo medical professionals,” said Trestman. “It just exposes people to risks.”

William Robiner, PhD — author of Clinical Psychology study — is a long-time opponent of RxP. The psychologist told Medscape Medical News he’s concerned about patient safety and “about some of the disingenuous reasons” that psychologists want to prescribe. Among these are the ability to increase status and income, said Robiner, a professor of medicine at the University of Minnesota Medical School, Minneapolis, and a board member of Psychologists Opposed to Prescription Privileges for Psychologists.

 

Adequate Training?

Only PhD and PsyD psychologists are eligible for RxP training, which entails a master’s in clinical psychopharmacology. After receiving the master’s, they must pass the Psychopharmacology Examination for Psychologists and then are only permitted to prescribe medications for mental health disorders.

They must also obtain a Drug Enforcement Administration license but can’t write prescriptions for schedule 2 medications. In some states, psychologists can prescribe buprenorphine and other opioid use disorder medications.

The APA has developed guidance for master’s programs, which currently number just over a handful in the United States.

At Fairleigh Dickinson University in New Jersey, students enrolled in the master’s program — a distance-learning format — complete 10 courses over five 15-week semesters. The curriculum spans a range of topics, from foundational sciences and legal and ethical considerations to strategies for treating specific disorders.

Derek Phillips, PhD, the program’s executive director, said that when he took the position in 2020, enrollment was capped at 45 students, but “we were not routinely enrolling the maximum.” Now, even with class size increased to 60 “we are consistently full and have a waitlist,” he told Medscape Medical News.

Interest is being driven in part by new laws in Colorado (2023) and Utah, said Phillips. But many are enrolling without intending to write a prescription, he said. The degree gives graduates the ability to better collaborate with other clinicians, teach clinical psychopharmacology, and be expert witnesses in medico-legal cases, he said.

In addition, the training gives students “a balanced and thorough biopsychosocial understanding of our patients,” he said. Students also see the “potential of being able to be a ‘one-stop-stop’ of mental health services,” said Phillips.

The American Board of Professional Psychology is developing a board certification in clinical psychopharmacology.

The APA states on its website that prescribing psychologists have “more training in diagnosing and treating (including prescribing) mental health disorders than primary care physicians.”

However, critics argue that the training falls short. Most psychologists, said Robiner, have not completed the undergraduate prerequisites — such as anatomy, physiology, and chemistry — that are required for other prescribing professionals.

In a 2019 article comparing the training of prescribing professionals, Robiner and colleagues reported that psychiatrists undergo 4- to 6-week rotations during medical school and accumulate 8000 clinical hours focused on psychiatric conditions over the course of their 4-year residencies.

States set requirements for clinical hours for prescribing psychologists, but they are generally elective and completed after individuals receive a master’s degree.

Robiner said psychologists aren’t trained in evaluating drug-related adverse events. “If you show a psychologist a rash, they have no idea whether that rash might be a medication adverse effect or poison ivy,” he said.

Trestman pointed out that many psychotropic medications have black box warnings. “The risk of toxicity is by no means trivial, and the majority of people who are seeking care in psychiatry have multiple comorbidities,” he said. “Giving people the equivalent of more or less 10 weeks of training is just woefully inappropriate,” Trestman said.

 

Increase in Access?

Psychology’s main argument for expanding its scope of practice is that it will increase the number of clinicians available to provide behavioral and mental health care.

Critics said that is a failed experiment, in part because so few psychologists have become prescribers, but also because most psychologists practice in the same areas as psychiatrists. Both specialists tend to cluster in urban regions, which already have high clinician density, said Trestman.

Psychologists are not practicing in underserved rural areas, as even APA data show. A 2018 APA snapshot of the workforce found that the highest density of psychologists was in Washington, DC, Massachusetts, and New York. South Carolina, West Virginia and Mississippi had the fewest number of psychologists per 100,000 people.

The University of Washington Rural Health Research Center reported in 2022 that in 2021, almost half of rural counties did not have a psychologist compared with 15.7% of urban counties.

Psychiatrists also are concentrated on the coasts and New England, according to a study by Ohio State researchers. The highest densities were in Washington, DC (79 per 100,000), Massachusetts (45.3), Rhode Island (42.6), Connecticut (38.6) and Vermont (37.7), whereas the lowest densities were in Idaho (11.8), Mississippi (11.8), Wyoming (12.4), Alabama (13.1), and Indiana (13.5). The study estimated that there were 57,163 psychiatrists responsible for the care of 333,287,557 Americans. “Clinical psychologists, psychotherapists, and counselors can provide alternative forms of intervention, though access to such services is also poor in rural areas,” wrote the authors.

The APA counters with data it says shows that RxP may have increased access. Using the number of psychology practices as a proxy for supply, the authors reported that practices grew in New Mexico, Illinois, Iowa, and Idaho — states that have implemented prescription privileges. Overall, there was an increase of 0.8047 practices per 100,000 residents per county.

However, the access argument “is seriously challenged by the reality of the limited number of psychologists who complete the pathway to prescribing,” Robiner and his colleague Tanya Tompkins countered in Clinical Psychology. They note that in Idaho — a state with shortages of psychologists and psychiatrists — just 10 of the state’s 615 psychologists had prescriptive authority. An estimated 5131 nonpsychologists are prescribers.

Robiner and Tompkins noted that it’s not clear why so few psychologists are pursuing RxP but that many seem to be unaware of the possibility.

 

Do Benefits Outweigh the Harms? 

There is not a large body of literature assessing the harms or benefits of prescribing privileges for psychologists.

Baker shared several studies by Phillip Hughes, PhD, an outcomes researcher at the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. In one study, Hughes found that patients of prescribing psychologists had a 24% lower rate of adverse drug events than patients of psychiatrists. Psychologists’ patients had lower rates of psychotropic polypharmacy but similar rates of emergency room use.

In another paper Hughes suggested that deaths attributable to mental illness had declined in New Mexico after it passed its law. There was no change in Louisiana.

With little evidence of harm — and ongoing provider shortages — making use of nonphysician prescribers is gaining traction with policymakers, claims the psychology association’s Baker, adding that in Utah, the Republican governor was the biggest supporter.

But psychiatrists argue that it’s more important to increase their numbers. Congress agreed in 2021 and 2023 to add 1200 new residency slots — in every specialty — to ease physician shortages. The Centers for Medicare & Medicaid Services recently announced that 70% of the new slots for July 2025 will go to primary care and psychiatry.

“Once those positions are in place, it will be four more years before the first crop of new psychiatrists come out,” noted Trestman. “None of these fixes are quick,” he said.

Baker, Robiner, and Trestman reported no relevant financial relationships.

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

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

• Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
• Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
• Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

• Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
• Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
• Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

• Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
• Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
• Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

Two Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting access to a life-changing and life-saving medication for people with schizophrenia.

Members of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting on November 19 to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again. Clozapine — the only FDA-approved drug for treatment-resistant schizophrenia — can cause severe neutropenia, so is subject to a Risk Evaluation and Management Strategy (REMS).

Calling the current rules overly burdensome, a majority of committee members voted against continuing a requirement that pharmacies and physicians must provide documentation of a patient’s absolute neutrophil count (ANC) results through the REMS. Monitoring should continue, as directed in the labeling, said the panel.

Panelists also voted overwhelmingly that it is not necessary to mandate physician education about clozapine’s risk of neutropenia and the need for ANC monitoring.

The panel did not vote, however, on whether the REMS should be eliminated altogether. The FDA did not pose that as a voting question for the panels’ consideration.

Following intense lobbying by the American Psychiatric Association (APA), the National Alliance on Mental Illness, and others, the FDA announced in 2022 that the agency would exercise “enforcement discretion” by allowing prescribers and pharmacists to skirt the clozapine REMS rules. But the agency doesn’t know whether the program is meeting its goals, said Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research.

Among other things, the REMS requires that physicians and pharmacists be certified to prescribe and dispense the drug, that patients be enrolled, and that patient status forms be submitted monthly, showing ANC levels and appropriateness of continuing treatment. 

At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000–1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine.

“We know the drug is being underutilized,” said Farchione, adding that the agency wants to ensure that physicians and pharmacists “can use the drug, use it safely and help the patients who need it.” 

 

REMS a ‘Hindrance’

As reported by this news organization, research presented earlier this year at the APA annual meeting showed that the risk of moderate and severe neutropenia is low to minimal in people taking clozapine for treatment-resistant schizophrenia. Those findings prompted the study’s investigators to suggest clozapine REMS should be reconsidered.

In the November 19th committee meeting, many panelists said that clozapine was no more dangerous than many antipsychotics and that the administrative requirements were preventing clinicians from prescribing.

“I have fantasized for years about abolishing the clozapine REMS,” said Jacob S. Ballon, MD, MPH, a temporary panel member and associate professor of psychiatry at Stanford University in California.

Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, agreed.

“I strongly feel that the REMS at this point is just a hindrance,” Narendran said. “I think you should get rid of the REMS.”

However, panelist Walter Dunn, MD, PhD, staff psychiatrist at the VA Greater Los Angeles Healthcare System, cautioned that modifying or eliminating the REMS might not necessarily increase prescribers. If monitoring ANC levels is still recommended in labeling, clinicians will still regard it as the standard of care, said Dunn. And “there are a whole host of other issues associated with clozapine,” that he said were “more concerning.” 

Many patients are accessing clozapine without going through the REMS, which is also of concern to the FDA and drug manufacturers. 

“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers.

Leah Hart, PharmD, a risk management analyst with the FDA, told the panel that the agency estimates that 25%-35% of patients taking clozapine may not be participating in the REMS. 

“Today, prescribers, pharmacies, and patients do not have to participate in the REMS in order patients to obtain clozapine,” Hart said.

 

Public Testimony Sways Panel

But psychiatrists, pharmacists, families, and patients who testified during the 90-minute open portion of the meeting disagreed with that assessment, saying the REMS program had a devastatingly chilling effect on clozapine access.

Patty Taggart of Las Vegas said her daughter had nine suicide attempts over the past 14 years, while having tried eight different antipsychotics. In August, after the most-recent attempt, Taggart begged the psychiatrist to prescribe clozapine to her daughter. The clinician refused, citing the REMS. After her daughter’s discharge, Taggart said she found another provider who would prescribe the medication.

Lisa Castellanos said her son Daniel had been treated with a variety of antipsychotics but denied clozapine until he was arrested in 2012 for assault during a psychotic break. The state used the medication to improve Daniel’s mental state so he could stand trial. But when he went to jail after accepting a plea deal, the prison stopped the clozapine. Daniel has since deteriorated and was recently ruled ineligible for parole.

Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements. 

Many panelists said they were moved by patients and family testimony. A dozen or more members of the public were wearing black t-shirts with white writing that declared: “Clozapine is the safest antipsychotic in the world.” 

 

‘Blood-for-Drug Program’

Brian Barnett, MD, director of the psychiatric treatment-resistance program at the Cleveland Clinic in Ohio, said during the public portion of the meeting that “many pharmacies simply refuse to dispense clozapine likely because of the administrative burden and lack of financial incentives.” 

Others want faxed lab results even when the results have been filed electronically, he said. “One of the most dangerous features of the current REMS system is its inflexibility, driven by the so-called ‘no blood, no drug’ ethos which has been baked into the minds of America’s pharmacists.”

“This is a blood-for-drug program,” agreed Rachel Strieff of Tempe, Arizona, who noted that her advocacy group, Angry Moms, and others had submitted 4,000 signatures calling for the end of the REMS. “The largest category of patients harmed by the clozapine REMS have never taken a single dose,” she said, noting that millions of eligible individuals are not getting the drug.

Panel chair James Floyd, MD, professor of medicine at the University of Washington, Seattle, said the public testimony was “very moving.” Families and patients had described “the intensity of suffering that people go through prior to getting to clozapine,” he added.

“We have to listen to that,” said Floyd.


“I want you to know that we hear you,” said Farchione. “We’re here today because of you and your loved ones. And your stories are important, and your experience is important, and what you’ve shared today will have an impact on regulatory decision making.”

While the FDA typically follows its panels’ advice, it’s unclear if the agency will do so for clozapine REMS or when it will release its final decision.

A version of this article appeared on Medscape.com.

Two Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting access to a life-changing and life-saving medication for people with schizophrenia.

Members of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting on November 19 to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again. Clozapine — the only FDA-approved drug for treatment-resistant schizophrenia — can cause severe neutropenia, so is subject to a Risk Evaluation and Management Strategy (REMS).

Calling the current rules overly burdensome, a majority of committee members voted against continuing a requirement that pharmacies and physicians must provide documentation of a patient’s absolute neutrophil count (ANC) results through the REMS. Monitoring should continue, as directed in the labeling, said the panel.

Panelists also voted overwhelmingly that it is not necessary to mandate physician education about clozapine’s risk of neutropenia and the need for ANC monitoring.

The panel did not vote, however, on whether the REMS should be eliminated altogether. The FDA did not pose that as a voting question for the panels’ consideration.

Following intense lobbying by the American Psychiatric Association (APA), the National Alliance on Mental Illness, and others, the FDA announced in 2022 that the agency would exercise “enforcement discretion” by allowing prescribers and pharmacists to skirt the clozapine REMS rules. But the agency doesn’t know whether the program is meeting its goals, said Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research.

Among other things, the REMS requires that physicians and pharmacists be certified to prescribe and dispense the drug, that patients be enrolled, and that patient status forms be submitted monthly, showing ANC levels and appropriateness of continuing treatment. 

At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000–1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine.

“We know the drug is being underutilized,” said Farchione, adding that the agency wants to ensure that physicians and pharmacists “can use the drug, use it safely and help the patients who need it.” 

 

REMS a ‘Hindrance’

As reported by this news organization, research presented earlier this year at the APA annual meeting showed that the risk of moderate and severe neutropenia is low to minimal in people taking clozapine for treatment-resistant schizophrenia. Those findings prompted the study’s investigators to suggest clozapine REMS should be reconsidered.

In the November 19th committee meeting, many panelists said that clozapine was no more dangerous than many antipsychotics and that the administrative requirements were preventing clinicians from prescribing.

“I have fantasized for years about abolishing the clozapine REMS,” said Jacob S. Ballon, MD, MPH, a temporary panel member and associate professor of psychiatry at Stanford University in California.

Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, agreed.

“I strongly feel that the REMS at this point is just a hindrance,” Narendran said. “I think you should get rid of the REMS.”

However, panelist Walter Dunn, MD, PhD, staff psychiatrist at the VA Greater Los Angeles Healthcare System, cautioned that modifying or eliminating the REMS might not necessarily increase prescribers. If monitoring ANC levels is still recommended in labeling, clinicians will still regard it as the standard of care, said Dunn. And “there are a whole host of other issues associated with clozapine,” that he said were “more concerning.” 

Many patients are accessing clozapine without going through the REMS, which is also of concern to the FDA and drug manufacturers. 

“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers.

Leah Hart, PharmD, a risk management analyst with the FDA, told the panel that the agency estimates that 25%-35% of patients taking clozapine may not be participating in the REMS. 

“Today, prescribers, pharmacies, and patients do not have to participate in the REMS in order patients to obtain clozapine,” Hart said.

 

Public Testimony Sways Panel

But psychiatrists, pharmacists, families, and patients who testified during the 90-minute open portion of the meeting disagreed with that assessment, saying the REMS program had a devastatingly chilling effect on clozapine access.

Patty Taggart of Las Vegas said her daughter had nine suicide attempts over the past 14 years, while having tried eight different antipsychotics. In August, after the most-recent attempt, Taggart begged the psychiatrist to prescribe clozapine to her daughter. The clinician refused, citing the REMS. After her daughter’s discharge, Taggart said she found another provider who would prescribe the medication.

Lisa Castellanos said her son Daniel had been treated with a variety of antipsychotics but denied clozapine until he was arrested in 2012 for assault during a psychotic break. The state used the medication to improve Daniel’s mental state so he could stand trial. But when he went to jail after accepting a plea deal, the prison stopped the clozapine. Daniel has since deteriorated and was recently ruled ineligible for parole.

Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements. 

Many panelists said they were moved by patients and family testimony. A dozen or more members of the public were wearing black t-shirts with white writing that declared: “Clozapine is the safest antipsychotic in the world.” 

 

‘Blood-for-Drug Program’

Brian Barnett, MD, director of the psychiatric treatment-resistance program at the Cleveland Clinic in Ohio, said during the public portion of the meeting that “many pharmacies simply refuse to dispense clozapine likely because of the administrative burden and lack of financial incentives.” 

Others want faxed lab results even when the results have been filed electronically, he said. “One of the most dangerous features of the current REMS system is its inflexibility, driven by the so-called ‘no blood, no drug’ ethos which has been baked into the minds of America’s pharmacists.”

“This is a blood-for-drug program,” agreed Rachel Strieff of Tempe, Arizona, who noted that her advocacy group, Angry Moms, and others had submitted 4,000 signatures calling for the end of the REMS. “The largest category of patients harmed by the clozapine REMS have never taken a single dose,” she said, noting that millions of eligible individuals are not getting the drug.

Panel chair James Floyd, MD, professor of medicine at the University of Washington, Seattle, said the public testimony was “very moving.” Families and patients had described “the intensity of suffering that people go through prior to getting to clozapine,” he added.

“We have to listen to that,” said Floyd.


“I want you to know that we hear you,” said Farchione. “We’re here today because of you and your loved ones. And your stories are important, and your experience is important, and what you’ve shared today will have an impact on regulatory decision making.”

While the FDA typically follows its panels’ advice, it’s unclear if the agency will do so for clozapine REMS or when it will release its final decision.

A version of this article appeared on Medscape.com.

Two Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting access to a life-changing and life-saving medication for people with schizophrenia.

Members of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting on November 19 to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again. Clozapine — the only FDA-approved drug for treatment-resistant schizophrenia — can cause severe neutropenia, so is subject to a Risk Evaluation and Management Strategy (REMS).

Calling the current rules overly burdensome, a majority of committee members voted against continuing a requirement that pharmacies and physicians must provide documentation of a patient’s absolute neutrophil count (ANC) results through the REMS. Monitoring should continue, as directed in the labeling, said the panel.

Panelists also voted overwhelmingly that it is not necessary to mandate physician education about clozapine’s risk of neutropenia and the need for ANC monitoring.

The panel did not vote, however, on whether the REMS should be eliminated altogether. The FDA did not pose that as a voting question for the panels’ consideration.

Following intense lobbying by the American Psychiatric Association (APA), the National Alliance on Mental Illness, and others, the FDA announced in 2022 that the agency would exercise “enforcement discretion” by allowing prescribers and pharmacists to skirt the clozapine REMS rules. But the agency doesn’t know whether the program is meeting its goals, said Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research.

Among other things, the REMS requires that physicians and pharmacists be certified to prescribe and dispense the drug, that patients be enrolled, and that patient status forms be submitted monthly, showing ANC levels and appropriateness of continuing treatment. 

At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000–1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine.

“We know the drug is being underutilized,” said Farchione, adding that the agency wants to ensure that physicians and pharmacists “can use the drug, use it safely and help the patients who need it.” 

 

REMS a ‘Hindrance’

As reported by this news organization, research presented earlier this year at the APA annual meeting showed that the risk of moderate and severe neutropenia is low to minimal in people taking clozapine for treatment-resistant schizophrenia. Those findings prompted the study’s investigators to suggest clozapine REMS should be reconsidered.

In the November 19th committee meeting, many panelists said that clozapine was no more dangerous than many antipsychotics and that the administrative requirements were preventing clinicians from prescribing.

“I have fantasized for years about abolishing the clozapine REMS,” said Jacob S. Ballon, MD, MPH, a temporary panel member and associate professor of psychiatry at Stanford University in California.

Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, agreed.

“I strongly feel that the REMS at this point is just a hindrance,” Narendran said. “I think you should get rid of the REMS.”

However, panelist Walter Dunn, MD, PhD, staff psychiatrist at the VA Greater Los Angeles Healthcare System, cautioned that modifying or eliminating the REMS might not necessarily increase prescribers. If monitoring ANC levels is still recommended in labeling, clinicians will still regard it as the standard of care, said Dunn. And “there are a whole host of other issues associated with clozapine,” that he said were “more concerning.” 

Many patients are accessing clozapine without going through the REMS, which is also of concern to the FDA and drug manufacturers. 

“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers.

Leah Hart, PharmD, a risk management analyst with the FDA, told the panel that the agency estimates that 25%-35% of patients taking clozapine may not be participating in the REMS. 

“Today, prescribers, pharmacies, and patients do not have to participate in the REMS in order patients to obtain clozapine,” Hart said.

 

Public Testimony Sways Panel

But psychiatrists, pharmacists, families, and patients who testified during the 90-minute open portion of the meeting disagreed with that assessment, saying the REMS program had a devastatingly chilling effect on clozapine access.

Patty Taggart of Las Vegas said her daughter had nine suicide attempts over the past 14 years, while having tried eight different antipsychotics. In August, after the most-recent attempt, Taggart begged the psychiatrist to prescribe clozapine to her daughter. The clinician refused, citing the REMS. After her daughter’s discharge, Taggart said she found another provider who would prescribe the medication.

Lisa Castellanos said her son Daniel had been treated with a variety of antipsychotics but denied clozapine until he was arrested in 2012 for assault during a psychotic break. The state used the medication to improve Daniel’s mental state so he could stand trial. But when he went to jail after accepting a plea deal, the prison stopped the clozapine. Daniel has since deteriorated and was recently ruled ineligible for parole.

Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements. 

Many panelists said they were moved by patients and family testimony. A dozen or more members of the public were wearing black t-shirts with white writing that declared: “Clozapine is the safest antipsychotic in the world.” 

 

‘Blood-for-Drug Program’

Brian Barnett, MD, director of the psychiatric treatment-resistance program at the Cleveland Clinic in Ohio, said during the public portion of the meeting that “many pharmacies simply refuse to dispense clozapine likely because of the administrative burden and lack of financial incentives.” 

Others want faxed lab results even when the results have been filed electronically, he said. “One of the most dangerous features of the current REMS system is its inflexibility, driven by the so-called ‘no blood, no drug’ ethos which has been baked into the minds of America’s pharmacists.”

“This is a blood-for-drug program,” agreed Rachel Strieff of Tempe, Arizona, who noted that her advocacy group, Angry Moms, and others had submitted 4,000 signatures calling for the end of the REMS. “The largest category of patients harmed by the clozapine REMS have never taken a single dose,” she said, noting that millions of eligible individuals are not getting the drug.

Panel chair James Floyd, MD, professor of medicine at the University of Washington, Seattle, said the public testimony was “very moving.” Families and patients had described “the intensity of suffering that people go through prior to getting to clozapine,” he added.

“We have to listen to that,” said Floyd.


“I want you to know that we hear you,” said Farchione. “We’re here today because of you and your loved ones. And your stories are important, and your experience is important, and what you’ve shared today will have an impact on regulatory decision making.”

While the FDA typically follows its panels’ advice, it’s unclear if the agency will do so for clozapine REMS or when it will release its final decision.

A version of this article appeared on Medscape.com.