MDedge Neurology

Noninvasive brain stimulation has the potential to boost a patient’s placebo experience or blunt the nocebo experience, according to results of a new study published in the Proceedings of the National Academy of Sciences (PNAS).

“Placebo and nocebo effects are a critical component of clinical care and efficacy studies,” said senior author Jian Kong, MD, associate professor in the department of psychiatry at Massachusetts General Hospital, Charlestown campus. “Harnessing these effects in clinical practice and research could facilitate the development of new pain management methods,” he said. “Healing may involve multiple components: the self-healing properties of the body; the nonspecific effects of treatment (i.e., placebo effect); and the specific effect of a physical or pharmacologic intervention. Therefore, enhancing the placebo effect may ultimately boost the overall therapeutic effect of existing treatment,” he explained, emphasizing that the results are preliminary and should be interpreted with caution.

The authors noted that reducing nocebo effects could also be a major benefit “since patients discontinue prescribed medications, make unnecessary medical visits, and take additional medications to counteract adverse effects that are actually nocebo effects.”


 

Testing the hypothesis

The randomized, double-blind, sham-controlled study used transcranial direct current stimulation (tDCS), which delivers an electrical current to the brain via scalp electrodes. The aim was to see if stimulating the dorsolateral prefrontal cortex with tDCS could alter the brain’s perception of placebo and nocebo experiences.

The study included 81 participants (37 females, mean age: 27.4 years), who were randomized into one of three tDCS groups (anodal, cathodal, or sham).

All participants were first conditioned to believe that an inert cream was either lidocaine or capsaicin and that this cream could either dull the impact of a painful heat stimulus (placebo analgesia) or exacerbate it (nocebo hyperalgesia). Participants were then placed into a functional MRI scanner where tDCS was initiated. Painful stimuli were then applied to spots on their forearms where they believed they had either lidocaine, capsaicin, or a neutral control cream and they rated the pain using the Gracely Sensory Scale.

Placebo analgesia was defined as the difference between perceived pain intensity where participants believed they had lidocaine cream compared with where they believed they had control cream. Nocebo hyperalgesia was defined as the difference between perceived pain intensity where they believed they had capsaicin cream compared with where they believed they had control cream.

The researchers found that compared with sham tDCS, cathodal tDCS showed significant effects in increasing placebo analgesia and brain responses in the ventromedial prefrontal cortex (vmPFC), while anodal tDCS showed significant effects in inhibiting nocebo hyperalgesia and brain responses in the insula.

“The potential to enhance salubrious placebo effects and/or diminish treatment-interfering nocebo effects may have clinical significance,” the authors noted. “For example, clinical studies have suggested that expectancy is positively associated with chronic pain improvement, and using conditioning-like expectancy manipulation, we have shown that significantly boosting expectancy can improve treatment outcome.”
 

Proof of concept

Asked to comment on the study, Brian E. McGeeney, MD, of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston, said “the findings are a proof of concept that it is possible to use noninvasive brain stimulation to modulate placebo and nocebo pain effects.”

Although the findings do not have immediate clinical application, they are “exciting” and “break new ground in expectancy research,” he said.

“It is important to recognize that the researchers are trying to utilize a purported expectancy mechanism rather than attempting to alter placebo/nocebo by verbal and other cues. It remains to be seen whether the manipulation of brief experimental pain like this can translate into altered chronic pain over time, the main clinical goal. Current tDCS therapy for various reasons is necessarily brief and one can ask whether there are meaningful changes from brief stimulation. Such results can foster speculation as to whether direct strategic placement of intracranial stimulation leads could result in more longstanding similar benefits.”

Dr. Kong holds equity in a startup company (MNT) and a pending patent to develop new peripheral neuromodulation tools, but declares no conflict of interest. All other authors declare no conflict of interest.

Noninvasive brain stimulation has the potential to boost a patient’s placebo experience or blunt the nocebo experience, according to results of a new study published in the Proceedings of the National Academy of Sciences (PNAS).

“Placebo and nocebo effects are a critical component of clinical care and efficacy studies,” said senior author Jian Kong, MD, associate professor in the department of psychiatry at Massachusetts General Hospital, Charlestown campus. “Harnessing these effects in clinical practice and research could facilitate the development of new pain management methods,” he said. “Healing may involve multiple components: the self-healing properties of the body; the nonspecific effects of treatment (i.e., placebo effect); and the specific effect of a physical or pharmacologic intervention. Therefore, enhancing the placebo effect may ultimately boost the overall therapeutic effect of existing treatment,” he explained, emphasizing that the results are preliminary and should be interpreted with caution.

The authors noted that reducing nocebo effects could also be a major benefit “since patients discontinue prescribed medications, make unnecessary medical visits, and take additional medications to counteract adverse effects that are actually nocebo effects.”


 

Testing the hypothesis

The randomized, double-blind, sham-controlled study used transcranial direct current stimulation (tDCS), which delivers an electrical current to the brain via scalp electrodes. The aim was to see if stimulating the dorsolateral prefrontal cortex with tDCS could alter the brain’s perception of placebo and nocebo experiences.

The study included 81 participants (37 females, mean age: 27.4 years), who were randomized into one of three tDCS groups (anodal, cathodal, or sham).

All participants were first conditioned to believe that an inert cream was either lidocaine or capsaicin and that this cream could either dull the impact of a painful heat stimulus (placebo analgesia) or exacerbate it (nocebo hyperalgesia). Participants were then placed into a functional MRI scanner where tDCS was initiated. Painful stimuli were then applied to spots on their forearms where they believed they had either lidocaine, capsaicin, or a neutral control cream and they rated the pain using the Gracely Sensory Scale.

Placebo analgesia was defined as the difference between perceived pain intensity where participants believed they had lidocaine cream compared with where they believed they had control cream. Nocebo hyperalgesia was defined as the difference between perceived pain intensity where they believed they had capsaicin cream compared with where they believed they had control cream.

The researchers found that compared with sham tDCS, cathodal tDCS showed significant effects in increasing placebo analgesia and brain responses in the ventromedial prefrontal cortex (vmPFC), while anodal tDCS showed significant effects in inhibiting nocebo hyperalgesia and brain responses in the insula.

“The potential to enhance salubrious placebo effects and/or diminish treatment-interfering nocebo effects may have clinical significance,” the authors noted. “For example, clinical studies have suggested that expectancy is positively associated with chronic pain improvement, and using conditioning-like expectancy manipulation, we have shown that significantly boosting expectancy can improve treatment outcome.”
 

Proof of concept

Asked to comment on the study, Brian E. McGeeney, MD, of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston, said “the findings are a proof of concept that it is possible to use noninvasive brain stimulation to modulate placebo and nocebo pain effects.”

Although the findings do not have immediate clinical application, they are “exciting” and “break new ground in expectancy research,” he said.

“It is important to recognize that the researchers are trying to utilize a purported expectancy mechanism rather than attempting to alter placebo/nocebo by verbal and other cues. It remains to be seen whether the manipulation of brief experimental pain like this can translate into altered chronic pain over time, the main clinical goal. Current tDCS therapy for various reasons is necessarily brief and one can ask whether there are meaningful changes from brief stimulation. Such results can foster speculation as to whether direct strategic placement of intracranial stimulation leads could result in more longstanding similar benefits.”

Dr. Kong holds equity in a startup company (MNT) and a pending patent to develop new peripheral neuromodulation tools, but declares no conflict of interest. All other authors declare no conflict of interest.

Noninvasive brain stimulation has the potential to boost a patient’s placebo experience or blunt the nocebo experience, according to results of a new study published in the Proceedings of the National Academy of Sciences (PNAS).

“Placebo and nocebo effects are a critical component of clinical care and efficacy studies,” said senior author Jian Kong, MD, associate professor in the department of psychiatry at Massachusetts General Hospital, Charlestown campus. “Harnessing these effects in clinical practice and research could facilitate the development of new pain management methods,” he said. “Healing may involve multiple components: the self-healing properties of the body; the nonspecific effects of treatment (i.e., placebo effect); and the specific effect of a physical or pharmacologic intervention. Therefore, enhancing the placebo effect may ultimately boost the overall therapeutic effect of existing treatment,” he explained, emphasizing that the results are preliminary and should be interpreted with caution.

The authors noted that reducing nocebo effects could also be a major benefit “since patients discontinue prescribed medications, make unnecessary medical visits, and take additional medications to counteract adverse effects that are actually nocebo effects.”


 

Testing the hypothesis

The randomized, double-blind, sham-controlled study used transcranial direct current stimulation (tDCS), which delivers an electrical current to the brain via scalp electrodes. The aim was to see if stimulating the dorsolateral prefrontal cortex with tDCS could alter the brain’s perception of placebo and nocebo experiences.

The study included 81 participants (37 females, mean age: 27.4 years), who were randomized into one of three tDCS groups (anodal, cathodal, or sham).

All participants were first conditioned to believe that an inert cream was either lidocaine or capsaicin and that this cream could either dull the impact of a painful heat stimulus (placebo analgesia) or exacerbate it (nocebo hyperalgesia). Participants were then placed into a functional MRI scanner where tDCS was initiated. Painful stimuli were then applied to spots on their forearms where they believed they had either lidocaine, capsaicin, or a neutral control cream and they rated the pain using the Gracely Sensory Scale.

Placebo analgesia was defined as the difference between perceived pain intensity where participants believed they had lidocaine cream compared with where they believed they had control cream. Nocebo hyperalgesia was defined as the difference between perceived pain intensity where they believed they had capsaicin cream compared with where they believed they had control cream.

The researchers found that compared with sham tDCS, cathodal tDCS showed significant effects in increasing placebo analgesia and brain responses in the ventromedial prefrontal cortex (vmPFC), while anodal tDCS showed significant effects in inhibiting nocebo hyperalgesia and brain responses in the insula.

“The potential to enhance salubrious placebo effects and/or diminish treatment-interfering nocebo effects may have clinical significance,” the authors noted. “For example, clinical studies have suggested that expectancy is positively associated with chronic pain improvement, and using conditioning-like expectancy manipulation, we have shown that significantly boosting expectancy can improve treatment outcome.”
 

Proof of concept

Asked to comment on the study, Brian E. McGeeney, MD, of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston, said “the findings are a proof of concept that it is possible to use noninvasive brain stimulation to modulate placebo and nocebo pain effects.”

Although the findings do not have immediate clinical application, they are “exciting” and “break new ground in expectancy research,” he said.

“It is important to recognize that the researchers are trying to utilize a purported expectancy mechanism rather than attempting to alter placebo/nocebo by verbal and other cues. It remains to be seen whether the manipulation of brief experimental pain like this can translate into altered chronic pain over time, the main clinical goal. Current tDCS therapy for various reasons is necessarily brief and one can ask whether there are meaningful changes from brief stimulation. Such results can foster speculation as to whether direct strategic placement of intracranial stimulation leads could result in more longstanding similar benefits.”

Dr. Kong holds equity in a startup company (MNT) and a pending patent to develop new peripheral neuromodulation tools, but declares no conflict of interest. All other authors declare no conflict of interest.

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Ubrelvy and Nurtec are the latest in acute migraine treatment, both with solid data to back them up.

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

Ubrelvy and Nurtec are the latest in acute migraine treatment, both with solid data to back them up.

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

Ubrelvy and Nurtec are the latest in acute migraine treatment, both with solid data to back them up.

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

A novel, once-nightly formulation of sodium oxybate is safe and effective for treating both subjective and objective symptoms of narcolepsy, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its coprimary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and 9 g). Patients receiving the drug showed significantly greater improvements on the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CGI-I), and mean weekly attacks of cataplexy, compared with those who received placebo.

The new analyses, which focused on key secondary outcomes, showed that all three doses of the novel agent were associated with significant improvements in sleep quality, refreshing nature of sleep, sleep paralysis, disturbed nocturnal sleep, and scores on the Epworth Sleepiness Scale (ESS).

Principal investigator Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, New York, said in a news release that the results represent “the promise of a potential new treatment strategy for physicians and patients.”

“I am particularly impressed by the consistency of results as early as 3 weeks with only a 6-g dose,” he added.

Dr. Thorpy, who is also a professor of neurology at the Albert Einstein College of Medicine, noted that the new formulation will be more convenient for patients. “The advantage of this medication is its once-nightly formulation, so patients don’t need to awaken during the night and can actually have a better night’s sleep,” he said.

Dr. Thorpy presented the study findings at the 2021 annual meeting of the American Academy of Neurology.

FT218 is currently under review by the U.S. Food and Drug Administration, which has set Oct. 15 as the Prescription Drug User Fee Act target date.

Forced awakening

Sodium oxybate was first approved by the FDA in 2002 to treat cataplexy in adults with narcolepsy and was expanded in 2005 to also treat excessive daytime sleepiness (EDS). That formulation is indicated for twice-nightly administration, with the second dose taken 2.5-4 hours after the first.

“The need for forced awakening to take the second dose ... may result in noncompliance, which may lead to reduced efficacy and/or mistimed doses,” the investigators noted.

FT218 is a modified-release version of sodium oxybate. A single 6-g dose of the investigational agent “has shown bioequivalent exposure to twice-nightly immediate-release [sodium oxybate] given as two 3-g doses,” wrote the researchers.

It also currently has Orphan Drug Designation from the FDA for the treatment of narcolepsy.

The randomized, double-blind, placebo-controlled, multicenter REST-ON study was conducted from November 2016 to March 2020 and included patients 16 years or older who had narcolepsy type 1 or type 2.

Patients received the active treatment (n = 107; mean age, 30.9 years; 64.5% women) or placebo (n = 105; mean age, 31.6 years; 71.4% women) according to a four-period forced uptitration dosing schedule of 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks.

Secondary outcome measures included the ESS, sleep quality/refreshing nature of sleep on a visual analog scale, sleep paralysis and hypnagogic hallucinations on a sleep symptoms diary, disturbed nocturnal sleep on polysomnographic measures, and number of arousals as defined per the American Academy of Sleep Medicine Score Manual.

Reports of adverse events (AEs) were collected from time of informed consent until 7 days after the last dose received.

Improvement across doses

Results showed that, compared with placebo, improvement in disturbed nocturnal sleep from baseline was significantly greater for the active treatment at 6 g at week 3 (mean between-group difference, –11; P < .001), at 7.5 g at week 8 (mean difference, –17.7; P < .001), and at 9 g at week 13 (mean difference, –22.6; P < .001).

The mean difference between the three doses and placebo for reduction in number of arousals was –11.3 (P < .05), –19.4 (P < .001), and –23.7 (P < .001), respectively. And the 6 g at week 3, 7.5 g at week 8, and 9 g at week 13 doses showed significant (P < .001) improvements versus placebo on the ESS (mean difference, –2.1, –3.2, and –3.9, respectively).

All three doses also showed significant improvement in sleep quality and refreshing nature of sleep (P < .001 for all comparisons), as well as improvement of sleep paralysis (P = .04, P = .02, and P = .04, respectively).

There were no significant differences between FT218 and placebo for improvement in hypnagogic hallucinations. Dr. Thorpy noted that the number of patients with baseline hallucinations “was relatively small,” which may have led to this finding. “Had there been a much larger population with hallucinations, I suspect that we would have seen a statistically significant improvement there as well,” he said.

Generally well tolerated

The investigators noted that FT218 was “generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions.”

Treatment-related AEs that occurred in more than 2% of the patients receiving FT218 included nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Seven serious AEs were reported, including five in those assigned to the active treatment. This included one case each of diabetes inadequate control, paresthesia, perirectal abscess, hypertension, and suicidal ideation. Only the case of suicidal ideation was considered to be a treatment-related AE.

The investigators noted that, although they have not yet delved into subgroup analysis to look for differences among sex, age, or race, they plan to do so in the future.

Overall, the results indicate that “FT218 is an effective agent not only for the major symptoms of sleepiness and cataplexy, but also the quality of sleep at night,” said Dr. Thorpy.

Asked whether he thinks the FDA will approve the drug, he said that it should be “straightforward” because it’s just a different formulation of an already-approved agent. “I very much expect there will not be any problems in this medication being approved,” Dr. Thorpy said.

Benefits ‘sleep architecture’

Commenting on the findings, Logan Schneider, MD, codirector of the Stanford/VA Alzheimer’s Center and clinical assistant professor at the Stanford Sleep Center, Redwood City, Calif., said that the investigators’ focus on these secondary outcomes “was really worthwhile.”

Dr. Schneider, who was not involved in the research, noted that, because the study only included patients with narcolepsy, the results can’t be extrapolated to groups who have other sleep disorders.

Still, “it is worthwhile now to expand beyond the two primary symptoms that are, in my consideration, life threatening: daytime sleepiness and cataplexy. We should also address more of the quality of life and other aspects of narcolepsy, including disturbed nocturnal sleep and sleep quality issues related to that,” he said.

“Being able to address those aspects and say, ‘I have a therapy that clearly helps the multidimensionality of our patients’ is very vindicating,” Dr. Schneider noted.

He was also impressed with the various measures the researchers used, rather than relying just on patient reports, “which are subject to recollection difficulties. This was a nice way to quantify possibly as a diagnostic marker the underlying disruption of sleep, as well as a possible treatment marker to show how well a therapy works.”

“It actually shows a beneficial effect on sleep architecture,” Dr. Schneider said.

The study was funded by Avadel Pharmaceuticals. Dr. Thorpy is a consultant/advisory board member for Avadel, Axsome, Balance Therapeutics, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceutical. Dr. Schneider reports being an adviser and/or on the speakers’ bureau for similar drugs by Jazz Pharmaceuticals and Harmony Biosciences.

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

A novel, once-nightly formulation of sodium oxybate is safe and effective for treating both subjective and objective symptoms of narcolepsy, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its coprimary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and 9 g). Patients receiving the drug showed significantly greater improvements on the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CGI-I), and mean weekly attacks of cataplexy, compared with those who received placebo.

The new analyses, which focused on key secondary outcomes, showed that all three doses of the novel agent were associated with significant improvements in sleep quality, refreshing nature of sleep, sleep paralysis, disturbed nocturnal sleep, and scores on the Epworth Sleepiness Scale (ESS).

Principal investigator Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, New York, said in a news release that the results represent “the promise of a potential new treatment strategy for physicians and patients.”

“I am particularly impressed by the consistency of results as early as 3 weeks with only a 6-g dose,” he added.

Dr. Thorpy, who is also a professor of neurology at the Albert Einstein College of Medicine, noted that the new formulation will be more convenient for patients. “The advantage of this medication is its once-nightly formulation, so patients don’t need to awaken during the night and can actually have a better night’s sleep,” he said.

Dr. Thorpy presented the study findings at the 2021 annual meeting of the American Academy of Neurology.

FT218 is currently under review by the U.S. Food and Drug Administration, which has set Oct. 15 as the Prescription Drug User Fee Act target date.

Forced awakening

Sodium oxybate was first approved by the FDA in 2002 to treat cataplexy in adults with narcolepsy and was expanded in 2005 to also treat excessive daytime sleepiness (EDS). That formulation is indicated for twice-nightly administration, with the second dose taken 2.5-4 hours after the first.

“The need for forced awakening to take the second dose ... may result in noncompliance, which may lead to reduced efficacy and/or mistimed doses,” the investigators noted.

FT218 is a modified-release version of sodium oxybate. A single 6-g dose of the investigational agent “has shown bioequivalent exposure to twice-nightly immediate-release [sodium oxybate] given as two 3-g doses,” wrote the researchers.

It also currently has Orphan Drug Designation from the FDA for the treatment of narcolepsy.

The randomized, double-blind, placebo-controlled, multicenter REST-ON study was conducted from November 2016 to March 2020 and included patients 16 years or older who had narcolepsy type 1 or type 2.

Patients received the active treatment (n = 107; mean age, 30.9 years; 64.5% women) or placebo (n = 105; mean age, 31.6 years; 71.4% women) according to a four-period forced uptitration dosing schedule of 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks.

Secondary outcome measures included the ESS, sleep quality/refreshing nature of sleep on a visual analog scale, sleep paralysis and hypnagogic hallucinations on a sleep symptoms diary, disturbed nocturnal sleep on polysomnographic measures, and number of arousals as defined per the American Academy of Sleep Medicine Score Manual.

Reports of adverse events (AEs) were collected from time of informed consent until 7 days after the last dose received.

Improvement across doses

Results showed that, compared with placebo, improvement in disturbed nocturnal sleep from baseline was significantly greater for the active treatment at 6 g at week 3 (mean between-group difference, –11; P < .001), at 7.5 g at week 8 (mean difference, –17.7; P < .001), and at 9 g at week 13 (mean difference, –22.6; P < .001).

The mean difference between the three doses and placebo for reduction in number of arousals was –11.3 (P < .05), –19.4 (P < .001), and –23.7 (P < .001), respectively. And the 6 g at week 3, 7.5 g at week 8, and 9 g at week 13 doses showed significant (P < .001) improvements versus placebo on the ESS (mean difference, –2.1, –3.2, and –3.9, respectively).

All three doses also showed significant improvement in sleep quality and refreshing nature of sleep (P < .001 for all comparisons), as well as improvement of sleep paralysis (P = .04, P = .02, and P = .04, respectively).

There were no significant differences between FT218 and placebo for improvement in hypnagogic hallucinations. Dr. Thorpy noted that the number of patients with baseline hallucinations “was relatively small,” which may have led to this finding. “Had there been a much larger population with hallucinations, I suspect that we would have seen a statistically significant improvement there as well,” he said.

Generally well tolerated

The investigators noted that FT218 was “generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions.”

Treatment-related AEs that occurred in more than 2% of the patients receiving FT218 included nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Seven serious AEs were reported, including five in those assigned to the active treatment. This included one case each of diabetes inadequate control, paresthesia, perirectal abscess, hypertension, and suicidal ideation. Only the case of suicidal ideation was considered to be a treatment-related AE.

The investigators noted that, although they have not yet delved into subgroup analysis to look for differences among sex, age, or race, they plan to do so in the future.

Overall, the results indicate that “FT218 is an effective agent not only for the major symptoms of sleepiness and cataplexy, but also the quality of sleep at night,” said Dr. Thorpy.

Asked whether he thinks the FDA will approve the drug, he said that it should be “straightforward” because it’s just a different formulation of an already-approved agent. “I very much expect there will not be any problems in this medication being approved,” Dr. Thorpy said.

Benefits ‘sleep architecture’

Commenting on the findings, Logan Schneider, MD, codirector of the Stanford/VA Alzheimer’s Center and clinical assistant professor at the Stanford Sleep Center, Redwood City, Calif., said that the investigators’ focus on these secondary outcomes “was really worthwhile.”

Dr. Schneider, who was not involved in the research, noted that, because the study only included patients with narcolepsy, the results can’t be extrapolated to groups who have other sleep disorders.

Still, “it is worthwhile now to expand beyond the two primary symptoms that are, in my consideration, life threatening: daytime sleepiness and cataplexy. We should also address more of the quality of life and other aspects of narcolepsy, including disturbed nocturnal sleep and sleep quality issues related to that,” he said.

“Being able to address those aspects and say, ‘I have a therapy that clearly helps the multidimensionality of our patients’ is very vindicating,” Dr. Schneider noted.

He was also impressed with the various measures the researchers used, rather than relying just on patient reports, “which are subject to recollection difficulties. This was a nice way to quantify possibly as a diagnostic marker the underlying disruption of sleep, as well as a possible treatment marker to show how well a therapy works.”

“It actually shows a beneficial effect on sleep architecture,” Dr. Schneider said.

The study was funded by Avadel Pharmaceuticals. Dr. Thorpy is a consultant/advisory board member for Avadel, Axsome, Balance Therapeutics, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceutical. Dr. Schneider reports being an adviser and/or on the speakers’ bureau for similar drugs by Jazz Pharmaceuticals and Harmony Biosciences.

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

A novel, once-nightly formulation of sodium oxybate is safe and effective for treating both subjective and objective symptoms of narcolepsy, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its coprimary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and 9 g). Patients receiving the drug showed significantly greater improvements on the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CGI-I), and mean weekly attacks of cataplexy, compared with those who received placebo.

The new analyses, which focused on key secondary outcomes, showed that all three doses of the novel agent were associated with significant improvements in sleep quality, refreshing nature of sleep, sleep paralysis, disturbed nocturnal sleep, and scores on the Epworth Sleepiness Scale (ESS).

Principal investigator Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, New York, said in a news release that the results represent “the promise of a potential new treatment strategy for physicians and patients.”

“I am particularly impressed by the consistency of results as early as 3 weeks with only a 6-g dose,” he added.

Dr. Thorpy, who is also a professor of neurology at the Albert Einstein College of Medicine, noted that the new formulation will be more convenient for patients. “The advantage of this medication is its once-nightly formulation, so patients don’t need to awaken during the night and can actually have a better night’s sleep,” he said.

Dr. Thorpy presented the study findings at the 2021 annual meeting of the American Academy of Neurology.

FT218 is currently under review by the U.S. Food and Drug Administration, which has set Oct. 15 as the Prescription Drug User Fee Act target date.

Forced awakening

Sodium oxybate was first approved by the FDA in 2002 to treat cataplexy in adults with narcolepsy and was expanded in 2005 to also treat excessive daytime sleepiness (EDS). That formulation is indicated for twice-nightly administration, with the second dose taken 2.5-4 hours after the first.

“The need for forced awakening to take the second dose ... may result in noncompliance, which may lead to reduced efficacy and/or mistimed doses,” the investigators noted.

FT218 is a modified-release version of sodium oxybate. A single 6-g dose of the investigational agent “has shown bioequivalent exposure to twice-nightly immediate-release [sodium oxybate] given as two 3-g doses,” wrote the researchers.

It also currently has Orphan Drug Designation from the FDA for the treatment of narcolepsy.

The randomized, double-blind, placebo-controlled, multicenter REST-ON study was conducted from November 2016 to March 2020 and included patients 16 years or older who had narcolepsy type 1 or type 2.

Patients received the active treatment (n = 107; mean age, 30.9 years; 64.5% women) or placebo (n = 105; mean age, 31.6 years; 71.4% women) according to a four-period forced uptitration dosing schedule of 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks.

Secondary outcome measures included the ESS, sleep quality/refreshing nature of sleep on a visual analog scale, sleep paralysis and hypnagogic hallucinations on a sleep symptoms diary, disturbed nocturnal sleep on polysomnographic measures, and number of arousals as defined per the American Academy of Sleep Medicine Score Manual.

Reports of adverse events (AEs) were collected from time of informed consent until 7 days after the last dose received.

Improvement across doses

Results showed that, compared with placebo, improvement in disturbed nocturnal sleep from baseline was significantly greater for the active treatment at 6 g at week 3 (mean between-group difference, –11; P < .001), at 7.5 g at week 8 (mean difference, –17.7; P < .001), and at 9 g at week 13 (mean difference, –22.6; P < .001).

The mean difference between the three doses and placebo for reduction in number of arousals was –11.3 (P < .05), –19.4 (P < .001), and –23.7 (P < .001), respectively. And the 6 g at week 3, 7.5 g at week 8, and 9 g at week 13 doses showed significant (P < .001) improvements versus placebo on the ESS (mean difference, –2.1, –3.2, and –3.9, respectively).

All three doses also showed significant improvement in sleep quality and refreshing nature of sleep (P < .001 for all comparisons), as well as improvement of sleep paralysis (P = .04, P = .02, and P = .04, respectively).

There were no significant differences between FT218 and placebo for improvement in hypnagogic hallucinations. Dr. Thorpy noted that the number of patients with baseline hallucinations “was relatively small,” which may have led to this finding. “Had there been a much larger population with hallucinations, I suspect that we would have seen a statistically significant improvement there as well,” he said.

Generally well tolerated

The investigators noted that FT218 was “generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions.”

Treatment-related AEs that occurred in more than 2% of the patients receiving FT218 included nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Seven serious AEs were reported, including five in those assigned to the active treatment. This included one case each of diabetes inadequate control, paresthesia, perirectal abscess, hypertension, and suicidal ideation. Only the case of suicidal ideation was considered to be a treatment-related AE.

The investigators noted that, although they have not yet delved into subgroup analysis to look for differences among sex, age, or race, they plan to do so in the future.

Overall, the results indicate that “FT218 is an effective agent not only for the major symptoms of sleepiness and cataplexy, but also the quality of sleep at night,” said Dr. Thorpy.

Asked whether he thinks the FDA will approve the drug, he said that it should be “straightforward” because it’s just a different formulation of an already-approved agent. “I very much expect there will not be any problems in this medication being approved,” Dr. Thorpy said.

Benefits ‘sleep architecture’

Commenting on the findings, Logan Schneider, MD, codirector of the Stanford/VA Alzheimer’s Center and clinical assistant professor at the Stanford Sleep Center, Redwood City, Calif., said that the investigators’ focus on these secondary outcomes “was really worthwhile.”

Dr. Schneider, who was not involved in the research, noted that, because the study only included patients with narcolepsy, the results can’t be extrapolated to groups who have other sleep disorders.

Still, “it is worthwhile now to expand beyond the two primary symptoms that are, in my consideration, life threatening: daytime sleepiness and cataplexy. We should also address more of the quality of life and other aspects of narcolepsy, including disturbed nocturnal sleep and sleep quality issues related to that,” he said.

“Being able to address those aspects and say, ‘I have a therapy that clearly helps the multidimensionality of our patients’ is very vindicating,” Dr. Schneider noted.

He was also impressed with the various measures the researchers used, rather than relying just on patient reports, “which are subject to recollection difficulties. This was a nice way to quantify possibly as a diagnostic marker the underlying disruption of sleep, as well as a possible treatment marker to show how well a therapy works.”

“It actually shows a beneficial effect on sleep architecture,” Dr. Schneider said.

The study was funded by Avadel Pharmaceuticals. Dr. Thorpy is a consultant/advisory board member for Avadel, Axsome, Balance Therapeutics, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceutical. Dr. Schneider reports being an adviser and/or on the speakers’ bureau for similar drugs by Jazz Pharmaceuticals and Harmony Biosciences.

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

Motor problems in children may be a harbinger of serious mental illness, new research suggests.

Investigators found that motor abnormalities were twice as common among those who develop psychosis or depression, compared with their counterparts in the general population, suggesting that these abnormalities may help predict vulnerability and provide an opportunity for early intervention.

“We have learned there are motor signs that are measurable in adolescence [that are] more prevalent in these disorders,” said lead investigator Katherine S. F. Damme, PhD, adolescent development and preventive treatment program (ADAPT), Northwestern University, Chicago. 

A core symptom

There has been a lot of interest in the pathophysiology of psychosis and in detecting it early, said Dr. Damme. “It has devastating effects, and early intervention is of great importance,” she added.

However, previous research has typically focused on affect or cognition, rather than on motor signs, despite the fact that motor signs are a “core symptom of both psychosis and depression.”

The prevalence and presentation of motor signs in adolescence, which is a “critical time for identifying these risk markers” because of their proximity to the onset of psychosis, has been understudied, Dr. Damme said.

For their study, the investigators gathered motor function data from the Adolescent Brain Cognitive Development Study (ABCD), which included 10,835 children aged 9-11 years with broad demographic diversity from 21 sites across the United States.

Overall, 27.6% of the children were reported to have least one motor sign; approximately 3% were reported to have two or more motor signs.

The most common of these was dyscoordination, which was endorsed by 19.3% of participants. In addition, 8.8% were reported to have had experienced developmental motor delays, 1.5% had psychomotor agitation, and 0.3% had psychomotor retardation.

The investigators determined that 4.6% of participants met criteria for depression, 2.6% for a psychosis, and 1.8% for comorbid psychosis and depression.

Motor signs were much more common among children with depression, psychosis, or both than among those who did not have these conditions; 45.8% reported having at least one motor sign.

Developmental motor delays and dyscoordination occurred at about the same rate in both patients with depression and those with psychosis. Rates were higher among patients with both of these conditions than among those with either condition alone.

In contrast, psychomotor agitation was more common among patients with depression alone and among those with comorbid depression and psychosis than among patients with psychosis alone. The rate of psychomotor retardation was increased among patients with psychosis alone but was less common among patients with comorbidity than in the healthy control group.

Familial vulnerability

The investigators also assessed participants who had not been diagnosed with a mental illness but who had a family history of depression only (28.9%), a relative with psychosis-like experiences (0.6%), or a family history of both depression and psychosis experiences (1.8%).

Although the effect size was smaller, there was a higher rate of motor signs among participants with a family history of these conditions, Dr. Damme said. “Again, we see that it’s elevated across developmental motor delays and at a similar rate in people who have depression and psychosis.”

In addition, psychomotor agitation was linked to depression with psychosis and depression without it.

Sensorimotor connectivity network data for the cohort indicated there was no main effect of diagnosis on corticostriatal connectivity.

However, more depressive symptoms were related to less connectivity (P = .024). There was a similar finding for psychotic-like experiences. The total number of such experiences related to lower connectivity (P < .001).

During the postpresentation discussion, Ian Kelleher, MD, PhD, honorary clinical lecturer in psychiatry at the Royal College of Surgeons in Ireland, Dublin, said he was “surprised” by the finding that the rate of psychomotor retardation was lower among participants with psychosis and depression.

Dr. Damme noted that some of the motor sign item ratings came by way of a child interview and that some of these item ratings came from the adults in the children’s lives.

She added that she was not entirely sure whether asking an 8- to 11-year-old in a clinical interview whether they are experiencing motor signs “might be the best way to get at motor slowing.”

Subtle features

Commenting on the findings in an interview, Peter F. Liddle, MD, PhD, professor of psychiatry, at the University of Nottingham (England), noted that the “features we’re talking about are pretty subtle.

“What I’ve been wondering about for some time is whether we should be getting video recordings and using machine learning approaches to teach a computer to recognize normal movements vs abnormal movements, and particularly facial expression,” said Dr. Liddle, who was not involved with the research.

He called the current study “interesting” but noted several factors that affect the potential utility of the findings in predicting outcomes.

First, they “may not be very good for distinguishing schizophrenia from mood disorders; but if the question is simply determining which young person might go on to develop a significant mental disorder, then it may be useful,” Dr. Liddle said.

He endorsed the investigators’ conclusion that motor abnormalities may be a transdiagnostic marker. Beyond that, they may be “more useful as a predictor of the likely long-term severity, but that’s my own hypothesis based on my work,” he added.

Another question concerns the sensitivity of motor abnormalities as a predictive marker. With the rate of the abnormalities identified in those who developed psychosis and depression about double the rate in the overall population, “it sounds like those assessors were fairly sensitive. … but not all that specific,” said Dr. Liddle.

A third issue relates to treatment. “By the time people get sent to a psychiatrist for assessment for possible impending psychotic illness, they’ve often already had medication,” typically an antidepressant or antipsychotic.

“It’s very well established that dopamine-blocking antipsychotics produce hypokinesia and also dyskinesia,” which could then become a confounding factor, Dr. Liddle said.

The study was funded by grants from the National Institute of Mental Health. The study authors and Dr. Liddle have disclosed no relevant financial relationships.

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

Motor problems in children may be a harbinger of serious mental illness, new research suggests.

Investigators found that motor abnormalities were twice as common among those who develop psychosis or depression, compared with their counterparts in the general population, suggesting that these abnormalities may help predict vulnerability and provide an opportunity for early intervention.

“We have learned there are motor signs that are measurable in adolescence [that are] more prevalent in these disorders,” said lead investigator Katherine S. F. Damme, PhD, adolescent development and preventive treatment program (ADAPT), Northwestern University, Chicago. 

A core symptom

There has been a lot of interest in the pathophysiology of psychosis and in detecting it early, said Dr. Damme. “It has devastating effects, and early intervention is of great importance,” she added.

However, previous research has typically focused on affect or cognition, rather than on motor signs, despite the fact that motor signs are a “core symptom of both psychosis and depression.”

The prevalence and presentation of motor signs in adolescence, which is a “critical time for identifying these risk markers” because of their proximity to the onset of psychosis, has been understudied, Dr. Damme said.

For their study, the investigators gathered motor function data from the Adolescent Brain Cognitive Development Study (ABCD), which included 10,835 children aged 9-11 years with broad demographic diversity from 21 sites across the United States.

Overall, 27.6% of the children were reported to have least one motor sign; approximately 3% were reported to have two or more motor signs.

The most common of these was dyscoordination, which was endorsed by 19.3% of participants. In addition, 8.8% were reported to have had experienced developmental motor delays, 1.5% had psychomotor agitation, and 0.3% had psychomotor retardation.

The investigators determined that 4.6% of participants met criteria for depression, 2.6% for a psychosis, and 1.8% for comorbid psychosis and depression.

Motor signs were much more common among children with depression, psychosis, or both than among those who did not have these conditions; 45.8% reported having at least one motor sign.

Developmental motor delays and dyscoordination occurred at about the same rate in both patients with depression and those with psychosis. Rates were higher among patients with both of these conditions than among those with either condition alone.

In contrast, psychomotor agitation was more common among patients with depression alone and among those with comorbid depression and psychosis than among patients with psychosis alone. The rate of psychomotor retardation was increased among patients with psychosis alone but was less common among patients with comorbidity than in the healthy control group.

Familial vulnerability

The investigators also assessed participants who had not been diagnosed with a mental illness but who had a family history of depression only (28.9%), a relative with psychosis-like experiences (0.6%), or a family history of both depression and psychosis experiences (1.8%).

Although the effect size was smaller, there was a higher rate of motor signs among participants with a family history of these conditions, Dr. Damme said. “Again, we see that it’s elevated across developmental motor delays and at a similar rate in people who have depression and psychosis.”

In addition, psychomotor agitation was linked to depression with psychosis and depression without it.

Sensorimotor connectivity network data for the cohort indicated there was no main effect of diagnosis on corticostriatal connectivity.

However, more depressive symptoms were related to less connectivity (P = .024). There was a similar finding for psychotic-like experiences. The total number of such experiences related to lower connectivity (P < .001).

During the postpresentation discussion, Ian Kelleher, MD, PhD, honorary clinical lecturer in psychiatry at the Royal College of Surgeons in Ireland, Dublin, said he was “surprised” by the finding that the rate of psychomotor retardation was lower among participants with psychosis and depression.

Dr. Damme noted that some of the motor sign item ratings came by way of a child interview and that some of these item ratings came from the adults in the children’s lives.

She added that she was not entirely sure whether asking an 8- to 11-year-old in a clinical interview whether they are experiencing motor signs “might be the best way to get at motor slowing.”

Subtle features

Commenting on the findings in an interview, Peter F. Liddle, MD, PhD, professor of psychiatry, at the University of Nottingham (England), noted that the “features we’re talking about are pretty subtle.

“What I’ve been wondering about for some time is whether we should be getting video recordings and using machine learning approaches to teach a computer to recognize normal movements vs abnormal movements, and particularly facial expression,” said Dr. Liddle, who was not involved with the research.

He called the current study “interesting” but noted several factors that affect the potential utility of the findings in predicting outcomes.

First, they “may not be very good for distinguishing schizophrenia from mood disorders; but if the question is simply determining which young person might go on to develop a significant mental disorder, then it may be useful,” Dr. Liddle said.

He endorsed the investigators’ conclusion that motor abnormalities may be a transdiagnostic marker. Beyond that, they may be “more useful as a predictor of the likely long-term severity, but that’s my own hypothesis based on my work,” he added.

Another question concerns the sensitivity of motor abnormalities as a predictive marker. With the rate of the abnormalities identified in those who developed psychosis and depression about double the rate in the overall population, “it sounds like those assessors were fairly sensitive. … but not all that specific,” said Dr. Liddle.

A third issue relates to treatment. “By the time people get sent to a psychiatrist for assessment for possible impending psychotic illness, they’ve often already had medication,” typically an antidepressant or antipsychotic.

“It’s very well established that dopamine-blocking antipsychotics produce hypokinesia and also dyskinesia,” which could then become a confounding factor, Dr. Liddle said.

The study was funded by grants from the National Institute of Mental Health. The study authors and Dr. Liddle have disclosed no relevant financial relationships.

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

Motor problems in children may be a harbinger of serious mental illness, new research suggests.

Investigators found that motor abnormalities were twice as common among those who develop psychosis or depression, compared with their counterparts in the general population, suggesting that these abnormalities may help predict vulnerability and provide an opportunity for early intervention.

“We have learned there are motor signs that are measurable in adolescence [that are] more prevalent in these disorders,” said lead investigator Katherine S. F. Damme, PhD, adolescent development and preventive treatment program (ADAPT), Northwestern University, Chicago. 

A core symptom

There has been a lot of interest in the pathophysiology of psychosis and in detecting it early, said Dr. Damme. “It has devastating effects, and early intervention is of great importance,” she added.

However, previous research has typically focused on affect or cognition, rather than on motor signs, despite the fact that motor signs are a “core symptom of both psychosis and depression.”

The prevalence and presentation of motor signs in adolescence, which is a “critical time for identifying these risk markers” because of their proximity to the onset of psychosis, has been understudied, Dr. Damme said.

For their study, the investigators gathered motor function data from the Adolescent Brain Cognitive Development Study (ABCD), which included 10,835 children aged 9-11 years with broad demographic diversity from 21 sites across the United States.

Overall, 27.6% of the children were reported to have least one motor sign; approximately 3% were reported to have two or more motor signs.

The most common of these was dyscoordination, which was endorsed by 19.3% of participants. In addition, 8.8% were reported to have had experienced developmental motor delays, 1.5% had psychomotor agitation, and 0.3% had psychomotor retardation.

The investigators determined that 4.6% of participants met criteria for depression, 2.6% for a psychosis, and 1.8% for comorbid psychosis and depression.

Motor signs were much more common among children with depression, psychosis, or both than among those who did not have these conditions; 45.8% reported having at least one motor sign.

Developmental motor delays and dyscoordination occurred at about the same rate in both patients with depression and those with psychosis. Rates were higher among patients with both of these conditions than among those with either condition alone.

In contrast, psychomotor agitation was more common among patients with depression alone and among those with comorbid depression and psychosis than among patients with psychosis alone. The rate of psychomotor retardation was increased among patients with psychosis alone but was less common among patients with comorbidity than in the healthy control group.

Familial vulnerability

The investigators also assessed participants who had not been diagnosed with a mental illness but who had a family history of depression only (28.9%), a relative with psychosis-like experiences (0.6%), or a family history of both depression and psychosis experiences (1.8%).

Although the effect size was smaller, there was a higher rate of motor signs among participants with a family history of these conditions, Dr. Damme said. “Again, we see that it’s elevated across developmental motor delays and at a similar rate in people who have depression and psychosis.”

In addition, psychomotor agitation was linked to depression with psychosis and depression without it.

Sensorimotor connectivity network data for the cohort indicated there was no main effect of diagnosis on corticostriatal connectivity.

However, more depressive symptoms were related to less connectivity (P = .024). There was a similar finding for psychotic-like experiences. The total number of such experiences related to lower connectivity (P < .001).

During the postpresentation discussion, Ian Kelleher, MD, PhD, honorary clinical lecturer in psychiatry at the Royal College of Surgeons in Ireland, Dublin, said he was “surprised” by the finding that the rate of psychomotor retardation was lower among participants with psychosis and depression.

Dr. Damme noted that some of the motor sign item ratings came by way of a child interview and that some of these item ratings came from the adults in the children’s lives.

She added that she was not entirely sure whether asking an 8- to 11-year-old in a clinical interview whether they are experiencing motor signs “might be the best way to get at motor slowing.”

Subtle features

Commenting on the findings in an interview, Peter F. Liddle, MD, PhD, professor of psychiatry, at the University of Nottingham (England), noted that the “features we’re talking about are pretty subtle.

“What I’ve been wondering about for some time is whether we should be getting video recordings and using machine learning approaches to teach a computer to recognize normal movements vs abnormal movements, and particularly facial expression,” said Dr. Liddle, who was not involved with the research.

He called the current study “interesting” but noted several factors that affect the potential utility of the findings in predicting outcomes.

First, they “may not be very good for distinguishing schizophrenia from mood disorders; but if the question is simply determining which young person might go on to develop a significant mental disorder, then it may be useful,” Dr. Liddle said.

He endorsed the investigators’ conclusion that motor abnormalities may be a transdiagnostic marker. Beyond that, they may be “more useful as a predictor of the likely long-term severity, but that’s my own hypothesis based on my work,” he added.

Another question concerns the sensitivity of motor abnormalities as a predictive marker. With the rate of the abnormalities identified in those who developed psychosis and depression about double the rate in the overall population, “it sounds like those assessors were fairly sensitive. … but not all that specific,” said Dr. Liddle.

A third issue relates to treatment. “By the time people get sent to a psychiatrist for assessment for possible impending psychotic illness, they’ve often already had medication,” typically an antidepressant or antipsychotic.

“It’s very well established that dopamine-blocking antipsychotics produce hypokinesia and also dyskinesia,” which could then become a confounding factor, Dr. Liddle said.

The study was funded by grants from the National Institute of Mental Health. The study authors and Dr. Liddle have disclosed no relevant financial relationships.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the annual meeting of the American College of Physicians.

Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.

However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.

“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.

He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.

Restricted sleep is a good place to start for chronic insomnia, he continued.

Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.

Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.

“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
 

Sleep specialists in short supply

Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.

He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.

CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.

However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.

Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.

“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
 

Insomnia among older patients

Interest in helping older patients with insomnia dominated the chat session associated with the talk.

Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.

Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.

If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.

“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.

Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.

Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.

He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.

He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.

Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.

“It has no measurable effect in a third of patients and at least unacceptable side effects in another third.  Right off the bat, it’s not efficacious in two thirds of patients.”

Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”

Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.

Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.

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

Asking a patient who has concerns about memory loss–particular questions can guide referral decisions, according to new research.

Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) annual Internal Medicine meeting.

Is the patient forgetting to buy things in a store, having trouble recalling events, forgetting important dates? How often do these incidents occur?

These questions “will help get at how pervasive and how likely the memory loss is affecting their lives, versus a subjective complaint that doesn’t have much impact on the day-to-day function,” she said.

It’s also important to ask whether other neurocognitive symptoms accompany the memory loss, Dr. Richie noted.

Does the patient search for words, struggle with attention, or have problems with executive function? Does the patient have psychiatric symptoms, such as hallucinations or delusions, or other neurologic complaints, including weakness, numbness, vision change, or movement disorders?

“When you know how many neurocognitive symptoms they have, think about how [those symptoms] are affecting their safety and functional status. How are they on their activities of daily living?” Dr. Richie suggests.

Also ask whether the patient is taking medications and whether they drive a vehicle. If they do drive, do they get lost?

“These are all going to help you determine the acuity of the workup,” she said.

After a thorough history, cognitive screening is the next consideration.
 

Cognitive screening can be performed in minutes

One of the tests Dr. Richie recommends is the Mini-Cog. It takes 3 minutes to administer and has been formally recommended by the Alzheimer’s Association because it can be completed in the time frame of a Medicare wellness visit, she said.

It entails a three-word recall and clock-drawing test.

Dr. Richie said it’s important to eliminate some key causes first: “Certainly if the patient has signs and symptoms of depression, pseudodementia is a very real and treatable disease you do not want to miss and should consider in these patients,” she pointed out.

Systemic medical conditions can also lead to memory loss.

If there’s an acute component to the complaint, a new infection or medication withdrawal or a side effect could be driving it, so that’s key in questioning.

Dr. Richie explained that the American Academy of Neurology recommends a very limited workup.

“It’s really just to check their thyroid, their vitamin B12 levels, and then a one-time picture of their brain, which can be either MRI or a CT, to look for structural problems or vascular dementia or hydrocephalus, etc.”

“You do not routinely need spinal fluid testing or an EEG,” she emphasized.

Signs that a neurologist should be involved include a rapid decline, signs of potential seizures, or that the patient doesn’t seem safe in their condition.

Neuropsychological testing is helpful, but it takes nearly 3 hours and may not be a good choice for restless or aggressive patients, Dr. Richie said.

Such testing is often not available, and if it is, insurance coverage is often a barrier because many plans don’t cover it.

Patients often ask about drugs and supplements they see advertised to help with memory loss. Medications are not helpful for mild cognitive impairment, although there is evidence that some are beneficial for patients with dementia, Dr. Richie said.

Celine Goetz, MD, assistant professor of internal medicine at Rush University Medical Center, Chicago, Illinois, told this news organization that it’s easy to relate to the fear that patients and families feel when cognitive impairment begins to emerge.

“[Dr.] Richie’s talk was right on point for internists like myself who see many patients with memory complaints, cognitive impairment, and dementia. I think we’re all terrified of losing our memory and the social and functional impairment that comes with that,” she said.

Although cognitive impairment and dementia aren’t curable or reversible, Dr. Goetz noted, internists can help patients optimize management of conditions such as diabetes and heart disease, which can affect cognitive function.

Dr. Richie pointed out that some interventions lack evidence for the treatment of mild cognitive impairment, but Dr. Goetz emphasized that resources are plentiful and can be effective in combination.

“Engaging social workers, pharmacists, nutritionists, physical and occupational therapists, and, on the inpatient side, delirium protocols, chaplains, and music therapists make a huge difference in patient care,” she said.

Dr. Richie and Dr. Goetz report no relevant financial relationships.

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

Asking a patient who has concerns about memory loss–particular questions can guide referral decisions, according to new research.

Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) annual Internal Medicine meeting.

Is the patient forgetting to buy things in a store, having trouble recalling events, forgetting important dates? How often do these incidents occur?

These questions “will help get at how pervasive and how likely the memory loss is affecting their lives, versus a subjective complaint that doesn’t have much impact on the day-to-day function,” she said.

It’s also important to ask whether other neurocognitive symptoms accompany the memory loss, Dr. Richie noted.

Does the patient search for words, struggle with attention, or have problems with executive function? Does the patient have psychiatric symptoms, such as hallucinations or delusions, or other neurologic complaints, including weakness, numbness, vision change, or movement disorders?

“When you know how many neurocognitive symptoms they have, think about how [those symptoms] are affecting their safety and functional status. How are they on their activities of daily living?” Dr. Richie suggests.

Also ask whether the patient is taking medications and whether they drive a vehicle. If they do drive, do they get lost?

“These are all going to help you determine the acuity of the workup,” she said.

After a thorough history, cognitive screening is the next consideration.
 

Cognitive screening can be performed in minutes

One of the tests Dr. Richie recommends is the Mini-Cog. It takes 3 minutes to administer and has been formally recommended by the Alzheimer’s Association because it can be completed in the time frame of a Medicare wellness visit, she said.

It entails a three-word recall and clock-drawing test.

Dr. Richie said it’s important to eliminate some key causes first: “Certainly if the patient has signs and symptoms of depression, pseudodementia is a very real and treatable disease you do not want to miss and should consider in these patients,” she pointed out.

Systemic medical conditions can also lead to memory loss.

If there’s an acute component to the complaint, a new infection or medication withdrawal or a side effect could be driving it, so that’s key in questioning.

Dr. Richie explained that the American Academy of Neurology recommends a very limited workup.

“It’s really just to check their thyroid, their vitamin B12 levels, and then a one-time picture of their brain, which can be either MRI or a CT, to look for structural problems or vascular dementia or hydrocephalus, etc.”

“You do not routinely need spinal fluid testing or an EEG,” she emphasized.

Signs that a neurologist should be involved include a rapid decline, signs of potential seizures, or that the patient doesn’t seem safe in their condition.

Neuropsychological testing is helpful, but it takes nearly 3 hours and may not be a good choice for restless or aggressive patients, Dr. Richie said.

Such testing is often not available, and if it is, insurance coverage is often a barrier because many plans don’t cover it.

Patients often ask about drugs and supplements they see advertised to help with memory loss. Medications are not helpful for mild cognitive impairment, although there is evidence that some are beneficial for patients with dementia, Dr. Richie said.

Celine Goetz, MD, assistant professor of internal medicine at Rush University Medical Center, Chicago, Illinois, told this news organization that it’s easy to relate to the fear that patients and families feel when cognitive impairment begins to emerge.

“[Dr.] Richie’s talk was right on point for internists like myself who see many patients with memory complaints, cognitive impairment, and dementia. I think we’re all terrified of losing our memory and the social and functional impairment that comes with that,” she said.

Although cognitive impairment and dementia aren’t curable or reversible, Dr. Goetz noted, internists can help patients optimize management of conditions such as diabetes and heart disease, which can affect cognitive function.

Dr. Richie pointed out that some interventions lack evidence for the treatment of mild cognitive impairment, but Dr. Goetz emphasized that resources are plentiful and can be effective in combination.

“Engaging social workers, pharmacists, nutritionists, physical and occupational therapists, and, on the inpatient side, delirium protocols, chaplains, and music therapists make a huge difference in patient care,” she said.

Dr. Richie and Dr. Goetz report no relevant financial relationships.

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

Asking a patient who has concerns about memory loss–particular questions can guide referral decisions, according to new research.

Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) annual Internal Medicine meeting.

Is the patient forgetting to buy things in a store, having trouble recalling events, forgetting important dates? How often do these incidents occur?

These questions “will help get at how pervasive and how likely the memory loss is affecting their lives, versus a subjective complaint that doesn’t have much impact on the day-to-day function,” she said.

It’s also important to ask whether other neurocognitive symptoms accompany the memory loss, Dr. Richie noted.

Does the patient search for words, struggle with attention, or have problems with executive function? Does the patient have psychiatric symptoms, such as hallucinations or delusions, or other neurologic complaints, including weakness, numbness, vision change, or movement disorders?

“When you know how many neurocognitive symptoms they have, think about how [those symptoms] are affecting their safety and functional status. How are they on their activities of daily living?” Dr. Richie suggests.

Also ask whether the patient is taking medications and whether they drive a vehicle. If they do drive, do they get lost?

“These are all going to help you determine the acuity of the workup,” she said.

After a thorough history, cognitive screening is the next consideration.
 

Cognitive screening can be performed in minutes

One of the tests Dr. Richie recommends is the Mini-Cog. It takes 3 minutes to administer and has been formally recommended by the Alzheimer’s Association because it can be completed in the time frame of a Medicare wellness visit, she said.

It entails a three-word recall and clock-drawing test.

Dr. Richie said it’s important to eliminate some key causes first: “Certainly if the patient has signs and symptoms of depression, pseudodementia is a very real and treatable disease you do not want to miss and should consider in these patients,” she pointed out.

Systemic medical conditions can also lead to memory loss.

If there’s an acute component to the complaint, a new infection or medication withdrawal or a side effect could be driving it, so that’s key in questioning.

Dr. Richie explained that the American Academy of Neurology recommends a very limited workup.

“It’s really just to check their thyroid, their vitamin B12 levels, and then a one-time picture of their brain, which can be either MRI or a CT, to look for structural problems or vascular dementia or hydrocephalus, etc.”

“You do not routinely need spinal fluid testing or an EEG,” she emphasized.

Signs that a neurologist should be involved include a rapid decline, signs of potential seizures, or that the patient doesn’t seem safe in their condition.

Neuropsychological testing is helpful, but it takes nearly 3 hours and may not be a good choice for restless or aggressive patients, Dr. Richie said.

Such testing is often not available, and if it is, insurance coverage is often a barrier because many plans don’t cover it.

Patients often ask about drugs and supplements they see advertised to help with memory loss. Medications are not helpful for mild cognitive impairment, although there is evidence that some are beneficial for patients with dementia, Dr. Richie said.

Celine Goetz, MD, assistant professor of internal medicine at Rush University Medical Center, Chicago, Illinois, told this news organization that it’s easy to relate to the fear that patients and families feel when cognitive impairment begins to emerge.

“[Dr.] Richie’s talk was right on point for internists like myself who see many patients with memory complaints, cognitive impairment, and dementia. I think we’re all terrified of losing our memory and the social and functional impairment that comes with that,” she said.

Although cognitive impairment and dementia aren’t curable or reversible, Dr. Goetz noted, internists can help patients optimize management of conditions such as diabetes and heart disease, which can affect cognitive function.

Dr. Richie pointed out that some interventions lack evidence for the treatment of mild cognitive impairment, but Dr. Goetz emphasized that resources are plentiful and can be effective in combination.

“Engaging social workers, pharmacists, nutritionists, physical and occupational therapists, and, on the inpatient side, delirium protocols, chaplains, and music therapists make a huge difference in patient care,” she said.

Dr. Richie and Dr. Goetz report no relevant financial relationships.

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

Physicians and nonphysicians clearly differ in whether or not a PhD or EdD should be able to call themselves ‘doctor,’ a new Medscape poll Who Should Get to Be Called ‘Doctor’? shows. The topic has clearly struck a nerve, since a record number of respondents – over 12,000 – voted in the poll.

Most physicians think it’s appropriate for people with other doctorate degrees such as a PhD or EdD to call themselves ‘doctor,’ although slightly more than half said it depends on the context.

The controversy over who gets to be called a doctor was reignited when a Wall Street Journal opinion piece criticized First Lady Jill Biden, EdD, for wanting to be called “Dr Biden.” The piece also challenged the idea that having a PhD is worth the honorific of ‘doctor.’

Medical ethicist Arthur Caplan, PhD, disagreed with that viewpoint, saying the context matters. For example, he prefers to be called “professor” when he’s introduced to the public rather than “doctor” to avoid any confusion about his professional status.

More than 12,000 clinicians including physicians, medical students, nurses, pharmacists, and other health care professionals responded to the poll. The non-MD clinicians were the most likely to say it was always appropriate to be called “doctor” while physicians were the least likely.
 

Context matters

Large percentages of clinicians – 54% of doctors, 62% of medical students, and 41% of nurses – said that the context matters for being called “doctor.’’

“I earned my PhD in 1995 and my MD in 2000. I think it is contextual. In a research or University setting, “Dr.” seems appropriate for a PhD. That same person in public should probably not hold themselves out as “Dr.” So, maybe MDs and DOs can choose, while others maintain the title in their specific setting.” 

Some readers proposed that people with MDs call themselves physicians rather than doctors. Said one: “Anyone with a terminal doctorate degree has the right to use the word doctor.  As a physician when someone asks what I do, I say: ‘I am a physician.’ Problem solved. There can only be one physician but there are many types of doctors.”

Physicians and nurses differed most in their views. Just 24% of physicians said it was always appropriate for people with other doctorate degrees to call themselves doctor whereas about an equal number (22%) thought it was never appropriate.

In contrast, 43% of nurses (including advance practice nurses) said it was always appropriate for people with non-MD doctorates to be called doctor. Only 16% said it’s never appropriate. 

This difference may reflect the growing number of nurses with doctorate degrees, either a DNP or PhD, who want to be called doctor in clinical settings.

Age made a difference too. Only 16% of physicians younger than age 45 said it was always appropriate for people with non-MD doctorate degrees to be called doctor, compared with 27% of physicians aged 45 and up.

Medical students (31%) were also more likely than physicians to say it was always appropriate for non-MD doctorates to use the title “doctor” and 64% said it depends on the context. This was noteworthy because twice as many medical students as physicians (16% vs. 8%) said they work in academia, research, or military government settings.
 

Too many ‘doctors’ confuse the public

Physicians (70%) were also more likely to say it was always or often confusing for the public to hear someone without a medical degree addressed as “doctor.” Only 6% of physicians thought it was never or rarely confusing.

Nurses disagreed. Just 45% said that it was always or often confusing while 16% said it was never or rarely confusing.

Medical students were more aligned with physicians on this issue – 60% said it was always or often confusing to the public and just 10% said it was never or rarely confusing.  

One reader commented, “The problem is the confusion the ‘doctor’ title causes for patients, especially in a hospital setting. Is the ‘doctor’ a physician, a pharmacist, a psychologist, a nurse, etc., etc.? We need to think not of our own egos but if and how  the confusion about this plethora of titles may be hindering good patient care.”

These concerns are not unfounded. The American Medical Association reported in its Truth in Advertising campaign that “patients mistake physicians with nonphysician providers” based on an online survey of 802 adults in 2018. The participants thought these specialists were MDs: dentists (61%), podiatrists (67%), optometrists (47%), psychologists (43%), doctors of nursing (39%), and chiropractors (27%).

The AMA has advocated that states pass the “Health Care Professional Transparency Act,” which New Jersey has enacted. The law requires all health care professionals dealing with patients to wear a name tag that clearly identifies their licensure. Health care professionals must also display their education, training, and licensure in their office.

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

Physicians and nonphysicians clearly differ in whether or not a PhD or EdD should be able to call themselves ‘doctor,’ a new Medscape poll Who Should Get to Be Called ‘Doctor’? shows. The topic has clearly struck a nerve, since a record number of respondents – over 12,000 – voted in the poll.

Most physicians think it’s appropriate for people with other doctorate degrees such as a PhD or EdD to call themselves ‘doctor,’ although slightly more than half said it depends on the context.

The controversy over who gets to be called a doctor was reignited when a Wall Street Journal opinion piece criticized First Lady Jill Biden, EdD, for wanting to be called “Dr Biden.” The piece also challenged the idea that having a PhD is worth the honorific of ‘doctor.’

Medical ethicist Arthur Caplan, PhD, disagreed with that viewpoint, saying the context matters. For example, he prefers to be called “professor” when he’s introduced to the public rather than “doctor” to avoid any confusion about his professional status.

More than 12,000 clinicians including physicians, medical students, nurses, pharmacists, and other health care professionals responded to the poll. The non-MD clinicians were the most likely to say it was always appropriate to be called “doctor” while physicians were the least likely.
 

Context matters

Large percentages of clinicians – 54% of doctors, 62% of medical students, and 41% of nurses – said that the context matters for being called “doctor.’’

“I earned my PhD in 1995 and my MD in 2000. I think it is contextual. In a research or University setting, “Dr.” seems appropriate for a PhD. That same person in public should probably not hold themselves out as “Dr.” So, maybe MDs and DOs can choose, while others maintain the title in their specific setting.” 

Some readers proposed that people with MDs call themselves physicians rather than doctors. Said one: “Anyone with a terminal doctorate degree has the right to use the word doctor.  As a physician when someone asks what I do, I say: ‘I am a physician.’ Problem solved. There can only be one physician but there are many types of doctors.”

Physicians and nurses differed most in their views. Just 24% of physicians said it was always appropriate for people with other doctorate degrees to call themselves doctor whereas about an equal number (22%) thought it was never appropriate.

In contrast, 43% of nurses (including advance practice nurses) said it was always appropriate for people with non-MD doctorates to be called doctor. Only 16% said it’s never appropriate. 

This difference may reflect the growing number of nurses with doctorate degrees, either a DNP or PhD, who want to be called doctor in clinical settings.

Age made a difference too. Only 16% of physicians younger than age 45 said it was always appropriate for people with non-MD doctorate degrees to be called doctor, compared with 27% of physicians aged 45 and up.

Medical students (31%) were also more likely than physicians to say it was always appropriate for non-MD doctorates to use the title “doctor” and 64% said it depends on the context. This was noteworthy because twice as many medical students as physicians (16% vs. 8%) said they work in academia, research, or military government settings.
 

Too many ‘doctors’ confuse the public

Physicians (70%) were also more likely to say it was always or often confusing for the public to hear someone without a medical degree addressed as “doctor.” Only 6% of physicians thought it was never or rarely confusing.

Nurses disagreed. Just 45% said that it was always or often confusing while 16% said it was never or rarely confusing.

Medical students were more aligned with physicians on this issue – 60% said it was always or often confusing to the public and just 10% said it was never or rarely confusing.  

One reader commented, “The problem is the confusion the ‘doctor’ title causes for patients, especially in a hospital setting. Is the ‘doctor’ a physician, a pharmacist, a psychologist, a nurse, etc., etc.? We need to think not of our own egos but if and how  the confusion about this plethora of titles may be hindering good patient care.”

These concerns are not unfounded. The American Medical Association reported in its Truth in Advertising campaign that “patients mistake physicians with nonphysician providers” based on an online survey of 802 adults in 2018. The participants thought these specialists were MDs: dentists (61%), podiatrists (67%), optometrists (47%), psychologists (43%), doctors of nursing (39%), and chiropractors (27%).

The AMA has advocated that states pass the “Health Care Professional Transparency Act,” which New Jersey has enacted. The law requires all health care professionals dealing with patients to wear a name tag that clearly identifies their licensure. Health care professionals must also display their education, training, and licensure in their office.

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

Physicians and nonphysicians clearly differ in whether or not a PhD or EdD should be able to call themselves ‘doctor,’ a new Medscape poll Who Should Get to Be Called ‘Doctor’? shows. The topic has clearly struck a nerve, since a record number of respondents – over 12,000 – voted in the poll.

Most physicians think it’s appropriate for people with other doctorate degrees such as a PhD or EdD to call themselves ‘doctor,’ although slightly more than half said it depends on the context.

The controversy over who gets to be called a doctor was reignited when a Wall Street Journal opinion piece criticized First Lady Jill Biden, EdD, for wanting to be called “Dr Biden.” The piece also challenged the idea that having a PhD is worth the honorific of ‘doctor.’

Medical ethicist Arthur Caplan, PhD, disagreed with that viewpoint, saying the context matters. For example, he prefers to be called “professor” when he’s introduced to the public rather than “doctor” to avoid any confusion about his professional status.

More than 12,000 clinicians including physicians, medical students, nurses, pharmacists, and other health care professionals responded to the poll. The non-MD clinicians were the most likely to say it was always appropriate to be called “doctor” while physicians were the least likely.
 

Context matters

Large percentages of clinicians – 54% of doctors, 62% of medical students, and 41% of nurses – said that the context matters for being called “doctor.’’

“I earned my PhD in 1995 and my MD in 2000. I think it is contextual. In a research or University setting, “Dr.” seems appropriate for a PhD. That same person in public should probably not hold themselves out as “Dr.” So, maybe MDs and DOs can choose, while others maintain the title in their specific setting.” 

Some readers proposed that people with MDs call themselves physicians rather than doctors. Said one: “Anyone with a terminal doctorate degree has the right to use the word doctor.  As a physician when someone asks what I do, I say: ‘I am a physician.’ Problem solved. There can only be one physician but there are many types of doctors.”

Physicians and nurses differed most in their views. Just 24% of physicians said it was always appropriate for people with other doctorate degrees to call themselves doctor whereas about an equal number (22%) thought it was never appropriate.

In contrast, 43% of nurses (including advance practice nurses) said it was always appropriate for people with non-MD doctorates to be called doctor. Only 16% said it’s never appropriate. 

This difference may reflect the growing number of nurses with doctorate degrees, either a DNP or PhD, who want to be called doctor in clinical settings.

Age made a difference too. Only 16% of physicians younger than age 45 said it was always appropriate for people with non-MD doctorate degrees to be called doctor, compared with 27% of physicians aged 45 and up.

Medical students (31%) were also more likely than physicians to say it was always appropriate for non-MD doctorates to use the title “doctor” and 64% said it depends on the context. This was noteworthy because twice as many medical students as physicians (16% vs. 8%) said they work in academia, research, or military government settings.
 

Too many ‘doctors’ confuse the public

Physicians (70%) were also more likely to say it was always or often confusing for the public to hear someone without a medical degree addressed as “doctor.” Only 6% of physicians thought it was never or rarely confusing.

Nurses disagreed. Just 45% said that it was always or often confusing while 16% said it was never or rarely confusing.

Medical students were more aligned with physicians on this issue – 60% said it was always or often confusing to the public and just 10% said it was never or rarely confusing.  

One reader commented, “The problem is the confusion the ‘doctor’ title causes for patients, especially in a hospital setting. Is the ‘doctor’ a physician, a pharmacist, a psychologist, a nurse, etc., etc.? We need to think not of our own egos but if and how  the confusion about this plethora of titles may be hindering good patient care.”

These concerns are not unfounded. The American Medical Association reported in its Truth in Advertising campaign that “patients mistake physicians with nonphysician providers” based on an online survey of 802 adults in 2018. The participants thought these specialists were MDs: dentists (61%), podiatrists (67%), optometrists (47%), psychologists (43%), doctors of nursing (39%), and chiropractors (27%).

The AMA has advocated that states pass the “Health Care Professional Transparency Act,” which New Jersey has enacted. The law requires all health care professionals dealing with patients to wear a name tag that clearly identifies their licensure. Health care professionals must also display their education, training, and licensure in their office.

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

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

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

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

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

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

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