A recent claim against a New Jersey physician attracted considerable attention in both the medical and legal communities, not only because it resulted in a substantial jury award, but because that award was not covered by malpractice insurance.

It is a good reminder for the rest of us: Your malpractice policy covers only allegations of malpractice, which is generally defined as negligence or deviation from the standard of care. This case involved a charge of discrimination against a hearing-impaired patient – which meant the physician not only had to fund his own defense, but was personally responsible for the $400,000 award against him.

The Americans with Disabilities Act (ADA) was designed to protect individuals with various disabilities against discrimination in various public situations – including, specifically, “the professional office of a health care professional.”

When the disability is impaired hearing, the law requires physicians to provide any “auxiliary aids and services” that might be necessary to insure clear communication between doctor and patient. In the vast majority of such situations, a pad and pencil will satisfy that requirement. But occasionally it does not, particularly when complex medical concepts are involved; and in such cases, as the New Jersey trial demonstrated, failure to make the necessary extra effort can be very expensive.

The claim involved a hearing-impaired patient with lupus erythematosus under treatment by a rheumatologist. For almost 2 years the patient’s partner and her daughter provided translation; but that arrangement was inadequate, she testified, because her partner and daughter were unfamiliar with medical terminology and she was “unable to understand and participate in her care,” which left her “unaware of risks and available alternatives.”

She repeatedly requested that the rheumatologist provide an American Sign Language interpreter for her office visits. He refused on grounds that the cost of an interpreter would exceed the payment he would receive for the visits, which made it an “undue financial burden,” and therefore exempt from ADA requirements.

But the undue-burden exemption is not automatic; it must be demonstrated in court. And the jury decided the rheumatologist’s annual income of $425,000 rendered the cost of an interpreter quite affordable.

The lessons are clear: Physicians must take antidiscrimination laws seriously, particularly when uninsurable issues are involved; and we must be constantly aware of the needs of disabled patients, to be sure their care is not substantially different from that of any other patient.

In the case of hearing-impaired or deaf patients, it is important to remember that forms of communication that are quite adequate for most are not appropriate for some. Lip reading, written notes, and the use of family members as interpreters may be perfectly acceptable to one patient and unsuitable for another.

If the patient agrees to written notes and lip reading, as most do, you need to remember to speak slowly, and to write down critical information to avoid any miscommunications. And as always, it is crucial to document all communication, as well as the methods used for that communication – specifically including the fact that the patient agreed to those forms of communication. Documentation, as I’ve often said, is like garlic: There is no such thing as too much of it.

Should a patient not agree that written notes are sufficient, other alternatives can be offered: computer transcription, assistive listening devices, videotext displays (often available in hospitals), and telecommunication devices such as TTY and TDD. But if the patient rejects all of those options and continues to insist on a professional interpreter, the precedent set by the New Jersey case suggests that you need to acquiesce, even if the interpreter’s fee exceeds the visit reimbursement – and the ADA prohibits you from passing your cost along to the patient. But any such cost will be far less than a noninsured judgment against you.

If you must go that route, make sure the interpreter you hire is familiar with medical terminology, and is not acquainted or related to the patient (for HIPAA reasons). Your state may have an online registry of available interpreters, or your hospital may have a sign language interpreter on its staff that they might allow you to “borrow.”

The good news is several states have responded to this issue by introducing legislation that would require health insurance carriers to pay for the cost of interpreters, although none, as of this writing, have yet become law.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

A recent claim against a New Jersey physician attracted considerable attention in both the medical and legal communities, not only because it resulted in a substantial jury award, but because that award was not covered by malpractice insurance.

It is a good reminder for the rest of us: Your malpractice policy covers only allegations of malpractice, which is generally defined as negligence or deviation from the standard of care. This case involved a charge of discrimination against a hearing-impaired patient – which meant the physician not only had to fund his own defense, but was personally responsible for the $400,000 award against him.

The Americans with Disabilities Act (ADA) was designed to protect individuals with various disabilities against discrimination in various public situations – including, specifically, “the professional office of a health care professional.”

When the disability is impaired hearing, the law requires physicians to provide any “auxiliary aids and services” that might be necessary to insure clear communication between doctor and patient. In the vast majority of such situations, a pad and pencil will satisfy that requirement. But occasionally it does not, particularly when complex medical concepts are involved; and in such cases, as the New Jersey trial demonstrated, failure to make the necessary extra effort can be very expensive.

The claim involved a hearing-impaired patient with lupus erythematosus under treatment by a rheumatologist. For almost 2 years the patient’s partner and her daughter provided translation; but that arrangement was inadequate, she testified, because her partner and daughter were unfamiliar with medical terminology and she was “unable to understand and participate in her care,” which left her “unaware of risks and available alternatives.”

She repeatedly requested that the rheumatologist provide an American Sign Language interpreter for her office visits. He refused on grounds that the cost of an interpreter would exceed the payment he would receive for the visits, which made it an “undue financial burden,” and therefore exempt from ADA requirements.

But the undue-burden exemption is not automatic; it must be demonstrated in court. And the jury decided the rheumatologist’s annual income of $425,000 rendered the cost of an interpreter quite affordable.

The lessons are clear: Physicians must take antidiscrimination laws seriously, particularly when uninsurable issues are involved; and we must be constantly aware of the needs of disabled patients, to be sure their care is not substantially different from that of any other patient.

In the case of hearing-impaired or deaf patients, it is important to remember that forms of communication that are quite adequate for most are not appropriate for some. Lip reading, written notes, and the use of family members as interpreters may be perfectly acceptable to one patient and unsuitable for another.

If the patient agrees to written notes and lip reading, as most do, you need to remember to speak slowly, and to write down critical information to avoid any miscommunications. And as always, it is crucial to document all communication, as well as the methods used for that communication – specifically including the fact that the patient agreed to those forms of communication. Documentation, as I’ve often said, is like garlic: There is no such thing as too much of it.

Should a patient not agree that written notes are sufficient, other alternatives can be offered: computer transcription, assistive listening devices, videotext displays (often available in hospitals), and telecommunication devices such as TTY and TDD. But if the patient rejects all of those options and continues to insist on a professional interpreter, the precedent set by the New Jersey case suggests that you need to acquiesce, even if the interpreter’s fee exceeds the visit reimbursement – and the ADA prohibits you from passing your cost along to the patient. But any such cost will be far less than a noninsured judgment against you.

If you must go that route, make sure the interpreter you hire is familiar with medical terminology, and is not acquainted or related to the patient (for HIPAA reasons). Your state may have an online registry of available interpreters, or your hospital may have a sign language interpreter on its staff that they might allow you to “borrow.”

The good news is several states have responded to this issue by introducing legislation that would require health insurance carriers to pay for the cost of interpreters, although none, as of this writing, have yet become law.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

A recent claim against a New Jersey physician attracted considerable attention in both the medical and legal communities, not only because it resulted in a substantial jury award, but because that award was not covered by malpractice insurance.

It is a good reminder for the rest of us: Your malpractice policy covers only allegations of malpractice, which is generally defined as negligence or deviation from the standard of care. This case involved a charge of discrimination against a hearing-impaired patient – which meant the physician not only had to fund his own defense, but was personally responsible for the $400,000 award against him.

The Americans with Disabilities Act (ADA) was designed to protect individuals with various disabilities against discrimination in various public situations – including, specifically, “the professional office of a health care professional.”

When the disability is impaired hearing, the law requires physicians to provide any “auxiliary aids and services” that might be necessary to insure clear communication between doctor and patient. In the vast majority of such situations, a pad and pencil will satisfy that requirement. But occasionally it does not, particularly when complex medical concepts are involved; and in such cases, as the New Jersey trial demonstrated, failure to make the necessary extra effort can be very expensive.

The claim involved a hearing-impaired patient with lupus erythematosus under treatment by a rheumatologist. For almost 2 years the patient’s partner and her daughter provided translation; but that arrangement was inadequate, she testified, because her partner and daughter were unfamiliar with medical terminology and she was “unable to understand and participate in her care,” which left her “unaware of risks and available alternatives.”

She repeatedly requested that the rheumatologist provide an American Sign Language interpreter for her office visits. He refused on grounds that the cost of an interpreter would exceed the payment he would receive for the visits, which made it an “undue financial burden,” and therefore exempt from ADA requirements.

But the undue-burden exemption is not automatic; it must be demonstrated in court. And the jury decided the rheumatologist’s annual income of $425,000 rendered the cost of an interpreter quite affordable.

The lessons are clear: Physicians must take antidiscrimination laws seriously, particularly when uninsurable issues are involved; and we must be constantly aware of the needs of disabled patients, to be sure their care is not substantially different from that of any other patient.

In the case of hearing-impaired or deaf patients, it is important to remember that forms of communication that are quite adequate for most are not appropriate for some. Lip reading, written notes, and the use of family members as interpreters may be perfectly acceptable to one patient and unsuitable for another.

If the patient agrees to written notes and lip reading, as most do, you need to remember to speak slowly, and to write down critical information to avoid any miscommunications. And as always, it is crucial to document all communication, as well as the methods used for that communication – specifically including the fact that the patient agreed to those forms of communication. Documentation, as I’ve often said, is like garlic: There is no such thing as too much of it.

Should a patient not agree that written notes are sufficient, other alternatives can be offered: computer transcription, assistive listening devices, videotext displays (often available in hospitals), and telecommunication devices such as TTY and TDD. But if the patient rejects all of those options and continues to insist on a professional interpreter, the precedent set by the New Jersey case suggests that you need to acquiesce, even if the interpreter’s fee exceeds the visit reimbursement – and the ADA prohibits you from passing your cost along to the patient. But any such cost will be far less than a noninsured judgment against you.

If you must go that route, make sure the interpreter you hire is familiar with medical terminology, and is not acquainted or related to the patient (for HIPAA reasons). Your state may have an online registry of available interpreters, or your hospital may have a sign language interpreter on its staff that they might allow you to “borrow.”

The good news is several states have responded to this issue by introducing legislation that would require health insurance carriers to pay for the cost of interpreters, although none, as of this writing, have yet become law.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Despite being widely prescribed, muscle relaxants are largely ineffective for low back pain, new research suggests.

Results of a large systematic review and meta-analysis of randomized controlled trials show very “low certainty evidence” that non-benzodiazepine antispasmodics provide meaningful improvement in pain intensity in patients with low back pain – and may actually increase adverse event risk.

“We found that muscle relaxants might reduce pain in the short term, but on average, the effect is probably too small to be important, and most patients wouldn’t be able to feel any difference in their pain compared to taking a placebo,” study investigator Aidan Cashin, PhD, with the Center for Pain IMPACT, Neuroscience Research Australia, and University of New South Wales, Sydney, told this news organization. “There is also an increased risk of side effects,” he added.

The study was published online July 7 in The BMJ.
 

Global problem

Low back pain is a major global public health problem that burdens individuals, health care systems, and societies.

“Most people, around 80%, will have at least one episode of low back pain during their life,” Dr. Cashin noted.

Muscle relaxants, a broad class of drugs that include non-benzodiazepine antispasmodics and antispastics, are often prescribed for low back pain. In 2020 alone, prescriptions exceeded 1.3 million in England and topped 30 million in the United States.

“However, clinical practice guidelines have provided conflicting recommendations for the use of muscle relaxants to treat low back pain,” Dr. Cashin said.

To assess the efficacy and safety of muscle relaxants, the researchers conducted a detailed analysis of 31 randomized controlled trials that compared muscle relaxants with placebo, usual care, or no treatment in a total of 6,505 adults with nonspecific low back pain.

For acute low back pain, they found “very low certainty evidence” that non-benzodiazepine antispasmodics might reduce pain intensity at 2 weeks or less, but the effect is small – less than 8 points on a 0 to 100 point scale – and not clinically meaningful.

They found little to no effect of non-benzodiazepine antispasmodics on pain intensity at 3 to 13 weeks or on disability at any follow-up time points. None of the trials assessed the effect of muscle relaxants on long-term outcomes.

There was also low-certainty and very-low-certainty evidence that non-benzodiazepine antispasmodics might increase the risk of an adverse event, commonly dizziness, drowsiness, headache, and nausea (relative risk 1.6; 95% confidence interval, 1.2-2.0).
 

Better research needed

“We were surprised by the findings, as earlier research suggested that muscle relaxants did reduce pain intensity. But when we included all of the most up-to-date research, the results became much less certain,” said Dr. Cashin.

“We were also surprised to see that so much of the research wasn’t done very well, which means that we can’t be very certain in the results. There is a clear need to improve how research is done for low back pain so that we better understand whether medicines can help people or not,” Dr. Cashin said.

“We would encourage clinicians to discuss this uncertainty in the efficacy and safety of muscle relaxants with patients, sharing information about the possibility for a worthwhile benefit in pain reduction but increased risk of experiencing a nonserious adverse event, to allow them to make informed treatment decisions,” corresponding author James McAuley, PhD, University of New South Wales, said in an interview.

“We know that no matter what medicines people with low back pain are taking, they should avoid staying in bed, and they should try to be active and continue with their usual activities, including work, as much as they can. High-quality research shows that people who do this are more likely to recover faster and more completely,” said Dr. McAuley.
 

A symptom, not a diagnosis

Reached for comment, Andrew Hecht, MD, chief of spine surgery at Mount Sinai Health System, New York, noted that acute low back pain is “a symptom, not a diagnosis, and most episodes of acute low back pain without leg pain will resolve within a few weeks no matter what you do.”

“For people who have an episode of acute low back pain, we typically use anti-inflammatory medications, combined with a short, low dose course of a muscle relaxant if necessary, depending on the severity of symptoms, to help get you over the worst part of it,” Dr. Hecht said.

“We are trying to help the patient feel better in the short term and get more physically strong with therapy to try to reduce the frequency of these attacks in the future,” he added.

“But each patient is different. It’s not one-size-fits-all, and we don’t give prolonged courses of muscle relaxants because they have some side effects, like sedation,” Dr. Hecht cautioned.

The study had no specific funding. Dr. Cashin, Dr. McAuley, and Dr. Hecht have disclosed no relevant financial relationships.

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

Despite being widely prescribed, muscle relaxants are largely ineffective for low back pain, new research suggests.

Results of a large systematic review and meta-analysis of randomized controlled trials show very “low certainty evidence” that non-benzodiazepine antispasmodics provide meaningful improvement in pain intensity in patients with low back pain – and may actually increase adverse event risk.

“We found that muscle relaxants might reduce pain in the short term, but on average, the effect is probably too small to be important, and most patients wouldn’t be able to feel any difference in their pain compared to taking a placebo,” study investigator Aidan Cashin, PhD, with the Center for Pain IMPACT, Neuroscience Research Australia, and University of New South Wales, Sydney, told this news organization. “There is also an increased risk of side effects,” he added.

The study was published online July 7 in The BMJ.
 

Global problem

Low back pain is a major global public health problem that burdens individuals, health care systems, and societies.

“Most people, around 80%, will have at least one episode of low back pain during their life,” Dr. Cashin noted.

Muscle relaxants, a broad class of drugs that include non-benzodiazepine antispasmodics and antispastics, are often prescribed for low back pain. In 2020 alone, prescriptions exceeded 1.3 million in England and topped 30 million in the United States.

“However, clinical practice guidelines have provided conflicting recommendations for the use of muscle relaxants to treat low back pain,” Dr. Cashin said.

To assess the efficacy and safety of muscle relaxants, the researchers conducted a detailed analysis of 31 randomized controlled trials that compared muscle relaxants with placebo, usual care, or no treatment in a total of 6,505 adults with nonspecific low back pain.

For acute low back pain, they found “very low certainty evidence” that non-benzodiazepine antispasmodics might reduce pain intensity at 2 weeks or less, but the effect is small – less than 8 points on a 0 to 100 point scale – and not clinically meaningful.

They found little to no effect of non-benzodiazepine antispasmodics on pain intensity at 3 to 13 weeks or on disability at any follow-up time points. None of the trials assessed the effect of muscle relaxants on long-term outcomes.

There was also low-certainty and very-low-certainty evidence that non-benzodiazepine antispasmodics might increase the risk of an adverse event, commonly dizziness, drowsiness, headache, and nausea (relative risk 1.6; 95% confidence interval, 1.2-2.0).
 

Better research needed

“We were surprised by the findings, as earlier research suggested that muscle relaxants did reduce pain intensity. But when we included all of the most up-to-date research, the results became much less certain,” said Dr. Cashin.

“We were also surprised to see that so much of the research wasn’t done very well, which means that we can’t be very certain in the results. There is a clear need to improve how research is done for low back pain so that we better understand whether medicines can help people or not,” Dr. Cashin said.

“We would encourage clinicians to discuss this uncertainty in the efficacy and safety of muscle relaxants with patients, sharing information about the possibility for a worthwhile benefit in pain reduction but increased risk of experiencing a nonserious adverse event, to allow them to make informed treatment decisions,” corresponding author James McAuley, PhD, University of New South Wales, said in an interview.

“We know that no matter what medicines people with low back pain are taking, they should avoid staying in bed, and they should try to be active and continue with their usual activities, including work, as much as they can. High-quality research shows that people who do this are more likely to recover faster and more completely,” said Dr. McAuley.
 

A symptom, not a diagnosis

Reached for comment, Andrew Hecht, MD, chief of spine surgery at Mount Sinai Health System, New York, noted that acute low back pain is “a symptom, not a diagnosis, and most episodes of acute low back pain without leg pain will resolve within a few weeks no matter what you do.”

“For people who have an episode of acute low back pain, we typically use anti-inflammatory medications, combined with a short, low dose course of a muscle relaxant if necessary, depending on the severity of symptoms, to help get you over the worst part of it,” Dr. Hecht said.

“We are trying to help the patient feel better in the short term and get more physically strong with therapy to try to reduce the frequency of these attacks in the future,” he added.

“But each patient is different. It’s not one-size-fits-all, and we don’t give prolonged courses of muscle relaxants because they have some side effects, like sedation,” Dr. Hecht cautioned.

The study had no specific funding. Dr. Cashin, Dr. McAuley, and Dr. Hecht have disclosed no relevant financial relationships.

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

Despite being widely prescribed, muscle relaxants are largely ineffective for low back pain, new research suggests.

Results of a large systematic review and meta-analysis of randomized controlled trials show very “low certainty evidence” that non-benzodiazepine antispasmodics provide meaningful improvement in pain intensity in patients with low back pain – and may actually increase adverse event risk.

“We found that muscle relaxants might reduce pain in the short term, but on average, the effect is probably too small to be important, and most patients wouldn’t be able to feel any difference in their pain compared to taking a placebo,” study investigator Aidan Cashin, PhD, with the Center for Pain IMPACT, Neuroscience Research Australia, and University of New South Wales, Sydney, told this news organization. “There is also an increased risk of side effects,” he added.

The study was published online July 7 in The BMJ.
 

Global problem

Low back pain is a major global public health problem that burdens individuals, health care systems, and societies.

“Most people, around 80%, will have at least one episode of low back pain during their life,” Dr. Cashin noted.

Muscle relaxants, a broad class of drugs that include non-benzodiazepine antispasmodics and antispastics, are often prescribed for low back pain. In 2020 alone, prescriptions exceeded 1.3 million in England and topped 30 million in the United States.

“However, clinical practice guidelines have provided conflicting recommendations for the use of muscle relaxants to treat low back pain,” Dr. Cashin said.

To assess the efficacy and safety of muscle relaxants, the researchers conducted a detailed analysis of 31 randomized controlled trials that compared muscle relaxants with placebo, usual care, or no treatment in a total of 6,505 adults with nonspecific low back pain.

For acute low back pain, they found “very low certainty evidence” that non-benzodiazepine antispasmodics might reduce pain intensity at 2 weeks or less, but the effect is small – less than 8 points on a 0 to 100 point scale – and not clinically meaningful.

They found little to no effect of non-benzodiazepine antispasmodics on pain intensity at 3 to 13 weeks or on disability at any follow-up time points. None of the trials assessed the effect of muscle relaxants on long-term outcomes.

There was also low-certainty and very-low-certainty evidence that non-benzodiazepine antispasmodics might increase the risk of an adverse event, commonly dizziness, drowsiness, headache, and nausea (relative risk 1.6; 95% confidence interval, 1.2-2.0).
 

Better research needed

“We were surprised by the findings, as earlier research suggested that muscle relaxants did reduce pain intensity. But when we included all of the most up-to-date research, the results became much less certain,” said Dr. Cashin.

“We were also surprised to see that so much of the research wasn’t done very well, which means that we can’t be very certain in the results. There is a clear need to improve how research is done for low back pain so that we better understand whether medicines can help people or not,” Dr. Cashin said.

“We would encourage clinicians to discuss this uncertainty in the efficacy and safety of muscle relaxants with patients, sharing information about the possibility for a worthwhile benefit in pain reduction but increased risk of experiencing a nonserious adverse event, to allow them to make informed treatment decisions,” corresponding author James McAuley, PhD, University of New South Wales, said in an interview.

“We know that no matter what medicines people with low back pain are taking, they should avoid staying in bed, and they should try to be active and continue with their usual activities, including work, as much as they can. High-quality research shows that people who do this are more likely to recover faster and more completely,” said Dr. McAuley.
 

A symptom, not a diagnosis

Reached for comment, Andrew Hecht, MD, chief of spine surgery at Mount Sinai Health System, New York, noted that acute low back pain is “a symptom, not a diagnosis, and most episodes of acute low back pain without leg pain will resolve within a few weeks no matter what you do.”

“For people who have an episode of acute low back pain, we typically use anti-inflammatory medications, combined with a short, low dose course of a muscle relaxant if necessary, depending on the severity of symptoms, to help get you over the worst part of it,” Dr. Hecht said.

“We are trying to help the patient feel better in the short term and get more physically strong with therapy to try to reduce the frequency of these attacks in the future,” he added.

“But each patient is different. It’s not one-size-fits-all, and we don’t give prolonged courses of muscle relaxants because they have some side effects, like sedation,” Dr. Hecht cautioned.

The study had no specific funding. Dr. Cashin, Dr. McAuley, and Dr. Hecht have disclosed no relevant financial relationships.

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

Habitual coffee drinking was not associated with a heightened risk of cardiac arrhythmias in a study of more than 300,000 people.

In fact, an adjusted analysis found that “each additional cup of coffee intake was associated with a 3% lower risk of incident arrhythmia,” Eun-jeong Kim, MD, of the division of cardiology at the University of California, San Francisco, and colleagues reported in JAMA Internal Medicine.

In addition, genetic differences that affect caffeine metabolism did not significantly influence the odds of arrhythmias, the researchers found.

Still, these findings should not necessarily encourage people to start drinking coffee if they don’t already, or to guzzle additional cups with abandon, they said.

American Heart Association

“We certainly don’t want to say drink coffee and it will reduce your risk of arrhythmias,” study author Gregory M. Marcus, MD, MAS, associate chief of cardiology for research at UCSF Health, said in an interview. “But rather, we think the main point is that a blanket prohibition against coffee or caffeine to reduce the risk of arrhythmias among patients who have a diagnosis of arrhythmias is likely unwarranted. And given some evidence that coffee consumption may actually have other benefits regarding diabetes, mood, and perhaps overall mortality, it may be problematic to admonish patients to avoid coffee or caffeine when it is not really warranted.”
 

Methods and results

The conventional wisdom that caffeine increases arrhythmic risk has not been well substantiated. To further examine whether moderate, habitual coffee drinking relates to arrhythmia risk, and whether certain genetic variants influence the association, Dr. Kim and colleagues analyzed data from the UK Biobank. They focused on longitudinal data collected between 2006 and 2018 from 386,258 people who did not have a prior diagnosis of arrhythmia.

Participants had an average age of 56 years, and about 52% were female. They provided information about their coffee consumption, and the researchers grouped the participants into eight categories based on their daily coffee intake: 0, less than 1, 1, 2, 3, 4, 5, and 6 or more cups per day.

Over an average follow-up of 4.5 years, 16,979 participants developed an incident arrhythmia. After adjusting for demographic characteristics, comorbid conditions, and lifestyle habits, the decreased risk with each cup of coffee was similar for atrial fibrillation or flutter (hazard ratio, 0.97) and supraventricular tachycardia (HR, 0.96).

Taking into account genetic variations that relate to caffeine metabolism did not modify the findings. Mendelian randomization analyses that used a polygenic score of inherited caffeine metabolism patterns “failed to provide evidence that caffeine consumption leads to a greater risk of arrhythmias,” the researchers said.

Professional society guidelines have suggested staying away from caffeinated products to reduce the risk of arrhythmia, but this guidance has “relied on assumed mechanisms and a small observational study from 1980,” the authors wrote. Subsequent research has indicated that coffee’s reputation of increasing the risk of arrhythmia may be undeserved.

“The investigators should be commended on performing a high-quality observational study to try to further understand the association between coffee consumption and arrhythmias, or the lack of one,” commented Zachary D. Goldberger, MD, MS, with the division of cardiovascular medicine at the University of Wisconsin–Madison, who was not involved in the study. “This is not a randomized, controlled trial, and coffee consumption was self-reported, but the methods employed are rigorous, despite these and other important limitations. However, we need to be extremely cautious in how we interpret these findings, and not use these data as a prescription for more coffee. It’s important to recognize that this study is not telling us to drink more coffee, or start drinking coffee, to protect against developing arrhythmias. However, it should offer more reassurance that moderate coffee consumption is not necessarily harmful, and will not always lead to arrhythmias. This is important, given the widespread notion that coffee is universally proarrhythmic.”
 

A call for personalized guidance

“As the investigators note, there are definitely biologically plausible reasons how coffee and caffeine may not cause arrhythmias, and may be possibly protective in some, despite being a stimulant,” Dr. Goldberger said. “However, if your patient is reporting palpitations or symptoms of an arrhythmia, and feels they be related to coffee or caffeine, we should not use this study to tell them that coffee may not be the culprit. We need to listen to our patients, and the decision to reduce coffee consumption to reduce these symptoms needs to be personalized.”

The effect size was small, and only about 4% of the participants developed an arrhythmia, Dr. Goldberger and Rodney A. Hayward, MD, wrote in an invited commentary on the study in JAMA Internal Medicine. Dr. Hayward is a professor of public health and internal medicine at the University of Michigan, Ann Arbor, and a senior investigator at the Ann Arbor Veterans Affairs Center for Clinical Management Research.

“Unfortunately, coffee consumption was self-reported at a single time point. Not only can this lead to recall bias, but subsequent and substantial changes in coffee consumption are also possible, including reductions due to new signs or symptoms,” they said.
 

No evidence that coffee ups risk for developing arrhythmias

Another recent study suggests that people may alter their coffee consumption depending on their baseline cardiovascular health, according to the commentary.

Overall, the results “strengthen the evidence that caffeine is not proarrhythmic, but they should not be taken as proving that coffee is an antiarrhythmic—this distinction is of paramount importance,” Dr. Goldberger and Dr. Hayward wrote. “Health care professionals can reassure patients that there is no evidence that drinking coffee increases the risk for developing arrhythmias. This is particularly important for the many patients with benign palpitations who are devastated when they think, or are told, that they have to stop drinking coffee. Given current evidence, this is entirely a patient-preference decision, not a medical one.”

Dr. Marcus, a cardiac electrophysiologist, sees patients with arrhythmias all the time. They tend to “come in fairly convinced that caffeine is to be avoided when they have arrhythmias,” he said. “Often, they been told by their primary care physician or their general cardiologist to avoid caffeine because they have an arrhythmia.

“What I suggest to my patients is that they feel free to go ahead and experiment and try coffee,” Dr. Marcus said.

Still, Dr. Marcus suspects that there are some individuals in whom caffeine is a trigger for the arrhythmia. But evidence indicates these cases likely are rare, and avoiding caffeine need not apply to the general population, particularly “given the potential health benefits of benefits of coffee and also, frankly, just the enhanced quality of life that people can enjoy drinking a good cup of coffee.”

The research was conducted using the UK Biobank resource, which was established by the Wellcome Trust, the Medical Research Council, the U.K. Department of Health, and the Scottish government. The UK Biobank has received funding from other agencies and foundations as well. Dr. Marcus disclosed grants from Baylis, Medtronic, and Eight Sleep outside the submitted work. In addition, he reported consulting for Johnson & Johnson and InCarda, and holding equity in InCarda. A coauthor received salary support from the National Institutes of Health during the study. Dr. Goldberger and Dr. Hayward disclosed no conflicts of interest.

jremaly@mdedge.com

Habitual coffee drinking was not associated with a heightened risk of cardiac arrhythmias in a study of more than 300,000 people.

In fact, an adjusted analysis found that “each additional cup of coffee intake was associated with a 3% lower risk of incident arrhythmia,” Eun-jeong Kim, MD, of the division of cardiology at the University of California, San Francisco, and colleagues reported in JAMA Internal Medicine.

In addition, genetic differences that affect caffeine metabolism did not significantly influence the odds of arrhythmias, the researchers found.

Still, these findings should not necessarily encourage people to start drinking coffee if they don’t already, or to guzzle additional cups with abandon, they said.

American Heart Association

“We certainly don’t want to say drink coffee and it will reduce your risk of arrhythmias,” study author Gregory M. Marcus, MD, MAS, associate chief of cardiology for research at UCSF Health, said in an interview. “But rather, we think the main point is that a blanket prohibition against coffee or caffeine to reduce the risk of arrhythmias among patients who have a diagnosis of arrhythmias is likely unwarranted. And given some evidence that coffee consumption may actually have other benefits regarding diabetes, mood, and perhaps overall mortality, it may be problematic to admonish patients to avoid coffee or caffeine when it is not really warranted.”
 

Methods and results

The conventional wisdom that caffeine increases arrhythmic risk has not been well substantiated. To further examine whether moderate, habitual coffee drinking relates to arrhythmia risk, and whether certain genetic variants influence the association, Dr. Kim and colleagues analyzed data from the UK Biobank. They focused on longitudinal data collected between 2006 and 2018 from 386,258 people who did not have a prior diagnosis of arrhythmia.

Participants had an average age of 56 years, and about 52% were female. They provided information about their coffee consumption, and the researchers grouped the participants into eight categories based on their daily coffee intake: 0, less than 1, 1, 2, 3, 4, 5, and 6 or more cups per day.

Over an average follow-up of 4.5 years, 16,979 participants developed an incident arrhythmia. After adjusting for demographic characteristics, comorbid conditions, and lifestyle habits, the decreased risk with each cup of coffee was similar for atrial fibrillation or flutter (hazard ratio, 0.97) and supraventricular tachycardia (HR, 0.96).

Taking into account genetic variations that relate to caffeine metabolism did not modify the findings. Mendelian randomization analyses that used a polygenic score of inherited caffeine metabolism patterns “failed to provide evidence that caffeine consumption leads to a greater risk of arrhythmias,” the researchers said.

Professional society guidelines have suggested staying away from caffeinated products to reduce the risk of arrhythmia, but this guidance has “relied on assumed mechanisms and a small observational study from 1980,” the authors wrote. Subsequent research has indicated that coffee’s reputation of increasing the risk of arrhythmia may be undeserved.

“The investigators should be commended on performing a high-quality observational study to try to further understand the association between coffee consumption and arrhythmias, or the lack of one,” commented Zachary D. Goldberger, MD, MS, with the division of cardiovascular medicine at the University of Wisconsin–Madison, who was not involved in the study. “This is not a randomized, controlled trial, and coffee consumption was self-reported, but the methods employed are rigorous, despite these and other important limitations. However, we need to be extremely cautious in how we interpret these findings, and not use these data as a prescription for more coffee. It’s important to recognize that this study is not telling us to drink more coffee, or start drinking coffee, to protect against developing arrhythmias. However, it should offer more reassurance that moderate coffee consumption is not necessarily harmful, and will not always lead to arrhythmias. This is important, given the widespread notion that coffee is universally proarrhythmic.”
 

A call for personalized guidance

“As the investigators note, there are definitely biologically plausible reasons how coffee and caffeine may not cause arrhythmias, and may be possibly protective in some, despite being a stimulant,” Dr. Goldberger said. “However, if your patient is reporting palpitations or symptoms of an arrhythmia, and feels they be related to coffee or caffeine, we should not use this study to tell them that coffee may not be the culprit. We need to listen to our patients, and the decision to reduce coffee consumption to reduce these symptoms needs to be personalized.”

The effect size was small, and only about 4% of the participants developed an arrhythmia, Dr. Goldberger and Rodney A. Hayward, MD, wrote in an invited commentary on the study in JAMA Internal Medicine. Dr. Hayward is a professor of public health and internal medicine at the University of Michigan, Ann Arbor, and a senior investigator at the Ann Arbor Veterans Affairs Center for Clinical Management Research.

“Unfortunately, coffee consumption was self-reported at a single time point. Not only can this lead to recall bias, but subsequent and substantial changes in coffee consumption are also possible, including reductions due to new signs or symptoms,” they said.
 

No evidence that coffee ups risk for developing arrhythmias

Another recent study suggests that people may alter their coffee consumption depending on their baseline cardiovascular health, according to the commentary.

Overall, the results “strengthen the evidence that caffeine is not proarrhythmic, but they should not be taken as proving that coffee is an antiarrhythmic—this distinction is of paramount importance,” Dr. Goldberger and Dr. Hayward wrote. “Health care professionals can reassure patients that there is no evidence that drinking coffee increases the risk for developing arrhythmias. This is particularly important for the many patients with benign palpitations who are devastated when they think, or are told, that they have to stop drinking coffee. Given current evidence, this is entirely a patient-preference decision, not a medical one.”

Dr. Marcus, a cardiac electrophysiologist, sees patients with arrhythmias all the time. They tend to “come in fairly convinced that caffeine is to be avoided when they have arrhythmias,” he said. “Often, they been told by their primary care physician or their general cardiologist to avoid caffeine because they have an arrhythmia.

“What I suggest to my patients is that they feel free to go ahead and experiment and try coffee,” Dr. Marcus said.

Still, Dr. Marcus suspects that there are some individuals in whom caffeine is a trigger for the arrhythmia. But evidence indicates these cases likely are rare, and avoiding caffeine need not apply to the general population, particularly “given the potential health benefits of benefits of coffee and also, frankly, just the enhanced quality of life that people can enjoy drinking a good cup of coffee.”

The research was conducted using the UK Biobank resource, which was established by the Wellcome Trust, the Medical Research Council, the U.K. Department of Health, and the Scottish government. The UK Biobank has received funding from other agencies and foundations as well. Dr. Marcus disclosed grants from Baylis, Medtronic, and Eight Sleep outside the submitted work. In addition, he reported consulting for Johnson & Johnson and InCarda, and holding equity in InCarda. A coauthor received salary support from the National Institutes of Health during the study. Dr. Goldberger and Dr. Hayward disclosed no conflicts of interest.

jremaly@mdedge.com

Habitual coffee drinking was not associated with a heightened risk of cardiac arrhythmias in a study of more than 300,000 people.

In fact, an adjusted analysis found that “each additional cup of coffee intake was associated with a 3% lower risk of incident arrhythmia,” Eun-jeong Kim, MD, of the division of cardiology at the University of California, San Francisco, and colleagues reported in JAMA Internal Medicine.

In addition, genetic differences that affect caffeine metabolism did not significantly influence the odds of arrhythmias, the researchers found.

Still, these findings should not necessarily encourage people to start drinking coffee if they don’t already, or to guzzle additional cups with abandon, they said.

American Heart Association

“We certainly don’t want to say drink coffee and it will reduce your risk of arrhythmias,” study author Gregory M. Marcus, MD, MAS, associate chief of cardiology for research at UCSF Health, said in an interview. “But rather, we think the main point is that a blanket prohibition against coffee or caffeine to reduce the risk of arrhythmias among patients who have a diagnosis of arrhythmias is likely unwarranted. And given some evidence that coffee consumption may actually have other benefits regarding diabetes, mood, and perhaps overall mortality, it may be problematic to admonish patients to avoid coffee or caffeine when it is not really warranted.”
 

Methods and results

The conventional wisdom that caffeine increases arrhythmic risk has not been well substantiated. To further examine whether moderate, habitual coffee drinking relates to arrhythmia risk, and whether certain genetic variants influence the association, Dr. Kim and colleagues analyzed data from the UK Biobank. They focused on longitudinal data collected between 2006 and 2018 from 386,258 people who did not have a prior diagnosis of arrhythmia.

Participants had an average age of 56 years, and about 52% were female. They provided information about their coffee consumption, and the researchers grouped the participants into eight categories based on their daily coffee intake: 0, less than 1, 1, 2, 3, 4, 5, and 6 or more cups per day.

Over an average follow-up of 4.5 years, 16,979 participants developed an incident arrhythmia. After adjusting for demographic characteristics, comorbid conditions, and lifestyle habits, the decreased risk with each cup of coffee was similar for atrial fibrillation or flutter (hazard ratio, 0.97) and supraventricular tachycardia (HR, 0.96).

Taking into account genetic variations that relate to caffeine metabolism did not modify the findings. Mendelian randomization analyses that used a polygenic score of inherited caffeine metabolism patterns “failed to provide evidence that caffeine consumption leads to a greater risk of arrhythmias,” the researchers said.

Professional society guidelines have suggested staying away from caffeinated products to reduce the risk of arrhythmia, but this guidance has “relied on assumed mechanisms and a small observational study from 1980,” the authors wrote. Subsequent research has indicated that coffee’s reputation of increasing the risk of arrhythmia may be undeserved.

“The investigators should be commended on performing a high-quality observational study to try to further understand the association between coffee consumption and arrhythmias, or the lack of one,” commented Zachary D. Goldberger, MD, MS, with the division of cardiovascular medicine at the University of Wisconsin–Madison, who was not involved in the study. “This is not a randomized, controlled trial, and coffee consumption was self-reported, but the methods employed are rigorous, despite these and other important limitations. However, we need to be extremely cautious in how we interpret these findings, and not use these data as a prescription for more coffee. It’s important to recognize that this study is not telling us to drink more coffee, or start drinking coffee, to protect against developing arrhythmias. However, it should offer more reassurance that moderate coffee consumption is not necessarily harmful, and will not always lead to arrhythmias. This is important, given the widespread notion that coffee is universally proarrhythmic.”
 

A call for personalized guidance

“As the investigators note, there are definitely biologically plausible reasons how coffee and caffeine may not cause arrhythmias, and may be possibly protective in some, despite being a stimulant,” Dr. Goldberger said. “However, if your patient is reporting palpitations or symptoms of an arrhythmia, and feels they be related to coffee or caffeine, we should not use this study to tell them that coffee may not be the culprit. We need to listen to our patients, and the decision to reduce coffee consumption to reduce these symptoms needs to be personalized.”

The effect size was small, and only about 4% of the participants developed an arrhythmia, Dr. Goldberger and Rodney A. Hayward, MD, wrote in an invited commentary on the study in JAMA Internal Medicine. Dr. Hayward is a professor of public health and internal medicine at the University of Michigan, Ann Arbor, and a senior investigator at the Ann Arbor Veterans Affairs Center for Clinical Management Research.

“Unfortunately, coffee consumption was self-reported at a single time point. Not only can this lead to recall bias, but subsequent and substantial changes in coffee consumption are also possible, including reductions due to new signs or symptoms,” they said.
 

No evidence that coffee ups risk for developing arrhythmias

Another recent study suggests that people may alter their coffee consumption depending on their baseline cardiovascular health, according to the commentary.

Overall, the results “strengthen the evidence that caffeine is not proarrhythmic, but they should not be taken as proving that coffee is an antiarrhythmic—this distinction is of paramount importance,” Dr. Goldberger and Dr. Hayward wrote. “Health care professionals can reassure patients that there is no evidence that drinking coffee increases the risk for developing arrhythmias. This is particularly important for the many patients with benign palpitations who are devastated when they think, or are told, that they have to stop drinking coffee. Given current evidence, this is entirely a patient-preference decision, not a medical one.”

Dr. Marcus, a cardiac electrophysiologist, sees patients with arrhythmias all the time. They tend to “come in fairly convinced that caffeine is to be avoided when they have arrhythmias,” he said. “Often, they been told by their primary care physician or their general cardiologist to avoid caffeine because they have an arrhythmia.

“What I suggest to my patients is that they feel free to go ahead and experiment and try coffee,” Dr. Marcus said.

Still, Dr. Marcus suspects that there are some individuals in whom caffeine is a trigger for the arrhythmia. But evidence indicates these cases likely are rare, and avoiding caffeine need not apply to the general population, particularly “given the potential health benefits of benefits of coffee and also, frankly, just the enhanced quality of life that people can enjoy drinking a good cup of coffee.”

The research was conducted using the UK Biobank resource, which was established by the Wellcome Trust, the Medical Research Council, the U.K. Department of Health, and the Scottish government. The UK Biobank has received funding from other agencies and foundations as well. Dr. Marcus disclosed grants from Baylis, Medtronic, and Eight Sleep outside the submitted work. In addition, he reported consulting for Johnson & Johnson and InCarda, and holding equity in InCarda. A coauthor received salary support from the National Institutes of Health during the study. Dr. Goldberger and Dr. Hayward disclosed no conflicts of interest.

jremaly@mdedge.com

Most U.S. prescriptions for the thyroid hormone replacement drug levothyroxine are not appropriate for patients with mild subclinical hypothyroidism, a trend that has remained steady for a decade despite evidence showing no significant benefits for those patients, new research shows.

“These results suggest substantial overuse of levothyroxine during the entire duration of the study, suggesting opportunities to improve care,” wrote the authors of the study published in JAMA Internal Medicine.

“There have been previous reports of increased levothyroxine overuse in the U.S., but this is the first paper to describe the nature of the drivers of the overuse,” first author Juan P. Brito, MD, of the division of endocrinology, diabetes, metabolism and nutrition, department of internal medicine, Mayo Clinic, Rochester, Minn., said in an interview.

The findings underscore the need to improve awareness of the ongoing overuse, said the authors of an accompanying editorial.

“We hope [this study] resonates as a call to action for clinicians to stop treating patients with mild subclinical hypothyroidism,” they wrote.
 

Only 8% of those receiving levothyroxine had overt hypothyroidism

For the study, Dr. Brito and colleagues analyzed data of adults enrolled in Medicare Advantage who filled levothyroxine prescriptions between January 2008 and December 2018 and had thyrotropin levels measured within 3 months prior to the prescription. Patients with a history of thyroid surgery, thyroid cancer, central hypothyroidism, or who were pregnant, were excluded from the study.

In the 110,842 patients who started levothyroxine during the study period, there were no significant changes in median thyrotropin levels at the time of treatment initiation, with a median level in 2008 of 5.8 mIU/L and a level in 2018 of 5.3 mIU/L (P = .79).

In a subanalysis of 58,706 patients for whom thyrotropin as well as free thyroxine (FT4 or T4) levels were available – which allowed for the determination of the level of hypothyroidism – levothyroxine was initiated for overt hypothyroidism in only 8.4% of cases.

In as many as 61.0% of cases, patients had subclinical hypothyroidism, and in 30.5% of cases, patients had normal thyroid levels.

While the proportion of adults with overt hypothyroidism initiated on levothyroxine significantly increased over the 10 years (7.6% to 8.4%; P = .02), rates of those with subclinical hypothyroidism remained unchanged (59.3% to 65.7%; P = .36), as did the proportion with normal thyroid function (32.9% to 26.2%; P = .84).

A closer look at patients specifically with subclinical hypothyroidism showed there were also no changes in the proportion with mild subclinical hypothyroidism (thyrotropin level of 4.5 mIU/L to <10 mIU/L with normal FT4 or T4) between the beginning and end of the study period (48.2% vs. 57.9%; P = .73). Rates of moderate subclinical hypothyroidism (thyrotropin level 10-19.9 mIU/L) were also similar (8.5% to 6.4%; P = .16).
 

No significant benefit, but ample undesirable effects

The authors underscore that levothyroxine has been shown time and again to offer no significant benefit to patients with subclinical hypothyroidism of any type, emphasized in a 2018 meta-analysis of 21 randomized, controlled trials.

“Frequent initiation of levothyroxine in these patients is at odds with evidence demonstrating no significant association of levothyroxine replacement with measures of health-related quality of life, thyroid-related symptoms, depressive symptoms, fatigue, or cognitive function,” they explained.

In addition to showing no benefit for subclinical hypothyroidism, levothyroxine is associated with a host of unwanted side effects, noted editorialists William K. Silverstein, MD, of Sunnybrook Health Sciences Centre, department of medicine, University of Toronto, and Deborah Grady, MD, of the department of medicine, University of California, San Francisco.

Some studies have shown a link between long-term levothyroxine therapy and an increased risk of cardiovascular disease, cardiac dysrhythmias, osteoporosis, and fractures, they explained.

In addition, unnecessary treatment “increases pill burden and costs, necessitates routine physician visits and blood work, and requires modification of daily routines so that patients can take medications on an empty stomach,” the editorialists wrote.

Importantly, evidence shows that once levothyroxine treatment for subclinical hypothyroidism is started, most patients will continue the therapy for life, they added.

The fact that levothyroxine is among the most commonly prescribed drugs in the United States, with about 7% of the population estimated to have an active prescription when overt hypothyroidism affects only about 0.2%-2% of the population, underscores the extent of levothyroxine overuse, Dr. Silverstein said in an interview. 

“The really notable surprise was how pervasive inappropriate use of levothyroxine was,” he said. “The fact that only 8% of patients had a biochemical indication for treatment is striking.”
 

Potential solutions: ‘Shift the conversation’

In terms of potential solutions to the problem, Dr. Silverstein suggested laboratories change reference ranges so that only thyrotropin values greater than 10 mIU/L are reported as abnormal.

“Studies have shown that changing the thyrotropin reference range is associated with clinicians’ prescribing patterns,” he noted.

Dr. Brito agreed, noting that “there are many guidelines with different hypothyroidism thresholds, so we need to be more consistent about the message to clinicians.

“In addition, we have to come up with different approaches to symptoms that have nothing to do with levothyroxine,” Dr. Brito said.

“I try to explain to patients that it’s very unlikely that subclinical hypothyroidism would be driving significant symptoms like fatigue, weight gain, and hair loss,” Dr. Brito said. “So, one approach is to shift the conversation from how your thyroid is causing this to ‘how are we going to treat the symptoms?’ ”

The study was supported by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. Silverstein has reported no relevant financial relationships.

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

Most U.S. prescriptions for the thyroid hormone replacement drug levothyroxine are not appropriate for patients with mild subclinical hypothyroidism, a trend that has remained steady for a decade despite evidence showing no significant benefits for those patients, new research shows.

“These results suggest substantial overuse of levothyroxine during the entire duration of the study, suggesting opportunities to improve care,” wrote the authors of the study published in JAMA Internal Medicine.

“There have been previous reports of increased levothyroxine overuse in the U.S., but this is the first paper to describe the nature of the drivers of the overuse,” first author Juan P. Brito, MD, of the division of endocrinology, diabetes, metabolism and nutrition, department of internal medicine, Mayo Clinic, Rochester, Minn., said in an interview.

The findings underscore the need to improve awareness of the ongoing overuse, said the authors of an accompanying editorial.

“We hope [this study] resonates as a call to action for clinicians to stop treating patients with mild subclinical hypothyroidism,” they wrote.
 

Only 8% of those receiving levothyroxine had overt hypothyroidism

For the study, Dr. Brito and colleagues analyzed data of adults enrolled in Medicare Advantage who filled levothyroxine prescriptions between January 2008 and December 2018 and had thyrotropin levels measured within 3 months prior to the prescription. Patients with a history of thyroid surgery, thyroid cancer, central hypothyroidism, or who were pregnant, were excluded from the study.

In the 110,842 patients who started levothyroxine during the study period, there were no significant changes in median thyrotropin levels at the time of treatment initiation, with a median level in 2008 of 5.8 mIU/L and a level in 2018 of 5.3 mIU/L (P = .79).

In a subanalysis of 58,706 patients for whom thyrotropin as well as free thyroxine (FT4 or T4) levels were available – which allowed for the determination of the level of hypothyroidism – levothyroxine was initiated for overt hypothyroidism in only 8.4% of cases.

In as many as 61.0% of cases, patients had subclinical hypothyroidism, and in 30.5% of cases, patients had normal thyroid levels.

While the proportion of adults with overt hypothyroidism initiated on levothyroxine significantly increased over the 10 years (7.6% to 8.4%; P = .02), rates of those with subclinical hypothyroidism remained unchanged (59.3% to 65.7%; P = .36), as did the proportion with normal thyroid function (32.9% to 26.2%; P = .84).

A closer look at patients specifically with subclinical hypothyroidism showed there were also no changes in the proportion with mild subclinical hypothyroidism (thyrotropin level of 4.5 mIU/L to <10 mIU/L with normal FT4 or T4) between the beginning and end of the study period (48.2% vs. 57.9%; P = .73). Rates of moderate subclinical hypothyroidism (thyrotropin level 10-19.9 mIU/L) were also similar (8.5% to 6.4%; P = .16).
 

No significant benefit, but ample undesirable effects

The authors underscore that levothyroxine has been shown time and again to offer no significant benefit to patients with subclinical hypothyroidism of any type, emphasized in a 2018 meta-analysis of 21 randomized, controlled trials.

“Frequent initiation of levothyroxine in these patients is at odds with evidence demonstrating no significant association of levothyroxine replacement with measures of health-related quality of life, thyroid-related symptoms, depressive symptoms, fatigue, or cognitive function,” they explained.

In addition to showing no benefit for subclinical hypothyroidism, levothyroxine is associated with a host of unwanted side effects, noted editorialists William K. Silverstein, MD, of Sunnybrook Health Sciences Centre, department of medicine, University of Toronto, and Deborah Grady, MD, of the department of medicine, University of California, San Francisco.

Some studies have shown a link between long-term levothyroxine therapy and an increased risk of cardiovascular disease, cardiac dysrhythmias, osteoporosis, and fractures, they explained.

In addition, unnecessary treatment “increases pill burden and costs, necessitates routine physician visits and blood work, and requires modification of daily routines so that patients can take medications on an empty stomach,” the editorialists wrote.

Importantly, evidence shows that once levothyroxine treatment for subclinical hypothyroidism is started, most patients will continue the therapy for life, they added.

The fact that levothyroxine is among the most commonly prescribed drugs in the United States, with about 7% of the population estimated to have an active prescription when overt hypothyroidism affects only about 0.2%-2% of the population, underscores the extent of levothyroxine overuse, Dr. Silverstein said in an interview. 

“The really notable surprise was how pervasive inappropriate use of levothyroxine was,” he said. “The fact that only 8% of patients had a biochemical indication for treatment is striking.”
 

Potential solutions: ‘Shift the conversation’

In terms of potential solutions to the problem, Dr. Silverstein suggested laboratories change reference ranges so that only thyrotropin values greater than 10 mIU/L are reported as abnormal.

“Studies have shown that changing the thyrotropin reference range is associated with clinicians’ prescribing patterns,” he noted.

Dr. Brito agreed, noting that “there are many guidelines with different hypothyroidism thresholds, so we need to be more consistent about the message to clinicians.

“In addition, we have to come up with different approaches to symptoms that have nothing to do with levothyroxine,” Dr. Brito said.

“I try to explain to patients that it’s very unlikely that subclinical hypothyroidism would be driving significant symptoms like fatigue, weight gain, and hair loss,” Dr. Brito said. “So, one approach is to shift the conversation from how your thyroid is causing this to ‘how are we going to treat the symptoms?’ ”

The study was supported by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. Silverstein has reported no relevant financial relationships.

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

Most U.S. prescriptions for the thyroid hormone replacement drug levothyroxine are not appropriate for patients with mild subclinical hypothyroidism, a trend that has remained steady for a decade despite evidence showing no significant benefits for those patients, new research shows.

“These results suggest substantial overuse of levothyroxine during the entire duration of the study, suggesting opportunities to improve care,” wrote the authors of the study published in JAMA Internal Medicine.

“There have been previous reports of increased levothyroxine overuse in the U.S., but this is the first paper to describe the nature of the drivers of the overuse,” first author Juan P. Brito, MD, of the division of endocrinology, diabetes, metabolism and nutrition, department of internal medicine, Mayo Clinic, Rochester, Minn., said in an interview.

The findings underscore the need to improve awareness of the ongoing overuse, said the authors of an accompanying editorial.

“We hope [this study] resonates as a call to action for clinicians to stop treating patients with mild subclinical hypothyroidism,” they wrote.
 

Only 8% of those receiving levothyroxine had overt hypothyroidism

For the study, Dr. Brito and colleagues analyzed data of adults enrolled in Medicare Advantage who filled levothyroxine prescriptions between January 2008 and December 2018 and had thyrotropin levels measured within 3 months prior to the prescription. Patients with a history of thyroid surgery, thyroid cancer, central hypothyroidism, or who were pregnant, were excluded from the study.

In the 110,842 patients who started levothyroxine during the study period, there were no significant changes in median thyrotropin levels at the time of treatment initiation, with a median level in 2008 of 5.8 mIU/L and a level in 2018 of 5.3 mIU/L (P = .79).

In a subanalysis of 58,706 patients for whom thyrotropin as well as free thyroxine (FT4 or T4) levels were available – which allowed for the determination of the level of hypothyroidism – levothyroxine was initiated for overt hypothyroidism in only 8.4% of cases.

In as many as 61.0% of cases, patients had subclinical hypothyroidism, and in 30.5% of cases, patients had normal thyroid levels.

While the proportion of adults with overt hypothyroidism initiated on levothyroxine significantly increased over the 10 years (7.6% to 8.4%; P = .02), rates of those with subclinical hypothyroidism remained unchanged (59.3% to 65.7%; P = .36), as did the proportion with normal thyroid function (32.9% to 26.2%; P = .84).

A closer look at patients specifically with subclinical hypothyroidism showed there were also no changes in the proportion with mild subclinical hypothyroidism (thyrotropin level of 4.5 mIU/L to <10 mIU/L with normal FT4 or T4) between the beginning and end of the study period (48.2% vs. 57.9%; P = .73). Rates of moderate subclinical hypothyroidism (thyrotropin level 10-19.9 mIU/L) were also similar (8.5% to 6.4%; P = .16).
 

No significant benefit, but ample undesirable effects

The authors underscore that levothyroxine has been shown time and again to offer no significant benefit to patients with subclinical hypothyroidism of any type, emphasized in a 2018 meta-analysis of 21 randomized, controlled trials.

“Frequent initiation of levothyroxine in these patients is at odds with evidence demonstrating no significant association of levothyroxine replacement with measures of health-related quality of life, thyroid-related symptoms, depressive symptoms, fatigue, or cognitive function,” they explained.

In addition to showing no benefit for subclinical hypothyroidism, levothyroxine is associated with a host of unwanted side effects, noted editorialists William K. Silverstein, MD, of Sunnybrook Health Sciences Centre, department of medicine, University of Toronto, and Deborah Grady, MD, of the department of medicine, University of California, San Francisco.

Some studies have shown a link between long-term levothyroxine therapy and an increased risk of cardiovascular disease, cardiac dysrhythmias, osteoporosis, and fractures, they explained.

In addition, unnecessary treatment “increases pill burden and costs, necessitates routine physician visits and blood work, and requires modification of daily routines so that patients can take medications on an empty stomach,” the editorialists wrote.

Importantly, evidence shows that once levothyroxine treatment for subclinical hypothyroidism is started, most patients will continue the therapy for life, they added.

The fact that levothyroxine is among the most commonly prescribed drugs in the United States, with about 7% of the population estimated to have an active prescription when overt hypothyroidism affects only about 0.2%-2% of the population, underscores the extent of levothyroxine overuse, Dr. Silverstein said in an interview. 

“The really notable surprise was how pervasive inappropriate use of levothyroxine was,” he said. “The fact that only 8% of patients had a biochemical indication for treatment is striking.”
 

Potential solutions: ‘Shift the conversation’

In terms of potential solutions to the problem, Dr. Silverstein suggested laboratories change reference ranges so that only thyrotropin values greater than 10 mIU/L are reported as abnormal.

“Studies have shown that changing the thyrotropin reference range is associated with clinicians’ prescribing patterns,” he noted.

Dr. Brito agreed, noting that “there are many guidelines with different hypothyroidism thresholds, so we need to be more consistent about the message to clinicians.

“In addition, we have to come up with different approaches to symptoms that have nothing to do with levothyroxine,” Dr. Brito said.

“I try to explain to patients that it’s very unlikely that subclinical hypothyroidism would be driving significant symptoms like fatigue, weight gain, and hair loss,” Dr. Brito said. “So, one approach is to shift the conversation from how your thyroid is causing this to ‘how are we going to treat the symptoms?’ ”

The study was supported by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. Silverstein has reported no relevant financial relationships.

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

Iatrogenic delivery for suspected fetal growth restriction (FGR) may be associated with an increased likelihood of poorer school outcomes among infants born severely small for gestational age, a study of children in Australia suggests.

Compared with severely small infants who were not suspected of having FGR, those delivered by early induction of labor or cesarean delivery prior to labor because of suspected FGR tended to have worse developmental and educational outcomes, researchers reported in JAMA.

“It raises the question: in our efforts to improve outcomes in babies that are small, are we potentially doing more harm than good?” said Robert M. Silver, MD, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, who was not involved in the study. “I think that is a very important question to ask.”

However, “we can’t make that conclusion based on this one study,” he said in an interview. It could be that, in cases where severely small infants were delivered early, there may have been testing that indicated acute risks, and these infants may have tended to be sicker overall. “It may have been that if those babies weren’t delivered, they would have suffered a stillbirth or major brain injury,” Dr. Silver said. “It is really important that we acknowledge that we shouldn’t change our clinical practice” based on this one study.”

At the same time, the study underscores questions and challenges that surround the definition, identification, and management of suspected FGR, Dr. Silver said.

The study authors described their research as exploratory. In a related editorial Dr. Silver and Nathan R. Blue, MD said the findings should be considered hypothesis generating.

For the study, Roshan John Selvaratnam, BMedSc(Hons), a researcher affiliated with Monash University, Melbourne, and colleagues analyzed data from 181,902 children with developmental outcomes and 425,717 children with educational outcomes in Australia. They included children born at 32 weeks’ or more gestation between 2003 and 2013.

Severely small infants delivered early for suspected FGR had an average gestation of 37.9 weeks, whereas those not suspected of having FGR had an average gestation of 39.4 weeks.

Among infants who were severely small for gestational age, those delivered early for suspected FGR were more likely to be in the bottom 10th percentile on at least two developmental domains when they started school, compared with those not suspected of having FGR (16.2% vs. 12.7%; adjusted odds ratio, 1.36). They also were more likely to have low test scores in subsequent years. In grade 7, for example, the adjusted odds ratio for scoring below the national minimum standard on at least two educational domains was 1.33 (13.4% vs. 10.5%).

The researchers defined severely small for gestational age as birth weight below the third percentile. Among infants with normal growth, defined as birth weight at the 10th percentile or greater, school outcomes did not significantly differ between those with early delivery for suspected FGR and those not suspected of having FGR. Approximately 8% of the infants with normal growth had poor developmental outcomes.

The study authors described the dilemma that clinicians face with suspected FGR: “Either intervene early to prevent a small risk of stillbirth but potentially cause immediate and lifelong harm to the child or accept the increasing risk of stillbirth associated with prolonging the pregnancy to avoid more common neonatal and longer-term morbidities.”

It could be that severely small infants with suspected FGR in the study were “more compromised than those not suspected of having FGR,” which might explain the outcomes, Mr. Selvaratnam and coauthors wrote.

Another more plausible explanation is that “iatrogenic prematurity was harmful,” they said.

The researchers were unable to adjust for many factors that may influence academic success, including smoking and alcohol use during pregnancy, maternal body mass index, and breastfeeding, they noted. They also lacked information about the etiology for FGR and whether children had genetic abnormalities.

The study also does not take into account neonatal, infant, and childhood complications, Dr. Silver and Dr. Blue wrote in their editorial. “Nonetheless, these data are a welcome contribution given the knowledge gaps with regard to the optimal obstetric management of FGR.”

The establishment of a diagnostic standard for FGR is needed to properly investigate ways to improve risk stratification, diagnosis, and management, Dr. Silver and Dr. Blue added.

“What we have to do is get better at predicting which babies are at very high risk for continuing the pregnancy and which babies are at low risk for continuing the pregnancy so that we can better decide which babies would benefit from slightly early delivery,” Dr. Silver said.

Improved detection and management of FGR may be on the horizon. “Our ability to image the placental function has gotten a lot better, and I think that is really going to help us,” Dr. Silver said. Studies that aim to further improve the ability to assess whether babies are getting adequate blood flow during pregnancy are ongoing, which could further help doctors evaluate risks.

The study investigators and Dr. Silver had no conflict of interest disclosures. Dr. Blue disclosed grants from Samsung Medison and personal fees from Elsevier. The study was supported by a grant from the Australian government’s National Health and Medical Research Council Program, and Mr. Selvaratnam is supported by scholarships from an Australian government research training program and the National Centre of Research Excellence in Stillbirth.

jremaly@mdedge.com

Iatrogenic delivery for suspected fetal growth restriction (FGR) may be associated with an increased likelihood of poorer school outcomes among infants born severely small for gestational age, a study of children in Australia suggests.

Compared with severely small infants who were not suspected of having FGR, those delivered by early induction of labor or cesarean delivery prior to labor because of suspected FGR tended to have worse developmental and educational outcomes, researchers reported in JAMA.

“It raises the question: in our efforts to improve outcomes in babies that are small, are we potentially doing more harm than good?” said Robert M. Silver, MD, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, who was not involved in the study. “I think that is a very important question to ask.”

However, “we can’t make that conclusion based on this one study,” he said in an interview. It could be that, in cases where severely small infants were delivered early, there may have been testing that indicated acute risks, and these infants may have tended to be sicker overall. “It may have been that if those babies weren’t delivered, they would have suffered a stillbirth or major brain injury,” Dr. Silver said. “It is really important that we acknowledge that we shouldn’t change our clinical practice” based on this one study.”

At the same time, the study underscores questions and challenges that surround the definition, identification, and management of suspected FGR, Dr. Silver said.

The study authors described their research as exploratory. In a related editorial Dr. Silver and Nathan R. Blue, MD said the findings should be considered hypothesis generating.

For the study, Roshan John Selvaratnam, BMedSc(Hons), a researcher affiliated with Monash University, Melbourne, and colleagues analyzed data from 181,902 children with developmental outcomes and 425,717 children with educational outcomes in Australia. They included children born at 32 weeks’ or more gestation between 2003 and 2013.

Severely small infants delivered early for suspected FGR had an average gestation of 37.9 weeks, whereas those not suspected of having FGR had an average gestation of 39.4 weeks.

Among infants who were severely small for gestational age, those delivered early for suspected FGR were more likely to be in the bottom 10th percentile on at least two developmental domains when they started school, compared with those not suspected of having FGR (16.2% vs. 12.7%; adjusted odds ratio, 1.36). They also were more likely to have low test scores in subsequent years. In grade 7, for example, the adjusted odds ratio for scoring below the national minimum standard on at least two educational domains was 1.33 (13.4% vs. 10.5%).

The researchers defined severely small for gestational age as birth weight below the third percentile. Among infants with normal growth, defined as birth weight at the 10th percentile or greater, school outcomes did not significantly differ between those with early delivery for suspected FGR and those not suspected of having FGR. Approximately 8% of the infants with normal growth had poor developmental outcomes.

The study authors described the dilemma that clinicians face with suspected FGR: “Either intervene early to prevent a small risk of stillbirth but potentially cause immediate and lifelong harm to the child or accept the increasing risk of stillbirth associated with prolonging the pregnancy to avoid more common neonatal and longer-term morbidities.”

It could be that severely small infants with suspected FGR in the study were “more compromised than those not suspected of having FGR,” which might explain the outcomes, Mr. Selvaratnam and coauthors wrote.

Another more plausible explanation is that “iatrogenic prematurity was harmful,” they said.

The researchers were unable to adjust for many factors that may influence academic success, including smoking and alcohol use during pregnancy, maternal body mass index, and breastfeeding, they noted. They also lacked information about the etiology for FGR and whether children had genetic abnormalities.

The study also does not take into account neonatal, infant, and childhood complications, Dr. Silver and Dr. Blue wrote in their editorial. “Nonetheless, these data are a welcome contribution given the knowledge gaps with regard to the optimal obstetric management of FGR.”

The establishment of a diagnostic standard for FGR is needed to properly investigate ways to improve risk stratification, diagnosis, and management, Dr. Silver and Dr. Blue added.

“What we have to do is get better at predicting which babies are at very high risk for continuing the pregnancy and which babies are at low risk for continuing the pregnancy so that we can better decide which babies would benefit from slightly early delivery,” Dr. Silver said.

Improved detection and management of FGR may be on the horizon. “Our ability to image the placental function has gotten a lot better, and I think that is really going to help us,” Dr. Silver said. Studies that aim to further improve the ability to assess whether babies are getting adequate blood flow during pregnancy are ongoing, which could further help doctors evaluate risks.

The study investigators and Dr. Silver had no conflict of interest disclosures. Dr. Blue disclosed grants from Samsung Medison and personal fees from Elsevier. The study was supported by a grant from the Australian government’s National Health and Medical Research Council Program, and Mr. Selvaratnam is supported by scholarships from an Australian government research training program and the National Centre of Research Excellence in Stillbirth.

jremaly@mdedge.com

Iatrogenic delivery for suspected fetal growth restriction (FGR) may be associated with an increased likelihood of poorer school outcomes among infants born severely small for gestational age, a study of children in Australia suggests.

Compared with severely small infants who were not suspected of having FGR, those delivered by early induction of labor or cesarean delivery prior to labor because of suspected FGR tended to have worse developmental and educational outcomes, researchers reported in JAMA.

“It raises the question: in our efforts to improve outcomes in babies that are small, are we potentially doing more harm than good?” said Robert M. Silver, MD, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, who was not involved in the study. “I think that is a very important question to ask.”

However, “we can’t make that conclusion based on this one study,” he said in an interview. It could be that, in cases where severely small infants were delivered early, there may have been testing that indicated acute risks, and these infants may have tended to be sicker overall. “It may have been that if those babies weren’t delivered, they would have suffered a stillbirth or major brain injury,” Dr. Silver said. “It is really important that we acknowledge that we shouldn’t change our clinical practice” based on this one study.”

At the same time, the study underscores questions and challenges that surround the definition, identification, and management of suspected FGR, Dr. Silver said.

The study authors described their research as exploratory. In a related editorial Dr. Silver and Nathan R. Blue, MD said the findings should be considered hypothesis generating.

For the study, Roshan John Selvaratnam, BMedSc(Hons), a researcher affiliated with Monash University, Melbourne, and colleagues analyzed data from 181,902 children with developmental outcomes and 425,717 children with educational outcomes in Australia. They included children born at 32 weeks’ or more gestation between 2003 and 2013.

Severely small infants delivered early for suspected FGR had an average gestation of 37.9 weeks, whereas those not suspected of having FGR had an average gestation of 39.4 weeks.

Among infants who were severely small for gestational age, those delivered early for suspected FGR were more likely to be in the bottom 10th percentile on at least two developmental domains when they started school, compared with those not suspected of having FGR (16.2% vs. 12.7%; adjusted odds ratio, 1.36). They also were more likely to have low test scores in subsequent years. In grade 7, for example, the adjusted odds ratio for scoring below the national minimum standard on at least two educational domains was 1.33 (13.4% vs. 10.5%).

The researchers defined severely small for gestational age as birth weight below the third percentile. Among infants with normal growth, defined as birth weight at the 10th percentile or greater, school outcomes did not significantly differ between those with early delivery for suspected FGR and those not suspected of having FGR. Approximately 8% of the infants with normal growth had poor developmental outcomes.

The study authors described the dilemma that clinicians face with suspected FGR: “Either intervene early to prevent a small risk of stillbirth but potentially cause immediate and lifelong harm to the child or accept the increasing risk of stillbirth associated with prolonging the pregnancy to avoid more common neonatal and longer-term morbidities.”

It could be that severely small infants with suspected FGR in the study were “more compromised than those not suspected of having FGR,” which might explain the outcomes, Mr. Selvaratnam and coauthors wrote.

Another more plausible explanation is that “iatrogenic prematurity was harmful,” they said.

The researchers were unable to adjust for many factors that may influence academic success, including smoking and alcohol use during pregnancy, maternal body mass index, and breastfeeding, they noted. They also lacked information about the etiology for FGR and whether children had genetic abnormalities.

The study also does not take into account neonatal, infant, and childhood complications, Dr. Silver and Dr. Blue wrote in their editorial. “Nonetheless, these data are a welcome contribution given the knowledge gaps with regard to the optimal obstetric management of FGR.”

The establishment of a diagnostic standard for FGR is needed to properly investigate ways to improve risk stratification, diagnosis, and management, Dr. Silver and Dr. Blue added.

“What we have to do is get better at predicting which babies are at very high risk for continuing the pregnancy and which babies are at low risk for continuing the pregnancy so that we can better decide which babies would benefit from slightly early delivery,” Dr. Silver said.

Improved detection and management of FGR may be on the horizon. “Our ability to image the placental function has gotten a lot better, and I think that is really going to help us,” Dr. Silver said. Studies that aim to further improve the ability to assess whether babies are getting adequate blood flow during pregnancy are ongoing, which could further help doctors evaluate risks.

The study investigators and Dr. Silver had no conflict of interest disclosures. Dr. Blue disclosed grants from Samsung Medison and personal fees from Elsevier. The study was supported by a grant from the Australian government’s National Health and Medical Research Council Program, and Mr. Selvaratnam is supported by scholarships from an Australian government research training program and the National Centre of Research Excellence in Stillbirth.

jremaly@mdedge.com

ANSWER

The correct answer is all of the above (choice “f”).

DISCUSSION

The most likely diagnostic explanation for this patient’s presentation is erythema annulare centrifugum (EAC; choice “c”). However, this diagnosis is often difficult to establish, in part because of the broad differential and also because the very existence of EAC is far from well established.

The overwhelming consensus is that EAC represents a hypersensitivity reaction to an unknown antigen. It can be triggered by a wide variety of micro-organisms, stress, or even pregnancy.

In this case, there was no clinical or historical reason to suspect an underlying cancer, Lyme disease, or lupus, nor did the biopsy results suggest any of these.

The key takeaway here is to urge providers to avoid jumping onto a diagnostic bandwagon before considering a wider differential. Indeed, size matters when it relates to the length of one’s differential diagnosis list. If you don’t consider it, you can’t diagnose it.

TREATMENT

Fortunately, EAC nearly always resolves, with or without treatment. This patient received reassurance as such but was scheduled to return for a check of his lesions in 2 months. At that point, they had resolved.

ANSWER

The correct answer is all of the above (choice “f”).

DISCUSSION

The most likely diagnostic explanation for this patient’s presentation is erythema annulare centrifugum (EAC; choice “c”). However, this diagnosis is often difficult to establish, in part because of the broad differential and also because the very existence of EAC is far from well established.

The overwhelming consensus is that EAC represents a hypersensitivity reaction to an unknown antigen. It can be triggered by a wide variety of micro-organisms, stress, or even pregnancy.

In this case, there was no clinical or historical reason to suspect an underlying cancer, Lyme disease, or lupus, nor did the biopsy results suggest any of these.

The key takeaway here is to urge providers to avoid jumping onto a diagnostic bandwagon before considering a wider differential. Indeed, size matters when it relates to the length of one’s differential diagnosis list. If you don’t consider it, you can’t diagnose it.

TREATMENT

Fortunately, EAC nearly always resolves, with or without treatment. This patient received reassurance as such but was scheduled to return for a check of his lesions in 2 months. At that point, they had resolved.

ANSWER

The correct answer is all of the above (choice “f”).

DISCUSSION

The most likely diagnostic explanation for this patient’s presentation is erythema annulare centrifugum (EAC; choice “c”). However, this diagnosis is often difficult to establish, in part because of the broad differential and also because the very existence of EAC is far from well established.

The overwhelming consensus is that EAC represents a hypersensitivity reaction to an unknown antigen. It can be triggered by a wide variety of micro-organisms, stress, or even pregnancy.

In this case, there was no clinical or historical reason to suspect an underlying cancer, Lyme disease, or lupus, nor did the biopsy results suggest any of these.

The key takeaway here is to urge providers to avoid jumping onto a diagnostic bandwagon before considering a wider differential. Indeed, size matters when it relates to the length of one’s differential diagnosis list. If you don’t consider it, you can’t diagnose it.

TREATMENT

Fortunately, EAC nearly always resolves, with or without treatment. This patient received reassurance as such but was scheduled to return for a check of his lesions in 2 months. At that point, they had resolved.

Worldwide, nearly 8% of men who have sex with men (MSM) may have syphilis, a new systematic review and meta-analysis suggests. This estimate, generated from 275 studies across 77 countries, is 15 times greater than the most recent estimates of syphilis prevalence in men in a general population.

“That disparity is absolutely unacceptable,” Matthew Chico, PhD, associate professor at the London School of Hygiene and Tropical Medicine, and senior author of the review, said in an interview.

Although the World Health Organization (WHO) aims to reduce the global prevalence of syphilis by 90% by 2030, an ambitious goal set in 2016, recent research suggests syphilis numbers are moving in the opposite direction. Cases in the United States rose 74% between 2015 and 2019, and other nations, such as Australia, South Korea, and the United Kingdom, are seeing similar trends.

Syphilis prevalence is generally higher in MSM, largely in subpopulations of men who have multiple sexual partners, Kenneth Mayer, MD, said in an interview. Dr. Mayer is medical research director at the Fenway Institute, Boston, and was not involved with the study.

Health literacy, lack of access to care, and medical mistrust can all be challenges to screening, identifying, and treating the infection in this population.

Reducing syphilis cases will require focusing interventions on higher-risk groups such as MSM, said Dr. Chico; however, there was “a real dearth in knowledge about the most likely prevalence of syphilis among MSM on a global level,” he said.

To help fill in the gaps, Dr. Chico and his research team collected studies that included syphilis prevalence data for MSM published between Jan. 1, 2000, and Feb. 1, 2020. Researchers excluded studies that included only MSM living with HIV, injection drug users, patients who routinely visit sexually transmitted infection (STI) clinics, and people seeking care only for STIs or other genital symptoms, because these studies would have skewed global syphilis prevalence estimates higher.

Their review, published July 8 in The Lancet Global Health, found that the pooled global prevalence of syphilis from 2000-2020 in MSM was 7.5%. It ranged from 1.9% in Australia and New Zealand to 10.6% in Latin America and the Caribbean. In comparison, the WHO estimates that globally, 0.5% of men in a general population have syphilis, a 15-fold difference.

This elevated estimate is not surprising, and the review provides a more international view of syphilis. Earlier attempts to estimate the prevalence of syphilis among MSM were generally conducted in higher-income countries such as the United States, Dr. Mayer said. “It’s important that clinicians recognize that this is a global health issue, so they can do the appropriate screening.”

The review found that regions in which the prevalence of HIV was above 5% had higher rates of syphilis (8.7%) compared to regions in which the prevalence of HIV was below 5% (6.6%). Pooled syphilis prevalence estimates were also higher for lower-middle-income and upper-middle-income countries (8.7% and 8.6%, respectively).

Global syphilis prevalence dipped from 8.9% in studies from 2000 to 2009 to 6.6% in studies from 2010 to 2020. In Europe, Northern America, Latin America, the Caribbean, and Oceania (excluding Australia and New Zealand), syphilis prevalence estimates for 2015-2020 were higher compared with 2010-2014.

The authors acknowledged that there were some limitations to the study, particularly that regions of Eastern and Southeastern Asia contributed more than half (54.5%) of the global data points used in the study and accounted for more than 82% of the study’s participants. This highlights the lack of data from other regions around the world, Dr. Chico said.

Dr. Chico said these findings “serve as a clarion call to action” to focus interventions on groups at higher risk for syphilis, such as MSM, in the effort to drastically reduce syphilis cases around the world. Dr. Mayer agrees. “[Syphilis] is a readily diagnosable and treatable infection,” he said. “It definitely is something that we should be able to get a handle on, but that requires paying attention to the different subgroups who have particularly high rates of the infection.”

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

Worldwide, nearly 8% of men who have sex with men (MSM) may have syphilis, a new systematic review and meta-analysis suggests. This estimate, generated from 275 studies across 77 countries, is 15 times greater than the most recent estimates of syphilis prevalence in men in a general population.

“That disparity is absolutely unacceptable,” Matthew Chico, PhD, associate professor at the London School of Hygiene and Tropical Medicine, and senior author of the review, said in an interview.

Although the World Health Organization (WHO) aims to reduce the global prevalence of syphilis by 90% by 2030, an ambitious goal set in 2016, recent research suggests syphilis numbers are moving in the opposite direction. Cases in the United States rose 74% between 2015 and 2019, and other nations, such as Australia, South Korea, and the United Kingdom, are seeing similar trends.

Syphilis prevalence is generally higher in MSM, largely in subpopulations of men who have multiple sexual partners, Kenneth Mayer, MD, said in an interview. Dr. Mayer is medical research director at the Fenway Institute, Boston, and was not involved with the study.

Health literacy, lack of access to care, and medical mistrust can all be challenges to screening, identifying, and treating the infection in this population.

Reducing syphilis cases will require focusing interventions on higher-risk groups such as MSM, said Dr. Chico; however, there was “a real dearth in knowledge about the most likely prevalence of syphilis among MSM on a global level,” he said.

To help fill in the gaps, Dr. Chico and his research team collected studies that included syphilis prevalence data for MSM published between Jan. 1, 2000, and Feb. 1, 2020. Researchers excluded studies that included only MSM living with HIV, injection drug users, patients who routinely visit sexually transmitted infection (STI) clinics, and people seeking care only for STIs or other genital symptoms, because these studies would have skewed global syphilis prevalence estimates higher.

Their review, published July 8 in The Lancet Global Health, found that the pooled global prevalence of syphilis from 2000-2020 in MSM was 7.5%. It ranged from 1.9% in Australia and New Zealand to 10.6% in Latin America and the Caribbean. In comparison, the WHO estimates that globally, 0.5% of men in a general population have syphilis, a 15-fold difference.

This elevated estimate is not surprising, and the review provides a more international view of syphilis. Earlier attempts to estimate the prevalence of syphilis among MSM were generally conducted in higher-income countries such as the United States, Dr. Mayer said. “It’s important that clinicians recognize that this is a global health issue, so they can do the appropriate screening.”

The review found that regions in which the prevalence of HIV was above 5% had higher rates of syphilis (8.7%) compared to regions in which the prevalence of HIV was below 5% (6.6%). Pooled syphilis prevalence estimates were also higher for lower-middle-income and upper-middle-income countries (8.7% and 8.6%, respectively).

Global syphilis prevalence dipped from 8.9% in studies from 2000 to 2009 to 6.6% in studies from 2010 to 2020. In Europe, Northern America, Latin America, the Caribbean, and Oceania (excluding Australia and New Zealand), syphilis prevalence estimates for 2015-2020 were higher compared with 2010-2014.

The authors acknowledged that there were some limitations to the study, particularly that regions of Eastern and Southeastern Asia contributed more than half (54.5%) of the global data points used in the study and accounted for more than 82% of the study’s participants. This highlights the lack of data from other regions around the world, Dr. Chico said.

Dr. Chico said these findings “serve as a clarion call to action” to focus interventions on groups at higher risk for syphilis, such as MSM, in the effort to drastically reduce syphilis cases around the world. Dr. Mayer agrees. “[Syphilis] is a readily diagnosable and treatable infection,” he said. “It definitely is something that we should be able to get a handle on, but that requires paying attention to the different subgroups who have particularly high rates of the infection.”

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

Worldwide, nearly 8% of men who have sex with men (MSM) may have syphilis, a new systematic review and meta-analysis suggests. This estimate, generated from 275 studies across 77 countries, is 15 times greater than the most recent estimates of syphilis prevalence in men in a general population.

“That disparity is absolutely unacceptable,” Matthew Chico, PhD, associate professor at the London School of Hygiene and Tropical Medicine, and senior author of the review, said in an interview.

Although the World Health Organization (WHO) aims to reduce the global prevalence of syphilis by 90% by 2030, an ambitious goal set in 2016, recent research suggests syphilis numbers are moving in the opposite direction. Cases in the United States rose 74% between 2015 and 2019, and other nations, such as Australia, South Korea, and the United Kingdom, are seeing similar trends.

Syphilis prevalence is generally higher in MSM, largely in subpopulations of men who have multiple sexual partners, Kenneth Mayer, MD, said in an interview. Dr. Mayer is medical research director at the Fenway Institute, Boston, and was not involved with the study.

Health literacy, lack of access to care, and medical mistrust can all be challenges to screening, identifying, and treating the infection in this population.

Reducing syphilis cases will require focusing interventions on higher-risk groups such as MSM, said Dr. Chico; however, there was “a real dearth in knowledge about the most likely prevalence of syphilis among MSM on a global level,” he said.

To help fill in the gaps, Dr. Chico and his research team collected studies that included syphilis prevalence data for MSM published between Jan. 1, 2000, and Feb. 1, 2020. Researchers excluded studies that included only MSM living with HIV, injection drug users, patients who routinely visit sexually transmitted infection (STI) clinics, and people seeking care only for STIs or other genital symptoms, because these studies would have skewed global syphilis prevalence estimates higher.

Their review, published July 8 in The Lancet Global Health, found that the pooled global prevalence of syphilis from 2000-2020 in MSM was 7.5%. It ranged from 1.9% in Australia and New Zealand to 10.6% in Latin America and the Caribbean. In comparison, the WHO estimates that globally, 0.5% of men in a general population have syphilis, a 15-fold difference.

This elevated estimate is not surprising, and the review provides a more international view of syphilis. Earlier attempts to estimate the prevalence of syphilis among MSM were generally conducted in higher-income countries such as the United States, Dr. Mayer said. “It’s important that clinicians recognize that this is a global health issue, so they can do the appropriate screening.”

The review found that regions in which the prevalence of HIV was above 5% had higher rates of syphilis (8.7%) compared to regions in which the prevalence of HIV was below 5% (6.6%). Pooled syphilis prevalence estimates were also higher for lower-middle-income and upper-middle-income countries (8.7% and 8.6%, respectively).

Global syphilis prevalence dipped from 8.9% in studies from 2000 to 2009 to 6.6% in studies from 2010 to 2020. In Europe, Northern America, Latin America, the Caribbean, and Oceania (excluding Australia and New Zealand), syphilis prevalence estimates for 2015-2020 were higher compared with 2010-2014.

The authors acknowledged that there were some limitations to the study, particularly that regions of Eastern and Southeastern Asia contributed more than half (54.5%) of the global data points used in the study and accounted for more than 82% of the study’s participants. This highlights the lack of data from other regions around the world, Dr. Chico said.

Dr. Chico said these findings “serve as a clarion call to action” to focus interventions on groups at higher risk for syphilis, such as MSM, in the effort to drastically reduce syphilis cases around the world. Dr. Mayer agrees. “[Syphilis] is a readily diagnosable and treatable infection,” he said. “It definitely is something that we should be able to get a handle on, but that requires paying attention to the different subgroups who have particularly high rates of the infection.”

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

Thoughtful, targeted approaches are needed to increase COVID-19 vaccination rates in Black and Latinx communities, which often distrust the health care system and face barriers to vaccine access, new data show.

“Black, Latinx, and Native American individuals represent about a combined 60% of COVID-19 deaths, despite comprising significantly less of the United States population,” said Jacinda C. Abdul-Mutakabbir, PharmD, from Loma Linda (Calif.) University.

“To put this into perspective, Black individuals represent 13.4% of the United States population, while Native Americans represent 1.6%, clearly showing the disproportionate outcomes here,” she explained during her online presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

The vaccine creates an opportunity to change the disproportionate way COVID-19 has affected racial and ethnic communities, said Dr. Abdul-Mutakabbir, but “a long history of mistreatment within the U.S. health care system decreases their trust for the system to use fair practices when delivering these vaccines.”

For people in minority communities, often “the fear of cost associated with health care keeps them from being vaccinated,” she said. “Also, there is a lack of vaccines actually allocated to these communities, or inconsistent computer-based sign-ups that make WiFi mandatory, which in turn has created additional barriers for vaccination access.”

Loma Linda University maintains the largest mass-vaccination site in San Bernardino County, the fourth-largest county in southern California. However, only 3.0% of the people vaccinated there have been Black. And although 8% of the state’s population is Black, only 2.7% of the Black population has been vaccinated.

In contrast, Black Californians have accounted for about 20% of COVID-19 cases in the state, and 20%-30% of COVID-19 deaths.

To promote equitable access to COVID-19 vaccines, Dr. Abdul-Mutakabbir and colleagues developed a “three-tiered approach.” First, they had local Black faith leaders hold summits ahead of the vaccination clinics. Next, at those summits, they had a Black pharmacist educate attendees about the vaccines. And finally, they held a low-barrier community vaccination clinic in a Black community, where the pharmacist oversaw the transport and preparation of the vaccines.

Because access, transportation, and internet are all barriers to vaccination, the clinic used paper-based registration and was held as a pop-up clinic at a local Black church. The team held two clinics for the first Moderna dose, one clinic for the second Moderna dose, and one clinic for the Johnson & Johnson one-dose vaccine.

During the Moderna first-dose clinics, 673 vaccinations were administered, and during the second-dose clinic, 366 were administered. Early data showed a return rate of 87%, but the team has yet to update the final numbers, Dr. Abdul-Mutakabbir reported. During the Johnson & Johnson clinic, 314 vaccinations were administered, nearly half to Black people. After the community vaccination clinics, the mass vaccination site saw a 0.6% increase in vaccinations for Black people.

Dr. Abdul-Mutakabbir’s team also held three community clinics in Latinx communities. During the first-dose Moderna pop-up clinic, 258 vaccinations were administered, and during the second-dose clinic, 253 were, for a 98% return rate. Approximately 92% of those vaccinated were Latinx. 

The study findings are not surprising, said Rhea Boyd, MD, director of equity and justice for California Children’s Trust.

“The barriers to vaccination are known and clear,” she said in an interview. “Mobile clinics with paper appointments address a number of those barriers head on, like transportation, internet access, and accessibility. Having Black providers leading the effort and church leaders involved also has been shown to increase confidence in the operations and process.”

Information campaigns can help counter online disinformation. Ultimately, however, “the main barrier to vaccination is access,” Dr. Boyd said. “Address access and rates will increase.”

The health inequities seen in vaccination rates among Black and Latinx people “are a product of structural and systemic racism,” Dr. Abdul-Mutakabbir said. “To create equitable processes, it is essential that we evaluate how we approach each of these different minoritized groups.”

Dr. Abdul-Mutakabbir disclosed no relevant financial relationships. Dr. Boyd codeveloped THE CONVERSATION, a national campaign to bring credible information about the COVID vaccines to Black and Latinx communities in partnership with KFF, BCAC, and Unidos US.

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

Thoughtful, targeted approaches are needed to increase COVID-19 vaccination rates in Black and Latinx communities, which often distrust the health care system and face barriers to vaccine access, new data show.

“Black, Latinx, and Native American individuals represent about a combined 60% of COVID-19 deaths, despite comprising significantly less of the United States population,” said Jacinda C. Abdul-Mutakabbir, PharmD, from Loma Linda (Calif.) University.

“To put this into perspective, Black individuals represent 13.4% of the United States population, while Native Americans represent 1.6%, clearly showing the disproportionate outcomes here,” she explained during her online presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

The vaccine creates an opportunity to change the disproportionate way COVID-19 has affected racial and ethnic communities, said Dr. Abdul-Mutakabbir, but “a long history of mistreatment within the U.S. health care system decreases their trust for the system to use fair practices when delivering these vaccines.”

For people in minority communities, often “the fear of cost associated with health care keeps them from being vaccinated,” she said. “Also, there is a lack of vaccines actually allocated to these communities, or inconsistent computer-based sign-ups that make WiFi mandatory, which in turn has created additional barriers for vaccination access.”

Loma Linda University maintains the largest mass-vaccination site in San Bernardino County, the fourth-largest county in southern California. However, only 3.0% of the people vaccinated there have been Black. And although 8% of the state’s population is Black, only 2.7% of the Black population has been vaccinated.

In contrast, Black Californians have accounted for about 20% of COVID-19 cases in the state, and 20%-30% of COVID-19 deaths.

To promote equitable access to COVID-19 vaccines, Dr. Abdul-Mutakabbir and colleagues developed a “three-tiered approach.” First, they had local Black faith leaders hold summits ahead of the vaccination clinics. Next, at those summits, they had a Black pharmacist educate attendees about the vaccines. And finally, they held a low-barrier community vaccination clinic in a Black community, where the pharmacist oversaw the transport and preparation of the vaccines.

Because access, transportation, and internet are all barriers to vaccination, the clinic used paper-based registration and was held as a pop-up clinic at a local Black church. The team held two clinics for the first Moderna dose, one clinic for the second Moderna dose, and one clinic for the Johnson & Johnson one-dose vaccine.

During the Moderna first-dose clinics, 673 vaccinations were administered, and during the second-dose clinic, 366 were administered. Early data showed a return rate of 87%, but the team has yet to update the final numbers, Dr. Abdul-Mutakabbir reported. During the Johnson & Johnson clinic, 314 vaccinations were administered, nearly half to Black people. After the community vaccination clinics, the mass vaccination site saw a 0.6% increase in vaccinations for Black people.

Dr. Abdul-Mutakabbir’s team also held three community clinics in Latinx communities. During the first-dose Moderna pop-up clinic, 258 vaccinations were administered, and during the second-dose clinic, 253 were, for a 98% return rate. Approximately 92% of those vaccinated were Latinx. 

The study findings are not surprising, said Rhea Boyd, MD, director of equity and justice for California Children’s Trust.

“The barriers to vaccination are known and clear,” she said in an interview. “Mobile clinics with paper appointments address a number of those barriers head on, like transportation, internet access, and accessibility. Having Black providers leading the effort and church leaders involved also has been shown to increase confidence in the operations and process.”

Information campaigns can help counter online disinformation. Ultimately, however, “the main barrier to vaccination is access,” Dr. Boyd said. “Address access and rates will increase.”

The health inequities seen in vaccination rates among Black and Latinx people “are a product of structural and systemic racism,” Dr. Abdul-Mutakabbir said. “To create equitable processes, it is essential that we evaluate how we approach each of these different minoritized groups.”

Dr. Abdul-Mutakabbir disclosed no relevant financial relationships. Dr. Boyd codeveloped THE CONVERSATION, a national campaign to bring credible information about the COVID vaccines to Black and Latinx communities in partnership with KFF, BCAC, and Unidos US.

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

Thoughtful, targeted approaches are needed to increase COVID-19 vaccination rates in Black and Latinx communities, which often distrust the health care system and face barriers to vaccine access, new data show.

“Black, Latinx, and Native American individuals represent about a combined 60% of COVID-19 deaths, despite comprising significantly less of the United States population,” said Jacinda C. Abdul-Mutakabbir, PharmD, from Loma Linda (Calif.) University.

“To put this into perspective, Black individuals represent 13.4% of the United States population, while Native Americans represent 1.6%, clearly showing the disproportionate outcomes here,” she explained during her online presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

The vaccine creates an opportunity to change the disproportionate way COVID-19 has affected racial and ethnic communities, said Dr. Abdul-Mutakabbir, but “a long history of mistreatment within the U.S. health care system decreases their trust for the system to use fair practices when delivering these vaccines.”

For people in minority communities, often “the fear of cost associated with health care keeps them from being vaccinated,” she said. “Also, there is a lack of vaccines actually allocated to these communities, or inconsistent computer-based sign-ups that make WiFi mandatory, which in turn has created additional barriers for vaccination access.”

Loma Linda University maintains the largest mass-vaccination site in San Bernardino County, the fourth-largest county in southern California. However, only 3.0% of the people vaccinated there have been Black. And although 8% of the state’s population is Black, only 2.7% of the Black population has been vaccinated.

In contrast, Black Californians have accounted for about 20% of COVID-19 cases in the state, and 20%-30% of COVID-19 deaths.

To promote equitable access to COVID-19 vaccines, Dr. Abdul-Mutakabbir and colleagues developed a “three-tiered approach.” First, they had local Black faith leaders hold summits ahead of the vaccination clinics. Next, at those summits, they had a Black pharmacist educate attendees about the vaccines. And finally, they held a low-barrier community vaccination clinic in a Black community, where the pharmacist oversaw the transport and preparation of the vaccines.

Because access, transportation, and internet are all barriers to vaccination, the clinic used paper-based registration and was held as a pop-up clinic at a local Black church. The team held two clinics for the first Moderna dose, one clinic for the second Moderna dose, and one clinic for the Johnson & Johnson one-dose vaccine.

During the Moderna first-dose clinics, 673 vaccinations were administered, and during the second-dose clinic, 366 were administered. Early data showed a return rate of 87%, but the team has yet to update the final numbers, Dr. Abdul-Mutakabbir reported. During the Johnson & Johnson clinic, 314 vaccinations were administered, nearly half to Black people. After the community vaccination clinics, the mass vaccination site saw a 0.6% increase in vaccinations for Black people.

Dr. Abdul-Mutakabbir’s team also held three community clinics in Latinx communities. During the first-dose Moderna pop-up clinic, 258 vaccinations were administered, and during the second-dose clinic, 253 were, for a 98% return rate. Approximately 92% of those vaccinated were Latinx. 

The study findings are not surprising, said Rhea Boyd, MD, director of equity and justice for California Children’s Trust.

“The barriers to vaccination are known and clear,” she said in an interview. “Mobile clinics with paper appointments address a number of those barriers head on, like transportation, internet access, and accessibility. Having Black providers leading the effort and church leaders involved also has been shown to increase confidence in the operations and process.”

Information campaigns can help counter online disinformation. Ultimately, however, “the main barrier to vaccination is access,” Dr. Boyd said. “Address access and rates will increase.”

The health inequities seen in vaccination rates among Black and Latinx people “are a product of structural and systemic racism,” Dr. Abdul-Mutakabbir said. “To create equitable processes, it is essential that we evaluate how we approach each of these different minoritized groups.”

Dr. Abdul-Mutakabbir disclosed no relevant financial relationships. Dr. Boyd codeveloped THE CONVERSATION, a national campaign to bring credible information about the COVID vaccines to Black and Latinx communities in partnership with KFF, BCAC, and Unidos US.

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

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

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

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

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

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

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

A homeopathic doctor licensed in California was arrested July 14 and charged with a scheme to sell homeoprophylaxis immunization pellets and to falsify COVID-19 vaccination cards by making it appear that her customers had received the Moderna vaccine, according to the U.S. Department of Justice.

Juli A. Mazi, 41, of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent vaccination record cards, the DOJ said in a news release.

In April, according to federal authorities, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General, stating that family members had purchased the immunization pellets from Ms. Mazi. The complainant stated that the family members had told her/him that Ms. Mazi had said the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The affidavit noted that none of the family members had received injections of any of the COVID-19 vaccines authorized by the Food and Drug Administration.

However, the complainant said, Ms. Mazi sent COVID-19 vaccination cards listing Moderna to the complainant family. Ms. Mazi allegedly instructed the family members to mark the cards to falsely state that they had received the Moderna vaccine on the date that they ingested the homeoprophylaxis immunization pellets.

She also allegedly provided instructions on how to fraudulently complete the cards to make it appear that a customer had received two doses of the Moderna vaccine. She even supplied Moderna lot numbers to enter on the cards.

In addition, Ms. Mazi allegedly offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

Ms. Mazi further stated that her customers could provide the pellets to children for COVID-19 immunity, and that “the dose is actually the same for babies,” the news release said.

Ms. Mazi is alleged to have falsely claimed that ingesting the pellets would result in full lifelong immunity from COVID-19. In addition, she exploited the disinformation and fear surrounding COVID-19 vaccination by falsely claiming that the FDA-authorized vaccines contain “toxic ingredients,” the DOJ said.
 

Homeopathic preparations

According to the DOJ, “Homeophrophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity.”

According to Australia’s National Centre for Immunisation Research & Surveillance (NCIRS), a private organization funded by the Australian and New South Wales governments, there is no high-quality research showing that homeopathic preparations are effective in preventing infectious disease.

Typical homeopathic preparations dilute a disease, tissue, or plant extract in water “to the point where none of the original material is contained within the preparation by the end of the process,” an NCIRS fact sheet says.

Referring to Ms. Mazi, Deputy Attorney General Lisa Monaco said in the news release, “This defendant allegedly defrauded and endangered the public by preying on fears and spreading misinformation about FDA-authorized vaccinations, while also peddling fake treatments that put people’s lives at risk.

“Even worse, the defendant allegedly created counterfeit COVID-19 vaccination cards and instructed her customers to falsely mark that they had received a vaccine, allowing them to circumvent efforts to contain the spread of the disease.”

The case against Ms. Mazi was brought in coordination with the DOJ Health Care Fraud Unit’s COVID-19 Interagency Working Group, which organizes efforts to address illegal activity involving health care programs during the pandemic.

The fraud unit leads the department’s Health Care Fraud Strike Force, which has existed since 2007. In May, U.S. Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force in partnership with other government agencies to combat and prevent pandemic-related fraud.

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

A homeopathic doctor licensed in California was arrested July 14 and charged with a scheme to sell homeoprophylaxis immunization pellets and to falsify COVID-19 vaccination cards by making it appear that her customers had received the Moderna vaccine, according to the U.S. Department of Justice.

Juli A. Mazi, 41, of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent vaccination record cards, the DOJ said in a news release.

In April, according to federal authorities, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General, stating that family members had purchased the immunization pellets from Ms. Mazi. The complainant stated that the family members had told her/him that Ms. Mazi had said the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The affidavit noted that none of the family members had received injections of any of the COVID-19 vaccines authorized by the Food and Drug Administration.

However, the complainant said, Ms. Mazi sent COVID-19 vaccination cards listing Moderna to the complainant family. Ms. Mazi allegedly instructed the family members to mark the cards to falsely state that they had received the Moderna vaccine on the date that they ingested the homeoprophylaxis immunization pellets.

She also allegedly provided instructions on how to fraudulently complete the cards to make it appear that a customer had received two doses of the Moderna vaccine. She even supplied Moderna lot numbers to enter on the cards.

In addition, Ms. Mazi allegedly offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

Ms. Mazi further stated that her customers could provide the pellets to children for COVID-19 immunity, and that “the dose is actually the same for babies,” the news release said.

Ms. Mazi is alleged to have falsely claimed that ingesting the pellets would result in full lifelong immunity from COVID-19. In addition, she exploited the disinformation and fear surrounding COVID-19 vaccination by falsely claiming that the FDA-authorized vaccines contain “toxic ingredients,” the DOJ said.
 

Homeopathic preparations

According to the DOJ, “Homeophrophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity.”

According to Australia’s National Centre for Immunisation Research & Surveillance (NCIRS), a private organization funded by the Australian and New South Wales governments, there is no high-quality research showing that homeopathic preparations are effective in preventing infectious disease.

Typical homeopathic preparations dilute a disease, tissue, or plant extract in water “to the point where none of the original material is contained within the preparation by the end of the process,” an NCIRS fact sheet says.

Referring to Ms. Mazi, Deputy Attorney General Lisa Monaco said in the news release, “This defendant allegedly defrauded and endangered the public by preying on fears and spreading misinformation about FDA-authorized vaccinations, while also peddling fake treatments that put people’s lives at risk.

“Even worse, the defendant allegedly created counterfeit COVID-19 vaccination cards and instructed her customers to falsely mark that they had received a vaccine, allowing them to circumvent efforts to contain the spread of the disease.”

The case against Ms. Mazi was brought in coordination with the DOJ Health Care Fraud Unit’s COVID-19 Interagency Working Group, which organizes efforts to address illegal activity involving health care programs during the pandemic.

The fraud unit leads the department’s Health Care Fraud Strike Force, which has existed since 2007. In May, U.S. Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force in partnership with other government agencies to combat and prevent pandemic-related fraud.

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

A homeopathic doctor licensed in California was arrested July 14 and charged with a scheme to sell homeoprophylaxis immunization pellets and to falsify COVID-19 vaccination cards by making it appear that her customers had received the Moderna vaccine, according to the U.S. Department of Justice.

Juli A. Mazi, 41, of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent vaccination record cards, the DOJ said in a news release.

In April, according to federal authorities, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General, stating that family members had purchased the immunization pellets from Ms. Mazi. The complainant stated that the family members had told her/him that Ms. Mazi had said the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The affidavit noted that none of the family members had received injections of any of the COVID-19 vaccines authorized by the Food and Drug Administration.

However, the complainant said, Ms. Mazi sent COVID-19 vaccination cards listing Moderna to the complainant family. Ms. Mazi allegedly instructed the family members to mark the cards to falsely state that they had received the Moderna vaccine on the date that they ingested the homeoprophylaxis immunization pellets.

She also allegedly provided instructions on how to fraudulently complete the cards to make it appear that a customer had received two doses of the Moderna vaccine. She even supplied Moderna lot numbers to enter on the cards.

In addition, Ms. Mazi allegedly offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

Ms. Mazi further stated that her customers could provide the pellets to children for COVID-19 immunity, and that “the dose is actually the same for babies,” the news release said.

Ms. Mazi is alleged to have falsely claimed that ingesting the pellets would result in full lifelong immunity from COVID-19. In addition, she exploited the disinformation and fear surrounding COVID-19 vaccination by falsely claiming that the FDA-authorized vaccines contain “toxic ingredients,” the DOJ said.
 

Homeopathic preparations

According to the DOJ, “Homeophrophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity.”

According to Australia’s National Centre for Immunisation Research & Surveillance (NCIRS), a private organization funded by the Australian and New South Wales governments, there is no high-quality research showing that homeopathic preparations are effective in preventing infectious disease.

Typical homeopathic preparations dilute a disease, tissue, or plant extract in water “to the point where none of the original material is contained within the preparation by the end of the process,” an NCIRS fact sheet says.

Referring to Ms. Mazi, Deputy Attorney General Lisa Monaco said in the news release, “This defendant allegedly defrauded and endangered the public by preying on fears and spreading misinformation about FDA-authorized vaccinations, while also peddling fake treatments that put people’s lives at risk.

“Even worse, the defendant allegedly created counterfeit COVID-19 vaccination cards and instructed her customers to falsely mark that they had received a vaccine, allowing them to circumvent efforts to contain the spread of the disease.”

The case against Ms. Mazi was brought in coordination with the DOJ Health Care Fraud Unit’s COVID-19 Interagency Working Group, which organizes efforts to address illegal activity involving health care programs during the pandemic.

The fraud unit leads the department’s Health Care Fraud Strike Force, which has existed since 2007. In May, U.S. Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force in partnership with other government agencies to combat and prevent pandemic-related fraud.

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