MDedge Endocrinology

I dream of alien abductions

There he goes! It’s lunchtime and your colleague Tom is going on and on again about that time he was abducted by aliens. It sounds ridiculous, but he does make some convincing arguments. Tom thinks it was real, but could it have all just been in his head?

Engin Akyurt/Pixabay

Lucid dreaming may help explain alleged alien abductions. During a lucid dream, people know that they’re dreaming, and can also have some control over how the dreams play out. During some dream states, a person can feel intense sensations, such as terror and paralysis, so it’s no wonder these dreams feel so real.

In a recent study, scientists encouraged 152 participants who had self-identified as lucid dreamers to dream about aliens. Many (75%) of the participants were able to dream about alien encounters, and 15% “achieved relatively realistic experiences,” the investigators reported.

So cut Tom some slack. He’s not crazy, he might just have lucid dreaming privileges. Tell him he should dream about something more fun, like a vacation in the Bahamas.
 

Follow your heart: Drink more coffee

It seems like the world is divided into coffee drinkers and non–coffee drinkers. Then there’s decaf and regular drinkers. Whichever camp you fall into, know this: The widespread belief that caffeine consumption has an effect on your heart is all beans.

s-photo/iStockphoto.com

In what is the largest investigation of its kind, researchers from the University of California, San Francisco, looked into whether drinking caffeinated coffee was linked to a risk for heart arrhythmia. They also researched whether patients with genetic variants that affect their metabolism could change that association. Almost 400,000 people with a mean age of 56 years participated in the study. More than half of the participants were women.

The investigators analyzed the participants’ self-reported coffee consumption using a technique called Mendelian randomization to leverage genetic data with the participants’ relationship with caffeine, making it an even field and not relying on the participant consumption self-reporting for outcomes as in previous studies.

What they found, after the 4-year follow up, was nothing short of myth busting.

“We found no evidence that caffeine consumption leads to a greater risk of arrhythmias,” said senior and corresponding author Gregory Marcus, MD. “Our population-based study provides reassurance that common prohibitions against caffeine to reduce arrhythmia risk are likely unwarranted.”

There was no evidence of a heightened risk of arrhythmias in participants who were genetically predisposed to metabolize caffeine differently from those who were not. And, there was a 3% reduction of arrhythmias in patients who consumed higher amounts of coffee.

We are not lobbying for Big Caffeine, but this study adds to the reported health benefits linked to coffee, which already include reduced risk for cancer, diabetes, and Parkinson’s disease, with an added bonus of anti-inflammatory benefits. So, the next time you’re hesitant to pour that second cup of Joe, just go for it. Your heart can take it.
 

Bored? Feeling down? Don’t play Candy Crush

Now hang on, aren’t those the perfect times to play video games? If there’s nothing else to do, why not open Candy Crush and mindlessly power through the levels?

pxfuel

Because, according to a study by a group of Canadian researchers, it’s actually the worst thing you can do. Well, maybe not literally, but it’s not helpful. Researchers recruited 60 Candy Crush players who were at various levels in the game. They had the participants play early levels that were far too easy or levels balanced with their gameplay abilities.

Players in the easy-level group got bored and quit far earlier than did those in the advanced-level group. The group playing to their abilities were able to access a “flow” state and focus all their attention on the game. While this is all well and good for their gaming performance, according to the researchers, it confirms the theory that playing to escape boredom or negative emotions is more likely to lead to addiction. As with all addictions, the temporary high can give way to a self-repeating loop, causing patients to ignore real life and deepen depression.

The researchers hope their findings will encourage game developers to “consider implementing responsible video gaming tools directly within their games.” Comedy gold. Perhaps Canadians’ idea of capitalism is a little different from that of those south of the border.
 

Hiccups and vaccine refusal

Tonight, LOTME News dives into the fetid cesspool that is international politics and comes out with … hiccups?

But first, a word from our sponsor, Fearless Boxing Club of South Etobicoke, Ontario.

Are you looking to flout public health restrictions? Do you want to spend time in an enclosed space with other people who haven’t gotten the COVID-19 vaccine? Do you “feel safer waiting until more research is done on the side effects being discovered right now”? (We are not making this up.)

Then join the Fearless Boxing Club, because we “will not be accepting any vaccinated members.” Our founders, Mohammed Abedeen and Krystal Glazier-Roscoe, are working hard to exclude “those who received the experimental COVID vaccine.” (Still not making it up.)

And now, back to the news.

Brazilian president Jair Bolsonaro was hospitalized recently for a severe case of hiccups that may have been related to a stab wound he received in 2018. [Nope, didn’t make that up, either.]

djedj/Pixabay

Mr. Bolsonaro had been hiccuping for 10 days, and was experiencing abdominal pain and difficulty speaking, when he entered the hospital on July 14. Since being stabbed while on the campaign trail, he has undergone several operations, which may have led to the partial intestinal obstruction that caused his latest symptoms.

His medical team advised Mr. Bolsonaro to go on a diet to aid his recovery, but when he was released on July 18 he said, “I hope in 10 days I’ll be eating barbecued ribs.” (Maybe this is all just a lucid dream. Probably shouldn’t have had ribs right before bed.)

I dream of alien abductions

There he goes! It’s lunchtime and your colleague Tom is going on and on again about that time he was abducted by aliens. It sounds ridiculous, but he does make some convincing arguments. Tom thinks it was real, but could it have all just been in his head?

Engin Akyurt/Pixabay

Lucid dreaming may help explain alleged alien abductions. During a lucid dream, people know that they’re dreaming, and can also have some control over how the dreams play out. During some dream states, a person can feel intense sensations, such as terror and paralysis, so it’s no wonder these dreams feel so real.

In a recent study, scientists encouraged 152 participants who had self-identified as lucid dreamers to dream about aliens. Many (75%) of the participants were able to dream about alien encounters, and 15% “achieved relatively realistic experiences,” the investigators reported.

So cut Tom some slack. He’s not crazy, he might just have lucid dreaming privileges. Tell him he should dream about something more fun, like a vacation in the Bahamas.
 

Follow your heart: Drink more coffee

It seems like the world is divided into coffee drinkers and non–coffee drinkers. Then there’s decaf and regular drinkers. Whichever camp you fall into, know this: The widespread belief that caffeine consumption has an effect on your heart is all beans.

s-photo/iStockphoto.com

In what is the largest investigation of its kind, researchers from the University of California, San Francisco, looked into whether drinking caffeinated coffee was linked to a risk for heart arrhythmia. They also researched whether patients with genetic variants that affect their metabolism could change that association. Almost 400,000 people with a mean age of 56 years participated in the study. More than half of the participants were women.

The investigators analyzed the participants’ self-reported coffee consumption using a technique called Mendelian randomization to leverage genetic data with the participants’ relationship with caffeine, making it an even field and not relying on the participant consumption self-reporting for outcomes as in previous studies.

What they found, after the 4-year follow up, was nothing short of myth busting.

“We found no evidence that caffeine consumption leads to a greater risk of arrhythmias,” said senior and corresponding author Gregory Marcus, MD. “Our population-based study provides reassurance that common prohibitions against caffeine to reduce arrhythmia risk are likely unwarranted.”

There was no evidence of a heightened risk of arrhythmias in participants who were genetically predisposed to metabolize caffeine differently from those who were not. And, there was a 3% reduction of arrhythmias in patients who consumed higher amounts of coffee.

We are not lobbying for Big Caffeine, but this study adds to the reported health benefits linked to coffee, which already include reduced risk for cancer, diabetes, and Parkinson’s disease, with an added bonus of anti-inflammatory benefits. So, the next time you’re hesitant to pour that second cup of Joe, just go for it. Your heart can take it.
 

Bored? Feeling down? Don’t play Candy Crush

Now hang on, aren’t those the perfect times to play video games? If there’s nothing else to do, why not open Candy Crush and mindlessly power through the levels?

pxfuel

Because, according to a study by a group of Canadian researchers, it’s actually the worst thing you can do. Well, maybe not literally, but it’s not helpful. Researchers recruited 60 Candy Crush players who were at various levels in the game. They had the participants play early levels that were far too easy or levels balanced with their gameplay abilities.

Players in the easy-level group got bored and quit far earlier than did those in the advanced-level group. The group playing to their abilities were able to access a “flow” state and focus all their attention on the game. While this is all well and good for their gaming performance, according to the researchers, it confirms the theory that playing to escape boredom or negative emotions is more likely to lead to addiction. As with all addictions, the temporary high can give way to a self-repeating loop, causing patients to ignore real life and deepen depression.

The researchers hope their findings will encourage game developers to “consider implementing responsible video gaming tools directly within their games.” Comedy gold. Perhaps Canadians’ idea of capitalism is a little different from that of those south of the border.
 

Hiccups and vaccine refusal

Tonight, LOTME News dives into the fetid cesspool that is international politics and comes out with … hiccups?

But first, a word from our sponsor, Fearless Boxing Club of South Etobicoke, Ontario.

Are you looking to flout public health restrictions? Do you want to spend time in an enclosed space with other people who haven’t gotten the COVID-19 vaccine? Do you “feel safer waiting until more research is done on the side effects being discovered right now”? (We are not making this up.)

Then join the Fearless Boxing Club, because we “will not be accepting any vaccinated members.” Our founders, Mohammed Abedeen and Krystal Glazier-Roscoe, are working hard to exclude “those who received the experimental COVID vaccine.” (Still not making it up.)

And now, back to the news.

Brazilian president Jair Bolsonaro was hospitalized recently for a severe case of hiccups that may have been related to a stab wound he received in 2018. [Nope, didn’t make that up, either.]

djedj/Pixabay

Mr. Bolsonaro had been hiccuping for 10 days, and was experiencing abdominal pain and difficulty speaking, when he entered the hospital on July 14. Since being stabbed while on the campaign trail, he has undergone several operations, which may have led to the partial intestinal obstruction that caused his latest symptoms.

His medical team advised Mr. Bolsonaro to go on a diet to aid his recovery, but when he was released on July 18 he said, “I hope in 10 days I’ll be eating barbecued ribs.” (Maybe this is all just a lucid dream. Probably shouldn’t have had ribs right before bed.)

I dream of alien abductions

There he goes! It’s lunchtime and your colleague Tom is going on and on again about that time he was abducted by aliens. It sounds ridiculous, but he does make some convincing arguments. Tom thinks it was real, but could it have all just been in his head?

Engin Akyurt/Pixabay

Lucid dreaming may help explain alleged alien abductions. During a lucid dream, people know that they’re dreaming, and can also have some control over how the dreams play out. During some dream states, a person can feel intense sensations, such as terror and paralysis, so it’s no wonder these dreams feel so real.

In a recent study, scientists encouraged 152 participants who had self-identified as lucid dreamers to dream about aliens. Many (75%) of the participants were able to dream about alien encounters, and 15% “achieved relatively realistic experiences,” the investigators reported.

So cut Tom some slack. He’s not crazy, he might just have lucid dreaming privileges. Tell him he should dream about something more fun, like a vacation in the Bahamas.
 

Follow your heart: Drink more coffee

It seems like the world is divided into coffee drinkers and non–coffee drinkers. Then there’s decaf and regular drinkers. Whichever camp you fall into, know this: The widespread belief that caffeine consumption has an effect on your heart is all beans.

s-photo/iStockphoto.com

In what is the largest investigation of its kind, researchers from the University of California, San Francisco, looked into whether drinking caffeinated coffee was linked to a risk for heart arrhythmia. They also researched whether patients with genetic variants that affect their metabolism could change that association. Almost 400,000 people with a mean age of 56 years participated in the study. More than half of the participants were women.

The investigators analyzed the participants’ self-reported coffee consumption using a technique called Mendelian randomization to leverage genetic data with the participants’ relationship with caffeine, making it an even field and not relying on the participant consumption self-reporting for outcomes as in previous studies.

What they found, after the 4-year follow up, was nothing short of myth busting.

“We found no evidence that caffeine consumption leads to a greater risk of arrhythmias,” said senior and corresponding author Gregory Marcus, MD. “Our population-based study provides reassurance that common prohibitions against caffeine to reduce arrhythmia risk are likely unwarranted.”

There was no evidence of a heightened risk of arrhythmias in participants who were genetically predisposed to metabolize caffeine differently from those who were not. And, there was a 3% reduction of arrhythmias in patients who consumed higher amounts of coffee.

We are not lobbying for Big Caffeine, but this study adds to the reported health benefits linked to coffee, which already include reduced risk for cancer, diabetes, and Parkinson’s disease, with an added bonus of anti-inflammatory benefits. So, the next time you’re hesitant to pour that second cup of Joe, just go for it. Your heart can take it.
 

Bored? Feeling down? Don’t play Candy Crush

Now hang on, aren’t those the perfect times to play video games? If there’s nothing else to do, why not open Candy Crush and mindlessly power through the levels?

pxfuel

Because, according to a study by a group of Canadian researchers, it’s actually the worst thing you can do. Well, maybe not literally, but it’s not helpful. Researchers recruited 60 Candy Crush players who were at various levels in the game. They had the participants play early levels that were far too easy or levels balanced with their gameplay abilities.

Players in the easy-level group got bored and quit far earlier than did those in the advanced-level group. The group playing to their abilities were able to access a “flow” state and focus all their attention on the game. While this is all well and good for their gaming performance, according to the researchers, it confirms the theory that playing to escape boredom or negative emotions is more likely to lead to addiction. As with all addictions, the temporary high can give way to a self-repeating loop, causing patients to ignore real life and deepen depression.

The researchers hope their findings will encourage game developers to “consider implementing responsible video gaming tools directly within their games.” Comedy gold. Perhaps Canadians’ idea of capitalism is a little different from that of those south of the border.
 

Hiccups and vaccine refusal

Tonight, LOTME News dives into the fetid cesspool that is international politics and comes out with … hiccups?

But first, a word from our sponsor, Fearless Boxing Club of South Etobicoke, Ontario.

Are you looking to flout public health restrictions? Do you want to spend time in an enclosed space with other people who haven’t gotten the COVID-19 vaccine? Do you “feel safer waiting until more research is done on the side effects being discovered right now”? (We are not making this up.)

Then join the Fearless Boxing Club, because we “will not be accepting any vaccinated members.” Our founders, Mohammed Abedeen and Krystal Glazier-Roscoe, are working hard to exclude “those who received the experimental COVID vaccine.” (Still not making it up.)

And now, back to the news.

Brazilian president Jair Bolsonaro was hospitalized recently for a severe case of hiccups that may have been related to a stab wound he received in 2018. [Nope, didn’t make that up, either.]

djedj/Pixabay

Mr. Bolsonaro had been hiccuping for 10 days, and was experiencing abdominal pain and difficulty speaking, when he entered the hospital on July 14. Since being stabbed while on the campaign trail, he has undergone several operations, which may have led to the partial intestinal obstruction that caused his latest symptoms.

His medical team advised Mr. Bolsonaro to go on a diet to aid his recovery, but when he was released on July 18 he said, “I hope in 10 days I’ll be eating barbecued ribs.” (Maybe this is all just a lucid dream. Probably shouldn’t have had ribs right before bed.)

Among patients hospitalized for COVID-19, those who had been taking statins had a substantially lower risk of death in a new large observational study.

Results showed that use of statins prior to admission was linked to a greater than 40% reduction in mortality and a greater than 25% reduction in risk of developing a severe outcome.

The findings come an analysis of data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry on more than 10,000 patients hospitalized with COVID-19 at 104 hospitals across the United States published in PLoS One.

While several other studies have suggested benefits of statins in COVID-19, this is by far the largest study so far on this topic.

“I would say this is the most reliable study on statins in COVID-19 to date, with the results adjusted for many confounders, including socioeconomic factors and insurance type,” lead author Lori B. Daniels, MD, told this news organization. “However, it still an observational study and therefore falls short of a randomized study. But I would think a randomized study of statins in COVID-19 is probably not feasible, so this study provides excellent data at an observational level.”

After propensity matching for cardiovascular disease, results showed that most of the benefit of statins occurred in patients with known cardiovascular disease.

“While most patients taking statins will have cardiovascular disease, there are also many patients who take these drugs who don’t have heart disease but do have cardiovascular risk factors, such as those with raised cholesterol, or a family history of cardiovascular disease. For [such patients], the effect of statins was also in the same direction but it was not significant. This doesn’t exclude an effect,” noted Dr. Daniels, who is professor of medicine and director of cardiovascular intensive care at the University of California, San Diego.

“We are not saying that everyone should rush out and take a statin if they do not have risk factors for cardiovascular in order to lower their risk of dying from COVID. But if individuals do have an indication for a statin and are not taking one of these dugs this is another good reason to start taking them now,” she added.

The investigators embarked on the study because, although previous observational studies have found that statins may reduce the severity of COVID-19 infection, these studies have been limited in size with mostly single-center or regional studies, and some results have been conflicting. They therefore conducted the current, much larger analysis, in the AHA COVID-19 CVD Registry which systematically collected hospitalized patient–level data in a broad and diverse hospital and patient population across the United States.

For the analysis, the researchers analyzed data from 10,541 patients hospitalized with COVID-19 through September 2020 at 104 U.S. hospitals enrolled in the AHA registry to evaluate the associations between statin use and outcomes.

Most patients (71%) had either cardiovascular disease, hypertension, or both. Prior to admission, 42% of subjects used statins, with 7% being on statins alone and 35% on statins plus antihypertensives. Death (or discharge to hospice) occurred in 2,212 subjects (21%).

Results showed that outpatient use of statins, either alone or with antihypertensives, was associated with a 41% reduced risk of death (odds ratio, 0.59; 95% confidence interval, 0.50-0.69), after adjusting for demographic characteristics, underlying conditions, insurance status, hospital site, and concurrent medications. Statin use was also associated with a roughly 25% lower adjusted odds of developing severe disease.

Noting that patients on statins are also likely to be on antihypertensive medication, the researchers found that the statin benefit on mortality was seen in both patients taking a statin alone (OR, 0.54) and in those taking statins with an antihypertensive medication (OR, 0.60).

Use of antihypertensive drugs was associated with a smaller, albeit still substantial, 27% lower odds of death (OR, 0.73; 95% CI, 0.62-0.87).

In propensity-matched analyses, use of statins and/or antihypertensives was tied to a 32% reduced risk of death among those with a history of CVD and/or hypertension (OR, 0.68; 95% CI, 0.58-0.81). An observed 16% reduction in odds of death with statins and/or antihypertensive drugs among those without cardiovascular disease and/or hypertension was not statistically significant (OR, 0.84; 95% CI, 0.58-1.22).
 

Stabilizing the underlying disease

The researchers pointed out that the results of the propensity matching analysis are consistent with the hypothesis that the major benefit of these medications accrues from treating and/or stabilizing underlying disease.

“Although it is well known that statins improve long-term outcomes among patients with or at elevated risk for cardiovascular disease, the association with a large short-term benefit which accrues in the setting of hospitalization for COVID-19 is a new and intriguing finding,” they said.

They cited several “plausible mechanisms whereby statins could directly mitigate outcomes in COVID-19 beyond treating underlying disease conditions,” including anti-inflammatory effects and a direct inhibitory effect on the SARS-CoV-2 virus.

Dr. Daniels elaborated more on the potential mechanism at play in an interview: “I think what is happening is that the statin is stabilizing the coronary disease so patients are less likely to die from MI or stroke, and this gives them more time and strength to recover from COVID-19.”

She added: “Statins may also have some direct anti-COVID effects such as an anti-inflammatory actions, but I would guess that this is probably not the primary effect behind what we’re seeing here.”
 

‘Important clinical implications’

The authors say their findings have “important clinical implications.”

They noted that early in the pandemic there was speculation that certain medications, including statins, and the ACE inhibitor/angiotensin receptor blocker (ARB) classes of antihypertensives may confer an increased susceptibility to COVID-19 positivity and/or severity.

“Our study reinforces the AHA and others’ recommendations that not only is it safe to remain on these medications, but they may substantially reduce risk of severe COVID-19 and especially death from COVID-19, particularly statins, and particularly among those with associated underlying conditions,” the authors stressed.

Dr. Daniels added that, although statins are very safe drugs, there are always some patients who prefer not to take medication even if indicated, and others who may have borderline indications and decide not to take a statin at present.

“This study may persuade these patients that taking a statin is the right thing to do. It may give those patients on the cusp of thinking about taking one of these drugs a reason to go ahead,” she said.
 

‘Provocative but not definitive’

Commenting on the study, Robert Harrington, MD, professor of medicine and chair of the department of medicine at Stanford (Calif.) University, said: “These are interesting observational data but as such have all the limitations of nonrandomized comparisons despite the best attempts to adjust for a variety of potential confounders. For example, is this an effect of statins (perhaps through some anti-inflammatory mechanism) or is it more an effect that can be attributed to the patients who are prescribed and taking a statin, compared with those who are not?”

He added: “The primary clinical benefit of statins, based on many large randomized clinical trials, seems to be derived from their LDL lowering effect. Observational studies have suggested potential benefits from anti-inflammatory effects of statins, but the randomized trials have not confirmed these observations. So, the current data are interesting, even provocative, but ultimately hypothesis generating rather than definitive.”

Also commenting on the study, Steven Nissen, MD, professor of medicine at the Cleveland Clinic, said: “While statins have many established benefits, their role in preventing COVID-19 complications is very speculative. Like all observational studies, the current study must be viewed as hypothesis generating, not definitive evidence of benefit. There are many potential confounders. I’m skeptical.”

The authors of this study received no specific funding for this work and report no competing interests. Dr. Harrington was AHA president when the COVID registry was created and he is still a member of the AHA board, which has oversight over the project.

Among patients hospitalized for COVID-19, those who had been taking statins had a substantially lower risk of death in a new large observational study.

Results showed that use of statins prior to admission was linked to a greater than 40% reduction in mortality and a greater than 25% reduction in risk of developing a severe outcome.

The findings come an analysis of data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry on more than 10,000 patients hospitalized with COVID-19 at 104 hospitals across the United States published in PLoS One.

While several other studies have suggested benefits of statins in COVID-19, this is by far the largest study so far on this topic.

“I would say this is the most reliable study on statins in COVID-19 to date, with the results adjusted for many confounders, including socioeconomic factors and insurance type,” lead author Lori B. Daniels, MD, told this news organization. “However, it still an observational study and therefore falls short of a randomized study. But I would think a randomized study of statins in COVID-19 is probably not feasible, so this study provides excellent data at an observational level.”

After propensity matching for cardiovascular disease, results showed that most of the benefit of statins occurred in patients with known cardiovascular disease.

“While most patients taking statins will have cardiovascular disease, there are also many patients who take these drugs who don’t have heart disease but do have cardiovascular risk factors, such as those with raised cholesterol, or a family history of cardiovascular disease. For [such patients], the effect of statins was also in the same direction but it was not significant. This doesn’t exclude an effect,” noted Dr. Daniels, who is professor of medicine and director of cardiovascular intensive care at the University of California, San Diego.

“We are not saying that everyone should rush out and take a statin if they do not have risk factors for cardiovascular in order to lower their risk of dying from COVID. But if individuals do have an indication for a statin and are not taking one of these dugs this is another good reason to start taking them now,” she added.

The investigators embarked on the study because, although previous observational studies have found that statins may reduce the severity of COVID-19 infection, these studies have been limited in size with mostly single-center or regional studies, and some results have been conflicting. They therefore conducted the current, much larger analysis, in the AHA COVID-19 CVD Registry which systematically collected hospitalized patient–level data in a broad and diverse hospital and patient population across the United States.

For the analysis, the researchers analyzed data from 10,541 patients hospitalized with COVID-19 through September 2020 at 104 U.S. hospitals enrolled in the AHA registry to evaluate the associations between statin use and outcomes.

Most patients (71%) had either cardiovascular disease, hypertension, or both. Prior to admission, 42% of subjects used statins, with 7% being on statins alone and 35% on statins plus antihypertensives. Death (or discharge to hospice) occurred in 2,212 subjects (21%).

Results showed that outpatient use of statins, either alone or with antihypertensives, was associated with a 41% reduced risk of death (odds ratio, 0.59; 95% confidence interval, 0.50-0.69), after adjusting for demographic characteristics, underlying conditions, insurance status, hospital site, and concurrent medications. Statin use was also associated with a roughly 25% lower adjusted odds of developing severe disease.

Noting that patients on statins are also likely to be on antihypertensive medication, the researchers found that the statin benefit on mortality was seen in both patients taking a statin alone (OR, 0.54) and in those taking statins with an antihypertensive medication (OR, 0.60).

Use of antihypertensive drugs was associated with a smaller, albeit still substantial, 27% lower odds of death (OR, 0.73; 95% CI, 0.62-0.87).

In propensity-matched analyses, use of statins and/or antihypertensives was tied to a 32% reduced risk of death among those with a history of CVD and/or hypertension (OR, 0.68; 95% CI, 0.58-0.81). An observed 16% reduction in odds of death with statins and/or antihypertensive drugs among those without cardiovascular disease and/or hypertension was not statistically significant (OR, 0.84; 95% CI, 0.58-1.22).
 

Stabilizing the underlying disease

The researchers pointed out that the results of the propensity matching analysis are consistent with the hypothesis that the major benefit of these medications accrues from treating and/or stabilizing underlying disease.

“Although it is well known that statins improve long-term outcomes among patients with or at elevated risk for cardiovascular disease, the association with a large short-term benefit which accrues in the setting of hospitalization for COVID-19 is a new and intriguing finding,” they said.

They cited several “plausible mechanisms whereby statins could directly mitigate outcomes in COVID-19 beyond treating underlying disease conditions,” including anti-inflammatory effects and a direct inhibitory effect on the SARS-CoV-2 virus.

Dr. Daniels elaborated more on the potential mechanism at play in an interview: “I think what is happening is that the statin is stabilizing the coronary disease so patients are less likely to die from MI or stroke, and this gives them more time and strength to recover from COVID-19.”

She added: “Statins may also have some direct anti-COVID effects such as an anti-inflammatory actions, but I would guess that this is probably not the primary effect behind what we’re seeing here.”
 

‘Important clinical implications’

The authors say their findings have “important clinical implications.”

They noted that early in the pandemic there was speculation that certain medications, including statins, and the ACE inhibitor/angiotensin receptor blocker (ARB) classes of antihypertensives may confer an increased susceptibility to COVID-19 positivity and/or severity.

“Our study reinforces the AHA and others’ recommendations that not only is it safe to remain on these medications, but they may substantially reduce risk of severe COVID-19 and especially death from COVID-19, particularly statins, and particularly among those with associated underlying conditions,” the authors stressed.

Dr. Daniels added that, although statins are very safe drugs, there are always some patients who prefer not to take medication even if indicated, and others who may have borderline indications and decide not to take a statin at present.

“This study may persuade these patients that taking a statin is the right thing to do. It may give those patients on the cusp of thinking about taking one of these drugs a reason to go ahead,” she said.
 

‘Provocative but not definitive’

Commenting on the study, Robert Harrington, MD, professor of medicine and chair of the department of medicine at Stanford (Calif.) University, said: “These are interesting observational data but as such have all the limitations of nonrandomized comparisons despite the best attempts to adjust for a variety of potential confounders. For example, is this an effect of statins (perhaps through some anti-inflammatory mechanism) or is it more an effect that can be attributed to the patients who are prescribed and taking a statin, compared with those who are not?”

He added: “The primary clinical benefit of statins, based on many large randomized clinical trials, seems to be derived from their LDL lowering effect. Observational studies have suggested potential benefits from anti-inflammatory effects of statins, but the randomized trials have not confirmed these observations. So, the current data are interesting, even provocative, but ultimately hypothesis generating rather than definitive.”

Also commenting on the study, Steven Nissen, MD, professor of medicine at the Cleveland Clinic, said: “While statins have many established benefits, their role in preventing COVID-19 complications is very speculative. Like all observational studies, the current study must be viewed as hypothesis generating, not definitive evidence of benefit. There are many potential confounders. I’m skeptical.”

The authors of this study received no specific funding for this work and report no competing interests. Dr. Harrington was AHA president when the COVID registry was created and he is still a member of the AHA board, which has oversight over the project.

Among patients hospitalized for COVID-19, those who had been taking statins had a substantially lower risk of death in a new large observational study.

Results showed that use of statins prior to admission was linked to a greater than 40% reduction in mortality and a greater than 25% reduction in risk of developing a severe outcome.

The findings come an analysis of data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry on more than 10,000 patients hospitalized with COVID-19 at 104 hospitals across the United States published in PLoS One.

While several other studies have suggested benefits of statins in COVID-19, this is by far the largest study so far on this topic.

“I would say this is the most reliable study on statins in COVID-19 to date, with the results adjusted for many confounders, including socioeconomic factors and insurance type,” lead author Lori B. Daniels, MD, told this news organization. “However, it still an observational study and therefore falls short of a randomized study. But I would think a randomized study of statins in COVID-19 is probably not feasible, so this study provides excellent data at an observational level.”

After propensity matching for cardiovascular disease, results showed that most of the benefit of statins occurred in patients with known cardiovascular disease.

“While most patients taking statins will have cardiovascular disease, there are also many patients who take these drugs who don’t have heart disease but do have cardiovascular risk factors, such as those with raised cholesterol, or a family history of cardiovascular disease. For [such patients], the effect of statins was also in the same direction but it was not significant. This doesn’t exclude an effect,” noted Dr. Daniels, who is professor of medicine and director of cardiovascular intensive care at the University of California, San Diego.

“We are not saying that everyone should rush out and take a statin if they do not have risk factors for cardiovascular in order to lower their risk of dying from COVID. But if individuals do have an indication for a statin and are not taking one of these dugs this is another good reason to start taking them now,” she added.

The investigators embarked on the study because, although previous observational studies have found that statins may reduce the severity of COVID-19 infection, these studies have been limited in size with mostly single-center or regional studies, and some results have been conflicting. They therefore conducted the current, much larger analysis, in the AHA COVID-19 CVD Registry which systematically collected hospitalized patient–level data in a broad and diverse hospital and patient population across the United States.

For the analysis, the researchers analyzed data from 10,541 patients hospitalized with COVID-19 through September 2020 at 104 U.S. hospitals enrolled in the AHA registry to evaluate the associations between statin use and outcomes.

Most patients (71%) had either cardiovascular disease, hypertension, or both. Prior to admission, 42% of subjects used statins, with 7% being on statins alone and 35% on statins plus antihypertensives. Death (or discharge to hospice) occurred in 2,212 subjects (21%).

Results showed that outpatient use of statins, either alone or with antihypertensives, was associated with a 41% reduced risk of death (odds ratio, 0.59; 95% confidence interval, 0.50-0.69), after adjusting for demographic characteristics, underlying conditions, insurance status, hospital site, and concurrent medications. Statin use was also associated with a roughly 25% lower adjusted odds of developing severe disease.

Noting that patients on statins are also likely to be on antihypertensive medication, the researchers found that the statin benefit on mortality was seen in both patients taking a statin alone (OR, 0.54) and in those taking statins with an antihypertensive medication (OR, 0.60).

Use of antihypertensive drugs was associated with a smaller, albeit still substantial, 27% lower odds of death (OR, 0.73; 95% CI, 0.62-0.87).

In propensity-matched analyses, use of statins and/or antihypertensives was tied to a 32% reduced risk of death among those with a history of CVD and/or hypertension (OR, 0.68; 95% CI, 0.58-0.81). An observed 16% reduction in odds of death with statins and/or antihypertensive drugs among those without cardiovascular disease and/or hypertension was not statistically significant (OR, 0.84; 95% CI, 0.58-1.22).
 

Stabilizing the underlying disease

The researchers pointed out that the results of the propensity matching analysis are consistent with the hypothesis that the major benefit of these medications accrues from treating and/or stabilizing underlying disease.

“Although it is well known that statins improve long-term outcomes among patients with or at elevated risk for cardiovascular disease, the association with a large short-term benefit which accrues in the setting of hospitalization for COVID-19 is a new and intriguing finding,” they said.

They cited several “plausible mechanisms whereby statins could directly mitigate outcomes in COVID-19 beyond treating underlying disease conditions,” including anti-inflammatory effects and a direct inhibitory effect on the SARS-CoV-2 virus.

Dr. Daniels elaborated more on the potential mechanism at play in an interview: “I think what is happening is that the statin is stabilizing the coronary disease so patients are less likely to die from MI or stroke, and this gives them more time and strength to recover from COVID-19.”

She added: “Statins may also have some direct anti-COVID effects such as an anti-inflammatory actions, but I would guess that this is probably not the primary effect behind what we’re seeing here.”
 

‘Important clinical implications’

The authors say their findings have “important clinical implications.”

They noted that early in the pandemic there was speculation that certain medications, including statins, and the ACE inhibitor/angiotensin receptor blocker (ARB) classes of antihypertensives may confer an increased susceptibility to COVID-19 positivity and/or severity.

“Our study reinforces the AHA and others’ recommendations that not only is it safe to remain on these medications, but they may substantially reduce risk of severe COVID-19 and especially death from COVID-19, particularly statins, and particularly among those with associated underlying conditions,” the authors stressed.

Dr. Daniels added that, although statins are very safe drugs, there are always some patients who prefer not to take medication even if indicated, and others who may have borderline indications and decide not to take a statin at present.

“This study may persuade these patients that taking a statin is the right thing to do. It may give those patients on the cusp of thinking about taking one of these drugs a reason to go ahead,” she said.
 

‘Provocative but not definitive’

Commenting on the study, Robert Harrington, MD, professor of medicine and chair of the department of medicine at Stanford (Calif.) University, said: “These are interesting observational data but as such have all the limitations of nonrandomized comparisons despite the best attempts to adjust for a variety of potential confounders. For example, is this an effect of statins (perhaps through some anti-inflammatory mechanism) or is it more an effect that can be attributed to the patients who are prescribed and taking a statin, compared with those who are not?”

He added: “The primary clinical benefit of statins, based on many large randomized clinical trials, seems to be derived from their LDL lowering effect. Observational studies have suggested potential benefits from anti-inflammatory effects of statins, but the randomized trials have not confirmed these observations. So, the current data are interesting, even provocative, but ultimately hypothesis generating rather than definitive.”

Also commenting on the study, Steven Nissen, MD, professor of medicine at the Cleveland Clinic, said: “While statins have many established benefits, their role in preventing COVID-19 complications is very speculative. Like all observational studies, the current study must be viewed as hypothesis generating, not definitive evidence of benefit. There are many potential confounders. I’m skeptical.”

The authors of this study received no specific funding for this work and report no competing interests. Dr. Harrington was AHA president when the COVID registry was created and he is still a member of the AHA board, which has oversight over the project.

“Purported” weight-loss products –12 dietary supplements and 2 alternative therapies – lack high-quality evidence to back up claims of efficacy, a systematic review by the Obesity Society reports.

Sally Kubetin/MDedge News

Most of the more than 300 published randomized controlled trials in the review were small and short, and only 0.5% found a statistically significant weight loss of up to 5 kg, John A. Batsis, MD, from the University of North Carolina at Chapel Hill, and colleagues reported in the journal Obesity.

“Despite the poor quality of these studies with high degrees of bias, most still failed to show efficacy of the product they were testing,” Srividya Kidambi, MD, from the Medical College of Wisconsin, Milwaukee, and colleagues from the Obesity Society’s Clinical Committee pointed out in an accompanying commentary.

“Yet these are the studies that are often used to support manufacturers’ claims of ‘clinically proven’ in their marketing,” they noted.

Most consumers, they continued, are unaware that these nondrug weight-loss products are not regulated by the Food and Drug Administration, but rather, if their ingredients are “generally regarded as safe,” they are treated as dietary supplements and require little or no testing to show either efficacy or safety.

“Our patients need to become aware that dietary supplements for weight loss are nothing more than a pipe dream, and as clinicians we would do well to talk with our patients and help steer them toward science-based treatments rather than the ‘Wild West’ of dietary supplements that are marketed for weight loss,” Scott Kahan, MD, MPH, coauthor of the review and commentary, told this news organization.

The dietary supplement industry has a strong lobby against legislation for more rigorous requirements for claims, noted Dr. Kahan, of the National Center for Weight and Wellness as well as George Washington University, Washington.

However, “there has to be some level of protection for consumers” who are faced with ads by “healthy skinny people saying this [product] can change your life.”

Clinical providers need to guide patients to “evidence-based interventions to support weight loss such as behavioral weight-loss interventions, [FDA-approved] medications, or bariatric surgery,” said Dr. Batsis, who also coauthored the commentary.

There is a “critical need” for more rigorous trials, and a partnership between researchers, funders, and industry, he added.

According to Dr. Kidambi and colleagues, “the use of these products will continue as long as they are allowed to be marketed with the aforementioned limited federal oversight and there is a lack of access to evidence-based obesity treatments.”

The commentary authors “call on regulatory authorities to critically examine the dietary supplement industry, including their role in promoting misleading claims and marketing products that have the potential to harm patients.”

They also urged public and private health insurance plans to “provide adequate resources for obesity management.”

And clinicians should “consider the lack of evidence for non–FDA-approved dietary supplements and therapies and guide their patients toward tested weight-management approaches.”
 

Subpar evidence, booming industry

“Annual sales of dietary supplements for weight loss are booming with an industry valued at $30 billion worldwide, despite subpar evidence” of efficacy, the commentary authors wrote by way of background.

After the Dietary Supplement Health and Education Act of 1994, the National Institutes of Health’s Office of Dietary Supplements was established “to strengthen the knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, and educating the public,” they explained.

However, dietary supplements and alternative therapies are endorsed by influencers and celebrities and marketed as a panacea for obesity and weight gain.
 

Literature review finds scant evidence

Consumers may believe that the “clinically proven” claims of efficacy of these “natural” weight-loss treatments have been thoroughly evaluated for safety and efficacy by the FDA, and clinicians lack information to counsel patients about this.

Therefore, although the Office of Dietary Supplements’ work has importantly advanced the science, the review authors wrote, members of the Obesity Society believed it was important to evaluate and perform a qualitative synthesis of the evidence for efficacy of non–FDA-regulated weight-loss supplements and alternative therapies to better inform clinicians and consumers.

From more than 20,000 citations of 53 dietary supplements and alternative therapies promoted for weight loss, the researchers identified 314 randomized controlled trials of 14 products that each had at least 5 randomized controlled trials.

The two types of alternative therapies in the review were mind-body interventions – which included behavioral therapies (for example, mindfulness and stress management), hypnosis, meditation, or massage – and acupuncture.

Several popular and widely used products (for example, human chorionic gonadotropin, raspberry ketones, nicotinamide adenine dinucleotide, vitamin infusions) did not meet the predefined number of published randomized controlled trials to be eligible for inclusion in the review.

The greatest number of trials were for acupuncture (45 trials), green tea (38), conjugated linoleic acid (31), ephedra with or without caffeine (31), mind-body therapies (22), and calcium and vitamin D (22). There were fewer trials of garcinia and/or hydroxycitrate (15), chitosan (9), phaseolus (7), pyruvate (7), chocolate/cocoa (6), chromium (6), guar gum (5), and phenylpropylamine (5).

Of the 314 studies, only 52 studies (16.5%) demonstrated that the products were efficacious and low risk, and only 16 studies (0.5%) reported a statistically significant between-group weight loss (0.3-4.93 kg).

For more information, in addition to their review and commentary, the authors refer clinicians to a dietary supplement label database.

The study was supported in part by grants from the National Institute on Aging. Dr. Batsis reported equity in SynchroHealth. Dr. Kidambi reported being the medical director for TOPS Center for Metabolic Health at the Medical College of Wisconsin, which is supported by TOPS. Dr. Kahan reported serving as a consultant for Novo Nordisk, Vivus, Gelesis, and Pfizer.

“Purported” weight-loss products –12 dietary supplements and 2 alternative therapies – lack high-quality evidence to back up claims of efficacy, a systematic review by the Obesity Society reports.

Sally Kubetin/MDedge News

Most of the more than 300 published randomized controlled trials in the review were small and short, and only 0.5% found a statistically significant weight loss of up to 5 kg, John A. Batsis, MD, from the University of North Carolina at Chapel Hill, and colleagues reported in the journal Obesity.

“Despite the poor quality of these studies with high degrees of bias, most still failed to show efficacy of the product they were testing,” Srividya Kidambi, MD, from the Medical College of Wisconsin, Milwaukee, and colleagues from the Obesity Society’s Clinical Committee pointed out in an accompanying commentary.

“Yet these are the studies that are often used to support manufacturers’ claims of ‘clinically proven’ in their marketing,” they noted.

Most consumers, they continued, are unaware that these nondrug weight-loss products are not regulated by the Food and Drug Administration, but rather, if their ingredients are “generally regarded as safe,” they are treated as dietary supplements and require little or no testing to show either efficacy or safety.

“Our patients need to become aware that dietary supplements for weight loss are nothing more than a pipe dream, and as clinicians we would do well to talk with our patients and help steer them toward science-based treatments rather than the ‘Wild West’ of dietary supplements that are marketed for weight loss,” Scott Kahan, MD, MPH, coauthor of the review and commentary, told this news organization.

The dietary supplement industry has a strong lobby against legislation for more rigorous requirements for claims, noted Dr. Kahan, of the National Center for Weight and Wellness as well as George Washington University, Washington.

However, “there has to be some level of protection for consumers” who are faced with ads by “healthy skinny people saying this [product] can change your life.”

Clinical providers need to guide patients to “evidence-based interventions to support weight loss such as behavioral weight-loss interventions, [FDA-approved] medications, or bariatric surgery,” said Dr. Batsis, who also coauthored the commentary.

There is a “critical need” for more rigorous trials, and a partnership between researchers, funders, and industry, he added.

According to Dr. Kidambi and colleagues, “the use of these products will continue as long as they are allowed to be marketed with the aforementioned limited federal oversight and there is a lack of access to evidence-based obesity treatments.”

The commentary authors “call on regulatory authorities to critically examine the dietary supplement industry, including their role in promoting misleading claims and marketing products that have the potential to harm patients.”

They also urged public and private health insurance plans to “provide adequate resources for obesity management.”

And clinicians should “consider the lack of evidence for non–FDA-approved dietary supplements and therapies and guide their patients toward tested weight-management approaches.”
 

Subpar evidence, booming industry

“Annual sales of dietary supplements for weight loss are booming with an industry valued at $30 billion worldwide, despite subpar evidence” of efficacy, the commentary authors wrote by way of background.

After the Dietary Supplement Health and Education Act of 1994, the National Institutes of Health’s Office of Dietary Supplements was established “to strengthen the knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, and educating the public,” they explained.

However, dietary supplements and alternative therapies are endorsed by influencers and celebrities and marketed as a panacea for obesity and weight gain.
 

Literature review finds scant evidence

Consumers may believe that the “clinically proven” claims of efficacy of these “natural” weight-loss treatments have been thoroughly evaluated for safety and efficacy by the FDA, and clinicians lack information to counsel patients about this.

Therefore, although the Office of Dietary Supplements’ work has importantly advanced the science, the review authors wrote, members of the Obesity Society believed it was important to evaluate and perform a qualitative synthesis of the evidence for efficacy of non–FDA-regulated weight-loss supplements and alternative therapies to better inform clinicians and consumers.

From more than 20,000 citations of 53 dietary supplements and alternative therapies promoted for weight loss, the researchers identified 314 randomized controlled trials of 14 products that each had at least 5 randomized controlled trials.

The two types of alternative therapies in the review were mind-body interventions – which included behavioral therapies (for example, mindfulness and stress management), hypnosis, meditation, or massage – and acupuncture.

Several popular and widely used products (for example, human chorionic gonadotropin, raspberry ketones, nicotinamide adenine dinucleotide, vitamin infusions) did not meet the predefined number of published randomized controlled trials to be eligible for inclusion in the review.

The greatest number of trials were for acupuncture (45 trials), green tea (38), conjugated linoleic acid (31), ephedra with or without caffeine (31), mind-body therapies (22), and calcium and vitamin D (22). There were fewer trials of garcinia and/or hydroxycitrate (15), chitosan (9), phaseolus (7), pyruvate (7), chocolate/cocoa (6), chromium (6), guar gum (5), and phenylpropylamine (5).

Of the 314 studies, only 52 studies (16.5%) demonstrated that the products were efficacious and low risk, and only 16 studies (0.5%) reported a statistically significant between-group weight loss (0.3-4.93 kg).

For more information, in addition to their review and commentary, the authors refer clinicians to a dietary supplement label database.

The study was supported in part by grants from the National Institute on Aging. Dr. Batsis reported equity in SynchroHealth. Dr. Kidambi reported being the medical director for TOPS Center for Metabolic Health at the Medical College of Wisconsin, which is supported by TOPS. Dr. Kahan reported serving as a consultant for Novo Nordisk, Vivus, Gelesis, and Pfizer.

“Purported” weight-loss products –12 dietary supplements and 2 alternative therapies – lack high-quality evidence to back up claims of efficacy, a systematic review by the Obesity Society reports.

Sally Kubetin/MDedge News

Most of the more than 300 published randomized controlled trials in the review were small and short, and only 0.5% found a statistically significant weight loss of up to 5 kg, John A. Batsis, MD, from the University of North Carolina at Chapel Hill, and colleagues reported in the journal Obesity.

“Despite the poor quality of these studies with high degrees of bias, most still failed to show efficacy of the product they were testing,” Srividya Kidambi, MD, from the Medical College of Wisconsin, Milwaukee, and colleagues from the Obesity Society’s Clinical Committee pointed out in an accompanying commentary.

“Yet these are the studies that are often used to support manufacturers’ claims of ‘clinically proven’ in their marketing,” they noted.

Most consumers, they continued, are unaware that these nondrug weight-loss products are not regulated by the Food and Drug Administration, but rather, if their ingredients are “generally regarded as safe,” they are treated as dietary supplements and require little or no testing to show either efficacy or safety.

“Our patients need to become aware that dietary supplements for weight loss are nothing more than a pipe dream, and as clinicians we would do well to talk with our patients and help steer them toward science-based treatments rather than the ‘Wild West’ of dietary supplements that are marketed for weight loss,” Scott Kahan, MD, MPH, coauthor of the review and commentary, told this news organization.

The dietary supplement industry has a strong lobby against legislation for more rigorous requirements for claims, noted Dr. Kahan, of the National Center for Weight and Wellness as well as George Washington University, Washington.

However, “there has to be some level of protection for consumers” who are faced with ads by “healthy skinny people saying this [product] can change your life.”

Clinical providers need to guide patients to “evidence-based interventions to support weight loss such as behavioral weight-loss interventions, [FDA-approved] medications, or bariatric surgery,” said Dr. Batsis, who also coauthored the commentary.

There is a “critical need” for more rigorous trials, and a partnership between researchers, funders, and industry, he added.

According to Dr. Kidambi and colleagues, “the use of these products will continue as long as they are allowed to be marketed with the aforementioned limited federal oversight and there is a lack of access to evidence-based obesity treatments.”

The commentary authors “call on regulatory authorities to critically examine the dietary supplement industry, including their role in promoting misleading claims and marketing products that have the potential to harm patients.”

They also urged public and private health insurance plans to “provide adequate resources for obesity management.”

And clinicians should “consider the lack of evidence for non–FDA-approved dietary supplements and therapies and guide their patients toward tested weight-management approaches.”
 

Subpar evidence, booming industry

“Annual sales of dietary supplements for weight loss are booming with an industry valued at $30 billion worldwide, despite subpar evidence” of efficacy, the commentary authors wrote by way of background.

After the Dietary Supplement Health and Education Act of 1994, the National Institutes of Health’s Office of Dietary Supplements was established “to strengthen the knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, and educating the public,” they explained.

However, dietary supplements and alternative therapies are endorsed by influencers and celebrities and marketed as a panacea for obesity and weight gain.
 

Literature review finds scant evidence

Consumers may believe that the “clinically proven” claims of efficacy of these “natural” weight-loss treatments have been thoroughly evaluated for safety and efficacy by the FDA, and clinicians lack information to counsel patients about this.

Therefore, although the Office of Dietary Supplements’ work has importantly advanced the science, the review authors wrote, members of the Obesity Society believed it was important to evaluate and perform a qualitative synthesis of the evidence for efficacy of non–FDA-regulated weight-loss supplements and alternative therapies to better inform clinicians and consumers.

From more than 20,000 citations of 53 dietary supplements and alternative therapies promoted for weight loss, the researchers identified 314 randomized controlled trials of 14 products that each had at least 5 randomized controlled trials.

The two types of alternative therapies in the review were mind-body interventions – which included behavioral therapies (for example, mindfulness and stress management), hypnosis, meditation, or massage – and acupuncture.

Several popular and widely used products (for example, human chorionic gonadotropin, raspberry ketones, nicotinamide adenine dinucleotide, vitamin infusions) did not meet the predefined number of published randomized controlled trials to be eligible for inclusion in the review.

The greatest number of trials were for acupuncture (45 trials), green tea (38), conjugated linoleic acid (31), ephedra with or without caffeine (31), mind-body therapies (22), and calcium and vitamin D (22). There were fewer trials of garcinia and/or hydroxycitrate (15), chitosan (9), phaseolus (7), pyruvate (7), chocolate/cocoa (6), chromium (6), guar gum (5), and phenylpropylamine (5).

Of the 314 studies, only 52 studies (16.5%) demonstrated that the products were efficacious and low risk, and only 16 studies (0.5%) reported a statistically significant between-group weight loss (0.3-4.93 kg).

For more information, in addition to their review and commentary, the authors refer clinicians to a dietary supplement label database.

The study was supported in part by grants from the National Institute on Aging. Dr. Batsis reported equity in SynchroHealth. Dr. Kidambi reported being the medical director for TOPS Center for Metabolic Health at the Medical College of Wisconsin, which is supported by TOPS. Dr. Kahan reported serving as a consultant for Novo Nordisk, Vivus, Gelesis, and Pfizer.

The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN).

Olivier Le Moal/Getty Images

The approval is specific for the treatment of chronic pain associated with PDN using the Nevro’s Senza System with 10 kHz stimulation. It is intended for patients whose pain is refractory to, or who can’t tolerate, conventional medical treatment. According to the company, there are currently about 2.3 million individuals with refractory PDN in the United States.

The 10 kHz device, called HFX, involves minimally invasive epidural implantation of the stimulator device, which delivers mild electrical impulses to the nerves to interrupt pain signal to the brain. Such spinal cord stimulation “is a straightforward, well-established treatment for chronic pain that’s been used for over 30 years,” according to the company, although this is the first approval of the modality specifically for PDN.

Asked to comment, Rodica Pop-Busui MD, PhD, the Larry D. Soderquist Professor in Diabetes at the University of Michigan, Ann Arbor, said that “the approval of the Nevro 10kHz high-frequency spinal cord stimulation to treat pain associated with diabetic neuropathy has the potential for benefit for many patients with diabetes and painful diabetic peripheral neuropathy.”

She noted that, “although there are several other pharmacological agents that currently carry the FDA approval for PDN, this is a condition that is notoriously difficult to treat, particularly when taking into account the actual number needed to treat with a specific agent to achieve a clinically meaningful pain reduction, as well as the spectrum of side effects and drug-drug interactions in a patient population that require many other additional agents to manage diabetes and comorbidities on a daily basis. Thus, this new therapeutic approach besides effective pain reduction has the additional benefit of bypassing drug interactions.” Dr. Pop-Busui was the lead author on the American Diabetes Association’s 2017 position statement on diabetic neuropathy.

She also cautioned, on the other hand, that “it is not very clear yet how easy it will be for all eligible patients to have access to this technology, what will be the actual costs, the insurance coverage, or the acceptance by patients across various sociodemographic backgrounds from the at-large clinical care. However, given the challenges we encounter to treat diabetic neuropathy and particularly the pain associated with it, it is quite encouraging to see that the tools available to help our patients are now broader.”

Both 6-and 12-month results show benefit

The FDA approval was based on 6-month data from a prospective, multicenter, open-label randomized clinical trial published in JAMA Neurology.

Use of the 10-kHz SCS device was compared with conventional treatment alone in 216 patients with PDN refractory to gabapentinoids and at least one other analgesic class and lower limb pain intensity of 5 cm or more on a 10-cm visual analog scale.

The primary endpoint, percentage of participants reporting 50% pain relief or more without worsening of baseline neurologic deficits at 3 months, was met by 5 of 94 (5%) patients in the conventional group, compared with 75 of 95 (79%) with the 10-kHz SCS plus conventional treatment (P < .001).

Infections requiring device explant occurred in two patients in the 10-kHz SCS group (2%).

At 12 months, those in the original SCS group plus 86% of subjects given the option to cross over from the conventional treatment group showed “clear and sustained” benefits of the 10-kHz SCS with regard to lower-limb pain, pain interference with daily living, sleep quality, and activity, Erika Petersen, MD, director of the section of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences, Little Rock , reported at the 2021 annual scientific sessions of the ADA.

Infection was the most common study-related adverse event, affecting 8 of 154 patients with the SCS implants (5.2%). Three resolved with conservative treatment and five (3.2%) required removal of the device.

The patients will be followed for a total of 24 months.

Commercial launch of HFX in the United States will begin immediately, the company said.

Dr. Pop-Busui has received consultant fees in the last 12 months from Averitas Pharma, Boehringer Ingelheim, Nevro, and Novo Nordisk. Dr. Petersen has financial relationships with Nevro, Medtronic, and several other neuromodulator makers.

The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN).

Olivier Le Moal/Getty Images

The approval is specific for the treatment of chronic pain associated with PDN using the Nevro’s Senza System with 10 kHz stimulation. It is intended for patients whose pain is refractory to, or who can’t tolerate, conventional medical treatment. According to the company, there are currently about 2.3 million individuals with refractory PDN in the United States.

The 10 kHz device, called HFX, involves minimally invasive epidural implantation of the stimulator device, which delivers mild electrical impulses to the nerves to interrupt pain signal to the brain. Such spinal cord stimulation “is a straightforward, well-established treatment for chronic pain that’s been used for over 30 years,” according to the company, although this is the first approval of the modality specifically for PDN.

Asked to comment, Rodica Pop-Busui MD, PhD, the Larry D. Soderquist Professor in Diabetes at the University of Michigan, Ann Arbor, said that “the approval of the Nevro 10kHz high-frequency spinal cord stimulation to treat pain associated with diabetic neuropathy has the potential for benefit for many patients with diabetes and painful diabetic peripheral neuropathy.”

She noted that, “although there are several other pharmacological agents that currently carry the FDA approval for PDN, this is a condition that is notoriously difficult to treat, particularly when taking into account the actual number needed to treat with a specific agent to achieve a clinically meaningful pain reduction, as well as the spectrum of side effects and drug-drug interactions in a patient population that require many other additional agents to manage diabetes and comorbidities on a daily basis. Thus, this new therapeutic approach besides effective pain reduction has the additional benefit of bypassing drug interactions.” Dr. Pop-Busui was the lead author on the American Diabetes Association’s 2017 position statement on diabetic neuropathy.

She also cautioned, on the other hand, that “it is not very clear yet how easy it will be for all eligible patients to have access to this technology, what will be the actual costs, the insurance coverage, or the acceptance by patients across various sociodemographic backgrounds from the at-large clinical care. However, given the challenges we encounter to treat diabetic neuropathy and particularly the pain associated with it, it is quite encouraging to see that the tools available to help our patients are now broader.”

Both 6-and 12-month results show benefit

The FDA approval was based on 6-month data from a prospective, multicenter, open-label randomized clinical trial published in JAMA Neurology.

Use of the 10-kHz SCS device was compared with conventional treatment alone in 216 patients with PDN refractory to gabapentinoids and at least one other analgesic class and lower limb pain intensity of 5 cm or more on a 10-cm visual analog scale.

The primary endpoint, percentage of participants reporting 50% pain relief or more without worsening of baseline neurologic deficits at 3 months, was met by 5 of 94 (5%) patients in the conventional group, compared with 75 of 95 (79%) with the 10-kHz SCS plus conventional treatment (P < .001).

Infections requiring device explant occurred in two patients in the 10-kHz SCS group (2%).

At 12 months, those in the original SCS group plus 86% of subjects given the option to cross over from the conventional treatment group showed “clear and sustained” benefits of the 10-kHz SCS with regard to lower-limb pain, pain interference with daily living, sleep quality, and activity, Erika Petersen, MD, director of the section of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences, Little Rock , reported at the 2021 annual scientific sessions of the ADA.

Infection was the most common study-related adverse event, affecting 8 of 154 patients with the SCS implants (5.2%). Three resolved with conservative treatment and five (3.2%) required removal of the device.

The patients will be followed for a total of 24 months.

Commercial launch of HFX in the United States will begin immediately, the company said.

Dr. Pop-Busui has received consultant fees in the last 12 months from Averitas Pharma, Boehringer Ingelheim, Nevro, and Novo Nordisk. Dr. Petersen has financial relationships with Nevro, Medtronic, and several other neuromodulator makers.

The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN).

Olivier Le Moal/Getty Images

The approval is specific for the treatment of chronic pain associated with PDN using the Nevro’s Senza System with 10 kHz stimulation. It is intended for patients whose pain is refractory to, or who can’t tolerate, conventional medical treatment. According to the company, there are currently about 2.3 million individuals with refractory PDN in the United States.

The 10 kHz device, called HFX, involves minimally invasive epidural implantation of the stimulator device, which delivers mild electrical impulses to the nerves to interrupt pain signal to the brain. Such spinal cord stimulation “is a straightforward, well-established treatment for chronic pain that’s been used for over 30 years,” according to the company, although this is the first approval of the modality specifically for PDN.

Asked to comment, Rodica Pop-Busui MD, PhD, the Larry D. Soderquist Professor in Diabetes at the University of Michigan, Ann Arbor, said that “the approval of the Nevro 10kHz high-frequency spinal cord stimulation to treat pain associated with diabetic neuropathy has the potential for benefit for many patients with diabetes and painful diabetic peripheral neuropathy.”

She noted that, “although there are several other pharmacological agents that currently carry the FDA approval for PDN, this is a condition that is notoriously difficult to treat, particularly when taking into account the actual number needed to treat with a specific agent to achieve a clinically meaningful pain reduction, as well as the spectrum of side effects and drug-drug interactions in a patient population that require many other additional agents to manage diabetes and comorbidities on a daily basis. Thus, this new therapeutic approach besides effective pain reduction has the additional benefit of bypassing drug interactions.” Dr. Pop-Busui was the lead author on the American Diabetes Association’s 2017 position statement on diabetic neuropathy.

She also cautioned, on the other hand, that “it is not very clear yet how easy it will be for all eligible patients to have access to this technology, what will be the actual costs, the insurance coverage, or the acceptance by patients across various sociodemographic backgrounds from the at-large clinical care. However, given the challenges we encounter to treat diabetic neuropathy and particularly the pain associated with it, it is quite encouraging to see that the tools available to help our patients are now broader.”

Both 6-and 12-month results show benefit

The FDA approval was based on 6-month data from a prospective, multicenter, open-label randomized clinical trial published in JAMA Neurology.

Use of the 10-kHz SCS device was compared with conventional treatment alone in 216 patients with PDN refractory to gabapentinoids and at least one other analgesic class and lower limb pain intensity of 5 cm or more on a 10-cm visual analog scale.

The primary endpoint, percentage of participants reporting 50% pain relief or more without worsening of baseline neurologic deficits at 3 months, was met by 5 of 94 (5%) patients in the conventional group, compared with 75 of 95 (79%) with the 10-kHz SCS plus conventional treatment (P < .001).

Infections requiring device explant occurred in two patients in the 10-kHz SCS group (2%).

At 12 months, those in the original SCS group plus 86% of subjects given the option to cross over from the conventional treatment group showed “clear and sustained” benefits of the 10-kHz SCS with regard to lower-limb pain, pain interference with daily living, sleep quality, and activity, Erika Petersen, MD, director of the section of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences, Little Rock , reported at the 2021 annual scientific sessions of the ADA.

Infection was the most common study-related adverse event, affecting 8 of 154 patients with the SCS implants (5.2%). Three resolved with conservative treatment and five (3.2%) required removal of the device.

The patients will be followed for a total of 24 months.

Commercial launch of HFX in the United States will begin immediately, the company said.

Dr. Pop-Busui has received consultant fees in the last 12 months from Averitas Pharma, Boehringer Ingelheim, Nevro, and Novo Nordisk. Dr. Petersen has financial relationships with Nevro, Medtronic, and several other neuromodulator makers.

In patients with intermediate risk of atherosclerotic cardiovascular disease along with risk-enhancing factors, coronary artery calcium scoring may help more precisely calculate their need for statin therapy.

Furthermore, when the need for statin treatment isn’t so clear and patients need additional risk assessment, the scoring can provide further information to personalize clinical decision making, according to a cross-sectional study of 1,688 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) published in JAMA Cardiology.

And regardless of coronary artery calcium (CAC), a low ankle brachial index (ABI) score is a marker for statin therapy, the study found.

The study looked at CAC scoring in the context of ABI and other risk-enhancing factors identified in the 2018 American Heart Association/American College of Cardiology cholesterol management guidelines: a family history of premature atherosclerotic cardiovascular disease (ASCVD), lipid and inflammatory biomarkers, chronic kidney disease, chronic inflammatory conditions, premature menopause or preeclampsia, and South Asian ancestry.

Any number of these factors can indicate the need for statins in people with borderline or intermediate risk. The guidelines also call for selective use of CAC to aid the decision-making process for statin therapy when the risk for developing atherosclerosis isn’t so clear.

“The novel risk-enhancing factors are not perfect,” said lead author Jaideep Patel, MD, director of preventive cardiology at Johns Hopkins Heart Center at Greater Baltimore Medical Center. He noted that the 2018 dyslipidemia guidelines suggested the risk for cardiovascular events rises when new risk-enhancing factors emerge, and that it was difficult to predict the extent to which each enhancer could change the 10-year risk. 
 

Utility of CAC

“In this setting, the most significant finding that supports the utility of CAC scoring is when CAC is absent – a CAC of 0 – even in the setting of any of these enhancers, whether it be single or multiple, the 10-year risk remains extremely low – at the very least below the accepted threshold to initiate statin therapy,” Dr. Patel said.

That threshold is below the 7.5% 10-year ASCVD incidence rate. Over the 12-year mean study follow-up, the ASCVD incidence rate among patients with a CAC score of 0 for all risk-enhancing factors was 7.5 events per 1,000 person years, with one exception: ABI had an incidence rate of 10.4 events per 1,000 person years. “A low ABI score should trigger statin initiation irrespective of CAC score,” Dr. Patel said.

The study found a CAC score of 0 in 45.7% of those with one or two risk-enhancing factors versus 40.3% in those with three or more. “Across all the risk enhancers (except low ABI), the prevalence of CAC of 0 was greater than 50% in women; that is, enhancers overestimate risk,” Dr. Patel said. “The prevalence of CAC of 0 was approximately 40% across all risk enhancers; that is, enhancers overestimate risk.”

Dr. Patel said previous studies have suggested the risk of a major cardiovascular event was almost identical for statin and nonstatin users with a CAC score of 0. “If there is uncertainty about statin use after the physician-patient risk discussion,” he said, “CAC scoring may be helpful to guide the use of statin therapy.”

Senior author Mahmoud Al Rifai, MD, MPH, added: “For example, if CAC was absent, a statin could be deprescribed if there’s disutility on the part of the patient, with ongoing lifestyle and risk factor modification efforts.” Dr. Al Rifai is a cardiology fellow at Baylor College of Medicine, Houston.

Dr. Patel said: “Alternatively, if CAC was present, then it would be prudent to continue statin therapy.”

While South Asian ethnicity is a risk enhancing factor, the investigators acknowledged that MESA didn’t recruit this population group.
 

Study confirms guidelines

The study “supports the contention of the [AHA/ACC] guidelines that, in people who are in this intermediate risk range, there may be factors that either favor statin treatment or suggest that statin treatment could be deferred,” said Neil J. Stone, MD, of Northwestern University, Chicago, and author of the 2013 ASCVD risk calculator. “The guidelines pointed out that risk-enhancing factors may be associated with an increase in lifetime risk, not necessarily short term, and so could inform a more personalized risk discussion.”

The study findings validate the utility of CAC for guiding statin therapy, Dr. Stone said. “For those who have felt that a calcium score is not useful,” he said, “this is additional evidence to show that, in the context of making a decision in those at intermediate risk as proposed by the guidelines, a calcium score is indeed very useful.”

Dr. Stone added: “An important clinical point not mentioned by the authors is that, when the patient has a CAC score of 0 and risk factors, this may be exactly the time to be aggressive with lifestyle to prevent them from developing a positive CAC score and atherosclerosis, because once atherosclerosis is present, treatment may not restore the risk back to the original lower state.”

Dr. Patel, Dr. Al Rifai, and Dr. Stone have no relevant relationships to disclose. A number of study coauthors disclosed multiple financial relationships.

In patients with intermediate risk of atherosclerotic cardiovascular disease along with risk-enhancing factors, coronary artery calcium scoring may help more precisely calculate their need for statin therapy.

Furthermore, when the need for statin treatment isn’t so clear and patients need additional risk assessment, the scoring can provide further information to personalize clinical decision making, according to a cross-sectional study of 1,688 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) published in JAMA Cardiology.

And regardless of coronary artery calcium (CAC), a low ankle brachial index (ABI) score is a marker for statin therapy, the study found.

The study looked at CAC scoring in the context of ABI and other risk-enhancing factors identified in the 2018 American Heart Association/American College of Cardiology cholesterol management guidelines: a family history of premature atherosclerotic cardiovascular disease (ASCVD), lipid and inflammatory biomarkers, chronic kidney disease, chronic inflammatory conditions, premature menopause or preeclampsia, and South Asian ancestry.

Any number of these factors can indicate the need for statins in people with borderline or intermediate risk. The guidelines also call for selective use of CAC to aid the decision-making process for statin therapy when the risk for developing atherosclerosis isn’t so clear.

“The novel risk-enhancing factors are not perfect,” said lead author Jaideep Patel, MD, director of preventive cardiology at Johns Hopkins Heart Center at Greater Baltimore Medical Center. He noted that the 2018 dyslipidemia guidelines suggested the risk for cardiovascular events rises when new risk-enhancing factors emerge, and that it was difficult to predict the extent to which each enhancer could change the 10-year risk. 
 

Utility of CAC

“In this setting, the most significant finding that supports the utility of CAC scoring is when CAC is absent – a CAC of 0 – even in the setting of any of these enhancers, whether it be single or multiple, the 10-year risk remains extremely low – at the very least below the accepted threshold to initiate statin therapy,” Dr. Patel said.

That threshold is below the 7.5% 10-year ASCVD incidence rate. Over the 12-year mean study follow-up, the ASCVD incidence rate among patients with a CAC score of 0 for all risk-enhancing factors was 7.5 events per 1,000 person years, with one exception: ABI had an incidence rate of 10.4 events per 1,000 person years. “A low ABI score should trigger statin initiation irrespective of CAC score,” Dr. Patel said.

The study found a CAC score of 0 in 45.7% of those with one or two risk-enhancing factors versus 40.3% in those with three or more. “Across all the risk enhancers (except low ABI), the prevalence of CAC of 0 was greater than 50% in women; that is, enhancers overestimate risk,” Dr. Patel said. “The prevalence of CAC of 0 was approximately 40% across all risk enhancers; that is, enhancers overestimate risk.”

Dr. Patel said previous studies have suggested the risk of a major cardiovascular event was almost identical for statin and nonstatin users with a CAC score of 0. “If there is uncertainty about statin use after the physician-patient risk discussion,” he said, “CAC scoring may be helpful to guide the use of statin therapy.”

Senior author Mahmoud Al Rifai, MD, MPH, added: “For example, if CAC was absent, a statin could be deprescribed if there’s disutility on the part of the patient, with ongoing lifestyle and risk factor modification efforts.” Dr. Al Rifai is a cardiology fellow at Baylor College of Medicine, Houston.

Dr. Patel said: “Alternatively, if CAC was present, then it would be prudent to continue statin therapy.”

While South Asian ethnicity is a risk enhancing factor, the investigators acknowledged that MESA didn’t recruit this population group.
 

Study confirms guidelines

The study “supports the contention of the [AHA/ACC] guidelines that, in people who are in this intermediate risk range, there may be factors that either favor statin treatment or suggest that statin treatment could be deferred,” said Neil J. Stone, MD, of Northwestern University, Chicago, and author of the 2013 ASCVD risk calculator. “The guidelines pointed out that risk-enhancing factors may be associated with an increase in lifetime risk, not necessarily short term, and so could inform a more personalized risk discussion.”

The study findings validate the utility of CAC for guiding statin therapy, Dr. Stone said. “For those who have felt that a calcium score is not useful,” he said, “this is additional evidence to show that, in the context of making a decision in those at intermediate risk as proposed by the guidelines, a calcium score is indeed very useful.”

Dr. Stone added: “An important clinical point not mentioned by the authors is that, when the patient has a CAC score of 0 and risk factors, this may be exactly the time to be aggressive with lifestyle to prevent them from developing a positive CAC score and atherosclerosis, because once atherosclerosis is present, treatment may not restore the risk back to the original lower state.”

Dr. Patel, Dr. Al Rifai, and Dr. Stone have no relevant relationships to disclose. A number of study coauthors disclosed multiple financial relationships.

In patients with intermediate risk of atherosclerotic cardiovascular disease along with risk-enhancing factors, coronary artery calcium scoring may help more precisely calculate their need for statin therapy.

Furthermore, when the need for statin treatment isn’t so clear and patients need additional risk assessment, the scoring can provide further information to personalize clinical decision making, according to a cross-sectional study of 1,688 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) published in JAMA Cardiology.

And regardless of coronary artery calcium (CAC), a low ankle brachial index (ABI) score is a marker for statin therapy, the study found.

The study looked at CAC scoring in the context of ABI and other risk-enhancing factors identified in the 2018 American Heart Association/American College of Cardiology cholesterol management guidelines: a family history of premature atherosclerotic cardiovascular disease (ASCVD), lipid and inflammatory biomarkers, chronic kidney disease, chronic inflammatory conditions, premature menopause or preeclampsia, and South Asian ancestry.

Any number of these factors can indicate the need for statins in people with borderline or intermediate risk. The guidelines also call for selective use of CAC to aid the decision-making process for statin therapy when the risk for developing atherosclerosis isn’t so clear.

“The novel risk-enhancing factors are not perfect,” said lead author Jaideep Patel, MD, director of preventive cardiology at Johns Hopkins Heart Center at Greater Baltimore Medical Center. He noted that the 2018 dyslipidemia guidelines suggested the risk for cardiovascular events rises when new risk-enhancing factors emerge, and that it was difficult to predict the extent to which each enhancer could change the 10-year risk. 
 

Utility of CAC

“In this setting, the most significant finding that supports the utility of CAC scoring is when CAC is absent – a CAC of 0 – even in the setting of any of these enhancers, whether it be single or multiple, the 10-year risk remains extremely low – at the very least below the accepted threshold to initiate statin therapy,” Dr. Patel said.

That threshold is below the 7.5% 10-year ASCVD incidence rate. Over the 12-year mean study follow-up, the ASCVD incidence rate among patients with a CAC score of 0 for all risk-enhancing factors was 7.5 events per 1,000 person years, with one exception: ABI had an incidence rate of 10.4 events per 1,000 person years. “A low ABI score should trigger statin initiation irrespective of CAC score,” Dr. Patel said.

The study found a CAC score of 0 in 45.7% of those with one or two risk-enhancing factors versus 40.3% in those with three or more. “Across all the risk enhancers (except low ABI), the prevalence of CAC of 0 was greater than 50% in women; that is, enhancers overestimate risk,” Dr. Patel said. “The prevalence of CAC of 0 was approximately 40% across all risk enhancers; that is, enhancers overestimate risk.”

Dr. Patel said previous studies have suggested the risk of a major cardiovascular event was almost identical for statin and nonstatin users with a CAC score of 0. “If there is uncertainty about statin use after the physician-patient risk discussion,” he said, “CAC scoring may be helpful to guide the use of statin therapy.”

Senior author Mahmoud Al Rifai, MD, MPH, added: “For example, if CAC was absent, a statin could be deprescribed if there’s disutility on the part of the patient, with ongoing lifestyle and risk factor modification efforts.” Dr. Al Rifai is a cardiology fellow at Baylor College of Medicine, Houston.

Dr. Patel said: “Alternatively, if CAC was present, then it would be prudent to continue statin therapy.”

While South Asian ethnicity is a risk enhancing factor, the investigators acknowledged that MESA didn’t recruit this population group.
 

Study confirms guidelines

The study “supports the contention of the [AHA/ACC] guidelines that, in people who are in this intermediate risk range, there may be factors that either favor statin treatment or suggest that statin treatment could be deferred,” said Neil J. Stone, MD, of Northwestern University, Chicago, and author of the 2013 ASCVD risk calculator. “The guidelines pointed out that risk-enhancing factors may be associated with an increase in lifetime risk, not necessarily short term, and so could inform a more personalized risk discussion.”

The study findings validate the utility of CAC for guiding statin therapy, Dr. Stone said. “For those who have felt that a calcium score is not useful,” he said, “this is additional evidence to show that, in the context of making a decision in those at intermediate risk as proposed by the guidelines, a calcium score is indeed very useful.”

Dr. Stone added: “An important clinical point not mentioned by the authors is that, when the patient has a CAC score of 0 and risk factors, this may be exactly the time to be aggressive with lifestyle to prevent them from developing a positive CAC score and atherosclerosis, because once atherosclerosis is present, treatment may not restore the risk back to the original lower state.”

Dr. Patel, Dr. Al Rifai, and Dr. Stone have no relevant relationships to disclose. A number of study coauthors disclosed multiple financial relationships.

The U.S. Food and Drug Administration (FDA) aims to update the labeling on all statins to remove the drugs’ blanket contraindication in all pregnant patients, the agency has announced. The change should reinforce for both physicians and patients that statin use in women with unrecognized pregnancy is unlikely to be harmful, it said.

“Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate.”

The revision should emphasize for clinicians “that statins are safe to prescribe in patients who can become pregnant and help them reassure patients with unintended statin exposure in early pregnancy,” the FDA explained.

Removal of the broadly worded contraindication should “enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke." That includes women with homozygous familial hypercholesterolemia and those who are prescribed statins for secondary prevention, the agency said.

Clinicians “should discontinue statin therapy in most pregnant patients, or they can consider the ongoing therapeutic needs of the individual patient, particularly those at very high risk for cardiovascular events during pregnancy. Because of the chronic nature of cardiovascular disease, treatment of hyperlipidemia is not generally necessary during pregnancy.”

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

The U.S. Food and Drug Administration (FDA) aims to update the labeling on all statins to remove the drugs’ blanket contraindication in all pregnant patients, the agency has announced. The change should reinforce for both physicians and patients that statin use in women with unrecognized pregnancy is unlikely to be harmful, it said.

“Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate.”

The revision should emphasize for clinicians “that statins are safe to prescribe in patients who can become pregnant and help them reassure patients with unintended statin exposure in early pregnancy,” the FDA explained.

Removal of the broadly worded contraindication should “enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke." That includes women with homozygous familial hypercholesterolemia and those who are prescribed statins for secondary prevention, the agency said.

Clinicians “should discontinue statin therapy in most pregnant patients, or they can consider the ongoing therapeutic needs of the individual patient, particularly those at very high risk for cardiovascular events during pregnancy. Because of the chronic nature of cardiovascular disease, treatment of hyperlipidemia is not generally necessary during pregnancy.”

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

The U.S. Food and Drug Administration (FDA) aims to update the labeling on all statins to remove the drugs’ blanket contraindication in all pregnant patients, the agency has announced. The change should reinforce for both physicians and patients that statin use in women with unrecognized pregnancy is unlikely to be harmful, it said.

“Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate.”

The revision should emphasize for clinicians “that statins are safe to prescribe in patients who can become pregnant and help them reassure patients with unintended statin exposure in early pregnancy,” the FDA explained.

Removal of the broadly worded contraindication should “enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke." That includes women with homozygous familial hypercholesterolemia and those who are prescribed statins for secondary prevention, the agency said.

Clinicians “should discontinue statin therapy in most pregnant patients, or they can consider the ongoing therapeutic needs of the individual patient, particularly those at very high risk for cardiovascular events during pregnancy. Because of the chronic nature of cardiovascular disease, treatment of hyperlipidemia is not generally necessary during pregnancy.”

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

Patients with rheumatoid arthritis currently being treated with low doses of oral glucocorticoids (GCs) had a 59% increased risk of sustaining a vertebral fracture when compared with past users, results of a retrospective cohort study have shown.

izusek/Getty Images

Although the overall risk of an osteoporotic fracture was not increased when comparing current and past GC users, with a hazard ratio of 1.14 (95% confidence interval, 0.98-1.33), the HR for sustaining a spinal fracture was 1.59 (95% CI, 1.11-2.29).

“Clinicians should be aware that, even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased,” Shahab Abtahi, MD, of Maastricht (the Netherlands) University and coauthors reported in Rheumatology.

This is important considering around a quarter of RA patients are treated with GCs in the United Kingdom in accordance with European recommendations, they observed.

Conflicting randomized and observational findings on whether or not osteoporotic fractures might be linked to the use of low-dose GCs prompted Dr. Abtahi and associates to see if there were any signals in real-world data. To do so, they used data one of the world’s largest primary care databases – the Clinical Practice Research Datalink (CPRD), which consists of anonymized patient data from a network of primary care practices across the United Kingdom.

Altogether, the records of more than 15,000 patients with RA aged 50 years and older who were held in the CRPD between 1997 and 2017 were pulled for analysis, and just half (n = 7,039) were receiving or had received GC therapy. Low-dose GC therapy was defined as a prednisolone equivalent dose (PED) of 7.5 mg or less per day.

The use of low-dose GCs use during three key time periods was considered: within the past 6 months (current users), within the past 7-12 months (recent users), and within the past year (past users).

The analyses involved time-dependent Cox proportional-hazards models to look for associations between GC use and all types of osteoporotic fracture, including the risk for incident hip, vertebral, humeral, forearm, pelvis, and rib fractures. They were adjusted for various lifestyle parameters, comorbidities, and the use of other medications.

“Current GC use was further broken down into subcategories based on average daily and cumulative dose,” Dr. Abtahi observed. As might be expected, doses even lower than 7.5 mg or less PED did not increase the chance of any osteoporotic fracture but there was an increased risk for some types with higher average daily doses, notably at the hip and pelvis, as well as the spine.

“Low-dose oral GC therapy was associated with an increased risk of clinical vertebral fracture, while the risk of other individual OP fracture sites was not increased,” said the team, adding that the main results remained unchanged regardless of short- or long-term use.

“We know that vertebral fracture risk is markedly increased in RA, and it is well known that GC therapy in particular affects trabecular bone, which is abundantly present in lumbar vertebrae,” Dr. Abtahi wrote.

“Therefore, we can hypothesize that the beneficial effect of low-dose GC therapy on suppressing the background inflammation of RA could probably be enough to offset its negative effect on bone synthesis in most fracture sites but not in vertebrae,” they suggested.

One of the limitations of the study is that the researchers lacked data on the disease activity of the patients or if they were being treated with biologic therapy. This means that confounding by disease severity might be an issue with only those with higher disease activity being treated with GCs and thus were at higher risk for fractures.

“Another limitation was a potential misclassification of exposure with oral GCs, as we had only prescribing information from CPRD, which is roughly two steps behind actual drug use by patients,” the researchers conceded. The average duration of GC use was estimated at 3.7 years, which is an indication of actual use.

A detection bias may also be involved with regard to vertebral fractures, with complaints of back pain maybe being discussed more often when prescribing GCs, leading to more referrals for possible fracture assessment.

Dr. Abtahi and a fellow coauthor disclosed receiving research and other funding from several pharmaceutical companies unrelated to this study. All other coauthors had no conflicts of interest.

Patients with rheumatoid arthritis currently being treated with low doses of oral glucocorticoids (GCs) had a 59% increased risk of sustaining a vertebral fracture when compared with past users, results of a retrospective cohort study have shown.

izusek/Getty Images

Although the overall risk of an osteoporotic fracture was not increased when comparing current and past GC users, with a hazard ratio of 1.14 (95% confidence interval, 0.98-1.33), the HR for sustaining a spinal fracture was 1.59 (95% CI, 1.11-2.29).

“Clinicians should be aware that, even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased,” Shahab Abtahi, MD, of Maastricht (the Netherlands) University and coauthors reported in Rheumatology.

This is important considering around a quarter of RA patients are treated with GCs in the United Kingdom in accordance with European recommendations, they observed.

Conflicting randomized and observational findings on whether or not osteoporotic fractures might be linked to the use of low-dose GCs prompted Dr. Abtahi and associates to see if there were any signals in real-world data. To do so, they used data one of the world’s largest primary care databases – the Clinical Practice Research Datalink (CPRD), which consists of anonymized patient data from a network of primary care practices across the United Kingdom.

Altogether, the records of more than 15,000 patients with RA aged 50 years and older who were held in the CRPD between 1997 and 2017 were pulled for analysis, and just half (n = 7,039) were receiving or had received GC therapy. Low-dose GC therapy was defined as a prednisolone equivalent dose (PED) of 7.5 mg or less per day.

The use of low-dose GCs use during three key time periods was considered: within the past 6 months (current users), within the past 7-12 months (recent users), and within the past year (past users).

The analyses involved time-dependent Cox proportional-hazards models to look for associations between GC use and all types of osteoporotic fracture, including the risk for incident hip, vertebral, humeral, forearm, pelvis, and rib fractures. They were adjusted for various lifestyle parameters, comorbidities, and the use of other medications.

“Current GC use was further broken down into subcategories based on average daily and cumulative dose,” Dr. Abtahi observed. As might be expected, doses even lower than 7.5 mg or less PED did not increase the chance of any osteoporotic fracture but there was an increased risk for some types with higher average daily doses, notably at the hip and pelvis, as well as the spine.

“Low-dose oral GC therapy was associated with an increased risk of clinical vertebral fracture, while the risk of other individual OP fracture sites was not increased,” said the team, adding that the main results remained unchanged regardless of short- or long-term use.

“We know that vertebral fracture risk is markedly increased in RA, and it is well known that GC therapy in particular affects trabecular bone, which is abundantly present in lumbar vertebrae,” Dr. Abtahi wrote.

“Therefore, we can hypothesize that the beneficial effect of low-dose GC therapy on suppressing the background inflammation of RA could probably be enough to offset its negative effect on bone synthesis in most fracture sites but not in vertebrae,” they suggested.

One of the limitations of the study is that the researchers lacked data on the disease activity of the patients or if they were being treated with biologic therapy. This means that confounding by disease severity might be an issue with only those with higher disease activity being treated with GCs and thus were at higher risk for fractures.

“Another limitation was a potential misclassification of exposure with oral GCs, as we had only prescribing information from CPRD, which is roughly two steps behind actual drug use by patients,” the researchers conceded. The average duration of GC use was estimated at 3.7 years, which is an indication of actual use.

A detection bias may also be involved with regard to vertebral fractures, with complaints of back pain maybe being discussed more often when prescribing GCs, leading to more referrals for possible fracture assessment.

Dr. Abtahi and a fellow coauthor disclosed receiving research and other funding from several pharmaceutical companies unrelated to this study. All other coauthors had no conflicts of interest.

Patients with rheumatoid arthritis currently being treated with low doses of oral glucocorticoids (GCs) had a 59% increased risk of sustaining a vertebral fracture when compared with past users, results of a retrospective cohort study have shown.

izusek/Getty Images

Although the overall risk of an osteoporotic fracture was not increased when comparing current and past GC users, with a hazard ratio of 1.14 (95% confidence interval, 0.98-1.33), the HR for sustaining a spinal fracture was 1.59 (95% CI, 1.11-2.29).

“Clinicians should be aware that, even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased,” Shahab Abtahi, MD, of Maastricht (the Netherlands) University and coauthors reported in Rheumatology.

This is important considering around a quarter of RA patients are treated with GCs in the United Kingdom in accordance with European recommendations, they observed.

Conflicting randomized and observational findings on whether or not osteoporotic fractures might be linked to the use of low-dose GCs prompted Dr. Abtahi and associates to see if there were any signals in real-world data. To do so, they used data one of the world’s largest primary care databases – the Clinical Practice Research Datalink (CPRD), which consists of anonymized patient data from a network of primary care practices across the United Kingdom.

Altogether, the records of more than 15,000 patients with RA aged 50 years and older who were held in the CRPD between 1997 and 2017 were pulled for analysis, and just half (n = 7,039) were receiving or had received GC therapy. Low-dose GC therapy was defined as a prednisolone equivalent dose (PED) of 7.5 mg or less per day.

The use of low-dose GCs use during three key time periods was considered: within the past 6 months (current users), within the past 7-12 months (recent users), and within the past year (past users).

The analyses involved time-dependent Cox proportional-hazards models to look for associations between GC use and all types of osteoporotic fracture, including the risk for incident hip, vertebral, humeral, forearm, pelvis, and rib fractures. They were adjusted for various lifestyle parameters, comorbidities, and the use of other medications.

“Current GC use was further broken down into subcategories based on average daily and cumulative dose,” Dr. Abtahi observed. As might be expected, doses even lower than 7.5 mg or less PED did not increase the chance of any osteoporotic fracture but there was an increased risk for some types with higher average daily doses, notably at the hip and pelvis, as well as the spine.

“Low-dose oral GC therapy was associated with an increased risk of clinical vertebral fracture, while the risk of other individual OP fracture sites was not increased,” said the team, adding that the main results remained unchanged regardless of short- or long-term use.

“We know that vertebral fracture risk is markedly increased in RA, and it is well known that GC therapy in particular affects trabecular bone, which is abundantly present in lumbar vertebrae,” Dr. Abtahi wrote.

“Therefore, we can hypothesize that the beneficial effect of low-dose GC therapy on suppressing the background inflammation of RA could probably be enough to offset its negative effect on bone synthesis in most fracture sites but not in vertebrae,” they suggested.

One of the limitations of the study is that the researchers lacked data on the disease activity of the patients or if they were being treated with biologic therapy. This means that confounding by disease severity might be an issue with only those with higher disease activity being treated with GCs and thus were at higher risk for fractures.

“Another limitation was a potential misclassification of exposure with oral GCs, as we had only prescribing information from CPRD, which is roughly two steps behind actual drug use by patients,” the researchers conceded. The average duration of GC use was estimated at 3.7 years, which is an indication of actual use.

A detection bias may also be involved with regard to vertebral fractures, with complaints of back pain maybe being discussed more often when prescribing GCs, leading to more referrals for possible fracture assessment.

Dr. Abtahi and a fellow coauthor disclosed receiving research and other funding from several pharmaceutical companies unrelated to this study. All other coauthors had no conflicts of interest.

Bicycle riding may help people with diabetes live longer, new research suggests.

NicolasMcComber/E+/Getty Images

Among more than 7,000 adults with diabetes in 10 Western European countries followed for about 15 years, those who cycled regularly were significantly less likely to die of any cause or of cardiovascular causes, even after accounting for differences in factors such as sex, age, educational level, diet, comorbidities, and other physical activities.

“The association between cycling and all-cause and CVD [cardiovascular disease] mortality in this study of person[s] with diabetes was of the same magnitude and direction as observed in the healthy population,” wrote Mathias Ried-Larsen, PhD, of the Centre for Physical Activity Research, Rigshospitalet, Copenhagen, and colleagues. The findings were published online July 19, 2021, in JAMA Internal Medicine.

In an accompanying Editor’s Note, JAMA Internal Medicine editor Rita F. Redberg, MD, and two deputy editors said that the new data add to previous studies showing benefits of cycling, compared with other physical activities. “The analysis from Ried-Larsen and colleagues strengthens the epidemiologic data on cycling and strongly suggests that it may contribute directly to longer and healthier lives,” they wrote.

Dr. Redberg, of the University of California, San Francisco, told this news organization: “I think the number of cyclists grew greatly during pandemic, when there was little auto traffic, and people did not want to take public transportation. Cities that add bike lanes, especially protected bike lanes, see an increase in cyclists. I think Americans can cycle more, would enjoy cycling more, and would live longer [by] cycling, to work and for pleasure.”

Dr. Redberg disclosed that she is “an avid cyclist and am currently on a bike ride in Glacier National Park. ... This group [Climate Ride] raises money for more bike lanes, promotes climate change awareness, has paid for solar panels at Glacier, and more.”

However, Dr. Redberg and colleagues also “recognize that cycling requires fitness, a good sense of balance, and the means to purchase a bicycle. We also understand that regular cycling requires living in an area where it is reasonably safe, and we celebrate the installation of more bike lanes, particularly protected lanes, in many cities around the world.”

But, despite the limitations of an observational study and possible selection bias of people who are able to cycle, “it is important to share this evidence for the potentially large health benefits of cycling, which almost surely generalize to persons without diabetes.”
 

Cycling tied to lower all-cause and CVD mortality

The prospective cohort study included 7,459 adults with diabetes from the European Prospective Investigation into Cancer and Nutrition. All were assessed during 1992-1998 and again in 1996-2011, with a mean follow-up of roughly 15 years. During that time, there were 1,673 deaths from all causes, with 811 attributed to CVD.

Compared with no cycling, those who reported any cycling had a 24% lower risk of death from any cause over a 5-year period, after adjustment for confounders and for other physical activity. The greatest risk reduction was seen in those who reported cycling between 150-299 minutes per week, particularly in CVD mortality.

In a subanalysis of 5,423 individuals with 10.7 years of follow-up, there were 975 all-cause deaths and 429 from CVD. Individuals who began or continued cycling during follow-up experienced reductions of about 35% for both all-cause and CVD mortality, compared with those who never cycled.

Dr. Redberg and colleagues added that “there are environmental benefits to increasing the use of cycling for commuting and other transport because cycling helps to decrease the adverse environmental and health effects of automobile exhaust.”

They concluded: “As avid and/or aspiring cyclists ourselves, we are sold on the mental and physical benefits of getting to work and seeing the world on two wheels, self-propelled, and think it is well worth a try.”

The study work was supported by the Health Research Fund of Instituto de Salud Carlos III; the Spanish regional governments of Andalucía, Asturias, Basque Country, Murcia, and Navarra; and the Catalan Institute of Oncology. The Centre for Physical Activity Research is supported by a grant from TrygFonden. Dr. Ried-Larsen reported personal fees from Novo Nordisk. Dr. Redberg reported receiving grants from Arnold Ventures; the Greenwall Foundation; and the National Heart, Lung, and Blood Institute.

Bicycle riding may help people with diabetes live longer, new research suggests.

NicolasMcComber/E+/Getty Images

Among more than 7,000 adults with diabetes in 10 Western European countries followed for about 15 years, those who cycled regularly were significantly less likely to die of any cause or of cardiovascular causes, even after accounting for differences in factors such as sex, age, educational level, diet, comorbidities, and other physical activities.

“The association between cycling and all-cause and CVD [cardiovascular disease] mortality in this study of person[s] with diabetes was of the same magnitude and direction as observed in the healthy population,” wrote Mathias Ried-Larsen, PhD, of the Centre for Physical Activity Research, Rigshospitalet, Copenhagen, and colleagues. The findings were published online July 19, 2021, in JAMA Internal Medicine.

In an accompanying Editor’s Note, JAMA Internal Medicine editor Rita F. Redberg, MD, and two deputy editors said that the new data add to previous studies showing benefits of cycling, compared with other physical activities. “The analysis from Ried-Larsen and colleagues strengthens the epidemiologic data on cycling and strongly suggests that it may contribute directly to longer and healthier lives,” they wrote.

Dr. Redberg, of the University of California, San Francisco, told this news organization: “I think the number of cyclists grew greatly during pandemic, when there was little auto traffic, and people did not want to take public transportation. Cities that add bike lanes, especially protected bike lanes, see an increase in cyclists. I think Americans can cycle more, would enjoy cycling more, and would live longer [by] cycling, to work and for pleasure.”

Dr. Redberg disclosed that she is “an avid cyclist and am currently on a bike ride in Glacier National Park. ... This group [Climate Ride] raises money for more bike lanes, promotes climate change awareness, has paid for solar panels at Glacier, and more.”

However, Dr. Redberg and colleagues also “recognize that cycling requires fitness, a good sense of balance, and the means to purchase a bicycle. We also understand that regular cycling requires living in an area where it is reasonably safe, and we celebrate the installation of more bike lanes, particularly protected lanes, in many cities around the world.”

But, despite the limitations of an observational study and possible selection bias of people who are able to cycle, “it is important to share this evidence for the potentially large health benefits of cycling, which almost surely generalize to persons without diabetes.”
 

Cycling tied to lower all-cause and CVD mortality

The prospective cohort study included 7,459 adults with diabetes from the European Prospective Investigation into Cancer and Nutrition. All were assessed during 1992-1998 and again in 1996-2011, with a mean follow-up of roughly 15 years. During that time, there were 1,673 deaths from all causes, with 811 attributed to CVD.

Compared with no cycling, those who reported any cycling had a 24% lower risk of death from any cause over a 5-year period, after adjustment for confounders and for other physical activity. The greatest risk reduction was seen in those who reported cycling between 150-299 minutes per week, particularly in CVD mortality.

In a subanalysis of 5,423 individuals with 10.7 years of follow-up, there were 975 all-cause deaths and 429 from CVD. Individuals who began or continued cycling during follow-up experienced reductions of about 35% for both all-cause and CVD mortality, compared with those who never cycled.

Dr. Redberg and colleagues added that “there are environmental benefits to increasing the use of cycling for commuting and other transport because cycling helps to decrease the adverse environmental and health effects of automobile exhaust.”

They concluded: “As avid and/or aspiring cyclists ourselves, we are sold on the mental and physical benefits of getting to work and seeing the world on two wheels, self-propelled, and think it is well worth a try.”

The study work was supported by the Health Research Fund of Instituto de Salud Carlos III; the Spanish regional governments of Andalucía, Asturias, Basque Country, Murcia, and Navarra; and the Catalan Institute of Oncology. The Centre for Physical Activity Research is supported by a grant from TrygFonden. Dr. Ried-Larsen reported personal fees from Novo Nordisk. Dr. Redberg reported receiving grants from Arnold Ventures; the Greenwall Foundation; and the National Heart, Lung, and Blood Institute.

Bicycle riding may help people with diabetes live longer, new research suggests.

NicolasMcComber/E+/Getty Images

Among more than 7,000 adults with diabetes in 10 Western European countries followed for about 15 years, those who cycled regularly were significantly less likely to die of any cause or of cardiovascular causes, even after accounting for differences in factors such as sex, age, educational level, diet, comorbidities, and other physical activities.

“The association between cycling and all-cause and CVD [cardiovascular disease] mortality in this study of person[s] with diabetes was of the same magnitude and direction as observed in the healthy population,” wrote Mathias Ried-Larsen, PhD, of the Centre for Physical Activity Research, Rigshospitalet, Copenhagen, and colleagues. The findings were published online July 19, 2021, in JAMA Internal Medicine.

In an accompanying Editor’s Note, JAMA Internal Medicine editor Rita F. Redberg, MD, and two deputy editors said that the new data add to previous studies showing benefits of cycling, compared with other physical activities. “The analysis from Ried-Larsen and colleagues strengthens the epidemiologic data on cycling and strongly suggests that it may contribute directly to longer and healthier lives,” they wrote.

Dr. Redberg, of the University of California, San Francisco, told this news organization: “I think the number of cyclists grew greatly during pandemic, when there was little auto traffic, and people did not want to take public transportation. Cities that add bike lanes, especially protected bike lanes, see an increase in cyclists. I think Americans can cycle more, would enjoy cycling more, and would live longer [by] cycling, to work and for pleasure.”

Dr. Redberg disclosed that she is “an avid cyclist and am currently on a bike ride in Glacier National Park. ... This group [Climate Ride] raises money for more bike lanes, promotes climate change awareness, has paid for solar panels at Glacier, and more.”

However, Dr. Redberg and colleagues also “recognize that cycling requires fitness, a good sense of balance, and the means to purchase a bicycle. We also understand that regular cycling requires living in an area where it is reasonably safe, and we celebrate the installation of more bike lanes, particularly protected lanes, in many cities around the world.”

But, despite the limitations of an observational study and possible selection bias of people who are able to cycle, “it is important to share this evidence for the potentially large health benefits of cycling, which almost surely generalize to persons without diabetes.”
 

Cycling tied to lower all-cause and CVD mortality

The prospective cohort study included 7,459 adults with diabetes from the European Prospective Investigation into Cancer and Nutrition. All were assessed during 1992-1998 and again in 1996-2011, with a mean follow-up of roughly 15 years. During that time, there were 1,673 deaths from all causes, with 811 attributed to CVD.

Compared with no cycling, those who reported any cycling had a 24% lower risk of death from any cause over a 5-year period, after adjustment for confounders and for other physical activity. The greatest risk reduction was seen in those who reported cycling between 150-299 minutes per week, particularly in CVD mortality.

In a subanalysis of 5,423 individuals with 10.7 years of follow-up, there were 975 all-cause deaths and 429 from CVD. Individuals who began or continued cycling during follow-up experienced reductions of about 35% for both all-cause and CVD mortality, compared with those who never cycled.

Dr. Redberg and colleagues added that “there are environmental benefits to increasing the use of cycling for commuting and other transport because cycling helps to decrease the adverse environmental and health effects of automobile exhaust.”

They concluded: “As avid and/or aspiring cyclists ourselves, we are sold on the mental and physical benefits of getting to work and seeing the world on two wheels, self-propelled, and think it is well worth a try.”

The study work was supported by the Health Research Fund of Instituto de Salud Carlos III; the Spanish regional governments of Andalucía, Asturias, Basque Country, Murcia, and Navarra; and the Catalan Institute of Oncology. The Centre for Physical Activity Research is supported by a grant from TrygFonden. Dr. Ried-Larsen reported personal fees from Novo Nordisk. Dr. Redberg reported receiving grants from Arnold Ventures; the Greenwall Foundation; and the National Heart, Lung, and Blood Institute.

Dear big-tech AI company,

Perhaps artificial intelligence is “the most profound technology that humanity will ever develop and work on,” as Google CEO Sundar Pichai recently said. If that’s true, can you please find a way to help us physicians?

I do understand, the benefits of artificial intelligence today are already profound and protean. Thanks to AI, I can translate Italian to English in real time in the same voice as an Italian speaker. I can be driven home autonomously by our Tesla. AI helps keep me safe by predicting crimes, on time by predicting traffic, and healthy by designing plant proteins that taste just like beef. I can even use AI to build a sprinkler to keep people off my new lawn.

In medicine, the AI news is so good that a frisson of excitement spreads vertically and horizontally across all health care. AI can detect pulmonary nodules, identify melanomas, develop new drugs – speed vaccine discovery! – and detect malignant cells on a biopsy slide. It can help predict who is going to crash in the ICU and recognize when someone is about to fall out of bed in the surgical unit. Even just this sampling of benefits proves how significant and impactful AI is in improving quality of life for patients and populations.

However, much of what I do every day in medicine cannot be solved with a neat quantitative analysis. The vast majority of my patients do not have a melanoma to be diagnosed or diabetic retinopathy to be scanned. What they want and need is time spent with me, their doctor. Although the schedule says I have 15 minutes (insufficient to begin with), patients are running late and are double booked, and I’ve loads of notes to type, medications to review, and messages to answer. Most days, I have only a fraction of 15 minutes to spend face to face with each patient.

Can AI please help us? How about reviewing the reams of data from my patient’s chart and presenting it to me succinctly? Rather than my tediously clicking through pathology reports, just summarize what skin cancers my patient has had and when. Rather than learning that my patient already failed Protopic a year ago, let me know that before I sign the order and promise: “Now, this ointment will work.” Even better, suggest alternative treatments that I might not be thinking of and which might do just the trick. Oh, and given my EMR has all the data required to determine billing codes, can you just drop that in for me when I’m done? Lastly, if the patient’s insurance is going to reject this claim or that medication, can AI please complete the authorization/paperwork/signed notary document/letter from U.S. senator that will be needed for it to be accepted?

I know this is possible. If we can blast a 70-year-old businessman into space on a private jet, surely you can invent an AI that gives us more time to spend with patients. Proposals postmarked by Dec. 31, 2021, please.


I’m sincerely yours,

Jeff Benabio, MD, MBA
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Dear big-tech AI company,

Perhaps artificial intelligence is “the most profound technology that humanity will ever develop and work on,” as Google CEO Sundar Pichai recently said. If that’s true, can you please find a way to help us physicians?

I do understand, the benefits of artificial intelligence today are already profound and protean. Thanks to AI, I can translate Italian to English in real time in the same voice as an Italian speaker. I can be driven home autonomously by our Tesla. AI helps keep me safe by predicting crimes, on time by predicting traffic, and healthy by designing plant proteins that taste just like beef. I can even use AI to build a sprinkler to keep people off my new lawn.

In medicine, the AI news is so good that a frisson of excitement spreads vertically and horizontally across all health care. AI can detect pulmonary nodules, identify melanomas, develop new drugs – speed vaccine discovery! – and detect malignant cells on a biopsy slide. It can help predict who is going to crash in the ICU and recognize when someone is about to fall out of bed in the surgical unit. Even just this sampling of benefits proves how significant and impactful AI is in improving quality of life for patients and populations.

However, much of what I do every day in medicine cannot be solved with a neat quantitative analysis. The vast majority of my patients do not have a melanoma to be diagnosed or diabetic retinopathy to be scanned. What they want and need is time spent with me, their doctor. Although the schedule says I have 15 minutes (insufficient to begin with), patients are running late and are double booked, and I’ve loads of notes to type, medications to review, and messages to answer. Most days, I have only a fraction of 15 minutes to spend face to face with each patient.

Can AI please help us? How about reviewing the reams of data from my patient’s chart and presenting it to me succinctly? Rather than my tediously clicking through pathology reports, just summarize what skin cancers my patient has had and when. Rather than learning that my patient already failed Protopic a year ago, let me know that before I sign the order and promise: “Now, this ointment will work.” Even better, suggest alternative treatments that I might not be thinking of and which might do just the trick. Oh, and given my EMR has all the data required to determine billing codes, can you just drop that in for me when I’m done? Lastly, if the patient’s insurance is going to reject this claim or that medication, can AI please complete the authorization/paperwork/signed notary document/letter from U.S. senator that will be needed for it to be accepted?

I know this is possible. If we can blast a 70-year-old businessman into space on a private jet, surely you can invent an AI that gives us more time to spend with patients. Proposals postmarked by Dec. 31, 2021, please.


I’m sincerely yours,

Jeff Benabio, MD, MBA
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Dear big-tech AI company,

Perhaps artificial intelligence is “the most profound technology that humanity will ever develop and work on,” as Google CEO Sundar Pichai recently said. If that’s true, can you please find a way to help us physicians?

I do understand, the benefits of artificial intelligence today are already profound and protean. Thanks to AI, I can translate Italian to English in real time in the same voice as an Italian speaker. I can be driven home autonomously by our Tesla. AI helps keep me safe by predicting crimes, on time by predicting traffic, and healthy by designing plant proteins that taste just like beef. I can even use AI to build a sprinkler to keep people off my new lawn.

In medicine, the AI news is so good that a frisson of excitement spreads vertically and horizontally across all health care. AI can detect pulmonary nodules, identify melanomas, develop new drugs – speed vaccine discovery! – and detect malignant cells on a biopsy slide. It can help predict who is going to crash in the ICU and recognize when someone is about to fall out of bed in the surgical unit. Even just this sampling of benefits proves how significant and impactful AI is in improving quality of life for patients and populations.

However, much of what I do every day in medicine cannot be solved with a neat quantitative analysis. The vast majority of my patients do not have a melanoma to be diagnosed or diabetic retinopathy to be scanned. What they want and need is time spent with me, their doctor. Although the schedule says I have 15 minutes (insufficient to begin with), patients are running late and are double booked, and I’ve loads of notes to type, medications to review, and messages to answer. Most days, I have only a fraction of 15 minutes to spend face to face with each patient.

Can AI please help us? How about reviewing the reams of data from my patient’s chart and presenting it to me succinctly? Rather than my tediously clicking through pathology reports, just summarize what skin cancers my patient has had and when. Rather than learning that my patient already failed Protopic a year ago, let me know that before I sign the order and promise: “Now, this ointment will work.” Even better, suggest alternative treatments that I might not be thinking of and which might do just the trick. Oh, and given my EMR has all the data required to determine billing codes, can you just drop that in for me when I’m done? Lastly, if the patient’s insurance is going to reject this claim or that medication, can AI please complete the authorization/paperwork/signed notary document/letter from U.S. senator that will be needed for it to be accepted?

I know this is possible. If we can blast a 70-year-old businessman into space on a private jet, surely you can invent an AI that gives us more time to spend with patients. Proposals postmarked by Dec. 31, 2021, please.


I’m sincerely yours,

Jeff Benabio, MD, MBA
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Martin D. Greenberg, MD, was sued in May for secretly using his own sperm to inseminate one of his infertility patients 38 years earlier. The patient’s daughter found out last year when she used a DNA test from 23andme to learn about her family history. The 77-year-old New York gynecologist is retired in Florida.

Dr. Greenberg is one of more than 30 U.S. physicians who have so far been identified as having used their own sperm without telling their patients, and more cases are likely. All but one of the cases took place before 1990. Most of them came to light in the past few years, when biological offspring found out from home DNA tests.

“It is a gross betrayal of the trust that a patient puts in her doctor. It is an absolute perversion of the practice of medicine,” said Dev Sethi, a plaintiff attorney who sued a Tucson, Ariz., physician who inseminated at least 10 patients with his own sperm. “The hubris of a doctor to impregnate his own patient, in some effort to either save money or populate the world with his offspring, is striking.”

Why would these physicians use their own sperm and then keep it secret? Why were there so many of them? When their offspring now try to communicate with them, do they want to have a relationship? And how do they react when they’re found out?

The doctors’ behavior mystifies Sigal Klipstein, MD, a reproductive endocrinologist in Hoffman Estates, Ill., who is chair of the ethics committee of the American Society for Reproductive Medicine.

“These doctors lived with secrets for many years. How do you live with that as a doctor?” said Dr. Klipstein, who was still in high school when most of these cases occurred. “It surprises me that anybody would do this.”
 

Lack of training and lots of secrecy

Were these physicians particularly selfish or egotistical? Or was expedience the prime motivation?

At the time, there was little training in the techniques and ethics of infertility care, said Jody Madeira, JD, PhD, a law professor at Indiana University, Bloomington, who has closely studied the doctors.

“Many of them were ob.gyns., but they did not take CME courses for this work,” she said. The subspecialty of reproductive endocrinology and infertility was just beginning in the early 1970s, according an ASRM spokesman.

Treatment of infertility was a rather hush-hush topic at that time, which made it easier to be deceptive. In 1955, an Illinois court held that artificial insemination constituted adultery. “The social stigma resulting from the practice forces the parents to keep secret the infant’s origin,” a law review article from 1955 stated.

“In the 1950s and 1960s and even into the 1970s and 1980s, infertility treatments were considered shameful, and patients were often advised to keep their treatment to themselves,” Dr. Madeira said. “With everything so secret, it was easy to be deceptive.”

The field has become more sophisticated since then, Dr. Klipstein said. “For known donors, there is a legal contract between the recipient and donor. And it is no longer possible to be an anonymous donor. People can find you through DNA tests.”

Owing to changes in the field as well as the growing likelihood of being caught through DNA tests, most experts believe that rampant infertility fraud ended long ago.
 

How they were found out

When the doctors were active, there was little risk of being exposed. In those times, paternity tests were based on broad factors such as blood type and were unreliable. More accurate DNA tests were underway, but the doctors’ offspring did not think of using them because they suspected nothing.

Most of the doctors’ deeds only came to light with the rise of a new industry – home DNA testing for people who are curious about their family background. First came 23andme in 2007, then Ancestry.com in 2015. The number of people being tested reached almost 2 million in 2016, 7 million in 2017, and 30 million in 2020.

As more people entered company databases, it became easier to pinpoint biological fathers through other relatives. This explains how doctors who had not taken a home DNA test were identified.

The home tests have been shown to be highly accurate. None of the results for doctors accused of using their own sperm have proven to be false, and courts recognize similar DNA tests as proof of paternity.

But when found out, many of the physicians disputed the results and acted as if they could still keep their secret. “I don’t deny it; I don’t admit it,” Paul Brennan Jones, MD, a Colorado doctor, said when he was accused of siring eight children through his infertility patients decades before. Asked whether he would provide a DNA sample, the 80-year-old doctor responded: “No ... because I don’t want to have any incriminating evidence against me.”
 

How often did it happen?

Donor Deceived, a website that monitors these cases, reports 32 cases of physicians surreptitiously providing sperm to their patients. Eleven of the doctors are linked to 1 known offspring, two are linked to more than 75 offspring, one to 15, one to 10, three to 9, three to 7, and two to 5.

“It’s unlikely that any of the doctors did it just once,” said Adam B. Wolf, a San Francisco attorney who is representing the plaintiff in the Greenberg case. “It’s happened before. When doctors get the idea to do something crazy, they do it multiple times.”

Mr. Wolf believes that, because most people haven’t taken a DNA test, there are many more biological children of infertility doctors who have yet to come forward.

Many of the doctors who were found out have negotiated settlements with patients, under which they pay undisclosed sums of money in exchange for the patient’s keeping silent. Mr. Wolf said that, of the two dozen victims of sperm-donor doctors his law firm has represented, all but three have settled.

“We give an opportunity to the doctor to resolve the claims without having to publicly out this person for using his own sperm in his patients,” Mr. Wolf said. “Most doctors jump at the opportunity to not be known as the kind of person who would do that.”

Cases about to go to trial have been withdrawn because of being settled. In May, a case against Gerald E. Mortimer, MD, in Idaho, was dismissed after 3 years of litigation. The judge had made some key decisions that made it less likely that Dr. Mortimer would win. Dr. Mortimer’s biological daughter filed the initial case. She alleged medical negligence, failure to obtain informed consent, fraud, battery, intentional infliction of emotional distress, and several other causes of action.

Dr. Madeira objects to the use of confidential settlements, because other offspring cannot be alerted. But she also believes that, as more people find out about their parentage through DNA tests, it will be harder for accused doctors to make confidential settlements with all of them, and the doctors will eventually be identified.

In settlements, offspring ask for the medical histories of these doctors. So far, offspring have linked the development of Tay-Sachs disease, cystic fibrosis, and ovarian cancer with these doctors.
 

Denial: Physicians’ most frequent reaction

Once identified, most of the doctors denied the charge. When Gary Phillip Wood, MD, of Arkansas, was tracked down by his biological son, Dr. Wood insisted he had had a vasectomy years before the man was born but still would not agree to a DNA test. He died in April 2021.

None of the identified sperm doctors were interested in having a relationship with their newly identified offspring. When Gary Vandenberg, MD, of California, was contacted by his biological daughter, he abruptly ended the conversation, wishing her “good luck in life,” she recalled. “When I first found out, I was very suicidal. I did not want this existence. I still have those days. My husband had to take off work and stay home quite a bit to make sure I didn’t do anything to myself.”

When Gary Don Davis, MD, of Idaho, was asked about his paternity, he replied: “Let me check on that. Goodbye.” He could not be reached after that, and he died a few months later.

The accused doctors often have no medical records of their work. Dr. Wood said that all his records had been destroyed, and Dr. Greenberg said he did not have any records on his accuser and doubted that he had ever treated her. A 1977 survey found that more than half of infertility doctors did not keep any medical records so as to preserve the donor’s anonymity.

Many of the accused doctors said they used their own sperm because they were deeply committed to helping their patients. At one physician’s trial, his defense attorney said: “If Cecil made any mistakes, it was in losing his objectivity and trying so hard to get patients pregnant.”
 

Was it really ethically wrong?

Many of the doctors don’t accept that they did any harm, says Julie D. Cantor, MD, JD, a former adjunct professor at the University of California, Los Angeles. “These doctors seemed to be thinking: ‘The patient wanted to get pregnant and have a baby, and that’s what happened, so no harm done.’ But the entire interaction is based on a lie.”

The doctors also had the problem of having to use fresh sperm rather than frozen sperm, as is used today. Sperm had to be used within hours of being produced. If the donor did not show up at the time of the appointment, the doctor might decide to keep the appointment with the patient anyway and provide his own sperm.

However, “these doctors didn’t have to use their own sperm,” Mr. Wolf said. “They could have rescheduled the appointment until a new donor could be found.”

Some say that the doctors seemed to have had a very high opinion of themselves and their own sperm. “Some of them had savior complexes,” Dr. Madeira said. “They seemed to be thinking: ‘I’m giving the gift of life, and I’m the only one who can really do it, because I have great genes.’ ”

When Kim McMorries, MD, of Texas, was confronted with the fact that he had donated sperm 33 years before, he insisted that it was ethical at the time. “When this occurred, it was not considered wrong,” he wrote in an email to his biological daughter.

Today, doctors are bound by the doctrine of informed consent, which holds that patients should be informed about all steps taken in their care. The term was coined by a judge in 1960, and it took some time for some in the medical world to fully accept informed consent. Still, Dr. Madeira asserts it was always unethical to secretly fertilize patients.

“Even in the more paternalistic era of the 1970s and 1980s, it was not right to lie to your patients about such an important part of their lives,” she said.

Some sperm doctors insisted that they had received informed consent when the patient agreed to use an anonymous donor. “Dr. Kiken did that which he was asked to do,” wrote the attorneys for Michael S. Kiken, MD, of Virginia. “Anonymous donor meant that the patient would not know the donor’s identity, he would be anonymous to her.”

Dr. Madeira does not accept this argument either. “The doctor may have thought it was understood that he could be the anonymous person, but the patients did not see it that way,” she said. “They were not expecting the anonymous donor would be their own doctor.”

“I think what happened is a crime,” said Dr. Klipstein. “It’s an ethical violation, a fracture in the trust between doctor and patient.”

Existing laws, however, don’t make it easy to prosecute the doctors. When lawsuits are filed against these doctors, “you have to shoehorn existing statutes to fit the facts, and that may not be a terrific fit,” Dr. Cantor said.

The doctors have been charged with battery, fraud, negligence, breach of duty, unjust enrichment, and rape. But none of them have been found guilty specifically of secretly using their own sperm. Two of the doctors were convicted, but for other offenses, such as perjury for denying their involvement.

Since 2019, five states – Arizona, Colorado, Florida, Indiana, and Texas – have passed statutes specifically outlawing infertility fraud. In addition, a 1995 California law requires identifying the sperm donor.

It may be difficult, however, to apply these new laws to offenses by aging sperm doctors that happened decades ago. “Some states have inflexible limits on the amount of time in which you can sue, even if you didn’t know about the problem until recently,” Dr. Madeira said. “Texas, for example, allows civil lawsuits only up to 10 years after commission.”

Before the fertility fraud physicians can be brought to justice, many of them might just fade away.

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

Martin D. Greenberg, MD, was sued in May for secretly using his own sperm to inseminate one of his infertility patients 38 years earlier. The patient’s daughter found out last year when she used a DNA test from 23andme to learn about her family history. The 77-year-old New York gynecologist is retired in Florida.

Dr. Greenberg is one of more than 30 U.S. physicians who have so far been identified as having used their own sperm without telling their patients, and more cases are likely. All but one of the cases took place before 1990. Most of them came to light in the past few years, when biological offspring found out from home DNA tests.

“It is a gross betrayal of the trust that a patient puts in her doctor. It is an absolute perversion of the practice of medicine,” said Dev Sethi, a plaintiff attorney who sued a Tucson, Ariz., physician who inseminated at least 10 patients with his own sperm. “The hubris of a doctor to impregnate his own patient, in some effort to either save money or populate the world with his offspring, is striking.”

Why would these physicians use their own sperm and then keep it secret? Why were there so many of them? When their offspring now try to communicate with them, do they want to have a relationship? And how do they react when they’re found out?

The doctors’ behavior mystifies Sigal Klipstein, MD, a reproductive endocrinologist in Hoffman Estates, Ill., who is chair of the ethics committee of the American Society for Reproductive Medicine.

“These doctors lived with secrets for many years. How do you live with that as a doctor?” said Dr. Klipstein, who was still in high school when most of these cases occurred. “It surprises me that anybody would do this.”
 

Lack of training and lots of secrecy

Were these physicians particularly selfish or egotistical? Or was expedience the prime motivation?

At the time, there was little training in the techniques and ethics of infertility care, said Jody Madeira, JD, PhD, a law professor at Indiana University, Bloomington, who has closely studied the doctors.

“Many of them were ob.gyns., but they did not take CME courses for this work,” she said. The subspecialty of reproductive endocrinology and infertility was just beginning in the early 1970s, according an ASRM spokesman.

Treatment of infertility was a rather hush-hush topic at that time, which made it easier to be deceptive. In 1955, an Illinois court held that artificial insemination constituted adultery. “The social stigma resulting from the practice forces the parents to keep secret the infant’s origin,” a law review article from 1955 stated.

“In the 1950s and 1960s and even into the 1970s and 1980s, infertility treatments were considered shameful, and patients were often advised to keep their treatment to themselves,” Dr. Madeira said. “With everything so secret, it was easy to be deceptive.”

The field has become more sophisticated since then, Dr. Klipstein said. “For known donors, there is a legal contract between the recipient and donor. And it is no longer possible to be an anonymous donor. People can find you through DNA tests.”

Owing to changes in the field as well as the growing likelihood of being caught through DNA tests, most experts believe that rampant infertility fraud ended long ago.
 

How they were found out

When the doctors were active, there was little risk of being exposed. In those times, paternity tests were based on broad factors such as blood type and were unreliable. More accurate DNA tests were underway, but the doctors’ offspring did not think of using them because they suspected nothing.

Most of the doctors’ deeds only came to light with the rise of a new industry – home DNA testing for people who are curious about their family background. First came 23andme in 2007, then Ancestry.com in 2015. The number of people being tested reached almost 2 million in 2016, 7 million in 2017, and 30 million in 2020.

As more people entered company databases, it became easier to pinpoint biological fathers through other relatives. This explains how doctors who had not taken a home DNA test were identified.

The home tests have been shown to be highly accurate. None of the results for doctors accused of using their own sperm have proven to be false, and courts recognize similar DNA tests as proof of paternity.

But when found out, many of the physicians disputed the results and acted as if they could still keep their secret. “I don’t deny it; I don’t admit it,” Paul Brennan Jones, MD, a Colorado doctor, said when he was accused of siring eight children through his infertility patients decades before. Asked whether he would provide a DNA sample, the 80-year-old doctor responded: “No ... because I don’t want to have any incriminating evidence against me.”
 

How often did it happen?

Donor Deceived, a website that monitors these cases, reports 32 cases of physicians surreptitiously providing sperm to their patients. Eleven of the doctors are linked to 1 known offspring, two are linked to more than 75 offspring, one to 15, one to 10, three to 9, three to 7, and two to 5.

“It’s unlikely that any of the doctors did it just once,” said Adam B. Wolf, a San Francisco attorney who is representing the plaintiff in the Greenberg case. “It’s happened before. When doctors get the idea to do something crazy, they do it multiple times.”

Mr. Wolf believes that, because most people haven’t taken a DNA test, there are many more biological children of infertility doctors who have yet to come forward.

Many of the doctors who were found out have negotiated settlements with patients, under which they pay undisclosed sums of money in exchange for the patient’s keeping silent. Mr. Wolf said that, of the two dozen victims of sperm-donor doctors his law firm has represented, all but three have settled.

“We give an opportunity to the doctor to resolve the claims without having to publicly out this person for using his own sperm in his patients,” Mr. Wolf said. “Most doctors jump at the opportunity to not be known as the kind of person who would do that.”

Cases about to go to trial have been withdrawn because of being settled. In May, a case against Gerald E. Mortimer, MD, in Idaho, was dismissed after 3 years of litigation. The judge had made some key decisions that made it less likely that Dr. Mortimer would win. Dr. Mortimer’s biological daughter filed the initial case. She alleged medical negligence, failure to obtain informed consent, fraud, battery, intentional infliction of emotional distress, and several other causes of action.

Dr. Madeira objects to the use of confidential settlements, because other offspring cannot be alerted. But she also believes that, as more people find out about their parentage through DNA tests, it will be harder for accused doctors to make confidential settlements with all of them, and the doctors will eventually be identified.

In settlements, offspring ask for the medical histories of these doctors. So far, offspring have linked the development of Tay-Sachs disease, cystic fibrosis, and ovarian cancer with these doctors.
 

Denial: Physicians’ most frequent reaction

Once identified, most of the doctors denied the charge. When Gary Phillip Wood, MD, of Arkansas, was tracked down by his biological son, Dr. Wood insisted he had had a vasectomy years before the man was born but still would not agree to a DNA test. He died in April 2021.

None of the identified sperm doctors were interested in having a relationship with their newly identified offspring. When Gary Vandenberg, MD, of California, was contacted by his biological daughter, he abruptly ended the conversation, wishing her “good luck in life,” she recalled. “When I first found out, I was very suicidal. I did not want this existence. I still have those days. My husband had to take off work and stay home quite a bit to make sure I didn’t do anything to myself.”

When Gary Don Davis, MD, of Idaho, was asked about his paternity, he replied: “Let me check on that. Goodbye.” He could not be reached after that, and he died a few months later.

The accused doctors often have no medical records of their work. Dr. Wood said that all his records had been destroyed, and Dr. Greenberg said he did not have any records on his accuser and doubted that he had ever treated her. A 1977 survey found that more than half of infertility doctors did not keep any medical records so as to preserve the donor’s anonymity.

Many of the accused doctors said they used their own sperm because they were deeply committed to helping their patients. At one physician’s trial, his defense attorney said: “If Cecil made any mistakes, it was in losing his objectivity and trying so hard to get patients pregnant.”
 

Was it really ethically wrong?

Many of the doctors don’t accept that they did any harm, says Julie D. Cantor, MD, JD, a former adjunct professor at the University of California, Los Angeles. “These doctors seemed to be thinking: ‘The patient wanted to get pregnant and have a baby, and that’s what happened, so no harm done.’ But the entire interaction is based on a lie.”

The doctors also had the problem of having to use fresh sperm rather than frozen sperm, as is used today. Sperm had to be used within hours of being produced. If the donor did not show up at the time of the appointment, the doctor might decide to keep the appointment with the patient anyway and provide his own sperm.

However, “these doctors didn’t have to use their own sperm,” Mr. Wolf said. “They could have rescheduled the appointment until a new donor could be found.”

Some say that the doctors seemed to have had a very high opinion of themselves and their own sperm. “Some of them had savior complexes,” Dr. Madeira said. “They seemed to be thinking: ‘I’m giving the gift of life, and I’m the only one who can really do it, because I have great genes.’ ”

When Kim McMorries, MD, of Texas, was confronted with the fact that he had donated sperm 33 years before, he insisted that it was ethical at the time. “When this occurred, it was not considered wrong,” he wrote in an email to his biological daughter.

Today, doctors are bound by the doctrine of informed consent, which holds that patients should be informed about all steps taken in their care. The term was coined by a judge in 1960, and it took some time for some in the medical world to fully accept informed consent. Still, Dr. Madeira asserts it was always unethical to secretly fertilize patients.

“Even in the more paternalistic era of the 1970s and 1980s, it was not right to lie to your patients about such an important part of their lives,” she said.

Some sperm doctors insisted that they had received informed consent when the patient agreed to use an anonymous donor. “Dr. Kiken did that which he was asked to do,” wrote the attorneys for Michael S. Kiken, MD, of Virginia. “Anonymous donor meant that the patient would not know the donor’s identity, he would be anonymous to her.”

Dr. Madeira does not accept this argument either. “The doctor may have thought it was understood that he could be the anonymous person, but the patients did not see it that way,” she said. “They were not expecting the anonymous donor would be their own doctor.”

“I think what happened is a crime,” said Dr. Klipstein. “It’s an ethical violation, a fracture in the trust between doctor and patient.”

Existing laws, however, don’t make it easy to prosecute the doctors. When lawsuits are filed against these doctors, “you have to shoehorn existing statutes to fit the facts, and that may not be a terrific fit,” Dr. Cantor said.

The doctors have been charged with battery, fraud, negligence, breach of duty, unjust enrichment, and rape. But none of them have been found guilty specifically of secretly using their own sperm. Two of the doctors were convicted, but for other offenses, such as perjury for denying their involvement.

Since 2019, five states – Arizona, Colorado, Florida, Indiana, and Texas – have passed statutes specifically outlawing infertility fraud. In addition, a 1995 California law requires identifying the sperm donor.

It may be difficult, however, to apply these new laws to offenses by aging sperm doctors that happened decades ago. “Some states have inflexible limits on the amount of time in which you can sue, even if you didn’t know about the problem until recently,” Dr. Madeira said. “Texas, for example, allows civil lawsuits only up to 10 years after commission.”

Before the fertility fraud physicians can be brought to justice, many of them might just fade away.

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

Martin D. Greenberg, MD, was sued in May for secretly using his own sperm to inseminate one of his infertility patients 38 years earlier. The patient’s daughter found out last year when she used a DNA test from 23andme to learn about her family history. The 77-year-old New York gynecologist is retired in Florida.

Dr. Greenberg is one of more than 30 U.S. physicians who have so far been identified as having used their own sperm without telling their patients, and more cases are likely. All but one of the cases took place before 1990. Most of them came to light in the past few years, when biological offspring found out from home DNA tests.

“It is a gross betrayal of the trust that a patient puts in her doctor. It is an absolute perversion of the practice of medicine,” said Dev Sethi, a plaintiff attorney who sued a Tucson, Ariz., physician who inseminated at least 10 patients with his own sperm. “The hubris of a doctor to impregnate his own patient, in some effort to either save money or populate the world with his offspring, is striking.”

Why would these physicians use their own sperm and then keep it secret? Why were there so many of them? When their offspring now try to communicate with them, do they want to have a relationship? And how do they react when they’re found out?

The doctors’ behavior mystifies Sigal Klipstein, MD, a reproductive endocrinologist in Hoffman Estates, Ill., who is chair of the ethics committee of the American Society for Reproductive Medicine.

“These doctors lived with secrets for many years. How do you live with that as a doctor?” said Dr. Klipstein, who was still in high school when most of these cases occurred. “It surprises me that anybody would do this.”
 

Lack of training and lots of secrecy

Were these physicians particularly selfish or egotistical? Or was expedience the prime motivation?

At the time, there was little training in the techniques and ethics of infertility care, said Jody Madeira, JD, PhD, a law professor at Indiana University, Bloomington, who has closely studied the doctors.

“Many of them were ob.gyns., but they did not take CME courses for this work,” she said. The subspecialty of reproductive endocrinology and infertility was just beginning in the early 1970s, according an ASRM spokesman.

Treatment of infertility was a rather hush-hush topic at that time, which made it easier to be deceptive. In 1955, an Illinois court held that artificial insemination constituted adultery. “The social stigma resulting from the practice forces the parents to keep secret the infant’s origin,” a law review article from 1955 stated.

“In the 1950s and 1960s and even into the 1970s and 1980s, infertility treatments were considered shameful, and patients were often advised to keep their treatment to themselves,” Dr. Madeira said. “With everything so secret, it was easy to be deceptive.”

The field has become more sophisticated since then, Dr. Klipstein said. “For known donors, there is a legal contract between the recipient and donor. And it is no longer possible to be an anonymous donor. People can find you through DNA tests.”

Owing to changes in the field as well as the growing likelihood of being caught through DNA tests, most experts believe that rampant infertility fraud ended long ago.
 

How they were found out

When the doctors were active, there was little risk of being exposed. In those times, paternity tests were based on broad factors such as blood type and were unreliable. More accurate DNA tests were underway, but the doctors’ offspring did not think of using them because they suspected nothing.

Most of the doctors’ deeds only came to light with the rise of a new industry – home DNA testing for people who are curious about their family background. First came 23andme in 2007, then Ancestry.com in 2015. The number of people being tested reached almost 2 million in 2016, 7 million in 2017, and 30 million in 2020.

As more people entered company databases, it became easier to pinpoint biological fathers through other relatives. This explains how doctors who had not taken a home DNA test were identified.

The home tests have been shown to be highly accurate. None of the results for doctors accused of using their own sperm have proven to be false, and courts recognize similar DNA tests as proof of paternity.

But when found out, many of the physicians disputed the results and acted as if they could still keep their secret. “I don’t deny it; I don’t admit it,” Paul Brennan Jones, MD, a Colorado doctor, said when he was accused of siring eight children through his infertility patients decades before. Asked whether he would provide a DNA sample, the 80-year-old doctor responded: “No ... because I don’t want to have any incriminating evidence against me.”
 

How often did it happen?

Donor Deceived, a website that monitors these cases, reports 32 cases of physicians surreptitiously providing sperm to their patients. Eleven of the doctors are linked to 1 known offspring, two are linked to more than 75 offspring, one to 15, one to 10, three to 9, three to 7, and two to 5.

“It’s unlikely that any of the doctors did it just once,” said Adam B. Wolf, a San Francisco attorney who is representing the plaintiff in the Greenberg case. “It’s happened before. When doctors get the idea to do something crazy, they do it multiple times.”

Mr. Wolf believes that, because most people haven’t taken a DNA test, there are many more biological children of infertility doctors who have yet to come forward.

Many of the doctors who were found out have negotiated settlements with patients, under which they pay undisclosed sums of money in exchange for the patient’s keeping silent. Mr. Wolf said that, of the two dozen victims of sperm-donor doctors his law firm has represented, all but three have settled.

“We give an opportunity to the doctor to resolve the claims without having to publicly out this person for using his own sperm in his patients,” Mr. Wolf said. “Most doctors jump at the opportunity to not be known as the kind of person who would do that.”

Cases about to go to trial have been withdrawn because of being settled. In May, a case against Gerald E. Mortimer, MD, in Idaho, was dismissed after 3 years of litigation. The judge had made some key decisions that made it less likely that Dr. Mortimer would win. Dr. Mortimer’s biological daughter filed the initial case. She alleged medical negligence, failure to obtain informed consent, fraud, battery, intentional infliction of emotional distress, and several other causes of action.

Dr. Madeira objects to the use of confidential settlements, because other offspring cannot be alerted. But she also believes that, as more people find out about their parentage through DNA tests, it will be harder for accused doctors to make confidential settlements with all of them, and the doctors will eventually be identified.

In settlements, offspring ask for the medical histories of these doctors. So far, offspring have linked the development of Tay-Sachs disease, cystic fibrosis, and ovarian cancer with these doctors.
 

Denial: Physicians’ most frequent reaction

Once identified, most of the doctors denied the charge. When Gary Phillip Wood, MD, of Arkansas, was tracked down by his biological son, Dr. Wood insisted he had had a vasectomy years before the man was born but still would not agree to a DNA test. He died in April 2021.

None of the identified sperm doctors were interested in having a relationship with their newly identified offspring. When Gary Vandenberg, MD, of California, was contacted by his biological daughter, he abruptly ended the conversation, wishing her “good luck in life,” she recalled. “When I first found out, I was very suicidal. I did not want this existence. I still have those days. My husband had to take off work and stay home quite a bit to make sure I didn’t do anything to myself.”

When Gary Don Davis, MD, of Idaho, was asked about his paternity, he replied: “Let me check on that. Goodbye.” He could not be reached after that, and he died a few months later.

The accused doctors often have no medical records of their work. Dr. Wood said that all his records had been destroyed, and Dr. Greenberg said he did not have any records on his accuser and doubted that he had ever treated her. A 1977 survey found that more than half of infertility doctors did not keep any medical records so as to preserve the donor’s anonymity.

Many of the accused doctors said they used their own sperm because they were deeply committed to helping their patients. At one physician’s trial, his defense attorney said: “If Cecil made any mistakes, it was in losing his objectivity and trying so hard to get patients pregnant.”
 

Was it really ethically wrong?

Many of the doctors don’t accept that they did any harm, says Julie D. Cantor, MD, JD, a former adjunct professor at the University of California, Los Angeles. “These doctors seemed to be thinking: ‘The patient wanted to get pregnant and have a baby, and that’s what happened, so no harm done.’ But the entire interaction is based on a lie.”

The doctors also had the problem of having to use fresh sperm rather than frozen sperm, as is used today. Sperm had to be used within hours of being produced. If the donor did not show up at the time of the appointment, the doctor might decide to keep the appointment with the patient anyway and provide his own sperm.

However, “these doctors didn’t have to use their own sperm,” Mr. Wolf said. “They could have rescheduled the appointment until a new donor could be found.”

Some say that the doctors seemed to have had a very high opinion of themselves and their own sperm. “Some of them had savior complexes,” Dr. Madeira said. “They seemed to be thinking: ‘I’m giving the gift of life, and I’m the only one who can really do it, because I have great genes.’ ”

When Kim McMorries, MD, of Texas, was confronted with the fact that he had donated sperm 33 years before, he insisted that it was ethical at the time. “When this occurred, it was not considered wrong,” he wrote in an email to his biological daughter.

Today, doctors are bound by the doctrine of informed consent, which holds that patients should be informed about all steps taken in their care. The term was coined by a judge in 1960, and it took some time for some in the medical world to fully accept informed consent. Still, Dr. Madeira asserts it was always unethical to secretly fertilize patients.

“Even in the more paternalistic era of the 1970s and 1980s, it was not right to lie to your patients about such an important part of their lives,” she said.

Some sperm doctors insisted that they had received informed consent when the patient agreed to use an anonymous donor. “Dr. Kiken did that which he was asked to do,” wrote the attorneys for Michael S. Kiken, MD, of Virginia. “Anonymous donor meant that the patient would not know the donor’s identity, he would be anonymous to her.”

Dr. Madeira does not accept this argument either. “The doctor may have thought it was understood that he could be the anonymous person, but the patients did not see it that way,” she said. “They were not expecting the anonymous donor would be their own doctor.”

“I think what happened is a crime,” said Dr. Klipstein. “It’s an ethical violation, a fracture in the trust between doctor and patient.”

Existing laws, however, don’t make it easy to prosecute the doctors. When lawsuits are filed against these doctors, “you have to shoehorn existing statutes to fit the facts, and that may not be a terrific fit,” Dr. Cantor said.

The doctors have been charged with battery, fraud, negligence, breach of duty, unjust enrichment, and rape. But none of them have been found guilty specifically of secretly using their own sperm. Two of the doctors were convicted, but for other offenses, such as perjury for denying their involvement.

Since 2019, five states – Arizona, Colorado, Florida, Indiana, and Texas – have passed statutes specifically outlawing infertility fraud. In addition, a 1995 California law requires identifying the sperm donor.

It may be difficult, however, to apply these new laws to offenses by aging sperm doctors that happened decades ago. “Some states have inflexible limits on the amount of time in which you can sue, even if you didn’t know about the problem until recently,” Dr. Madeira said. “Texas, for example, allows civil lawsuits only up to 10 years after commission.”

Before the fertility fraud physicians can be brought to justice, many of them might just fade away.

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