Rheumatology News

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

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

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

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

About one-third of U.S. adults struggled with medical debt during the pandemic, according to data from a Commonwealth Fund survey released July 16.

Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.

The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.

For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.

“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.

“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.

Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.

Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.

“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.

When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.

According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.

George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.

“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”

He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.

“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”

For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.

Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.

“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”

Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.

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

A Tennessee woman is suing a family physician and physician assistant (PA) after her husband’s death from COVID-19, claiming the health providers failed to properly test the man and rendered improper care that led to his demise.

Shirley Dimoh of Memphis alleges her husband Peter Dimoh, 66, received inadequate care when he presented with COVID-19 symptoms to May Medical Group in Munford, Tenn., on November 19, 2020. Physician assistant Robert Moody ordered a COVID-19 blood test for Mr. Dimoh, rather than a nasal swab test, which was sent to an Atlanta lab for analysis, according to the lawsuit.

By the time the Dimohs were informed of the positive result on November 23, Mr. Dimoh was seriously ill and showed signs of severe infection, the claim alleges. Family physician David Krapf, DO, then prescribed methocarbamol, a muscle relaxant, which the complaint claims exacerbated Mr. Dimoh’s infection, caused serious adverse reactions, and led to his death on December 16, 2020.

“Mr. Dimoh had multiple comorbid conditions and he had a positive test, he should have been referred to a specialist at a higher level of care,” said Duncan E. Ragsdale, a Memphis-based attorney representing Shirley Dimoh. “This is not something for a family physician or a physician assistant to be attempting to handle. It’s my belief this was a preventable death.”

Shirley Dimoh filed a lawsuit against May Medical Group, Moody, Krapf, and several others on June 23, 2021, in the Circuit Court of Tennessee, 13th Judicial District. She accuses the group of negligence, failure to refer, and failure to supervise, among other claims. She is requesting $5 million in damages.

May Medical Group did not return phone or email messages seeking comment for this story. The group had not issued a reply to the lawsuit as of this article’s deadline. An attorney for the practice is not yet listed in court records.
 

Wife had COVID-19 first, treated by same PA

Shirley Dimoh was the first of the couple to contract COVID-19. She visited May Medical Group with COVID-19 symptoms on November 9, according to the lawsuit. The same physician assistant allegedly prescribed antibiotics and sent Shirley Dimoh to the health department for a rapid nasal swab test. After a positive test resulted, she was prescribed more antibiotics, steroids, and other medications, according to the claim. She recovered without complications.

The plaintiff alleges the medical practice did not warn Peter Dimoh of the risk of contracting COVID-19 from contact with Shirley Dimoh or offer prophylactics against infection. Peter Dimoh had underlying conditions that included diabetes and kidney failure, according to Mr. Ragsdale.

It’s unclear why Peter Dimoh may have been prescribed methocarbamol after his positive COVID-19 test on November 23. The same day, Shirley Dimoh went to the pharmacy to pick up her husband’s prescription because he was too sick to go himself, the complaint states. Mr. Dimoh took the medication three times a day as prescribed. The methocarbamol was “unreasonably dangerous” for Mr. Dimoh at the time and caused an injury he would have not incurred otherwise, the suit claims.

On November 28, Mr. Dimoh collapsed and was taken by ambulance to Methodist Hospital in Memphis. He was treated for COVID-19 as well as bacterial pneumonia, severe sepsis, and sytemic inflammatory response syndrome, according to the complaint. He died December 16 from respiratory and heart failure.

“What’s interesting about this case is that you’ve got a good example and a bad example together,” Mr. Ragsdale said. “In other words, the good example is they treated her appropriately, she recovered. They didn’t treat him at all, he died. I don’t know how you could have a better counter position established by the same practice.”
 

Family has sued for malpractice before

Before his death, Peter Dimoh was the plaintiff in another medical negligence suit. In 2013, he sued the Center for Oral and Facial Surgery of Memphis and two oral surgeons for allegedly operating on him improperly and causing an adverse outcome.  

Mr. Dimoh underwent oral surgery on February 8, 2012, at the center. The day of his operation, Mr. Dimoh’s A1c and glucose levels were grossly elevated, according to the claim, which was also represented by Mr. Ragsdale. Surgeons concluded, incorrectly, that Mr. Dimoh’s diabetes was under control, the complaint alleges, failed to order preoperative antibiotics, operated on him, and caused a bacterial infection at the operative site. The infection allegedly resulted in osteomyelitis of Mr. Dimoh’s left mandible with a pathologic fracture.

The complaint also alleges that although Mr. Dimoh signed a consent form for the surgery, the defendants failed to obtain his consent because they were unaware his diabetes was not under control and they did not explain the risks of surgery while in such a condition. The suit alleges lack of informed consent, negligence, and gross negligence by the practice and requests $2 million in damages. 

Court documents show the suit was voluntarily withdrawn in 2018 without prejudice and reissued in 2019. In January 2021, the court was given notice of Mr. Dimoh’s death, and a motion was made to substitute another plaintiff, according to Shelby County court records.

An attorney for the Center for Oral and Facial Surgery of Memphis did not return a message seeking comment.

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

A Tennessee woman is suing a family physician and physician assistant (PA) after her husband’s death from COVID-19, claiming the health providers failed to properly test the man and rendered improper care that led to his demise.

Shirley Dimoh of Memphis alleges her husband Peter Dimoh, 66, received inadequate care when he presented with COVID-19 symptoms to May Medical Group in Munford, Tenn., on November 19, 2020. Physician assistant Robert Moody ordered a COVID-19 blood test for Mr. Dimoh, rather than a nasal swab test, which was sent to an Atlanta lab for analysis, according to the lawsuit.

By the time the Dimohs were informed of the positive result on November 23, Mr. Dimoh was seriously ill and showed signs of severe infection, the claim alleges. Family physician David Krapf, DO, then prescribed methocarbamol, a muscle relaxant, which the complaint claims exacerbated Mr. Dimoh’s infection, caused serious adverse reactions, and led to his death on December 16, 2020.

“Mr. Dimoh had multiple comorbid conditions and he had a positive test, he should have been referred to a specialist at a higher level of care,” said Duncan E. Ragsdale, a Memphis-based attorney representing Shirley Dimoh. “This is not something for a family physician or a physician assistant to be attempting to handle. It’s my belief this was a preventable death.”

Shirley Dimoh filed a lawsuit against May Medical Group, Moody, Krapf, and several others on June 23, 2021, in the Circuit Court of Tennessee, 13th Judicial District. She accuses the group of negligence, failure to refer, and failure to supervise, among other claims. She is requesting $5 million in damages.

May Medical Group did not return phone or email messages seeking comment for this story. The group had not issued a reply to the lawsuit as of this article’s deadline. An attorney for the practice is not yet listed in court records.
 

Wife had COVID-19 first, treated by same PA

Shirley Dimoh was the first of the couple to contract COVID-19. She visited May Medical Group with COVID-19 symptoms on November 9, according to the lawsuit. The same physician assistant allegedly prescribed antibiotics and sent Shirley Dimoh to the health department for a rapid nasal swab test. After a positive test resulted, she was prescribed more antibiotics, steroids, and other medications, according to the claim. She recovered without complications.

The plaintiff alleges the medical practice did not warn Peter Dimoh of the risk of contracting COVID-19 from contact with Shirley Dimoh or offer prophylactics against infection. Peter Dimoh had underlying conditions that included diabetes and kidney failure, according to Mr. Ragsdale.

It’s unclear why Peter Dimoh may have been prescribed methocarbamol after his positive COVID-19 test on November 23. The same day, Shirley Dimoh went to the pharmacy to pick up her husband’s prescription because he was too sick to go himself, the complaint states. Mr. Dimoh took the medication three times a day as prescribed. The methocarbamol was “unreasonably dangerous” for Mr. Dimoh at the time and caused an injury he would have not incurred otherwise, the suit claims.

On November 28, Mr. Dimoh collapsed and was taken by ambulance to Methodist Hospital in Memphis. He was treated for COVID-19 as well as bacterial pneumonia, severe sepsis, and sytemic inflammatory response syndrome, according to the complaint. He died December 16 from respiratory and heart failure.

“What’s interesting about this case is that you’ve got a good example and a bad example together,” Mr. Ragsdale said. “In other words, the good example is they treated her appropriately, she recovered. They didn’t treat him at all, he died. I don’t know how you could have a better counter position established by the same practice.”
 

Family has sued for malpractice before

Before his death, Peter Dimoh was the plaintiff in another medical negligence suit. In 2013, he sued the Center for Oral and Facial Surgery of Memphis and two oral surgeons for allegedly operating on him improperly and causing an adverse outcome.  

Mr. Dimoh underwent oral surgery on February 8, 2012, at the center. The day of his operation, Mr. Dimoh’s A1c and glucose levels were grossly elevated, according to the claim, which was also represented by Mr. Ragsdale. Surgeons concluded, incorrectly, that Mr. Dimoh’s diabetes was under control, the complaint alleges, failed to order preoperative antibiotics, operated on him, and caused a bacterial infection at the operative site. The infection allegedly resulted in osteomyelitis of Mr. Dimoh’s left mandible with a pathologic fracture.

The complaint also alleges that although Mr. Dimoh signed a consent form for the surgery, the defendants failed to obtain his consent because they were unaware his diabetes was not under control and they did not explain the risks of surgery while in such a condition. The suit alleges lack of informed consent, negligence, and gross negligence by the practice and requests $2 million in damages. 

Court documents show the suit was voluntarily withdrawn in 2018 without prejudice and reissued in 2019. In January 2021, the court was given notice of Mr. Dimoh’s death, and a motion was made to substitute another plaintiff, according to Shelby County court records.

An attorney for the Center for Oral and Facial Surgery of Memphis did not return a message seeking comment.

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

A Tennessee woman is suing a family physician and physician assistant (PA) after her husband’s death from COVID-19, claiming the health providers failed to properly test the man and rendered improper care that led to his demise.

Shirley Dimoh of Memphis alleges her husband Peter Dimoh, 66, received inadequate care when he presented with COVID-19 symptoms to May Medical Group in Munford, Tenn., on November 19, 2020. Physician assistant Robert Moody ordered a COVID-19 blood test for Mr. Dimoh, rather than a nasal swab test, which was sent to an Atlanta lab for analysis, according to the lawsuit.

By the time the Dimohs were informed of the positive result on November 23, Mr. Dimoh was seriously ill and showed signs of severe infection, the claim alleges. Family physician David Krapf, DO, then prescribed methocarbamol, a muscle relaxant, which the complaint claims exacerbated Mr. Dimoh’s infection, caused serious adverse reactions, and led to his death on December 16, 2020.

“Mr. Dimoh had multiple comorbid conditions and he had a positive test, he should have been referred to a specialist at a higher level of care,” said Duncan E. Ragsdale, a Memphis-based attorney representing Shirley Dimoh. “This is not something for a family physician or a physician assistant to be attempting to handle. It’s my belief this was a preventable death.”

Shirley Dimoh filed a lawsuit against May Medical Group, Moody, Krapf, and several others on June 23, 2021, in the Circuit Court of Tennessee, 13th Judicial District. She accuses the group of negligence, failure to refer, and failure to supervise, among other claims. She is requesting $5 million in damages.

May Medical Group did not return phone or email messages seeking comment for this story. The group had not issued a reply to the lawsuit as of this article’s deadline. An attorney for the practice is not yet listed in court records.
 

Wife had COVID-19 first, treated by same PA

Shirley Dimoh was the first of the couple to contract COVID-19. She visited May Medical Group with COVID-19 symptoms on November 9, according to the lawsuit. The same physician assistant allegedly prescribed antibiotics and sent Shirley Dimoh to the health department for a rapid nasal swab test. After a positive test resulted, she was prescribed more antibiotics, steroids, and other medications, according to the claim. She recovered without complications.

The plaintiff alleges the medical practice did not warn Peter Dimoh of the risk of contracting COVID-19 from contact with Shirley Dimoh or offer prophylactics against infection. Peter Dimoh had underlying conditions that included diabetes and kidney failure, according to Mr. Ragsdale.

It’s unclear why Peter Dimoh may have been prescribed methocarbamol after his positive COVID-19 test on November 23. The same day, Shirley Dimoh went to the pharmacy to pick up her husband’s prescription because he was too sick to go himself, the complaint states. Mr. Dimoh took the medication three times a day as prescribed. The methocarbamol was “unreasonably dangerous” for Mr. Dimoh at the time and caused an injury he would have not incurred otherwise, the suit claims.

On November 28, Mr. Dimoh collapsed and was taken by ambulance to Methodist Hospital in Memphis. He was treated for COVID-19 as well as bacterial pneumonia, severe sepsis, and sytemic inflammatory response syndrome, according to the complaint. He died December 16 from respiratory and heart failure.

“What’s interesting about this case is that you’ve got a good example and a bad example together,” Mr. Ragsdale said. “In other words, the good example is they treated her appropriately, she recovered. They didn’t treat him at all, he died. I don’t know how you could have a better counter position established by the same practice.”
 

Family has sued for malpractice before

Before his death, Peter Dimoh was the plaintiff in another medical negligence suit. In 2013, he sued the Center for Oral and Facial Surgery of Memphis and two oral surgeons for allegedly operating on him improperly and causing an adverse outcome.  

Mr. Dimoh underwent oral surgery on February 8, 2012, at the center. The day of his operation, Mr. Dimoh’s A1c and glucose levels were grossly elevated, according to the claim, which was also represented by Mr. Ragsdale. Surgeons concluded, incorrectly, that Mr. Dimoh’s diabetes was under control, the complaint alleges, failed to order preoperative antibiotics, operated on him, and caused a bacterial infection at the operative site. The infection allegedly resulted in osteomyelitis of Mr. Dimoh’s left mandible with a pathologic fracture.

The complaint also alleges that although Mr. Dimoh signed a consent form for the surgery, the defendants failed to obtain his consent because they were unaware his diabetes was not under control and they did not explain the risks of surgery while in such a condition. The suit alleges lack of informed consent, negligence, and gross negligence by the practice and requests $2 million in damages. 

Court documents show the suit was voluntarily withdrawn in 2018 without prejudice and reissued in 2019. In January 2021, the court was given notice of Mr. Dimoh’s death, and a motion was made to substitute another plaintiff, according to Shelby County court records.

An attorney for the Center for Oral and Facial Surgery of Memphis did not return a message seeking comment.

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

With COVID, the fun never ends

Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!

sabelskaya/iStock/Getty Images Plus

Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”

Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.

Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.

Joe: Sounds like communism to me, Tony. I’ll say Cuba.

Tony: Sorry Joe, that’s incorrect. Don?

Don: The friends and families sound like freedom-loving Americans, so it must be America.

Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?

Joe: That’s fake news, Tony. It’s gotta be false.

Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.

Don: That’s bulls#&@! I won this thing! I’ll see you in court!
 

More money, more life

Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.

utah778/Thinkstock

Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.

“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.

But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.

We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
 

Holding the ‘health care and wellness’ gun

Cigarettes are not good for us. We know this.

seanika/ThinkStock

It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.

Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.

Philip Morris International is actually leaning hard into nonsmoking means of tobacco consumption, even going so far as to brand itself a “health care and wellness company” on a mission to “unsmoke the world.” And if those aren’t egregious business euphemisms, we don’t know what is.

Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?

So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.

Okay, we lied, it’s the second one.
 

Autopsy of the living dead

Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.

Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.

It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.

Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
 

With COVID, the fun never ends

Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!

sabelskaya/iStock/Getty Images Plus

Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”

Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.

Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.

Joe: Sounds like communism to me, Tony. I’ll say Cuba.

Tony: Sorry Joe, that’s incorrect. Don?

Don: The friends and families sound like freedom-loving Americans, so it must be America.

Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?

Joe: That’s fake news, Tony. It’s gotta be false.

Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.

Don: That’s bulls#&@! I won this thing! I’ll see you in court!
 

More money, more life

Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.

utah778/Thinkstock

Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.

“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.

But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.

We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
 

Holding the ‘health care and wellness’ gun

Cigarettes are not good for us. We know this.

seanika/ThinkStock

It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.

Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.

Philip Morris International is actually leaning hard into nonsmoking means of tobacco consumption, even going so far as to brand itself a “health care and wellness company” on a mission to “unsmoke the world.” And if those aren’t egregious business euphemisms, we don’t know what is.

Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?

So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.

Okay, we lied, it’s the second one.
 

Autopsy of the living dead

Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.

Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.

It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.

Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
 

With COVID, the fun never ends

Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!

sabelskaya/iStock/Getty Images Plus

Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”

Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.

Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.

Joe: Sounds like communism to me, Tony. I’ll say Cuba.

Tony: Sorry Joe, that’s incorrect. Don?

Don: The friends and families sound like freedom-loving Americans, so it must be America.

Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?

Joe: That’s fake news, Tony. It’s gotta be false.

Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.

Don: That’s bulls#&@! I won this thing! I’ll see you in court!
 

More money, more life

Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.

utah778/Thinkstock

Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.

“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.

But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.

We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
 

Holding the ‘health care and wellness’ gun

Cigarettes are not good for us. We know this.

seanika/ThinkStock

It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.

Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.

Philip Morris International is actually leaning hard into nonsmoking means of tobacco consumption, even going so far as to brand itself a “health care and wellness company” on a mission to “unsmoke the world.” And if those aren’t egregious business euphemisms, we don’t know what is.

Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?

So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.

Okay, we lied, it’s the second one.
 

Autopsy of the living dead

Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.

Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.

It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.

Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
 

Drinking six or more cups of coffee per day is associated with smaller brain volume and a 53% increased risk for dementia compared with light coffee consumption (1-2 cups per day), according to the results of a large study.

amenic181/Getty Images

“With coffee intake, moderation is the key, and especially high levels of consumption may have adverse long-term effects on the brain,” said study investigator Elina Hypponen, PhD, professor of nutritional and genetic epidemiology and director of the Australian Center for Precision Health at the University of South Australia.

“These new data are concerning, and there is a need to conduct further carefully controlled studies to clarify the effects of coffee on the brain.”

The study was published online June 24 in Nutritional Neuroscience.
 

Potent stimulant

Coffee is a potent nervous system stimulant and is among the most popular nonalcoholic beverages. Some previous research suggests it benefits the brain, but the investigators noted that other research shows a negative or U-shaped relationship.

To investigate, the researchers examined data from the U.K. Biobank, a long-term prospective epidemiologic study of more than 500,000 participants aged 37-73 years who were recruited in 22 assessment centers in the United Kingdom between March 2006 and October 2010.

During the baseline assessment, information was gathered using touchscreen questionnaires, verbal interviews, and physical examinations that involved collection of blood, urine, and saliva samples. An imaging substudy was incorporated in 2014, the goal of which was to conduct brain, heart, and body MRI imaging for 100,000 participants.

The investigators conducted analyses on disease outcomes for 398,646 participants for whom information on habitual coffee consumption was available. Brain volume analyses were conducted in 17,702 participants for whom valid brain imaging data were available.

Participants reported coffee intake in cups per day. Researchers grouped coffee consumption into seven categories: nondrinkers, decaffeinated coffee drinkers, and caffeinated coffee drinkers who consumed less than 1 cup/d, 1-2 cups/d, 3-4 cups/d, 5-6 cups/d, and more than 6 cups/d.

The reference category was those who consumed 1-2 cups/d, rather than those who abstained from coffee, because persons who abstain are more likely to be at suboptimal health.

“Comparing the health of coffee drinkers to the health of those choosing to abstain from coffee will typically lead to an impression of a health benefit, even if there would not be one,” said Dr. Hypponen.

The researchers obtained total and regional brain volumes from the MRI imaging substudy starting 4-6 years after baseline assessment. They accessed information on incident dementia and stroke using primary care data, hospital admission electronic health records, national death registers, and self-reported medical conditions.

Covariates included socioeconomic, health, and other factors, such as smoking, alcohol and tea consumption, physical activity, stressful life events, and body mass index.

The investigators found that there was a linear inverse association between coffee consumption and total brain volume (fully adjusted beta per cup, –1.42; 95% confidence interval, –1.89 to –0.94), with consistent patterns for gray matter, white matter, and hippocampal volumes.

There was no evidence to support an association with white matter hyperintensity (WMH) volume (beta –0.01; 95% CI, –0.07 to 0.05).
 

Higher consumption, higher risk

The analysis also revealed a nonlinear association between coffee consumption and the odds of dementia (P nonlinearity = .0001), with slightly higher odds seen with non–coffee drinkers and decaffeinated-coffee drinkers and more notable increases for participants in the highest categories of coffee consumption compared with light coffee drinkers.

After adjustment for all covariates, the odds ratio of dementia among persons in the category of coffee intake was 1.53 (95% CI, 1.28-1.83). After full adjustments, the association with heavy coffee consumption and stroke was not significant, although “we can’t exclude a weak effect,” said Dr. Hypponen.

“For the highest coffee consumption group, the data support an association which may be anywhere from 0% to 37% higher odds of stroke after full adjustment,” she added.

People at risk for hypertension may develop “unpleasant sensations” and stop drinking coffee before a serious adverse event occurs, said Dr. Hypponen. In a previous study, she and her colleagues showed that those who have genetically higher blood pressure tend to drink less coffee than their counterparts without the condition.

“This type of effect might be expected to naturally limit the adverse effects of coffee on the risk of stroke,” said Dr. Hypponen.

The odds remained elevated for participants drinking more than 6 cups/d after the researchers accounted for sleep quality. There were no differences in risk between men and women or by age.

An examination of the consumption of tea, which often contains caffeine, did not show an association with brain volume or the odds of dementia or stroke.

“We don’t know whether the difference between associations seen for coffee and tea intake reflects the difference in related caffeine intake or some other explanation, such as dehydration or effects operating through blood cholesterol,” said Dr. Hypponen.

Although reverse causation is possible, there’s no reason to believe that it is relevant to the study results. Genetic evidence suggests a causal role of higher coffee intake on risk for Alzheimer’s disease. In addition, results of a clinical trial support the association between higher caffeine intake and smaller gray matter volume, said Dr. Hypponen.

The mechanisms linking coffee consumption to brain volumes and dementia are not well established. However, Dr. Hypponen noted that caffeine has been used to induce apoptosis in cancer studies using glial cells.

“Furthermore, adenosine receptors, which mediate many of the effects of caffeine in the brain, have been suggested to influence the release of growth factors, which in turn can have an influence on astrocyte proliferation and angiogenesis in the brain,” she said.

Some types of coffee contain cafestol, which increases blood cholesterol and can have adverse effects though related mechanisms, said Dr. Hypponen.

The mechanism may also involve dehydration, which may have a harmful effect on the brain. The study suggested a correlation between dehydration and high coffee intake. “Of course, if this is the case, it is good news, as then we can do something about it simply by drinking some water every time we have a cup of coffee,” she said.
 

Misleading conclusions

Coffee contains antioxidants, and although previous studies have suggested it might be beneficial, this hypothesis is “too simplistic,” said Dr. Hypponen. “While coffee is not going to be all ‘bad’ either, there are a lot of controversies and suggestions about beneficial effects of coffee which may not be true, or at least do not reflect the full story.”

If the drinking of coffee is at least partly determined by an individual’s health status, then that would often lead to misleading conclusions in observational studies, said Dr. Hypponen.

“When one uses as a comparison people who already have poor health and who do not drink coffee because of that, coffee intake will by default appear beneficial simply because there are more people with disease among those choosing abstinence,” she said.

Before now, there was “very little evidence about the association between coffee intake and brain morphology,” and the studies that were conducted were relatively small, said Dr. Hypponen.

One of these smaller studies included a group of women aged 13-30 years. It found that coffee consumption was not associated with total brain volumes, but the findings suggested a U-shaped association with hippocampal volume; higher values were seen both for nondrinkers and the groups with higher consumption.

A small study of elderly patients with diabetes showed no evidence of an association with white matter volume, but there was a possible age-dependent association with gray matter volume.

The largest of the earlier studies had results that were very similar to those of the current study, suggesting that increasing coffee intake is associated with smaller hippocampal volumes, said Dr. Hypponen.

One of the study’s limitations included the fact that full dietary information was available only for a subsample and that factors such as dehydration were measured at baseline rather than at the time of brain MRI.

Another possible study limitation was the use of self-reported data and the fact that lifestyle changes may have occurred between baseline and MRI or covariate measurement.

In addition, the study is subject to a healthy-volunteer bias, and its implications are restricted to White British persons. The association needs to be studied in other ethnic populations, the authors noted.
 

A reason to cut back?

Commenting on the findings, Walter Willett, MD, DrPH, professor of epidemiology and nutrition, Harvard T. H. Chan School of Public Health, Boston, said the study is large and quite well done.

“It does raise questions about an increase in risk of dementia with six or more cups of coffee per day,” said Dr. Willett. “At the same time, it provides reassurance about lack of adverse effects of coffee for those consuming three or four cups per day, and little increase in risk, if any, with five cups per day.”

It’s not entirely clear whether the increase in risk with six or more cups of coffee per day represents a “true effect” of coffee, inasmuch as the study did not seem to adjust fully for dietary factors, high consumption of alcohol, or past smoking, said Dr. Willett.

The findings don’t suggest that coffee lovers should give up their Java. “But six or more cups per day is a lot, and those who drink that much might consider cutting back a bit while research continues,” said Dr. Willett.

The study was supported by the National Health and Medical Research Council.

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

Drinking six or more cups of coffee per day is associated with smaller brain volume and a 53% increased risk for dementia compared with light coffee consumption (1-2 cups per day), according to the results of a large study.

amenic181/Getty Images

“With coffee intake, moderation is the key, and especially high levels of consumption may have adverse long-term effects on the brain,” said study investigator Elina Hypponen, PhD, professor of nutritional and genetic epidemiology and director of the Australian Center for Precision Health at the University of South Australia.

“These new data are concerning, and there is a need to conduct further carefully controlled studies to clarify the effects of coffee on the brain.”

The study was published online June 24 in Nutritional Neuroscience.
 

Potent stimulant

Coffee is a potent nervous system stimulant and is among the most popular nonalcoholic beverages. Some previous research suggests it benefits the brain, but the investigators noted that other research shows a negative or U-shaped relationship.

To investigate, the researchers examined data from the U.K. Biobank, a long-term prospective epidemiologic study of more than 500,000 participants aged 37-73 years who were recruited in 22 assessment centers in the United Kingdom between March 2006 and October 2010.

During the baseline assessment, information was gathered using touchscreen questionnaires, verbal interviews, and physical examinations that involved collection of blood, urine, and saliva samples. An imaging substudy was incorporated in 2014, the goal of which was to conduct brain, heart, and body MRI imaging for 100,000 participants.

The investigators conducted analyses on disease outcomes for 398,646 participants for whom information on habitual coffee consumption was available. Brain volume analyses were conducted in 17,702 participants for whom valid brain imaging data were available.

Participants reported coffee intake in cups per day. Researchers grouped coffee consumption into seven categories: nondrinkers, decaffeinated coffee drinkers, and caffeinated coffee drinkers who consumed less than 1 cup/d, 1-2 cups/d, 3-4 cups/d, 5-6 cups/d, and more than 6 cups/d.

The reference category was those who consumed 1-2 cups/d, rather than those who abstained from coffee, because persons who abstain are more likely to be at suboptimal health.

“Comparing the health of coffee drinkers to the health of those choosing to abstain from coffee will typically lead to an impression of a health benefit, even if there would not be one,” said Dr. Hypponen.

The researchers obtained total and regional brain volumes from the MRI imaging substudy starting 4-6 years after baseline assessment. They accessed information on incident dementia and stroke using primary care data, hospital admission electronic health records, national death registers, and self-reported medical conditions.

Covariates included socioeconomic, health, and other factors, such as smoking, alcohol and tea consumption, physical activity, stressful life events, and body mass index.

The investigators found that there was a linear inverse association between coffee consumption and total brain volume (fully adjusted beta per cup, –1.42; 95% confidence interval, –1.89 to –0.94), with consistent patterns for gray matter, white matter, and hippocampal volumes.

There was no evidence to support an association with white matter hyperintensity (WMH) volume (beta –0.01; 95% CI, –0.07 to 0.05).
 

Higher consumption, higher risk

The analysis also revealed a nonlinear association between coffee consumption and the odds of dementia (P nonlinearity = .0001), with slightly higher odds seen with non–coffee drinkers and decaffeinated-coffee drinkers and more notable increases for participants in the highest categories of coffee consumption compared with light coffee drinkers.

After adjustment for all covariates, the odds ratio of dementia among persons in the category of coffee intake was 1.53 (95% CI, 1.28-1.83). After full adjustments, the association with heavy coffee consumption and stroke was not significant, although “we can’t exclude a weak effect,” said Dr. Hypponen.

“For the highest coffee consumption group, the data support an association which may be anywhere from 0% to 37% higher odds of stroke after full adjustment,” she added.

People at risk for hypertension may develop “unpleasant sensations” and stop drinking coffee before a serious adverse event occurs, said Dr. Hypponen. In a previous study, she and her colleagues showed that those who have genetically higher blood pressure tend to drink less coffee than their counterparts without the condition.

“This type of effect might be expected to naturally limit the adverse effects of coffee on the risk of stroke,” said Dr. Hypponen.

The odds remained elevated for participants drinking more than 6 cups/d after the researchers accounted for sleep quality. There were no differences in risk between men and women or by age.

An examination of the consumption of tea, which often contains caffeine, did not show an association with brain volume or the odds of dementia or stroke.

“We don’t know whether the difference between associations seen for coffee and tea intake reflects the difference in related caffeine intake or some other explanation, such as dehydration or effects operating through blood cholesterol,” said Dr. Hypponen.

Although reverse causation is possible, there’s no reason to believe that it is relevant to the study results. Genetic evidence suggests a causal role of higher coffee intake on risk for Alzheimer’s disease. In addition, results of a clinical trial support the association between higher caffeine intake and smaller gray matter volume, said Dr. Hypponen.

The mechanisms linking coffee consumption to brain volumes and dementia are not well established. However, Dr. Hypponen noted that caffeine has been used to induce apoptosis in cancer studies using glial cells.

“Furthermore, adenosine receptors, which mediate many of the effects of caffeine in the brain, have been suggested to influence the release of growth factors, which in turn can have an influence on astrocyte proliferation and angiogenesis in the brain,” she said.

Some types of coffee contain cafestol, which increases blood cholesterol and can have adverse effects though related mechanisms, said Dr. Hypponen.

The mechanism may also involve dehydration, which may have a harmful effect on the brain. The study suggested a correlation between dehydration and high coffee intake. “Of course, if this is the case, it is good news, as then we can do something about it simply by drinking some water every time we have a cup of coffee,” she said.
 

Misleading conclusions

Coffee contains antioxidants, and although previous studies have suggested it might be beneficial, this hypothesis is “too simplistic,” said Dr. Hypponen. “While coffee is not going to be all ‘bad’ either, there are a lot of controversies and suggestions about beneficial effects of coffee which may not be true, or at least do not reflect the full story.”

If the drinking of coffee is at least partly determined by an individual’s health status, then that would often lead to misleading conclusions in observational studies, said Dr. Hypponen.

“When one uses as a comparison people who already have poor health and who do not drink coffee because of that, coffee intake will by default appear beneficial simply because there are more people with disease among those choosing abstinence,” she said.

Before now, there was “very little evidence about the association between coffee intake and brain morphology,” and the studies that were conducted were relatively small, said Dr. Hypponen.

One of these smaller studies included a group of women aged 13-30 years. It found that coffee consumption was not associated with total brain volumes, but the findings suggested a U-shaped association with hippocampal volume; higher values were seen both for nondrinkers and the groups with higher consumption.

A small study of elderly patients with diabetes showed no evidence of an association with white matter volume, but there was a possible age-dependent association with gray matter volume.

The largest of the earlier studies had results that were very similar to those of the current study, suggesting that increasing coffee intake is associated with smaller hippocampal volumes, said Dr. Hypponen.

One of the study’s limitations included the fact that full dietary information was available only for a subsample and that factors such as dehydration were measured at baseline rather than at the time of brain MRI.

Another possible study limitation was the use of self-reported data and the fact that lifestyle changes may have occurred between baseline and MRI or covariate measurement.

In addition, the study is subject to a healthy-volunteer bias, and its implications are restricted to White British persons. The association needs to be studied in other ethnic populations, the authors noted.
 

A reason to cut back?

Commenting on the findings, Walter Willett, MD, DrPH, professor of epidemiology and nutrition, Harvard T. H. Chan School of Public Health, Boston, said the study is large and quite well done.

“It does raise questions about an increase in risk of dementia with six or more cups of coffee per day,” said Dr. Willett. “At the same time, it provides reassurance about lack of adverse effects of coffee for those consuming three or four cups per day, and little increase in risk, if any, with five cups per day.”

It’s not entirely clear whether the increase in risk with six or more cups of coffee per day represents a “true effect” of coffee, inasmuch as the study did not seem to adjust fully for dietary factors, high consumption of alcohol, or past smoking, said Dr. Willett.

The findings don’t suggest that coffee lovers should give up their Java. “But six or more cups per day is a lot, and those who drink that much might consider cutting back a bit while research continues,” said Dr. Willett.

The study was supported by the National Health and Medical Research Council.

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

Drinking six or more cups of coffee per day is associated with smaller brain volume and a 53% increased risk for dementia compared with light coffee consumption (1-2 cups per day), according to the results of a large study.

amenic181/Getty Images

“With coffee intake, moderation is the key, and especially high levels of consumption may have adverse long-term effects on the brain,” said study investigator Elina Hypponen, PhD, professor of nutritional and genetic epidemiology and director of the Australian Center for Precision Health at the University of South Australia.

“These new data are concerning, and there is a need to conduct further carefully controlled studies to clarify the effects of coffee on the brain.”

The study was published online June 24 in Nutritional Neuroscience.
 

Potent stimulant

Coffee is a potent nervous system stimulant and is among the most popular nonalcoholic beverages. Some previous research suggests it benefits the brain, but the investigators noted that other research shows a negative or U-shaped relationship.

To investigate, the researchers examined data from the U.K. Biobank, a long-term prospective epidemiologic study of more than 500,000 participants aged 37-73 years who were recruited in 22 assessment centers in the United Kingdom between March 2006 and October 2010.

During the baseline assessment, information was gathered using touchscreen questionnaires, verbal interviews, and physical examinations that involved collection of blood, urine, and saliva samples. An imaging substudy was incorporated in 2014, the goal of which was to conduct brain, heart, and body MRI imaging for 100,000 participants.

The investigators conducted analyses on disease outcomes for 398,646 participants for whom information on habitual coffee consumption was available. Brain volume analyses were conducted in 17,702 participants for whom valid brain imaging data were available.

Participants reported coffee intake in cups per day. Researchers grouped coffee consumption into seven categories: nondrinkers, decaffeinated coffee drinkers, and caffeinated coffee drinkers who consumed less than 1 cup/d, 1-2 cups/d, 3-4 cups/d, 5-6 cups/d, and more than 6 cups/d.

The reference category was those who consumed 1-2 cups/d, rather than those who abstained from coffee, because persons who abstain are more likely to be at suboptimal health.

“Comparing the health of coffee drinkers to the health of those choosing to abstain from coffee will typically lead to an impression of a health benefit, even if there would not be one,” said Dr. Hypponen.

The researchers obtained total and regional brain volumes from the MRI imaging substudy starting 4-6 years after baseline assessment. They accessed information on incident dementia and stroke using primary care data, hospital admission electronic health records, national death registers, and self-reported medical conditions.

Covariates included socioeconomic, health, and other factors, such as smoking, alcohol and tea consumption, physical activity, stressful life events, and body mass index.

The investigators found that there was a linear inverse association between coffee consumption and total brain volume (fully adjusted beta per cup, –1.42; 95% confidence interval, –1.89 to –0.94), with consistent patterns for gray matter, white matter, and hippocampal volumes.

There was no evidence to support an association with white matter hyperintensity (WMH) volume (beta –0.01; 95% CI, –0.07 to 0.05).
 

Higher consumption, higher risk

The analysis also revealed a nonlinear association between coffee consumption and the odds of dementia (P nonlinearity = .0001), with slightly higher odds seen with non–coffee drinkers and decaffeinated-coffee drinkers and more notable increases for participants in the highest categories of coffee consumption compared with light coffee drinkers.

After adjustment for all covariates, the odds ratio of dementia among persons in the category of coffee intake was 1.53 (95% CI, 1.28-1.83). After full adjustments, the association with heavy coffee consumption and stroke was not significant, although “we can’t exclude a weak effect,” said Dr. Hypponen.

“For the highest coffee consumption group, the data support an association which may be anywhere from 0% to 37% higher odds of stroke after full adjustment,” she added.

People at risk for hypertension may develop “unpleasant sensations” and stop drinking coffee before a serious adverse event occurs, said Dr. Hypponen. In a previous study, she and her colleagues showed that those who have genetically higher blood pressure tend to drink less coffee than their counterparts without the condition.

“This type of effect might be expected to naturally limit the adverse effects of coffee on the risk of stroke,” said Dr. Hypponen.

The odds remained elevated for participants drinking more than 6 cups/d after the researchers accounted for sleep quality. There were no differences in risk between men and women or by age.

An examination of the consumption of tea, which often contains caffeine, did not show an association with brain volume or the odds of dementia or stroke.

“We don’t know whether the difference between associations seen for coffee and tea intake reflects the difference in related caffeine intake or some other explanation, such as dehydration or effects operating through blood cholesterol,” said Dr. Hypponen.

Although reverse causation is possible, there’s no reason to believe that it is relevant to the study results. Genetic evidence suggests a causal role of higher coffee intake on risk for Alzheimer’s disease. In addition, results of a clinical trial support the association between higher caffeine intake and smaller gray matter volume, said Dr. Hypponen.

The mechanisms linking coffee consumption to brain volumes and dementia are not well established. However, Dr. Hypponen noted that caffeine has been used to induce apoptosis in cancer studies using glial cells.

“Furthermore, adenosine receptors, which mediate many of the effects of caffeine in the brain, have been suggested to influence the release of growth factors, which in turn can have an influence on astrocyte proliferation and angiogenesis in the brain,” she said.

Some types of coffee contain cafestol, which increases blood cholesterol and can have adverse effects though related mechanisms, said Dr. Hypponen.

The mechanism may also involve dehydration, which may have a harmful effect on the brain. The study suggested a correlation between dehydration and high coffee intake. “Of course, if this is the case, it is good news, as then we can do something about it simply by drinking some water every time we have a cup of coffee,” she said.
 

Misleading conclusions

Coffee contains antioxidants, and although previous studies have suggested it might be beneficial, this hypothesis is “too simplistic,” said Dr. Hypponen. “While coffee is not going to be all ‘bad’ either, there are a lot of controversies and suggestions about beneficial effects of coffee which may not be true, or at least do not reflect the full story.”

If the drinking of coffee is at least partly determined by an individual’s health status, then that would often lead to misleading conclusions in observational studies, said Dr. Hypponen.

“When one uses as a comparison people who already have poor health and who do not drink coffee because of that, coffee intake will by default appear beneficial simply because there are more people with disease among those choosing abstinence,” she said.

Before now, there was “very little evidence about the association between coffee intake and brain morphology,” and the studies that were conducted were relatively small, said Dr. Hypponen.

One of these smaller studies included a group of women aged 13-30 years. It found that coffee consumption was not associated with total brain volumes, but the findings suggested a U-shaped association with hippocampal volume; higher values were seen both for nondrinkers and the groups with higher consumption.

A small study of elderly patients with diabetes showed no evidence of an association with white matter volume, but there was a possible age-dependent association with gray matter volume.

The largest of the earlier studies had results that were very similar to those of the current study, suggesting that increasing coffee intake is associated with smaller hippocampal volumes, said Dr. Hypponen.

One of the study’s limitations included the fact that full dietary information was available only for a subsample and that factors such as dehydration were measured at baseline rather than at the time of brain MRI.

Another possible study limitation was the use of self-reported data and the fact that lifestyle changes may have occurred between baseline and MRI or covariate measurement.

In addition, the study is subject to a healthy-volunteer bias, and its implications are restricted to White British persons. The association needs to be studied in other ethnic populations, the authors noted.
 

A reason to cut back?

Commenting on the findings, Walter Willett, MD, DrPH, professor of epidemiology and nutrition, Harvard T. H. Chan School of Public Health, Boston, said the study is large and quite well done.

“It does raise questions about an increase in risk of dementia with six or more cups of coffee per day,” said Dr. Willett. “At the same time, it provides reassurance about lack of adverse effects of coffee for those consuming three or four cups per day, and little increase in risk, if any, with five cups per day.”

It’s not entirely clear whether the increase in risk with six or more cups of coffee per day represents a “true effect” of coffee, inasmuch as the study did not seem to adjust fully for dietary factors, high consumption of alcohol, or past smoking, said Dr. Willett.

The findings don’t suggest that coffee lovers should give up their Java. “But six or more cups per day is a lot, and those who drink that much might consider cutting back a bit while research continues,” said Dr. Willett.

The study was supported by the National Health and Medical Research Council.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).

Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”

More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).

Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”

More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).

Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”

More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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