Commentary

 

In the struggle to understand and comply with new regulations, it’s easy to neglect older ones. Recently, I suggested reviewing your practice for potential Occupational Safety and Health Administration violations, which can be far more costly than anything MACRA has in store.

The same goes for HIPAA since HIPAA violations can be just as costly, in view of renewed governmental enforcement and some disturbing trends in completely unrelated government agencies.

As I wrote some time ago, the Office for Civil Rights (OCR) – which is responsible for enforcing HIPAA rules – launched a permanent audit program last year (Dermatology News, March 2016, page 62). You may recall the story of the Massachusetts dermatology group that lost a thumb drive containing unencrypted patient records, which cost them $150,000 in fines, even though there was no evidence that the information was ever found or exploited. That and similar examples signal the importance of reviewing your practice’s HIPAA compliance on a regular basis.

Your most basic review should be a yearly examination of every part of your office where patient information is handled to identify potential violations. Examples discovered in my office included computers at our front desk whose screens were visible to patients checking in or out; laptops that were left on counters overnight; emails between staff involving patients or their care; and documents slated for shredding that remained in a “to shred” bin for days. All of these issues were easily solved at minimal cost – respectively, screen protectors, locking all laptops after hours, new email rules, and eliminating the “to shred” bin, forcing immediate shredding of all sensitive documents. Make sure you correct any problems you find before the OCR auditors come calling. You can compare your office’s compliance status against the recommendations listed on the OCR website.

Where safeguarding protected health information is concerned, you must now assume the worst-case scenario: Previously, when protected health information was compromised, you would have to notify the affected patients (and the government) only if there was a “significant risk of financial or reputational harm.” But now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice to significant fines.

The biggest vulnerability in most practices is probably mobile devices carrying patient data; and that’s where the disturbing new trend comes in: Governments, both foreign and domestic, have developed an interest in the personal data on your devices. Travelers, including American citizens, now are being pressured into giving Customs and Border Protection officers access to their cellphones and laptops at airports.

As a physician, you can invoke HIPAA in such situations, since your devices likely contain patient data in some form. But rules may vary depending on where you are traveling to or from, and officials in other countries are not bound by U.S. HIPAA constraints.

So, how do you protect patients’ (and your personal) information from invasive searches? First, encrypt all of your data; encryption software is cheap, readily available, and easy to use. (I recently posted a list of inexpensive encryption applications on the website.) Desktop apps such as BitLocker or Apple’s FileVault let you encrypt your entire hard drive, requiring a password for decryption. (As always, I have no financial interest in anything I mention here.) To avoid surrendering the password, write it down and give it to a friend, then contact that person after crossing the border. It is easier to say you didn’t memorize it, as opposed to refusing to provide it – and nobody can compel you to reveal a password you don’t know.

Experts also recommend disabling the fingerprint sensor on your smartphone; customs officials have successfully used warrants to compel people to unlock their cellphones with a fingerprint. Because of your right to remain silent, it would be difficult (but not impossible) for them to force you to share your phone’s passcode.

A better alternative, in my view, is to travel with devices that have never contained any of your patient or personal data in the first place. Invest in a cheap phone and computer to use only when you are abroad; you don’t want your nice equipment lost or stolen, anyway. A budget Android phone that works with foreign SIM cards can be had for about $100; basic laptops run $500 or less.


 

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

 

In the struggle to understand and comply with new regulations, it’s easy to neglect older ones. Recently, I suggested reviewing your practice for potential Occupational Safety and Health Administration violations, which can be far more costly than anything MACRA has in store.

The same goes for HIPAA since HIPAA violations can be just as costly, in view of renewed governmental enforcement and some disturbing trends in completely unrelated government agencies.

As I wrote some time ago, the Office for Civil Rights (OCR) – which is responsible for enforcing HIPAA rules – launched a permanent audit program last year (Dermatology News, March 2016, page 62). You may recall the story of the Massachusetts dermatology group that lost a thumb drive containing unencrypted patient records, which cost them $150,000 in fines, even though there was no evidence that the information was ever found or exploited. That and similar examples signal the importance of reviewing your practice’s HIPAA compliance on a regular basis.

Your most basic review should be a yearly examination of every part of your office where patient information is handled to identify potential violations. Examples discovered in my office included computers at our front desk whose screens were visible to patients checking in or out; laptops that were left on counters overnight; emails between staff involving patients or their care; and documents slated for shredding that remained in a “to shred” bin for days. All of these issues were easily solved at minimal cost – respectively, screen protectors, locking all laptops after hours, new email rules, and eliminating the “to shred” bin, forcing immediate shredding of all sensitive documents. Make sure you correct any problems you find before the OCR auditors come calling. You can compare your office’s compliance status against the recommendations listed on the OCR website.

Where safeguarding protected health information is concerned, you must now assume the worst-case scenario: Previously, when protected health information was compromised, you would have to notify the affected patients (and the government) only if there was a “significant risk of financial or reputational harm.” But now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice to significant fines.

The biggest vulnerability in most practices is probably mobile devices carrying patient data; and that’s where the disturbing new trend comes in: Governments, both foreign and domestic, have developed an interest in the personal data on your devices. Travelers, including American citizens, now are being pressured into giving Customs and Border Protection officers access to their cellphones and laptops at airports.

As a physician, you can invoke HIPAA in such situations, since your devices likely contain patient data in some form. But rules may vary depending on where you are traveling to or from, and officials in other countries are not bound by U.S. HIPAA constraints.

So, how do you protect patients’ (and your personal) information from invasive searches? First, encrypt all of your data; encryption software is cheap, readily available, and easy to use. (I recently posted a list of inexpensive encryption applications on the website.) Desktop apps such as BitLocker or Apple’s FileVault let you encrypt your entire hard drive, requiring a password for decryption. (As always, I have no financial interest in anything I mention here.) To avoid surrendering the password, write it down and give it to a friend, then contact that person after crossing the border. It is easier to say you didn’t memorize it, as opposed to refusing to provide it – and nobody can compel you to reveal a password you don’t know.

Experts also recommend disabling the fingerprint sensor on your smartphone; customs officials have successfully used warrants to compel people to unlock their cellphones with a fingerprint. Because of your right to remain silent, it would be difficult (but not impossible) for them to force you to share your phone’s passcode.

A better alternative, in my view, is to travel with devices that have never contained any of your patient or personal data in the first place. Invest in a cheap phone and computer to use only when you are abroad; you don’t want your nice equipment lost or stolen, anyway. A budget Android phone that works with foreign SIM cards can be had for about $100; basic laptops run $500 or less.


 

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

 

In the struggle to understand and comply with new regulations, it’s easy to neglect older ones. Recently, I suggested reviewing your practice for potential Occupational Safety and Health Administration violations, which can be far more costly than anything MACRA has in store.

The same goes for HIPAA since HIPAA violations can be just as costly, in view of renewed governmental enforcement and some disturbing trends in completely unrelated government agencies.

As I wrote some time ago, the Office for Civil Rights (OCR) – which is responsible for enforcing HIPAA rules – launched a permanent audit program last year (Dermatology News, March 2016, page 62). You may recall the story of the Massachusetts dermatology group that lost a thumb drive containing unencrypted patient records, which cost them $150,000 in fines, even though there was no evidence that the information was ever found or exploited. That and similar examples signal the importance of reviewing your practice’s HIPAA compliance on a regular basis.

Your most basic review should be a yearly examination of every part of your office where patient information is handled to identify potential violations. Examples discovered in my office included computers at our front desk whose screens were visible to patients checking in or out; laptops that were left on counters overnight; emails between staff involving patients or their care; and documents slated for shredding that remained in a “to shred” bin for days. All of these issues were easily solved at minimal cost – respectively, screen protectors, locking all laptops after hours, new email rules, and eliminating the “to shred” bin, forcing immediate shredding of all sensitive documents. Make sure you correct any problems you find before the OCR auditors come calling. You can compare your office’s compliance status against the recommendations listed on the OCR website.

Where safeguarding protected health information is concerned, you must now assume the worst-case scenario: Previously, when protected health information was compromised, you would have to notify the affected patients (and the government) only if there was a “significant risk of financial or reputational harm.” But now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice to significant fines.

The biggest vulnerability in most practices is probably mobile devices carrying patient data; and that’s where the disturbing new trend comes in: Governments, both foreign and domestic, have developed an interest in the personal data on your devices. Travelers, including American citizens, now are being pressured into giving Customs and Border Protection officers access to their cellphones and laptops at airports.

As a physician, you can invoke HIPAA in such situations, since your devices likely contain patient data in some form. But rules may vary depending on where you are traveling to or from, and officials in other countries are not bound by U.S. HIPAA constraints.

So, how do you protect patients’ (and your personal) information from invasive searches? First, encrypt all of your data; encryption software is cheap, readily available, and easy to use. (I recently posted a list of inexpensive encryption applications on the website.) Desktop apps such as BitLocker or Apple’s FileVault let you encrypt your entire hard drive, requiring a password for decryption. (As always, I have no financial interest in anything I mention here.) To avoid surrendering the password, write it down and give it to a friend, then contact that person after crossing the border. It is easier to say you didn’t memorize it, as opposed to refusing to provide it – and nobody can compel you to reveal a password you don’t know.

Experts also recommend disabling the fingerprint sensor on your smartphone; customs officials have successfully used warrants to compel people to unlock their cellphones with a fingerprint. Because of your right to remain silent, it would be difficult (but not impossible) for them to force you to share your phone’s passcode.

A better alternative, in my view, is to travel with devices that have never contained any of your patient or personal data in the first place. Invest in a cheap phone and computer to use only when you are abroad; you don’t want your nice equipment lost or stolen, anyway. A budget Android phone that works with foreign SIM cards can be had for about $100; basic laptops run $500 or less.


 

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

 

You walk into an examining room and discover a 3-year-old in his underpants wearing a fireman’s hat and what must be his older sister’s rubber boots. You have to ask: “Are you going to be a firefighter when you grow up?” If he is a sensitive kid he will resist answering, “What do you think, Dr. Obvious?” and instead he politely replies, “Yes, and an EMT [emergency medical technician] too.”

Adults, even ones who have devoted their professional lives to the care of children, can’t seem to stifle the urge ask every young person they meet about his or her career plans. It is a strange sort of obsession, and may simply reflect the fact that most adults are at a loss for conversation starters when it comes to talking with young people. Children don’t seem to have much concern about the weather. And most of them don’t have opinions about the current political situation. They don’t have stories about their grandchildren they would love to bore you with. You could ask if the child has a pet, but that may be picking the scab of an unresolved family issue.

Most adults realize that their career plans prior to adolescence have no relationship to their present situation. Thinking back on this disconnect in their own lives may provide them with a good chuckle. But they also may hope to store away the child’s naive answer as ammunition for a future embarrassing challenge. “Do you remember that you once told me you were going to be a forest ranger?”

It may be that the child’s answer will give the adults an opportunity to share their “wisdom” based on their own career decisions. How lucky for the child who has stumbled on an unsolicited life coach.

For the most part, these interrogations about career planning are just idle banter. But as children get older, reality begins shining its harsh light on choices and decisions. What was once a seemingly harmless question about the distant future may no longer be so innocuous. I try to sound apologetic when I say to high school juniors and seniors, “I’m sure everyone is asking you, but what about college?” However, after reading a story in The Wall Street Journal, I now wonder whether I should be skipping the apology and just simply not raising the subject of college (“What’s Worse Than Waiting to Hear From Colleges? Getting Interrogated About It,” by Sue Shellenbarger, March 8, 2017).

In communities where most high school graduates have been on a college track since middle school, tension and anxiety hangs over the older adolescents like a cloud that darkens as application deadlines herald the long and painful wait for acceptance/rejection letters and emails. High school seniors are tired of thinking about the process and certainly don’t want to talk about. They consider questions about their future an invasion of their privacy. Redbubble, an online marketplace based in Australia, is seeing rising sales of T-shirts that read “Don’t ask me about college. Thanks.”

The unwelcome interrogations don’t stop with college acceptance. Adults want to know, “Have you chosen a major?” And as college graduation nears they can’t resist asking, “Do you have any job offers?”

Most adolescents and many 20-somethings don’t seem to have a career goal. It may be that they are afraid that the process of setting a goal will make them more vulnerable to failure. It also may be that revealing, “I’ve always wanted to be a ...” will label them as being a bit childish and weird.

Where does all this adolescent discomfort with the near future leave us pediatricians? The complete evaluation of a high school–age patient should include a question or questions about how our patient is weathering the college and career planning process. The challenge is how to present those questions in a manner that makes it clear that we aren’t just another one of those career-obsessed nosy adults.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

 

You walk into an examining room and discover a 3-year-old in his underpants wearing a fireman’s hat and what must be his older sister’s rubber boots. You have to ask: “Are you going to be a firefighter when you grow up?” If he is a sensitive kid he will resist answering, “What do you think, Dr. Obvious?” and instead he politely replies, “Yes, and an EMT [emergency medical technician] too.”

Adults, even ones who have devoted their professional lives to the care of children, can’t seem to stifle the urge ask every young person they meet about his or her career plans. It is a strange sort of obsession, and may simply reflect the fact that most adults are at a loss for conversation starters when it comes to talking with young people. Children don’t seem to have much concern about the weather. And most of them don’t have opinions about the current political situation. They don’t have stories about their grandchildren they would love to bore you with. You could ask if the child has a pet, but that may be picking the scab of an unresolved family issue.

Most adults realize that their career plans prior to adolescence have no relationship to their present situation. Thinking back on this disconnect in their own lives may provide them with a good chuckle. But they also may hope to store away the child’s naive answer as ammunition for a future embarrassing challenge. “Do you remember that you once told me you were going to be a forest ranger?”

It may be that the child’s answer will give the adults an opportunity to share their “wisdom” based on their own career decisions. How lucky for the child who has stumbled on an unsolicited life coach.

For the most part, these interrogations about career planning are just idle banter. But as children get older, reality begins shining its harsh light on choices and decisions. What was once a seemingly harmless question about the distant future may no longer be so innocuous. I try to sound apologetic when I say to high school juniors and seniors, “I’m sure everyone is asking you, but what about college?” However, after reading a story in The Wall Street Journal, I now wonder whether I should be skipping the apology and just simply not raising the subject of college (“What’s Worse Than Waiting to Hear From Colleges? Getting Interrogated About It,” by Sue Shellenbarger, March 8, 2017).

In communities where most high school graduates have been on a college track since middle school, tension and anxiety hangs over the older adolescents like a cloud that darkens as application deadlines herald the long and painful wait for acceptance/rejection letters and emails. High school seniors are tired of thinking about the process and certainly don’t want to talk about. They consider questions about their future an invasion of their privacy. Redbubble, an online marketplace based in Australia, is seeing rising sales of T-shirts that read “Don’t ask me about college. Thanks.”

The unwelcome interrogations don’t stop with college acceptance. Adults want to know, “Have you chosen a major?” And as college graduation nears they can’t resist asking, “Do you have any job offers?”

Most adolescents and many 20-somethings don’t seem to have a career goal. It may be that they are afraid that the process of setting a goal will make them more vulnerable to failure. It also may be that revealing, “I’ve always wanted to be a ...” will label them as being a bit childish and weird.

Where does all this adolescent discomfort with the near future leave us pediatricians? The complete evaluation of a high school–age patient should include a question or questions about how our patient is weathering the college and career planning process. The challenge is how to present those questions in a manner that makes it clear that we aren’t just another one of those career-obsessed nosy adults.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

 

You walk into an examining room and discover a 3-year-old in his underpants wearing a fireman’s hat and what must be his older sister’s rubber boots. You have to ask: “Are you going to be a firefighter when you grow up?” If he is a sensitive kid he will resist answering, “What do you think, Dr. Obvious?” and instead he politely replies, “Yes, and an EMT [emergency medical technician] too.”

Adults, even ones who have devoted their professional lives to the care of children, can’t seem to stifle the urge ask every young person they meet about his or her career plans. It is a strange sort of obsession, and may simply reflect the fact that most adults are at a loss for conversation starters when it comes to talking with young people. Children don’t seem to have much concern about the weather. And most of them don’t have opinions about the current political situation. They don’t have stories about their grandchildren they would love to bore you with. You could ask if the child has a pet, but that may be picking the scab of an unresolved family issue.

Most adults realize that their career plans prior to adolescence have no relationship to their present situation. Thinking back on this disconnect in their own lives may provide them with a good chuckle. But they also may hope to store away the child’s naive answer as ammunition for a future embarrassing challenge. “Do you remember that you once told me you were going to be a forest ranger?”

It may be that the child’s answer will give the adults an opportunity to share their “wisdom” based on their own career decisions. How lucky for the child who has stumbled on an unsolicited life coach.

For the most part, these interrogations about career planning are just idle banter. But as children get older, reality begins shining its harsh light on choices and decisions. What was once a seemingly harmless question about the distant future may no longer be so innocuous. I try to sound apologetic when I say to high school juniors and seniors, “I’m sure everyone is asking you, but what about college?” However, after reading a story in The Wall Street Journal, I now wonder whether I should be skipping the apology and just simply not raising the subject of college (“What’s Worse Than Waiting to Hear From Colleges? Getting Interrogated About It,” by Sue Shellenbarger, March 8, 2017).

In communities where most high school graduates have been on a college track since middle school, tension and anxiety hangs over the older adolescents like a cloud that darkens as application deadlines herald the long and painful wait for acceptance/rejection letters and emails. High school seniors are tired of thinking about the process and certainly don’t want to talk about. They consider questions about their future an invasion of their privacy. Redbubble, an online marketplace based in Australia, is seeing rising sales of T-shirts that read “Don’t ask me about college. Thanks.”

The unwelcome interrogations don’t stop with college acceptance. Adults want to know, “Have you chosen a major?” And as college graduation nears they can’t resist asking, “Do you have any job offers?”

Most adolescents and many 20-somethings don’t seem to have a career goal. It may be that they are afraid that the process of setting a goal will make them more vulnerable to failure. It also may be that revealing, “I’ve always wanted to be a ...” will label them as being a bit childish and weird.

Where does all this adolescent discomfort with the near future leave us pediatricians? The complete evaluation of a high school–age patient should include a question or questions about how our patient is weathering the college and career planning process. The challenge is how to present those questions in a manner that makes it clear that we aren’t just another one of those career-obsessed nosy adults.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

 

Where do we go from here?

More than 20 years after IV tissue plasminogen activator was officially approved for use in acute ischemic stroke, now data suggest mechanical thrombectomy is superior, regardless of whether tPA is given.

Granted, these are preliminary trials, and a lot more research needs to be done: randomized studies, determinations of which patients are the best candidates, which devices are most useful, etc.

This led to an email exchange between another neurologist and me recently, wondering if we should be notifying the interventionalists, too, as soon as a nonhemorrhagic stroke is rolled in. Why should we have all the fun? Heck, why bother me at all? If they’re better at it, call the interventionalists and let me sleep.

Of course, it’s not that simple. The data thus far suggest thrombectomy is best when used in anterior circulation strokes, with a National Institutes of Health Stroke Scale score of greater than 6, so obviously we shouldn’t be calling them in on every case.

You have to balance that against legal issues. It certainly isn’t too far-fetched to imagine being sued because you didn’t call an interventionalist, or another neurologist testifying that you fell below the standard of care by not doing so. The right person will say that about anything, regardless of clinical data.

This is still up in the air right now, as I doubt the interventionalists want to take acute ischemic stroke off our hands, nor do we want to give it up, either. It’s a disorder of the brain, and that is what we deal with, isn’t it?

The bottom line is that rumors about the death of tPA in acute ischemic stroke are greatly exaggerated. Only time will tell.

Medicine, for better or worse, is an inexact science. No one can predict outcomes, adverse reactions, or complications with 100% certainty. Which treatment will work best for which patient is never known. That’s why we need controlled trials to know which odds are best overall, and take it from there. Preliminary trials can be very helpful at pointing us in the right directions, but are for from definitive. As with so many other things, your mileage may vary.
 

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

 

Where do we go from here?

More than 20 years after IV tissue plasminogen activator was officially approved for use in acute ischemic stroke, now data suggest mechanical thrombectomy is superior, regardless of whether tPA is given.

Granted, these are preliminary trials, and a lot more research needs to be done: randomized studies, determinations of which patients are the best candidates, which devices are most useful, etc.

This led to an email exchange between another neurologist and me recently, wondering if we should be notifying the interventionalists, too, as soon as a nonhemorrhagic stroke is rolled in. Why should we have all the fun? Heck, why bother me at all? If they’re better at it, call the interventionalists and let me sleep.

Of course, it’s not that simple. The data thus far suggest thrombectomy is best when used in anterior circulation strokes, with a National Institutes of Health Stroke Scale score of greater than 6, so obviously we shouldn’t be calling them in on every case.

You have to balance that against legal issues. It certainly isn’t too far-fetched to imagine being sued because you didn’t call an interventionalist, or another neurologist testifying that you fell below the standard of care by not doing so. The right person will say that about anything, regardless of clinical data.

This is still up in the air right now, as I doubt the interventionalists want to take acute ischemic stroke off our hands, nor do we want to give it up, either. It’s a disorder of the brain, and that is what we deal with, isn’t it?

The bottom line is that rumors about the death of tPA in acute ischemic stroke are greatly exaggerated. Only time will tell.

Medicine, for better or worse, is an inexact science. No one can predict outcomes, adverse reactions, or complications with 100% certainty. Which treatment will work best for which patient is never known. That’s why we need controlled trials to know which odds are best overall, and take it from there. Preliminary trials can be very helpful at pointing us in the right directions, but are for from definitive. As with so many other things, your mileage may vary.
 

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

 

Where do we go from here?

More than 20 years after IV tissue plasminogen activator was officially approved for use in acute ischemic stroke, now data suggest mechanical thrombectomy is superior, regardless of whether tPA is given.

Granted, these are preliminary trials, and a lot more research needs to be done: randomized studies, determinations of which patients are the best candidates, which devices are most useful, etc.

This led to an email exchange between another neurologist and me recently, wondering if we should be notifying the interventionalists, too, as soon as a nonhemorrhagic stroke is rolled in. Why should we have all the fun? Heck, why bother me at all? If they’re better at it, call the interventionalists and let me sleep.

Of course, it’s not that simple. The data thus far suggest thrombectomy is best when used in anterior circulation strokes, with a National Institutes of Health Stroke Scale score of greater than 6, so obviously we shouldn’t be calling them in on every case.

You have to balance that against legal issues. It certainly isn’t too far-fetched to imagine being sued because you didn’t call an interventionalist, or another neurologist testifying that you fell below the standard of care by not doing so. The right person will say that about anything, regardless of clinical data.

This is still up in the air right now, as I doubt the interventionalists want to take acute ischemic stroke off our hands, nor do we want to give it up, either. It’s a disorder of the brain, and that is what we deal with, isn’t it?

The bottom line is that rumors about the death of tPA in acute ischemic stroke are greatly exaggerated. Only time will tell.

Medicine, for better or worse, is an inexact science. No one can predict outcomes, adverse reactions, or complications with 100% certainty. Which treatment will work best for which patient is never known. That’s why we need controlled trials to know which odds are best overall, and take it from there. Preliminary trials can be very helpful at pointing us in the right directions, but are for from definitive. As with so many other things, your mileage may vary.
 

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

 

Your first patient of the afternoon is a 9-year-old boy who moved to town several months ago. Mercifully, the second patient of the afternoon has canceled, giving you a few more minutes to get acquainted with this young man whose chief complaint is listed as “behavior problem.” You learn quickly that this family has relocated from a town just 20 miles away because they are seeking a school that is a “better fit” for your new patient.

Due to some miscommunications, the child’s old records have not arrived at your office. The mother says that her son is not taking any medication, and she isn’t sure if he has ever been given a diagnosis. You learn that he likes to argue and is prone to violent temper tantrums. Your initial brief exam does not suggest any cognitive deficits, but he exudes an aura of anger and discontent. You tell his mother that you will be glad to try to help, but you will need his old records and another longer visit before you can make any recommendations.

Two days later you see a fourth-grader you have known since birth. He rarely comes to the office with problems, but you understand that he is a good student, a competent athlete, and socially engaged. His chief complaint for this visit is “hair loss,” but you soon discover that he has trichotillomania and has recently begun having nightmares and experiencing enuresis. All of these symptoms began a month ago with arrival of a new student in his class whose violent outbursts have become increasingly more physical. I have borrowed this child’s scenario from a similar case study in a recent supplement to the Journal of Developmental & Behavioral Pediatrics titled, “Behavioral Changes Associated with a Disruptive New Student in the Classroom,” (J Dev Behav Pediatr. Feb/Mar 2017. doi: 10.1097/DBP.0000000000000175).

The afternoon following your visit with the hair-pulling fourth-grader, you receive the new patient’s records for which you have been waiting. The circle is completed as you read that this is his third school in 18 months, and the reports of his behavior make it clear that your two patients are classmates. This scenario of coincidence could easily have occurred in a small town like Brunswick, Maine, where I practiced, but I have manufactured it to raise several questions about social priorities and professional ethics.

Forty years ago, institutions housing individuals with Down syndrome started closing and the process of integrating children with a variety of cognitive and physical disabilities into traditional classrooms began. To the surprise of some people, this mainstreaming has generally gone well. Unfortunately, funding hasn’t always caught up with the demand for services. For the most part, children readily accept their challenged classmates who look, move, and sound different. The flailing and grunting of the child with spastic choreoathetosis using a wheelchair isn’t considered an interruption because “that’s just the way she is.”

However, there seems to be an invisible line that separates those children who seem to be incapable of stopping their potentially disruptive behavior from those children we assume “ought to know better” or whose parents we believe have failed at instilling even the most basic discipline. You can certainly question the validity of those assumptions. But it is clear that your new patient’s disruptive behavior is interfering with his classmates’ education, and in some cases threatening their health. Your patient with trichotillomania is probably the canary in a very unsettled mine.

Your dilemma as the pediatrician for these two boys is the same we face as a society. How do you effectively advocate for a positive educational atmosphere for children with a variety of special needs, some of which seem to be in direct conflict? You can ask the school system to be patient as you help the disruptive child get connected with the services he needs. But you know that could take several months at a minimum. Meanwhile your hair-pulling patient and his classmates are losing valuable educational opportunities by the day.

I don’t have the answer, but I suspect that somehow it is going to come down to affordability. Counseling, psychiatrists, and one on one classroom aids don’t come cheap, nor does the tuition for a special school in another school district. But we can’t discount the value of an education free of disruption.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected]

 

Your first patient of the afternoon is a 9-year-old boy who moved to town several months ago. Mercifully, the second patient of the afternoon has canceled, giving you a few more minutes to get acquainted with this young man whose chief complaint is listed as “behavior problem.” You learn quickly that this family has relocated from a town just 20 miles away because they are seeking a school that is a “better fit” for your new patient.

Due to some miscommunications, the child’s old records have not arrived at your office. The mother says that her son is not taking any medication, and she isn’t sure if he has ever been given a diagnosis. You learn that he likes to argue and is prone to violent temper tantrums. Your initial brief exam does not suggest any cognitive deficits, but he exudes an aura of anger and discontent. You tell his mother that you will be glad to try to help, but you will need his old records and another longer visit before you can make any recommendations.

Two days later you see a fourth-grader you have known since birth. He rarely comes to the office with problems, but you understand that he is a good student, a competent athlete, and socially engaged. His chief complaint for this visit is “hair loss,” but you soon discover that he has trichotillomania and has recently begun having nightmares and experiencing enuresis. All of these symptoms began a month ago with arrival of a new student in his class whose violent outbursts have become increasingly more physical. I have borrowed this child’s scenario from a similar case study in a recent supplement to the Journal of Developmental & Behavioral Pediatrics titled, “Behavioral Changes Associated with a Disruptive New Student in the Classroom,” (J Dev Behav Pediatr. Feb/Mar 2017. doi: 10.1097/DBP.0000000000000175).

The afternoon following your visit with the hair-pulling fourth-grader, you receive the new patient’s records for which you have been waiting. The circle is completed as you read that this is his third school in 18 months, and the reports of his behavior make it clear that your two patients are classmates. This scenario of coincidence could easily have occurred in a small town like Brunswick, Maine, where I practiced, but I have manufactured it to raise several questions about social priorities and professional ethics.

Forty years ago, institutions housing individuals with Down syndrome started closing and the process of integrating children with a variety of cognitive and physical disabilities into traditional classrooms began. To the surprise of some people, this mainstreaming has generally gone well. Unfortunately, funding hasn’t always caught up with the demand for services. For the most part, children readily accept their challenged classmates who look, move, and sound different. The flailing and grunting of the child with spastic choreoathetosis using a wheelchair isn’t considered an interruption because “that’s just the way she is.”

However, there seems to be an invisible line that separates those children who seem to be incapable of stopping their potentially disruptive behavior from those children we assume “ought to know better” or whose parents we believe have failed at instilling even the most basic discipline. You can certainly question the validity of those assumptions. But it is clear that your new patient’s disruptive behavior is interfering with his classmates’ education, and in some cases threatening their health. Your patient with trichotillomania is probably the canary in a very unsettled mine.

Your dilemma as the pediatrician for these two boys is the same we face as a society. How do you effectively advocate for a positive educational atmosphere for children with a variety of special needs, some of which seem to be in direct conflict? You can ask the school system to be patient as you help the disruptive child get connected with the services he needs. But you know that could take several months at a minimum. Meanwhile your hair-pulling patient and his classmates are losing valuable educational opportunities by the day.

I don’t have the answer, but I suspect that somehow it is going to come down to affordability. Counseling, psychiatrists, and one on one classroom aids don’t come cheap, nor does the tuition for a special school in another school district. But we can’t discount the value of an education free of disruption.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected]

 

Your first patient of the afternoon is a 9-year-old boy who moved to town several months ago. Mercifully, the second patient of the afternoon has canceled, giving you a few more minutes to get acquainted with this young man whose chief complaint is listed as “behavior problem.” You learn quickly that this family has relocated from a town just 20 miles away because they are seeking a school that is a “better fit” for your new patient.

Due to some miscommunications, the child’s old records have not arrived at your office. The mother says that her son is not taking any medication, and she isn’t sure if he has ever been given a diagnosis. You learn that he likes to argue and is prone to violent temper tantrums. Your initial brief exam does not suggest any cognitive deficits, but he exudes an aura of anger and discontent. You tell his mother that you will be glad to try to help, but you will need his old records and another longer visit before you can make any recommendations.

Two days later you see a fourth-grader you have known since birth. He rarely comes to the office with problems, but you understand that he is a good student, a competent athlete, and socially engaged. His chief complaint for this visit is “hair loss,” but you soon discover that he has trichotillomania and has recently begun having nightmares and experiencing enuresis. All of these symptoms began a month ago with arrival of a new student in his class whose violent outbursts have become increasingly more physical. I have borrowed this child’s scenario from a similar case study in a recent supplement to the Journal of Developmental & Behavioral Pediatrics titled, “Behavioral Changes Associated with a Disruptive New Student in the Classroom,” (J Dev Behav Pediatr. Feb/Mar 2017. doi: 10.1097/DBP.0000000000000175).

The afternoon following your visit with the hair-pulling fourth-grader, you receive the new patient’s records for which you have been waiting. The circle is completed as you read that this is his third school in 18 months, and the reports of his behavior make it clear that your two patients are classmates. This scenario of coincidence could easily have occurred in a small town like Brunswick, Maine, where I practiced, but I have manufactured it to raise several questions about social priorities and professional ethics.

Forty years ago, institutions housing individuals with Down syndrome started closing and the process of integrating children with a variety of cognitive and physical disabilities into traditional classrooms began. To the surprise of some people, this mainstreaming has generally gone well. Unfortunately, funding hasn’t always caught up with the demand for services. For the most part, children readily accept their challenged classmates who look, move, and sound different. The flailing and grunting of the child with spastic choreoathetosis using a wheelchair isn’t considered an interruption because “that’s just the way she is.”

However, there seems to be an invisible line that separates those children who seem to be incapable of stopping their potentially disruptive behavior from those children we assume “ought to know better” or whose parents we believe have failed at instilling even the most basic discipline. You can certainly question the validity of those assumptions. But it is clear that your new patient’s disruptive behavior is interfering with his classmates’ education, and in some cases threatening their health. Your patient with trichotillomania is probably the canary in a very unsettled mine.

Your dilemma as the pediatrician for these two boys is the same we face as a society. How do you effectively advocate for a positive educational atmosphere for children with a variety of special needs, some of which seem to be in direct conflict? You can ask the school system to be patient as you help the disruptive child get connected with the services he needs. But you know that could take several months at a minimum. Meanwhile your hair-pulling patient and his classmates are losing valuable educational opportunities by the day.

I don’t have the answer, but I suspect that somehow it is going to come down to affordability. Counseling, psychiatrists, and one on one classroom aids don’t come cheap, nor does the tuition for a special school in another school district. But we can’t discount the value of an education free of disruption.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected]

“Create a safe zone where anything can gain expression.”

– Carl Rogers, PhD

The patient

“I have no purpose,” Audrey said. She sat immobile, a woman of 45 who looked 10 years older. Audrey hated New York, the crowds, the weather. Her husband, a successful sales executive, supported her; a month earlier, they had moved from California to New York. Her depression and panic attacks dated back to childhood. She also suffered from arthritis, asthma, and lupus. Audrey told me that her parents, long dead, were dreadful. “My mother was the most abusive person. She put out cigarettes on my arm; beat the s*** out of me, my brother, and sister.” She said that in New York, she stayed in her apartment on her couch or shopped for clothes that, ultimately, remained in the closet.

According to Audrey, nothing helped. She was on psychoactive medications prescribed by her Beverly Hills psychiatrist – Cymbalta and Wellbutrin for depression, Klonopin for anxiety, Abilify for agitation. She also took Neurontin for nerve pain and opioids for arthritis, prescribed by a pain specialist.
 

The process

She was suffering from the trauma of losing a father when she was 3, and living with a mother who tortured her and interfered in her psychiatric treatment throughout adolescence. Audrey’s mother would insist on joining the session or breaking off therapy before it could be effective. Audrey was articulate and intelligent, a patient who could benefit from insight-oriented psychotherapy. We discussed additional options, including cognitive-behavioral therapy, meditation, and dynamic group therapy. Audrey wanted monthly sessions with me, mostly to discuss medication and how to tweak it. She discredited psychotherapy, so we settled for what I considered to be less than optimal care.

In residency and beyond, psychiatrists learn to develop a treatment plan based on the patient’s history and symptoms. Some individuals want to understand the origin of their suffering with a thrust toward recovery and independence. Others lack that capacity and need to shore up their defenses through supportive intervention. The direction of how to proceed is often a compromise between what the doctor sees as ideal and what the patient desires.
 

Outcome

All seemed stagnant for 2 years. Then, Audrey’s demeanor changed dramatically. She enjoyed walking her dog in Central Park; she reflected on her devoted husband, who encouraged her. Audrey’s transformation progressed.

Three months later, her husband took a position in Montreal. On a visit to New York, she told me that she no longer disliked the city, even the noise and the cold weather. I questioned what made the difference. “You saved my life,” Audrey said. I asked what she meant. “You were always there for me,” she said. “You made an effort to try to help me get better. ... You can be funny, witty.” She ventured that she had been through “a change of life, maybe a midlife crisis.” She made new friends in Montreal. “I’m getting rid of the negative people.” Audrey planned to continue psychiatric care in Montreal. In part, Audrey credited improvement to our sessions, and I told her I was grateful to be of help.

Another case

Arthur was a seriously ill, 88-year-old retired pulmonologist, so weak that he was being spoon-fed when I entered his room. He had a “fear of dying or living with disability” from diffuse lymphoma, complicated by tumor lysis syndrome after chemotherapy. “I don’t want to give up, for myself and my family,” he said.

Arthur told me about his struggles to achieve despite poverty in childhood. He needed a scholarship to attend a local college. There were trials at a medical school that failed out less capable students. He commuted and studied at the kitchen table until 3 a.m. Arthur’s mother-in-law had disapproved of him and wanted her daughter to marry a wealthy businessman. During their courtship, Arthur gave his girlfriend a gold bracelet, which he said she should keep it regardless of whether they broke up.

Arthur had a modest evaluation of his capabilities despite a good practice. Meanwhile, his home life progressed: Two of his three children became doctors; the third succeeded as an accountant. His marriage thrived.

At the end of our session, I expressed surprise that his mother-in-law had taken such a dim view of a suitor with determination, impressive credentials, and a future that would be a source of pride. I also assured him that he had chosen fine doctors for his care.

The next time I visited Arthur, he heaped praise on me for turning his life around. I had restored his hope. His daughter, who was visiting later, told me that, no matter how much the family and medical staff encouraged Arthur, “nothing happened until he met you.” I, of course, thanked Arthur for his gratitude and experienced amazement at the success of the talking cure.

 

Lessons learned

These examples fail to prove that the unraveling of psychodynamics has lost its place. And there is value in the variety of treatment and medications psychiatrists that can offer. But exceptions occur. Do they show there is magic in transference? Is there an ideal way for a therapist to behave? Should we influence the patient by giving advice or wait until he reaches conclusions? Psychiatrists try to free the patient from his suffering, enhancing his perspective, ultimately his independence. How often do we fail to understand how that happens when it does occur?

The flight into health

The early or sudden disappearance of symptoms is referred to as a flight into health, a perhaps-outdated concept that presents “a defense against the anxiety engendered by the prospect of further psychoanalytic exploration of the patient’s conflict” (Farlex Partner Medical Dictionary, 2012). Some patients settle for less. Either they reach their own conclusions, as did Audrey, or they unburden themselves to a compassionate listener, as did Arthur.

What to conclude

The methodical sometimes exists in psychiatric treatment but often not. The practice of medicine is based on science. As described by writer Lisa Randall in a review of the book “Reality Is Not What It Seems: The Journey to Quantum Gravity” (New York: Riverhead Books, 2017): “Science provides a systematic method of building up from the measured and tested … to realms that we don’t yet understand because measurements are not yet sufficiently precise or are too outside our limited perspective” (New York Times Book Review, March 5, 2017, p. 15). The author was describing physics, but her insight applies to medical specialties as well. It is alluring to try to understand our patients. The complexity of mental illness challenges psychiatrists to use science, compassion, and intuition.

Dr. Cohen is in private practice and is a clinical assistant professor of psychiatry at Weill Cornell Medical Center of New York-Presbyterian Hospital, and psychiatric consultant at the Hospital for Special Surgery, also in New York. She made changes to the patient narratives to protect their identities.

“Create a safe zone where anything can gain expression.”

– Carl Rogers, PhD

The patient

“I have no purpose,” Audrey said. She sat immobile, a woman of 45 who looked 10 years older. Audrey hated New York, the crowds, the weather. Her husband, a successful sales executive, supported her; a month earlier, they had moved from California to New York. Her depression and panic attacks dated back to childhood. She also suffered from arthritis, asthma, and lupus. Audrey told me that her parents, long dead, were dreadful. “My mother was the most abusive person. She put out cigarettes on my arm; beat the s*** out of me, my brother, and sister.” She said that in New York, she stayed in her apartment on her couch or shopped for clothes that, ultimately, remained in the closet.

According to Audrey, nothing helped. She was on psychoactive medications prescribed by her Beverly Hills psychiatrist – Cymbalta and Wellbutrin for depression, Klonopin for anxiety, Abilify for agitation. She also took Neurontin for nerve pain and opioids for arthritis, prescribed by a pain specialist.
 

The process

She was suffering from the trauma of losing a father when she was 3, and living with a mother who tortured her and interfered in her psychiatric treatment throughout adolescence. Audrey’s mother would insist on joining the session or breaking off therapy before it could be effective. Audrey was articulate and intelligent, a patient who could benefit from insight-oriented psychotherapy. We discussed additional options, including cognitive-behavioral therapy, meditation, and dynamic group therapy. Audrey wanted monthly sessions with me, mostly to discuss medication and how to tweak it. She discredited psychotherapy, so we settled for what I considered to be less than optimal care.

In residency and beyond, psychiatrists learn to develop a treatment plan based on the patient’s history and symptoms. Some individuals want to understand the origin of their suffering with a thrust toward recovery and independence. Others lack that capacity and need to shore up their defenses through supportive intervention. The direction of how to proceed is often a compromise between what the doctor sees as ideal and what the patient desires.
 

Outcome

All seemed stagnant for 2 years. Then, Audrey’s demeanor changed dramatically. She enjoyed walking her dog in Central Park; she reflected on her devoted husband, who encouraged her. Audrey’s transformation progressed.

Three months later, her husband took a position in Montreal. On a visit to New York, she told me that she no longer disliked the city, even the noise and the cold weather. I questioned what made the difference. “You saved my life,” Audrey said. I asked what she meant. “You were always there for me,” she said. “You made an effort to try to help me get better. ... You can be funny, witty.” She ventured that she had been through “a change of life, maybe a midlife crisis.” She made new friends in Montreal. “I’m getting rid of the negative people.” Audrey planned to continue psychiatric care in Montreal. In part, Audrey credited improvement to our sessions, and I told her I was grateful to be of help.

Another case

Arthur was a seriously ill, 88-year-old retired pulmonologist, so weak that he was being spoon-fed when I entered his room. He had a “fear of dying or living with disability” from diffuse lymphoma, complicated by tumor lysis syndrome after chemotherapy. “I don’t want to give up, for myself and my family,” he said.

Arthur told me about his struggles to achieve despite poverty in childhood. He needed a scholarship to attend a local college. There were trials at a medical school that failed out less capable students. He commuted and studied at the kitchen table until 3 a.m. Arthur’s mother-in-law had disapproved of him and wanted her daughter to marry a wealthy businessman. During their courtship, Arthur gave his girlfriend a gold bracelet, which he said she should keep it regardless of whether they broke up.

Arthur had a modest evaluation of his capabilities despite a good practice. Meanwhile, his home life progressed: Two of his three children became doctors; the third succeeded as an accountant. His marriage thrived.

At the end of our session, I expressed surprise that his mother-in-law had taken such a dim view of a suitor with determination, impressive credentials, and a future that would be a source of pride. I also assured him that he had chosen fine doctors for his care.

The next time I visited Arthur, he heaped praise on me for turning his life around. I had restored his hope. His daughter, who was visiting later, told me that, no matter how much the family and medical staff encouraged Arthur, “nothing happened until he met you.” I, of course, thanked Arthur for his gratitude and experienced amazement at the success of the talking cure.

 

Lessons learned

These examples fail to prove that the unraveling of psychodynamics has lost its place. And there is value in the variety of treatment and medications psychiatrists that can offer. But exceptions occur. Do they show there is magic in transference? Is there an ideal way for a therapist to behave? Should we influence the patient by giving advice or wait until he reaches conclusions? Psychiatrists try to free the patient from his suffering, enhancing his perspective, ultimately his independence. How often do we fail to understand how that happens when it does occur?

The flight into health

The early or sudden disappearance of symptoms is referred to as a flight into health, a perhaps-outdated concept that presents “a defense against the anxiety engendered by the prospect of further psychoanalytic exploration of the patient’s conflict” (Farlex Partner Medical Dictionary, 2012). Some patients settle for less. Either they reach their own conclusions, as did Audrey, or they unburden themselves to a compassionate listener, as did Arthur.

What to conclude

The methodical sometimes exists in psychiatric treatment but often not. The practice of medicine is based on science. As described by writer Lisa Randall in a review of the book “Reality Is Not What It Seems: The Journey to Quantum Gravity” (New York: Riverhead Books, 2017): “Science provides a systematic method of building up from the measured and tested … to realms that we don’t yet understand because measurements are not yet sufficiently precise or are too outside our limited perspective” (New York Times Book Review, March 5, 2017, p. 15). The author was describing physics, but her insight applies to medical specialties as well. It is alluring to try to understand our patients. The complexity of mental illness challenges psychiatrists to use science, compassion, and intuition.

Dr. Cohen is in private practice and is a clinical assistant professor of psychiatry at Weill Cornell Medical Center of New York-Presbyterian Hospital, and psychiatric consultant at the Hospital for Special Surgery, also in New York. She made changes to the patient narratives to protect their identities.

“Create a safe zone where anything can gain expression.”

– Carl Rogers, PhD

The patient

“I have no purpose,” Audrey said. She sat immobile, a woman of 45 who looked 10 years older. Audrey hated New York, the crowds, the weather. Her husband, a successful sales executive, supported her; a month earlier, they had moved from California to New York. Her depression and panic attacks dated back to childhood. She also suffered from arthritis, asthma, and lupus. Audrey told me that her parents, long dead, were dreadful. “My mother was the most abusive person. She put out cigarettes on my arm; beat the s*** out of me, my brother, and sister.” She said that in New York, she stayed in her apartment on her couch or shopped for clothes that, ultimately, remained in the closet.

According to Audrey, nothing helped. She was on psychoactive medications prescribed by her Beverly Hills psychiatrist – Cymbalta and Wellbutrin for depression, Klonopin for anxiety, Abilify for agitation. She also took Neurontin for nerve pain and opioids for arthritis, prescribed by a pain specialist.
 

The process

She was suffering from the trauma of losing a father when she was 3, and living with a mother who tortured her and interfered in her psychiatric treatment throughout adolescence. Audrey’s mother would insist on joining the session or breaking off therapy before it could be effective. Audrey was articulate and intelligent, a patient who could benefit from insight-oriented psychotherapy. We discussed additional options, including cognitive-behavioral therapy, meditation, and dynamic group therapy. Audrey wanted monthly sessions with me, mostly to discuss medication and how to tweak it. She discredited psychotherapy, so we settled for what I considered to be less than optimal care.

In residency and beyond, psychiatrists learn to develop a treatment plan based on the patient’s history and symptoms. Some individuals want to understand the origin of their suffering with a thrust toward recovery and independence. Others lack that capacity and need to shore up their defenses through supportive intervention. The direction of how to proceed is often a compromise between what the doctor sees as ideal and what the patient desires.
 

Outcome

All seemed stagnant for 2 years. Then, Audrey’s demeanor changed dramatically. She enjoyed walking her dog in Central Park; she reflected on her devoted husband, who encouraged her. Audrey’s transformation progressed.

Three months later, her husband took a position in Montreal. On a visit to New York, she told me that she no longer disliked the city, even the noise and the cold weather. I questioned what made the difference. “You saved my life,” Audrey said. I asked what she meant. “You were always there for me,” she said. “You made an effort to try to help me get better. ... You can be funny, witty.” She ventured that she had been through “a change of life, maybe a midlife crisis.” She made new friends in Montreal. “I’m getting rid of the negative people.” Audrey planned to continue psychiatric care in Montreal. In part, Audrey credited improvement to our sessions, and I told her I was grateful to be of help.

Another case

Arthur was a seriously ill, 88-year-old retired pulmonologist, so weak that he was being spoon-fed when I entered his room. He had a “fear of dying or living with disability” from diffuse lymphoma, complicated by tumor lysis syndrome after chemotherapy. “I don’t want to give up, for myself and my family,” he said.

Arthur told me about his struggles to achieve despite poverty in childhood. He needed a scholarship to attend a local college. There were trials at a medical school that failed out less capable students. He commuted and studied at the kitchen table until 3 a.m. Arthur’s mother-in-law had disapproved of him and wanted her daughter to marry a wealthy businessman. During their courtship, Arthur gave his girlfriend a gold bracelet, which he said she should keep it regardless of whether they broke up.

Arthur had a modest evaluation of his capabilities despite a good practice. Meanwhile, his home life progressed: Two of his three children became doctors; the third succeeded as an accountant. His marriage thrived.

At the end of our session, I expressed surprise that his mother-in-law had taken such a dim view of a suitor with determination, impressive credentials, and a future that would be a source of pride. I also assured him that he had chosen fine doctors for his care.

The next time I visited Arthur, he heaped praise on me for turning his life around. I had restored his hope. His daughter, who was visiting later, told me that, no matter how much the family and medical staff encouraged Arthur, “nothing happened until he met you.” I, of course, thanked Arthur for his gratitude and experienced amazement at the success of the talking cure.

 

Lessons learned

These examples fail to prove that the unraveling of psychodynamics has lost its place. And there is value in the variety of treatment and medications psychiatrists that can offer. But exceptions occur. Do they show there is magic in transference? Is there an ideal way for a therapist to behave? Should we influence the patient by giving advice or wait until he reaches conclusions? Psychiatrists try to free the patient from his suffering, enhancing his perspective, ultimately his independence. How often do we fail to understand how that happens when it does occur?

The flight into health

The early or sudden disappearance of symptoms is referred to as a flight into health, a perhaps-outdated concept that presents “a defense against the anxiety engendered by the prospect of further psychoanalytic exploration of the patient’s conflict” (Farlex Partner Medical Dictionary, 2012). Some patients settle for less. Either they reach their own conclusions, as did Audrey, or they unburden themselves to a compassionate listener, as did Arthur.

What to conclude

The methodical sometimes exists in psychiatric treatment but often not. The practice of medicine is based on science. As described by writer Lisa Randall in a review of the book “Reality Is Not What It Seems: The Journey to Quantum Gravity” (New York: Riverhead Books, 2017): “Science provides a systematic method of building up from the measured and tested … to realms that we don’t yet understand because measurements are not yet sufficiently precise or are too outside our limited perspective” (New York Times Book Review, March 5, 2017, p. 15). The author was describing physics, but her insight applies to medical specialties as well. It is alluring to try to understand our patients. The complexity of mental illness challenges psychiatrists to use science, compassion, and intuition.

Dr. Cohen is in private practice and is a clinical assistant professor of psychiatry at Weill Cornell Medical Center of New York-Presbyterian Hospital, and psychiatric consultant at the Hospital for Special Surgery, also in New York. She made changes to the patient narratives to protect their identities.

 

The best way to minimize death and disability in most patients having an acute ischemic stroke is rapid thrombolysis by infusion of tissue plasminogen activator. Mechanical clot removal – thrombectomy – has recently been shown even better, but it’s applicable to just a fraction of these stroke patients, and even for them thrombolysis remains, for the time being, the recommended first step, with thrombectomy following soon after.

The good news is that more eligible U.S. stroke patients than ever before get this effective treatment. As I reported recently from the International Stroke Conference, as of mid-2016, 68% of U.S. acute ischemic stroke patients treated at about 2,000 of the largest and most focused U.S. stroke hospitals received thrombolytic treatment within 60 minutes of their hospital arrival. That’s up from 30% in late 2009. Hooray! The sad news is that many eligible stroke patients seen at these hospitals don’t get treated this way. Simple math puts that figure at 32%. In other words, last year, nearly a third of U.S. stroke patients who should have received quick thrombolysis didn’t, even though they were taken to the country’s top stroke hospitals.

Courtesy American Heart Association

Even sadder, hospitals and stroke programs know what it takes to quickly deliver treatment with tissue plasminogen activator to virtually all eligible patients, but for whatever reason they have balked at putting this knowledge into practice.

How do I know that more universal rapid thrombolysis is possible? The 2016 numbers reported from the Get With the Guidelines (GWTG)–Stroke hospitals showed that roughly 2% of the 788 hospitals included in this analysis treated 90% or more of their eligible stroke patients with thrombolysis within an hour. That’s about 16 hospitals. Another 8%, upward of 60 hospitals, treated 80%-89% of their eligible stroke patients within this window. So a high level of thrombolysis treatment is possible. It just isn’t being done everywhere. About 20% of the hospitals in the program treated 40% or fewer of eligible patients they saw within the 60-minute window.

I have no idea why some hospitals do so well while others don’t, despite being in the GWTG-Stroke program that promotes excellence in stroke care delivery. In the most recent iteration of the GWTG–Stroke Target Stroke program, phase II, the organization promoted 11 steps for hospitals to take to optimize rapid delivery of thrombolysis. The obvious inference is that some hospitals are doing all 11 steps very well and consistently, and many others aren’t. Underperforming hospitals owe it to their patients to do a much better job; the top-performing hospitals show it’s possible.

I have heard a lot recently at meetings about how research has established that a range of medical treatments, if used diligently by patients as directed, will substantially improve and prolong their life. Patient compliance then becomes a big issue, and so now I’m hearing more about new approaches to improve compliance. But what about hospital compliance?

Treating acute ischemic stroke as well as possible is different from most disorders – it’s not about patient compliance. It’s about the ambulance that picks up the patient and the hospital where the patient gets taken. The success or failure of the acute treatment that the roughly 700,000 annual U.S. acute ischemic stroke patients receive lies entirely in the hands of the hospital staff. Fewer than 10% of U.S. stroke hospitals offer the vast majority of these patients the best care currently available. Many others don’t do as well, and a huge fraction remain woefully slow, even though everyone knows the pathway to doing better. Underperforming hospitals owe it to patients to up their game, and they need to start doing it now.

[email protected]

On Twitter @mitchelzoler

 

The best way to minimize death and disability in most patients having an acute ischemic stroke is rapid thrombolysis by infusion of tissue plasminogen activator. Mechanical clot removal – thrombectomy – has recently been shown even better, but it’s applicable to just a fraction of these stroke patients, and even for them thrombolysis remains, for the time being, the recommended first step, with thrombectomy following soon after.

The good news is that more eligible U.S. stroke patients than ever before get this effective treatment. As I reported recently from the International Stroke Conference, as of mid-2016, 68% of U.S. acute ischemic stroke patients treated at about 2,000 of the largest and most focused U.S. stroke hospitals received thrombolytic treatment within 60 minutes of their hospital arrival. That’s up from 30% in late 2009. Hooray! The sad news is that many eligible stroke patients seen at these hospitals don’t get treated this way. Simple math puts that figure at 32%. In other words, last year, nearly a third of U.S. stroke patients who should have received quick thrombolysis didn’t, even though they were taken to the country’s top stroke hospitals.

Courtesy American Heart Association

Even sadder, hospitals and stroke programs know what it takes to quickly deliver treatment with tissue plasminogen activator to virtually all eligible patients, but for whatever reason they have balked at putting this knowledge into practice.

How do I know that more universal rapid thrombolysis is possible? The 2016 numbers reported from the Get With the Guidelines (GWTG)–Stroke hospitals showed that roughly 2% of the 788 hospitals included in this analysis treated 90% or more of their eligible stroke patients with thrombolysis within an hour. That’s about 16 hospitals. Another 8%, upward of 60 hospitals, treated 80%-89% of their eligible stroke patients within this window. So a high level of thrombolysis treatment is possible. It just isn’t being done everywhere. About 20% of the hospitals in the program treated 40% or fewer of eligible patients they saw within the 60-minute window.

I have no idea why some hospitals do so well while others don’t, despite being in the GWTG-Stroke program that promotes excellence in stroke care delivery. In the most recent iteration of the GWTG–Stroke Target Stroke program, phase II, the organization promoted 11 steps for hospitals to take to optimize rapid delivery of thrombolysis. The obvious inference is that some hospitals are doing all 11 steps very well and consistently, and many others aren’t. Underperforming hospitals owe it to their patients to do a much better job; the top-performing hospitals show it’s possible.

I have heard a lot recently at meetings about how research has established that a range of medical treatments, if used diligently by patients as directed, will substantially improve and prolong their life. Patient compliance then becomes a big issue, and so now I’m hearing more about new approaches to improve compliance. But what about hospital compliance?

Treating acute ischemic stroke as well as possible is different from most disorders – it’s not about patient compliance. It’s about the ambulance that picks up the patient and the hospital where the patient gets taken. The success or failure of the acute treatment that the roughly 700,000 annual U.S. acute ischemic stroke patients receive lies entirely in the hands of the hospital staff. Fewer than 10% of U.S. stroke hospitals offer the vast majority of these patients the best care currently available. Many others don’t do as well, and a huge fraction remain woefully slow, even though everyone knows the pathway to doing better. Underperforming hospitals owe it to patients to up their game, and they need to start doing it now.

[email protected]

On Twitter @mitchelzoler

 

The best way to minimize death and disability in most patients having an acute ischemic stroke is rapid thrombolysis by infusion of tissue plasminogen activator. Mechanical clot removal – thrombectomy – has recently been shown even better, but it’s applicable to just a fraction of these stroke patients, and even for them thrombolysis remains, for the time being, the recommended first step, with thrombectomy following soon after.

The good news is that more eligible U.S. stroke patients than ever before get this effective treatment. As I reported recently from the International Stroke Conference, as of mid-2016, 68% of U.S. acute ischemic stroke patients treated at about 2,000 of the largest and most focused U.S. stroke hospitals received thrombolytic treatment within 60 minutes of their hospital arrival. That’s up from 30% in late 2009. Hooray! The sad news is that many eligible stroke patients seen at these hospitals don’t get treated this way. Simple math puts that figure at 32%. In other words, last year, nearly a third of U.S. stroke patients who should have received quick thrombolysis didn’t, even though they were taken to the country’s top stroke hospitals.

Courtesy American Heart Association

Even sadder, hospitals and stroke programs know what it takes to quickly deliver treatment with tissue plasminogen activator to virtually all eligible patients, but for whatever reason they have balked at putting this knowledge into practice.

How do I know that more universal rapid thrombolysis is possible? The 2016 numbers reported from the Get With the Guidelines (GWTG)–Stroke hospitals showed that roughly 2% of the 788 hospitals included in this analysis treated 90% or more of their eligible stroke patients with thrombolysis within an hour. That’s about 16 hospitals. Another 8%, upward of 60 hospitals, treated 80%-89% of their eligible stroke patients within this window. So a high level of thrombolysis treatment is possible. It just isn’t being done everywhere. About 20% of the hospitals in the program treated 40% or fewer of eligible patients they saw within the 60-minute window.

I have no idea why some hospitals do so well while others don’t, despite being in the GWTG-Stroke program that promotes excellence in stroke care delivery. In the most recent iteration of the GWTG–Stroke Target Stroke program, phase II, the organization promoted 11 steps for hospitals to take to optimize rapid delivery of thrombolysis. The obvious inference is that some hospitals are doing all 11 steps very well and consistently, and many others aren’t. Underperforming hospitals owe it to their patients to do a much better job; the top-performing hospitals show it’s possible.

I have heard a lot recently at meetings about how research has established that a range of medical treatments, if used diligently by patients as directed, will substantially improve and prolong their life. Patient compliance then becomes a big issue, and so now I’m hearing more about new approaches to improve compliance. But what about hospital compliance?

Treating acute ischemic stroke as well as possible is different from most disorders – it’s not about patient compliance. It’s about the ambulance that picks up the patient and the hospital where the patient gets taken. The success or failure of the acute treatment that the roughly 700,000 annual U.S. acute ischemic stroke patients receive lies entirely in the hands of the hospital staff. Fewer than 10% of U.S. stroke hospitals offer the vast majority of these patients the best care currently available. Many others don’t do as well, and a huge fraction remain woefully slow, even though everyone knows the pathway to doing better. Underperforming hospitals owe it to patients to up their game, and they need to start doing it now.

[email protected]

On Twitter @mitchelzoler

 

Question: Which of the following is correct?

A. The False Claims Act dates back to the Civil War era.

B. The FCA covers only patently false statements.

C. Material misrepresentation is insufficient.

D. Negligence constitutes a violation.

E. A qui tam lawsuit under FCA refers to a third party who has suffered personal harm.

Answer: A. The False Claims Act (FCA) is an old law, enacted by Congress in 1863 to impose liability for submitting a payment demand to the federal government when there is actual or constructive knowledge that the claim is false.¹ Many states now have their own versions of FCA.

Intent to defraud is not a required element, but knowing or reckless disregard of the truth or material misrepresentation are – whereas negligence is insufficient to constitute a violation.

Penalties include treble damages, costs, and attorney fees, as well as fines of $11,000 per false claim and possible imprisonment. Although FCA is the most prominent health care antifraud statute, there are many others, such as the antikickback statute, the Stark Law, HIPAA, and general criminal statutes covering theft, embezzlement, obstruction of criminal investigations, false statements, mail/wire fraud, and so on.

In the health care field, FCA most commonly involves false claims made to Medicare or Medicaid. Pitfalls include billing for noncovered services such as experimental treatments, double billing, unnecessary services, billing the government as the primary payer when inappropriate, or regularly waiving deductibles and copayments.

Other activities that constitute wrongdoing in this context include knowingly using another patient’s name for purposes of federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services.

The electronic medical record enables easy check-offs as documentation of actual work done, and fraud is implicated if the information is deliberately misleading, as in the example of upcoding.

Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all billing activities. Aggrieved or disgruntled employees or contractors, popularly known as whistle-blowers, can file a qui tam action. They stand to collect a substantial bounty, up to 30% of the proceeds. They do not have to show legal standing and need not sustain any personal injury.

FCA prosecutions are daily affairs, with egregious examples regularly making the news headlines. A few random pickings might give you an idea of the problem:

In 2015, in its largest case of health care fraud, the federal Department of Justice filed criminal charges against 243 individuals across the nation. Some of the violations included billings for intensive psychotherapy sessions for noncommunicative dementia patients, simply moving patients to different locations, and fraudulent prescriptions under Medicare Part D.

In 2016, a pain management clinic used “ill-equipped, desperate doctors in dire need of work” to write faked prescriptions for narcotics. The clinic owner, a doctor, was sentenced to 144 months in prison for running what was described as a “pill-mill zoo.”

Arguably, the most dramatic physician case occurred in 2017 and involved a Florida dermatologist who settled with the government for $18 million for treating patients for skin cancer they did not have. The action came from a qui tam lawsuit filed by another dermatologist.

A major development in the false claims law came with last year’s U.S. Supreme Court decision in Universal Health Services v. Escobar.²

This landmark case dealt with claims made by Arbour Counseling Services to the Massachusetts’ Medicaid program for mental health counseling and prescriptions, a satellite mental health facility of Universal Health Services. It turned out that relatively few Arbour employees were actually licensed to provide mental health counseling or authorized to prescribe medications. A death resulted from a reaction to an unlicensed prescription.

In a unanimous decision, the Supreme Court held that there can be FCA liability when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements. Technically referred to as “implied false certification,” such material omissions may amount to a misrepresentation and may be deemed fraudulent, even if the requirements were not expressly designated as conditions of payment.

In the words of the court, “Today’s decision holds that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.”

The implied false certification, or implied fraud, ruling has widespread implications, as it does not require a patently false statement. A material misrepresentation or omission may suffice.

There is concern that this ruling will open the floodgates of FCA prosecution. However, the federal Ninth Circuit Court of Appeals has recently quashed an attempt to invoke the implied certification claim in an FCA suit against DJO Global and Biomet, brought by a medical device salesman and his private investigator. Their rejected whistle-blower suit alleged that the defendants were providing their spinal bone growth stimulation devices for use on the cervical spine, even though Food and Drug Administration approval was for use only on the lumbar spine.

Another concern is, can an alleged wrong prognosis regarding life expectancy amount to a false claim?

Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.

AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice who did not have a life expectancy of 6 months or less. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis. Thus, AseraCare’s claims for those patients were false.

The case brought out the conflicting views of physicians: Did the medical records supported AseraCare’s certifications that the patients were eligible? The defendants argued that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.

AseraCare won a summary judgment defending against the $200 million lawsuit in the U.S. District Court for the Northern District of Alabama.³ In a memorandum opinion, the court began with Blaise Pascal’s axiom that “Contradiction is not a sign of falsity, nor the lack of contradiction the sign of truth.” Federal prosecutors have appealed to the federal 11th Circuit Court of Appeals, which recently heard oral arguments. Its decision is pending.

In support of the hospice center physicians, the American Medical Association and other organizations have filed an amicus brief asserting that a physician’s opinion may be deemed false only if no reasonable physician could hold that opinion.

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].

References

1. 31 U.S. Code, Section 3729(a)(1)(A).

2. Universal Health Services v. United States ex rel. Escobar, 579 U.S. ____ (2016).

3. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., Case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama.
 

 

Question: Which of the following is correct?

A. The False Claims Act dates back to the Civil War era.

B. The FCA covers only patently false statements.

C. Material misrepresentation is insufficient.

D. Negligence constitutes a violation.

E. A qui tam lawsuit under FCA refers to a third party who has suffered personal harm.

Answer: A. The False Claims Act (FCA) is an old law, enacted by Congress in 1863 to impose liability for submitting a payment demand to the federal government when there is actual or constructive knowledge that the claim is false.¹ Many states now have their own versions of FCA.

Intent to defraud is not a required element, but knowing or reckless disregard of the truth or material misrepresentation are – whereas negligence is insufficient to constitute a violation.

Penalties include treble damages, costs, and attorney fees, as well as fines of $11,000 per false claim and possible imprisonment. Although FCA is the most prominent health care antifraud statute, there are many others, such as the antikickback statute, the Stark Law, HIPAA, and general criminal statutes covering theft, embezzlement, obstruction of criminal investigations, false statements, mail/wire fraud, and so on.

In the health care field, FCA most commonly involves false claims made to Medicare or Medicaid. Pitfalls include billing for noncovered services such as experimental treatments, double billing, unnecessary services, billing the government as the primary payer when inappropriate, or regularly waiving deductibles and copayments.

Other activities that constitute wrongdoing in this context include knowingly using another patient’s name for purposes of federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services.

The electronic medical record enables easy check-offs as documentation of actual work done, and fraud is implicated if the information is deliberately misleading, as in the example of upcoding.

Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all billing activities. Aggrieved or disgruntled employees or contractors, popularly known as whistle-blowers, can file a qui tam action. They stand to collect a substantial bounty, up to 30% of the proceeds. They do not have to show legal standing and need not sustain any personal injury.

FCA prosecutions are daily affairs, with egregious examples regularly making the news headlines. A few random pickings might give you an idea of the problem:

In 2015, in its largest case of health care fraud, the federal Department of Justice filed criminal charges against 243 individuals across the nation. Some of the violations included billings for intensive psychotherapy sessions for noncommunicative dementia patients, simply moving patients to different locations, and fraudulent prescriptions under Medicare Part D.

In 2016, a pain management clinic used “ill-equipped, desperate doctors in dire need of work” to write faked prescriptions for narcotics. The clinic owner, a doctor, was sentenced to 144 months in prison for running what was described as a “pill-mill zoo.”

Arguably, the most dramatic physician case occurred in 2017 and involved a Florida dermatologist who settled with the government for $18 million for treating patients for skin cancer they did not have. The action came from a qui tam lawsuit filed by another dermatologist.

A major development in the false claims law came with last year’s U.S. Supreme Court decision in Universal Health Services v. Escobar.²

This landmark case dealt with claims made by Arbour Counseling Services to the Massachusetts’ Medicaid program for mental health counseling and prescriptions, a satellite mental health facility of Universal Health Services. It turned out that relatively few Arbour employees were actually licensed to provide mental health counseling or authorized to prescribe medications. A death resulted from a reaction to an unlicensed prescription.

In a unanimous decision, the Supreme Court held that there can be FCA liability when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements. Technically referred to as “implied false certification,” such material omissions may amount to a misrepresentation and may be deemed fraudulent, even if the requirements were not expressly designated as conditions of payment.

In the words of the court, “Today’s decision holds that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.”

The implied false certification, or implied fraud, ruling has widespread implications, as it does not require a patently false statement. A material misrepresentation or omission may suffice.

There is concern that this ruling will open the floodgates of FCA prosecution. However, the federal Ninth Circuit Court of Appeals has recently quashed an attempt to invoke the implied certification claim in an FCA suit against DJO Global and Biomet, brought by a medical device salesman and his private investigator. Their rejected whistle-blower suit alleged that the defendants were providing their spinal bone growth stimulation devices for use on the cervical spine, even though Food and Drug Administration approval was for use only on the lumbar spine.

Another concern is, can an alleged wrong prognosis regarding life expectancy amount to a false claim?

Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.

AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice who did not have a life expectancy of 6 months or less. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis. Thus, AseraCare’s claims for those patients were false.

The case brought out the conflicting views of physicians: Did the medical records supported AseraCare’s certifications that the patients were eligible? The defendants argued that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.

AseraCare won a summary judgment defending against the $200 million lawsuit in the U.S. District Court for the Northern District of Alabama.³ In a memorandum opinion, the court began with Blaise Pascal’s axiom that “Contradiction is not a sign of falsity, nor the lack of contradiction the sign of truth.” Federal prosecutors have appealed to the federal 11th Circuit Court of Appeals, which recently heard oral arguments. Its decision is pending.

In support of the hospice center physicians, the American Medical Association and other organizations have filed an amicus brief asserting that a physician’s opinion may be deemed false only if no reasonable physician could hold that opinion.

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].

References

1. 31 U.S. Code, Section 3729(a)(1)(A).

2. Universal Health Services v. United States ex rel. Escobar, 579 U.S. ____ (2016).

3. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., Case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama.
 

 

Question: Which of the following is correct?

A. The False Claims Act dates back to the Civil War era.

B. The FCA covers only patently false statements.

C. Material misrepresentation is insufficient.

D. Negligence constitutes a violation.

E. A qui tam lawsuit under FCA refers to a third party who has suffered personal harm.

Answer: A. The False Claims Act (FCA) is an old law, enacted by Congress in 1863 to impose liability for submitting a payment demand to the federal government when there is actual or constructive knowledge that the claim is false.¹ Many states now have their own versions of FCA.

Intent to defraud is not a required element, but knowing or reckless disregard of the truth or material misrepresentation are – whereas negligence is insufficient to constitute a violation.

Penalties include treble damages, costs, and attorney fees, as well as fines of $11,000 per false claim and possible imprisonment. Although FCA is the most prominent health care antifraud statute, there are many others, such as the antikickback statute, the Stark Law, HIPAA, and general criminal statutes covering theft, embezzlement, obstruction of criminal investigations, false statements, mail/wire fraud, and so on.

In the health care field, FCA most commonly involves false claims made to Medicare or Medicaid. Pitfalls include billing for noncovered services such as experimental treatments, double billing, unnecessary services, billing the government as the primary payer when inappropriate, or regularly waiving deductibles and copayments.

Other activities that constitute wrongdoing in this context include knowingly using another patient’s name for purposes of federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services.

The electronic medical record enables easy check-offs as documentation of actual work done, and fraud is implicated if the information is deliberately misleading, as in the example of upcoding.

Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all billing activities. Aggrieved or disgruntled employees or contractors, popularly known as whistle-blowers, can file a qui tam action. They stand to collect a substantial bounty, up to 30% of the proceeds. They do not have to show legal standing and need not sustain any personal injury.

FCA prosecutions are daily affairs, with egregious examples regularly making the news headlines. A few random pickings might give you an idea of the problem:

In 2015, in its largest case of health care fraud, the federal Department of Justice filed criminal charges against 243 individuals across the nation. Some of the violations included billings for intensive psychotherapy sessions for noncommunicative dementia patients, simply moving patients to different locations, and fraudulent prescriptions under Medicare Part D.

In 2016, a pain management clinic used “ill-equipped, desperate doctors in dire need of work” to write faked prescriptions for narcotics. The clinic owner, a doctor, was sentenced to 144 months in prison for running what was described as a “pill-mill zoo.”

Arguably, the most dramatic physician case occurred in 2017 and involved a Florida dermatologist who settled with the government for $18 million for treating patients for skin cancer they did not have. The action came from a qui tam lawsuit filed by another dermatologist.

A major development in the false claims law came with last year’s U.S. Supreme Court decision in Universal Health Services v. Escobar.²

This landmark case dealt with claims made by Arbour Counseling Services to the Massachusetts’ Medicaid program for mental health counseling and prescriptions, a satellite mental health facility of Universal Health Services. It turned out that relatively few Arbour employees were actually licensed to provide mental health counseling or authorized to prescribe medications. A death resulted from a reaction to an unlicensed prescription.

In a unanimous decision, the Supreme Court held that there can be FCA liability when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements. Technically referred to as “implied false certification,” such material omissions may amount to a misrepresentation and may be deemed fraudulent, even if the requirements were not expressly designated as conditions of payment.

In the words of the court, “Today’s decision holds that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.”

The implied false certification, or implied fraud, ruling has widespread implications, as it does not require a patently false statement. A material misrepresentation or omission may suffice.

There is concern that this ruling will open the floodgates of FCA prosecution. However, the federal Ninth Circuit Court of Appeals has recently quashed an attempt to invoke the implied certification claim in an FCA suit against DJO Global and Biomet, brought by a medical device salesman and his private investigator. Their rejected whistle-blower suit alleged that the defendants were providing their spinal bone growth stimulation devices for use on the cervical spine, even though Food and Drug Administration approval was for use only on the lumbar spine.

Another concern is, can an alleged wrong prognosis regarding life expectancy amount to a false claim?

Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.

AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice who did not have a life expectancy of 6 months or less. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis. Thus, AseraCare’s claims for those patients were false.

The case brought out the conflicting views of physicians: Did the medical records supported AseraCare’s certifications that the patients were eligible? The defendants argued that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.

AseraCare won a summary judgment defending against the $200 million lawsuit in the U.S. District Court for the Northern District of Alabama.³ In a memorandum opinion, the court began with Blaise Pascal’s axiom that “Contradiction is not a sign of falsity, nor the lack of contradiction the sign of truth.” Federal prosecutors have appealed to the federal 11th Circuit Court of Appeals, which recently heard oral arguments. Its decision is pending.

In support of the hospice center physicians, the American Medical Association and other organizations have filed an amicus brief asserting that a physician’s opinion may be deemed false only if no reasonable physician could hold that opinion.

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].

References

1. 31 U.S. Code, Section 3729(a)(1)(A).

2. Universal Health Services v. United States ex rel. Escobar, 579 U.S. ____ (2016).

3. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., Case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama.
 

 

We are in the midst of a revolution in genome editing. Science now exists in “AC,” or after CRISPR. Able to speedily and efficiently make genomic cuts with surgical precision, CRISPR/Cas9 is used almost ubiquitously now in the scientific community to study and alter DNA across fields ranging from medicine to agriculture to zoology. The possibilities of the biological and therapeutic implications are seemingly endless, as are the important ethical implications of their impact. Likely because of the latter, CRISPR technology has made its way from publications like Science and Nature into the lay public domains of Newsweek and NBC News.

In fact, CRISPR technology made its way into one of my favorite podcasts, WNYC’s “Radio Lab” in June 2015¹. The episode was entitled “Antibodies Part 1,” perhaps assuming that other technologies would also be discussed later although that has never happened. Actually, in an update early this year, the podcast jokingly addressed never moving on to “Part 2,” then followed with an update on how far CRISPR technology has progressed. Putting aside the technological advances and the early clinical applications, as well as the immense ethical considerations, CRISPR technology faces a new controversy, not one from a white coat but rather from a black robe.

This past December, the U.S. Patent and Trademark Office (USPTO) heard testimony over a CRISPR patent dispute, which centered on Jennifer Doudna, PhD, at the University of California, Berkeley, and Feng Zhang, PhD, at the Broad Institute, Cambridge, Mass. Both investigators have pioneered using the CRISPR/Cas9 system in their respective published work and each of their institutions have applied for patents to protect the application of the technology for scientific and therapeutic applications.

In her CommonHealth blog², Carey Goldberg of WBUR Boston Public Radio compared the case with the bout between undefeated Muhammad Ali and undefeated Joe Frazier at New York’s Madison Square Garden. Both men had legitimate claims to the title of World Heavyweight Champion. What transpired is now known as the “Fight of the Century.”

The analogy is apt. Boxing is about speed and control. Ali dominated the first three rounds with his jab, a punch that is both offensive with its attack and defensive in keeping one’s opponent at a distance. Dr. Doudna and her collaborator Emmanuelle Charpentier, PhD, published their work first (Science. 2012 Aug 17;337[6096]:816-21)³. UC Berkeley filed their patent first in May 2012.

Boxing is about timing and opportunity. Under the barrage of Ali’s jabs, Frazier found an inside position and caught Ali with a left hook. Dr. Zhang’s work followed closely after but had previously applied the technology in murine and human cells (Science. 2013 Feb 15; 339[6121]:819-23)⁴. The Broad Institute used this key difference to apply for its own patents under expedited review, which were granted in April 2014.

Boxing is about a punch and a counterpunch. Though fatigued, Ali continued to connect with combination punches. Frazier’s left hook pummeled Ali’s jaw. UC Berkeley filed an interference motion to invalidate the Broad Institute patent claim on the basis that the extension to eukaryotic cells was “obvious” based on the published work by Dr. Doudna’s group. In February, USPTO ruled that the Broad patent application may proceed, citing “patentably distinct subject matter.” Initial reports had indicated that Berkeley may appeal the decision, but no official filings have been made public.

Like the Fight of the Century, this case may go the distance and be decided by the judges. In a unanimous decision, Joe Frazier won the first of three epic bouts. The final scorecard is not known in the patent disputes; on March 28, the European Patent Office announced it will grant the patent application on behalf of Dr. Doudna and Dr. Charpentier.

Much like a prizefight, Wall Street has also been taking bets on who will prevail, with CRISPR-based biotech backing both sides mirroring the mid-bout odds, just as Ali dominated early with the jab, until Frazier evened the match with a left hook to the jaw. Ali fell to his knee on the canvas in the 11th round; will the European Patent Office decision prove to be a slip or a decisive knockdown? With so much at stake, the only assurance is that, as with the Ali-Frazier bout, there is likely more fighting to be done.

References:

1. Radio Lab

2. CommonHealth blog

3. Jinek M, et al., A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity. Science. 2012 Aug 17;337(6096):816-21.

4. Le Cong et al., Multiplex genome engineering using CRISPR/Cas Systems. Science. 2013 Feb 15;339(6121):819-23. Multiplex genome engineering using CRISPR/Cas Systems.

Science. 2017 Feb 15: Round one of CRISPR patent legal battle goes to the Broad Institute.

StreetInsider.com: CRISPR Therapeutics (CRSP) says EPO to grant CRISPR/Cas gene editing patent.
 

 

[email protected]

On Twitter @thedoctorisvin
 

Dr. Viny is with the Memorial Sloan-Kettering Cancer Center, N.Y., where he is a clinical instructor, is on the staff of the leukemia service, and is a clinical researcher in the Ross Levine Lab. Contact Dr. Viny at [email protected].

 

We are in the midst of a revolution in genome editing. Science now exists in “AC,” or after CRISPR. Able to speedily and efficiently make genomic cuts with surgical precision, CRISPR/Cas9 is used almost ubiquitously now in the scientific community to study and alter DNA across fields ranging from medicine to agriculture to zoology. The possibilities of the biological and therapeutic implications are seemingly endless, as are the important ethical implications of their impact. Likely because of the latter, CRISPR technology has made its way from publications like Science and Nature into the lay public domains of Newsweek and NBC News.

In fact, CRISPR technology made its way into one of my favorite podcasts, WNYC’s “Radio Lab” in June 2015¹. The episode was entitled “Antibodies Part 1,” perhaps assuming that other technologies would also be discussed later although that has never happened. Actually, in an update early this year, the podcast jokingly addressed never moving on to “Part 2,” then followed with an update on how far CRISPR technology has progressed. Putting aside the technological advances and the early clinical applications, as well as the immense ethical considerations, CRISPR technology faces a new controversy, not one from a white coat but rather from a black robe.

This past December, the U.S. Patent and Trademark Office (USPTO) heard testimony over a CRISPR patent dispute, which centered on Jennifer Doudna, PhD, at the University of California, Berkeley, and Feng Zhang, PhD, at the Broad Institute, Cambridge, Mass. Both investigators have pioneered using the CRISPR/Cas9 system in their respective published work and each of their institutions have applied for patents to protect the application of the technology for scientific and therapeutic applications.

In her CommonHealth blog², Carey Goldberg of WBUR Boston Public Radio compared the case with the bout between undefeated Muhammad Ali and undefeated Joe Frazier at New York’s Madison Square Garden. Both men had legitimate claims to the title of World Heavyweight Champion. What transpired is now known as the “Fight of the Century.”

The analogy is apt. Boxing is about speed and control. Ali dominated the first three rounds with his jab, a punch that is both offensive with its attack and defensive in keeping one’s opponent at a distance. Dr. Doudna and her collaborator Emmanuelle Charpentier, PhD, published their work first (Science. 2012 Aug 17;337[6096]:816-21)³. UC Berkeley filed their patent first in May 2012.

Boxing is about timing and opportunity. Under the barrage of Ali’s jabs, Frazier found an inside position and caught Ali with a left hook. Dr. Zhang’s work followed closely after but had previously applied the technology in murine and human cells (Science. 2013 Feb 15; 339[6121]:819-23)⁴. The Broad Institute used this key difference to apply for its own patents under expedited review, which were granted in April 2014.

Boxing is about a punch and a counterpunch. Though fatigued, Ali continued to connect with combination punches. Frazier’s left hook pummeled Ali’s jaw. UC Berkeley filed an interference motion to invalidate the Broad Institute patent claim on the basis that the extension to eukaryotic cells was “obvious” based on the published work by Dr. Doudna’s group. In February, USPTO ruled that the Broad patent application may proceed, citing “patentably distinct subject matter.” Initial reports had indicated that Berkeley may appeal the decision, but no official filings have been made public.

Like the Fight of the Century, this case may go the distance and be decided by the judges. In a unanimous decision, Joe Frazier won the first of three epic bouts. The final scorecard is not known in the patent disputes; on March 28, the European Patent Office announced it will grant the patent application on behalf of Dr. Doudna and Dr. Charpentier.

Much like a prizefight, Wall Street has also been taking bets on who will prevail, with CRISPR-based biotech backing both sides mirroring the mid-bout odds, just as Ali dominated early with the jab, until Frazier evened the match with a left hook to the jaw. Ali fell to his knee on the canvas in the 11th round; will the European Patent Office decision prove to be a slip or a decisive knockdown? With so much at stake, the only assurance is that, as with the Ali-Frazier bout, there is likely more fighting to be done.

References:

1. Radio Lab

2. CommonHealth blog

3. Jinek M, et al., A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity. Science. 2012 Aug 17;337(6096):816-21.

4. Le Cong et al., Multiplex genome engineering using CRISPR/Cas Systems. Science. 2013 Feb 15;339(6121):819-23. Multiplex genome engineering using CRISPR/Cas Systems.

Science. 2017 Feb 15: Round one of CRISPR patent legal battle goes to the Broad Institute.

StreetInsider.com: CRISPR Therapeutics (CRSP) says EPO to grant CRISPR/Cas gene editing patent.
 

 

[email protected]

On Twitter @thedoctorisvin
 

Dr. Viny is with the Memorial Sloan-Kettering Cancer Center, N.Y., where he is a clinical instructor, is on the staff of the leukemia service, and is a clinical researcher in the Ross Levine Lab. Contact Dr. Viny at [email protected].

 

We are in the midst of a revolution in genome editing. Science now exists in “AC,” or after CRISPR. Able to speedily and efficiently make genomic cuts with surgical precision, CRISPR/Cas9 is used almost ubiquitously now in the scientific community to study and alter DNA across fields ranging from medicine to agriculture to zoology. The possibilities of the biological and therapeutic implications are seemingly endless, as are the important ethical implications of their impact. Likely because of the latter, CRISPR technology has made its way from publications like Science and Nature into the lay public domains of Newsweek and NBC News.

In fact, CRISPR technology made its way into one of my favorite podcasts, WNYC’s “Radio Lab” in June 2015¹. The episode was entitled “Antibodies Part 1,” perhaps assuming that other technologies would also be discussed later although that has never happened. Actually, in an update early this year, the podcast jokingly addressed never moving on to “Part 2,” then followed with an update on how far CRISPR technology has progressed. Putting aside the technological advances and the early clinical applications, as well as the immense ethical considerations, CRISPR technology faces a new controversy, not one from a white coat but rather from a black robe.

This past December, the U.S. Patent and Trademark Office (USPTO) heard testimony over a CRISPR patent dispute, which centered on Jennifer Doudna, PhD, at the University of California, Berkeley, and Feng Zhang, PhD, at the Broad Institute, Cambridge, Mass. Both investigators have pioneered using the CRISPR/Cas9 system in their respective published work and each of their institutions have applied for patents to protect the application of the technology for scientific and therapeutic applications.

In her CommonHealth blog², Carey Goldberg of WBUR Boston Public Radio compared the case with the bout between undefeated Muhammad Ali and undefeated Joe Frazier at New York’s Madison Square Garden. Both men had legitimate claims to the title of World Heavyweight Champion. What transpired is now known as the “Fight of the Century.”

The analogy is apt. Boxing is about speed and control. Ali dominated the first three rounds with his jab, a punch that is both offensive with its attack and defensive in keeping one’s opponent at a distance. Dr. Doudna and her collaborator Emmanuelle Charpentier, PhD, published their work first (Science. 2012 Aug 17;337[6096]:816-21)³. UC Berkeley filed their patent first in May 2012.

Boxing is about timing and opportunity. Under the barrage of Ali’s jabs, Frazier found an inside position and caught Ali with a left hook. Dr. Zhang’s work followed closely after but had previously applied the technology in murine and human cells (Science. 2013 Feb 15; 339[6121]:819-23)⁴. The Broad Institute used this key difference to apply for its own patents under expedited review, which were granted in April 2014.

Boxing is about a punch and a counterpunch. Though fatigued, Ali continued to connect with combination punches. Frazier’s left hook pummeled Ali’s jaw. UC Berkeley filed an interference motion to invalidate the Broad Institute patent claim on the basis that the extension to eukaryotic cells was “obvious” based on the published work by Dr. Doudna’s group. In February, USPTO ruled that the Broad patent application may proceed, citing “patentably distinct subject matter.” Initial reports had indicated that Berkeley may appeal the decision, but no official filings have been made public.

Like the Fight of the Century, this case may go the distance and be decided by the judges. In a unanimous decision, Joe Frazier won the first of three epic bouts. The final scorecard is not known in the patent disputes; on March 28, the European Patent Office announced it will grant the patent application on behalf of Dr. Doudna and Dr. Charpentier.

Much like a prizefight, Wall Street has also been taking bets on who will prevail, with CRISPR-based biotech backing both sides mirroring the mid-bout odds, just as Ali dominated early with the jab, until Frazier evened the match with a left hook to the jaw. Ali fell to his knee on the canvas in the 11th round; will the European Patent Office decision prove to be a slip or a decisive knockdown? With so much at stake, the only assurance is that, as with the Ali-Frazier bout, there is likely more fighting to be done.

References:

1. Radio Lab

2. CommonHealth blog

3. Jinek M, et al., A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity. Science. 2012 Aug 17;337(6096):816-21.

4. Le Cong et al., Multiplex genome engineering using CRISPR/Cas Systems. Science. 2013 Feb 15;339(6121):819-23. Multiplex genome engineering using CRISPR/Cas Systems.

Science. 2017 Feb 15: Round one of CRISPR patent legal battle goes to the Broad Institute.

StreetInsider.com: CRISPR Therapeutics (CRSP) says EPO to grant CRISPR/Cas gene editing patent.
 

 

[email protected]

On Twitter @thedoctorisvin
 

Dr. Viny is with the Memorial Sloan-Kettering Cancer Center, N.Y., where he is a clinical instructor, is on the staff of the leukemia service, and is a clinical researcher in the Ross Levine Lab. Contact Dr. Viny at [email protected].

 

When the Joint Commission on Accreditation of Healthcare Organizations came to our hospital for a survey last fall, our administration was confident that the review would be favorable. The Joint Commission was stressing the reliability of hospitals and so were we. We had chartered a “High-Reliability Organization Enterprise Steering Committee” that was “empowered to make recommendations to the (executive board) on what is needed to achieve the goals of high reliability across the enterprise.” High reliability was a priority for our administration and for the Joint Commission. Unfortunately, nearly no one else knew what high reliability meant.

When physicians think about reliability, we think about reproducibility and precision. What often is less clear, then, is what our administrators mean when they discuss the importance of “high reliability” in a hospital or health care system.

In 2001, Karl E. Weick and Kathleen M. Sutcliffe published their book, “Managing the Unexpected: Resilient Performance in an Age of Uncertainty,” (Hoboken, N.J.: Jossey-Bass, 2001), which defined high-reliability organizations as those that reliably prevent error. They included examples from the military and from aviation. They proffered five principles to guide those organizations wishing to become highly reliable:

1. Preoccupation with failure.

2. Reluctance to simplify interpretations.

3. Sensitivity to operations.

4. Commitment to resilience.

5. Deference to expertise.

In September 2005, the Agency for Healthcare Research and Quality created a document to adapt the concepts developed by Mr. Weick and Ms. Sutcliffe to the health care industry, where opportunities to avoid error and prevent catastrophe abound. The eventual result has been steady progress in measuring avoidable health care errors, such as avoiding central line–associated blood stream infections and holding health care organizations accountable for their reduction. However, organizational cultures are difficult to change, and there is still a long way to go.

In contrast to large systems, individual providers can change quickly, especially if there is incentive to do so. What principles would increase our own ability to become a high-reliability individuals (HRIs):

• Recognize failure as systemic, not personal. Health care providers are humans, and humans make mistakes. Unfortunately, we come from a tradition that rewards success and penalizes failure. Research shows that is better to recognize failure as something to be prevented next time rather than to be punished now. Admonitions to pay attention, focus more, and remember better rely on fallible humans and reliably fail. Systems solutions, such as checklists, timeouts, and hard stops reliably succeed. HRIs should blame error less often on people, and more often on system failures.

• Simple solutions are preferred to complex requirements. Chemotherapy was once calculated and written by hand. Every cancer center can recall tragic disasters that occurred as a result of errors either by the ordering physician or by interpretations made by pharmacists and nurses. The introduction of electronic chemotherapy ordering has nearly eliminated these mistakes. HRIs can initiate technology solutions to their work to help reduce the risk of errors.

• Sensitivity to patients. Patients often desire to be included as partners in their care. In addition to being present and attentive to patients, why not enlist them as colleagues in care? For example, the patient who has their own calendar of chemotherapy treatments – complete with agents, doses, and schedules – will be more likely to question perceived errors. HRIs are transparent.

• Resilience in character. Learning to accept the potential for error requires acceptance that others also are trying to prevent error and are not judging your competence. The physician who attacks those who are trying to help reduces the psychological safety required for colleagues to speak up when potential errors are identified. Physicians will become HRIs only when they lower their defenses and become more teammates rather than a soloists.

• Deference to evidence. The “way it has always been” must give way to the way things are. Anecdotes and personal conviction do not meet scientific standards and should be abandoned in the face of evidence. Yet, this seemingly obvious principle often is disregarded when clinicians are presented with standardized treatment pathways and limited formularies in the name of autonomy; autonomy is fine until patients are endangered by it. The HRI practices evidence-based medicine.

Marty Makary, MD, explores most of these principles in his book “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care”(London: Bloomsbury Publishing, 2012). While written from a surgeon’s perspective, Dr. Makary exposes the dangerous state of modern medical care across all specialties. I recommend it as a sobering assessment of the way things are and as a prescription for health care systems and physicians to help them become more reliable.

How are you driving safety in your area? What are some best practices we can share with others? I invite you to reply to [email protected] to initiate a broader discussion of patient safety and reliability. Responses will be posted to hematologynews.com.

Dr. Kalaycio is Editor in Chief of Hematology News. Dr. Kalaycio chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

 

When the Joint Commission on Accreditation of Healthcare Organizations came to our hospital for a survey last fall, our administration was confident that the review would be favorable. The Joint Commission was stressing the reliability of hospitals and so were we. We had chartered a “High-Reliability Organization Enterprise Steering Committee” that was “empowered to make recommendations to the (executive board) on what is needed to achieve the goals of high reliability across the enterprise.” High reliability was a priority for our administration and for the Joint Commission. Unfortunately, nearly no one else knew what high reliability meant.

When physicians think about reliability, we think about reproducibility and precision. What often is less clear, then, is what our administrators mean when they discuss the importance of “high reliability” in a hospital or health care system.

In 2001, Karl E. Weick and Kathleen M. Sutcliffe published their book, “Managing the Unexpected: Resilient Performance in an Age of Uncertainty,” (Hoboken, N.J.: Jossey-Bass, 2001), which defined high-reliability organizations as those that reliably prevent error. They included examples from the military and from aviation. They proffered five principles to guide those organizations wishing to become highly reliable:

1. Preoccupation with failure.

2. Reluctance to simplify interpretations.

3. Sensitivity to operations.

4. Commitment to resilience.

5. Deference to expertise.

In September 2005, the Agency for Healthcare Research and Quality created a document to adapt the concepts developed by Mr. Weick and Ms. Sutcliffe to the health care industry, where opportunities to avoid error and prevent catastrophe abound. The eventual result has been steady progress in measuring avoidable health care errors, such as avoiding central line–associated blood stream infections and holding health care organizations accountable for their reduction. However, organizational cultures are difficult to change, and there is still a long way to go.

In contrast to large systems, individual providers can change quickly, especially if there is incentive to do so. What principles would increase our own ability to become a high-reliability individuals (HRIs):

• Recognize failure as systemic, not personal. Health care providers are humans, and humans make mistakes. Unfortunately, we come from a tradition that rewards success and penalizes failure. Research shows that is better to recognize failure as something to be prevented next time rather than to be punished now. Admonitions to pay attention, focus more, and remember better rely on fallible humans and reliably fail. Systems solutions, such as checklists, timeouts, and hard stops reliably succeed. HRIs should blame error less often on people, and more often on system failures.

• Simple solutions are preferred to complex requirements. Chemotherapy was once calculated and written by hand. Every cancer center can recall tragic disasters that occurred as a result of errors either by the ordering physician or by interpretations made by pharmacists and nurses. The introduction of electronic chemotherapy ordering has nearly eliminated these mistakes. HRIs can initiate technology solutions to their work to help reduce the risk of errors.

• Sensitivity to patients. Patients often desire to be included as partners in their care. In addition to being present and attentive to patients, why not enlist them as colleagues in care? For example, the patient who has their own calendar of chemotherapy treatments – complete with agents, doses, and schedules – will be more likely to question perceived errors. HRIs are transparent.

• Resilience in character. Learning to accept the potential for error requires acceptance that others also are trying to prevent error and are not judging your competence. The physician who attacks those who are trying to help reduces the psychological safety required for colleagues to speak up when potential errors are identified. Physicians will become HRIs only when they lower their defenses and become more teammates rather than a soloists.

• Deference to evidence. The “way it has always been” must give way to the way things are. Anecdotes and personal conviction do not meet scientific standards and should be abandoned in the face of evidence. Yet, this seemingly obvious principle often is disregarded when clinicians are presented with standardized treatment pathways and limited formularies in the name of autonomy; autonomy is fine until patients are endangered by it. The HRI practices evidence-based medicine.

Marty Makary, MD, explores most of these principles in his book “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care”(London: Bloomsbury Publishing, 2012). While written from a surgeon’s perspective, Dr. Makary exposes the dangerous state of modern medical care across all specialties. I recommend it as a sobering assessment of the way things are and as a prescription for health care systems and physicians to help them become more reliable.

How are you driving safety in your area? What are some best practices we can share with others? I invite you to reply to [email protected] to initiate a broader discussion of patient safety and reliability. Responses will be posted to hematologynews.com.

Dr. Kalaycio is Editor in Chief of Hematology News. Dr. Kalaycio chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

 

When the Joint Commission on Accreditation of Healthcare Organizations came to our hospital for a survey last fall, our administration was confident that the review would be favorable. The Joint Commission was stressing the reliability of hospitals and so were we. We had chartered a “High-Reliability Organization Enterprise Steering Committee” that was “empowered to make recommendations to the (executive board) on what is needed to achieve the goals of high reliability across the enterprise.” High reliability was a priority for our administration and for the Joint Commission. Unfortunately, nearly no one else knew what high reliability meant.

When physicians think about reliability, we think about reproducibility and precision. What often is less clear, then, is what our administrators mean when they discuss the importance of “high reliability” in a hospital or health care system.

In 2001, Karl E. Weick and Kathleen M. Sutcliffe published their book, “Managing the Unexpected: Resilient Performance in an Age of Uncertainty,” (Hoboken, N.J.: Jossey-Bass, 2001), which defined high-reliability organizations as those that reliably prevent error. They included examples from the military and from aviation. They proffered five principles to guide those organizations wishing to become highly reliable:

1. Preoccupation with failure.

2. Reluctance to simplify interpretations.

3. Sensitivity to operations.

4. Commitment to resilience.

5. Deference to expertise.

In September 2005, the Agency for Healthcare Research and Quality created a document to adapt the concepts developed by Mr. Weick and Ms. Sutcliffe to the health care industry, where opportunities to avoid error and prevent catastrophe abound. The eventual result has been steady progress in measuring avoidable health care errors, such as avoiding central line–associated blood stream infections and holding health care organizations accountable for their reduction. However, organizational cultures are difficult to change, and there is still a long way to go.

In contrast to large systems, individual providers can change quickly, especially if there is incentive to do so. What principles would increase our own ability to become a high-reliability individuals (HRIs):

• Recognize failure as systemic, not personal. Health care providers are humans, and humans make mistakes. Unfortunately, we come from a tradition that rewards success and penalizes failure. Research shows that is better to recognize failure as something to be prevented next time rather than to be punished now. Admonitions to pay attention, focus more, and remember better rely on fallible humans and reliably fail. Systems solutions, such as checklists, timeouts, and hard stops reliably succeed. HRIs should blame error less often on people, and more often on system failures.

• Simple solutions are preferred to complex requirements. Chemotherapy was once calculated and written by hand. Every cancer center can recall tragic disasters that occurred as a result of errors either by the ordering physician or by interpretations made by pharmacists and nurses. The introduction of electronic chemotherapy ordering has nearly eliminated these mistakes. HRIs can initiate technology solutions to their work to help reduce the risk of errors.

• Sensitivity to patients. Patients often desire to be included as partners in their care. In addition to being present and attentive to patients, why not enlist them as colleagues in care? For example, the patient who has their own calendar of chemotherapy treatments – complete with agents, doses, and schedules – will be more likely to question perceived errors. HRIs are transparent.

• Resilience in character. Learning to accept the potential for error requires acceptance that others also are trying to prevent error and are not judging your competence. The physician who attacks those who are trying to help reduces the psychological safety required for colleagues to speak up when potential errors are identified. Physicians will become HRIs only when they lower their defenses and become more teammates rather than a soloists.

• Deference to evidence. The “way it has always been” must give way to the way things are. Anecdotes and personal conviction do not meet scientific standards and should be abandoned in the face of evidence. Yet, this seemingly obvious principle often is disregarded when clinicians are presented with standardized treatment pathways and limited formularies in the name of autonomy; autonomy is fine until patients are endangered by it. The HRI practices evidence-based medicine.

Marty Makary, MD, explores most of these principles in his book “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care”(London: Bloomsbury Publishing, 2012). While written from a surgeon’s perspective, Dr. Makary exposes the dangerous state of modern medical care across all specialties. I recommend it as a sobering assessment of the way things are and as a prescription for health care systems and physicians to help them become more reliable.

How are you driving safety in your area? What are some best practices we can share with others? I invite you to reply to [email protected] to initiate a broader discussion of patient safety and reliability. Responses will be posted to hematologynews.com.

Dr. Kalaycio is Editor in Chief of Hematology News. Dr. Kalaycio chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

 

The impact of lipid-lowering drugs on patients’ mental states was on the minds of many attendees at the American College of Cardiology’s annual meeting in March.

The highest-profile report came from EBBINGHAUS (Evaluating PCSK9 Binding Antibody Influence on Cognitive Health in High Cardiovascular Risk Subjects), a substudy of the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, the meeting’s blockbuster. For the first time, it proved that profoundly lowering low density lipoprotein cholesterol with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab led to a significant reduction in adverse clinical events. EBBINGHAUS focused on about 2,000 of the 27,000 FOURIER patients and subjected equal numbers of placebo and evolocumab patients to a battery of cognitive and memory tests over a median of 20 months. The results showed no hint of a decrement in brain function in the patients taking evolocumab, compared with either their baseline state or the controls who received placebo.

Mitchel L. Zoler/Frontline Medical News

The reason why the researchers who designed FOURIER also ran EBBINGHAUS was that statins, the established lipid-lowering drugs, have received a bad rap, with alleged memory and cognitive side effects. As I reported in my news story on EBBINGHAUS, such clinicians as Sandra J. Lewis, MD, were concerned that patients were claiming that statins “make them dumb” on an almost daily basis. That’s a perception that she and others at the meeting attributed to Internet posts about statins that are filled with pseudoscience and horror tales. “We need your help to combat Dr. Google, who has a lot of statin misinformation,” pleaded Robert P. Giugliano, MD, lead investigator of EBBINGHAUS, during a press conference for his study.

That perception wasn’t helped when, in 2012, the Food and Drug Administration required the labels of all statins to include a reference to postmarketing reports of cognitive side effects such as memory impairment and confusion. The current label for one statin says: “There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins.”

Mitchel L. Zoler/Frontline Medical News

When the FDA issued its requirement in 2012, the rationale it presented could be objectively judged as modest at best. The agency said that “postmarketing adverse event reports generally described individuals over the age of 50 years who experienced notable, but ill-defined, memory loss or impairment that was reversible upon discontinuation of statin therapy. Time to onset of the event was highly variable, ranging from 1 day to years after statin exposure. The cases did not appear to be associated with fixed or progressive dementia, such as Alzheimer’s disease. The review did not reveal an association between the adverse event and the specific statin, the age of the individual, the statin dose, or concomitant medication use.” The FDA statement on the evidence behind its move added that “data from the observational studies and clinical trials did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline.”

Following the FDA’s action, a series of analyses appeared that reviewed the evidence and found nothing to substantiate the concern. For example, a 2012 review done in direct response to the FDA labeling change looked at case reports, observational studies, and randomized trials and found “no convincing evidence for change in cognitive function” with statin use (J Am Coll Cardiol. 2012 Sept 4;60[10]:875-81). A 2015 meta-analysis that reviewed 14 studies with cognitive testing on more than 27,000 people randomized to either a statin or placebo also found no evidence for a statin effect on mental function (J Gen Intern Med. 2015 March;30[3]:348-58). “Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted,” the meta-analysis authors concluded.

Despite this, concerns about the impact of statins on cognition and memory linger for many patients, witness the anecdotal experiences of clinicians at the meeting. This led a team of researchers at the University of Connecticut and Hartford Hospital to try to directly address the controversy. They also reported their findings at the ACC meeting.

They ran their study as part of a larger trial, STOMP (Effect of Statins on Skeletal Muscle Function and Performance), which randomized 420 healthy and statin-naive individuals to 6 months of treatment with 80 mg atorvastatin or placebo (Circulation. 2013 Jan 2;127[1]:96-103). Their memory substudy included 66 people from the atorvastatin group and 84 placebo-treated controls who averaged 49 years old. Participants underwent a battery of eight memory, cognitive, attention, and executive function tests after 6 months on treatment and again 2 months after statin treatment stopped.

Mitchel L. Zoler/Frontline Medical News

“We saw what many other [statin] studies saw: minimal effects in both groups,” reported Beth A. Taylor, PhD, director of exercise physiology research at Hartford (Conn.) Hospital at the meeting. The linchpin of the test battery was the Cognitive Failures Questionnaire. “No matter how we looked at the results [from this test] we saw no differences between the atorvastatin and placebo groups for cognitive failures,” Dr. Taylor said.

She and her associates took testing a step further and used an assessment never before applied to people taking statins. They ran functional MRIs on a subgroup of the participants while they took two additional memory tests at the end of 6 months on atorvastatin and again 2 months after atorvastatin stopped. They ran MRI scans during a figural memory task test on 42 placebo participants and 35 atorvastatin patients and during a Sternberg Task to test short-term memory on 68 people from the placebo group and 52 who received atorvastatin.

The functional MRI results showed some small but statistically significant changes during both tests in patterns of regional neural activation among those in the statin groups while on and off statins and also when compared with those who received placebo, but Dr. Taylor stressed that her group saw MRI differences between the statin and placebo subjects not only when people were on atorvastatin but also when they had been off the drug for 2 months. She also cautioned that “the clinical implications of the findings are unclear.”

Overall, the entire study’s results showed “no convincing evidence of measurable verbal or nonverbal memory dysfunction” linked with statin use, but Dr. Taylor also noted that the study was relatively small.

Mitchel L. Zoler/Frontline Medical News

Speaking as a discussant, Neil J. Stone, MD, who thoroughly reviewed the statin literature as chair of the American College of Cardiology/American Heart Association panel that issued the most recent U.S. guidelines for cholesterol treatment to reduce cardiovascular disease risk, noted that Dr. Taylor’s findings agreed with what his panel found: No signal exists for an effect of statin on cognition and memory. He also highlighted the challenge of looking for cognitive and memory effects that might be caused by statins in older people who already might have age-related memory problems or may have memory or cognitive impairments triggered by other drugs. “There are a lot of variables, with possible neurogenic causes, systemic causes, and exogenous causes of memory and cognitive changes,” Dr. Stone said.

Proving the absence of a problem is always difficult. Adding Dr. Taylor’s new evidence to the case that statins really are safe when it comes to cognition and memory will undoubtedly fail to convince committed skeptics.

 

[email protected]

On Twitter @mitchelzoler

 

The impact of lipid-lowering drugs on patients’ mental states was on the minds of many attendees at the American College of Cardiology’s annual meeting in March.

The highest-profile report came from EBBINGHAUS (Evaluating PCSK9 Binding Antibody Influence on Cognitive Health in High Cardiovascular Risk Subjects), a substudy of the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, the meeting’s blockbuster. For the first time, it proved that profoundly lowering low density lipoprotein cholesterol with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab led to a significant reduction in adverse clinical events. EBBINGHAUS focused on about 2,000 of the 27,000 FOURIER patients and subjected equal numbers of placebo and evolocumab patients to a battery of cognitive and memory tests over a median of 20 months. The results showed no hint of a decrement in brain function in the patients taking evolocumab, compared with either their baseline state or the controls who received placebo.

Mitchel L. Zoler/Frontline Medical News

The reason why the researchers who designed FOURIER also ran EBBINGHAUS was that statins, the established lipid-lowering drugs, have received a bad rap, with alleged memory and cognitive side effects. As I reported in my news story on EBBINGHAUS, such clinicians as Sandra J. Lewis, MD, were concerned that patients were claiming that statins “make them dumb” on an almost daily basis. That’s a perception that she and others at the meeting attributed to Internet posts about statins that are filled with pseudoscience and horror tales. “We need your help to combat Dr. Google, who has a lot of statin misinformation,” pleaded Robert P. Giugliano, MD, lead investigator of EBBINGHAUS, during a press conference for his study.

That perception wasn’t helped when, in 2012, the Food and Drug Administration required the labels of all statins to include a reference to postmarketing reports of cognitive side effects such as memory impairment and confusion. The current label for one statin says: “There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins.”

Mitchel L. Zoler/Frontline Medical News

When the FDA issued its requirement in 2012, the rationale it presented could be objectively judged as modest at best. The agency said that “postmarketing adverse event reports generally described individuals over the age of 50 years who experienced notable, but ill-defined, memory loss or impairment that was reversible upon discontinuation of statin therapy. Time to onset of the event was highly variable, ranging from 1 day to years after statin exposure. The cases did not appear to be associated with fixed or progressive dementia, such as Alzheimer’s disease. The review did not reveal an association between the adverse event and the specific statin, the age of the individual, the statin dose, or concomitant medication use.” The FDA statement on the evidence behind its move added that “data from the observational studies and clinical trials did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline.”

Following the FDA’s action, a series of analyses appeared that reviewed the evidence and found nothing to substantiate the concern. For example, a 2012 review done in direct response to the FDA labeling change looked at case reports, observational studies, and randomized trials and found “no convincing evidence for change in cognitive function” with statin use (J Am Coll Cardiol. 2012 Sept 4;60[10]:875-81). A 2015 meta-analysis that reviewed 14 studies with cognitive testing on more than 27,000 people randomized to either a statin or placebo also found no evidence for a statin effect on mental function (J Gen Intern Med. 2015 March;30[3]:348-58). “Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted,” the meta-analysis authors concluded.

Despite this, concerns about the impact of statins on cognition and memory linger for many patients, witness the anecdotal experiences of clinicians at the meeting. This led a team of researchers at the University of Connecticut and Hartford Hospital to try to directly address the controversy. They also reported their findings at the ACC meeting.

They ran their study as part of a larger trial, STOMP (Effect of Statins on Skeletal Muscle Function and Performance), which randomized 420 healthy and statin-naive individuals to 6 months of treatment with 80 mg atorvastatin or placebo (Circulation. 2013 Jan 2;127[1]:96-103). Their memory substudy included 66 people from the atorvastatin group and 84 placebo-treated controls who averaged 49 years old. Participants underwent a battery of eight memory, cognitive, attention, and executive function tests after 6 months on treatment and again 2 months after statin treatment stopped.

Mitchel L. Zoler/Frontline Medical News

“We saw what many other [statin] studies saw: minimal effects in both groups,” reported Beth A. Taylor, PhD, director of exercise physiology research at Hartford (Conn.) Hospital at the meeting. The linchpin of the test battery was the Cognitive Failures Questionnaire. “No matter how we looked at the results [from this test] we saw no differences between the atorvastatin and placebo groups for cognitive failures,” Dr. Taylor said.

She and her associates took testing a step further and used an assessment never before applied to people taking statins. They ran functional MRIs on a subgroup of the participants while they took two additional memory tests at the end of 6 months on atorvastatin and again 2 months after atorvastatin stopped. They ran MRI scans during a figural memory task test on 42 placebo participants and 35 atorvastatin patients and during a Sternberg Task to test short-term memory on 68 people from the placebo group and 52 who received atorvastatin.

The functional MRI results showed some small but statistically significant changes during both tests in patterns of regional neural activation among those in the statin groups while on and off statins and also when compared with those who received placebo, but Dr. Taylor stressed that her group saw MRI differences between the statin and placebo subjects not only when people were on atorvastatin but also when they had been off the drug for 2 months. She also cautioned that “the clinical implications of the findings are unclear.”

Overall, the entire study’s results showed “no convincing evidence of measurable verbal or nonverbal memory dysfunction” linked with statin use, but Dr. Taylor also noted that the study was relatively small.

Mitchel L. Zoler/Frontline Medical News

Speaking as a discussant, Neil J. Stone, MD, who thoroughly reviewed the statin literature as chair of the American College of Cardiology/American Heart Association panel that issued the most recent U.S. guidelines for cholesterol treatment to reduce cardiovascular disease risk, noted that Dr. Taylor’s findings agreed with what his panel found: No signal exists for an effect of statin on cognition and memory. He also highlighted the challenge of looking for cognitive and memory effects that might be caused by statins in older people who already might have age-related memory problems or may have memory or cognitive impairments triggered by other drugs. “There are a lot of variables, with possible neurogenic causes, systemic causes, and exogenous causes of memory and cognitive changes,” Dr. Stone said.

Proving the absence of a problem is always difficult. Adding Dr. Taylor’s new evidence to the case that statins really are safe when it comes to cognition and memory will undoubtedly fail to convince committed skeptics.

 

[email protected]

On Twitter @mitchelzoler

 

The impact of lipid-lowering drugs on patients’ mental states was on the minds of many attendees at the American College of Cardiology’s annual meeting in March.

The highest-profile report came from EBBINGHAUS (Evaluating PCSK9 Binding Antibody Influence on Cognitive Health in High Cardiovascular Risk Subjects), a substudy of the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, the meeting’s blockbuster. For the first time, it proved that profoundly lowering low density lipoprotein cholesterol with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab led to a significant reduction in adverse clinical events. EBBINGHAUS focused on about 2,000 of the 27,000 FOURIER patients and subjected equal numbers of placebo and evolocumab patients to a battery of cognitive and memory tests over a median of 20 months. The results showed no hint of a decrement in brain function in the patients taking evolocumab, compared with either their baseline state or the controls who received placebo.

Mitchel L. Zoler/Frontline Medical News

The reason why the researchers who designed FOURIER also ran EBBINGHAUS was that statins, the established lipid-lowering drugs, have received a bad rap, with alleged memory and cognitive side effects. As I reported in my news story on EBBINGHAUS, such clinicians as Sandra J. Lewis, MD, were concerned that patients were claiming that statins “make them dumb” on an almost daily basis. That’s a perception that she and others at the meeting attributed to Internet posts about statins that are filled with pseudoscience and horror tales. “We need your help to combat Dr. Google, who has a lot of statin misinformation,” pleaded Robert P. Giugliano, MD, lead investigator of EBBINGHAUS, during a press conference for his study.

That perception wasn’t helped when, in 2012, the Food and Drug Administration required the labels of all statins to include a reference to postmarketing reports of cognitive side effects such as memory impairment and confusion. The current label for one statin says: “There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins.”

Mitchel L. Zoler/Frontline Medical News

When the FDA issued its requirement in 2012, the rationale it presented could be objectively judged as modest at best. The agency said that “postmarketing adverse event reports generally described individuals over the age of 50 years who experienced notable, but ill-defined, memory loss or impairment that was reversible upon discontinuation of statin therapy. Time to onset of the event was highly variable, ranging from 1 day to years after statin exposure. The cases did not appear to be associated with fixed or progressive dementia, such as Alzheimer’s disease. The review did not reveal an association between the adverse event and the specific statin, the age of the individual, the statin dose, or concomitant medication use.” The FDA statement on the evidence behind its move added that “data from the observational studies and clinical trials did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline.”

Following the FDA’s action, a series of analyses appeared that reviewed the evidence and found nothing to substantiate the concern. For example, a 2012 review done in direct response to the FDA labeling change looked at case reports, observational studies, and randomized trials and found “no convincing evidence for change in cognitive function” with statin use (J Am Coll Cardiol. 2012 Sept 4;60[10]:875-81). A 2015 meta-analysis that reviewed 14 studies with cognitive testing on more than 27,000 people randomized to either a statin or placebo also found no evidence for a statin effect on mental function (J Gen Intern Med. 2015 March;30[3]:348-58). “Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted,” the meta-analysis authors concluded.

Despite this, concerns about the impact of statins on cognition and memory linger for many patients, witness the anecdotal experiences of clinicians at the meeting. This led a team of researchers at the University of Connecticut and Hartford Hospital to try to directly address the controversy. They also reported their findings at the ACC meeting.

They ran their study as part of a larger trial, STOMP (Effect of Statins on Skeletal Muscle Function and Performance), which randomized 420 healthy and statin-naive individuals to 6 months of treatment with 80 mg atorvastatin or placebo (Circulation. 2013 Jan 2;127[1]:96-103). Their memory substudy included 66 people from the atorvastatin group and 84 placebo-treated controls who averaged 49 years old. Participants underwent a battery of eight memory, cognitive, attention, and executive function tests after 6 months on treatment and again 2 months after statin treatment stopped.

Mitchel L. Zoler/Frontline Medical News

“We saw what many other [statin] studies saw: minimal effects in both groups,” reported Beth A. Taylor, PhD, director of exercise physiology research at Hartford (Conn.) Hospital at the meeting. The linchpin of the test battery was the Cognitive Failures Questionnaire. “No matter how we looked at the results [from this test] we saw no differences between the atorvastatin and placebo groups for cognitive failures,” Dr. Taylor said.

She and her associates took testing a step further and used an assessment never before applied to people taking statins. They ran functional MRIs on a subgroup of the participants while they took two additional memory tests at the end of 6 months on atorvastatin and again 2 months after atorvastatin stopped. They ran MRI scans during a figural memory task test on 42 placebo participants and 35 atorvastatin patients and during a Sternberg Task to test short-term memory on 68 people from the placebo group and 52 who received atorvastatin.

The functional MRI results showed some small but statistically significant changes during both tests in patterns of regional neural activation among those in the statin groups while on and off statins and also when compared with those who received placebo, but Dr. Taylor stressed that her group saw MRI differences between the statin and placebo subjects not only when people were on atorvastatin but also when they had been off the drug for 2 months. She also cautioned that “the clinical implications of the findings are unclear.”

Overall, the entire study’s results showed “no convincing evidence of measurable verbal or nonverbal memory dysfunction” linked with statin use, but Dr. Taylor also noted that the study was relatively small.

Mitchel L. Zoler/Frontline Medical News

Speaking as a discussant, Neil J. Stone, MD, who thoroughly reviewed the statin literature as chair of the American College of Cardiology/American Heart Association panel that issued the most recent U.S. guidelines for cholesterol treatment to reduce cardiovascular disease risk, noted that Dr. Taylor’s findings agreed with what his panel found: No signal exists for an effect of statin on cognition and memory. He also highlighted the challenge of looking for cognitive and memory effects that might be caused by statins in older people who already might have age-related memory problems or may have memory or cognitive impairments triggered by other drugs. “There are a lot of variables, with possible neurogenic causes, systemic causes, and exogenous causes of memory and cognitive changes,” Dr. Stone said.

Proving the absence of a problem is always difficult. Adding Dr. Taylor’s new evidence to the case that statins really are safe when it comes to cognition and memory will undoubtedly fail to convince committed skeptics.

 

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