Commentary

Emily is a 15-year-old girl who was referred by her pediatrician because of cutting behavior and conflict with her parents. Her parents reported that she has had a high body weight in the obese range since early in life. She had tried various diets without success, and her parents were frustrated with the pediatrician’s emphasis on weight over the years.

Mood problems had begun when she was in the sixth grade when she began to be severely bullied about her weight. Emily said this time was so difficult that she did not have clear memories of it. She described feeling numb. She began experiencing intense anxiety about school, and she was sometimes reluctant to attend and started cutting herself as a means of managing her emotions. In middle school, she began to fight back and associated herself with a group of “mean girls” who drank. She began having increasing conflict with her parents over the drinking and the cutting.

Discussion

Obesity is an extremely complex issue without simple answers. Severe obesity is correlated with numerous health risks including not only cardiovascular disease, type 2 diabetes, hypertension, and cancer, but also psychiatric problems such as depression, anxiety, body dissatisfaction, eating disorders, and unhealthy weight control behaviors. While some of these issues relate directly to the weight itself, many of the psychiatric concerns stem from society’s extremely harsh response to obesity.

We are all aware that the percentage of overweight and obese children, teens, and adults has increased in the past 50 years, although with some recent stabilization.¹ The rise in obesity is related to societal factors – the prevalence and advertising of nutrient-poor/high-calorie processed foods in the marketplace, the rise of technologies that have decreased the need for movement, increases in portion sizes in restaurants, especially fast food settings, as well as the subsidizing of unhealthy foods, limited access to and greater cost of more nutritious foods, and limited access to exercise opportunities in poorer areas. This is the “obesogenic environment.” As in numerous aspects of health, weight is also influenced by genetics. Those who are genetically more likely to gain weight are the ones who suffer most from these social changes.

The problem is that, except for bariatric surgery, the interventions prescribed for individuals with obesity don’t work for the vast majority of people in the long run. There is an assumption that if the obese would just eat and exercise the way a thin person does, then they would be thin. While there is evidence that lifestyle strategies that induce a negative energy balance through cutting calories (often by 500-1,000) and “programmed exercise” can help some people lose weight over the course of 6 months to a year, longer-term follow-up suggests that most people regain this weight in the long run, at 5 years out. Even the most optimistic estimates suggest that only about one out of five people can maintain weight losses of 10% in the long term with current standard lifestyle interventions.²

©kikkerdirk/Thinkstockphotos.com

There is evidence that someone attaining a particular body mass index (BMI) through dieting is not able to consume as many calories as another person who has always been at that BMI, requiring constant dietary restraint and a very high level of exercise to maintain the weight loss.³ The great majority of people who are unable to lose the weight, or briefly succeed and then gain the weight back or more, are seen as failing by society, by many medical professionals, and by themselves. There is clearly a need to focus more of our efforts on making changes on a societal level.

There also are alternative individual approaches that take the emphasis away from dieting and weight loss and instead focus on body acceptance and self-care. These interventions go by several names including mindful eating, intuitive eating, weight neutral, and “Health at Every Size.” This approach acknowledges the environmental and genetic factors beyond personal control and discusses how society pressures people to be thin. Instead of emphasizing repeated restrictive dieting, these programs stress maximizing health through making sustainable changes to increase activity and nutrition. These programs encourage people to care for themselves now rather than focusing on dieting toward a future weight where one can start enjoying life. Enjoyment of food, taking time to savor food, and being aware of when one is hungry and when not are central. For physical activity, the emphasis is on discovering something that is pleasurable and sustainable, rather than an onerous duty, as a means to an end of weight loss.⁴

Management

For Emily, struggling on the individual level, there is not a neat resolution. Psychotherapy to address anxiety, trauma, and substance abuse is indicated. Psychotherapy also should address Emily’s relationship with her body, as this is at the heart of many of these issues. Acknowledging the powerful stigma that society places on the obese while tolerating and even promoting an obesogenic environment, and the reality that weight loss is in fact extremely difficult, would open the door to a discussion with Emily and her family about what she wants and all her options to find the healthiest and most enjoyable way for her to live her life.

1. Pediatr Clin North Am. 2015 Oct;62(5):1241-61.

2. Annu Rev Nutr. 2001;21:323-41.

3. Am J Clin Nutr. 2005 Jul;82(1 Suppl):222S-225S.

4. Tylka TL, Annunziato RA, Burgard D, et al. “The Weight-Inclusive versus Weight-Normative Approach to Health: Evaluating the Evidence for Prioritizing Well-Being over Weight Loss.” J Obes. 2014;2014:983495. doi: 10.1155/2014/983495.

Dr. Hall is an assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington.

Emily is a 15-year-old girl who was referred by her pediatrician because of cutting behavior and conflict with her parents. Her parents reported that she has had a high body weight in the obese range since early in life. She had tried various diets without success, and her parents were frustrated with the pediatrician’s emphasis on weight over the years.

Mood problems had begun when she was in the sixth grade when she began to be severely bullied about her weight. Emily said this time was so difficult that she did not have clear memories of it. She described feeling numb. She began experiencing intense anxiety about school, and she was sometimes reluctant to attend and started cutting herself as a means of managing her emotions. In middle school, she began to fight back and associated herself with a group of “mean girls” who drank. She began having increasing conflict with her parents over the drinking and the cutting.

Discussion

Obesity is an extremely complex issue without simple answers. Severe obesity is correlated with numerous health risks including not only cardiovascular disease, type 2 diabetes, hypertension, and cancer, but also psychiatric problems such as depression, anxiety, body dissatisfaction, eating disorders, and unhealthy weight control behaviors. While some of these issues relate directly to the weight itself, many of the psychiatric concerns stem from society’s extremely harsh response to obesity.

We are all aware that the percentage of overweight and obese children, teens, and adults has increased in the past 50 years, although with some recent stabilization.¹ The rise in obesity is related to societal factors – the prevalence and advertising of nutrient-poor/high-calorie processed foods in the marketplace, the rise of technologies that have decreased the need for movement, increases in portion sizes in restaurants, especially fast food settings, as well as the subsidizing of unhealthy foods, limited access to and greater cost of more nutritious foods, and limited access to exercise opportunities in poorer areas. This is the “obesogenic environment.” As in numerous aspects of health, weight is also influenced by genetics. Those who are genetically more likely to gain weight are the ones who suffer most from these social changes.

The problem is that, except for bariatric surgery, the interventions prescribed for individuals with obesity don’t work for the vast majority of people in the long run. There is an assumption that if the obese would just eat and exercise the way a thin person does, then they would be thin. While there is evidence that lifestyle strategies that induce a negative energy balance through cutting calories (often by 500-1,000) and “programmed exercise” can help some people lose weight over the course of 6 months to a year, longer-term follow-up suggests that most people regain this weight in the long run, at 5 years out. Even the most optimistic estimates suggest that only about one out of five people can maintain weight losses of 10% in the long term with current standard lifestyle interventions.²

©kikkerdirk/Thinkstockphotos.com

There is evidence that someone attaining a particular body mass index (BMI) through dieting is not able to consume as many calories as another person who has always been at that BMI, requiring constant dietary restraint and a very high level of exercise to maintain the weight loss.³ The great majority of people who are unable to lose the weight, or briefly succeed and then gain the weight back or more, are seen as failing by society, by many medical professionals, and by themselves. There is clearly a need to focus more of our efforts on making changes on a societal level.

There also are alternative individual approaches that take the emphasis away from dieting and weight loss and instead focus on body acceptance and self-care. These interventions go by several names including mindful eating, intuitive eating, weight neutral, and “Health at Every Size.” This approach acknowledges the environmental and genetic factors beyond personal control and discusses how society pressures people to be thin. Instead of emphasizing repeated restrictive dieting, these programs stress maximizing health through making sustainable changes to increase activity and nutrition. These programs encourage people to care for themselves now rather than focusing on dieting toward a future weight where one can start enjoying life. Enjoyment of food, taking time to savor food, and being aware of when one is hungry and when not are central. For physical activity, the emphasis is on discovering something that is pleasurable and sustainable, rather than an onerous duty, as a means to an end of weight loss.⁴

Management

For Emily, struggling on the individual level, there is not a neat resolution. Psychotherapy to address anxiety, trauma, and substance abuse is indicated. Psychotherapy also should address Emily’s relationship with her body, as this is at the heart of many of these issues. Acknowledging the powerful stigma that society places on the obese while tolerating and even promoting an obesogenic environment, and the reality that weight loss is in fact extremely difficult, would open the door to a discussion with Emily and her family about what she wants and all her options to find the healthiest and most enjoyable way for her to live her life.

1. Pediatr Clin North Am. 2015 Oct;62(5):1241-61.

2. Annu Rev Nutr. 2001;21:323-41.

3. Am J Clin Nutr. 2005 Jul;82(1 Suppl):222S-225S.

4. Tylka TL, Annunziato RA, Burgard D, et al. “The Weight-Inclusive versus Weight-Normative Approach to Health: Evaluating the Evidence for Prioritizing Well-Being over Weight Loss.” J Obes. 2014;2014:983495. doi: 10.1155/2014/983495.

Dr. Hall is an assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington.

Emily is a 15-year-old girl who was referred by her pediatrician because of cutting behavior and conflict with her parents. Her parents reported that she has had a high body weight in the obese range since early in life. She had tried various diets without success, and her parents were frustrated with the pediatrician’s emphasis on weight over the years.

Mood problems had begun when she was in the sixth grade when she began to be severely bullied about her weight. Emily said this time was so difficult that she did not have clear memories of it. She described feeling numb. She began experiencing intense anxiety about school, and she was sometimes reluctant to attend and started cutting herself as a means of managing her emotions. In middle school, she began to fight back and associated herself with a group of “mean girls” who drank. She began having increasing conflict with her parents over the drinking and the cutting.

Discussion

Obesity is an extremely complex issue without simple answers. Severe obesity is correlated with numerous health risks including not only cardiovascular disease, type 2 diabetes, hypertension, and cancer, but also psychiatric problems such as depression, anxiety, body dissatisfaction, eating disorders, and unhealthy weight control behaviors. While some of these issues relate directly to the weight itself, many of the psychiatric concerns stem from society’s extremely harsh response to obesity.

We are all aware that the percentage of overweight and obese children, teens, and adults has increased in the past 50 years, although with some recent stabilization.¹ The rise in obesity is related to societal factors – the prevalence and advertising of nutrient-poor/high-calorie processed foods in the marketplace, the rise of technologies that have decreased the need for movement, increases in portion sizes in restaurants, especially fast food settings, as well as the subsidizing of unhealthy foods, limited access to and greater cost of more nutritious foods, and limited access to exercise opportunities in poorer areas. This is the “obesogenic environment.” As in numerous aspects of health, weight is also influenced by genetics. Those who are genetically more likely to gain weight are the ones who suffer most from these social changes.

The problem is that, except for bariatric surgery, the interventions prescribed for individuals with obesity don’t work for the vast majority of people in the long run. There is an assumption that if the obese would just eat and exercise the way a thin person does, then they would be thin. While there is evidence that lifestyle strategies that induce a negative energy balance through cutting calories (often by 500-1,000) and “programmed exercise” can help some people lose weight over the course of 6 months to a year, longer-term follow-up suggests that most people regain this weight in the long run, at 5 years out. Even the most optimistic estimates suggest that only about one out of five people can maintain weight losses of 10% in the long term with current standard lifestyle interventions.²

©kikkerdirk/Thinkstockphotos.com

There is evidence that someone attaining a particular body mass index (BMI) through dieting is not able to consume as many calories as another person who has always been at that BMI, requiring constant dietary restraint and a very high level of exercise to maintain the weight loss.³ The great majority of people who are unable to lose the weight, or briefly succeed and then gain the weight back or more, are seen as failing by society, by many medical professionals, and by themselves. There is clearly a need to focus more of our efforts on making changes on a societal level.

There also are alternative individual approaches that take the emphasis away from dieting and weight loss and instead focus on body acceptance and self-care. These interventions go by several names including mindful eating, intuitive eating, weight neutral, and “Health at Every Size.” This approach acknowledges the environmental and genetic factors beyond personal control and discusses how society pressures people to be thin. Instead of emphasizing repeated restrictive dieting, these programs stress maximizing health through making sustainable changes to increase activity and nutrition. These programs encourage people to care for themselves now rather than focusing on dieting toward a future weight where one can start enjoying life. Enjoyment of food, taking time to savor food, and being aware of when one is hungry and when not are central. For physical activity, the emphasis is on discovering something that is pleasurable and sustainable, rather than an onerous duty, as a means to an end of weight loss.⁴

Management

For Emily, struggling on the individual level, there is not a neat resolution. Psychotherapy to address anxiety, trauma, and substance abuse is indicated. Psychotherapy also should address Emily’s relationship with her body, as this is at the heart of many of these issues. Acknowledging the powerful stigma that society places on the obese while tolerating and even promoting an obesogenic environment, and the reality that weight loss is in fact extremely difficult, would open the door to a discussion with Emily and her family about what she wants and all her options to find the healthiest and most enjoyable way for her to live her life.

1. Pediatr Clin North Am. 2015 Oct;62(5):1241-61.

2. Annu Rev Nutr. 2001;21:323-41.

3. Am J Clin Nutr. 2005 Jul;82(1 Suppl):222S-225S.

4. Tylka TL, Annunziato RA, Burgard D, et al. “The Weight-Inclusive versus Weight-Normative Approach to Health: Evaluating the Evidence for Prioritizing Well-Being over Weight Loss.” J Obes. 2014;2014:983495. doi: 10.1155/2014/983495.

Dr. Hall is an assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington.

As orthopedic surgeons, we’ve made a commitment to lifelong learning. I can’t think of a single surgery that I perform the same way I did when I was in training. With rapidly evolving technology, continuously advancing procedures, and ever-increasing documentation requirements, it’s hard to stay on top of it all. We know your time is precious and that you have less of it than ever before. What little time you have that is not dedicated to work is reserved for your family or your hobbies. There’s no time to read every orthopedic journal, many filled with articles that have no practical value to your practice. That’s why we’ve created the new AJO. Our goal, as an editorial staff, is to provide a journal where every article, column, and feature contains information that directly benefits your practice, your patients, or your bottom line, and keeps you informed of the latest techniques, procedures, and products. We will help surgeons “work smarter, not harder,” implement new technologies into their practices, and find creative revenue streams that are both legal and compliant.

We’ve assembled a team of talented editors to accomplish this task, and will introduce them throughout the coming year. In this issue, you will meet our Deputy Editors-in-Chief and some of our new Associate Editors who’ve collaborated to bring you the “new AJO”.

At this year’s Academy, the AJO launched an extensive rebranding. We have a new look, a new logo, and a new creative directive. The journal will now feature new columns, invited articles, and innovative surgical techniques. We will publish 5 issues for the remainder of 2016. Our March/April issue is a special edition dedicated to baseball. In time for Spring Training/Opening Day, this issue includes articles from Major League Baseball’s physicians and trainers, a “Codes to Know” segment, “Tips of the Trade,” and a “Tools of the Trade” feature. “The Baseball Issue” will set the tone for what readers can expect from the “new AJO”.

Our first feature article, written by Jed Kuhn, takes a philosophical look at the evolution of the throwing shoulder, and invites the reader to help unlock some of the great shoulder anatomy mysteries by viewing them from a time when throwing was an activity of daily living. In ancient times, if you couldn’t throw, you couldn’t eat. We know that children who play baseball remodel their shoulder to allow for increased external rotation. Read Dr. Kuhn’s article and imagine when a shoulder optimized for throwing was a competitive advantage for survival.

Our second feature article is written by Stan Conte, a legend of the game and longtime trainer for the Los Angeles Dodgers. Dr. Conte studied injury trends in baseball over the past 18 seasons and provides an analysis of the staggering cost of placing players on the disabled list.

A baseball issue could not be complete without an article on Tommy John surgery. In this issue, AJO shares a revolutionary new technique for treating players with MUCL tears by author Jeffrey Dugas. Named the “Internal Brace”, Dr. Dugas shares his technique for augmenting the injured MUCL and we are proud to bring it to you first.

A recurring feature in the new AJO will be a section we refer to as “Codes to Know.” In partnership with Karen Zupko, AJO will present little-known coding secrets and proper coding techniques to help you get reimbursed appropriately for your work. This month, in the first article of a 3-part series, Alan Hirahara teaches us how to properly code for a diagnostic ultrasound examination of the shoulder. The article includes templates available for download to assist you with proper documentation. Parts 2 and 3 will provide a tutorial on the proper technique for examinations and injections.

While shoulder and elbow injuries get more attention, Major League Baseball’s Injury Panel has produced a look at the staggering amount of knee injuries over the 2011-2014 seasons, inspiring us to feature the knee in our 2 “Trade” Columns.

The “Tips of the Trade” column will continue, featuring this month a guide to identifying and treating meniscal root tears. A new segment, referred to as “Tools of the Trade,” reviews the latest products for all-inside meniscal repair. Our “Tools” section will feature announcements and reviews of the hottest new products, with a buying guide and surgical pearls from the surgeons who know them best.

While we are discussing the lower extremity, we should point out that we plan to do the “leg work” for you. Each AJO issue will have handouts that can be downloaded from our website and utilized in your practice. Read Robin West’s article entitled “Interval Throwing and Hitting Programs in Baseball: Biomechanics and Rehabilitation,” and download Return to Throwing and Hitting programs your patients and therapists can use.

Finally, I’d like to thank our previous Editor-in-Chief Dr. Peter McCann for his stewardship the last 10 years and recognize him for his dedication to the journal.

Thank you for reading AJO and for continuing to do so in the future. I know that collectively, we can turn AJO into a product worthy of its title. We know our past reputation. We are no longer that journal. Spend some time to get to know the “new AJO”, and make some room on your shelves, because the information between the covers will provide a template to implement new technologies and revenue streams into your practice and help fulfill your commitment to learning.

As orthopedic surgeons, we’ve made a commitment to lifelong learning. I can’t think of a single surgery that I perform the same way I did when I was in training. With rapidly evolving technology, continuously advancing procedures, and ever-increasing documentation requirements, it’s hard to stay on top of it all. We know your time is precious and that you have less of it than ever before. What little time you have that is not dedicated to work is reserved for your family or your hobbies. There’s no time to read every orthopedic journal, many filled with articles that have no practical value to your practice. That’s why we’ve created the new AJO. Our goal, as an editorial staff, is to provide a journal where every article, column, and feature contains information that directly benefits your practice, your patients, or your bottom line, and keeps you informed of the latest techniques, procedures, and products. We will help surgeons “work smarter, not harder,” implement new technologies into their practices, and find creative revenue streams that are both legal and compliant.

We’ve assembled a team of talented editors to accomplish this task, and will introduce them throughout the coming year. In this issue, you will meet our Deputy Editors-in-Chief and some of our new Associate Editors who’ve collaborated to bring you the “new AJO”.

At this year’s Academy, the AJO launched an extensive rebranding. We have a new look, a new logo, and a new creative directive. The journal will now feature new columns, invited articles, and innovative surgical techniques. We will publish 5 issues for the remainder of 2016. Our March/April issue is a special edition dedicated to baseball. In time for Spring Training/Opening Day, this issue includes articles from Major League Baseball’s physicians and trainers, a “Codes to Know” segment, “Tips of the Trade,” and a “Tools of the Trade” feature. “The Baseball Issue” will set the tone for what readers can expect from the “new AJO”.

Our first feature article, written by Jed Kuhn, takes a philosophical look at the evolution of the throwing shoulder, and invites the reader to help unlock some of the great shoulder anatomy mysteries by viewing them from a time when throwing was an activity of daily living. In ancient times, if you couldn’t throw, you couldn’t eat. We know that children who play baseball remodel their shoulder to allow for increased external rotation. Read Dr. Kuhn’s article and imagine when a shoulder optimized for throwing was a competitive advantage for survival.

Our second feature article is written by Stan Conte, a legend of the game and longtime trainer for the Los Angeles Dodgers. Dr. Conte studied injury trends in baseball over the past 18 seasons and provides an analysis of the staggering cost of placing players on the disabled list.

A baseball issue could not be complete without an article on Tommy John surgery. In this issue, AJO shares a revolutionary new technique for treating players with MUCL tears by author Jeffrey Dugas. Named the “Internal Brace”, Dr. Dugas shares his technique for augmenting the injured MUCL and we are proud to bring it to you first.

A recurring feature in the new AJO will be a section we refer to as “Codes to Know.” In partnership with Karen Zupko, AJO will present little-known coding secrets and proper coding techniques to help you get reimbursed appropriately for your work. This month, in the first article of a 3-part series, Alan Hirahara teaches us how to properly code for a diagnostic ultrasound examination of the shoulder. The article includes templates available for download to assist you with proper documentation. Parts 2 and 3 will provide a tutorial on the proper technique for examinations and injections.

While shoulder and elbow injuries get more attention, Major League Baseball’s Injury Panel has produced a look at the staggering amount of knee injuries over the 2011-2014 seasons, inspiring us to feature the knee in our 2 “Trade” Columns.

The “Tips of the Trade” column will continue, featuring this month a guide to identifying and treating meniscal root tears. A new segment, referred to as “Tools of the Trade,” reviews the latest products for all-inside meniscal repair. Our “Tools” section will feature announcements and reviews of the hottest new products, with a buying guide and surgical pearls from the surgeons who know them best.

While we are discussing the lower extremity, we should point out that we plan to do the “leg work” for you. Each AJO issue will have handouts that can be downloaded from our website and utilized in your practice. Read Robin West’s article entitled “Interval Throwing and Hitting Programs in Baseball: Biomechanics and Rehabilitation,” and download Return to Throwing and Hitting programs your patients and therapists can use.

Finally, I’d like to thank our previous Editor-in-Chief Dr. Peter McCann for his stewardship the last 10 years and recognize him for his dedication to the journal.

Thank you for reading AJO and for continuing to do so in the future. I know that collectively, we can turn AJO into a product worthy of its title. We know our past reputation. We are no longer that journal. Spend some time to get to know the “new AJO”, and make some room on your shelves, because the information between the covers will provide a template to implement new technologies and revenue streams into your practice and help fulfill your commitment to learning.

As orthopedic surgeons, we’ve made a commitment to lifelong learning. I can’t think of a single surgery that I perform the same way I did when I was in training. With rapidly evolving technology, continuously advancing procedures, and ever-increasing documentation requirements, it’s hard to stay on top of it all. We know your time is precious and that you have less of it than ever before. What little time you have that is not dedicated to work is reserved for your family or your hobbies. There’s no time to read every orthopedic journal, many filled with articles that have no practical value to your practice. That’s why we’ve created the new AJO. Our goal, as an editorial staff, is to provide a journal where every article, column, and feature contains information that directly benefits your practice, your patients, or your bottom line, and keeps you informed of the latest techniques, procedures, and products. We will help surgeons “work smarter, not harder,” implement new technologies into their practices, and find creative revenue streams that are both legal and compliant.

We’ve assembled a team of talented editors to accomplish this task, and will introduce them throughout the coming year. In this issue, you will meet our Deputy Editors-in-Chief and some of our new Associate Editors who’ve collaborated to bring you the “new AJO”.

At this year’s Academy, the AJO launched an extensive rebranding. We have a new look, a new logo, and a new creative directive. The journal will now feature new columns, invited articles, and innovative surgical techniques. We will publish 5 issues for the remainder of 2016. Our March/April issue is a special edition dedicated to baseball. In time for Spring Training/Opening Day, this issue includes articles from Major League Baseball’s physicians and trainers, a “Codes to Know” segment, “Tips of the Trade,” and a “Tools of the Trade” feature. “The Baseball Issue” will set the tone for what readers can expect from the “new AJO”.

Our first feature article, written by Jed Kuhn, takes a philosophical look at the evolution of the throwing shoulder, and invites the reader to help unlock some of the great shoulder anatomy mysteries by viewing them from a time when throwing was an activity of daily living. In ancient times, if you couldn’t throw, you couldn’t eat. We know that children who play baseball remodel their shoulder to allow for increased external rotation. Read Dr. Kuhn’s article and imagine when a shoulder optimized for throwing was a competitive advantage for survival.

Our second feature article is written by Stan Conte, a legend of the game and longtime trainer for the Los Angeles Dodgers. Dr. Conte studied injury trends in baseball over the past 18 seasons and provides an analysis of the staggering cost of placing players on the disabled list.

A baseball issue could not be complete without an article on Tommy John surgery. In this issue, AJO shares a revolutionary new technique for treating players with MUCL tears by author Jeffrey Dugas. Named the “Internal Brace”, Dr. Dugas shares his technique for augmenting the injured MUCL and we are proud to bring it to you first.

A recurring feature in the new AJO will be a section we refer to as “Codes to Know.” In partnership with Karen Zupko, AJO will present little-known coding secrets and proper coding techniques to help you get reimbursed appropriately for your work. This month, in the first article of a 3-part series, Alan Hirahara teaches us how to properly code for a diagnostic ultrasound examination of the shoulder. The article includes templates available for download to assist you with proper documentation. Parts 2 and 3 will provide a tutorial on the proper technique for examinations and injections.

While shoulder and elbow injuries get more attention, Major League Baseball’s Injury Panel has produced a look at the staggering amount of knee injuries over the 2011-2014 seasons, inspiring us to feature the knee in our 2 “Trade” Columns.

The “Tips of the Trade” column will continue, featuring this month a guide to identifying and treating meniscal root tears. A new segment, referred to as “Tools of the Trade,” reviews the latest products for all-inside meniscal repair. Our “Tools” section will feature announcements and reviews of the hottest new products, with a buying guide and surgical pearls from the surgeons who know them best.

While we are discussing the lower extremity, we should point out that we plan to do the “leg work” for you. Each AJO issue will have handouts that can be downloaded from our website and utilized in your practice. Read Robin West’s article entitled “Interval Throwing and Hitting Programs in Baseball: Biomechanics and Rehabilitation,” and download Return to Throwing and Hitting programs your patients and therapists can use.

Finally, I’d like to thank our previous Editor-in-Chief Dr. Peter McCann for his stewardship the last 10 years and recognize him for his dedication to the journal.

Thank you for reading AJO and for continuing to do so in the future. I know that collectively, we can turn AJO into a product worthy of its title. We know our past reputation. We are no longer that journal. Spend some time to get to know the “new AJO”, and make some room on your shelves, because the information between the covers will provide a template to implement new technologies and revenue streams into your practice and help fulfill your commitment to learning.

We’re always working toward medical breakthroughs so we can provide the most effective treatments for our patients with cutting-edge technology; however, there is a lot to be said about the techniques that have paved the way for new medical devices.

For certain conditions, the efficacy of classic procedures often cannot be matched by their modern successors. Subcision for treatment of deep depressed scars, for example, is often a more effective option than microneedling and can produce results with less healing time and fewer treatments, and at a more cost-effective price.

Both subcision and microneedling improve the appearance of scars by creating wounds in an effort to break up scar tissue and trigger collagen regrowth. Microneedling involves the use of a microneedling pen with several small needles that glide across the skin at different depths and speeds. Subcision is achieved with one larger gauge needle that is injected into scars at different angles and depths to break up scar tissue. Microneedling needles yield more epidermal damage than does subcision, causing more bleeding and ultimately lengthening the healing time.

The mechanism of subcising deeper scar tissue also seems to be more effective than that of microneedling. It often takes fewer subcision treatments than microneedling treatments to achieve comparable improvement of depressed scars. Microneedling needles are limited to penetrating at best 2.5 mm beneath the skin surface, while subcision allows the freedom to penetrate deeper into the dermis to reach deeper dermal scars. Subcising also creates larger channels within the scar tissue, which create more space for collagen regrowth, while microneedling does not.

A technique that has shown to improve treatment outcomes is the use of a 26- or 30-gauge needle, moving back and forth in a fanning pattern under the scar tissue while simultaneously injecting lidocaine or saline in those channels. The injection of a fluid component, particularly that of lidocaine, can both decrease the pain as well as inflate the scar in question, allowing more collagen regrowth and wound growth factors to fill the “gaps” created.

Unless scars have a significant epidermal component in addition to their dermal component, subcising the scar is a more effective and has faster healing times. Both procedures can cause bruising , edema, and erythema. However, the epidermal damage that can occur in microneedling has significantly more downtime.

In addition, subcision is a more cost-effective treatment than microneedling. The required materials for subcision are limited to materials that are readily used within practices: needles, syringes, saline, and lidocaine. Microneedling, on the other hand, requires purchase of expensive tools, including microneedling pens, sterile single-use microneedling tips, and protective sleeves for the device, in addition to topical skin care products to apply after the treatment to promote safe healing.

While microneedling is remarkably effective for treatment of superficial scars, fine lines, and hypopigmentation, subcision tends to be more effective for the treatment of deeper scars such as box-car acne scars.

We love new technology in our practices; however, sometimes our tried and true procedures may prove to be a better option in the appropriate patient.

Dr. Wesley and Dr. Talakoub are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

We’re always working toward medical breakthroughs so we can provide the most effective treatments for our patients with cutting-edge technology; however, there is a lot to be said about the techniques that have paved the way for new medical devices.

For certain conditions, the efficacy of classic procedures often cannot be matched by their modern successors. Subcision for treatment of deep depressed scars, for example, is often a more effective option than microneedling and can produce results with less healing time and fewer treatments, and at a more cost-effective price.

Both subcision and microneedling improve the appearance of scars by creating wounds in an effort to break up scar tissue and trigger collagen regrowth. Microneedling involves the use of a microneedling pen with several small needles that glide across the skin at different depths and speeds. Subcision is achieved with one larger gauge needle that is injected into scars at different angles and depths to break up scar tissue. Microneedling needles yield more epidermal damage than does subcision, causing more bleeding and ultimately lengthening the healing time.

The mechanism of subcising deeper scar tissue also seems to be more effective than that of microneedling. It often takes fewer subcision treatments than microneedling treatments to achieve comparable improvement of depressed scars. Microneedling needles are limited to penetrating at best 2.5 mm beneath the skin surface, while subcision allows the freedom to penetrate deeper into the dermis to reach deeper dermal scars. Subcising also creates larger channels within the scar tissue, which create more space for collagen regrowth, while microneedling does not.

A technique that has shown to improve treatment outcomes is the use of a 26- or 30-gauge needle, moving back and forth in a fanning pattern under the scar tissue while simultaneously injecting lidocaine or saline in those channels. The injection of a fluid component, particularly that of lidocaine, can both decrease the pain as well as inflate the scar in question, allowing more collagen regrowth and wound growth factors to fill the “gaps” created.

Unless scars have a significant epidermal component in addition to their dermal component, subcising the scar is a more effective and has faster healing times. Both procedures can cause bruising , edema, and erythema. However, the epidermal damage that can occur in microneedling has significantly more downtime.

In addition, subcision is a more cost-effective treatment than microneedling. The required materials for subcision are limited to materials that are readily used within practices: needles, syringes, saline, and lidocaine. Microneedling, on the other hand, requires purchase of expensive tools, including microneedling pens, sterile single-use microneedling tips, and protective sleeves for the device, in addition to topical skin care products to apply after the treatment to promote safe healing.

While microneedling is remarkably effective for treatment of superficial scars, fine lines, and hypopigmentation, subcision tends to be more effective for the treatment of deeper scars such as box-car acne scars.

We love new technology in our practices; however, sometimes our tried and true procedures may prove to be a better option in the appropriate patient.

Dr. Wesley and Dr. Talakoub are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

We’re always working toward medical breakthroughs so we can provide the most effective treatments for our patients with cutting-edge technology; however, there is a lot to be said about the techniques that have paved the way for new medical devices.

For certain conditions, the efficacy of classic procedures often cannot be matched by their modern successors. Subcision for treatment of deep depressed scars, for example, is often a more effective option than microneedling and can produce results with less healing time and fewer treatments, and at a more cost-effective price.

Both subcision and microneedling improve the appearance of scars by creating wounds in an effort to break up scar tissue and trigger collagen regrowth. Microneedling involves the use of a microneedling pen with several small needles that glide across the skin at different depths and speeds. Subcision is achieved with one larger gauge needle that is injected into scars at different angles and depths to break up scar tissue. Microneedling needles yield more epidermal damage than does subcision, causing more bleeding and ultimately lengthening the healing time.

The mechanism of subcising deeper scar tissue also seems to be more effective than that of microneedling. It often takes fewer subcision treatments than microneedling treatments to achieve comparable improvement of depressed scars. Microneedling needles are limited to penetrating at best 2.5 mm beneath the skin surface, while subcision allows the freedom to penetrate deeper into the dermis to reach deeper dermal scars. Subcising also creates larger channels within the scar tissue, which create more space for collagen regrowth, while microneedling does not.

A technique that has shown to improve treatment outcomes is the use of a 26- or 30-gauge needle, moving back and forth in a fanning pattern under the scar tissue while simultaneously injecting lidocaine or saline in those channels. The injection of a fluid component, particularly that of lidocaine, can both decrease the pain as well as inflate the scar in question, allowing more collagen regrowth and wound growth factors to fill the “gaps” created.

Unless scars have a significant epidermal component in addition to their dermal component, subcising the scar is a more effective and has faster healing times. Both procedures can cause bruising , edema, and erythema. However, the epidermal damage that can occur in microneedling has significantly more downtime.

In addition, subcision is a more cost-effective treatment than microneedling. The required materials for subcision are limited to materials that are readily used within practices: needles, syringes, saline, and lidocaine. Microneedling, on the other hand, requires purchase of expensive tools, including microneedling pens, sterile single-use microneedling tips, and protective sleeves for the device, in addition to topical skin care products to apply after the treatment to promote safe healing.

While microneedling is remarkably effective for treatment of superficial scars, fine lines, and hypopigmentation, subcision tends to be more effective for the treatment of deeper scars such as box-car acne scars.

We love new technology in our practices; however, sometimes our tried and true procedures may prove to be a better option in the appropriate patient.

Dr. Wesley and Dr. Talakoub are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

It seemed like a teachable moment. My student looked on as Laura took off her shoes and showed us livid, polycyclic plaques covering the dorsum of her left foot. The way her rash looked, bordering 10 obviously fungal toenails, left little doubt about the problem.

“I’m going to guess you’re using a steroid cream,” I said.

“Could I please tell you the whole story?” said Laura, with some impatience.

“Sure,” I said. I love whole stories.

So Laura told me hers, starting with her walk through the tall grass in the summer, followed by “poison ivy” that her primary care physician treated with “a cream.”

“Did the cream have hydrocortisone in it?”

“I think so,” she said. But that didn’t work, so her doctor prescribed another cream. That one seemed to help a bit, but then the rash got redder and itchier, so she got another cream. “I think it was called clobetasol,” Laura said.

“Several years ago,” Laura went on, “you said I had toenail fungus in my nails, but I didn’t want to take pills for it because it didn’t bother me enough.”

“Maybe now would be a good time,” I said.

After I had recommended oral and topical therapy (and stopped the clobetasol!), my student and I went into my office. Like most of my students, she is headed for a career in primary care, in her case, Family Medicine.

“What do you think?” I asked her. “How does this case reflect on the state of dermatology expertise in the primary care community?” We’ve been discussing this, because Laura’s was not the first such example, just the most egregious.

My student’s eyes widened. No need to belabor the point.

“The problem is not that Laura’s primary care physician made a mistake,” I said. “I make them too, like prescribing antifungal creams for eczema and steroid creams for fungi. The problem is not noticing that you’ve made the mistake – with the evidence literally staring you in the face – and then either fixing it, or else consulting someone else who can help you fix it.”

“I’m going to do a better job!” said my student, with feeling.

Perhaps she will. At least she will graduate medical school having learned that there is such a thing as nummular eczema and been told that not every round rash is a fungus. As with almost every 4th-year student who’s taken my elective for the last 35 years, she had little dermatology exposure until now beyond a couple of PowerPoint shows of exotic diseases. I had none either back in school, when dinosaurs roamed the earth.

After I graduated, my prestigious pediatric residency taught me a grand total of three dermatologic facts: 1. For tinea capitis, shine a Wood’s light on the scalp; 2. For pityriasis rosea, shine a Wood’s light on the body; and 3. If a groin wash involves the inguinal fold, it’s a yeast infection. I learned a lot, didn’t I?

Reflecting on Lesson #1, Trichophyton tonsurans, which doesn’t fluoresce, has predominated for half a century (and 90% of the time, the problem is seborrhea anyway). As for #2 and #3, never mind.

Decade after decade, the patients troop in: Eczemas treated as fungi, fungi treated with steroids, itchy rashes treated with permethrin, then treated again because the itch didn’t stop, because you can’t kill bugs that aren’t there.

Clinical dermatology is not rocket science. Eczema and fungus are so common that it is hardly possible not to encounter them in daily practice. Generations of providers come and go, yet the same clinical missteps persist.

Why are the common skin problems of ordinary patients not a priority in medical education? Why do so many practitioners keep doing the same things and not get better at doing them?

Perhaps such common problems just pass under the educational radar. Maybe these diseases aren’t sexy enough, their poor outcomes not consequential enough. Maybe the shoe just doesn’t pinch hard enough on these itchy, polycyclic plaques.

My students are very young and earnest. They mean to get out into the world and do a good job. Many challenges before them, which now include crushing, mind-numbing bureaucratic demands. Can we ask that, while they are busy clicking drop-down boxes on their EHR’s and mastering genomic medicine, they also treat eczema as eczema and fungus as fungus?

One hopes so.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

It seemed like a teachable moment. My student looked on as Laura took off her shoes and showed us livid, polycyclic plaques covering the dorsum of her left foot. The way her rash looked, bordering 10 obviously fungal toenails, left little doubt about the problem.

“I’m going to guess you’re using a steroid cream,” I said.

“Could I please tell you the whole story?” said Laura, with some impatience.

“Sure,” I said. I love whole stories.

So Laura told me hers, starting with her walk through the tall grass in the summer, followed by “poison ivy” that her primary care physician treated with “a cream.”

“Did the cream have hydrocortisone in it?”

“I think so,” she said. But that didn’t work, so her doctor prescribed another cream. That one seemed to help a bit, but then the rash got redder and itchier, so she got another cream. “I think it was called clobetasol,” Laura said.

“Several years ago,” Laura went on, “you said I had toenail fungus in my nails, but I didn’t want to take pills for it because it didn’t bother me enough.”

“Maybe now would be a good time,” I said.

After I had recommended oral and topical therapy (and stopped the clobetasol!), my student and I went into my office. Like most of my students, she is headed for a career in primary care, in her case, Family Medicine.

“What do you think?” I asked her. “How does this case reflect on the state of dermatology expertise in the primary care community?” We’ve been discussing this, because Laura’s was not the first such example, just the most egregious.

My student’s eyes widened. No need to belabor the point.

“The problem is not that Laura’s primary care physician made a mistake,” I said. “I make them too, like prescribing antifungal creams for eczema and steroid creams for fungi. The problem is not noticing that you’ve made the mistake – with the evidence literally staring you in the face – and then either fixing it, or else consulting someone else who can help you fix it.”

“I’m going to do a better job!” said my student, with feeling.

Perhaps she will. At least she will graduate medical school having learned that there is such a thing as nummular eczema and been told that not every round rash is a fungus. As with almost every 4th-year student who’s taken my elective for the last 35 years, she had little dermatology exposure until now beyond a couple of PowerPoint shows of exotic diseases. I had none either back in school, when dinosaurs roamed the earth.

After I graduated, my prestigious pediatric residency taught me a grand total of three dermatologic facts: 1. For tinea capitis, shine a Wood’s light on the scalp; 2. For pityriasis rosea, shine a Wood’s light on the body; and 3. If a groin wash involves the inguinal fold, it’s a yeast infection. I learned a lot, didn’t I?

Reflecting on Lesson #1, Trichophyton tonsurans, which doesn’t fluoresce, has predominated for half a century (and 90% of the time, the problem is seborrhea anyway). As for #2 and #3, never mind.

Decade after decade, the patients troop in: Eczemas treated as fungi, fungi treated with steroids, itchy rashes treated with permethrin, then treated again because the itch didn’t stop, because you can’t kill bugs that aren’t there.

Clinical dermatology is not rocket science. Eczema and fungus are so common that it is hardly possible not to encounter them in daily practice. Generations of providers come and go, yet the same clinical missteps persist.

Why are the common skin problems of ordinary patients not a priority in medical education? Why do so many practitioners keep doing the same things and not get better at doing them?

Perhaps such common problems just pass under the educational radar. Maybe these diseases aren’t sexy enough, their poor outcomes not consequential enough. Maybe the shoe just doesn’t pinch hard enough on these itchy, polycyclic plaques.

My students are very young and earnest. They mean to get out into the world and do a good job. Many challenges before them, which now include crushing, mind-numbing bureaucratic demands. Can we ask that, while they are busy clicking drop-down boxes on their EHR’s and mastering genomic medicine, they also treat eczema as eczema and fungus as fungus?

One hopes so.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

It seemed like a teachable moment. My student looked on as Laura took off her shoes and showed us livid, polycyclic plaques covering the dorsum of her left foot. The way her rash looked, bordering 10 obviously fungal toenails, left little doubt about the problem.

“I’m going to guess you’re using a steroid cream,” I said.

“Could I please tell you the whole story?” said Laura, with some impatience.

“Sure,” I said. I love whole stories.

So Laura told me hers, starting with her walk through the tall grass in the summer, followed by “poison ivy” that her primary care physician treated with “a cream.”

“Did the cream have hydrocortisone in it?”

“I think so,” she said. But that didn’t work, so her doctor prescribed another cream. That one seemed to help a bit, but then the rash got redder and itchier, so she got another cream. “I think it was called clobetasol,” Laura said.

“Several years ago,” Laura went on, “you said I had toenail fungus in my nails, but I didn’t want to take pills for it because it didn’t bother me enough.”

“Maybe now would be a good time,” I said.

After I had recommended oral and topical therapy (and stopped the clobetasol!), my student and I went into my office. Like most of my students, she is headed for a career in primary care, in her case, Family Medicine.

“What do you think?” I asked her. “How does this case reflect on the state of dermatology expertise in the primary care community?” We’ve been discussing this, because Laura’s was not the first such example, just the most egregious.

My student’s eyes widened. No need to belabor the point.

“The problem is not that Laura’s primary care physician made a mistake,” I said. “I make them too, like prescribing antifungal creams for eczema and steroid creams for fungi. The problem is not noticing that you’ve made the mistake – with the evidence literally staring you in the face – and then either fixing it, or else consulting someone else who can help you fix it.”

“I’m going to do a better job!” said my student, with feeling.

Perhaps she will. At least she will graduate medical school having learned that there is such a thing as nummular eczema and been told that not every round rash is a fungus. As with almost every 4th-year student who’s taken my elective for the last 35 years, she had little dermatology exposure until now beyond a couple of PowerPoint shows of exotic diseases. I had none either back in school, when dinosaurs roamed the earth.

After I graduated, my prestigious pediatric residency taught me a grand total of three dermatologic facts: 1. For tinea capitis, shine a Wood’s light on the scalp; 2. For pityriasis rosea, shine a Wood’s light on the body; and 3. If a groin wash involves the inguinal fold, it’s a yeast infection. I learned a lot, didn’t I?

Reflecting on Lesson #1, Trichophyton tonsurans, which doesn’t fluoresce, has predominated for half a century (and 90% of the time, the problem is seborrhea anyway). As for #2 and #3, never mind.

Decade after decade, the patients troop in: Eczemas treated as fungi, fungi treated with steroids, itchy rashes treated with permethrin, then treated again because the itch didn’t stop, because you can’t kill bugs that aren’t there.

Clinical dermatology is not rocket science. Eczema and fungus are so common that it is hardly possible not to encounter them in daily practice. Generations of providers come and go, yet the same clinical missteps persist.

Why are the common skin problems of ordinary patients not a priority in medical education? Why do so many practitioners keep doing the same things and not get better at doing them?

Perhaps such common problems just pass under the educational radar. Maybe these diseases aren’t sexy enough, their poor outcomes not consequential enough. Maybe the shoe just doesn’t pinch hard enough on these itchy, polycyclic plaques.

My students are very young and earnest. They mean to get out into the world and do a good job. Many challenges before them, which now include crushing, mind-numbing bureaucratic demands. Can we ask that, while they are busy clicking drop-down boxes on their EHR’s and mastering genomic medicine, they also treat eczema as eczema and fungus as fungus?

One hopes so.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

The U.S. program to develop biosimilar agents – somewhat akin to generic drugs for complex, biologic molecules that have come off patent protection – is gathering momentum, with the first U.S. biosimilar, Zarxio, approved by the Food and Drug Administration in March 2015 and with the second, a biosimilar to infliximab, recommended by an FDA advisory committee on Feb. 9 of this year.

What’s striking about the burgeoning biosimilar development process, created by the Affordable Care Act, is how it has morphed the FDA from its traditional role as an objective arbiter of a drug’s safety and efficacy into an active partner in shepherding biosimilars onto the market.

As explained on Feb. 4 in testimony before a Congressional committee by Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, the Biologic Price Competition and Innovation Act that was part of the Affordable Care Act launched a new U.S. drug-development pathway expressly for biosimilars. To implement that law, the FDA created an entirely new infrastructure within the agency – the Biosimilar Product Development Program – to help guide prospective manufacturers (called sponsors) of biosimilars through the regulatory and research hurdles to get a new biosimilar approved and into the hands of U.S. patients.

According to Dr. Woodcock, this program involves many steps where FDA staffers provide “review” and “advice” to sponsors on the studies they need to conduct and the analysis they need to perform to get their new products to market. The sponsor joins this program by paying an upfront fee that the FDA uses to keep the program running. Once a sponsor of a prospective biosimilar is in the program, the FDA’s staff helps guide the biosimilar development to a smooth conclusion.

To some extent, the FDA staff fills a similar role for conventional drug-development enterprises, conferring with manufacturers from the outset on matters such as the types and design of studies needed to insure success. What’s different about the biosimilar program is that conventional-drug development went on well before the FDA (or its predecessor) entered the scene, and the U.S. government created the FDA to police and regulate the drug production industry and protect the public against unscrupulous manufacturers of ineffective or dangerous drugs.

In contrast, the FDA itself created this new biosimilar development structure, and Dr. Woodcock noted that the in-depth review and advice meetings that the FDA offers to prospective biosimilar sponsors “has no counterpart in the Prescription Drug User Fee Act program and is unique” to the biosimilar program.

The consequence of having the FDA create the biosimilar development program from the ground up and structure it to provide such intimate input from the agency to sponsors at every step of the way seems to give the agency a notable and somewhat unnerving investment in the program’s success.

Dr. Woodcock called the approval of Zarxio an “exciting accomplishment,” and in her testimony before Congress she trumpeted the fact that as of January 2016 the biosimilar program was working on 59 proposed products that would mimic 18 different reference-product biologics. She also said that the FDA is “excited about the growing demand” for biosimilar-oriented meetings and marketing applications.

Don’t get me wrong: I think that the biosimilar concept is great, and has the potential to make what have become life-changing treatments more affordable and more available. And making the FDA such an active participant in getting biosimilar drugs created and approved is undoubtedly the most efficient way to accomplish this.

But in the process, the biosimilar program has changed the FDA from its more disengaged role as objective pharmaceutical judge into an active and seemingly not completely neutral codeveloper, risking at least the appearance of lost impartiality. Given that the FDA now wears two very different hats, we need to trust that the integrity and dedication of its staff will keep them from confusing their roles as proponent and gatekeeper.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

The U.S. program to develop biosimilar agents – somewhat akin to generic drugs for complex, biologic molecules that have come off patent protection – is gathering momentum, with the first U.S. biosimilar, Zarxio, approved by the Food and Drug Administration in March 2015 and with the second, a biosimilar to infliximab, recommended by an FDA advisory committee on Feb. 9 of this year.

What’s striking about the burgeoning biosimilar development process, created by the Affordable Care Act, is how it has morphed the FDA from its traditional role as an objective arbiter of a drug’s safety and efficacy into an active partner in shepherding biosimilars onto the market.

As explained on Feb. 4 in testimony before a Congressional committee by Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, the Biologic Price Competition and Innovation Act that was part of the Affordable Care Act launched a new U.S. drug-development pathway expressly for biosimilars. To implement that law, the FDA created an entirely new infrastructure within the agency – the Biosimilar Product Development Program – to help guide prospective manufacturers (called sponsors) of biosimilars through the regulatory and research hurdles to get a new biosimilar approved and into the hands of U.S. patients.

According to Dr. Woodcock, this program involves many steps where FDA staffers provide “review” and “advice” to sponsors on the studies they need to conduct and the analysis they need to perform to get their new products to market. The sponsor joins this program by paying an upfront fee that the FDA uses to keep the program running. Once a sponsor of a prospective biosimilar is in the program, the FDA’s staff helps guide the biosimilar development to a smooth conclusion.

To some extent, the FDA staff fills a similar role for conventional drug-development enterprises, conferring with manufacturers from the outset on matters such as the types and design of studies needed to insure success. What’s different about the biosimilar program is that conventional-drug development went on well before the FDA (or its predecessor) entered the scene, and the U.S. government created the FDA to police and regulate the drug production industry and protect the public against unscrupulous manufacturers of ineffective or dangerous drugs.

In contrast, the FDA itself created this new biosimilar development structure, and Dr. Woodcock noted that the in-depth review and advice meetings that the FDA offers to prospective biosimilar sponsors “has no counterpart in the Prescription Drug User Fee Act program and is unique” to the biosimilar program.

The consequence of having the FDA create the biosimilar development program from the ground up and structure it to provide such intimate input from the agency to sponsors at every step of the way seems to give the agency a notable and somewhat unnerving investment in the program’s success.

Dr. Woodcock called the approval of Zarxio an “exciting accomplishment,” and in her testimony before Congress she trumpeted the fact that as of January 2016 the biosimilar program was working on 59 proposed products that would mimic 18 different reference-product biologics. She also said that the FDA is “excited about the growing demand” for biosimilar-oriented meetings and marketing applications.

Don’t get me wrong: I think that the biosimilar concept is great, and has the potential to make what have become life-changing treatments more affordable and more available. And making the FDA such an active participant in getting biosimilar drugs created and approved is undoubtedly the most efficient way to accomplish this.

But in the process, the biosimilar program has changed the FDA from its more disengaged role as objective pharmaceutical judge into an active and seemingly not completely neutral codeveloper, risking at least the appearance of lost impartiality. Given that the FDA now wears two very different hats, we need to trust that the integrity and dedication of its staff will keep them from confusing their roles as proponent and gatekeeper.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

The U.S. program to develop biosimilar agents – somewhat akin to generic drugs for complex, biologic molecules that have come off patent protection – is gathering momentum, with the first U.S. biosimilar, Zarxio, approved by the Food and Drug Administration in March 2015 and with the second, a biosimilar to infliximab, recommended by an FDA advisory committee on Feb. 9 of this year.

What’s striking about the burgeoning biosimilar development process, created by the Affordable Care Act, is how it has morphed the FDA from its traditional role as an objective arbiter of a drug’s safety and efficacy into an active partner in shepherding biosimilars onto the market.

As explained on Feb. 4 in testimony before a Congressional committee by Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, the Biologic Price Competition and Innovation Act that was part of the Affordable Care Act launched a new U.S. drug-development pathway expressly for biosimilars. To implement that law, the FDA created an entirely new infrastructure within the agency – the Biosimilar Product Development Program – to help guide prospective manufacturers (called sponsors) of biosimilars through the regulatory and research hurdles to get a new biosimilar approved and into the hands of U.S. patients.

According to Dr. Woodcock, this program involves many steps where FDA staffers provide “review” and “advice” to sponsors on the studies they need to conduct and the analysis they need to perform to get their new products to market. The sponsor joins this program by paying an upfront fee that the FDA uses to keep the program running. Once a sponsor of a prospective biosimilar is in the program, the FDA’s staff helps guide the biosimilar development to a smooth conclusion.

To some extent, the FDA staff fills a similar role for conventional drug-development enterprises, conferring with manufacturers from the outset on matters such as the types and design of studies needed to insure success. What’s different about the biosimilar program is that conventional-drug development went on well before the FDA (or its predecessor) entered the scene, and the U.S. government created the FDA to police and regulate the drug production industry and protect the public against unscrupulous manufacturers of ineffective or dangerous drugs.

In contrast, the FDA itself created this new biosimilar development structure, and Dr. Woodcock noted that the in-depth review and advice meetings that the FDA offers to prospective biosimilar sponsors “has no counterpart in the Prescription Drug User Fee Act program and is unique” to the biosimilar program.

The consequence of having the FDA create the biosimilar development program from the ground up and structure it to provide such intimate input from the agency to sponsors at every step of the way seems to give the agency a notable and somewhat unnerving investment in the program’s success.

Dr. Woodcock called the approval of Zarxio an “exciting accomplishment,” and in her testimony before Congress she trumpeted the fact that as of January 2016 the biosimilar program was working on 59 proposed products that would mimic 18 different reference-product biologics. She also said that the FDA is “excited about the growing demand” for biosimilar-oriented meetings and marketing applications.

Don’t get me wrong: I think that the biosimilar concept is great, and has the potential to make what have become life-changing treatments more affordable and more available. And making the FDA such an active participant in getting biosimilar drugs created and approved is undoubtedly the most efficient way to accomplish this.

But in the process, the biosimilar program has changed the FDA from its more disengaged role as objective pharmaceutical judge into an active and seemingly not completely neutral codeveloper, risking at least the appearance of lost impartiality. Given that the FDA now wears two very different hats, we need to trust that the integrity and dedication of its staff will keep them from confusing their roles as proponent and gatekeeper.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

A 69-year-old man is evaluated for fatigue. He undergoes a colonoscopy and is found to have a right-sided colon cancer. His hematocrit is 33 with an MCV of 72. His ferritin level is 3. What do you recommend to help with his iron deficiency?

A. Ferrous sulfate 325 mg daily.

B. Ferrous sulfate 325 mg b.i.d.

C. Ferrous sulfate 325 mg t.i.d.

Treatment of iron deficiency with oral iron has traditionally been done by giving 150-200 mg of elemental iron (which is equal to three 325 mg tablets of iron sulfate).¹ This dosing regimen has considerable gastrointestinal side effects. Recent research into iron absorption suggests that the higher the dose of iron given, the more absorption may be hindered. In a study of 54 women who had low ferritin levels, lower daily doses of iron – and not giving it multiple times a day – led to better iron absorption.²

In a study of elderly patients with iron deficiency, 90 hospitalized elderly patients older than 80 years with iron deficiency anemia were randomized to receive elemental iron as 15 mg or 50 mg of liquid ferrous gluconate, or 150 mg of ferrous calcium citrate for 60 days.³ Two months of iron treatment raised hemoglobin and ferritin levels to a similar degree in all groups, with no significant differences between the 15-mg, 50-mg, and 150-mg groups.

There was a significant difference in abdominal discomfort, with much less (20%) in the patients who received 15 mg of ferrous gluconate, compared with 60% in those who received 50 mg and 70% in those receiving 150 mg (P less than .05 comparing 15 mg with 50 mg and 150 mg). Statistically significant differences were also seen for nausea/vomiting, constipation, and dropout, with much lower rates seen in the low-dose (15-mg) group.

In a study of iron supplementation in individuals undergoing blood donation, a single daily dose of iron was used (37.5 mg of elemental iron) in half of the subjects, with the rest of the subjects receiving no iron.⁴ The mean age of the participants was 48 years.

Subjects who received the once-daily low-dose iron recovered much more quickly toward predonation hematocrit than did those who did not receive the low-dose iron (time to 80% hemoglobin recovery, 32 days vs. 92 days in the non–iron treated patients, P = .02). The effect was more dramatic in subjects who started with a low ferritin level (defined as less than 26), where time to 80% hemoglobin recovery was 36 days in the iron-treated patients vs. 153 days for the no-iron group.

The results of this study are in line with what we know about avid iron absorption in iron deficient patients, and the success of low doses in a younger patient population is encouraging.

In a small study looking at two different doses of elemental iron for the treatment of iron deficiency, 24 women (ages 18-35 years) with iron deficiency were randomized to 60 mg or 80 mg of elemental iron or placebo for 16 weeks.⁵ There was no difference in normalization of ferritin levels in the women who received either dose of iron. There was also no difference in side effects between the groups.

This study is small and had minimal difference in iron dose. In addition, the dosing was given once a day for both groups. I suspect that the lack of difference in side effects was due to both the small size of the study and the minimal difference in iron dose.

What does this all mean? I think that the most appropriate dosing for oral iron replacement is a single daily low-dose iron preparation. Whether that dose is 15 mg of elemental iron to 68 mg of elemental iron (the amount in a 325-mg ferrous sulfate tablet) isn’t clear. Low doses appear to be effective, and avoiding high doses likely decreases side effects without sacrificing efficacy.

References

1. Fairbanks V.F., Beutler E. Iron deficiency, in “Williams Textbook of Hematology, 6th ed. Beutler E., Coller B.S., Lichtman M.A., Kipps T.J., eds. (New York: McGraw-Hill; 2001, pp. 460-2).

2. Blood. 2015 Oct 22;126(17):1981-9.

3. Am J Med. 2005 Oct;118(10):1142-7.

4. JAMA. 2015 Feb 10;313(6):575-83.

5. Nutrients. 2014 Apr 4;6(4):1394-405.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

A 69-year-old man is evaluated for fatigue. He undergoes a colonoscopy and is found to have a right-sided colon cancer. His hematocrit is 33 with an MCV of 72. His ferritin level is 3. What do you recommend to help with his iron deficiency?

A. Ferrous sulfate 325 mg daily.

B. Ferrous sulfate 325 mg b.i.d.

C. Ferrous sulfate 325 mg t.i.d.

Treatment of iron deficiency with oral iron has traditionally been done by giving 150-200 mg of elemental iron (which is equal to three 325 mg tablets of iron sulfate).¹ This dosing regimen has considerable gastrointestinal side effects. Recent research into iron absorption suggests that the higher the dose of iron given, the more absorption may be hindered. In a study of 54 women who had low ferritin levels, lower daily doses of iron – and not giving it multiple times a day – led to better iron absorption.²

In a study of elderly patients with iron deficiency, 90 hospitalized elderly patients older than 80 years with iron deficiency anemia were randomized to receive elemental iron as 15 mg or 50 mg of liquid ferrous gluconate, or 150 mg of ferrous calcium citrate for 60 days.³ Two months of iron treatment raised hemoglobin and ferritin levels to a similar degree in all groups, with no significant differences between the 15-mg, 50-mg, and 150-mg groups.

There was a significant difference in abdominal discomfort, with much less (20%) in the patients who received 15 mg of ferrous gluconate, compared with 60% in those who received 50 mg and 70% in those receiving 150 mg (P less than .05 comparing 15 mg with 50 mg and 150 mg). Statistically significant differences were also seen for nausea/vomiting, constipation, and dropout, with much lower rates seen in the low-dose (15-mg) group.

In a study of iron supplementation in individuals undergoing blood donation, a single daily dose of iron was used (37.5 mg of elemental iron) in half of the subjects, with the rest of the subjects receiving no iron.⁴ The mean age of the participants was 48 years.

Subjects who received the once-daily low-dose iron recovered much more quickly toward predonation hematocrit than did those who did not receive the low-dose iron (time to 80% hemoglobin recovery, 32 days vs. 92 days in the non–iron treated patients, P = .02). The effect was more dramatic in subjects who started with a low ferritin level (defined as less than 26), where time to 80% hemoglobin recovery was 36 days in the iron-treated patients vs. 153 days for the no-iron group.

The results of this study are in line with what we know about avid iron absorption in iron deficient patients, and the success of low doses in a younger patient population is encouraging.

In a small study looking at two different doses of elemental iron for the treatment of iron deficiency, 24 women (ages 18-35 years) with iron deficiency were randomized to 60 mg or 80 mg of elemental iron or placebo for 16 weeks.⁵ There was no difference in normalization of ferritin levels in the women who received either dose of iron. There was also no difference in side effects between the groups.

This study is small and had minimal difference in iron dose. In addition, the dosing was given once a day for both groups. I suspect that the lack of difference in side effects was due to both the small size of the study and the minimal difference in iron dose.

What does this all mean? I think that the most appropriate dosing for oral iron replacement is a single daily low-dose iron preparation. Whether that dose is 15 mg of elemental iron to 68 mg of elemental iron (the amount in a 325-mg ferrous sulfate tablet) isn’t clear. Low doses appear to be effective, and avoiding high doses likely decreases side effects without sacrificing efficacy.

References

1. Fairbanks V.F., Beutler E. Iron deficiency, in “Williams Textbook of Hematology, 6th ed. Beutler E., Coller B.S., Lichtman M.A., Kipps T.J., eds. (New York: McGraw-Hill; 2001, pp. 460-2).

2. Blood. 2015 Oct 22;126(17):1981-9.

3. Am J Med. 2005 Oct;118(10):1142-7.

4. JAMA. 2015 Feb 10;313(6):575-83.

5. Nutrients. 2014 Apr 4;6(4):1394-405.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

A 69-year-old man is evaluated for fatigue. He undergoes a colonoscopy and is found to have a right-sided colon cancer. His hematocrit is 33 with an MCV of 72. His ferritin level is 3. What do you recommend to help with his iron deficiency?

A. Ferrous sulfate 325 mg daily.

B. Ferrous sulfate 325 mg b.i.d.

C. Ferrous sulfate 325 mg t.i.d.

Treatment of iron deficiency with oral iron has traditionally been done by giving 150-200 mg of elemental iron (which is equal to three 325 mg tablets of iron sulfate).¹ This dosing regimen has considerable gastrointestinal side effects. Recent research into iron absorption suggests that the higher the dose of iron given, the more absorption may be hindered. In a study of 54 women who had low ferritin levels, lower daily doses of iron – and not giving it multiple times a day – led to better iron absorption.²

In a study of elderly patients with iron deficiency, 90 hospitalized elderly patients older than 80 years with iron deficiency anemia were randomized to receive elemental iron as 15 mg or 50 mg of liquid ferrous gluconate, or 150 mg of ferrous calcium citrate for 60 days.³ Two months of iron treatment raised hemoglobin and ferritin levels to a similar degree in all groups, with no significant differences between the 15-mg, 50-mg, and 150-mg groups.

There was a significant difference in abdominal discomfort, with much less (20%) in the patients who received 15 mg of ferrous gluconate, compared with 60% in those who received 50 mg and 70% in those receiving 150 mg (P less than .05 comparing 15 mg with 50 mg and 150 mg). Statistically significant differences were also seen for nausea/vomiting, constipation, and dropout, with much lower rates seen in the low-dose (15-mg) group.

In a study of iron supplementation in individuals undergoing blood donation, a single daily dose of iron was used (37.5 mg of elemental iron) in half of the subjects, with the rest of the subjects receiving no iron.⁴ The mean age of the participants was 48 years.

Subjects who received the once-daily low-dose iron recovered much more quickly toward predonation hematocrit than did those who did not receive the low-dose iron (time to 80% hemoglobin recovery, 32 days vs. 92 days in the non–iron treated patients, P = .02). The effect was more dramatic in subjects who started with a low ferritin level (defined as less than 26), where time to 80% hemoglobin recovery was 36 days in the iron-treated patients vs. 153 days for the no-iron group.

The results of this study are in line with what we know about avid iron absorption in iron deficient patients, and the success of low doses in a younger patient population is encouraging.

In a small study looking at two different doses of elemental iron for the treatment of iron deficiency, 24 women (ages 18-35 years) with iron deficiency were randomized to 60 mg or 80 mg of elemental iron or placebo for 16 weeks.⁵ There was no difference in normalization of ferritin levels in the women who received either dose of iron. There was also no difference in side effects between the groups.

This study is small and had minimal difference in iron dose. In addition, the dosing was given once a day for both groups. I suspect that the lack of difference in side effects was due to both the small size of the study and the minimal difference in iron dose.

What does this all mean? I think that the most appropriate dosing for oral iron replacement is a single daily low-dose iron preparation. Whether that dose is 15 mg of elemental iron to 68 mg of elemental iron (the amount in a 325-mg ferrous sulfate tablet) isn’t clear. Low doses appear to be effective, and avoiding high doses likely decreases side effects without sacrificing efficacy.

References

1. Fairbanks V.F., Beutler E. Iron deficiency, in “Williams Textbook of Hematology, 6th ed. Beutler E., Coller B.S., Lichtman M.A., Kipps T.J., eds. (New York: McGraw-Hill; 2001, pp. 460-2).

2. Blood. 2015 Oct 22;126(17):1981-9.

3. Am J Med. 2005 Oct;118(10):1142-7.

4. JAMA. 2015 Feb 10;313(6):575-83.

5. Nutrients. 2014 Apr 4;6(4):1394-405.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

Question: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu

Question: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu

Question: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu