Commentary

Two disturbing patients came by last week.

The first was a frail old man. His daughter brought him. She said he’d been living in Florida and “shown up” on her doorstep.

As a dermatologist, I’m not often thrown by what I see, but this unfortunate man’s face was hard to look at, with a gaping hole where his left nasolabial fold should have been.

How long had the cancer been there to gouge that hole? How could he neglect it so long? What kind of relationship (or nonrelationship) with his child did it take for this to happen?

I didn’t pursue these questions. Instead, I referred him and his daughter to a skin oncology center where, I hoped, therapy could manage a situation whose severity could surely have been prevented.

Two days later, a Russian woman came in. Remarkably hale at the age of 95 years, she spoke no English. The man who accompanied her, a relative youngster in his mid-70’s, was not a relative, just a stranger who took pity on a fellow visitor to a Russian senior center. “She has two sons,” he explained, “but they live in Minnesota and Texas.”

Her problem was also a basal cell, but this one was on the back of her right ear, large but manageable. I arranged to remove the lesion and offered to speak with her sons. Neither ever called.

Disease is a physical problem in a social context. Patients often present with problems they ignored until other people insisted they take care of them. Parents bring their children. Women drag their husbands. Patients tolerate their itch until their coworkers get annoyed “at seeing me scratch like a monkey.” In situations like these – you can come up with many others – the problem is not just with the patients, but with the people in their vicinity. Sometimes there are people in patients’ lives who notice and care, who demand, “Have that looked at!” But what if nobody cares? Or what if there is no one around at all?

Factors like mental, family, and social dysfunction often underlie whether and to what extent the diseases we diagnose get treated. As practicing physicians, we have little control over such factors. We just try to manage what presents in our offices.

So we make assumptions– that patients can afford to see us, that they have the common sense to come, that they have family or friends who encourage them to come and make doing that possible.

In cases like the ones I’ve just described, these assumptions were wrong. The old man from Florida probably rarely left his apartment, and when he did people just looked away in disgust. He wasn’t their problem. In both cases family was nowhere to be found. How many such lonely and neglected people are there with no support systems, who don’t show up on our office doorstep until it is hard or impossible to take care of them?

I sometimes think back to a case that has haunted me since my early years, when I worked in several Boston-area health centers and sometimes made house calls in gritty neighborhoods. One day I was called to see a patient on the first floor of a rundown example of one of Boston’s wood-frame triple-deckers.

The front door was open. No one was around. I wandered past the parlor into a bedroom. There lay the patient: A woman in late middle age, lying on her back in a dirty nightgown, staring at the ceiling. That image has haunted me for 30 years.

I no longer remember what her skin problem was, just the pitiful sight of her and all the questions it raised: Where was everybody? Who looked after this woman? Who cooked for her, shopped for her? If I prescribed something, who would see that she got it and used it?

I didn’t know. Even if I did, there was nothing I could do about it. Doctors in practice can’t make families stay together, or weave a social safety net that neglected people don’t slip through.

When something lies beyond the scope of what you take to be your responsibility, it’s easier to look away. Now and then a neglected patient forces us to face our own limitations and pay attention to what we have been not looking at.

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

Two disturbing patients came by last week.

The first was a frail old man. His daughter brought him. She said he’d been living in Florida and “shown up” on her doorstep.

As a dermatologist, I’m not often thrown by what I see, but this unfortunate man’s face was hard to look at, with a gaping hole where his left nasolabial fold should have been.

How long had the cancer been there to gouge that hole? How could he neglect it so long? What kind of relationship (or nonrelationship) with his child did it take for this to happen?

I didn’t pursue these questions. Instead, I referred him and his daughter to a skin oncology center where, I hoped, therapy could manage a situation whose severity could surely have been prevented.

Two days later, a Russian woman came in. Remarkably hale at the age of 95 years, she spoke no English. The man who accompanied her, a relative youngster in his mid-70’s, was not a relative, just a stranger who took pity on a fellow visitor to a Russian senior center. “She has two sons,” he explained, “but they live in Minnesota and Texas.”

Her problem was also a basal cell, but this one was on the back of her right ear, large but manageable. I arranged to remove the lesion and offered to speak with her sons. Neither ever called.

Disease is a physical problem in a social context. Patients often present with problems they ignored until other people insisted they take care of them. Parents bring their children. Women drag their husbands. Patients tolerate their itch until their coworkers get annoyed “at seeing me scratch like a monkey.” In situations like these – you can come up with many others – the problem is not just with the patients, but with the people in their vicinity. Sometimes there are people in patients’ lives who notice and care, who demand, “Have that looked at!” But what if nobody cares? Or what if there is no one around at all?

Factors like mental, family, and social dysfunction often underlie whether and to what extent the diseases we diagnose get treated. As practicing physicians, we have little control over such factors. We just try to manage what presents in our offices.

So we make assumptions– that patients can afford to see us, that they have the common sense to come, that they have family or friends who encourage them to come and make doing that possible.

In cases like the ones I’ve just described, these assumptions were wrong. The old man from Florida probably rarely left his apartment, and when he did people just looked away in disgust. He wasn’t their problem. In both cases family was nowhere to be found. How many such lonely and neglected people are there with no support systems, who don’t show up on our office doorstep until it is hard or impossible to take care of them?

I sometimes think back to a case that has haunted me since my early years, when I worked in several Boston-area health centers and sometimes made house calls in gritty neighborhoods. One day I was called to see a patient on the first floor of a rundown example of one of Boston’s wood-frame triple-deckers.

The front door was open. No one was around. I wandered past the parlor into a bedroom. There lay the patient: A woman in late middle age, lying on her back in a dirty nightgown, staring at the ceiling. That image has haunted me for 30 years.

I no longer remember what her skin problem was, just the pitiful sight of her and all the questions it raised: Where was everybody? Who looked after this woman? Who cooked for her, shopped for her? If I prescribed something, who would see that she got it and used it?

I didn’t know. Even if I did, there was nothing I could do about it. Doctors in practice can’t make families stay together, or weave a social safety net that neglected people don’t slip through.

When something lies beyond the scope of what you take to be your responsibility, it’s easier to look away. Now and then a neglected patient forces us to face our own limitations and pay attention to what we have been not looking at.

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

Two disturbing patients came by last week.

The first was a frail old man. His daughter brought him. She said he’d been living in Florida and “shown up” on her doorstep.

As a dermatologist, I’m not often thrown by what I see, but this unfortunate man’s face was hard to look at, with a gaping hole where his left nasolabial fold should have been.

How long had the cancer been there to gouge that hole? How could he neglect it so long? What kind of relationship (or nonrelationship) with his child did it take for this to happen?

I didn’t pursue these questions. Instead, I referred him and his daughter to a skin oncology center where, I hoped, therapy could manage a situation whose severity could surely have been prevented.

Two days later, a Russian woman came in. Remarkably hale at the age of 95 years, she spoke no English. The man who accompanied her, a relative youngster in his mid-70’s, was not a relative, just a stranger who took pity on a fellow visitor to a Russian senior center. “She has two sons,” he explained, “but they live in Minnesota and Texas.”

Her problem was also a basal cell, but this one was on the back of her right ear, large but manageable. I arranged to remove the lesion and offered to speak with her sons. Neither ever called.

Disease is a physical problem in a social context. Patients often present with problems they ignored until other people insisted they take care of them. Parents bring their children. Women drag their husbands. Patients tolerate their itch until their coworkers get annoyed “at seeing me scratch like a monkey.” In situations like these – you can come up with many others – the problem is not just with the patients, but with the people in their vicinity. Sometimes there are people in patients’ lives who notice and care, who demand, “Have that looked at!” But what if nobody cares? Or what if there is no one around at all?

Factors like mental, family, and social dysfunction often underlie whether and to what extent the diseases we diagnose get treated. As practicing physicians, we have little control over such factors. We just try to manage what presents in our offices.

So we make assumptions– that patients can afford to see us, that they have the common sense to come, that they have family or friends who encourage them to come and make doing that possible.

In cases like the ones I’ve just described, these assumptions were wrong. The old man from Florida probably rarely left his apartment, and when he did people just looked away in disgust. He wasn’t their problem. In both cases family was nowhere to be found. How many such lonely and neglected people are there with no support systems, who don’t show up on our office doorstep until it is hard or impossible to take care of them?

I sometimes think back to a case that has haunted me since my early years, when I worked in several Boston-area health centers and sometimes made house calls in gritty neighborhoods. One day I was called to see a patient on the first floor of a rundown example of one of Boston’s wood-frame triple-deckers.

The front door was open. No one was around. I wandered past the parlor into a bedroom. There lay the patient: A woman in late middle age, lying on her back in a dirty nightgown, staring at the ceiling. That image has haunted me for 30 years.

I no longer remember what her skin problem was, just the pitiful sight of her and all the questions it raised: Where was everybody? Who looked after this woman? Who cooked for her, shopped for her? If I prescribed something, who would see that she got it and used it?

I didn’t know. Even if I did, there was nothing I could do about it. Doctors in practice can’t make families stay together, or weave a social safety net that neglected people don’t slip through.

When something lies beyond the scope of what you take to be your responsibility, it’s easier to look away. Now and then a neglected patient forces us to face our own limitations and pay attention to what we have been not looking at.

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

The case had been straightforward. My patient had primary hyperparathyroidism and her localization studies had shown a single parathyroid adenoma. In the operating room, with her under general anesthesia, I had found and removed the abnormal parathyroid gland. The intraoperative parathyroid hormone levels were being run outside the OR door. I was getting ready to close with my fellow when I happened to palpate the thyroid isthmus. There was a firm nodule right in the center of the isthmus. The thyroid looked fine, but the nodule was unmistakable.

This was a surprise. The patient had undergone an ultrasound in radiology the week before, and the study was notable for there being no thyroid nodules. We had performed our own ultrasound in the OR. We had confirmed the location of the parathyroid adenoma and saw no thyroid nodules. I was faced with the initial question of what to do with this incidental finding. Although I could not see the nodule, certainly by feel, it was suspicious, but it was also very small – several millimeters at most. One option was to simply ignore the finding – certainly a bad choice. I knew that the patient had come to the hospital with her sister and a close friend. They were both in the waiting room expecting my update as soon as we were finished. I could have discussed this unexpected finding with the sister and friend, but I felt certain that no one would object to me removing a small piece of thyroid when this added little or no risk. It seemed unnecessary to seek permission to do this small additional procedure.

We proceeded to resect the nodule within the thyroid gland, taking enough adjacent thyroid tissue that I never actually saw the nodule. Once it was removed, I faced another question: Should I send it for frozen section? This seemed to be an easy one to answer. If I was suspicious enough to remove it, I should also know what it is.

The frozen section report was called in a short time later. It was a 4-mm papillary thyroid cancer (PTC) that was within normal thyroid tissue. I had been expecting this possible result. Now I had more choices. I could talk with the family/friend in the waiting room and seek advice on what to do. Alternatively, I could simply say that the presence of PTC was enough of a reason to just take out the thyroid gland since I had not expected this finding and the negative preoperative ultrasound had certainly missed this small tumor (and there might even be others). Finally, I could simply close the patient based on the fact that a 4-mm PTC is of no real clinical significance. Certainly, if this small PTC had been removed with a thyroid lobe for other reasons, we would never go back to take out the rest of the thyroid gland.

As I considered these options, it seemed clear to me that if I went to talk with the family/friend with an unexpected diagnosis of cancer, it was very likely that the patient would wind up with a bigger operation than might be necessary. Ten or fifteen years ago, most surgeons would have removed the thyroid gland for almost any diagnosis of PTC so that patients could go on to receive radioactive iodine. However, today many patients with small incidental PTCs found on lobectomy are simply followed with surveillance ultrasounds because the risks of recurrence or spread are very low. It was clear that I had no basis to take out the whole thyroid gland for a small PTC that was already out. It also seemed unwise to ask what to do, when I felt certain that I knew what was best for the patient. Of course, the suggestion that “I knew what was best for the patient” is a very paternalistic thing to say. It suggests that the medical issues trump all others. It is also quite contrary to the movement of medical ethics in the last several decades that has emphasized shared decision making yet doing what is best for the patient is what surgical patients expect of their surgeons.

I decided to close the patient and then explain what I did and why I did it. She might have been angry with me that I had found a cancer and had not taken out her thyroid gland. However, I felt that the medical evidence supported a less-aggressive surgical approach. In addition, I could always take out her thyroid if she was too worried by the concept of surveillance but I could never put it back if I had removed it!

The patient was understandably surprised and concerned when talked to her. Her first response was one of concern about recurrence. She wanted to know how I knew that there was no more cancer in her thyroid gland. I explained that I actually could not know that, but based on the ultrasound, there was no evidence of any clinically significant thyroid cancer. Fortunately, she was ultimately relieved that the thyroid cancer had been found even though it raised concerns for the future that she had never considered previously.

Whenever surgeons operate on patients under general anesthesia, we are faced with the potential need to make decisions for our patients without the patient’s input. Sometimes it is appropriate to seek input from family when there are multiple good options. However, surgery requires surgeons to make many decisions on their patient’s behalf with no input from the patient – that is, surgeons are expected to act paternalistically in the OR. Rather than being detrimental to the ethical care of patients, such limited paternalism is sometimes the best that we can offer our patients and critical to our role as surgeon.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

The case had been straightforward. My patient had primary hyperparathyroidism and her localization studies had shown a single parathyroid adenoma. In the operating room, with her under general anesthesia, I had found and removed the abnormal parathyroid gland. The intraoperative parathyroid hormone levels were being run outside the OR door. I was getting ready to close with my fellow when I happened to palpate the thyroid isthmus. There was a firm nodule right in the center of the isthmus. The thyroid looked fine, but the nodule was unmistakable.

This was a surprise. The patient had undergone an ultrasound in radiology the week before, and the study was notable for there being no thyroid nodules. We had performed our own ultrasound in the OR. We had confirmed the location of the parathyroid adenoma and saw no thyroid nodules. I was faced with the initial question of what to do with this incidental finding. Although I could not see the nodule, certainly by feel, it was suspicious, but it was also very small – several millimeters at most. One option was to simply ignore the finding – certainly a bad choice. I knew that the patient had come to the hospital with her sister and a close friend. They were both in the waiting room expecting my update as soon as we were finished. I could have discussed this unexpected finding with the sister and friend, but I felt certain that no one would object to me removing a small piece of thyroid when this added little or no risk. It seemed unnecessary to seek permission to do this small additional procedure.

We proceeded to resect the nodule within the thyroid gland, taking enough adjacent thyroid tissue that I never actually saw the nodule. Once it was removed, I faced another question: Should I send it for frozen section? This seemed to be an easy one to answer. If I was suspicious enough to remove it, I should also know what it is.

The frozen section report was called in a short time later. It was a 4-mm papillary thyroid cancer (PTC) that was within normal thyroid tissue. I had been expecting this possible result. Now I had more choices. I could talk with the family/friend in the waiting room and seek advice on what to do. Alternatively, I could simply say that the presence of PTC was enough of a reason to just take out the thyroid gland since I had not expected this finding and the negative preoperative ultrasound had certainly missed this small tumor (and there might even be others). Finally, I could simply close the patient based on the fact that a 4-mm PTC is of no real clinical significance. Certainly, if this small PTC had been removed with a thyroid lobe for other reasons, we would never go back to take out the rest of the thyroid gland.

As I considered these options, it seemed clear to me that if I went to talk with the family/friend with an unexpected diagnosis of cancer, it was very likely that the patient would wind up with a bigger operation than might be necessary. Ten or fifteen years ago, most surgeons would have removed the thyroid gland for almost any diagnosis of PTC so that patients could go on to receive radioactive iodine. However, today many patients with small incidental PTCs found on lobectomy are simply followed with surveillance ultrasounds because the risks of recurrence or spread are very low. It was clear that I had no basis to take out the whole thyroid gland for a small PTC that was already out. It also seemed unwise to ask what to do, when I felt certain that I knew what was best for the patient. Of course, the suggestion that “I knew what was best for the patient” is a very paternalistic thing to say. It suggests that the medical issues trump all others. It is also quite contrary to the movement of medical ethics in the last several decades that has emphasized shared decision making yet doing what is best for the patient is what surgical patients expect of their surgeons.

I decided to close the patient and then explain what I did and why I did it. She might have been angry with me that I had found a cancer and had not taken out her thyroid gland. However, I felt that the medical evidence supported a less-aggressive surgical approach. In addition, I could always take out her thyroid if she was too worried by the concept of surveillance but I could never put it back if I had removed it!

The patient was understandably surprised and concerned when talked to her. Her first response was one of concern about recurrence. She wanted to know how I knew that there was no more cancer in her thyroid gland. I explained that I actually could not know that, but based on the ultrasound, there was no evidence of any clinically significant thyroid cancer. Fortunately, she was ultimately relieved that the thyroid cancer had been found even though it raised concerns for the future that she had never considered previously.

Whenever surgeons operate on patients under general anesthesia, we are faced with the potential need to make decisions for our patients without the patient’s input. Sometimes it is appropriate to seek input from family when there are multiple good options. However, surgery requires surgeons to make many decisions on their patient’s behalf with no input from the patient – that is, surgeons are expected to act paternalistically in the OR. Rather than being detrimental to the ethical care of patients, such limited paternalism is sometimes the best that we can offer our patients and critical to our role as surgeon.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

The case had been straightforward. My patient had primary hyperparathyroidism and her localization studies had shown a single parathyroid adenoma. In the operating room, with her under general anesthesia, I had found and removed the abnormal parathyroid gland. The intraoperative parathyroid hormone levels were being run outside the OR door. I was getting ready to close with my fellow when I happened to palpate the thyroid isthmus. There was a firm nodule right in the center of the isthmus. The thyroid looked fine, but the nodule was unmistakable.

This was a surprise. The patient had undergone an ultrasound in radiology the week before, and the study was notable for there being no thyroid nodules. We had performed our own ultrasound in the OR. We had confirmed the location of the parathyroid adenoma and saw no thyroid nodules. I was faced with the initial question of what to do with this incidental finding. Although I could not see the nodule, certainly by feel, it was suspicious, but it was also very small – several millimeters at most. One option was to simply ignore the finding – certainly a bad choice. I knew that the patient had come to the hospital with her sister and a close friend. They were both in the waiting room expecting my update as soon as we were finished. I could have discussed this unexpected finding with the sister and friend, but I felt certain that no one would object to me removing a small piece of thyroid when this added little or no risk. It seemed unnecessary to seek permission to do this small additional procedure.

We proceeded to resect the nodule within the thyroid gland, taking enough adjacent thyroid tissue that I never actually saw the nodule. Once it was removed, I faced another question: Should I send it for frozen section? This seemed to be an easy one to answer. If I was suspicious enough to remove it, I should also know what it is.

The frozen section report was called in a short time later. It was a 4-mm papillary thyroid cancer (PTC) that was within normal thyroid tissue. I had been expecting this possible result. Now I had more choices. I could talk with the family/friend in the waiting room and seek advice on what to do. Alternatively, I could simply say that the presence of PTC was enough of a reason to just take out the thyroid gland since I had not expected this finding and the negative preoperative ultrasound had certainly missed this small tumor (and there might even be others). Finally, I could simply close the patient based on the fact that a 4-mm PTC is of no real clinical significance. Certainly, if this small PTC had been removed with a thyroid lobe for other reasons, we would never go back to take out the rest of the thyroid gland.

As I considered these options, it seemed clear to me that if I went to talk with the family/friend with an unexpected diagnosis of cancer, it was very likely that the patient would wind up with a bigger operation than might be necessary. Ten or fifteen years ago, most surgeons would have removed the thyroid gland for almost any diagnosis of PTC so that patients could go on to receive radioactive iodine. However, today many patients with small incidental PTCs found on lobectomy are simply followed with surveillance ultrasounds because the risks of recurrence or spread are very low. It was clear that I had no basis to take out the whole thyroid gland for a small PTC that was already out. It also seemed unwise to ask what to do, when I felt certain that I knew what was best for the patient. Of course, the suggestion that “I knew what was best for the patient” is a very paternalistic thing to say. It suggests that the medical issues trump all others. It is also quite contrary to the movement of medical ethics in the last several decades that has emphasized shared decision making yet doing what is best for the patient is what surgical patients expect of their surgeons.

I decided to close the patient and then explain what I did and why I did it. She might have been angry with me that I had found a cancer and had not taken out her thyroid gland. However, I felt that the medical evidence supported a less-aggressive surgical approach. In addition, I could always take out her thyroid if she was too worried by the concept of surveillance but I could never put it back if I had removed it!

The patient was understandably surprised and concerned when talked to her. Her first response was one of concern about recurrence. She wanted to know how I knew that there was no more cancer in her thyroid gland. I explained that I actually could not know that, but based on the ultrasound, there was no evidence of any clinically significant thyroid cancer. Fortunately, she was ultimately relieved that the thyroid cancer had been found even though it raised concerns for the future that she had never considered previously.

Whenever surgeons operate on patients under general anesthesia, we are faced with the potential need to make decisions for our patients without the patient’s input. Sometimes it is appropriate to seek input from family when there are multiple good options. However, surgery requires surgeons to make many decisions on their patient’s behalf with no input from the patient – that is, surgeons are expected to act paternalistically in the OR. Rather than being detrimental to the ethical care of patients, such limited paternalism is sometimes the best that we can offer our patients and critical to our role as surgeon.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

One of the greatest challenges you may face as a pediatrician is in helping your patients and families navigate the mental health system. Nearly 20% of children will experience a psychiatric illness before they turn 18, and a quarter of those will go on to experience a persistent or severe psychiatric illness. Whether a patient is experiencing symptoms that are mild or severe, their parents are likely to come to you first for an assessment and for help in finding a referral to the appropriate specialist.

Unlike the smooth process to refer to a neurologist or orthopedist, accessing treatment for mental health problems is often confusing and frustrating. Because of reimbursement that is below the cost of providing care, many community hospitals have closed their divisions of child and adolescent psychiatry, and academic medical centers often have a long wait for a provider. If you go through a patient’s insurance, usually the list of providers is woefully out-of-date, with most of them not accepting new referrals or insurance or both. If mental health services are “carved out” to cut costs, the primary insurer has no direct control of mental health services, and the carve out company is looking for providers willing to accept lower reimbursement and limit longer-term treatments. Faced with reimbursement and administrative demands by the carve out company, child psychiatrists, psychologists, and social workers that once staffed these services have chosen fee-for-service private offices that do not accept any insurance, leaving many communities without access to adequate resources. In private practice, these providers are busy, face no administrative demands to justify their work, and earn two or three times what insurers reimburse.

So families often turn to their schools and their pediatricians when faced with a mood, anxiety, or behavioral problem. While there is no straightforward solution to this problem of access, we have put together a “road map” to what services might be available and to help you in your approach to these patients.

It is first important to consider that mental health and developmental questions are now a major part of pediatric primary care. The majority of your visits will be well child care and psychosocial. So a part, maybe a third or half of mental health concerns might now be considered a routine part of primary care. Many practices are now doing psychosocial screening and more states are mandating reimbursement of this screening. Typically screening includes a CHATfor autism (Checklist for Autism in Toddlers), a developmental screen if indicated, a Pediatric Symptom Checklist for school-age children and adolescents, a Hamilton Rating Scale for Depression in adolescents, and a CRAFFTfor adolescent substance abuse. Some practices include a Hamilton or other depression screen for mothers of newborns and toddlers as maternal depression has a serious impact on the child and is responsive to treatment. If screening is reimbursed, some of that money could go to fund an on-site social worker, who can also bill for patient contact services, and thus provide the practice with an on-site mental health presence at break-even cost. This social worker may be expert in referring to local resources, may be trained in psychotherapy, or may even lead groups for parents of recent divorce, new mothers, facing attention-deficit/hyperactivity disorder (ADHD), etc.

The best place to start for a family with psychosocial concerns is to do a brief review of your patient’s day to day functioning – school, friends, family, activities, and mood. What is your best assessment of the problem, how much of the child and family’s life is affected, and how severe is the problem? There are many mental health problems for which the first-line treatment is a trial of medication according to an algorithm that you can use following American Academy of Pediatrics guidelines. For example, if considering stimulant treatment for a 7-year-old with possible attention difficulties, you can use broad screening instruments like the Pediatric Symptom Checklist or Childhood Behavior Checklist as well as the Vanderbilt Assessment Scales or Conners questionnaire that are specific for ADHD. Many pediatricians also are comfortable treating adolescent depression with medication and with comanagement from a social worker with a master’s degree or a doctorate level psychologist. Of course, treating depression requires a more careful interview, consideration of suicide risk, and more frequent follow-up visits.

As first-line treatment for depression and anxiety usually starts with psychotherapy, it is important to consider how you will access this component of mental health care. For those that don’t have a licensed clinical social worker on-site providing cognitive-behavioral therapy, many busy pediatric practices will establish a relationship with a therapist or group that has agreed to accept their referrals and accepts insurance reimbursement. If you are not fortunate enough to already have such a relationship, it can be fruitful to speak with colleagues in a busier practice about whom they use. It also can be fruitful to reach out to the graduate programs in psychology (PhD or PsyD programs) or social work in your community, to find out if they have a referral service or would like to connect recent graduates trying to establish themselves with referring pediatricians. Having a resource located in your office (employed by you or renting space) is ideal.

When a patient is presenting with a more complex set of symptoms or fails to respond to your initial treatments, then you will want to locate an appropriate referral to a child psychiatrist. If your group is affiliated with an academic medical center, find out what the procedure is for referring to their child psychiatrists or to the child psychiatry trainees. Often there is easy availability early in the academic year (summer), when children are less likely to present with problems and a new crop of trainees has arrived. Academic medical centers also will often be a hub for a lot of research activity, and research programs are usually eager to enroll patients without regard to their insurance. Good studies will provide patients with a formalized assessment that will clarify the diagnostic picture, ensuring that a child is on the path to the right treatment. Cultivating a connection with the research coordinator can ensure that your group knows about opportunities for free care that is easier to access than most.

Many states require schools to provide testing to clarify whether psychiatric symptoms, developmental issues, or learning disabilities are affecting a student’s ability to perform in school. Your office can educate parents that they should go to the school with their concerns and request a formal assessment. If testing indicates a condition, the school system is often required to provide appropriate educational services, such as tutoring for learning disabilities, occupational therapy, and social skills support for children on the autism spectrum, and even counseling for children with anxiety, mood, and behavioral issues. Often, the school psychologist or social worker will be a valuable resource in providing direct care to children or helping you and the parents identify excellent treaters in the community. For children with severe and persistent psychiatric illness, many states require that schools provide or pay for the services that are necessary to educate each child. This can mean anything from paying for an after school social skills group to paying for a therapeutic boarding school. In these cases, it is often helpful to have established a relationship with an educational consultant. These are usually social workers with expertise in mental health issues and the state’s educational system and regulations, and they will partner with parents for a modest fee to educate and empower parents so that they might get appropriate services from their schools. Again, it can be fruitful to speak with trusted colleagues and find one who has identified a local consultant that they trust.

Some states and counties have tried to address the problem of accessing psychiatric care for children, but often these are programs that have not been adequately marketed to pediatricians or families, so they may be under utilized. In Massachusetts and Connecticut, there is the state Child Psychiatry Access Project, which provides all pediatricians with free access to a consulting child psychiatrist by phone. It requires that pediatricians are willing to treat children themselves with the support and guidance of a consulting child psychiatrist, but it will also provide a face-to-face diagnostic evaluation of that child by a child psychiatrist so that they can in turn provide the best guidance to the pediatrician. And it provides a care coordinator who will help to identify appropriate treaters, such as a cognitive-behavioral therapist or a psychopharmacologist who accept the family’s insurance, when the pediatrician is unable to provide the recommended treatment. An online investigation through your state’s or county’s Office of Mental Health or your local Medical Society can help your office identify what resources may exist in your community.

Finally, your most critical task after a parent has come to you with concerns about their child’s mood, thinking, or behavior, may be in educating and supporting those parents. Prepare the parents by explaining to them how the mental health system is more fragmented and frustrating than most other medical specialties. Remind them that psychiatric symptoms and illnesses are eminently treatable, and it will be worth patiently navigating this complex system to eventually access the right care for their child. It can be helpful to suggest to them that if they can possibly afford to pay out-of-pocket for the appropriate care, it will make excellent treatment much easier to access in a timely way. It can be meaningful for parents to hear from you that it is worthwhile for them to call or write their insurance company and complain if that company has restricted access to child psychiatric care. They are, after all, the customers of their insurance company, and it is the silence, shame, and stigma surrounding psychiatric illness that has enabled insurance companies to restrict access to effective care. Finally, it can be very powerful to connect parents with support or advocacy organizations that will help them in navigating this system and in speaking up to their insurance companies, state health, or education agencies or in the press in ways that will diminish the stigma that still surrounds these problems. The National Alliance on Mental Illness (www.nami.org), The Bazelon Center for Mental Health Law (www.bazelon.org), and the American Academy of Child and Adolescent Psychiatry (www.aacap.org) all have excellent online resources that also help identify local organizations and resources for parents. If insurance companies refused to pay for potentially life-saving chemotherapy for a pediatric cancer, you can imagine that there would be many parents protesting to those insurers, to the news, and even to their local or state governments. Mental health care should be no different, as the problems can be as disabling and life-threatening and effective treatments and even cures exist.

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston. E-mail them at [email protected].

One of the greatest challenges you may face as a pediatrician is in helping your patients and families navigate the mental health system. Nearly 20% of children will experience a psychiatric illness before they turn 18, and a quarter of those will go on to experience a persistent or severe psychiatric illness. Whether a patient is experiencing symptoms that are mild or severe, their parents are likely to come to you first for an assessment and for help in finding a referral to the appropriate specialist.

Unlike the smooth process to refer to a neurologist or orthopedist, accessing treatment for mental health problems is often confusing and frustrating. Because of reimbursement that is below the cost of providing care, many community hospitals have closed their divisions of child and adolescent psychiatry, and academic medical centers often have a long wait for a provider. If you go through a patient’s insurance, usually the list of providers is woefully out-of-date, with most of them not accepting new referrals or insurance or both. If mental health services are “carved out” to cut costs, the primary insurer has no direct control of mental health services, and the carve out company is looking for providers willing to accept lower reimbursement and limit longer-term treatments. Faced with reimbursement and administrative demands by the carve out company, child psychiatrists, psychologists, and social workers that once staffed these services have chosen fee-for-service private offices that do not accept any insurance, leaving many communities without access to adequate resources. In private practice, these providers are busy, face no administrative demands to justify their work, and earn two or three times what insurers reimburse.

So families often turn to their schools and their pediatricians when faced with a mood, anxiety, or behavioral problem. While there is no straightforward solution to this problem of access, we have put together a “road map” to what services might be available and to help you in your approach to these patients.

It is first important to consider that mental health and developmental questions are now a major part of pediatric primary care. The majority of your visits will be well child care and psychosocial. So a part, maybe a third or half of mental health concerns might now be considered a routine part of primary care. Many practices are now doing psychosocial screening and more states are mandating reimbursement of this screening. Typically screening includes a CHATfor autism (Checklist for Autism in Toddlers), a developmental screen if indicated, a Pediatric Symptom Checklist for school-age children and adolescents, a Hamilton Rating Scale for Depression in adolescents, and a CRAFFTfor adolescent substance abuse. Some practices include a Hamilton or other depression screen for mothers of newborns and toddlers as maternal depression has a serious impact on the child and is responsive to treatment. If screening is reimbursed, some of that money could go to fund an on-site social worker, who can also bill for patient contact services, and thus provide the practice with an on-site mental health presence at break-even cost. This social worker may be expert in referring to local resources, may be trained in psychotherapy, or may even lead groups for parents of recent divorce, new mothers, facing attention-deficit/hyperactivity disorder (ADHD), etc.

The best place to start for a family with psychosocial concerns is to do a brief review of your patient’s day to day functioning – school, friends, family, activities, and mood. What is your best assessment of the problem, how much of the child and family’s life is affected, and how severe is the problem? There are many mental health problems for which the first-line treatment is a trial of medication according to an algorithm that you can use following American Academy of Pediatrics guidelines. For example, if considering stimulant treatment for a 7-year-old with possible attention difficulties, you can use broad screening instruments like the Pediatric Symptom Checklist or Childhood Behavior Checklist as well as the Vanderbilt Assessment Scales or Conners questionnaire that are specific for ADHD. Many pediatricians also are comfortable treating adolescent depression with medication and with comanagement from a social worker with a master’s degree or a doctorate level psychologist. Of course, treating depression requires a more careful interview, consideration of suicide risk, and more frequent follow-up visits.

As first-line treatment for depression and anxiety usually starts with psychotherapy, it is important to consider how you will access this component of mental health care. For those that don’t have a licensed clinical social worker on-site providing cognitive-behavioral therapy, many busy pediatric practices will establish a relationship with a therapist or group that has agreed to accept their referrals and accepts insurance reimbursement. If you are not fortunate enough to already have such a relationship, it can be fruitful to speak with colleagues in a busier practice about whom they use. It also can be fruitful to reach out to the graduate programs in psychology (PhD or PsyD programs) or social work in your community, to find out if they have a referral service or would like to connect recent graduates trying to establish themselves with referring pediatricians. Having a resource located in your office (employed by you or renting space) is ideal.

When a patient is presenting with a more complex set of symptoms or fails to respond to your initial treatments, then you will want to locate an appropriate referral to a child psychiatrist. If your group is affiliated with an academic medical center, find out what the procedure is for referring to their child psychiatrists or to the child psychiatry trainees. Often there is easy availability early in the academic year (summer), when children are less likely to present with problems and a new crop of trainees has arrived. Academic medical centers also will often be a hub for a lot of research activity, and research programs are usually eager to enroll patients without regard to their insurance. Good studies will provide patients with a formalized assessment that will clarify the diagnostic picture, ensuring that a child is on the path to the right treatment. Cultivating a connection with the research coordinator can ensure that your group knows about opportunities for free care that is easier to access than most.

Many states require schools to provide testing to clarify whether psychiatric symptoms, developmental issues, or learning disabilities are affecting a student’s ability to perform in school. Your office can educate parents that they should go to the school with their concerns and request a formal assessment. If testing indicates a condition, the school system is often required to provide appropriate educational services, such as tutoring for learning disabilities, occupational therapy, and social skills support for children on the autism spectrum, and even counseling for children with anxiety, mood, and behavioral issues. Often, the school psychologist or social worker will be a valuable resource in providing direct care to children or helping you and the parents identify excellent treaters in the community. For children with severe and persistent psychiatric illness, many states require that schools provide or pay for the services that are necessary to educate each child. This can mean anything from paying for an after school social skills group to paying for a therapeutic boarding school. In these cases, it is often helpful to have established a relationship with an educational consultant. These are usually social workers with expertise in mental health issues and the state’s educational system and regulations, and they will partner with parents for a modest fee to educate and empower parents so that they might get appropriate services from their schools. Again, it can be fruitful to speak with trusted colleagues and find one who has identified a local consultant that they trust.

Some states and counties have tried to address the problem of accessing psychiatric care for children, but often these are programs that have not been adequately marketed to pediatricians or families, so they may be under utilized. In Massachusetts and Connecticut, there is the state Child Psychiatry Access Project, which provides all pediatricians with free access to a consulting child psychiatrist by phone. It requires that pediatricians are willing to treat children themselves with the support and guidance of a consulting child psychiatrist, but it will also provide a face-to-face diagnostic evaluation of that child by a child psychiatrist so that they can in turn provide the best guidance to the pediatrician. And it provides a care coordinator who will help to identify appropriate treaters, such as a cognitive-behavioral therapist or a psychopharmacologist who accept the family’s insurance, when the pediatrician is unable to provide the recommended treatment. An online investigation through your state’s or county’s Office of Mental Health or your local Medical Society can help your office identify what resources may exist in your community.

Finally, your most critical task after a parent has come to you with concerns about their child’s mood, thinking, or behavior, may be in educating and supporting those parents. Prepare the parents by explaining to them how the mental health system is more fragmented and frustrating than most other medical specialties. Remind them that psychiatric symptoms and illnesses are eminently treatable, and it will be worth patiently navigating this complex system to eventually access the right care for their child. It can be helpful to suggest to them that if they can possibly afford to pay out-of-pocket for the appropriate care, it will make excellent treatment much easier to access in a timely way. It can be meaningful for parents to hear from you that it is worthwhile for them to call or write their insurance company and complain if that company has restricted access to child psychiatric care. They are, after all, the customers of their insurance company, and it is the silence, shame, and stigma surrounding psychiatric illness that has enabled insurance companies to restrict access to effective care. Finally, it can be very powerful to connect parents with support or advocacy organizations that will help them in navigating this system and in speaking up to their insurance companies, state health, or education agencies or in the press in ways that will diminish the stigma that still surrounds these problems. The National Alliance on Mental Illness (www.nami.org), The Bazelon Center for Mental Health Law (www.bazelon.org), and the American Academy of Child and Adolescent Psychiatry (www.aacap.org) all have excellent online resources that also help identify local organizations and resources for parents. If insurance companies refused to pay for potentially life-saving chemotherapy for a pediatric cancer, you can imagine that there would be many parents protesting to those insurers, to the news, and even to their local or state governments. Mental health care should be no different, as the problems can be as disabling and life-threatening and effective treatments and even cures exist.

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston. E-mail them at [email protected].

One of the greatest challenges you may face as a pediatrician is in helping your patients and families navigate the mental health system. Nearly 20% of children will experience a psychiatric illness before they turn 18, and a quarter of those will go on to experience a persistent or severe psychiatric illness. Whether a patient is experiencing symptoms that are mild or severe, their parents are likely to come to you first for an assessment and for help in finding a referral to the appropriate specialist.

Unlike the smooth process to refer to a neurologist or orthopedist, accessing treatment for mental health problems is often confusing and frustrating. Because of reimbursement that is below the cost of providing care, many community hospitals have closed their divisions of child and adolescent psychiatry, and academic medical centers often have a long wait for a provider. If you go through a patient’s insurance, usually the list of providers is woefully out-of-date, with most of them not accepting new referrals or insurance or both. If mental health services are “carved out” to cut costs, the primary insurer has no direct control of mental health services, and the carve out company is looking for providers willing to accept lower reimbursement and limit longer-term treatments. Faced with reimbursement and administrative demands by the carve out company, child psychiatrists, psychologists, and social workers that once staffed these services have chosen fee-for-service private offices that do not accept any insurance, leaving many communities without access to adequate resources. In private practice, these providers are busy, face no administrative demands to justify their work, and earn two or three times what insurers reimburse.

So families often turn to their schools and their pediatricians when faced with a mood, anxiety, or behavioral problem. While there is no straightforward solution to this problem of access, we have put together a “road map” to what services might be available and to help you in your approach to these patients.

It is first important to consider that mental health and developmental questions are now a major part of pediatric primary care. The majority of your visits will be well child care and psychosocial. So a part, maybe a third or half of mental health concerns might now be considered a routine part of primary care. Many practices are now doing psychosocial screening and more states are mandating reimbursement of this screening. Typically screening includes a CHATfor autism (Checklist for Autism in Toddlers), a developmental screen if indicated, a Pediatric Symptom Checklist for school-age children and adolescents, a Hamilton Rating Scale for Depression in adolescents, and a CRAFFTfor adolescent substance abuse. Some practices include a Hamilton or other depression screen for mothers of newborns and toddlers as maternal depression has a serious impact on the child and is responsive to treatment. If screening is reimbursed, some of that money could go to fund an on-site social worker, who can also bill for patient contact services, and thus provide the practice with an on-site mental health presence at break-even cost. This social worker may be expert in referring to local resources, may be trained in psychotherapy, or may even lead groups for parents of recent divorce, new mothers, facing attention-deficit/hyperactivity disorder (ADHD), etc.

The best place to start for a family with psychosocial concerns is to do a brief review of your patient’s day to day functioning – school, friends, family, activities, and mood. What is your best assessment of the problem, how much of the child and family’s life is affected, and how severe is the problem? There are many mental health problems for which the first-line treatment is a trial of medication according to an algorithm that you can use following American Academy of Pediatrics guidelines. For example, if considering stimulant treatment for a 7-year-old with possible attention difficulties, you can use broad screening instruments like the Pediatric Symptom Checklist or Childhood Behavior Checklist as well as the Vanderbilt Assessment Scales or Conners questionnaire that are specific for ADHD. Many pediatricians also are comfortable treating adolescent depression with medication and with comanagement from a social worker with a master’s degree or a doctorate level psychologist. Of course, treating depression requires a more careful interview, consideration of suicide risk, and more frequent follow-up visits.

As first-line treatment for depression and anxiety usually starts with psychotherapy, it is important to consider how you will access this component of mental health care. For those that don’t have a licensed clinical social worker on-site providing cognitive-behavioral therapy, many busy pediatric practices will establish a relationship with a therapist or group that has agreed to accept their referrals and accepts insurance reimbursement. If you are not fortunate enough to already have such a relationship, it can be fruitful to speak with colleagues in a busier practice about whom they use. It also can be fruitful to reach out to the graduate programs in psychology (PhD or PsyD programs) or social work in your community, to find out if they have a referral service or would like to connect recent graduates trying to establish themselves with referring pediatricians. Having a resource located in your office (employed by you or renting space) is ideal.

When a patient is presenting with a more complex set of symptoms or fails to respond to your initial treatments, then you will want to locate an appropriate referral to a child psychiatrist. If your group is affiliated with an academic medical center, find out what the procedure is for referring to their child psychiatrists or to the child psychiatry trainees. Often there is easy availability early in the academic year (summer), when children are less likely to present with problems and a new crop of trainees has arrived. Academic medical centers also will often be a hub for a lot of research activity, and research programs are usually eager to enroll patients without regard to their insurance. Good studies will provide patients with a formalized assessment that will clarify the diagnostic picture, ensuring that a child is on the path to the right treatment. Cultivating a connection with the research coordinator can ensure that your group knows about opportunities for free care that is easier to access than most.

Many states require schools to provide testing to clarify whether psychiatric symptoms, developmental issues, or learning disabilities are affecting a student’s ability to perform in school. Your office can educate parents that they should go to the school with their concerns and request a formal assessment. If testing indicates a condition, the school system is often required to provide appropriate educational services, such as tutoring for learning disabilities, occupational therapy, and social skills support for children on the autism spectrum, and even counseling for children with anxiety, mood, and behavioral issues. Often, the school psychologist or social worker will be a valuable resource in providing direct care to children or helping you and the parents identify excellent treaters in the community. For children with severe and persistent psychiatric illness, many states require that schools provide or pay for the services that are necessary to educate each child. This can mean anything from paying for an after school social skills group to paying for a therapeutic boarding school. In these cases, it is often helpful to have established a relationship with an educational consultant. These are usually social workers with expertise in mental health issues and the state’s educational system and regulations, and they will partner with parents for a modest fee to educate and empower parents so that they might get appropriate services from their schools. Again, it can be fruitful to speak with trusted colleagues and find one who has identified a local consultant that they trust.

Some states and counties have tried to address the problem of accessing psychiatric care for children, but often these are programs that have not been adequately marketed to pediatricians or families, so they may be under utilized. In Massachusetts and Connecticut, there is the state Child Psychiatry Access Project, which provides all pediatricians with free access to a consulting child psychiatrist by phone. It requires that pediatricians are willing to treat children themselves with the support and guidance of a consulting child psychiatrist, but it will also provide a face-to-face diagnostic evaluation of that child by a child psychiatrist so that they can in turn provide the best guidance to the pediatrician. And it provides a care coordinator who will help to identify appropriate treaters, such as a cognitive-behavioral therapist or a psychopharmacologist who accept the family’s insurance, when the pediatrician is unable to provide the recommended treatment. An online investigation through your state’s or county’s Office of Mental Health or your local Medical Society can help your office identify what resources may exist in your community.

Finally, your most critical task after a parent has come to you with concerns about their child’s mood, thinking, or behavior, may be in educating and supporting those parents. Prepare the parents by explaining to them how the mental health system is more fragmented and frustrating than most other medical specialties. Remind them that psychiatric symptoms and illnesses are eminently treatable, and it will be worth patiently navigating this complex system to eventually access the right care for their child. It can be helpful to suggest to them that if they can possibly afford to pay out-of-pocket for the appropriate care, it will make excellent treatment much easier to access in a timely way. It can be meaningful for parents to hear from you that it is worthwhile for them to call or write their insurance company and complain if that company has restricted access to child psychiatric care. They are, after all, the customers of their insurance company, and it is the silence, shame, and stigma surrounding psychiatric illness that has enabled insurance companies to restrict access to effective care. Finally, it can be very powerful to connect parents with support or advocacy organizations that will help them in navigating this system and in speaking up to their insurance companies, state health, or education agencies or in the press in ways that will diminish the stigma that still surrounds these problems. The National Alliance on Mental Illness (www.nami.org), The Bazelon Center for Mental Health Law (www.bazelon.org), and the American Academy of Child and Adolescent Psychiatry (www.aacap.org) all have excellent online resources that also help identify local organizations and resources for parents. If insurance companies refused to pay for potentially life-saving chemotherapy for a pediatric cancer, you can imagine that there would be many parents protesting to those insurers, to the news, and even to their local or state governments. Mental health care should be no different, as the problems can be as disabling and life-threatening and effective treatments and even cures exist.

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston. E-mail them at [email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus 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 [email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus 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 [email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus 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 [email protected].

During an adolescent visit, we all can agree that getting answers to even the simplest of questions can be a day’s work. Despite the reason for the visit, it always is important to ask a few basic questions in hopes that it might unveil a less obvious condition, or one that potentially could cause harm later. Asking the right questions is as important as getting the right answer to make a correct diagnosis. Questions that are too general usually yield zero information for diagnostic purposes. Adolescents are concrete thinkers; therefore, if we don’t ask the question in several different ways, we are likely not to get the right answers, or any at all.

Two questions that I feel must be asked at every female-patient visit are, “When was your last period?” and “How often does your period come?” Answers to these two questions can assist in diagnosing several medical conditions that otherwise might have gone unnoticed.

Amenorrhea, or absence of menses, is established if a female has never had a period by age 15 years (primary) or has gone 6 months or greater without one (secondary). Primary amenorrhea is generally caused by genetic or anatomic abnormalities, and commonly is identified at an earlier age. But if the presentation of the genetic disorder is not classic, such as in Turner’s syndrome, it may go unnoticed and the first clue may be amenorrhea.

Pregnancy is an obvious consideration with amenorrhea. But the picture is a little less clear when light or irregular periods are present. Postmenarche menstrual cycles are commonly irregular and not without risk of pregnancy if the adolescent becomes sexually active. Also, a patient with an ectopic pregnancy tends to have oligomenorrhea before the amenorrhea. Therefore, regardless of age, if the periods are abnormal, a pregnancy test should be done.

Early polycystic ovarian syndrome (PCOS) also can present as irregular/ infrequent periods. Many of the common signs such as hirsutism or acne may be minor and not convincing. In an age where obesity is so common, a clear picture is less likely, so PCOS may not be considered. PCOS is the No. 1 cause of infertility in women, and if suspected should be worked up.

Anovulation or dysfunctional ovaries, as seen in PCOS, may not be obvious early on. As stated, oligomenorrhea is very common in the first few years following menarche, but persistent oligomenorrhea is not normal. General guidelines state that oligomenorrhea post menarche is likely to be a sign of anovulation if 1 year post menarche, less than four menstrual cycles; 2 years post menarche, less than six menstrual cycles; 3-5 years post menarche, less than eight menstrual cycles; and greater than 5 years post menarche, less than nine menstrual cycles. Heavy bleeding occurring less than every 21 days is also a sign.

Thyroid dysfunction is a common consideration when the menstrual cycle is abnormal, and we normally attribute heavy periods to hypothyroidism and amenorrhea or irregular periods to hyperthyroidism. The truth is thyroid dysfunction – regardless of whether the hormone is high or low – can present in either fashion. Other endocrine disorders – such as adrenal hyperplasia, prolactinomas, or metabolic syndromes – also disrupt the menstrual cycle, but initial presentations can be vague and only the prudent investigator will identify the disorder.

If the patient appears underweight, careful evaluation for anorexia should be done. Irregular periods present with caloric deprivation. Questions should be asked about body image to determine if this is a concern.

Once it is established that there is a menstrual dysfunction, a careful physical exam should follow. Screening labs and a pelvic ultrasound will help identify the dysfunction, but a referral to an endocrinologist still should follow if the results are equivocal or unclear.

As demonstrated, those two simple questions have the potential to unveil so many disorders that likely would go unnoticed for months to years. Every encounter is an opportunity to obtain information regardless of the chief complaint. Posing questions in several different ways lessens the likelihood that the question will be misunderstood and compensates for varied levels of intellect.

Remember, you have to ask the right question to get the right answer!

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

During an adolescent visit, we all can agree that getting answers to even the simplest of questions can be a day’s work. Despite the reason for the visit, it always is important to ask a few basic questions in hopes that it might unveil a less obvious condition, or one that potentially could cause harm later. Asking the right questions is as important as getting the right answer to make a correct diagnosis. Questions that are too general usually yield zero information for diagnostic purposes. Adolescents are concrete thinkers; therefore, if we don’t ask the question in several different ways, we are likely not to get the right answers, or any at all.

Two questions that I feel must be asked at every female-patient visit are, “When was your last period?” and “How often does your period come?” Answers to these two questions can assist in diagnosing several medical conditions that otherwise might have gone unnoticed.

Amenorrhea, or absence of menses, is established if a female has never had a period by age 15 years (primary) or has gone 6 months or greater without one (secondary). Primary amenorrhea is generally caused by genetic or anatomic abnormalities, and commonly is identified at an earlier age. But if the presentation of the genetic disorder is not classic, such as in Turner’s syndrome, it may go unnoticed and the first clue may be amenorrhea.

Pregnancy is an obvious consideration with amenorrhea. But the picture is a little less clear when light or irregular periods are present. Postmenarche menstrual cycles are commonly irregular and not without risk of pregnancy if the adolescent becomes sexually active. Also, a patient with an ectopic pregnancy tends to have oligomenorrhea before the amenorrhea. Therefore, regardless of age, if the periods are abnormal, a pregnancy test should be done.

Early polycystic ovarian syndrome (PCOS) also can present as irregular/ infrequent periods. Many of the common signs such as hirsutism or acne may be minor and not convincing. In an age where obesity is so common, a clear picture is less likely, so PCOS may not be considered. PCOS is the No. 1 cause of infertility in women, and if suspected should be worked up.

Anovulation or dysfunctional ovaries, as seen in PCOS, may not be obvious early on. As stated, oligomenorrhea is very common in the first few years following menarche, but persistent oligomenorrhea is not normal. General guidelines state that oligomenorrhea post menarche is likely to be a sign of anovulation if 1 year post menarche, less than four menstrual cycles; 2 years post menarche, less than six menstrual cycles; 3-5 years post menarche, less than eight menstrual cycles; and greater than 5 years post menarche, less than nine menstrual cycles. Heavy bleeding occurring less than every 21 days is also a sign.

Thyroid dysfunction is a common consideration when the menstrual cycle is abnormal, and we normally attribute heavy periods to hypothyroidism and amenorrhea or irregular periods to hyperthyroidism. The truth is thyroid dysfunction – regardless of whether the hormone is high or low – can present in either fashion. Other endocrine disorders – such as adrenal hyperplasia, prolactinomas, or metabolic syndromes – also disrupt the menstrual cycle, but initial presentations can be vague and only the prudent investigator will identify the disorder.

If the patient appears underweight, careful evaluation for anorexia should be done. Irregular periods present with caloric deprivation. Questions should be asked about body image to determine if this is a concern.

Once it is established that there is a menstrual dysfunction, a careful physical exam should follow. Screening labs and a pelvic ultrasound will help identify the dysfunction, but a referral to an endocrinologist still should follow if the results are equivocal or unclear.

As demonstrated, those two simple questions have the potential to unveil so many disorders that likely would go unnoticed for months to years. Every encounter is an opportunity to obtain information regardless of the chief complaint. Posing questions in several different ways lessens the likelihood that the question will be misunderstood and compensates for varied levels of intellect.

Remember, you have to ask the right question to get the right answer!

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

During an adolescent visit, we all can agree that getting answers to even the simplest of questions can be a day’s work. Despite the reason for the visit, it always is important to ask a few basic questions in hopes that it might unveil a less obvious condition, or one that potentially could cause harm later. Asking the right questions is as important as getting the right answer to make a correct diagnosis. Questions that are too general usually yield zero information for diagnostic purposes. Adolescents are concrete thinkers; therefore, if we don’t ask the question in several different ways, we are likely not to get the right answers, or any at all.

Two questions that I feel must be asked at every female-patient visit are, “When was your last period?” and “How often does your period come?” Answers to these two questions can assist in diagnosing several medical conditions that otherwise might have gone unnoticed.

Amenorrhea, or absence of menses, is established if a female has never had a period by age 15 years (primary) or has gone 6 months or greater without one (secondary). Primary amenorrhea is generally caused by genetic or anatomic abnormalities, and commonly is identified at an earlier age. But if the presentation of the genetic disorder is not classic, such as in Turner’s syndrome, it may go unnoticed and the first clue may be amenorrhea.

Pregnancy is an obvious consideration with amenorrhea. But the picture is a little less clear when light or irregular periods are present. Postmenarche menstrual cycles are commonly irregular and not without risk of pregnancy if the adolescent becomes sexually active. Also, a patient with an ectopic pregnancy tends to have oligomenorrhea before the amenorrhea. Therefore, regardless of age, if the periods are abnormal, a pregnancy test should be done.

Early polycystic ovarian syndrome (PCOS) also can present as irregular/ infrequent periods. Many of the common signs such as hirsutism or acne may be minor and not convincing. In an age where obesity is so common, a clear picture is less likely, so PCOS may not be considered. PCOS is the No. 1 cause of infertility in women, and if suspected should be worked up.

Anovulation or dysfunctional ovaries, as seen in PCOS, may not be obvious early on. As stated, oligomenorrhea is very common in the first few years following menarche, but persistent oligomenorrhea is not normal. General guidelines state that oligomenorrhea post menarche is likely to be a sign of anovulation if 1 year post menarche, less than four menstrual cycles; 2 years post menarche, less than six menstrual cycles; 3-5 years post menarche, less than eight menstrual cycles; and greater than 5 years post menarche, less than nine menstrual cycles. Heavy bleeding occurring less than every 21 days is also a sign.

Thyroid dysfunction is a common consideration when the menstrual cycle is abnormal, and we normally attribute heavy periods to hypothyroidism and amenorrhea or irregular periods to hyperthyroidism. The truth is thyroid dysfunction – regardless of whether the hormone is high or low – can present in either fashion. Other endocrine disorders – such as adrenal hyperplasia, prolactinomas, or metabolic syndromes – also disrupt the menstrual cycle, but initial presentations can be vague and only the prudent investigator will identify the disorder.

If the patient appears underweight, careful evaluation for anorexia should be done. Irregular periods present with caloric deprivation. Questions should be asked about body image to determine if this is a concern.

Once it is established that there is a menstrual dysfunction, a careful physical exam should follow. Screening labs and a pelvic ultrasound will help identify the dysfunction, but a referral to an endocrinologist still should follow if the results are equivocal or unclear.

As demonstrated, those two simple questions have the potential to unveil so many disorders that likely would go unnoticed for months to years. Every encounter is an opportunity to obtain information regardless of the chief complaint. Posing questions in several different ways lessens the likelihood that the question will be misunderstood and compensates for varied levels of intellect.

Remember, you have to ask the right question to get the right answer!

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

Fecal incontinence is a devastating and isolating condition. Sales of adult diapers are a $7 billion global market and the fastest-growing household products business. Which is where a lot of our patients with this condition remain – at home.

Fecal incontinence (FI) is a condition characterized by continuous or recurrent uncontrolled passage of fecal material. The prevalence may be as high as 15%. Risk factors include physical disabilities, dementia, diabetes, urinary incontinence, chronic diarrhea, and multiparity. One-third of patients will talk to us about it. Which for some of us may be suitable, given our inability to offer good treatments.

If patients do mention it, evaluation involves taking a good history. We need to differentiate incontinence from fecal urgency and frequency. Anorectal examination should look for a bilateral anal wink (absence suggests nerve damage). Some form of endoscopic examination should be performed in most patients. Further evaluation/referral will be based upon findings.

Treatment includes improving stool consistency (e.g., fiber for loose stool) and reducing frequency (e.g., loperamide for diarrhea), and this is generally where I start. Hyoscyamine may be helpful for post-meal leakage. Scheduled defecation and amitriptyline may be of benefit to some patients.

Dr. Henri Damon of Hospices Civils de Lyon, France, and his colleagues conducted a multicenter study of perineal retraining for FI (Dig. Liver Dis. 2014;46:237-42). The intervention included perineal retraining and biofeedback. The protocol was based upon 20 sessions of 30 minutes performed within a 4-month period. The intervention was standardized. Eighty patients were included in the control group, with 77 in the biofeedback group.

The success rate was significantly higher in the biofeedback group (57% vs. 37%; P < .021). Stool frequency, leakage, and urgency significantly decreased. Perineal retraining was significantly associated with a higher chance of self-rated improvement.

The take-home message is that perineal retraining is an effective component of FI treatment. Combining it with improved perianal skin hygiene, bowel habit ritualization, and the addition of fiber as a bulking agent and loperamide for diarrhea offers the greatest hope for patients suffering from this challenging condition.

Our job is to figure out where and how our patients can access the level of expertise needed to do the training.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

Fecal incontinence is a devastating and isolating condition. Sales of adult diapers are a $7 billion global market and the fastest-growing household products business. Which is where a lot of our patients with this condition remain – at home.

Fecal incontinence (FI) is a condition characterized by continuous or recurrent uncontrolled passage of fecal material. The prevalence may be as high as 15%. Risk factors include physical disabilities, dementia, diabetes, urinary incontinence, chronic diarrhea, and multiparity. One-third of patients will talk to us about it. Which for some of us may be suitable, given our inability to offer good treatments.

If patients do mention it, evaluation involves taking a good history. We need to differentiate incontinence from fecal urgency and frequency. Anorectal examination should look for a bilateral anal wink (absence suggests nerve damage). Some form of endoscopic examination should be performed in most patients. Further evaluation/referral will be based upon findings.

Treatment includes improving stool consistency (e.g., fiber for loose stool) and reducing frequency (e.g., loperamide for diarrhea), and this is generally where I start. Hyoscyamine may be helpful for post-meal leakage. Scheduled defecation and amitriptyline may be of benefit to some patients.

Dr. Henri Damon of Hospices Civils de Lyon, France, and his colleagues conducted a multicenter study of perineal retraining for FI (Dig. Liver Dis. 2014;46:237-42). The intervention included perineal retraining and biofeedback. The protocol was based upon 20 sessions of 30 minutes performed within a 4-month period. The intervention was standardized. Eighty patients were included in the control group, with 77 in the biofeedback group.

The success rate was significantly higher in the biofeedback group (57% vs. 37%; P < .021). Stool frequency, leakage, and urgency significantly decreased. Perineal retraining was significantly associated with a higher chance of self-rated improvement.

The take-home message is that perineal retraining is an effective component of FI treatment. Combining it with improved perianal skin hygiene, bowel habit ritualization, and the addition of fiber as a bulking agent and loperamide for diarrhea offers the greatest hope for patients suffering from this challenging condition.

Our job is to figure out where and how our patients can access the level of expertise needed to do the training.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

Fecal incontinence is a devastating and isolating condition. Sales of adult diapers are a $7 billion global market and the fastest-growing household products business. Which is where a lot of our patients with this condition remain – at home.

Fecal incontinence (FI) is a condition characterized by continuous or recurrent uncontrolled passage of fecal material. The prevalence may be as high as 15%. Risk factors include physical disabilities, dementia, diabetes, urinary incontinence, chronic diarrhea, and multiparity. One-third of patients will talk to us about it. Which for some of us may be suitable, given our inability to offer good treatments.

If patients do mention it, evaluation involves taking a good history. We need to differentiate incontinence from fecal urgency and frequency. Anorectal examination should look for a bilateral anal wink (absence suggests nerve damage). Some form of endoscopic examination should be performed in most patients. Further evaluation/referral will be based upon findings.

Treatment includes improving stool consistency (e.g., fiber for loose stool) and reducing frequency (e.g., loperamide for diarrhea), and this is generally where I start. Hyoscyamine may be helpful for post-meal leakage. Scheduled defecation and amitriptyline may be of benefit to some patients.

Dr. Henri Damon of Hospices Civils de Lyon, France, and his colleagues conducted a multicenter study of perineal retraining for FI (Dig. Liver Dis. 2014;46:237-42). The intervention included perineal retraining and biofeedback. The protocol was based upon 20 sessions of 30 minutes performed within a 4-month period. The intervention was standardized. Eighty patients were included in the control group, with 77 in the biofeedback group.

The success rate was significantly higher in the biofeedback group (57% vs. 37%; P < .021). Stool frequency, leakage, and urgency significantly decreased. Perineal retraining was significantly associated with a higher chance of self-rated improvement.

The take-home message is that perineal retraining is an effective component of FI treatment. Combining it with improved perianal skin hygiene, bowel habit ritualization, and the addition of fiber as a bulking agent and loperamide for diarrhea offers the greatest hope for patients suffering from this challenging condition.

Our job is to figure out where and how our patients can access the level of expertise needed to do the training.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.