The US Preventive Services Task Force (USPSTF) recently published a clinical guideline on the use of calcium and vitamin D supplements to prevent fractures in adults.¹ This agency “strives to make accurate, up-to-date, and relevant recommendations about preventive services in primary care,”² and within those parameters they generally succeed. But I am confused about the value of this specific guideline, and apparently I am not alone.

The task force came to several major conclusions about calcium and vitamin D supplementation to prevent fractures:

• There is insufficient evidence to offer guidance on supplementation in premeno-pausal women or in men
• One should not prescribe supplementation of 400 IU or less of vitamin D₃ or 1 g or less of calcium in postmenopausal women
• The data are insufficient to assess the harm and benefit of higher doses of supplemental vitamin D or calcium.

The task force stuck to their rules and weighed the data within the constraints of the specific question they were charged to address.

A challenge to clinicians attempting to apply rigidly defined, evidence-based conclusions is that the more precisely a question is addressed, the more limited is the answer’s applicability in clinical practice. Thus, Dr. Robin Dore, in this issue of the Journal, says that she believes there are benefits of vitamin D and calcium supplementation beyond primary prevention of fractures, and the benefits are not negated by the magnitude of potential harm (stated to be “small” by the USPSTF).

We are bombarded by clinical practice guidelines, and we don’t know which will be externally imposed as a measure of quality by which our practice performance will be assessed. In the clinic, we encounter a series of individual patients with whom we make individual treatment decisions. Like the inhabitants of Lake Wobegon, few of our patients are the “average patient” as derived from cross-sectional studies. Some have occult celiac disease, others are on proton pump inhibitors, some are lactose-intolerant, and some are on intermittent prednisone. For these patients, should the USPSTF guidelines warrant the extra effort and time to individually document why the guidelines don’t fit and why we made the clinical judgment to not follow them? Additionally, how many patients in the clinical studies used by the USPSTF fit into these or other unique categories and may have thus contaminated the data? I don’t see in these guidelines recommendations on how best to assess calcium and vitamin D intake and absorption in our patients in a practical manner. After all, supplementation is in addition to the actual intake of dietary sources.

For me, further confusion stems from trying to clinically couple the logic of such carefully analyzed, accurately stated, and tightly focused guidelines with what we already know (and apparently don’t know). We know that severe vitamin D deficiency clearly causes low bone density and fractures from osteomalacia, and the Institute of Medicine has previously stated that adequate vitamin D is beneficial and so should be supplemented.³ Vitamin D deficiency is a continuum and is very unlikely to be defined by the quantity of supplementation. Additionally, the USPSTF has previously published guidelines on supplementing vitamin D intake to prevent falls—falls being a major preventable cause of primary fractures. There seems to be some conceptual incongruence between these guidelines.

While epidemiologic studies have incorporated estimates of dietary and supplemental intake of calcium and vitamin D, what likely really matters is the absorption and the achieved blood levels and tissue incorporation. As shown in the examples above, many variables influence these in individual patients. And most troublesome is that there is no agreement as to the appropriate target level for circulating vitamin D. I agree with two-thirds of the task force’s conclusions—we have insufficient evidence. Are these really guidelines, or a plea for the gathering of appropriate outcome data?

The US Preventive Services Task Force (USPSTF) recently published a clinical guideline on the use of calcium and vitamin D supplements to prevent fractures in adults.¹ This agency “strives to make accurate, up-to-date, and relevant recommendations about preventive services in primary care,”² and within those parameters they generally succeed. But I am confused about the value of this specific guideline, and apparently I am not alone.

The task force came to several major conclusions about calcium and vitamin D supplementation to prevent fractures:

• There is insufficient evidence to offer guidance on supplementation in premeno-pausal women or in men
• One should not prescribe supplementation of 400 IU or less of vitamin D₃ or 1 g or less of calcium in postmenopausal women
• The data are insufficient to assess the harm and benefit of higher doses of supplemental vitamin D or calcium.

The task force stuck to their rules and weighed the data within the constraints of the specific question they were charged to address.

A challenge to clinicians attempting to apply rigidly defined, evidence-based conclusions is that the more precisely a question is addressed, the more limited is the answer’s applicability in clinical practice. Thus, Dr. Robin Dore, in this issue of the Journal, says that she believes there are benefits of vitamin D and calcium supplementation beyond primary prevention of fractures, and the benefits are not negated by the magnitude of potential harm (stated to be “small” by the USPSTF).

We are bombarded by clinical practice guidelines, and we don’t know which will be externally imposed as a measure of quality by which our practice performance will be assessed. In the clinic, we encounter a series of individual patients with whom we make individual treatment decisions. Like the inhabitants of Lake Wobegon, few of our patients are the “average patient” as derived from cross-sectional studies. Some have occult celiac disease, others are on proton pump inhibitors, some are lactose-intolerant, and some are on intermittent prednisone. For these patients, should the USPSTF guidelines warrant the extra effort and time to individually document why the guidelines don’t fit and why we made the clinical judgment to not follow them? Additionally, how many patients in the clinical studies used by the USPSTF fit into these or other unique categories and may have thus contaminated the data? I don’t see in these guidelines recommendations on how best to assess calcium and vitamin D intake and absorption in our patients in a practical manner. After all, supplementation is in addition to the actual intake of dietary sources.

For me, further confusion stems from trying to clinically couple the logic of such carefully analyzed, accurately stated, and tightly focused guidelines with what we already know (and apparently don’t know). We know that severe vitamin D deficiency clearly causes low bone density and fractures from osteomalacia, and the Institute of Medicine has previously stated that adequate vitamin D is beneficial and so should be supplemented.³ Vitamin D deficiency is a continuum and is very unlikely to be defined by the quantity of supplementation. Additionally, the USPSTF has previously published guidelines on supplementing vitamin D intake to prevent falls—falls being a major preventable cause of primary fractures. There seems to be some conceptual incongruence between these guidelines.

While epidemiologic studies have incorporated estimates of dietary and supplemental intake of calcium and vitamin D, what likely really matters is the absorption and the achieved blood levels and tissue incorporation. As shown in the examples above, many variables influence these in individual patients. And most troublesome is that there is no agreement as to the appropriate target level for circulating vitamin D. I agree with two-thirds of the task force’s conclusions—we have insufficient evidence. Are these really guidelines, or a plea for the gathering of appropriate outcome data?

The US Preventive Services Task Force (USPSTF) recently published a clinical guideline on the use of calcium and vitamin D supplements to prevent fractures in adults.¹ This agency “strives to make accurate, up-to-date, and relevant recommendations about preventive services in primary care,”² and within those parameters they generally succeed. But I am confused about the value of this specific guideline, and apparently I am not alone.

The task force came to several major conclusions about calcium and vitamin D supplementation to prevent fractures:

• There is insufficient evidence to offer guidance on supplementation in premeno-pausal women or in men
• One should not prescribe supplementation of 400 IU or less of vitamin D₃ or 1 g or less of calcium in postmenopausal women
• The data are insufficient to assess the harm and benefit of higher doses of supplemental vitamin D or calcium.

The task force stuck to their rules and weighed the data within the constraints of the specific question they were charged to address.

A challenge to clinicians attempting to apply rigidly defined, evidence-based conclusions is that the more precisely a question is addressed, the more limited is the answer’s applicability in clinical practice. Thus, Dr. Robin Dore, in this issue of the Journal, says that she believes there are benefits of vitamin D and calcium supplementation beyond primary prevention of fractures, and the benefits are not negated by the magnitude of potential harm (stated to be “small” by the USPSTF).

We are bombarded by clinical practice guidelines, and we don’t know which will be externally imposed as a measure of quality by which our practice performance will be assessed. In the clinic, we encounter a series of individual patients with whom we make individual treatment decisions. Like the inhabitants of Lake Wobegon, few of our patients are the “average patient” as derived from cross-sectional studies. Some have occult celiac disease, others are on proton pump inhibitors, some are lactose-intolerant, and some are on intermittent prednisone. For these patients, should the USPSTF guidelines warrant the extra effort and time to individually document why the guidelines don’t fit and why we made the clinical judgment to not follow them? Additionally, how many patients in the clinical studies used by the USPSTF fit into these or other unique categories and may have thus contaminated the data? I don’t see in these guidelines recommendations on how best to assess calcium and vitamin D intake and absorption in our patients in a practical manner. After all, supplementation is in addition to the actual intake of dietary sources.

For me, further confusion stems from trying to clinically couple the logic of such carefully analyzed, accurately stated, and tightly focused guidelines with what we already know (and apparently don’t know). We know that severe vitamin D deficiency clearly causes low bone density and fractures from osteomalacia, and the Institute of Medicine has previously stated that adequate vitamin D is beneficial and so should be supplemented.³ Vitamin D deficiency is a continuum and is very unlikely to be defined by the quantity of supplementation. Additionally, the USPSTF has previously published guidelines on supplementing vitamin D intake to prevent falls—falls being a major preventable cause of primary fractures. There seems to be some conceptual incongruence between these guidelines.

While epidemiologic studies have incorporated estimates of dietary and supplemental intake of calcium and vitamin D, what likely really matters is the absorption and the achieved blood levels and tissue incorporation. As shown in the examples above, many variables influence these in individual patients. And most troublesome is that there is no agreement as to the appropriate target level for circulating vitamin D. I agree with two-thirds of the task force’s conclusions—we have insufficient evidence. Are these really guidelines, or a plea for the gathering of appropriate outcome data?

The United States preventive services task force (USPSTF) recently threw cold water on the use of calcium and vitamin D supplements to prevent fractures in adults, either finding inadequate evidence to make a recommendation or recommending against supplementation, depending on the population and the doses used.¹

Complicating this issue, several recent studies have raised concern about the long-term cardiovascular risk of calcium supplementation.

With so many people taking calcium supplements, how do we put this into context for our patients? I believe that we need to consider the whole person when discussing these supplements, as there are data that they also help reduce the risk of falls, cancer, and even overall mortality rates.

THE USPSTF’S METHODS

The USPSTF bases its recommendations on explicit criteria² developed by its Evidence-based Practice Center, which is under contract to the US Agency for Healthcare Research and Quality to conduct systematic reviews of the evidence on specific topics in clinical prevention. The USPSTF grades the strength of the evidence for the effectiveness of specific clinical preventive services as:

• A (strongly recommended)
• B (recommended)
• C (no recommendation)
• D (recommended against)
• I (insufficient evidence to make a recommendation for or against).

USPSTF recommendations consider the evidence of both benefit and harm of the intervention but do not include the cost of the intervention in the assessment.³

THE USPSTF’S GRADES ON CALCIUM AND VITAMIN D SUPPLEMENTATION

The USPSTF made the following recommendations in February 2013 about the use of calcium and vitamin D supplementation:

• For primary prevention of fractures in premenopausal women and men: grade I (current evidence is insufficient to assess the balance of the benefits and harms)
• For primary prevention of fractures in noninstitutionalized postmenopausal women, in daily doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium: also grade I
• For primary prevention of fractures in noninstitutionalized postmenopausal women, in daily doses of 400 IU or less of vitamin D and 1,000 mg or less of calcium: grade D (the USPSTF recommends against it, as these doses increase the incidence of renal stones and there is “adequate” evidence that these doses have no effect on the incidence of fractures).

WHAT THE USPSTF DID NOT DISCUSS

These recommendations do not apply to everybody. Rather, the document discusses “the effectiveness of specific clinical preventive services for patients without related signs or symptoms,”¹ and states that the recommendations do not pertain to patients with osteoporosis or vitamin D deficiency or those who have had fractures.

Also, the document does not discuss the use of calcium supplementation by itself in fracture prevention. nor does it discuss possible benefits of calcium and vitamin D other than fracture prevention, such as reducing the risk of falls, cancer, or death. Further, the document states that “appropriate intake” of vitamin D and calcium is “essential to overall health”¹ but does not state the amount that is considered appropriate.

The document does refer the reader to other USPSTF recommendations concerning screening for osteoporosis in women age 65 and older and in younger women who demonstrate the fracture risk of a 65-year-old woman,⁴ as well as to its recommendation for vitamin D supplementation to prevent falls in community-dwelling adults age 65 and older who are at higher risk of falls.⁵

Not included: A new meta-analysis

The USPSTF document also notes that after their review was completed, another metaanalysis concluded that fracture risk may be reduced by taking vitamin D in doses of 800 IU or higher.⁶

In that study, Bischoff-Ferrari et al⁶ performed a pooled analysis of vitamin D dose requirements for fracture prevention from 11 double-blind, randomized, controlled trials of oral vitamin D supplementation taken either daily or at weekly or 4-month intervals with or without calcium, compared with placebo or calcium alone in people age 65 and older. The primary end points were the incidence of hip fracture and any nonvertebral fracture according to Cox regression analysis, with adjustment for age, sex, community or institutional dwelling, and study. The aim was to evaluate actual vitamin D intake rather than the assigned dosage groups in the trials.

On the basis of actual vitamin D intake, the incidence of hip fracture was significantly (30%) lower in people with the highest actual intake (792–2,000 IU per day) than in controls. There was no reduction in the risk of hip fracture at any actual intake levels lower than 792 IU per day. Using this same analytic technique, the reduction in the incidence of nonvertebral fracture at the highest actual intake level was 16%.

Why were their findings different than those of the USPSTF? The authors hypothesized that some previous high-quality trials of vitamin D supplementation either showed no benefit because the participants were noncompliant and thus took less than the intended dose of vitamin D, or showed an unexpected benefit because the participants actually took more vitamin D than was specified in the study.

The USPSTF recommendations did not include studies of vitamin D without calcium, whereas Bischoff-Ferrari et al did, which could also explain some of the differences in the findings, as not all of the studies included in the two documents were the same. Several previous meta-analyses suggested that the dose of vitamin D was irrelevant when vitamin D was combined with calcium.

The data from Bischoff-Ferrari et al suggested that at the highest actual intake level of vitamin D, a smaller amount of calcium supplementation (< 1,000 mg daily) may be more beneficial in reducing fracture risk than a larger amount (≥ 1,000 mg daily). This is important, given the current level of concern initially raised by Bolland et al⁷ and others about the possible risks of higher doses of calcium supplements increasing cardiovascular risk. (More on this below.)

WHAT OTHER ORGANIZATIONS SAY

Both the National Osteoporosis Foundation and the American Society of Bone and Mineral Research suggest following the 2010 recommendations of the Institute of Medicine⁸ on calcium and vitamin D instead of those of the USPSTF, as the former address the overall health benefits of calcium and vitamin D in healthy individuals rather than only fracture prevention.

Neither the Institute of Medicine nor the USPSTF, however, addresses vitamin D requirements of people at high risk, such as those with vitamin D deficiency due to very little sun exposure, dark skin, problems absorbing dietary fat, or medications that interfere with vitamin D absorption, or those with osteoporosis.

The Institute of Medicine suggests that, for healthy adults under age 71, an adequate vitamin D intake is 600 IU daily, and for healthy adults age 71 and older it is 800 IU daily. They state that the safe upper limit for daily intake of vitamin D is 4,000 IU. As for adequate calcium intake, the daily recommendation is 1,200 mg for women ages 50 through 70, and 1,200 mg for all adults age 71 and older. As I have already discussed, the Institute of Medicine recommendations are based on the overall health benefits of calcium and vitamin D rather than solely on fracture prevention. Monitoring of vitamin D levels is not recommended unless the patient has osteoporosis or is at risk for vitamin D deficiency.

Risks of calcium supplementation

Much has been written recently about the risks of calcium supplementation.

This concern was first raised in 2008 by Bolland et al⁷ in a post hoc analysis of data collected to evaluate the effect of calcium supplements on bone density and fracture.⁷ More myocardial infarctions occurred in the calcium supplement group than in the placebo group, but the difference was not statistically significant, and the events occurred only in those who took more than 1,000 mg of calcium daily.

The same group reanalyzed data from the Women’s Health Initiative and found a 24% higher risk of myocardial infarction in women who took calcium with or without vitamin D, but only in those women assigned to take calcium supplementation who had not taken calcium supplements before the study began.⁹

More recently, Xiao et al¹⁰ evaluated the effect of both dietary and supplemental calcium on cardiovascular disease mortality rates.¹⁰ This was a prospective study of 388,229 men and women who participated in the National Institutes of Health-American Association of Retired Persons Diet and Heart Study. Supplemental calcium intake was associated with an elevated risk of cardiovascular disease in men, but not in women. Dietary calcium intake was unrelated to cardiovascular death.

The latest study to address this issue was from the Swedish Mammography Cohort, a population-based cohort that included 61,433 women born between 1914 and 1948, with a mean follow-up of 19 years.¹¹ Diet was evaluated by food frequency questionnaires. A daily dietary intake of calcium below 600 mg was associated with higher risks of all-cause mortality, cardiovascular disease, ischemic heart disease, and stroke. However, compared with women whose daily calcium intake was between 600 and 999 mg, a dietary intake of more than 1,400 mg/day was associated with a higher death rate, with a hazard ratio for all-cause mortality of 1.40, cardiovascular disease 1.49, and ischemic heart disease 2.14.

Unfortunately, none of these studies were designed to assess the risk of cardiovascular disease related to calcium supplementation. Like the USPSTF, both the National Osteoporosis Foundation and the American Society of Bone and Mineral Research state that this type of study is needed to clarify both the benefit and risk of calcium supplementation.

Until these data are available, the American Society of Bone and Mineral Research has advised doctors and their patients “to discuss the best strategy for each individual patient, putting supplements as the last resort for healthier adults if they cannot reach recommended levels through the intake of calcium and vitamin rich foods.” For adults who cannot tolerate dairy products, calcium can be obtained from calcium-supplemented foods such as orange juice and Jello and from nondairy sources such as leafy green vegetables, almonds, garbanzo beans, tofu, and eggs.¹²

The National Osteoporosis Foundation suggests following the Institute of Medicine recommendations for adequate calcium and vitamin D rather than the USPSTF recommendations, most likely because the former are based on the overall health benefits of calcium and vitamin D rather than fracture prevention only. However, it reminds us that the Institute of Medicine recommendations do not apply to patients who are at the highest risk of fracture, ie, those with osteoporosis and vitamin D deficiency.

TAKE-HOME POINTS

• All medications, including those available over the counter, have benefits and risks.
• Even the USPSTF states that for a healthy lifestyle, the diet should contain adequate calcium and vitamin D intake.
• When following guidelines, practitioners should be certain that the guidelines pertain to the population they are treating—for example, not to apply the Institute of Medicine recommendations to a woman with a hip fracture, but that a healthy premenopausal woman who is taking calcium supplements should be advised to stop the supplements and focus on dietary sources of calcium.
• Only if individuals cannot obtain the recommended amount of calcium in their diet is it advisable for them to take a calcium supplement.

My recommendations

Based on the information summarized above, I recommend that my patients obtain as much calcium as possible from their diet—between 600 and 1,200 mg daily—and to take a calcium supplement only if they cannot obtain that amount of calcium in the diet. However, 24-hour calcium excretion is not recommended as a marker of calcium intake.

I also advise my patients to take a vitamin D supplement, per the Institute of Medicine report for overall good health. The USPSTF recommendations concerning vitamin D and calcium address only fracture prevention. As I am responsible for the overall health of my patients, not just fracture prevention, I choose to follow the National Osteoporosis Foundation and Institute of Medicine recommendations, not those of the USPSTF.

The United States preventive services task force (USPSTF) recently threw cold water on the use of calcium and vitamin D supplements to prevent fractures in adults, either finding inadequate evidence to make a recommendation or recommending against supplementation, depending on the population and the doses used.¹

Complicating this issue, several recent studies have raised concern about the long-term cardiovascular risk of calcium supplementation.

With so many people taking calcium supplements, how do we put this into context for our patients? I believe that we need to consider the whole person when discussing these supplements, as there are data that they also help reduce the risk of falls, cancer, and even overall mortality rates.

THE USPSTF’S METHODS

The USPSTF bases its recommendations on explicit criteria² developed by its Evidence-based Practice Center, which is under contract to the US Agency for Healthcare Research and Quality to conduct systematic reviews of the evidence on specific topics in clinical prevention. The USPSTF grades the strength of the evidence for the effectiveness of specific clinical preventive services as:

• A (strongly recommended)
• B (recommended)
• C (no recommendation)
• D (recommended against)
• I (insufficient evidence to make a recommendation for or against).

USPSTF recommendations consider the evidence of both benefit and harm of the intervention but do not include the cost of the intervention in the assessment.³

THE USPSTF’S GRADES ON CALCIUM AND VITAMIN D SUPPLEMENTATION

The USPSTF made the following recommendations in February 2013 about the use of calcium and vitamin D supplementation:

• For primary prevention of fractures in premenopausal women and men: grade I (current evidence is insufficient to assess the balance of the benefits and harms)
• For primary prevention of fractures in noninstitutionalized postmenopausal women, in daily doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium: also grade I
• For primary prevention of fractures in noninstitutionalized postmenopausal women, in daily doses of 400 IU or less of vitamin D and 1,000 mg or less of calcium: grade D (the USPSTF recommends against it, as these doses increase the incidence of renal stones and there is “adequate” evidence that these doses have no effect on the incidence of fractures).

WHAT THE USPSTF DID NOT DISCUSS

These recommendations do not apply to everybody. Rather, the document discusses “the effectiveness of specific clinical preventive services for patients without related signs or symptoms,”¹ and states that the recommendations do not pertain to patients with osteoporosis or vitamin D deficiency or those who have had fractures.

Also, the document does not discuss the use of calcium supplementation by itself in fracture prevention. nor does it discuss possible benefits of calcium and vitamin D other than fracture prevention, such as reducing the risk of falls, cancer, or death. Further, the document states that “appropriate intake” of vitamin D and calcium is “essential to overall health”¹ but does not state the amount that is considered appropriate.

The document does refer the reader to other USPSTF recommendations concerning screening for osteoporosis in women age 65 and older and in younger women who demonstrate the fracture risk of a 65-year-old woman,⁴ as well as to its recommendation for vitamin D supplementation to prevent falls in community-dwelling adults age 65 and older who are at higher risk of falls.⁵

Not included: A new meta-analysis

The USPSTF document also notes that after their review was completed, another metaanalysis concluded that fracture risk may be reduced by taking vitamin D in doses of 800 IU or higher.⁶

In that study, Bischoff-Ferrari et al⁶ performed a pooled analysis of vitamin D dose requirements for fracture prevention from 11 double-blind, randomized, controlled trials of oral vitamin D supplementation taken either daily or at weekly or 4-month intervals with or without calcium, compared with placebo or calcium alone in people age 65 and older. The primary end points were the incidence of hip fracture and any nonvertebral fracture according to Cox regression analysis, with adjustment for age, sex, community or institutional dwelling, and study. The aim was to evaluate actual vitamin D intake rather than the assigned dosage groups in the trials.

On the basis of actual vitamin D intake, the incidence of hip fracture was significantly (30%) lower in people with the highest actual intake (792–2,000 IU per day) than in controls. There was no reduction in the risk of hip fracture at any actual intake levels lower than 792 IU per day. Using this same analytic technique, the reduction in the incidence of nonvertebral fracture at the highest actual intake level was 16%.

Why were their findings different than those of the USPSTF? The authors hypothesized that some previous high-quality trials of vitamin D supplementation either showed no benefit because the participants were noncompliant and thus took less than the intended dose of vitamin D, or showed an unexpected benefit because the participants actually took more vitamin D than was specified in the study.

The USPSTF recommendations did not include studies of vitamin D without calcium, whereas Bischoff-Ferrari et al did, which could also explain some of the differences in the findings, as not all of the studies included in the two documents were the same. Several previous meta-analyses suggested that the dose of vitamin D was irrelevant when vitamin D was combined with calcium.

The data from Bischoff-Ferrari et al suggested that at the highest actual intake level of vitamin D, a smaller amount of calcium supplementation (< 1,000 mg daily) may be more beneficial in reducing fracture risk than a larger amount (≥ 1,000 mg daily). This is important, given the current level of concern initially raised by Bolland et al⁷ and others about the possible risks of higher doses of calcium supplements increasing cardiovascular risk. (More on this below.)

WHAT OTHER ORGANIZATIONS SAY

Both the National Osteoporosis Foundation and the American Society of Bone and Mineral Research suggest following the 2010 recommendations of the Institute of Medicine⁸ on calcium and vitamin D instead of those of the USPSTF, as the former address the overall health benefits of calcium and vitamin D in healthy individuals rather than only fracture prevention.

Neither the Institute of Medicine nor the USPSTF, however, addresses vitamin D requirements of people at high risk, such as those with vitamin D deficiency due to very little sun exposure, dark skin, problems absorbing dietary fat, or medications that interfere with vitamin D absorption, or those with osteoporosis.

The Institute of Medicine suggests that, for healthy adults under age 71, an adequate vitamin D intake is 600 IU daily, and for healthy adults age 71 and older it is 800 IU daily. They state that the safe upper limit for daily intake of vitamin D is 4,000 IU. As for adequate calcium intake, the daily recommendation is 1,200 mg for women ages 50 through 70, and 1,200 mg for all adults age 71 and older. As I have already discussed, the Institute of Medicine recommendations are based on the overall health benefits of calcium and vitamin D rather than solely on fracture prevention. Monitoring of vitamin D levels is not recommended unless the patient has osteoporosis or is at risk for vitamin D deficiency.

Risks of calcium supplementation

Much has been written recently about the risks of calcium supplementation.

This concern was first raised in 2008 by Bolland et al⁷ in a post hoc analysis of data collected to evaluate the effect of calcium supplements on bone density and fracture.⁷ More myocardial infarctions occurred in the calcium supplement group than in the placebo group, but the difference was not statistically significant, and the events occurred only in those who took more than 1,000 mg of calcium daily.

The same group reanalyzed data from the Women’s Health Initiative and found a 24% higher risk of myocardial infarction in women who took calcium with or without vitamin D, but only in those women assigned to take calcium supplementation who had not taken calcium supplements before the study began.⁹

More recently, Xiao et al¹⁰ evaluated the effect of both dietary and supplemental calcium on cardiovascular disease mortality rates.¹⁰ This was a prospective study of 388,229 men and women who participated in the National Institutes of Health-American Association of Retired Persons Diet and Heart Study. Supplemental calcium intake was associated with an elevated risk of cardiovascular disease in men, but not in women. Dietary calcium intake was unrelated to cardiovascular death.

The latest study to address this issue was from the Swedish Mammography Cohort, a population-based cohort that included 61,433 women born between 1914 and 1948, with a mean follow-up of 19 years.¹¹ Diet was evaluated by food frequency questionnaires. A daily dietary intake of calcium below 600 mg was associated with higher risks of all-cause mortality, cardiovascular disease, ischemic heart disease, and stroke. However, compared with women whose daily calcium intake was between 600 and 999 mg, a dietary intake of more than 1,400 mg/day was associated with a higher death rate, with a hazard ratio for all-cause mortality of 1.40, cardiovascular disease 1.49, and ischemic heart disease 2.14.

Unfortunately, none of these studies were designed to assess the risk of cardiovascular disease related to calcium supplementation. Like the USPSTF, both the National Osteoporosis Foundation and the American Society of Bone and Mineral Research state that this type of study is needed to clarify both the benefit and risk of calcium supplementation.

Until these data are available, the American Society of Bone and Mineral Research has advised doctors and their patients “to discuss the best strategy for each individual patient, putting supplements as the last resort for healthier adults if they cannot reach recommended levels through the intake of calcium and vitamin rich foods.” For adults who cannot tolerate dairy products, calcium can be obtained from calcium-supplemented foods such as orange juice and Jello and from nondairy sources such as leafy green vegetables, almonds, garbanzo beans, tofu, and eggs.¹²

The National Osteoporosis Foundation suggests following the Institute of Medicine recommendations for adequate calcium and vitamin D rather than the USPSTF recommendations, most likely because the former are based on the overall health benefits of calcium and vitamin D rather than fracture prevention only. However, it reminds us that the Institute of Medicine recommendations do not apply to patients who are at the highest risk of fracture, ie, those with osteoporosis and vitamin D deficiency.

TAKE-HOME POINTS

• All medications, including those available over the counter, have benefits and risks.
• Even the USPSTF states that for a healthy lifestyle, the diet should contain adequate calcium and vitamin D intake.
• When following guidelines, practitioners should be certain that the guidelines pertain to the population they are treating—for example, not to apply the Institute of Medicine recommendations to a woman with a hip fracture, but that a healthy premenopausal woman who is taking calcium supplements should be advised to stop the supplements and focus on dietary sources of calcium.
• Only if individuals cannot obtain the recommended amount of calcium in their diet is it advisable for them to take a calcium supplement.

My recommendations

Based on the information summarized above, I recommend that my patients obtain as much calcium as possible from their diet—between 600 and 1,200 mg daily—and to take a calcium supplement only if they cannot obtain that amount of calcium in the diet. However, 24-hour calcium excretion is not recommended as a marker of calcium intake.

I also advise my patients to take a vitamin D supplement, per the Institute of Medicine report for overall good health. The USPSTF recommendations concerning vitamin D and calcium address only fracture prevention. As I am responsible for the overall health of my patients, not just fracture prevention, I choose to follow the National Osteoporosis Foundation and Institute of Medicine recommendations, not those of the USPSTF.

The United States preventive services task force (USPSTF) recently threw cold water on the use of calcium and vitamin D supplements to prevent fractures in adults, either finding inadequate evidence to make a recommendation or recommending against supplementation, depending on the population and the doses used.¹

Complicating this issue, several recent studies have raised concern about the long-term cardiovascular risk of calcium supplementation.

With so many people taking calcium supplements, how do we put this into context for our patients? I believe that we need to consider the whole person when discussing these supplements, as there are data that they also help reduce the risk of falls, cancer, and even overall mortality rates.

THE USPSTF’S METHODS

The USPSTF bases its recommendations on explicit criteria² developed by its Evidence-based Practice Center, which is under contract to the US Agency for Healthcare Research and Quality to conduct systematic reviews of the evidence on specific topics in clinical prevention. The USPSTF grades the strength of the evidence for the effectiveness of specific clinical preventive services as:

• A (strongly recommended)
• B (recommended)
• C (no recommendation)
• D (recommended against)
• I (insufficient evidence to make a recommendation for or against).

USPSTF recommendations consider the evidence of both benefit and harm of the intervention but do not include the cost of the intervention in the assessment.³

THE USPSTF’S GRADES ON CALCIUM AND VITAMIN D SUPPLEMENTATION

The USPSTF made the following recommendations in February 2013 about the use of calcium and vitamin D supplementation:

• For primary prevention of fractures in premenopausal women and men: grade I (current evidence is insufficient to assess the balance of the benefits and harms)
• For primary prevention of fractures in noninstitutionalized postmenopausal women, in daily doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium: also grade I
• For primary prevention of fractures in noninstitutionalized postmenopausal women, in daily doses of 400 IU or less of vitamin D and 1,000 mg or less of calcium: grade D (the USPSTF recommends against it, as these doses increase the incidence of renal stones and there is “adequate” evidence that these doses have no effect on the incidence of fractures).

WHAT THE USPSTF DID NOT DISCUSS

These recommendations do not apply to everybody. Rather, the document discusses “the effectiveness of specific clinical preventive services for patients without related signs or symptoms,”¹ and states that the recommendations do not pertain to patients with osteoporosis or vitamin D deficiency or those who have had fractures.

Also, the document does not discuss the use of calcium supplementation by itself in fracture prevention. nor does it discuss possible benefits of calcium and vitamin D other than fracture prevention, such as reducing the risk of falls, cancer, or death. Further, the document states that “appropriate intake” of vitamin D and calcium is “essential to overall health”¹ but does not state the amount that is considered appropriate.

The document does refer the reader to other USPSTF recommendations concerning screening for osteoporosis in women age 65 and older and in younger women who demonstrate the fracture risk of a 65-year-old woman,⁴ as well as to its recommendation for vitamin D supplementation to prevent falls in community-dwelling adults age 65 and older who are at higher risk of falls.⁵

Not included: A new meta-analysis

The USPSTF document also notes that after their review was completed, another metaanalysis concluded that fracture risk may be reduced by taking vitamin D in doses of 800 IU or higher.⁶

In that study, Bischoff-Ferrari et al⁶ performed a pooled analysis of vitamin D dose requirements for fracture prevention from 11 double-blind, randomized, controlled trials of oral vitamin D supplementation taken either daily or at weekly or 4-month intervals with or without calcium, compared with placebo or calcium alone in people age 65 and older. The primary end points were the incidence of hip fracture and any nonvertebral fracture according to Cox regression analysis, with adjustment for age, sex, community or institutional dwelling, and study. The aim was to evaluate actual vitamin D intake rather than the assigned dosage groups in the trials.

On the basis of actual vitamin D intake, the incidence of hip fracture was significantly (30%) lower in people with the highest actual intake (792–2,000 IU per day) than in controls. There was no reduction in the risk of hip fracture at any actual intake levels lower than 792 IU per day. Using this same analytic technique, the reduction in the incidence of nonvertebral fracture at the highest actual intake level was 16%.

Why were their findings different than those of the USPSTF? The authors hypothesized that some previous high-quality trials of vitamin D supplementation either showed no benefit because the participants were noncompliant and thus took less than the intended dose of vitamin D, or showed an unexpected benefit because the participants actually took more vitamin D than was specified in the study.

The USPSTF recommendations did not include studies of vitamin D without calcium, whereas Bischoff-Ferrari et al did, which could also explain some of the differences in the findings, as not all of the studies included in the two documents were the same. Several previous meta-analyses suggested that the dose of vitamin D was irrelevant when vitamin D was combined with calcium.

The data from Bischoff-Ferrari et al suggested that at the highest actual intake level of vitamin D, a smaller amount of calcium supplementation (< 1,000 mg daily) may be more beneficial in reducing fracture risk than a larger amount (≥ 1,000 mg daily). This is important, given the current level of concern initially raised by Bolland et al⁷ and others about the possible risks of higher doses of calcium supplements increasing cardiovascular risk. (More on this below.)

WHAT OTHER ORGANIZATIONS SAY

Both the National Osteoporosis Foundation and the American Society of Bone and Mineral Research suggest following the 2010 recommendations of the Institute of Medicine⁸ on calcium and vitamin D instead of those of the USPSTF, as the former address the overall health benefits of calcium and vitamin D in healthy individuals rather than only fracture prevention.

Neither the Institute of Medicine nor the USPSTF, however, addresses vitamin D requirements of people at high risk, such as those with vitamin D deficiency due to very little sun exposure, dark skin, problems absorbing dietary fat, or medications that interfere with vitamin D absorption, or those with osteoporosis.

The Institute of Medicine suggests that, for healthy adults under age 71, an adequate vitamin D intake is 600 IU daily, and for healthy adults age 71 and older it is 800 IU daily. They state that the safe upper limit for daily intake of vitamin D is 4,000 IU. As for adequate calcium intake, the daily recommendation is 1,200 mg for women ages 50 through 70, and 1,200 mg for all adults age 71 and older. As I have already discussed, the Institute of Medicine recommendations are based on the overall health benefits of calcium and vitamin D rather than solely on fracture prevention. Monitoring of vitamin D levels is not recommended unless the patient has osteoporosis or is at risk for vitamin D deficiency.

Risks of calcium supplementation

Much has been written recently about the risks of calcium supplementation.

This concern was first raised in 2008 by Bolland et al⁷ in a post hoc analysis of data collected to evaluate the effect of calcium supplements on bone density and fracture.⁷ More myocardial infarctions occurred in the calcium supplement group than in the placebo group, but the difference was not statistically significant, and the events occurred only in those who took more than 1,000 mg of calcium daily.

The same group reanalyzed data from the Women’s Health Initiative and found a 24% higher risk of myocardial infarction in women who took calcium with or without vitamin D, but only in those women assigned to take calcium supplementation who had not taken calcium supplements before the study began.⁹

More recently, Xiao et al¹⁰ evaluated the effect of both dietary and supplemental calcium on cardiovascular disease mortality rates.¹⁰ This was a prospective study of 388,229 men and women who participated in the National Institutes of Health-American Association of Retired Persons Diet and Heart Study. Supplemental calcium intake was associated with an elevated risk of cardiovascular disease in men, but not in women. Dietary calcium intake was unrelated to cardiovascular death.

The latest study to address this issue was from the Swedish Mammography Cohort, a population-based cohort that included 61,433 women born between 1914 and 1948, with a mean follow-up of 19 years.¹¹ Diet was evaluated by food frequency questionnaires. A daily dietary intake of calcium below 600 mg was associated with higher risks of all-cause mortality, cardiovascular disease, ischemic heart disease, and stroke. However, compared with women whose daily calcium intake was between 600 and 999 mg, a dietary intake of more than 1,400 mg/day was associated with a higher death rate, with a hazard ratio for all-cause mortality of 1.40, cardiovascular disease 1.49, and ischemic heart disease 2.14.

Unfortunately, none of these studies were designed to assess the risk of cardiovascular disease related to calcium supplementation. Like the USPSTF, both the National Osteoporosis Foundation and the American Society of Bone and Mineral Research state that this type of study is needed to clarify both the benefit and risk of calcium supplementation.

Until these data are available, the American Society of Bone and Mineral Research has advised doctors and their patients “to discuss the best strategy for each individual patient, putting supplements as the last resort for healthier adults if they cannot reach recommended levels through the intake of calcium and vitamin rich foods.” For adults who cannot tolerate dairy products, calcium can be obtained from calcium-supplemented foods such as orange juice and Jello and from nondairy sources such as leafy green vegetables, almonds, garbanzo beans, tofu, and eggs.¹²

The National Osteoporosis Foundation suggests following the Institute of Medicine recommendations for adequate calcium and vitamin D rather than the USPSTF recommendations, most likely because the former are based on the overall health benefits of calcium and vitamin D rather than fracture prevention only. However, it reminds us that the Institute of Medicine recommendations do not apply to patients who are at the highest risk of fracture, ie, those with osteoporosis and vitamin D deficiency.

TAKE-HOME POINTS

• All medications, including those available over the counter, have benefits and risks.
• Even the USPSTF states that for a healthy lifestyle, the diet should contain adequate calcium and vitamin D intake.
• When following guidelines, practitioners should be certain that the guidelines pertain to the population they are treating—for example, not to apply the Institute of Medicine recommendations to a woman with a hip fracture, but that a healthy premenopausal woman who is taking calcium supplements should be advised to stop the supplements and focus on dietary sources of calcium.
• Only if individuals cannot obtain the recommended amount of calcium in their diet is it advisable for them to take a calcium supplement.

My recommendations

Based on the information summarized above, I recommend that my patients obtain as much calcium as possible from their diet—between 600 and 1,200 mg daily—and to take a calcium supplement only if they cannot obtain that amount of calcium in the diet. However, 24-hour calcium excretion is not recommended as a marker of calcium intake.

I also advise my patients to take a vitamin D supplement, per the Institute of Medicine report for overall good health. The USPSTF recommendations concerning vitamin D and calcium address only fracture prevention. As I am responsible for the overall health of my patients, not just fracture prevention, I choose to follow the National Osteoporosis Foundation and Institute of Medicine recommendations, not those of the USPSTF.

To the Editor: We recently read the article by Dr. Emmanuel Bravo.¹ In his comprehensive paper, he defined a road map for the workup of resistant hypertension. Resistant hypertension is a challenging problem in everyday practice, with multiple pitfalls at each step from diagnosis to treatment.

Although not mentioned in the paper, obstructive sleep apnea is strongly associated with hypertension, and its prevalence in patients with resistant hypertension can be as high as 83%.² The upper airway resistance syndrome is another form of sleep-disordered breathing in which transient increases in upper airway resistance result in repetitive electroencephalographic arousals. Unlike obstructive sleep apnea, upper airway resistance syndrome is not associated with apnea or diminished airflow, although snoring and excessive daytime somnolence are common. Repeated arousals, desaturations, or both during sleep lead to recurrent sympathetic surges with resultant nocturnal hypertension. There are a number of reports in the literature of large blood-pressure reductions after continuous positive airway pressure treatment.³

In conclusion, sleep-disordered breathing syndromes should be sought vigorously in cases of resistant hypertension, and every effort should be taken for proper management.

To the Editor: We recently read the article by Dr. Emmanuel Bravo.¹ In his comprehensive paper, he defined a road map for the workup of resistant hypertension. Resistant hypertension is a challenging problem in everyday practice, with multiple pitfalls at each step from diagnosis to treatment.

Although not mentioned in the paper, obstructive sleep apnea is strongly associated with hypertension, and its prevalence in patients with resistant hypertension can be as high as 83%.² The upper airway resistance syndrome is another form of sleep-disordered breathing in which transient increases in upper airway resistance result in repetitive electroencephalographic arousals. Unlike obstructive sleep apnea, upper airway resistance syndrome is not associated with apnea or diminished airflow, although snoring and excessive daytime somnolence are common. Repeated arousals, desaturations, or both during sleep lead to recurrent sympathetic surges with resultant nocturnal hypertension. There are a number of reports in the literature of large blood-pressure reductions after continuous positive airway pressure treatment.³

In conclusion, sleep-disordered breathing syndromes should be sought vigorously in cases of resistant hypertension, and every effort should be taken for proper management.

To the Editor: We recently read the article by Dr. Emmanuel Bravo.¹ In his comprehensive paper, he defined a road map for the workup of resistant hypertension. Resistant hypertension is a challenging problem in everyday practice, with multiple pitfalls at each step from diagnosis to treatment.

Although not mentioned in the paper, obstructive sleep apnea is strongly associated with hypertension, and its prevalence in patients with resistant hypertension can be as high as 83%.² The upper airway resistance syndrome is another form of sleep-disordered breathing in which transient increases in upper airway resistance result in repetitive electroencephalographic arousals. Unlike obstructive sleep apnea, upper airway resistance syndrome is not associated with apnea or diminished airflow, although snoring and excessive daytime somnolence are common. Repeated arousals, desaturations, or both during sleep lead to recurrent sympathetic surges with resultant nocturnal hypertension. There are a number of reports in the literature of large blood-pressure reductions after continuous positive airway pressure treatment.³

In conclusion, sleep-disordered breathing syndromes should be sought vigorously in cases of resistant hypertension, and every effort should be taken for proper management.

Experts have argued for decades about how best to manage opiate dependence, with practitioners generally subscribing to one of two strategies: either total abstinence or medication-assisted treatment (MAT).

Although MAT has proven efficacy, it has been slow to gain acceptance, and the gold standard of care since the 1930s has been abstinence-based treatment. Among elite institutional holdouts against MAT was the Hazelden Treatment Center, a leading treatment institution and publishing house that had been wedded to the abstinence model since it was founded in 1949.¹ Now, Hazelden has gone on record as embracing MAT, raising the possibility that the two predominant treatment philosophies for opiate-dependent patients may no longer be at odds.

FROM ABSTINENCE TO METHADONE MAINTENANCE

The modern day abstinence-based movement in this country started in the decade before the founding of Hazelden. In 1935, the US government opened the first of two federal drug treatment centers, known as the United States Narcotic Farm, in Lexington, KY.² The move by the government to get into the addiction treatment business largely stemmed from frustration over the growing problem of addiction at that time, coupled with a dearth of treatment options for addicts in the wake of the 1914 Harrison Narcotics Act.

The Narcotic Farm was an impressive facility—for all intents and purposes, a specialized prison—that initially housed 1,200 people. In addition to prisoners, it also accepted voluntary, nonprisoner patients. In many ways, it was ahead of its time. It offered a wide variety of services, including detoxification, group therapy, individual therapy, psychiatric and medical services, and vocational rehabilitation.² Housed on the premises was the Addiction Research Center at Lexington, the first intramural research branch of the National Institute of Mental Health. After the “Blue Grass” mandatory commitment laws were passed in the 1940s, even the voluntary patients were ultimately committed for a 1-year sentence at Lexington. This facility, and its sister facility in Ft. Worth, TX, would have been the envy of any modern-day abstinence-based treatment center in terms of the services offered and the long lengths of stay.

The quality of the program, as evidenced by the impressive array of services and long stays, would lead one to expect that its treatment outcomes over nearly 40 years of operation were equally stellar. However, in terms of outcomes the Farm was an abysmal failure, as shown by numerous studies demonstrating relapse rates of more than 90% in the patients discharged from it.^2,3

Similar frustrations at other abstinence-based treatment centers from the 1940s through the 1960s led Dr. Vincent Dole, the “father of methadone maintenance,” to conclude in 1971 that after detoxification from opiates, “human addicts almost always return to use of narcotics after they leave the hospital where they have been detoxified.”⁴ That realization inspired Dr. Dole and his wife and colleague Dr. Marie Nyswander to revisit the idea of medication-assisted treatment, an approach previously used by the morphine maintenance clinics of the early 1900s. This work led to the development of government-sanctioned methadone clinics across America and to the realization that long-term recovery was possible with medication, even without a lengthy hospital stay. For this revolutionary work on opiate addiction, Dr. Dole won the prestigious Lasker Award in 1988.

The major reason for the success of methadone was that, because of its pharmacokinetic profile, it could stabilize the patient through once-daily dosing without sedation or narcosis. As noted by Dr. Dole, once patients are on a stable dosing regimen, the obsessive preoccupation with drug use fades away.⁵

Despite its success, methadone maintenance had its share of detractors. It was fraught with controversy because it was viewed as a crutch, and those who were on it were often not considered by their abstinent peers as being in true recovery. The reasons for the negative attitudes toward MAT are unclear but may reflect antiquated beliefs that addiction may be indicative of a failure of morals or will, and that patients ought to be able to simply stop using.

Whatever the reason for the animosity surrounding MAT, it should be noted that an expert consensus panel convened by the Betty Ford Center in 2007 agreed that patients on MAT met their consensus definition of sobriety.⁶ The issue of what constitutes recovery remains a very complex and hotly debated topic that is beyond the scope of this paper and that has been discussed elsewhere.^6,7

For more than 3 decades, methadone was the only medication available for MAT. Federal regulations limit the dispensing of methadone to licensed clinics, most of which are located in major metropolitan areas. Patients must go to the clinic every day to receive their dose of methadone—a major inconvenience, especially to those with transportation issues. Adding to the lack of appeal of methadone maintenance is that the clinics are typically located in the higher-crime areas of cities. Savvy drug dealers know the location of these clinics and often loiter on nearby street corners in an attempt to lure addicts away from recovery by flaunting their illicit drugs.

A final, very significant drawback of methadone is its safety profile. It is a full-agonist narcotic that can be fatal in overdose or in the induction phase, especially if taken with other drugs, such as benzodiazepines.

2003: BUPRENORPHINE-NALOXONE IS APPROVED

Such concerns led researchers to search for other medications to be used for MAT that could perhaps be prescribed in a typical outpatient physician practice. For many reasons, buprenorphine became the most promising candidate. In 2003, the US Food and Drug Administration approved the combination medication buprenorphine-naloxone (Sub-oxone) as only the second drug indicated for maintenance treatment of opioid dependence in the United States.

Buprenorphine differs from methadone in that it is a partial agonist at mu opiate receptors, and therefore has a “ceiling” or “plateau” effect in terms of dose-response and a much improved safety profile. Unlike methadone, buprenorphine can be prescribed in a doctor’s office and does not have to be dispensed at a government-approved clinic.

Unfortunately, buprenorphine-maintained patients seem to carry the same stigma in the recovery community as those maintained on methadone—that they are simply substituting one drug for another. Detractors usually fail to consider that, as with methadone, patients do not report getting “high” from taking buprenorphine. Patients will often state that when they first start taking it, they “feel something,” but after a few days of adjustment, they simply feel normal. They don’t feel high, they are no longer in withdrawal, their cravings are virtually eliminated, and their opiate receptors are effectively occupied and blocked, so there is no “high” in the event of a relapse.

What’s more, buprenorphine is not a medication that will help them deal with life’s stressors by “chemical coping.” Sober coping is a skill they must learn by actively participating in a solid 12-step-based recovery program and, in some cases, in psychotherapy. By removing the drug obsession, buprenorphine promotes and facilitates the important recovery goal of learning how to deal with life on life’s terms.

ADDICTION AS CHRONIC ILLNESS

Outcomes studies of addiction treatment have focused largely on rates of relapse after discharge from acute treatments such as residential rehabilitation, partial hospitalization, and intensive outpatient programs. With MAT, however, outcomes research has primarily looked at the duration of retention in treatment.

The change in focus between the two types of treatment coincides with a paradigm shift that views addiction as a chronic condition that requires ongoing care. Continued participation in prescribed care with demonstrated efficacy is considered to be the major indicator of success. Under the chronic illness model employed by MAT providers, if a patient reverted to briefly using a drug of abuse, this would be an issue to address in his ongoing treatment and would not necessarily indicate treatment failure as with the acute care model. Beyond retention rates, research has demonstrated that MAT with methadone results in reductions in rates of criminal activity, illicit drug use, acquisition of human immunodeficiency virus, and overall mortality.^8–10

In outcomes studies, MAT has repeatedly shown better efficacy than abstinence-based approaches. During the first 5 years of its implementation, in 4,000 patients, methadone maintenance boasted 1-year retention rates exceeding 98%.¹¹ Over the subsequent 3 years, with the number of patients approaching 35,000, the 1-year retention rates fell to around 60%—still far exceeding results of abstinence-based treatment and approximating the number cited in most modern studies.¹¹

The retention rates in buprenorphine programs are similarly promising. Studies of 12 to 13 weeks duration have shown retention rates of 52% to 79%.^12–15 Six-month studies have demonstrated retention rates of 43% to 100%.^16–19 Another study showed that 38% of opiate-dependent patients remained in treatment with buprenorphine at 5 years.²⁰ Surprisingly, most of the buprenorphine studies have been conducted in office-based practices, which are less structured than outpatient methadone programs.

MEDICATION-ASSISTED TREATMENT IS GAINING ACCEPTANCE

Data from decades of experience with MAT strongly support the conclusion that it is superior to abstinence-based approaches.

The importance of a patient staying in treatment cannot be overemphasized, as the consequence of failing in recovery may well be an early death. On average, heroin addicts lose about 18 years of life expectancy, and the mortality rate for injection users is roughly 2% per year.²¹ The mortality rate for heroin users is 6 to 20 times greater than for age-matched peers who are not drug users.²²

As high as these numbers are, they are even higher for abusers of prescription narcotics. The annual death rate associated with opioid pain relievers (4.8 per 100,000) is nearly double that associated with illicit drugs (2.8 per 100,000).²³

The recent and rather radical change in treatment philosophy by Hazelden came as a shock to some, a disappointment to others, and a welcome change to many who saw this as a move by one of the more respected treatment centers in the country to fall in line with the body of evidence that supports MAT for those suffering from opiate dependence. It remains a mystery why so many, if not most, addiction treatment centers in the United States cling to the abstinence-based philosophy despite the overwhelming data from decades of research and experience that show that abstinence does not work for the majority of opiate addicts.

Complete abstinence from opiate drugs of abuse and potentially addictive medications is a noble but perhaps unreachable goal for many sufferers. Hazelden’s announced acceptance of MAT gives credence to the value of recovery goals that are not entirely drug-free.

Dr. Dole was correct in stating that opiate addicts usually return to drugs if not provided with MAT. Treatment programs need to inform opiate-dependent patients that abstinence-based treatment offers only a 1 in 10 chance of success. Perhaps some patients, armed with the daunting statistics regarding abstinence, will be inspired to devote themselves wholeheartedly to their recovery in an effort to make it into that elite 10% group that achieves long-lasting recovery without the aid of medications. But for the other 90%, it is encouraging to hear that Hazelden, the model treatment center for most abstinence-based programs in this country, may now lead other abstinence-based centers to reconsider their treatment philosophies.

Historically, US doctors were not allowed by federal law to prescribe opiates for addiction treatment. With the passage of DATA 2000, buprenorphine (alone or in combination with naloxone) can be prescribed for addiction treatment only by providers who obtain a waiver from the US Drug Enforcement Administration (DEA). Any doctor can become qualified to prescribe buprenorphine or buprenorphinenaloxone after completing an 8-hour online training course (available at www.buppractice.com and at www.aaap.org/buprenorphine) and by obtaining a DATA 2000 waiver and a new prescribing number from the DEA. Doctors are initially limited to treating only 30 patients with buprenorphine-naloxone at any given time, but can apply for an extension to 100 patients after having had their waiver for 1 year.

As MAT continues to gain favor, demand will grow for more providers to obtain their waivers to prescribe buprenorphine and buprenorphine-naloxone. Historically, there have always been too few methadone clinics to meet the demand. One can hope that the growing number of waivered providers will greatly improve access to care by opiate addicts, no matter where they reside. Qualified prescribers of buprenorphine and buprenorphine-naloxone are limited by the federal restrictions on the numbers of patients they can treat. If the chronic disease of addiction is to be integrated into the continuing-care approach of modern medicine and managed alongside other chronic diseases, primary care providers who are not specialized in treating addiction will need to be become comfortable with maintaining patients on buprenorphine-naloxone.⁷ Presumably, such patients will have already been stabilized through participation in addiction treatment programs in their respective geographic areas. Primary care providers will need to develop relationships with local addictionologists and treatment programs so that they will be able to refer those in active addiction for induction and stabilization on MAT and will be able to refer those already stabilized on MAT back to such specialists when relapses occur.

We may finally be approaching a time when structured residential treatment and MAT are not mutually exclusive options for our patients. These treatment options must work together for optimal outcomes. Based on our experience with hundreds of patients at Cleveland Clinic’s Alcohol and Drug Recovery Center, we believe this change of treatment philosophy is long overdue. In clinical settings, patients do not fit cleanly into one treatment arm or another and often require a blended approach to effect long-lasting change. Hazelden’s shift of treatment philosophy is an indication that this research-supported viewpoint is gaining acceptance in the traditionally drug-free halls of addiction treatment programs.

Experts have argued for decades about how best to manage opiate dependence, with practitioners generally subscribing to one of two strategies: either total abstinence or medication-assisted treatment (MAT).

Although MAT has proven efficacy, it has been slow to gain acceptance, and the gold standard of care since the 1930s has been abstinence-based treatment. Among elite institutional holdouts against MAT was the Hazelden Treatment Center, a leading treatment institution and publishing house that had been wedded to the abstinence model since it was founded in 1949.¹ Now, Hazelden has gone on record as embracing MAT, raising the possibility that the two predominant treatment philosophies for opiate-dependent patients may no longer be at odds.

FROM ABSTINENCE TO METHADONE MAINTENANCE

The modern day abstinence-based movement in this country started in the decade before the founding of Hazelden. In 1935, the US government opened the first of two federal drug treatment centers, known as the United States Narcotic Farm, in Lexington, KY.² The move by the government to get into the addiction treatment business largely stemmed from frustration over the growing problem of addiction at that time, coupled with a dearth of treatment options for addicts in the wake of the 1914 Harrison Narcotics Act.

The Narcotic Farm was an impressive facility—for all intents and purposes, a specialized prison—that initially housed 1,200 people. In addition to prisoners, it also accepted voluntary, nonprisoner patients. In many ways, it was ahead of its time. It offered a wide variety of services, including detoxification, group therapy, individual therapy, psychiatric and medical services, and vocational rehabilitation.² Housed on the premises was the Addiction Research Center at Lexington, the first intramural research branch of the National Institute of Mental Health. After the “Blue Grass” mandatory commitment laws were passed in the 1940s, even the voluntary patients were ultimately committed for a 1-year sentence at Lexington. This facility, and its sister facility in Ft. Worth, TX, would have been the envy of any modern-day abstinence-based treatment center in terms of the services offered and the long lengths of stay.

The quality of the program, as evidenced by the impressive array of services and long stays, would lead one to expect that its treatment outcomes over nearly 40 years of operation were equally stellar. However, in terms of outcomes the Farm was an abysmal failure, as shown by numerous studies demonstrating relapse rates of more than 90% in the patients discharged from it.^2,3

Similar frustrations at other abstinence-based treatment centers from the 1940s through the 1960s led Dr. Vincent Dole, the “father of methadone maintenance,” to conclude in 1971 that after detoxification from opiates, “human addicts almost always return to use of narcotics after they leave the hospital where they have been detoxified.”⁴ That realization inspired Dr. Dole and his wife and colleague Dr. Marie Nyswander to revisit the idea of medication-assisted treatment, an approach previously used by the morphine maintenance clinics of the early 1900s. This work led to the development of government-sanctioned methadone clinics across America and to the realization that long-term recovery was possible with medication, even without a lengthy hospital stay. For this revolutionary work on opiate addiction, Dr. Dole won the prestigious Lasker Award in 1988.

The major reason for the success of methadone was that, because of its pharmacokinetic profile, it could stabilize the patient through once-daily dosing without sedation or narcosis. As noted by Dr. Dole, once patients are on a stable dosing regimen, the obsessive preoccupation with drug use fades away.⁵

Despite its success, methadone maintenance had its share of detractors. It was fraught with controversy because it was viewed as a crutch, and those who were on it were often not considered by their abstinent peers as being in true recovery. The reasons for the negative attitudes toward MAT are unclear but may reflect antiquated beliefs that addiction may be indicative of a failure of morals or will, and that patients ought to be able to simply stop using.

Whatever the reason for the animosity surrounding MAT, it should be noted that an expert consensus panel convened by the Betty Ford Center in 2007 agreed that patients on MAT met their consensus definition of sobriety.⁶ The issue of what constitutes recovery remains a very complex and hotly debated topic that is beyond the scope of this paper and that has been discussed elsewhere.^6,7

For more than 3 decades, methadone was the only medication available for MAT. Federal regulations limit the dispensing of methadone to licensed clinics, most of which are located in major metropolitan areas. Patients must go to the clinic every day to receive their dose of methadone—a major inconvenience, especially to those with transportation issues. Adding to the lack of appeal of methadone maintenance is that the clinics are typically located in the higher-crime areas of cities. Savvy drug dealers know the location of these clinics and often loiter on nearby street corners in an attempt to lure addicts away from recovery by flaunting their illicit drugs.

A final, very significant drawback of methadone is its safety profile. It is a full-agonist narcotic that can be fatal in overdose or in the induction phase, especially if taken with other drugs, such as benzodiazepines.

2003: BUPRENORPHINE-NALOXONE IS APPROVED

Such concerns led researchers to search for other medications to be used for MAT that could perhaps be prescribed in a typical outpatient physician practice. For many reasons, buprenorphine became the most promising candidate. In 2003, the US Food and Drug Administration approved the combination medication buprenorphine-naloxone (Sub-oxone) as only the second drug indicated for maintenance treatment of opioid dependence in the United States.

Buprenorphine differs from methadone in that it is a partial agonist at mu opiate receptors, and therefore has a “ceiling” or “plateau” effect in terms of dose-response and a much improved safety profile. Unlike methadone, buprenorphine can be prescribed in a doctor’s office and does not have to be dispensed at a government-approved clinic.

Unfortunately, buprenorphine-maintained patients seem to carry the same stigma in the recovery community as those maintained on methadone—that they are simply substituting one drug for another. Detractors usually fail to consider that, as with methadone, patients do not report getting “high” from taking buprenorphine. Patients will often state that when they first start taking it, they “feel something,” but after a few days of adjustment, they simply feel normal. They don’t feel high, they are no longer in withdrawal, their cravings are virtually eliminated, and their opiate receptors are effectively occupied and blocked, so there is no “high” in the event of a relapse.

What’s more, buprenorphine is not a medication that will help them deal with life’s stressors by “chemical coping.” Sober coping is a skill they must learn by actively participating in a solid 12-step-based recovery program and, in some cases, in psychotherapy. By removing the drug obsession, buprenorphine promotes and facilitates the important recovery goal of learning how to deal with life on life’s terms.

ADDICTION AS CHRONIC ILLNESS

Outcomes studies of addiction treatment have focused largely on rates of relapse after discharge from acute treatments such as residential rehabilitation, partial hospitalization, and intensive outpatient programs. With MAT, however, outcomes research has primarily looked at the duration of retention in treatment.

The change in focus between the two types of treatment coincides with a paradigm shift that views addiction as a chronic condition that requires ongoing care. Continued participation in prescribed care with demonstrated efficacy is considered to be the major indicator of success. Under the chronic illness model employed by MAT providers, if a patient reverted to briefly using a drug of abuse, this would be an issue to address in his ongoing treatment and would not necessarily indicate treatment failure as with the acute care model. Beyond retention rates, research has demonstrated that MAT with methadone results in reductions in rates of criminal activity, illicit drug use, acquisition of human immunodeficiency virus, and overall mortality.^8–10

In outcomes studies, MAT has repeatedly shown better efficacy than abstinence-based approaches. During the first 5 years of its implementation, in 4,000 patients, methadone maintenance boasted 1-year retention rates exceeding 98%.¹¹ Over the subsequent 3 years, with the number of patients approaching 35,000, the 1-year retention rates fell to around 60%—still far exceeding results of abstinence-based treatment and approximating the number cited in most modern studies.¹¹

The retention rates in buprenorphine programs are similarly promising. Studies of 12 to 13 weeks duration have shown retention rates of 52% to 79%.^12–15 Six-month studies have demonstrated retention rates of 43% to 100%.^16–19 Another study showed that 38% of opiate-dependent patients remained in treatment with buprenorphine at 5 years.²⁰ Surprisingly, most of the buprenorphine studies have been conducted in office-based practices, which are less structured than outpatient methadone programs.

MEDICATION-ASSISTED TREATMENT IS GAINING ACCEPTANCE

Data from decades of experience with MAT strongly support the conclusion that it is superior to abstinence-based approaches.

The importance of a patient staying in treatment cannot be overemphasized, as the consequence of failing in recovery may well be an early death. On average, heroin addicts lose about 18 years of life expectancy, and the mortality rate for injection users is roughly 2% per year.²¹ The mortality rate for heroin users is 6 to 20 times greater than for age-matched peers who are not drug users.²²

As high as these numbers are, they are even higher for abusers of prescription narcotics. The annual death rate associated with opioid pain relievers (4.8 per 100,000) is nearly double that associated with illicit drugs (2.8 per 100,000).²³

The recent and rather radical change in treatment philosophy by Hazelden came as a shock to some, a disappointment to others, and a welcome change to many who saw this as a move by one of the more respected treatment centers in the country to fall in line with the body of evidence that supports MAT for those suffering from opiate dependence. It remains a mystery why so many, if not most, addiction treatment centers in the United States cling to the abstinence-based philosophy despite the overwhelming data from decades of research and experience that show that abstinence does not work for the majority of opiate addicts.

Complete abstinence from opiate drugs of abuse and potentially addictive medications is a noble but perhaps unreachable goal for many sufferers. Hazelden’s announced acceptance of MAT gives credence to the value of recovery goals that are not entirely drug-free.

Dr. Dole was correct in stating that opiate addicts usually return to drugs if not provided with MAT. Treatment programs need to inform opiate-dependent patients that abstinence-based treatment offers only a 1 in 10 chance of success. Perhaps some patients, armed with the daunting statistics regarding abstinence, will be inspired to devote themselves wholeheartedly to their recovery in an effort to make it into that elite 10% group that achieves long-lasting recovery without the aid of medications. But for the other 90%, it is encouraging to hear that Hazelden, the model treatment center for most abstinence-based programs in this country, may now lead other abstinence-based centers to reconsider their treatment philosophies.

Historically, US doctors were not allowed by federal law to prescribe opiates for addiction treatment. With the passage of DATA 2000, buprenorphine (alone or in combination with naloxone) can be prescribed for addiction treatment only by providers who obtain a waiver from the US Drug Enforcement Administration (DEA). Any doctor can become qualified to prescribe buprenorphine or buprenorphinenaloxone after completing an 8-hour online training course (available at www.buppractice.com and at www.aaap.org/buprenorphine) and by obtaining a DATA 2000 waiver and a new prescribing number from the DEA. Doctors are initially limited to treating only 30 patients with buprenorphine-naloxone at any given time, but can apply for an extension to 100 patients after having had their waiver for 1 year.

As MAT continues to gain favor, demand will grow for more providers to obtain their waivers to prescribe buprenorphine and buprenorphine-naloxone. Historically, there have always been too few methadone clinics to meet the demand. One can hope that the growing number of waivered providers will greatly improve access to care by opiate addicts, no matter where they reside. Qualified prescribers of buprenorphine and buprenorphine-naloxone are limited by the federal restrictions on the numbers of patients they can treat. If the chronic disease of addiction is to be integrated into the continuing-care approach of modern medicine and managed alongside other chronic diseases, primary care providers who are not specialized in treating addiction will need to be become comfortable with maintaining patients on buprenorphine-naloxone.⁷ Presumably, such patients will have already been stabilized through participation in addiction treatment programs in their respective geographic areas. Primary care providers will need to develop relationships with local addictionologists and treatment programs so that they will be able to refer those in active addiction for induction and stabilization on MAT and will be able to refer those already stabilized on MAT back to such specialists when relapses occur.

We may finally be approaching a time when structured residential treatment and MAT are not mutually exclusive options for our patients. These treatment options must work together for optimal outcomes. Based on our experience with hundreds of patients at Cleveland Clinic’s Alcohol and Drug Recovery Center, we believe this change of treatment philosophy is long overdue. In clinical settings, patients do not fit cleanly into one treatment arm or another and often require a blended approach to effect long-lasting change. Hazelden’s shift of treatment philosophy is an indication that this research-supported viewpoint is gaining acceptance in the traditionally drug-free halls of addiction treatment programs.

Experts have argued for decades about how best to manage opiate dependence, with practitioners generally subscribing to one of two strategies: either total abstinence or medication-assisted treatment (MAT).

Although MAT has proven efficacy, it has been slow to gain acceptance, and the gold standard of care since the 1930s has been abstinence-based treatment. Among elite institutional holdouts against MAT was the Hazelden Treatment Center, a leading treatment institution and publishing house that had been wedded to the abstinence model since it was founded in 1949.¹ Now, Hazelden has gone on record as embracing MAT, raising the possibility that the two predominant treatment philosophies for opiate-dependent patients may no longer be at odds.

FROM ABSTINENCE TO METHADONE MAINTENANCE

The modern day abstinence-based movement in this country started in the decade before the founding of Hazelden. In 1935, the US government opened the first of two federal drug treatment centers, known as the United States Narcotic Farm, in Lexington, KY.² The move by the government to get into the addiction treatment business largely stemmed from frustration over the growing problem of addiction at that time, coupled with a dearth of treatment options for addicts in the wake of the 1914 Harrison Narcotics Act.

The Narcotic Farm was an impressive facility—for all intents and purposes, a specialized prison—that initially housed 1,200 people. In addition to prisoners, it also accepted voluntary, nonprisoner patients. In many ways, it was ahead of its time. It offered a wide variety of services, including detoxification, group therapy, individual therapy, psychiatric and medical services, and vocational rehabilitation.² Housed on the premises was the Addiction Research Center at Lexington, the first intramural research branch of the National Institute of Mental Health. After the “Blue Grass” mandatory commitment laws were passed in the 1940s, even the voluntary patients were ultimately committed for a 1-year sentence at Lexington. This facility, and its sister facility in Ft. Worth, TX, would have been the envy of any modern-day abstinence-based treatment center in terms of the services offered and the long lengths of stay.

The quality of the program, as evidenced by the impressive array of services and long stays, would lead one to expect that its treatment outcomes over nearly 40 years of operation were equally stellar. However, in terms of outcomes the Farm was an abysmal failure, as shown by numerous studies demonstrating relapse rates of more than 90% in the patients discharged from it.^2,3

Similar frustrations at other abstinence-based treatment centers from the 1940s through the 1960s led Dr. Vincent Dole, the “father of methadone maintenance,” to conclude in 1971 that after detoxification from opiates, “human addicts almost always return to use of narcotics after they leave the hospital where they have been detoxified.”⁴ That realization inspired Dr. Dole and his wife and colleague Dr. Marie Nyswander to revisit the idea of medication-assisted treatment, an approach previously used by the morphine maintenance clinics of the early 1900s. This work led to the development of government-sanctioned methadone clinics across America and to the realization that long-term recovery was possible with medication, even without a lengthy hospital stay. For this revolutionary work on opiate addiction, Dr. Dole won the prestigious Lasker Award in 1988.

The major reason for the success of methadone was that, because of its pharmacokinetic profile, it could stabilize the patient through once-daily dosing without sedation or narcosis. As noted by Dr. Dole, once patients are on a stable dosing regimen, the obsessive preoccupation with drug use fades away.⁵

Despite its success, methadone maintenance had its share of detractors. It was fraught with controversy because it was viewed as a crutch, and those who were on it were often not considered by their abstinent peers as being in true recovery. The reasons for the negative attitudes toward MAT are unclear but may reflect antiquated beliefs that addiction may be indicative of a failure of morals or will, and that patients ought to be able to simply stop using.

Whatever the reason for the animosity surrounding MAT, it should be noted that an expert consensus panel convened by the Betty Ford Center in 2007 agreed that patients on MAT met their consensus definition of sobriety.⁶ The issue of what constitutes recovery remains a very complex and hotly debated topic that is beyond the scope of this paper and that has been discussed elsewhere.^6,7

For more than 3 decades, methadone was the only medication available for MAT. Federal regulations limit the dispensing of methadone to licensed clinics, most of which are located in major metropolitan areas. Patients must go to the clinic every day to receive their dose of methadone—a major inconvenience, especially to those with transportation issues. Adding to the lack of appeal of methadone maintenance is that the clinics are typically located in the higher-crime areas of cities. Savvy drug dealers know the location of these clinics and often loiter on nearby street corners in an attempt to lure addicts away from recovery by flaunting their illicit drugs.

A final, very significant drawback of methadone is its safety profile. It is a full-agonist narcotic that can be fatal in overdose or in the induction phase, especially if taken with other drugs, such as benzodiazepines.

2003: BUPRENORPHINE-NALOXONE IS APPROVED

Such concerns led researchers to search for other medications to be used for MAT that could perhaps be prescribed in a typical outpatient physician practice. For many reasons, buprenorphine became the most promising candidate. In 2003, the US Food and Drug Administration approved the combination medication buprenorphine-naloxone (Sub-oxone) as only the second drug indicated for maintenance treatment of opioid dependence in the United States.

Buprenorphine differs from methadone in that it is a partial agonist at mu opiate receptors, and therefore has a “ceiling” or “plateau” effect in terms of dose-response and a much improved safety profile. Unlike methadone, buprenorphine can be prescribed in a doctor’s office and does not have to be dispensed at a government-approved clinic.

Unfortunately, buprenorphine-maintained patients seem to carry the same stigma in the recovery community as those maintained on methadone—that they are simply substituting one drug for another. Detractors usually fail to consider that, as with methadone, patients do not report getting “high” from taking buprenorphine. Patients will often state that when they first start taking it, they “feel something,” but after a few days of adjustment, they simply feel normal. They don’t feel high, they are no longer in withdrawal, their cravings are virtually eliminated, and their opiate receptors are effectively occupied and blocked, so there is no “high” in the event of a relapse.

What’s more, buprenorphine is not a medication that will help them deal with life’s stressors by “chemical coping.” Sober coping is a skill they must learn by actively participating in a solid 12-step-based recovery program and, in some cases, in psychotherapy. By removing the drug obsession, buprenorphine promotes and facilitates the important recovery goal of learning how to deal with life on life’s terms.

ADDICTION AS CHRONIC ILLNESS

Outcomes studies of addiction treatment have focused largely on rates of relapse after discharge from acute treatments such as residential rehabilitation, partial hospitalization, and intensive outpatient programs. With MAT, however, outcomes research has primarily looked at the duration of retention in treatment.

The change in focus between the two types of treatment coincides with a paradigm shift that views addiction as a chronic condition that requires ongoing care. Continued participation in prescribed care with demonstrated efficacy is considered to be the major indicator of success. Under the chronic illness model employed by MAT providers, if a patient reverted to briefly using a drug of abuse, this would be an issue to address in his ongoing treatment and would not necessarily indicate treatment failure as with the acute care model. Beyond retention rates, research has demonstrated that MAT with methadone results in reductions in rates of criminal activity, illicit drug use, acquisition of human immunodeficiency virus, and overall mortality.^8–10

In outcomes studies, MAT has repeatedly shown better efficacy than abstinence-based approaches. During the first 5 years of its implementation, in 4,000 patients, methadone maintenance boasted 1-year retention rates exceeding 98%.¹¹ Over the subsequent 3 years, with the number of patients approaching 35,000, the 1-year retention rates fell to around 60%—still far exceeding results of abstinence-based treatment and approximating the number cited in most modern studies.¹¹

The retention rates in buprenorphine programs are similarly promising. Studies of 12 to 13 weeks duration have shown retention rates of 52% to 79%.^12–15 Six-month studies have demonstrated retention rates of 43% to 100%.^16–19 Another study showed that 38% of opiate-dependent patients remained in treatment with buprenorphine at 5 years.²⁰ Surprisingly, most of the buprenorphine studies have been conducted in office-based practices, which are less structured than outpatient methadone programs.

MEDICATION-ASSISTED TREATMENT IS GAINING ACCEPTANCE

Data from decades of experience with MAT strongly support the conclusion that it is superior to abstinence-based approaches.

The importance of a patient staying in treatment cannot be overemphasized, as the consequence of failing in recovery may well be an early death. On average, heroin addicts lose about 18 years of life expectancy, and the mortality rate for injection users is roughly 2% per year.²¹ The mortality rate for heroin users is 6 to 20 times greater than for age-matched peers who are not drug users.²²

As high as these numbers are, they are even higher for abusers of prescription narcotics. The annual death rate associated with opioid pain relievers (4.8 per 100,000) is nearly double that associated with illicit drugs (2.8 per 100,000).²³

The recent and rather radical change in treatment philosophy by Hazelden came as a shock to some, a disappointment to others, and a welcome change to many who saw this as a move by one of the more respected treatment centers in the country to fall in line with the body of evidence that supports MAT for those suffering from opiate dependence. It remains a mystery why so many, if not most, addiction treatment centers in the United States cling to the abstinence-based philosophy despite the overwhelming data from decades of research and experience that show that abstinence does not work for the majority of opiate addicts.

Complete abstinence from opiate drugs of abuse and potentially addictive medications is a noble but perhaps unreachable goal for many sufferers. Hazelden’s announced acceptance of MAT gives credence to the value of recovery goals that are not entirely drug-free.

Dr. Dole was correct in stating that opiate addicts usually return to drugs if not provided with MAT. Treatment programs need to inform opiate-dependent patients that abstinence-based treatment offers only a 1 in 10 chance of success. Perhaps some patients, armed with the daunting statistics regarding abstinence, will be inspired to devote themselves wholeheartedly to their recovery in an effort to make it into that elite 10% group that achieves long-lasting recovery without the aid of medications. But for the other 90%, it is encouraging to hear that Hazelden, the model treatment center for most abstinence-based programs in this country, may now lead other abstinence-based centers to reconsider their treatment philosophies.

Historically, US doctors were not allowed by federal law to prescribe opiates for addiction treatment. With the passage of DATA 2000, buprenorphine (alone or in combination with naloxone) can be prescribed for addiction treatment only by providers who obtain a waiver from the US Drug Enforcement Administration (DEA). Any doctor can become qualified to prescribe buprenorphine or buprenorphinenaloxone after completing an 8-hour online training course (available at www.buppractice.com and at www.aaap.org/buprenorphine) and by obtaining a DATA 2000 waiver and a new prescribing number from the DEA. Doctors are initially limited to treating only 30 patients with buprenorphine-naloxone at any given time, but can apply for an extension to 100 patients after having had their waiver for 1 year.

As MAT continues to gain favor, demand will grow for more providers to obtain their waivers to prescribe buprenorphine and buprenorphine-naloxone. Historically, there have always been too few methadone clinics to meet the demand. One can hope that the growing number of waivered providers will greatly improve access to care by opiate addicts, no matter where they reside. Qualified prescribers of buprenorphine and buprenorphine-naloxone are limited by the federal restrictions on the numbers of patients they can treat. If the chronic disease of addiction is to be integrated into the continuing-care approach of modern medicine and managed alongside other chronic diseases, primary care providers who are not specialized in treating addiction will need to be become comfortable with maintaining patients on buprenorphine-naloxone.⁷ Presumably, such patients will have already been stabilized through participation in addiction treatment programs in their respective geographic areas. Primary care providers will need to develop relationships with local addictionologists and treatment programs so that they will be able to refer those in active addiction for induction and stabilization on MAT and will be able to refer those already stabilized on MAT back to such specialists when relapses occur.

We may finally be approaching a time when structured residential treatment and MAT are not mutually exclusive options for our patients. These treatment options must work together for optimal outcomes. Based on our experience with hundreds of patients at Cleveland Clinic’s Alcohol and Drug Recovery Center, we believe this change of treatment philosophy is long overdue. In clinical settings, patients do not fit cleanly into one treatment arm or another and often require a blended approach to effect long-lasting change. Hazelden’s shift of treatment philosophy is an indication that this research-supported viewpoint is gaining acceptance in the traditionally drug-free halls of addiction treatment programs.

WASHINGTON – Teens and young adults are not the only ones who are distracted while driving. A survey of parents and caregivers shows they also are driving distracted – and putting their children at risk.

More than 600 parents and caregivers were surveyed while their children, aged 1-12 years, were being treated for any reason at one of two Michigan emergency rooms. They were asked how often they had engaged in any of 10 distracting behaviors – including talking on the phone, texting/surfing the Internet, using a navigation system, or reaching for the child or a toy – while driving with their child over the past month. Parents also were asked whether they had been in a motor vehicle collision.

©lisafx/iStockphoto.com

Almost 90% of drivers reported engaging in at least one technology-related distraction while driving their child in the past month. Phone calls were most commonly reported; texts were least common. The median number of distractions checked off in the survey was four, reported Dr. Michelle L. Macy at the annual meeting of the Pediatric Academic Societies.

Drivers who reported engaging in distracting behaviors were more likely to report having ever been in a crash, said Dr. Macy, clinical lecturer in the departments of emergency medicine and pediatrics at the University of Michigan and C.S. Mott Children’s Hospital, Ann Arbor.

Parents who disclosed using the phone – hand held or hands free – while driving were 2.6 times as likely to have reportedly been involved in a motor vehicle crash.

Dr. Macy reported that she had no disclosures. The research was funded by a grant from the Michigan Center for Advancing Safe Transportation throughout the Lifespan (M-CASTL). Dr. Macy also received support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

WASHINGTON – Teens and young adults are not the only ones who are distracted while driving. A survey of parents and caregivers shows they also are driving distracted – and putting their children at risk.

More than 600 parents and caregivers were surveyed while their children, aged 1-12 years, were being treated for any reason at one of two Michigan emergency rooms. They were asked how often they had engaged in any of 10 distracting behaviors – including talking on the phone, texting/surfing the Internet, using a navigation system, or reaching for the child or a toy – while driving with their child over the past month. Parents also were asked whether they had been in a motor vehicle collision.

©lisafx/iStockphoto.com

Almost 90% of drivers reported engaging in at least one technology-related distraction while driving their child in the past month. Phone calls were most commonly reported; texts were least common. The median number of distractions checked off in the survey was four, reported Dr. Michelle L. Macy at the annual meeting of the Pediatric Academic Societies.

Drivers who reported engaging in distracting behaviors were more likely to report having ever been in a crash, said Dr. Macy, clinical lecturer in the departments of emergency medicine and pediatrics at the University of Michigan and C.S. Mott Children’s Hospital, Ann Arbor.

Parents who disclosed using the phone – hand held or hands free – while driving were 2.6 times as likely to have reportedly been involved in a motor vehicle crash.

Dr. Macy reported that she had no disclosures. The research was funded by a grant from the Michigan Center for Advancing Safe Transportation throughout the Lifespan (M-CASTL). Dr. Macy also received support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

WASHINGTON – Teens and young adults are not the only ones who are distracted while driving. A survey of parents and caregivers shows they also are driving distracted – and putting their children at risk.

More than 600 parents and caregivers were surveyed while their children, aged 1-12 years, were being treated for any reason at one of two Michigan emergency rooms. They were asked how often they had engaged in any of 10 distracting behaviors – including talking on the phone, texting/surfing the Internet, using a navigation system, or reaching for the child or a toy – while driving with their child over the past month. Parents also were asked whether they had been in a motor vehicle collision.

©lisafx/iStockphoto.com

Almost 90% of drivers reported engaging in at least one technology-related distraction while driving their child in the past month. Phone calls were most commonly reported; texts were least common. The median number of distractions checked off in the survey was four, reported Dr. Michelle L. Macy at the annual meeting of the Pediatric Academic Societies.

Drivers who reported engaging in distracting behaviors were more likely to report having ever been in a crash, said Dr. Macy, clinical lecturer in the departments of emergency medicine and pediatrics at the University of Michigan and C.S. Mott Children’s Hospital, Ann Arbor.

Parents who disclosed using the phone – hand held or hands free – while driving were 2.6 times as likely to have reportedly been involved in a motor vehicle crash.

Dr. Macy reported that she had no disclosures. The research was funded by a grant from the Michigan Center for Advancing Safe Transportation throughout the Lifespan (M-CASTL). Dr. Macy also received support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Dr. Denis Fiallos Montero, who describes himself as "an old-time psychiatrist" who grew up during the Family Therapy days, wrote to me to point out "a great omission" in my recent discussion about some of the pioneers in our field ("Dr. Minuchin and the Ashtray," October 2012, p. 4).

Whom did I fail to mention? The late Dr. Murray Bowen.

Dr. Bowen was the originator of the American Family Therapy Association and served as the group’s first president, from 1978 to 1982. (See the Bowen Center website for details of his enduring legacy.)

This column is dedicated to these two gentlemen.

Individuation as a concept

The spirit of Murray Bowen sits in the corner at every family therapist’s family gathering and reminds us about triangulation! He told us clearly that one of the main tasks of individuation is finding the right level of differentiation from our parents.

Concepts of emotional fusion and emotional cutoff are helpful at this time of year, as many of us struggle with conflicted thoughts and feelings about our families of origin.

At one end of the differentiation spectrum is emotional fusion (overly close fused relationships); at the other end of the spectrum is emotional cutoff (disconnection between family members or refusal to engage with certain family members).

Bowen described emotional cutoffs as "the natural mechanisms people use to counter high anxiety or high emotional fusion that arise from unresolved issues with our family of origin" (Family Evaluation, New York: W.W. Norton and Co., 1988). He and his longtime colleague Dr. Michael E. Kerr noted that unresolved family issues get passed down through the generations, with successive generations being affected by seemingly mysterious emotional patterns and behaviors.

Common laments at this time of year are "I feel like a child when I go home," "I feel guilty when I go home," and "I want to take care of those parents of mine and make them do the right thing!" Or we think things like: "I feel angry that my parents do not understand or approve of me." Friends give advice: "Just go home for a short time. Try to avoid sensitive issues. Try to not get into things with them, and then you all will get along."

Gritting your teeth and powering through a family visit is exhausting. However, what is the alternative?

Bowen thought that to develop a healthy sense of self, you must be in good relation with your family of origin, and that all adults in the family should be in "comfortable emotional contact." A self-report scale called the Differentiation of Self Inventory (DSI) is based on Bowen’s theory, and measures emotional functioning, intimacy, and autonomy in interpersonal relationships.

Its subscales assess interpersonal (i.e., fusion and emotional cutoff) and intrapsychic dimensions of differentiation problems (i.e., emotional reactivity and difficulty taking an "I" position) (J. Counseling Psychol. 1998;45:235-46). The DSI has questions like: "I would never consider turning to any of my family members for emotional support," and "I often feel unsure when others are not around to help me make a decision."

Personal connections to theory

Bowen’s theories are helpful to me in thinking about my family of origin. I recently returned to Scotland to visit my Aunt Charlotte. My aunt is the living embodiment of an emotional cutoff.

The original family insult occurred before she was born. Her beloved brother Charlie, the first-born son, was killed in a car accident when he was a young child. Charlotte was the "replacement child," prescribed by the general practitioner to help my grandmother recover from the grief and loss of her son.

Of course, this was not a successful prescription, and the grief and sense of loss continued. However, more tragically, Aunt Charlotte’s mere presence triggered feelings of grief, anger, and guilt for her parents and sister.

Aunt Charlotte was the weakest and most sensitive member of our family. She suffered from asthma and, as an adult, was the victim of a car accident that left her cognitively impaired. (No one seemed to think it was ironic that the accident heightened the family’s anger and distaste for her, rather than provoke sympathy that she could now no longer live a productive life.)

Mentioning Aunt Charlotte’s name in our household raised everyone’s blood pressure. As a young teenager, I was acutely aware of the "unfairness" of the family’s responses to her. Although we all knew about Charlie’s death, we had little understanding of the connection between his death and how Aunt Charlotte was perceived.

I do remember the strong negative feelings in the house at holiday times, but neither my family nor I, as an adolescent, understood what was being enacted. As an adult, I have come to understand that the grief, anger, and emotional tension experienced by Charlie’s death were shifted and projected onto Aunt Charlotte.

Encouraged to seek a life of her own, she eventually moved away, to a small town, close to where her mother had been born and raised. She enjoyed volunteering at the house where Mary, Queen of Scots, had lived, a woman who herself was one of Scotland’s most tragic figures. The best way the family could function, it seemed, was to use emotional cutoff.

As an adult, I have been able to go back and talk with her and her friends, discussing the grief and trauma in the family. Understanding that an emotional cutoff was used to manage the unbearable emotional tensions in the family brings understanding and a way to think about what happened over the years. How much better if her parents and sister had been able to understand this, too!

Forerunner of the genogram

Bowen focused on helping family members develop emotional objectivity about their family relationships. Bowen would draw a family diagram, the forerunner of the genogram, and talk through the family influences on each member. His goal was to help the patient develop emotional object and a greater intellectual understanding about their family of origin. He wanted to help the patient understand the emotional tasks of differentiation.

In the case of Aunt Charlotte, therapy might not have been able to restore her to the family, but at least therapy would have given her and our family a deeper appreciation of the impact of trauma on family relationships and subsequent generations.

Healthy relationships with one’s family of origin mean having the right amount of differentiation. You know you have it when you can relate to your family members without regressing to the "child" position or the "parent" position – and when going home feels good, not fraught with angst, anger, or other strong and difficult emotions.

However, if it still doesn’t feel good because of unresolved problems, it is still possible to develop greater emotional objectivity and a deeper intellectual understanding.

Dr. Heru is with the department of psychiatry at the University of Colorado at Denver, Aurora. She has been a member of the Association of Family Psychiatrists since 2002 and currently serves as the organization’s treasurer. In addition, she is the coauthor of two books on working with families and is the author of numerous articles on this topic. 

Dr. Denis Fiallos Montero, who describes himself as "an old-time psychiatrist" who grew up during the Family Therapy days, wrote to me to point out "a great omission" in my recent discussion about some of the pioneers in our field ("Dr. Minuchin and the Ashtray," October 2012, p. 4).

Whom did I fail to mention? The late Dr. Murray Bowen.

Dr. Bowen was the originator of the American Family Therapy Association and served as the group’s first president, from 1978 to 1982. (See the Bowen Center website for details of his enduring legacy.)

This column is dedicated to these two gentlemen.

Individuation as a concept

The spirit of Murray Bowen sits in the corner at every family therapist’s family gathering and reminds us about triangulation! He told us clearly that one of the main tasks of individuation is finding the right level of differentiation from our parents.

Concepts of emotional fusion and emotional cutoff are helpful at this time of year, as many of us struggle with conflicted thoughts and feelings about our families of origin.

At one end of the differentiation spectrum is emotional fusion (overly close fused relationships); at the other end of the spectrum is emotional cutoff (disconnection between family members or refusal to engage with certain family members).

Bowen described emotional cutoffs as "the natural mechanisms people use to counter high anxiety or high emotional fusion that arise from unresolved issues with our family of origin" (Family Evaluation, New York: W.W. Norton and Co., 1988). He and his longtime colleague Dr. Michael E. Kerr noted that unresolved family issues get passed down through the generations, with successive generations being affected by seemingly mysterious emotional patterns and behaviors.

Common laments at this time of year are "I feel like a child when I go home," "I feel guilty when I go home," and "I want to take care of those parents of mine and make them do the right thing!" Or we think things like: "I feel angry that my parents do not understand or approve of me." Friends give advice: "Just go home for a short time. Try to avoid sensitive issues. Try to not get into things with them, and then you all will get along."

Gritting your teeth and powering through a family visit is exhausting. However, what is the alternative?

Bowen thought that to develop a healthy sense of self, you must be in good relation with your family of origin, and that all adults in the family should be in "comfortable emotional contact." A self-report scale called the Differentiation of Self Inventory (DSI) is based on Bowen’s theory, and measures emotional functioning, intimacy, and autonomy in interpersonal relationships.

Its subscales assess interpersonal (i.e., fusion and emotional cutoff) and intrapsychic dimensions of differentiation problems (i.e., emotional reactivity and difficulty taking an "I" position) (J. Counseling Psychol. 1998;45:235-46). The DSI has questions like: "I would never consider turning to any of my family members for emotional support," and "I often feel unsure when others are not around to help me make a decision."

Personal connections to theory

Bowen’s theories are helpful to me in thinking about my family of origin. I recently returned to Scotland to visit my Aunt Charlotte. My aunt is the living embodiment of an emotional cutoff.

The original family insult occurred before she was born. Her beloved brother Charlie, the first-born son, was killed in a car accident when he was a young child. Charlotte was the "replacement child," prescribed by the general practitioner to help my grandmother recover from the grief and loss of her son.

Of course, this was not a successful prescription, and the grief and sense of loss continued. However, more tragically, Aunt Charlotte’s mere presence triggered feelings of grief, anger, and guilt for her parents and sister.

Aunt Charlotte was the weakest and most sensitive member of our family. She suffered from asthma and, as an adult, was the victim of a car accident that left her cognitively impaired. (No one seemed to think it was ironic that the accident heightened the family’s anger and distaste for her, rather than provoke sympathy that she could now no longer live a productive life.)

Mentioning Aunt Charlotte’s name in our household raised everyone’s blood pressure. As a young teenager, I was acutely aware of the "unfairness" of the family’s responses to her. Although we all knew about Charlie’s death, we had little understanding of the connection between his death and how Aunt Charlotte was perceived.

I do remember the strong negative feelings in the house at holiday times, but neither my family nor I, as an adolescent, understood what was being enacted. As an adult, I have come to understand that the grief, anger, and emotional tension experienced by Charlie’s death were shifted and projected onto Aunt Charlotte.

Encouraged to seek a life of her own, she eventually moved away, to a small town, close to where her mother had been born and raised. She enjoyed volunteering at the house where Mary, Queen of Scots, had lived, a woman who herself was one of Scotland’s most tragic figures. The best way the family could function, it seemed, was to use emotional cutoff.

As an adult, I have been able to go back and talk with her and her friends, discussing the grief and trauma in the family. Understanding that an emotional cutoff was used to manage the unbearable emotional tensions in the family brings understanding and a way to think about what happened over the years. How much better if her parents and sister had been able to understand this, too!

Forerunner of the genogram

Bowen focused on helping family members develop emotional objectivity about their family relationships. Bowen would draw a family diagram, the forerunner of the genogram, and talk through the family influences on each member. His goal was to help the patient develop emotional object and a greater intellectual understanding about their family of origin. He wanted to help the patient understand the emotional tasks of differentiation.

In the case of Aunt Charlotte, therapy might not have been able to restore her to the family, but at least therapy would have given her and our family a deeper appreciation of the impact of trauma on family relationships and subsequent generations.

Healthy relationships with one’s family of origin mean having the right amount of differentiation. You know you have it when you can relate to your family members without regressing to the "child" position or the "parent" position – and when going home feels good, not fraught with angst, anger, or other strong and difficult emotions.

However, if it still doesn’t feel good because of unresolved problems, it is still possible to develop greater emotional objectivity and a deeper intellectual understanding.

Dr. Heru is with the department of psychiatry at the University of Colorado at Denver, Aurora. She has been a member of the Association of Family Psychiatrists since 2002 and currently serves as the organization’s treasurer. In addition, she is the coauthor of two books on working with families and is the author of numerous articles on this topic. 

Dr. Denis Fiallos Montero, who describes himself as "an old-time psychiatrist" who grew up during the Family Therapy days, wrote to me to point out "a great omission" in my recent discussion about some of the pioneers in our field ("Dr. Minuchin and the Ashtray," October 2012, p. 4).

Whom did I fail to mention? The late Dr. Murray Bowen.

Dr. Bowen was the originator of the American Family Therapy Association and served as the group’s first president, from 1978 to 1982. (See the Bowen Center website for details of his enduring legacy.)

This column is dedicated to these two gentlemen.

Individuation as a concept

The spirit of Murray Bowen sits in the corner at every family therapist’s family gathering and reminds us about triangulation! He told us clearly that one of the main tasks of individuation is finding the right level of differentiation from our parents.

Concepts of emotional fusion and emotional cutoff are helpful at this time of year, as many of us struggle with conflicted thoughts and feelings about our families of origin.

At one end of the differentiation spectrum is emotional fusion (overly close fused relationships); at the other end of the spectrum is emotional cutoff (disconnection between family members or refusal to engage with certain family members).

Bowen described emotional cutoffs as "the natural mechanisms people use to counter high anxiety or high emotional fusion that arise from unresolved issues with our family of origin" (Family Evaluation, New York: W.W. Norton and Co., 1988). He and his longtime colleague Dr. Michael E. Kerr noted that unresolved family issues get passed down through the generations, with successive generations being affected by seemingly mysterious emotional patterns and behaviors.

Common laments at this time of year are "I feel like a child when I go home," "I feel guilty when I go home," and "I want to take care of those parents of mine and make them do the right thing!" Or we think things like: "I feel angry that my parents do not understand or approve of me." Friends give advice: "Just go home for a short time. Try to avoid sensitive issues. Try to not get into things with them, and then you all will get along."

Gritting your teeth and powering through a family visit is exhausting. However, what is the alternative?

Bowen thought that to develop a healthy sense of self, you must be in good relation with your family of origin, and that all adults in the family should be in "comfortable emotional contact." A self-report scale called the Differentiation of Self Inventory (DSI) is based on Bowen’s theory, and measures emotional functioning, intimacy, and autonomy in interpersonal relationships.

Its subscales assess interpersonal (i.e., fusion and emotional cutoff) and intrapsychic dimensions of differentiation problems (i.e., emotional reactivity and difficulty taking an "I" position) (J. Counseling Psychol. 1998;45:235-46). The DSI has questions like: "I would never consider turning to any of my family members for emotional support," and "I often feel unsure when others are not around to help me make a decision."

Personal connections to theory

Bowen’s theories are helpful to me in thinking about my family of origin. I recently returned to Scotland to visit my Aunt Charlotte. My aunt is the living embodiment of an emotional cutoff.

The original family insult occurred before she was born. Her beloved brother Charlie, the first-born son, was killed in a car accident when he was a young child. Charlotte was the "replacement child," prescribed by the general practitioner to help my grandmother recover from the grief and loss of her son.

Of course, this was not a successful prescription, and the grief and sense of loss continued. However, more tragically, Aunt Charlotte’s mere presence triggered feelings of grief, anger, and guilt for her parents and sister.

Aunt Charlotte was the weakest and most sensitive member of our family. She suffered from asthma and, as an adult, was the victim of a car accident that left her cognitively impaired. (No one seemed to think it was ironic that the accident heightened the family’s anger and distaste for her, rather than provoke sympathy that she could now no longer live a productive life.)

Mentioning Aunt Charlotte’s name in our household raised everyone’s blood pressure. As a young teenager, I was acutely aware of the "unfairness" of the family’s responses to her. Although we all knew about Charlie’s death, we had little understanding of the connection between his death and how Aunt Charlotte was perceived.

I do remember the strong negative feelings in the house at holiday times, but neither my family nor I, as an adolescent, understood what was being enacted. As an adult, I have come to understand that the grief, anger, and emotional tension experienced by Charlie’s death were shifted and projected onto Aunt Charlotte.

Encouraged to seek a life of her own, she eventually moved away, to a small town, close to where her mother had been born and raised. She enjoyed volunteering at the house where Mary, Queen of Scots, had lived, a woman who herself was one of Scotland’s most tragic figures. The best way the family could function, it seemed, was to use emotional cutoff.

As an adult, I have been able to go back and talk with her and her friends, discussing the grief and trauma in the family. Understanding that an emotional cutoff was used to manage the unbearable emotional tensions in the family brings understanding and a way to think about what happened over the years. How much better if her parents and sister had been able to understand this, too!

Forerunner of the genogram

Bowen focused on helping family members develop emotional objectivity about their family relationships. Bowen would draw a family diagram, the forerunner of the genogram, and talk through the family influences on each member. His goal was to help the patient develop emotional object and a greater intellectual understanding about their family of origin. He wanted to help the patient understand the emotional tasks of differentiation.

In the case of Aunt Charlotte, therapy might not have been able to restore her to the family, but at least therapy would have given her and our family a deeper appreciation of the impact of trauma on family relationships and subsequent generations.

Healthy relationships with one’s family of origin mean having the right amount of differentiation. You know you have it when you can relate to your family members without regressing to the "child" position or the "parent" position – and when going home feels good, not fraught with angst, anger, or other strong and difficult emotions.

However, if it still doesn’t feel good because of unresolved problems, it is still possible to develop greater emotional objectivity and a deeper intellectual understanding.

Dr. Heru is with the department of psychiatry at the University of Colorado at Denver, Aurora. She has been a member of the Association of Family Psychiatrists since 2002 and currently serves as the organization’s treasurer. In addition, she is the coauthor of two books on working with families and is the author of numerous articles on this topic. 

Magnesium sulfate should not be used for more than 5-7 days in pregnant women in preterm labor, because in utero exposure may lead to hypocalcemia and an increased risk of osteopenia and bone fractures in newborns, the Food and Drug Administration announced May 30.

"The shortest duration of treatment that can result in harm to the baby is not known," the FDA stated.

The warning is based on epidemiologic studies that were mostly retrospective chart reviews, as well as 18 cases of newborns with skeletal anomalies whose mothers had been treated with magnesium sulfate for tocolysis. The cases had been reported to the FDA’s Adverse Event Reporting System (AERS) and were in the medical literature.

In these cases, exposure ranged from 8-12 weeks (average was almost 10 weeks), for an estimated average total maternal dose of 3,700 grams.

The newborns developed osteopenia-related skeletal anomalies, and some had multiple fractures of the ribs and long bones. The osteopenia and fractures were transient and had resolved in cases where the outcome was reported, according to the FDA.

Based on cases in the literature, "it is plausible that bone abnormalities in neonates are associated with prolonged in utero exposure to magnesium sulfate," since hypermagnesemia can cause hypocalcemia in the developing fetus, the FDA concluded.

Dr. Jeffrey Ecker, a high-risk obstetrician at Massachusetts General Hospital (MGH), Boston, said that this warning should not have an impact on practice because the length of exposure and maternal dose of magnesium sulfate cited in the FDA's statement are not recommended. The warning refers to cases of adverse outcomes in which magnesium sulfate was used for weeks at a time, which he said "would be unusual."

Magnesium sulfate is currently used to reduce the risk of cerebral palsy when premature delivery is anticipated, particularly at less than 32 weeks, and to reduce the risk of seizures in women with preeclampsia, two indications where there is good evidence that the use of magnesium sulfate improves outcomes, he noted in an interview.

There is much less evidence that it improves outcomes for the third use, as tocolysis, to delay delivery for 48 hours to allow for administration of steroids in women in preterm labor, said Dr. Ecker, also director of the maternal Fetal Medicine Fellowship at MGH and vice-chair of the American College of Obstetricians and Gynecologists' committee on obstetric practice. "But all three of those uses focus on very short term periods of exposure," he emphasized.*

The FDA is switching magnesium sulfate from a pregnancy category A (drugs for which adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester, and no evidence of risk in later trimesters) to pregnancy category D (drugs for which there is evidence of human fetal risks, but also potential benefits in pregnant women that may be acceptable in certain situations, despite the risks).

In addition to the new pregnancy category, the label for magnesium sulfate injection USP 50% will also have a new warning about these risks when administered for more than 5-7 days. There will be a new "labor and delivery" section pointing out that magnesium sulfate is not approved for treatment of preterm labor, the safety and efficacy of use for this indication "are not established," and "when used in pregnant women for conditions other than its approved indication, magnesium sulfate injection should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities."

Magnesium sulfate is FDA approved to prevent seizures in preeclampsia.

Serious adverse events associated with this drug should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

emechcatie@frontlinemedcom.com

* Updated 6/5/2013

Magnesium sulfate should not be used for more than 5-7 days in pregnant women in preterm labor, because in utero exposure may lead to hypocalcemia and an increased risk of osteopenia and bone fractures in newborns, the Food and Drug Administration announced May 30.

"The shortest duration of treatment that can result in harm to the baby is not known," the FDA stated.

The warning is based on epidemiologic studies that were mostly retrospective chart reviews, as well as 18 cases of newborns with skeletal anomalies whose mothers had been treated with magnesium sulfate for tocolysis. The cases had been reported to the FDA’s Adverse Event Reporting System (AERS) and were in the medical literature.

In these cases, exposure ranged from 8-12 weeks (average was almost 10 weeks), for an estimated average total maternal dose of 3,700 grams.

The newborns developed osteopenia-related skeletal anomalies, and some had multiple fractures of the ribs and long bones. The osteopenia and fractures were transient and had resolved in cases where the outcome was reported, according to the FDA.

Based on cases in the literature, "it is plausible that bone abnormalities in neonates are associated with prolonged in utero exposure to magnesium sulfate," since hypermagnesemia can cause hypocalcemia in the developing fetus, the FDA concluded.

Dr. Jeffrey Ecker, a high-risk obstetrician at Massachusetts General Hospital (MGH), Boston, said that this warning should not have an impact on practice because the length of exposure and maternal dose of magnesium sulfate cited in the FDA's statement are not recommended. The warning refers to cases of adverse outcomes in which magnesium sulfate was used for weeks at a time, which he said "would be unusual."

Magnesium sulfate is currently used to reduce the risk of cerebral palsy when premature delivery is anticipated, particularly at less than 32 weeks, and to reduce the risk of seizures in women with preeclampsia, two indications where there is good evidence that the use of magnesium sulfate improves outcomes, he noted in an interview.

There is much less evidence that it improves outcomes for the third use, as tocolysis, to delay delivery for 48 hours to allow for administration of steroids in women in preterm labor, said Dr. Ecker, also director of the maternal Fetal Medicine Fellowship at MGH and vice-chair of the American College of Obstetricians and Gynecologists' committee on obstetric practice. "But all three of those uses focus on very short term periods of exposure," he emphasized.*

The FDA is switching magnesium sulfate from a pregnancy category A (drugs for which adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester, and no evidence of risk in later trimesters) to pregnancy category D (drugs for which there is evidence of human fetal risks, but also potential benefits in pregnant women that may be acceptable in certain situations, despite the risks).

In addition to the new pregnancy category, the label for magnesium sulfate injection USP 50% will also have a new warning about these risks when administered for more than 5-7 days. There will be a new "labor and delivery" section pointing out that magnesium sulfate is not approved for treatment of preterm labor, the safety and efficacy of use for this indication "are not established," and "when used in pregnant women for conditions other than its approved indication, magnesium sulfate injection should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities."

Magnesium sulfate is FDA approved to prevent seizures in preeclampsia.

Serious adverse events associated with this drug should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

emechcatie@frontlinemedcom.com

* Updated 6/5/2013

Magnesium sulfate should not be used for more than 5-7 days in pregnant women in preterm labor, because in utero exposure may lead to hypocalcemia and an increased risk of osteopenia and bone fractures in newborns, the Food and Drug Administration announced May 30.

"The shortest duration of treatment that can result in harm to the baby is not known," the FDA stated.

The warning is based on epidemiologic studies that were mostly retrospective chart reviews, as well as 18 cases of newborns with skeletal anomalies whose mothers had been treated with magnesium sulfate for tocolysis. The cases had been reported to the FDA’s Adverse Event Reporting System (AERS) and were in the medical literature.

In these cases, exposure ranged from 8-12 weeks (average was almost 10 weeks), for an estimated average total maternal dose of 3,700 grams.

The newborns developed osteopenia-related skeletal anomalies, and some had multiple fractures of the ribs and long bones. The osteopenia and fractures were transient and had resolved in cases where the outcome was reported, according to the FDA.

Based on cases in the literature, "it is plausible that bone abnormalities in neonates are associated with prolonged in utero exposure to magnesium sulfate," since hypermagnesemia can cause hypocalcemia in the developing fetus, the FDA concluded.

Dr. Jeffrey Ecker, a high-risk obstetrician at Massachusetts General Hospital (MGH), Boston, said that this warning should not have an impact on practice because the length of exposure and maternal dose of magnesium sulfate cited in the FDA's statement are not recommended. The warning refers to cases of adverse outcomes in which magnesium sulfate was used for weeks at a time, which he said "would be unusual."

Magnesium sulfate is currently used to reduce the risk of cerebral palsy when premature delivery is anticipated, particularly at less than 32 weeks, and to reduce the risk of seizures in women with preeclampsia, two indications where there is good evidence that the use of magnesium sulfate improves outcomes, he noted in an interview.

There is much less evidence that it improves outcomes for the third use, as tocolysis, to delay delivery for 48 hours to allow for administration of steroids in women in preterm labor, said Dr. Ecker, also director of the maternal Fetal Medicine Fellowship at MGH and vice-chair of the American College of Obstetricians and Gynecologists' committee on obstetric practice. "But all three of those uses focus on very short term periods of exposure," he emphasized.*

The FDA is switching magnesium sulfate from a pregnancy category A (drugs for which adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester, and no evidence of risk in later trimesters) to pregnancy category D (drugs for which there is evidence of human fetal risks, but also potential benefits in pregnant women that may be acceptable in certain situations, despite the risks).

In addition to the new pregnancy category, the label for magnesium sulfate injection USP 50% will also have a new warning about these risks when administered for more than 5-7 days. There will be a new "labor and delivery" section pointing out that magnesium sulfate is not approved for treatment of preterm labor, the safety and efficacy of use for this indication "are not established," and "when used in pregnant women for conditions other than its approved indication, magnesium sulfate injection should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities."

Magnesium sulfate is FDA approved to prevent seizures in preeclampsia.

Serious adverse events associated with this drug should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

emechcatie@frontlinemedcom.com

* Updated 6/5/2013

WASHINGTON – Despite having knowledge of the symptoms and dangers of concussions, high school athletes are largely unwilling to report symptoms and abstain from play, according to a study of Cincinnati-area high school football players.

The vast majority of the athletes (91%) who responded to one of two surveys used in the study agreed with the statement, for instance, that it is "always or sometimes okay to play in a game with a concussion," reported Dr. Brit L. Anderson, a pediatric emergency fellow at Cincinnati Children’s Hospital Medical Center.

"High school football players are being successfully educated about concussions, from many important sources in their lives," Dr. Anderson reported at the annual meeting of the Pediatric Academic Societies. "Unfortunately, student knowledge does not translate into [safe] attitudes."

Of the 120 high school football players who participated in the study, 25% said they had suffered a concussion, and 70% said they had been taught about concussions. Most could identify the common signs and symptoms: Headache was identified by 93%, dizziness by 89%, difficulty remembering and sensitivity to light and sound by 78%, and difficulty concentrating by 76%. Only 53% correctly identified "feeling in a fog" as a symptom.

Almost all the athletes agreed that loss of consciousness is not a requirement for diagnosis of concussion (93%), and that one is at risk of serious injury or death if a second concussion occurs before the first is healed (92%). Many of the students (77%) also knew that an athlete who has had one concussion is more likely to sustain another.

Despite this knowledge, only 54% said they would always or sometimes report concussion symptoms to their coach, 53% said they would continue to play with a headache sustained in play, and 22% responded that "an athlete with a concussion has a responsibility to play in an important game," Dr. Anderson reported.

Dr. Anderson and her colleagues administered one of two similar validated surveys to the athletes to measure their knowledge and their attitudes about reporting symptoms and returning to play; most of the responses were pooled. The surveys were conducted on the first day of a football camp that drew athletes – largely upper-classmen – from local competitive high school football programs.

A mean knowledge and attitude score for each survey was calculated, and athletes with scores above and below the means were compared. There was no significant association between the mean knowledge score and the mean attitude score, nor between the mean attitude score and a history of previous concussion or recent concussion education.

There was a significant association, however, between the mean knowledge score and grade level, with the 9th graders (who comprised just 9% of the survey participants) having significantly lower scores than did the 10th, 11th, and 12th-graders, Dr. Anderson noted.

Notably, in response to one of the surveys, 91% indicated they would play a game with a concussion and 75% said they would "play through any injury in order for their team to win," she said.

Students were asked in the study to list who taught them about concussions; responses were equally divided between families, teachers, coaches, high school athletic trainers, and physicians, she noted.

Dr. Anderson reported that she had no relevant disclosures.

WASHINGTON – Despite having knowledge of the symptoms and dangers of concussions, high school athletes are largely unwilling to report symptoms and abstain from play, according to a study of Cincinnati-area high school football players.

The vast majority of the athletes (91%) who responded to one of two surveys used in the study agreed with the statement, for instance, that it is "always or sometimes okay to play in a game with a concussion," reported Dr. Brit L. Anderson, a pediatric emergency fellow at Cincinnati Children’s Hospital Medical Center.

"High school football players are being successfully educated about concussions, from many important sources in their lives," Dr. Anderson reported at the annual meeting of the Pediatric Academic Societies. "Unfortunately, student knowledge does not translate into [safe] attitudes."

Of the 120 high school football players who participated in the study, 25% said they had suffered a concussion, and 70% said they had been taught about concussions. Most could identify the common signs and symptoms: Headache was identified by 93%, dizziness by 89%, difficulty remembering and sensitivity to light and sound by 78%, and difficulty concentrating by 76%. Only 53% correctly identified "feeling in a fog" as a symptom.

Almost all the athletes agreed that loss of consciousness is not a requirement for diagnosis of concussion (93%), and that one is at risk of serious injury or death if a second concussion occurs before the first is healed (92%). Many of the students (77%) also knew that an athlete who has had one concussion is more likely to sustain another.

Despite this knowledge, only 54% said they would always or sometimes report concussion symptoms to their coach, 53% said they would continue to play with a headache sustained in play, and 22% responded that "an athlete with a concussion has a responsibility to play in an important game," Dr. Anderson reported.

Dr. Anderson and her colleagues administered one of two similar validated surveys to the athletes to measure their knowledge and their attitudes about reporting symptoms and returning to play; most of the responses were pooled. The surveys were conducted on the first day of a football camp that drew athletes – largely upper-classmen – from local competitive high school football programs.

A mean knowledge and attitude score for each survey was calculated, and athletes with scores above and below the means were compared. There was no significant association between the mean knowledge score and the mean attitude score, nor between the mean attitude score and a history of previous concussion or recent concussion education.

There was a significant association, however, between the mean knowledge score and grade level, with the 9th graders (who comprised just 9% of the survey participants) having significantly lower scores than did the 10th, 11th, and 12th-graders, Dr. Anderson noted.

Notably, in response to one of the surveys, 91% indicated they would play a game with a concussion and 75% said they would "play through any injury in order for their team to win," she said.

Students were asked in the study to list who taught them about concussions; responses were equally divided between families, teachers, coaches, high school athletic trainers, and physicians, she noted.

Dr. Anderson reported that she had no relevant disclosures.

WASHINGTON – Despite having knowledge of the symptoms and dangers of concussions, high school athletes are largely unwilling to report symptoms and abstain from play, according to a study of Cincinnati-area high school football players.

The vast majority of the athletes (91%) who responded to one of two surveys used in the study agreed with the statement, for instance, that it is "always or sometimes okay to play in a game with a concussion," reported Dr. Brit L. Anderson, a pediatric emergency fellow at Cincinnati Children’s Hospital Medical Center.

"High school football players are being successfully educated about concussions, from many important sources in their lives," Dr. Anderson reported at the annual meeting of the Pediatric Academic Societies. "Unfortunately, student knowledge does not translate into [safe] attitudes."

Of the 120 high school football players who participated in the study, 25% said they had suffered a concussion, and 70% said they had been taught about concussions. Most could identify the common signs and symptoms: Headache was identified by 93%, dizziness by 89%, difficulty remembering and sensitivity to light and sound by 78%, and difficulty concentrating by 76%. Only 53% correctly identified "feeling in a fog" as a symptom.

Almost all the athletes agreed that loss of consciousness is not a requirement for diagnosis of concussion (93%), and that one is at risk of serious injury or death if a second concussion occurs before the first is healed (92%). Many of the students (77%) also knew that an athlete who has had one concussion is more likely to sustain another.

Despite this knowledge, only 54% said they would always or sometimes report concussion symptoms to their coach, 53% said they would continue to play with a headache sustained in play, and 22% responded that "an athlete with a concussion has a responsibility to play in an important game," Dr. Anderson reported.

Dr. Anderson and her colleagues administered one of two similar validated surveys to the athletes to measure their knowledge and their attitudes about reporting symptoms and returning to play; most of the responses were pooled. The surveys were conducted on the first day of a football camp that drew athletes – largely upper-classmen – from local competitive high school football programs.

A mean knowledge and attitude score for each survey was calculated, and athletes with scores above and below the means were compared. There was no significant association between the mean knowledge score and the mean attitude score, nor between the mean attitude score and a history of previous concussion or recent concussion education.

There was a significant association, however, between the mean knowledge score and grade level, with the 9th graders (who comprised just 9% of the survey participants) having significantly lower scores than did the 10th, 11th, and 12th-graders, Dr. Anderson noted.

Notably, in response to one of the surveys, 91% indicated they would play a game with a concussion and 75% said they would "play through any injury in order for their team to win," she said.

Students were asked in the study to list who taught them about concussions; responses were equally divided between families, teachers, coaches, high school athletic trainers, and physicians, she noted.

Dr. Anderson reported that she had no relevant disclosures.

BREB, ROMANIA – While strolling through this village in the Maramures region in the northwest corner of Romania, I ask Ileana, "How many live in this village?" Ileana has just come home from high school in the nearest town and is wearing brightly colored sneakers, blue jeans, and a pink sweatshirt with the word "LOVE" emblazed in sparkles across her chest. She is touring us proudly around her village.

"400."

"400 people?"

"No, 400 families."

"How many in each family?"

"About six or seven."

On the large ornate wooden gate to the family homestead is the inscription: "Familie Hermann." All seven members of the Hermann family live in a three-room traditional wooden house. The house has a large porch, where the family eats, works, and sometimes sleeps in the warm weather.

Courtesy David Naylor

Maria, the 82-year-old grandmother, sits outside the gate on a small bench and watches the villagers stroll home from the fields with scythes and rakes on their shoulders. She welcomes her daughter and son-in-law back home. It is spring, and the villagers are cleaning the fields in preparation for the summer grass growing. In the fall, they will harvest the grass to feed their animals throughout the winter.

On the porch, in the quiet of a late afternoon, as 9-year-old Ioanna is doing her homework, her mother, Raluca, works on the intricacies of beading the border of Ioanna’s traditional costume to be worn on Easter Sunday. Ioanna watches her mother pin the black velvet jacket to her skirt and load the needle with the gold beads to make the stems for the purple and red flowers. She sees how to turn the green rows into leaves. She shows her mother her school work, as equally neat and carefully calligraphied as her mother’s beading. Concern for accuracy and aesthetics are the skills and values passed down through the generations.

Maria comes in from the gate and resumes shelling beans on the front porch. She doesn’t do as much work in the fields anymore. Instead, she sweeps the house, tends to the flower garden, and helps with the two children. Maria takes the clothes down from the clothesline that stretches across the front of the porch. These handmade, intricately stitched works of art have been washed in preparation for Easter.

Maria shows us the gown she will wear at her funeral. She wove the linen, and smocked the neck and wrists with traditional village colors. She is proud of her work, and we admire it. She takes her gown inside, along with all the other freshly laundered white blouses that men and women will wear during the traditional events throughout the year.

After Easter, when the weather warms, most of the village will make the pilgrimage up the mountain accompanying the shepherds taking the sheep to summer grazing. The milking of the sheep is a defining village event, and precise measures are recorded in a book or on a stick to indicate each person’s anticipated portion of future milkings. This is Stina, a serious celebration, and the villagers wear traditional dress for the feasting, drinking, and dancing.

Life in rural villages is physically hard, and family and communal living are not idyllic. There is no privacy in the village, perhaps no secrets.

There is no privileging of the individual over the family. The family functions as a unit, getting work done by the seasons, so the family can eat throughout the year. The sense of belonging is irrefutable.

There is room for individual pride, however, and this is expressed as skill in raking a straight row, making the best plum brandy, wood carving, and doing embroidery. Everyone has an opinion on which family is the best at their craft in the village. The Hermann family is recognized for their skill in textiles – particularly their embroidery.

The village has its characters: the most devout, the "bad boy," the lazy person, and the man who can’t hold his liquor. This man, the village drunk, frequently makes a trip to the psychiatric hospital in the town of Sighetu Marmatieti, when he gets out of hand. After a few weeks, he comes home quieter, and his good behavior will last for the best part of a year. There is no physician or nurse in the village, only a veterinarian who visits, when called, to care for the animals.

The darker stories of the village lie hidden, because for now, it is early spring, and the village flows with optimism, celebration, and courtship. The white, hand-crafted blouses manifest the feelings of anticipation as they billow and dance on each clothesline throughout the village. Belonging to the village means feeling the seasons unfold intuitively. These feelings sustain and nourish the village families throughout their lives.

Outside of the village, in the "real world," we try to create a sense of belonging. As a country of immigrants, we in America have sense of belonging that is scattered. Still, connecting with our past is too often beyond our grasp. What is belonging? What are its components?

Ways to think about belonging

Studies on belonging extend across many disciplines: psychoanalysis, attachment psychology, social and cultural studies to philosophy. How does a family psychiatrist think about belonging? What aspects of belonging can be incorporated into psychiatric care?

An unmet need for belonging leads to loneliness and lower life satisfaction. This finding came from a study of 436 participants from the Australian Unity Wellbeing database who completed several measurements, including the Need to Belong Scale according to David Mellor, Ph.D., and his colleagues(Pers. Individ. Dif. 2008;45:213-8). Dr. Vincenzo Di Nicola, a psychiatrist who has written extensively about family relationships, also has offered valuable perspective on belongingness: "Belonging is a way of rethinking relational being, how we define mental health, how we understand the expression of its vicissitudes, and how we organize care and healing for sufferers. To do this, we need to recognize how belonging is experienced and negotiated, free of the constraints of our habitual patterns of practice and thought, to imagine belonging without borders for settlers, sojourners, and travelers in the 21st century."

Belongingness traditionally has been seen as a core of family life. If your values are different from those of your family, if you have moved from the village to the city and don’t want to be a farmer, what values do you uphold? Do you now have a new set of people and values? Do you belong to a group/club/school? Belonging to a guild or religious order means that the guild or order becomes your new family. However, belongingness is more transient and a less substantial part of life, as people change jobs and careers, get divorced and remarried, move to other countries.

Who serves as the family for people with psychiatric illness? In a recent study, people with serious mental illness were interviewed and asked about the "communities" to which they belonged (Psychiatr. Serv. [doi: 10.1176/appi.ps.201200235]). The researchers found four "patterns of experience" that made up communities for the respondents. Communities were places where people with mental illness could receive help, especially in times of vulnerability.

In addition, communities were places to manage risk and minimize the anxiety felt in public setting by people with mental illness. The stigma experienced in the general community or even within their families led many respondents to identify more strongly with peers who had mental illness.

Communities also were seen as places where those with serious mental illness could "give back" and help others. So perhaps, in the same way as these respondents defined belongingness for themselves, we can define belongingness for all our patients.

Several components must be satisfied for a person to have a sense of belongingness.

• A community in which the person’s beliefs and values are upheld as sacred (meaningfulness).

• Rituals that bring people together and support the meaningfulness of their lives (meaningfulness).

• People who provide emotional and practical support for others (attachment).

• People who allow others to provide them with support (sense of self-efficacy).

• Generational transmission of skills, crafts, values, and beliefs (generativity).

A sense of place is another component that has been associated with a sense of belonging. After the Boston Marathon bombings, some people affirmed that their sense of belonging was consolidated by that event. For others, a sense of belonging becomes fixed in their sense of tragedy as a victim of an event. We see many patients with posttraumatic stress disorder who have been bound by the traumatizing event(s), and who find it difficult or impossible to move beyond that experience.

For Americans, perhaps the notion of "family values" can be parsed to include the idea and study of belongingness. Understanding what belongingness encompasses can help us discuss relational being with our patients. Where do you find that sense of belonging? For Ioanna, her sense of belonging is felt in the seasonal ebb and flow of village life. Her sense of belonging shows in her skill as she works with her crafts with her hands. Breb belongs to her, even as it opens its large wooden doors to the world.

Dr. Heru is with the department of psychiatry at the University of Colorado at Denver, Aurora. She is editor of the recently published book, "Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals" (New York: Routledge, 2013.

BREB, ROMANIA – While strolling through this village in the Maramures region in the northwest corner of Romania, I ask Ileana, "How many live in this village?" Ileana has just come home from high school in the nearest town and is wearing brightly colored sneakers, blue jeans, and a pink sweatshirt with the word "LOVE" emblazed in sparkles across her chest. She is touring us proudly around her village.

"400."

"400 people?"

"No, 400 families."

"How many in each family?"

"About six or seven."

On the large ornate wooden gate to the family homestead is the inscription: "Familie Hermann." All seven members of the Hermann family live in a three-room traditional wooden house. The house has a large porch, where the family eats, works, and sometimes sleeps in the warm weather.

Courtesy David Naylor

Maria, the 82-year-old grandmother, sits outside the gate on a small bench and watches the villagers stroll home from the fields with scythes and rakes on their shoulders. She welcomes her daughter and son-in-law back home. It is spring, and the villagers are cleaning the fields in preparation for the summer grass growing. In the fall, they will harvest the grass to feed their animals throughout the winter.

On the porch, in the quiet of a late afternoon, as 9-year-old Ioanna is doing her homework, her mother, Raluca, works on the intricacies of beading the border of Ioanna’s traditional costume to be worn on Easter Sunday. Ioanna watches her mother pin the black velvet jacket to her skirt and load the needle with the gold beads to make the stems for the purple and red flowers. She sees how to turn the green rows into leaves. She shows her mother her school work, as equally neat and carefully calligraphied as her mother’s beading. Concern for accuracy and aesthetics are the skills and values passed down through the generations.

Maria comes in from the gate and resumes shelling beans on the front porch. She doesn’t do as much work in the fields anymore. Instead, she sweeps the house, tends to the flower garden, and helps with the two children. Maria takes the clothes down from the clothesline that stretches across the front of the porch. These handmade, intricately stitched works of art have been washed in preparation for Easter.

Maria shows us the gown she will wear at her funeral. She wove the linen, and smocked the neck and wrists with traditional village colors. She is proud of her work, and we admire it. She takes her gown inside, along with all the other freshly laundered white blouses that men and women will wear during the traditional events throughout the year.

After Easter, when the weather warms, most of the village will make the pilgrimage up the mountain accompanying the shepherds taking the sheep to summer grazing. The milking of the sheep is a defining village event, and precise measures are recorded in a book or on a stick to indicate each person’s anticipated portion of future milkings. This is Stina, a serious celebration, and the villagers wear traditional dress for the feasting, drinking, and dancing.

Life in rural villages is physically hard, and family and communal living are not idyllic. There is no privacy in the village, perhaps no secrets.

There is no privileging of the individual over the family. The family functions as a unit, getting work done by the seasons, so the family can eat throughout the year. The sense of belonging is irrefutable.

There is room for individual pride, however, and this is expressed as skill in raking a straight row, making the best plum brandy, wood carving, and doing embroidery. Everyone has an opinion on which family is the best at their craft in the village. The Hermann family is recognized for their skill in textiles – particularly their embroidery.

The village has its characters: the most devout, the "bad boy," the lazy person, and the man who can’t hold his liquor. This man, the village drunk, frequently makes a trip to the psychiatric hospital in the town of Sighetu Marmatieti, when he gets out of hand. After a few weeks, he comes home quieter, and his good behavior will last for the best part of a year. There is no physician or nurse in the village, only a veterinarian who visits, when called, to care for the animals.

The darker stories of the village lie hidden, because for now, it is early spring, and the village flows with optimism, celebration, and courtship. The white, hand-crafted blouses manifest the feelings of anticipation as they billow and dance on each clothesline throughout the village. Belonging to the village means feeling the seasons unfold intuitively. These feelings sustain and nourish the village families throughout their lives.

Outside of the village, in the "real world," we try to create a sense of belonging. As a country of immigrants, we in America have sense of belonging that is scattered. Still, connecting with our past is too often beyond our grasp. What is belonging? What are its components?

Ways to think about belonging

Studies on belonging extend across many disciplines: psychoanalysis, attachment psychology, social and cultural studies to philosophy. How does a family psychiatrist think about belonging? What aspects of belonging can be incorporated into psychiatric care?

An unmet need for belonging leads to loneliness and lower life satisfaction. This finding came from a study of 436 participants from the Australian Unity Wellbeing database who completed several measurements, including the Need to Belong Scale according to David Mellor, Ph.D., and his colleagues(Pers. Individ. Dif. 2008;45:213-8). Dr. Vincenzo Di Nicola, a psychiatrist who has written extensively about family relationships, also has offered valuable perspective on belongingness: "Belonging is a way of rethinking relational being, how we define mental health, how we understand the expression of its vicissitudes, and how we organize care and healing for sufferers. To do this, we need to recognize how belonging is experienced and negotiated, free of the constraints of our habitual patterns of practice and thought, to imagine belonging without borders for settlers, sojourners, and travelers in the 21st century."

Belongingness traditionally has been seen as a core of family life. If your values are different from those of your family, if you have moved from the village to the city and don’t want to be a farmer, what values do you uphold? Do you now have a new set of people and values? Do you belong to a group/club/school? Belonging to a guild or religious order means that the guild or order becomes your new family. However, belongingness is more transient and a less substantial part of life, as people change jobs and careers, get divorced and remarried, move to other countries.

Who serves as the family for people with psychiatric illness? In a recent study, people with serious mental illness were interviewed and asked about the "communities" to which they belonged (Psychiatr. Serv. [doi: 10.1176/appi.ps.201200235]). The researchers found four "patterns of experience" that made up communities for the respondents. Communities were places where people with mental illness could receive help, especially in times of vulnerability.

In addition, communities were places to manage risk and minimize the anxiety felt in public setting by people with mental illness. The stigma experienced in the general community or even within their families led many respondents to identify more strongly with peers who had mental illness.

Communities also were seen as places where those with serious mental illness could "give back" and help others. So perhaps, in the same way as these respondents defined belongingness for themselves, we can define belongingness for all our patients.

Several components must be satisfied for a person to have a sense of belongingness.

• A community in which the person’s beliefs and values are upheld as sacred (meaningfulness).

• Rituals that bring people together and support the meaningfulness of their lives (meaningfulness).

• People who provide emotional and practical support for others (attachment).

• People who allow others to provide them with support (sense of self-efficacy).

• Generational transmission of skills, crafts, values, and beliefs (generativity).

A sense of place is another component that has been associated with a sense of belonging. After the Boston Marathon bombings, some people affirmed that their sense of belonging was consolidated by that event. For others, a sense of belonging becomes fixed in their sense of tragedy as a victim of an event. We see many patients with posttraumatic stress disorder who have been bound by the traumatizing event(s), and who find it difficult or impossible to move beyond that experience.

For Americans, perhaps the notion of "family values" can be parsed to include the idea and study of belongingness. Understanding what belongingness encompasses can help us discuss relational being with our patients. Where do you find that sense of belonging? For Ioanna, her sense of belonging is felt in the seasonal ebb and flow of village life. Her sense of belonging shows in her skill as she works with her crafts with her hands. Breb belongs to her, even as it opens its large wooden doors to the world.

Dr. Heru is with the department of psychiatry at the University of Colorado at Denver, Aurora. She is editor of the recently published book, "Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals" (New York: Routledge, 2013.

BREB, ROMANIA – While strolling through this village in the Maramures region in the northwest corner of Romania, I ask Ileana, "How many live in this village?" Ileana has just come home from high school in the nearest town and is wearing brightly colored sneakers, blue jeans, and a pink sweatshirt with the word "LOVE" emblazed in sparkles across her chest. She is touring us proudly around her village.

"400."

"400 people?"

"No, 400 families."

"How many in each family?"

"About six or seven."

On the large ornate wooden gate to the family homestead is the inscription: "Familie Hermann." All seven members of the Hermann family live in a three-room traditional wooden house. The house has a large porch, where the family eats, works, and sometimes sleeps in the warm weather.

Courtesy David Naylor

Maria, the 82-year-old grandmother, sits outside the gate on a small bench and watches the villagers stroll home from the fields with scythes and rakes on their shoulders. She welcomes her daughter and son-in-law back home. It is spring, and the villagers are cleaning the fields in preparation for the summer grass growing. In the fall, they will harvest the grass to feed their animals throughout the winter.

On the porch, in the quiet of a late afternoon, as 9-year-old Ioanna is doing her homework, her mother, Raluca, works on the intricacies of beading the border of Ioanna’s traditional costume to be worn on Easter Sunday. Ioanna watches her mother pin the black velvet jacket to her skirt and load the needle with the gold beads to make the stems for the purple and red flowers. She sees how to turn the green rows into leaves. She shows her mother her school work, as equally neat and carefully calligraphied as her mother’s beading. Concern for accuracy and aesthetics are the skills and values passed down through the generations.

Maria comes in from the gate and resumes shelling beans on the front porch. She doesn’t do as much work in the fields anymore. Instead, she sweeps the house, tends to the flower garden, and helps with the two children. Maria takes the clothes down from the clothesline that stretches across the front of the porch. These handmade, intricately stitched works of art have been washed in preparation for Easter.

Maria shows us the gown she will wear at her funeral. She wove the linen, and smocked the neck and wrists with traditional village colors. She is proud of her work, and we admire it. She takes her gown inside, along with all the other freshly laundered white blouses that men and women will wear during the traditional events throughout the year.

After Easter, when the weather warms, most of the village will make the pilgrimage up the mountain accompanying the shepherds taking the sheep to summer grazing. The milking of the sheep is a defining village event, and precise measures are recorded in a book or on a stick to indicate each person’s anticipated portion of future milkings. This is Stina, a serious celebration, and the villagers wear traditional dress for the feasting, drinking, and dancing.

Life in rural villages is physically hard, and family and communal living are not idyllic. There is no privacy in the village, perhaps no secrets.

There is no privileging of the individual over the family. The family functions as a unit, getting work done by the seasons, so the family can eat throughout the year. The sense of belonging is irrefutable.

There is room for individual pride, however, and this is expressed as skill in raking a straight row, making the best plum brandy, wood carving, and doing embroidery. Everyone has an opinion on which family is the best at their craft in the village. The Hermann family is recognized for their skill in textiles – particularly their embroidery.

The village has its characters: the most devout, the "bad boy," the lazy person, and the man who can’t hold his liquor. This man, the village drunk, frequently makes a trip to the psychiatric hospital in the town of Sighetu Marmatieti, when he gets out of hand. After a few weeks, he comes home quieter, and his good behavior will last for the best part of a year. There is no physician or nurse in the village, only a veterinarian who visits, when called, to care for the animals.

The darker stories of the village lie hidden, because for now, it is early spring, and the village flows with optimism, celebration, and courtship. The white, hand-crafted blouses manifest the feelings of anticipation as they billow and dance on each clothesline throughout the village. Belonging to the village means feeling the seasons unfold intuitively. These feelings sustain and nourish the village families throughout their lives.

Outside of the village, in the "real world," we try to create a sense of belonging. As a country of immigrants, we in America have sense of belonging that is scattered. Still, connecting with our past is too often beyond our grasp. What is belonging? What are its components?

Ways to think about belonging

Studies on belonging extend across many disciplines: psychoanalysis, attachment psychology, social and cultural studies to philosophy. How does a family psychiatrist think about belonging? What aspects of belonging can be incorporated into psychiatric care?

An unmet need for belonging leads to loneliness and lower life satisfaction. This finding came from a study of 436 participants from the Australian Unity Wellbeing database who completed several measurements, including the Need to Belong Scale according to David Mellor, Ph.D., and his colleagues(Pers. Individ. Dif. 2008;45:213-8). Dr. Vincenzo Di Nicola, a psychiatrist who has written extensively about family relationships, also has offered valuable perspective on belongingness: "Belonging is a way of rethinking relational being, how we define mental health, how we understand the expression of its vicissitudes, and how we organize care and healing for sufferers. To do this, we need to recognize how belonging is experienced and negotiated, free of the constraints of our habitual patterns of practice and thought, to imagine belonging without borders for settlers, sojourners, and travelers in the 21st century."

Belongingness traditionally has been seen as a core of family life. If your values are different from those of your family, if you have moved from the village to the city and don’t want to be a farmer, what values do you uphold? Do you now have a new set of people and values? Do you belong to a group/club/school? Belonging to a guild or religious order means that the guild or order becomes your new family. However, belongingness is more transient and a less substantial part of life, as people change jobs and careers, get divorced and remarried, move to other countries.

Who serves as the family for people with psychiatric illness? In a recent study, people with serious mental illness were interviewed and asked about the "communities" to which they belonged (Psychiatr. Serv. [doi: 10.1176/appi.ps.201200235]). The researchers found four "patterns of experience" that made up communities for the respondents. Communities were places where people with mental illness could receive help, especially in times of vulnerability.

In addition, communities were places to manage risk and minimize the anxiety felt in public setting by people with mental illness. The stigma experienced in the general community or even within their families led many respondents to identify more strongly with peers who had mental illness.

Communities also were seen as places where those with serious mental illness could "give back" and help others. So perhaps, in the same way as these respondents defined belongingness for themselves, we can define belongingness for all our patients.

Several components must be satisfied for a person to have a sense of belongingness.

• A community in which the person’s beliefs and values are upheld as sacred (meaningfulness).

• Rituals that bring people together and support the meaningfulness of their lives (meaningfulness).

• People who provide emotional and practical support for others (attachment).

• People who allow others to provide them with support (sense of self-efficacy).

• Generational transmission of skills, crafts, values, and beliefs (generativity).

A sense of place is another component that has been associated with a sense of belonging. After the Boston Marathon bombings, some people affirmed that their sense of belonging was consolidated by that event. For others, a sense of belonging becomes fixed in their sense of tragedy as a victim of an event. We see many patients with posttraumatic stress disorder who have been bound by the traumatizing event(s), and who find it difficult or impossible to move beyond that experience.

For Americans, perhaps the notion of "family values" can be parsed to include the idea and study of belongingness. Understanding what belongingness encompasses can help us discuss relational being with our patients. Where do you find that sense of belonging? For Ioanna, her sense of belonging is felt in the seasonal ebb and flow of village life. Her sense of belonging shows in her skill as she works with her crafts with her hands. Breb belongs to her, even as it opens its large wooden doors to the world.

Dr. Heru is with the department of psychiatry at the University of Colorado at Denver, Aurora. She is editor of the recently published book, "Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals" (New York: Routledge, 2013.

We have recently been informed by an American Heart Association committee that owning a pet decreases your cardiovascular risk. Since I am of the age when a coronary event is almost inevitable, the opinion of the committee caught my attention.

I am not much into pets, and I am not what you would call a dog lover; but I have had a dog that I really loved. Her name was Cassiopeia, "Cassie" for short, named after my then–10-year-old son’s favorite constellation. She was a warm and attentive golden retriever who jumped up on my car to greet me every evening when I came home from the hospital. My wife, who dutifully walked her every day, rarely got so much as a tail wag. She was clearly "my" dog and, like any person or animal that comes up to you at the end of the day with a lick or a kiss, was someone to be cherished.

In her 10th year, Cassie’s kidneys failed. After several weeks of daily administration of intravenous fluids, I gave up and took her to the vet to be euthanized. I freely admit that I was mildly depressed for a few weeks after she died. We never got another dog because my wife refused to continue to take care of an animal that never showed any appreciation.

The American Heart Association’s position on the benefit of pet ownership in the reduction of cardiovascular risk is one of at least three scientific statements that the organization makes each month. It did bring to mind the effect of Cassie on my psyche and the potentially beneficial effect that she had on my coronary arteries. However, I would have to admit I have failed to pay much attention to previous proclamations by well-meaning scientific bodies like the AHA committees. I have ignored the advice about my large coffee intake, my lack of daily exercise, and the amount of salt I put on my steak.

This particular statement by the AHA, however, was cautious about the justification of the canine-human interaction and indicated that there are scant randomized data to support the claim, and what existed related to cats, a species to which my wife is allergic. The recent dog–heart disease statement had come about as a result of a "growing number of news reports and medical studies" that purported to show a beneficial relationship between pet ownership and heart disease. It is amazing how one fails to notice a brouhaha right in our own midst. According to the New York Times account, the public uproar had reached such a "point that it would be reasonable to formally investigate" the issue.

But how would you ever try to design a trial testing the hypothesis that owning a dog was a panacea for cardiovascular disease? It is not clear what mechanism of action could be attributed to the presence of the dog. Was it exercise or depression? Of course, members of the committee jumped to the obvious relationship between exercising the dog and exercising the human. The particular species of dog certainly could have importance. Should it be a big friendly golden lab, a huge Great Dane, or a little Pekingese? Did its weight or disposition have any importance? How could you ever get rid of all of the variables? Forget the idea of a randomized trial; let’s just deal with the science of the matter.

I still could not forget Cassie and I tried to see how a new dog could help me. I thought about how my wife would take this, but I decided that her unhappiness would tip the balance against getting another dog. Another Cassie to bolster my psyche just doesn’t seem to be in the cards. In my own situation I wasn’t going to exercise the dog anyway. I had already assigned that responsibility to my wife, and I am not prepared to take that from her, even though she was willing to pass it on to someone else. I think that I will do without a dog and just try to carry on.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

We have recently been informed by an American Heart Association committee that owning a pet decreases your cardiovascular risk. Since I am of the age when a coronary event is almost inevitable, the opinion of the committee caught my attention.

I am not much into pets, and I am not what you would call a dog lover; but I have had a dog that I really loved. Her name was Cassiopeia, "Cassie" for short, named after my then–10-year-old son’s favorite constellation. She was a warm and attentive golden retriever who jumped up on my car to greet me every evening when I came home from the hospital. My wife, who dutifully walked her every day, rarely got so much as a tail wag. She was clearly "my" dog and, like any person or animal that comes up to you at the end of the day with a lick or a kiss, was someone to be cherished.

In her 10th year, Cassie’s kidneys failed. After several weeks of daily administration of intravenous fluids, I gave up and took her to the vet to be euthanized. I freely admit that I was mildly depressed for a few weeks after she died. We never got another dog because my wife refused to continue to take care of an animal that never showed any appreciation.

The American Heart Association’s position on the benefit of pet ownership in the reduction of cardiovascular risk is one of at least three scientific statements that the organization makes each month. It did bring to mind the effect of Cassie on my psyche and the potentially beneficial effect that she had on my coronary arteries. However, I would have to admit I have failed to pay much attention to previous proclamations by well-meaning scientific bodies like the AHA committees. I have ignored the advice about my large coffee intake, my lack of daily exercise, and the amount of salt I put on my steak.

This particular statement by the AHA, however, was cautious about the justification of the canine-human interaction and indicated that there are scant randomized data to support the claim, and what existed related to cats, a species to which my wife is allergic. The recent dog–heart disease statement had come about as a result of a "growing number of news reports and medical studies" that purported to show a beneficial relationship between pet ownership and heart disease. It is amazing how one fails to notice a brouhaha right in our own midst. According to the New York Times account, the public uproar had reached such a "point that it would be reasonable to formally investigate" the issue.

But how would you ever try to design a trial testing the hypothesis that owning a dog was a panacea for cardiovascular disease? It is not clear what mechanism of action could be attributed to the presence of the dog. Was it exercise or depression? Of course, members of the committee jumped to the obvious relationship between exercising the dog and exercising the human. The particular species of dog certainly could have importance. Should it be a big friendly golden lab, a huge Great Dane, or a little Pekingese? Did its weight or disposition have any importance? How could you ever get rid of all of the variables? Forget the idea of a randomized trial; let’s just deal with the science of the matter.

I still could not forget Cassie and I tried to see how a new dog could help me. I thought about how my wife would take this, but I decided that her unhappiness would tip the balance against getting another dog. Another Cassie to bolster my psyche just doesn’t seem to be in the cards. In my own situation I wasn’t going to exercise the dog anyway. I had already assigned that responsibility to my wife, and I am not prepared to take that from her, even though she was willing to pass it on to someone else. I think that I will do without a dog and just try to carry on.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

We have recently been informed by an American Heart Association committee that owning a pet decreases your cardiovascular risk. Since I am of the age when a coronary event is almost inevitable, the opinion of the committee caught my attention.

I am not much into pets, and I am not what you would call a dog lover; but I have had a dog that I really loved. Her name was Cassiopeia, "Cassie" for short, named after my then–10-year-old son’s favorite constellation. She was a warm and attentive golden retriever who jumped up on my car to greet me every evening when I came home from the hospital. My wife, who dutifully walked her every day, rarely got so much as a tail wag. She was clearly "my" dog and, like any person or animal that comes up to you at the end of the day with a lick or a kiss, was someone to be cherished.

In her 10th year, Cassie’s kidneys failed. After several weeks of daily administration of intravenous fluids, I gave up and took her to the vet to be euthanized. I freely admit that I was mildly depressed for a few weeks after she died. We never got another dog because my wife refused to continue to take care of an animal that never showed any appreciation.

The American Heart Association’s position on the benefit of pet ownership in the reduction of cardiovascular risk is one of at least three scientific statements that the organization makes each month. It did bring to mind the effect of Cassie on my psyche and the potentially beneficial effect that she had on my coronary arteries. However, I would have to admit I have failed to pay much attention to previous proclamations by well-meaning scientific bodies like the AHA committees. I have ignored the advice about my large coffee intake, my lack of daily exercise, and the amount of salt I put on my steak.

This particular statement by the AHA, however, was cautious about the justification of the canine-human interaction and indicated that there are scant randomized data to support the claim, and what existed related to cats, a species to which my wife is allergic. The recent dog–heart disease statement had come about as a result of a "growing number of news reports and medical studies" that purported to show a beneficial relationship between pet ownership and heart disease. It is amazing how one fails to notice a brouhaha right in our own midst. According to the New York Times account, the public uproar had reached such a "point that it would be reasonable to formally investigate" the issue.

But how would you ever try to design a trial testing the hypothesis that owning a dog was a panacea for cardiovascular disease? It is not clear what mechanism of action could be attributed to the presence of the dog. Was it exercise or depression? Of course, members of the committee jumped to the obvious relationship between exercising the dog and exercising the human. The particular species of dog certainly could have importance. Should it be a big friendly golden lab, a huge Great Dane, or a little Pekingese? Did its weight or disposition have any importance? How could you ever get rid of all of the variables? Forget the idea of a randomized trial; let’s just deal with the science of the matter.

I still could not forget Cassie and I tried to see how a new dog could help me. I thought about how my wife would take this, but I decided that her unhappiness would tip the balance against getting another dog. Another Cassie to bolster my psyche just doesn’t seem to be in the cards. In my own situation I wasn’t going to exercise the dog anyway. I had already assigned that responsibility to my wife, and I am not prepared to take that from her, even though she was willing to pass it on to someone else. I think that I will do without a dog and just try to carry on.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.