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Medication-assisted treatment of opiate dependence is gaining favor
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.
- White WL. Slaying the Dragon. The History of Addiction Treatment and Recovery in America. Bloomington, IL: Chestnut Health Systems/Lighthouse Institute; 1998:124–125,201.
- Kosten TR, Gorelick DA. The Lexington narcotic farm. Am J Psychiatry 2002; 159:22.
- Hunt GH, Odoroff ME. Followup study of narcotic drug addicts after hospitalization. Public Health Rep 1962; 77:41–54.
- Dole VP. Narcotic addiction, physical dependence and relapse. N Engl J Med 1972; 286:988–992.
- Dole VP. Implications of methadone maintenance for theories of narcotic addiction. JAMA 1988; 260:3025–3029.
- Betty Ford Institute Consensus Panel. What is recovery? A working definition from the Betty Ford Institute. J Subst Abuse Treat 2007; 33:221–228.
- McLellan AT. Have we evaluated addiction treatment correctly? Implications from a chronic care perspective. Addiction 2002; 97:249–252.
- Grönbladh L, Ohlund LS, Gunne LM. Mortality in heroin addiction: impact of methadone treatment. Acta Psychiatr Scand 1990; 82:223–227.
- Ball JC, Lange WR, Myers CP, Friedman SR. Reducing the risk of AIDS through methadone maintenance treatment. J Health Soc Behav 1988; 29:214–226.
- Martin J, Zweben JE, Payte JT. Opioid maintenance treatment. In:Ries RK, Fiellin DA, Miller SC, Saitzeds R, editors. Principles of Addiction Medicine. 4th ed. Philadelphia, PA: Lippincottt Williams & Wilkins, 2009:671–688.
- Dole VP, Nyswander ME. Methadone maintenance treatment. A tenyear perspective. JAMA 1976; 235:2117–2119.
- Cunningham C, Giovanniello A, Sacajiu G, et al. Buprenorphine treatment in an urban community health center: what to expect. Fam Med 2008; 40:500–506.
- Fiellin DA, Pantalon MV, Pakes JP, O’Connor PG, Chawarski M, Schottenfeld RS. Treatment of heroin dependence with buprenorphine in primary care. Am J Drug Alcohol Abuse 2002; 28:231–241.
- Fudala PJ, Bridge TP, Herbert S, et al; Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med 2003; 349:949–958.
- O’Connor PG, Oliveto AH, Shi JM, et al. A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic. Am J Med 1998; 105:100–105.
- Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med 2006; 355:365–374.
- Moore BA, Fiellin DA, Barry DT, et al. Primary care office-based buprenorphine treatment: comparison of heroin and prescription opioid dependent patients. J Gen Intern Med 2007; 22:527–530.
- Mintzer IL, Eisenberg M, Terra M, MacVane C, Himmelstein DU, Woolhandler S. Treating opioid addiction with buprenorphine-naloxone in community-based primary care settings. Ann Fam Med 2007; 5:146–150.
- O’Connor PG, Oliveto AH, Shi JM, et al. A pilot study of primary-carebased buprenorphine maintenance for heroin dependence. Am J Drug Alcohol Abuse 1996; 22:523–531.
- Fiellin DA, Moore BA, Sullivan LE, et al. Long-term treatment with buprenorphine/naloxone in primary care: results at 2–5 years. Am J Addict 2008; 17:116–120.
- Smyth B, Hoffman V, Fan J, Hser YI. Years of potential life lost among heroin addicts 33 years after treatment. Prev Med 2007; 44:369–374.
- Sporer KA. Acute heroin overdose. Ann Intern Med 1999; 130:584–590.
- Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers—United States, 1999–2008. MMWR Morb Mortal Wkly Rep 2011; 60:1487–1492.
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.
- White WL. Slaying the Dragon. The History of Addiction Treatment and Recovery in America. Bloomington, IL: Chestnut Health Systems/Lighthouse Institute; 1998:124–125,201.
- Kosten TR, Gorelick DA. The Lexington narcotic farm. Am J Psychiatry 2002; 159:22.
- Hunt GH, Odoroff ME. Followup study of narcotic drug addicts after hospitalization. Public Health Rep 1962; 77:41–54.
- Dole VP. Narcotic addiction, physical dependence and relapse. N Engl J Med 1972; 286:988–992.
- Dole VP. Implications of methadone maintenance for theories of narcotic addiction. JAMA 1988; 260:3025–3029.
- Betty Ford Institute Consensus Panel. What is recovery? A working definition from the Betty Ford Institute. J Subst Abuse Treat 2007; 33:221–228.
- McLellan AT. Have we evaluated addiction treatment correctly? Implications from a chronic care perspective. Addiction 2002; 97:249–252.
- Grönbladh L, Ohlund LS, Gunne LM. Mortality in heroin addiction: impact of methadone treatment. Acta Psychiatr Scand 1990; 82:223–227.
- Ball JC, Lange WR, Myers CP, Friedman SR. Reducing the risk of AIDS through methadone maintenance treatment. J Health Soc Behav 1988; 29:214–226.
- Martin J, Zweben JE, Payte JT. Opioid maintenance treatment. In:Ries RK, Fiellin DA, Miller SC, Saitzeds R, editors. Principles of Addiction Medicine. 4th ed. Philadelphia, PA: Lippincottt Williams & Wilkins, 2009:671–688.
- Dole VP, Nyswander ME. Methadone maintenance treatment. A tenyear perspective. JAMA 1976; 235:2117–2119.
- Cunningham C, Giovanniello A, Sacajiu G, et al. Buprenorphine treatment in an urban community health center: what to expect. Fam Med 2008; 40:500–506.
- Fiellin DA, Pantalon MV, Pakes JP, O’Connor PG, Chawarski M, Schottenfeld RS. Treatment of heroin dependence with buprenorphine in primary care. Am J Drug Alcohol Abuse 2002; 28:231–241.
- Fudala PJ, Bridge TP, Herbert S, et al; Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med 2003; 349:949–958.
- O’Connor PG, Oliveto AH, Shi JM, et al. A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic. Am J Med 1998; 105:100–105.
- Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med 2006; 355:365–374.
- Moore BA, Fiellin DA, Barry DT, et al. Primary care office-based buprenorphine treatment: comparison of heroin and prescription opioid dependent patients. J Gen Intern Med 2007; 22:527–530.
- Mintzer IL, Eisenberg M, Terra M, MacVane C, Himmelstein DU, Woolhandler S. Treating opioid addiction with buprenorphine-naloxone in community-based primary care settings. Ann Fam Med 2007; 5:146–150.
- O’Connor PG, Oliveto AH, Shi JM, et al. A pilot study of primary-carebased buprenorphine maintenance for heroin dependence. Am J Drug Alcohol Abuse 1996; 22:523–531.
- Fiellin DA, Moore BA, Sullivan LE, et al. Long-term treatment with buprenorphine/naloxone in primary care: results at 2–5 years. Am J Addict 2008; 17:116–120.
- Smyth B, Hoffman V, Fan J, Hser YI. Years of potential life lost among heroin addicts 33 years after treatment. Prev Med 2007; 44:369–374.
- Sporer KA. Acute heroin overdose. Ann Intern Med 1999; 130:584–590.
- Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers—United States, 1999–2008. MMWR Morb Mortal Wkly Rep 2011; 60:1487–1492.
- White WL. Slaying the Dragon. The History of Addiction Treatment and Recovery in America. Bloomington, IL: Chestnut Health Systems/Lighthouse Institute; 1998:124–125,201.
- Kosten TR, Gorelick DA. The Lexington narcotic farm. Am J Psychiatry 2002; 159:22.
- Hunt GH, Odoroff ME. Followup study of narcotic drug addicts after hospitalization. Public Health Rep 1962; 77:41–54.
- Dole VP. Narcotic addiction, physical dependence and relapse. N Engl J Med 1972; 286:988–992.
- Dole VP. Implications of methadone maintenance for theories of narcotic addiction. JAMA 1988; 260:3025–3029.
- Betty Ford Institute Consensus Panel. What is recovery? A working definition from the Betty Ford Institute. J Subst Abuse Treat 2007; 33:221–228.
- McLellan AT. Have we evaluated addiction treatment correctly? Implications from a chronic care perspective. Addiction 2002; 97:249–252.
- Grönbladh L, Ohlund LS, Gunne LM. Mortality in heroin addiction: impact of methadone treatment. Acta Psychiatr Scand 1990; 82:223–227.
- Ball JC, Lange WR, Myers CP, Friedman SR. Reducing the risk of AIDS through methadone maintenance treatment. J Health Soc Behav 1988; 29:214–226.
- Martin J, Zweben JE, Payte JT. Opioid maintenance treatment. In:Ries RK, Fiellin DA, Miller SC, Saitzeds R, editors. Principles of Addiction Medicine. 4th ed. Philadelphia, PA: Lippincottt Williams & Wilkins, 2009:671–688.
- Dole VP, Nyswander ME. Methadone maintenance treatment. A tenyear perspective. JAMA 1976; 235:2117–2119.
- Cunningham C, Giovanniello A, Sacajiu G, et al. Buprenorphine treatment in an urban community health center: what to expect. Fam Med 2008; 40:500–506.
- Fiellin DA, Pantalon MV, Pakes JP, O’Connor PG, Chawarski M, Schottenfeld RS. Treatment of heroin dependence with buprenorphine in primary care. Am J Drug Alcohol Abuse 2002; 28:231–241.
- Fudala PJ, Bridge TP, Herbert S, et al; Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med 2003; 349:949–958.
- O’Connor PG, Oliveto AH, Shi JM, et al. A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic. Am J Med 1998; 105:100–105.
- Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med 2006; 355:365–374.
- Moore BA, Fiellin DA, Barry DT, et al. Primary care office-based buprenorphine treatment: comparison of heroin and prescription opioid dependent patients. J Gen Intern Med 2007; 22:527–530.
- Mintzer IL, Eisenberg M, Terra M, MacVane C, Himmelstein DU, Woolhandler S. Treating opioid addiction with buprenorphine-naloxone in community-based primary care settings. Ann Fam Med 2007; 5:146–150.
- O’Connor PG, Oliveto AH, Shi JM, et al. A pilot study of primary-carebased buprenorphine maintenance for heroin dependence. Am J Drug Alcohol Abuse 1996; 22:523–531.
- Fiellin DA, Moore BA, Sullivan LE, et al. Long-term treatment with buprenorphine/naloxone in primary care: results at 2–5 years. Am J Addict 2008; 17:116–120.
- Smyth B, Hoffman V, Fan J, Hser YI. Years of potential life lost among heroin addicts 33 years after treatment. Prev Med 2007; 44:369–374.
- Sporer KA. Acute heroin overdose. Ann Intern Med 1999; 130:584–590.
- Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers—United States, 1999–2008. MMWR Morb Mortal Wkly Rep 2011; 60:1487–1492.
KEY POINTS
- Recidivism rates are high after detoxification without medication-assisted treatment.
- Whether staying in a maintenance program truly constitutes recovery continues to be debated, but patients on methadone or buprenorphine maintenance do not report getting “high”—they merely feel normal.
- Methadone is dispensed only in special clinics, whereas buprenorphine can be prescribed by a physician. Prescribing physicians must complete an 8-hour course online at www.buppractice.com or www.aaap.org/buprenorphine and obtain a waiver from the US Drug Enforcement Administration.
- With or without medication-assisted treatment, recovering addicts must learn the skill of sober coping by actively participating in a solid 12-step-based program and, in some cases, in psychotherapy.
Parents -not just teens-are distracted while driving
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.
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.
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.
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.
AT THE PAS ANNUAL MEETING
Major finding: Almost 90% of parents who were surveyed engaged in at least one technology-related distraction while driving their child in the past month.
Data source: A survey of more than 600 parents and caregivers of children aged 1-12 years.
Disclosures: Dr. Macy reported that she had no disclosures. The research was funded by a grant from the Michigan Center for Advancing Safe Transportation Across the Lifespan. Dr. Macy also received support from the Eunice Kennedy Shriver National Institute for Child Health and Human Development.
Homage to Dr. Murray Bowen
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.
FDA warns about magnesium sulfate effects on newborns
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.
* 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.
* 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.
* Updated 6/5/2013
Education not enough: Student attitudes on concussion are poor
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.
The findings raise the question of how effectively we are educating teenagers about the dangers of concussions. It is apparent that much more research needs to be done.
As physicians we must continue to educate all children and adolescents when they come in for sports physicals and check-ups about the symptoms and dangers of concussions. We need to utilize a multimodal approach – not only talking with our patients and their parents, but also giving them written information and even watching short video clips in which teens talk about the consequences of unreported, untreated concussions. In our practice, we share with many adolescents a Centers for Disease Control and Prevention–produced video called "Keeping Quiet Can Keep You Out of the Game."
It is estimated that only 40% of high schools in the United States have an athletic trainer, and in these communities, pediatricians play an especially important role. But even in areas where high school trainers are educating their student-athletes about concussions, physicians still need to play an active role in educating these teens as well as other children and teens in their practices and their communities. Young athletes and their parents must appreciate that a concussion is not just a ding to the head, or a bump, or a bruise. It is a serious injury that needs to be recognized, diagnosed, and treated properly. Too many concussions go unrecognized and untreated.
The most important element of treatment is cognitive and physical rest immediately afterward with careful monitoring when activities are resumed. In this light, the American Academy of Pediatrics will soon be releasing a "Return to Learn" paper on helping young athletes ease back into school properly after suffering concussions.
Dr. Joel Brenner chairs the American Academy of Pediatrics Council on Sports Medicine and Fitness and is the medical director of the sports medicine program at Children’s Hospital of the King’s Daughters in Norfolk, Va.
The findings raise the question of how effectively we are educating teenagers about the dangers of concussions. It is apparent that much more research needs to be done.
As physicians we must continue to educate all children and adolescents when they come in for sports physicals and check-ups about the symptoms and dangers of concussions. We need to utilize a multimodal approach – not only talking with our patients and their parents, but also giving them written information and even watching short video clips in which teens talk about the consequences of unreported, untreated concussions. In our practice, we share with many adolescents a Centers for Disease Control and Prevention–produced video called "Keeping Quiet Can Keep You Out of the Game."
It is estimated that only 40% of high schools in the United States have an athletic trainer, and in these communities, pediatricians play an especially important role. But even in areas where high school trainers are educating their student-athletes about concussions, physicians still need to play an active role in educating these teens as well as other children and teens in their practices and their communities. Young athletes and their parents must appreciate that a concussion is not just a ding to the head, or a bump, or a bruise. It is a serious injury that needs to be recognized, diagnosed, and treated properly. Too many concussions go unrecognized and untreated.
The most important element of treatment is cognitive and physical rest immediately afterward with careful monitoring when activities are resumed. In this light, the American Academy of Pediatrics will soon be releasing a "Return to Learn" paper on helping young athletes ease back into school properly after suffering concussions.
Dr. Joel Brenner chairs the American Academy of Pediatrics Council on Sports Medicine and Fitness and is the medical director of the sports medicine program at Children’s Hospital of the King’s Daughters in Norfolk, Va.
The findings raise the question of how effectively we are educating teenagers about the dangers of concussions. It is apparent that much more research needs to be done.
As physicians we must continue to educate all children and adolescents when they come in for sports physicals and check-ups about the symptoms and dangers of concussions. We need to utilize a multimodal approach – not only talking with our patients and their parents, but also giving them written information and even watching short video clips in which teens talk about the consequences of unreported, untreated concussions. In our practice, we share with many adolescents a Centers for Disease Control and Prevention–produced video called "Keeping Quiet Can Keep You Out of the Game."
It is estimated that only 40% of high schools in the United States have an athletic trainer, and in these communities, pediatricians play an especially important role. But even in areas where high school trainers are educating their student-athletes about concussions, physicians still need to play an active role in educating these teens as well as other children and teens in their practices and their communities. Young athletes and their parents must appreciate that a concussion is not just a ding to the head, or a bump, or a bruise. It is a serious injury that needs to be recognized, diagnosed, and treated properly. Too many concussions go unrecognized and untreated.
The most important element of treatment is cognitive and physical rest immediately afterward with careful monitoring when activities are resumed. In this light, the American Academy of Pediatrics will soon be releasing a "Return to Learn" paper on helping young athletes ease back into school properly after suffering concussions.
Dr. Joel Brenner chairs the American Academy of Pediatrics Council on Sports Medicine and Fitness and is the medical director of the sports medicine program at Children’s Hospital of the King’s Daughters in Norfolk, Va.
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.
AT THE PAS ANNUAL MEETING
Major finding: Many of the 120 high school football players who participated in a survey-based study (70%) were knowledgeable about concussions, and most could identify common signs and symptoms, but only about half said that they would report symptoms to their coach, and 91% of respondents to one survey indicated they would play a game with a concussion.
Data source: Two validated surveys used to assess athletes’ knowledge and attitudes about concussion
Disclosures: Dr. Anderson reported that she had no relevant disclosures.
Life in Romanian village offers lessons for our patients
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.
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.
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.
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.
Dogs and heart attacks
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.
Applied molecular profiling: evidence-based decision-making for anticancer therapy
Applied molecular profiling is a method for helping clinicians select the most appropriate therapy for a patient with cancer by determining the level of gene and/or protein expression within the cancer and comparing that expression pattern with the expression profiles of cancers with known outcomes. This approach facilitates the development and selection of tumor-specific therapies based on the identification of biomarkers within a tumor. Molecular characterization techniques such as immunohistochemistry, microarray analysis, and fluorescence in situ hybridization have facilitated identification and validation of a number of important solid tumor biomarkers, including HER2/neu, EGFR, EML4/ALK, and KIT, and can also be used to identify biomarkers (eg, BCR-ABL, CD20, CD30) in various hematologic malignancies. It is of note that molecular profiling can be used to identify targets in tumors for which a therapeutic agent may already be available, thus avoiding the administration of an unproven investigational agent. As the field of molecular profiling continues to evolve and next-generation techniques such as exome sequencing – sequencing 1% of the genome – and whole gene sequencing gain currency, biomarker identification and analysis will become less expensive and more efficient, and possibly allow for a pathway-oriented approach to treatment selection. Wider acceptance and use of molecular profiling should therefore help practicing physicians and oncology researchers keep pace with advances in the understanding of oncogenic expression in various malignancies and encourage the use of molecular profiling in earlier stages of cancer rather than as an option of last resort...
*Click on the link to the left for a PDF of the full article.
Applied molecular profiling is a method for helping clinicians select the most appropriate therapy for a patient with cancer by determining the level of gene and/or protein expression within the cancer and comparing that expression pattern with the expression profiles of cancers with known outcomes. This approach facilitates the development and selection of tumor-specific therapies based on the identification of biomarkers within a tumor. Molecular characterization techniques such as immunohistochemistry, microarray analysis, and fluorescence in situ hybridization have facilitated identification and validation of a number of important solid tumor biomarkers, including HER2/neu, EGFR, EML4/ALK, and KIT, and can also be used to identify biomarkers (eg, BCR-ABL, CD20, CD30) in various hematologic malignancies. It is of note that molecular profiling can be used to identify targets in tumors for which a therapeutic agent may already be available, thus avoiding the administration of an unproven investigational agent. As the field of molecular profiling continues to evolve and next-generation techniques such as exome sequencing – sequencing 1% of the genome – and whole gene sequencing gain currency, biomarker identification and analysis will become less expensive and more efficient, and possibly allow for a pathway-oriented approach to treatment selection. Wider acceptance and use of molecular profiling should therefore help practicing physicians and oncology researchers keep pace with advances in the understanding of oncogenic expression in various malignancies and encourage the use of molecular profiling in earlier stages of cancer rather than as an option of last resort...
*Click on the link to the left for a PDF of the full article.
Applied molecular profiling is a method for helping clinicians select the most appropriate therapy for a patient with cancer by determining the level of gene and/or protein expression within the cancer and comparing that expression pattern with the expression profiles of cancers with known outcomes. This approach facilitates the development and selection of tumor-specific therapies based on the identification of biomarkers within a tumor. Molecular characterization techniques such as immunohistochemistry, microarray analysis, and fluorescence in situ hybridization have facilitated identification and validation of a number of important solid tumor biomarkers, including HER2/neu, EGFR, EML4/ALK, and KIT, and can also be used to identify biomarkers (eg, BCR-ABL, CD20, CD30) in various hematologic malignancies. It is of note that molecular profiling can be used to identify targets in tumors for which a therapeutic agent may already be available, thus avoiding the administration of an unproven investigational agent. As the field of molecular profiling continues to evolve and next-generation techniques such as exome sequencing – sequencing 1% of the genome – and whole gene sequencing gain currency, biomarker identification and analysis will become less expensive and more efficient, and possibly allow for a pathway-oriented approach to treatment selection. Wider acceptance and use of molecular profiling should therefore help practicing physicians and oncology researchers keep pace with advances in the understanding of oncogenic expression in various malignancies and encourage the use of molecular profiling in earlier stages of cancer rather than as an option of last resort...
*Click on the link to the left for a PDF of the full article.
Anti-TNFs for ulcerative colitis up sepsis risk after some proctocolectomies
PHOENIX – Among patients with ulcerative colitis, preoperative therapy targeting tumor necrosis factor increases the risk of postoperative complications after two-stage restorative proctocolectomy procedures but not after three-stage ones, a study has shown.
A team at the Cleveland Clinic retrospectively assessed outcomes in more than 500 patients who underwent a restorative proctocolectomy for medically refractory ulcerative colitis during a recent 5-year period. Overall, 28% were receiving an agent that targets tumor necrosis factor (TNF) before their surgery.
The main results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that among patients having an initial total proctocolectomy (TPC) with ileoanal pouch–anal anastomosis, preoperative anti-TNF therapy more than doubled the risk of pelvic sepsis in the subsequent year.
In contrast, among patients having an initial subtotal colectomy (STC) with end ileostomy, preoperative anti-TNF therapy did not significantly affect the risk of complications overall, or in the subset who went on to have completion proctectomy and ileoanal pouch–anal anastomosis.
"Considering the lack of [a randomized controlled trial], our conclusion is that preoperative exposure to biologics is associated with an increased risk of pelvic sepsis after TPC with ileoanal pouch–anal anastomosis," commented lead investigator Dr. Jinyu Gu, a colorectal surgeon at the Cleveland Clinic. "This risk can be mitigated by the performance of initial STC."
The study’s senior investigator, Dr. P. Ravi Kiran, noted the importance of studying late complications in this population.
"We consciously decided to include patients who developed complications up to 1 year after surgery because quite often, these patients will not manifest their pelvic sepsis until the stoma is closed," he explained. "Some of the previous data from our institution have also shown that if someone were to get pelvic complications or septic complications that resemble Crohn’s disease, it is unlikely that it is really the disease that does it within 1 year after surgery; it is usually septic complications that manifest in a delayed fashion. ... A problem with any study that does not include patients for a prolonged follow-up is that you cannot really know what are the long-term complications because the presence of a stoma sometimes keeps the pelvic infection hidden."
"We, as colorectal surgeons, have been questioning what to do with patients who are on anti-TNF therapy when we operate on them," session comoderator Dr. Janice Rafferty, chief of the division of colon and rectal surgery at the University of Cincinnati, commented in an interview.
"I think this tells us that if we do a pouch procedure on them, and they are on anti-TNF therapy, their risk for pelvic sepsis is higher than if they had a three-stage procedure and we get them off of anti-TNF therapy," she said. "That probably supports what most colorectal surgeons suspect and want to do, but I think the gastroenterologists are currently pushing us, saying there is not a lot of evidence to say that they have a worse outcome."
Session comoderator Dr. Bruce Robb of Indiana University in Indianapolis agreed and noted that the findings support a recent shift toward multistage procedures in this population.
"For a long time, we were talking about two- versus one-stage procedures, and now we are going back, I think, especially with the advent of laparoscopy; people are much happier to do a three-stage procedure than they were even 10 years ago," he said. "This study sort of validates a change in practice pattern that’s already in place."
Dr. Gu’s team retrospectively assessed outcomes in 588 patients who underwent a restorative proctocolectomy for medically refractory ulcerative colitis between 2006 and 2010. Patients with complicated colitis, colitis-associated neoplasia, and Crohn’s disease were excluded.
The investigators assessed the rates of a variety of postoperative complications: pelvic sepsis, leaking of the colorectal stump, wound infection, postoperative hemorrhage, thromboembolism, urinary tract infection, and pneumonia.
Patients were defined as receiving anti-TNF therapy preoperatively if they had received at least 12 weeks of infliximab (Remicade) or at least 4 weeks of adalimumab (Humira) or certolizumab (Cimzia).
Of the 181 patients whose initial surgery was TPC with ileoanal pouch–anal anastomosis, 14% were receiving anti-TNF therapy preoperatively.
Within this group, the 30-day rate of complications did not differ significantly between patients who were and were not receiving preoperative anti-TNF therapy.
But the cumulative 1-year rate of pelvic sepsis was twice as high in patients receiving anti-TNF therapy (32% vs. 16%, P = .012). In adjusted analyses, these patients still had a more than doubling of the risk of pelvic sepsis (hazard ratio, 2.62; P = .027).
Of the 407 patients whose initial surgery was STC with end ileostomy, 35% were receiving anti-TNF agents preoperatively.
Within this group, patients taking anti-TNF agents preoperatively did not have an elevated risk of any of the complications studied at either 30 days or 1 year. The findings were similar among the subset who went on to have a completion proctectomy and ileoanal pouch–anal anastomosis.
Dr. Gu and Dr. Kiran both disclosed no relevant financial conflicts.
PHOENIX – Among patients with ulcerative colitis, preoperative therapy targeting tumor necrosis factor increases the risk of postoperative complications after two-stage restorative proctocolectomy procedures but not after three-stage ones, a study has shown.
A team at the Cleveland Clinic retrospectively assessed outcomes in more than 500 patients who underwent a restorative proctocolectomy for medically refractory ulcerative colitis during a recent 5-year period. Overall, 28% were receiving an agent that targets tumor necrosis factor (TNF) before their surgery.
The main results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that among patients having an initial total proctocolectomy (TPC) with ileoanal pouch–anal anastomosis, preoperative anti-TNF therapy more than doubled the risk of pelvic sepsis in the subsequent year.
In contrast, among patients having an initial subtotal colectomy (STC) with end ileostomy, preoperative anti-TNF therapy did not significantly affect the risk of complications overall, or in the subset who went on to have completion proctectomy and ileoanal pouch–anal anastomosis.
"Considering the lack of [a randomized controlled trial], our conclusion is that preoperative exposure to biologics is associated with an increased risk of pelvic sepsis after TPC with ileoanal pouch–anal anastomosis," commented lead investigator Dr. Jinyu Gu, a colorectal surgeon at the Cleveland Clinic. "This risk can be mitigated by the performance of initial STC."
The study’s senior investigator, Dr. P. Ravi Kiran, noted the importance of studying late complications in this population.
"We consciously decided to include patients who developed complications up to 1 year after surgery because quite often, these patients will not manifest their pelvic sepsis until the stoma is closed," he explained. "Some of the previous data from our institution have also shown that if someone were to get pelvic complications or septic complications that resemble Crohn’s disease, it is unlikely that it is really the disease that does it within 1 year after surgery; it is usually septic complications that manifest in a delayed fashion. ... A problem with any study that does not include patients for a prolonged follow-up is that you cannot really know what are the long-term complications because the presence of a stoma sometimes keeps the pelvic infection hidden."
"We, as colorectal surgeons, have been questioning what to do with patients who are on anti-TNF therapy when we operate on them," session comoderator Dr. Janice Rafferty, chief of the division of colon and rectal surgery at the University of Cincinnati, commented in an interview.
"I think this tells us that if we do a pouch procedure on them, and they are on anti-TNF therapy, their risk for pelvic sepsis is higher than if they had a three-stage procedure and we get them off of anti-TNF therapy," she said. "That probably supports what most colorectal surgeons suspect and want to do, but I think the gastroenterologists are currently pushing us, saying there is not a lot of evidence to say that they have a worse outcome."
Session comoderator Dr. Bruce Robb of Indiana University in Indianapolis agreed and noted that the findings support a recent shift toward multistage procedures in this population.
"For a long time, we were talking about two- versus one-stage procedures, and now we are going back, I think, especially with the advent of laparoscopy; people are much happier to do a three-stage procedure than they were even 10 years ago," he said. "This study sort of validates a change in practice pattern that’s already in place."
Dr. Gu’s team retrospectively assessed outcomes in 588 patients who underwent a restorative proctocolectomy for medically refractory ulcerative colitis between 2006 and 2010. Patients with complicated colitis, colitis-associated neoplasia, and Crohn’s disease were excluded.
The investigators assessed the rates of a variety of postoperative complications: pelvic sepsis, leaking of the colorectal stump, wound infection, postoperative hemorrhage, thromboembolism, urinary tract infection, and pneumonia.
Patients were defined as receiving anti-TNF therapy preoperatively if they had received at least 12 weeks of infliximab (Remicade) or at least 4 weeks of adalimumab (Humira) or certolizumab (Cimzia).
Of the 181 patients whose initial surgery was TPC with ileoanal pouch–anal anastomosis, 14% were receiving anti-TNF therapy preoperatively.
Within this group, the 30-day rate of complications did not differ significantly between patients who were and were not receiving preoperative anti-TNF therapy.
But the cumulative 1-year rate of pelvic sepsis was twice as high in patients receiving anti-TNF therapy (32% vs. 16%, P = .012). In adjusted analyses, these patients still had a more than doubling of the risk of pelvic sepsis (hazard ratio, 2.62; P = .027).
Of the 407 patients whose initial surgery was STC with end ileostomy, 35% were receiving anti-TNF agents preoperatively.
Within this group, patients taking anti-TNF agents preoperatively did not have an elevated risk of any of the complications studied at either 30 days or 1 year. The findings were similar among the subset who went on to have a completion proctectomy and ileoanal pouch–anal anastomosis.
Dr. Gu and Dr. Kiran both disclosed no relevant financial conflicts.
PHOENIX – Among patients with ulcerative colitis, preoperative therapy targeting tumor necrosis factor increases the risk of postoperative complications after two-stage restorative proctocolectomy procedures but not after three-stage ones, a study has shown.
A team at the Cleveland Clinic retrospectively assessed outcomes in more than 500 patients who underwent a restorative proctocolectomy for medically refractory ulcerative colitis during a recent 5-year period. Overall, 28% were receiving an agent that targets tumor necrosis factor (TNF) before their surgery.
The main results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that among patients having an initial total proctocolectomy (TPC) with ileoanal pouch–anal anastomosis, preoperative anti-TNF therapy more than doubled the risk of pelvic sepsis in the subsequent year.
In contrast, among patients having an initial subtotal colectomy (STC) with end ileostomy, preoperative anti-TNF therapy did not significantly affect the risk of complications overall, or in the subset who went on to have completion proctectomy and ileoanal pouch–anal anastomosis.
"Considering the lack of [a randomized controlled trial], our conclusion is that preoperative exposure to biologics is associated with an increased risk of pelvic sepsis after TPC with ileoanal pouch–anal anastomosis," commented lead investigator Dr. Jinyu Gu, a colorectal surgeon at the Cleveland Clinic. "This risk can be mitigated by the performance of initial STC."
The study’s senior investigator, Dr. P. Ravi Kiran, noted the importance of studying late complications in this population.
"We consciously decided to include patients who developed complications up to 1 year after surgery because quite often, these patients will not manifest their pelvic sepsis until the stoma is closed," he explained. "Some of the previous data from our institution have also shown that if someone were to get pelvic complications or septic complications that resemble Crohn’s disease, it is unlikely that it is really the disease that does it within 1 year after surgery; it is usually septic complications that manifest in a delayed fashion. ... A problem with any study that does not include patients for a prolonged follow-up is that you cannot really know what are the long-term complications because the presence of a stoma sometimes keeps the pelvic infection hidden."
"We, as colorectal surgeons, have been questioning what to do with patients who are on anti-TNF therapy when we operate on them," session comoderator Dr. Janice Rafferty, chief of the division of colon and rectal surgery at the University of Cincinnati, commented in an interview.
"I think this tells us that if we do a pouch procedure on them, and they are on anti-TNF therapy, their risk for pelvic sepsis is higher than if they had a three-stage procedure and we get them off of anti-TNF therapy," she said. "That probably supports what most colorectal surgeons suspect and want to do, but I think the gastroenterologists are currently pushing us, saying there is not a lot of evidence to say that they have a worse outcome."
Session comoderator Dr. Bruce Robb of Indiana University in Indianapolis agreed and noted that the findings support a recent shift toward multistage procedures in this population.
"For a long time, we were talking about two- versus one-stage procedures, and now we are going back, I think, especially with the advent of laparoscopy; people are much happier to do a three-stage procedure than they were even 10 years ago," he said. "This study sort of validates a change in practice pattern that’s already in place."
Dr. Gu’s team retrospectively assessed outcomes in 588 patients who underwent a restorative proctocolectomy for medically refractory ulcerative colitis between 2006 and 2010. Patients with complicated colitis, colitis-associated neoplasia, and Crohn’s disease were excluded.
The investigators assessed the rates of a variety of postoperative complications: pelvic sepsis, leaking of the colorectal stump, wound infection, postoperative hemorrhage, thromboembolism, urinary tract infection, and pneumonia.
Patients were defined as receiving anti-TNF therapy preoperatively if they had received at least 12 weeks of infliximab (Remicade) or at least 4 weeks of adalimumab (Humira) or certolizumab (Cimzia).
Of the 181 patients whose initial surgery was TPC with ileoanal pouch–anal anastomosis, 14% were receiving anti-TNF therapy preoperatively.
Within this group, the 30-day rate of complications did not differ significantly between patients who were and were not receiving preoperative anti-TNF therapy.
But the cumulative 1-year rate of pelvic sepsis was twice as high in patients receiving anti-TNF therapy (32% vs. 16%, P = .012). In adjusted analyses, these patients still had a more than doubling of the risk of pelvic sepsis (hazard ratio, 2.62; P = .027).
Of the 407 patients whose initial surgery was STC with end ileostomy, 35% were receiving anti-TNF agents preoperatively.
Within this group, patients taking anti-TNF agents preoperatively did not have an elevated risk of any of the complications studied at either 30 days or 1 year. The findings were similar among the subset who went on to have a completion proctectomy and ileoanal pouch–anal anastomosis.
Dr. Gu and Dr. Kiran both disclosed no relevant financial conflicts.
AT THE ASCRS ANNUAL MEETING
Major finding: Preoperative anti-TNF therapy increased the risk of sepsis after initial total proctocolectomy with ileoanal pouch–anal anastomosis (HR, 2.62). In contrast, it did not increase the risk of any complications after initial subtotal colectomy with end ileostomy.
Data source: A retrospective cohort study of 588 patients with ulcerative colitis
Disclosures: Dr. Gu and Dr. Kiran disclosed no relevant financial conflicts.
Hand Slammed in Door
A 48-year-old woman presents to the urgent care center with complaints of right hand pain second-ary to an injury she sustained earlier in the day. Her hand was accidentally caught in a metal door as it was being shut by someone else. The door struck her in the middorsal aspect of her hand. She is now complaining of pain and swelling. She is healthy except for mild but well-controlled hypertension. Her vital signs are normal. Examina-tion of her right hand shows mild to moderate soft tissue swelling and some early bruising. There is extreme tenderness over the fourth and fifth metacarpal bones. Good capillary refill time is noted, and sensation is intact. She is able to flex her fingers somewhat, although this is limited by the swelling. Radiograph of the right hand is obtained. What is your impression?