Opinion

 

There are currently 15 drugs indicated for adverse conditions of the urinary tract. The reported frequency of use in pregnancy and during breastfeeding for most of these agents is very low or completely absent.

The five subclasses of urinary tract agents are analgesics, antispasmodics, urinary acidifiers, urinary alkalinizers, and urinary germicides. With the exception of the three urinary germicides, anti-infectives are not covered in this column.

 

Analgesics

The analgesic subclass includes pentosan and phenazopyridine. Pentosan (Elmiron), a heparinlike compound, is an oral drug that is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. Systemic absorption is low, at about 6%. Because of the high molecular weight (4,000-6,000), it does not appear to cross the placenta, at least in the first half of pregnancy. A 1975 reference described its use in five women with preeclampsia. Each patient received 100 mg intramuscularly every 8 hours for about 5 days in the last weeks of pregnancy. No maternal benefit from the therapy was observed. There was apparently no fetal harm, but the neonatal outcomes were not described.

There are substantial – more than 900 – human pregnancy exposures in the first trimester with phenazopyridine. The exposures were not related to an increased risk of embryo-fetal harm and so use of the drug in pregnancy can be classified as compatible. However, the low molecular weight (about 214 for the free base) suggests that the drug will cross to the embryo and fetus.
 

Antispasmodics

The eight antispasmodics are darifenacin (Enablex), fesoterodine (Toviaz), flavoxate, mirabegron (Myrbetriq), oxybutynin (Ditropan XL), solifenacin (Vesicare), tolterodine (Detrol LA), and trospium.

These agents are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The molecular weights range between 342 and 508, suggesting that all will cross the human placenta. There are no human pregnancy data for six of these agents and very limited data for flavoxate and oxybutynin. There is no evidence of embryo-fetal harm from these two drugs, but only one case involved exposure in the first trimester.

In seven of these drugs, the animal data suggested low risk. There was no embryo harm from doses that were equal to or less than 10 times the human dose based on body surface area (BSA) or area under the concentration curve (AUC). Solifenacin did cause embryo toxicity in pregnant mice. There was no embryo toxicity in pregnant rats and rabbits, but the maximum doses used were very low. Overall, the available data suggest that exposure to an antispasmodic in pregnancy is low risk for embryo, fetal, and newborn harm.
 

Urinary acidifiers

Ammonium chloride is a urinary acidifier as well as a respiratory expectorant. There is a large amount of data related to when the drug was used as an expectorant. There was no evidence that this use was associated with large categories of major or minor malformations. However, there were possible associations with three individual defects: inguinal hernia, cataract, and any benign tumor. No reports describing its use as a urinary acidifier have been located. When large amounts are consumed near term, the drug may cause acidosis in the mother and fetus. The molecular weight (about 53) suggests that it will cross the placenta.

Urinary alkalinizers

Potassium citrate (Urocit-K) is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate with nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. The molecular weight (about 307) suggests it will cross the placenta. Only one case of its use in pregnancy has been located. The newborn had an unspecified defect but no other information was provided. The animal data in four species suggest low risk.

Urinary germicides

There are three urinary germicides: methenamine, methylene blue, and nitrofurantoin. Methenamine is available as methenamine mandelate (molecular weight abut 292) and methenamine hippurate (molecular weight about 319). Both are metabolized to formaldehyde (molecular weight about 30), the active agent. The molecular weights suggest that all will cross the placenta. The use of methenamine during pregnancy has been reported in more than 750 pregnancies. There have been no embryo or fetal adverse effects attributed to the drug.

The human data involving oral methylene blue, a weak urinary germicide, is limited to 55 exposures. There were three infants with birth defects (type not specified). Several reports have described the use of intra-amniotic injections to assist in the diagnosis of suspected membrane rupture. This use has resulted in newborns with hemolytic anemia, hyperbilirubinemia with or without Heinz body formation, blue staining of the skin, and methemoglobinemia. Fetal deaths have also been described. Recommendations to avoid the intra-amniotic use of methylene blue were issued more than 10 years ago. Moreover, the use of oral methylene blue as a urinary germicide is no longer recommended.

The low molecular weight (about 238) of nitrofurantoin suggests that it will cross the placenta. It is commonly used in pregnancy for the treatment or prophylaxis of urinary tract infections. The large amount of human data indicates that the risk of drug-induced birth defects is low. Several cohort studies have found no increased risk for birth defects. However, some case-control studies have found increased risks for hypoplastic left heart syndrome and oral clefts. A 2015 review concluded that this difference was due to the increased sensitivity of case-control studies to detect adverse effects (J Obstet Gynaecol Can. 2015 Feb;37[2]:150-6).

Use of the drug close to term may cause hemolytic anemia in newborns who are glucose-6-phosphate dehydrogenase (G6PD) deficient. Although rare, this may also occur in newborns who are not G6PD deficient. The best course is to avoid use of the drug close to delivery. As for use of the drug in the first trimester, ACOG’s Committee on Obstetric Practice stated in Committee Opinion No. 717 that nitrofurantoin was still thought to be appropriate when no other suitable alternative antibiotics were available (Obstet Gynecol. 2017 Sept;130[3]:666-7).
 

Breastfeeding

Except for methenamine and nitrofurantoin, there are no data related to the use of the urinary tract drugs during breastfeeding. Peak levels of methenamine occur at 1 hour, but no reports of adverse effects on nursing infants have been located. Several reports have described the use of nitrofurantoin during breastfeeding. Minor diarrhea was noted in two infants. However, breastfeeding an infant with G6PD deficiency could lead to hemolytic anemia.

Phenazopyridine should be used with caution especially for an infant younger than 1 month or with G6PD deficiency because of the risk for methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia.

Although there have been no reports of the use of mirabegron during lactation, the characteristics of the drug – low molecular weight (about 397), long elimination half life (50 hours), and moderate plasma protein binding (about 71%) – suggest that the drug will be excreted into milk, potentially in clinically significant amounts. There is also concern with use of tolterodine (molecular weight about 476) because both the primary drug and its equipotent metabolite may be excreted into milk.
 

Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.

 

There are currently 15 drugs indicated for adverse conditions of the urinary tract. The reported frequency of use in pregnancy and during breastfeeding for most of these agents is very low or completely absent.

The five subclasses of urinary tract agents are analgesics, antispasmodics, urinary acidifiers, urinary alkalinizers, and urinary germicides. With the exception of the three urinary germicides, anti-infectives are not covered in this column.

 

Analgesics

The analgesic subclass includes pentosan and phenazopyridine. Pentosan (Elmiron), a heparinlike compound, is an oral drug that is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. Systemic absorption is low, at about 6%. Because of the high molecular weight (4,000-6,000), it does not appear to cross the placenta, at least in the first half of pregnancy. A 1975 reference described its use in five women with preeclampsia. Each patient received 100 mg intramuscularly every 8 hours for about 5 days in the last weeks of pregnancy. No maternal benefit from the therapy was observed. There was apparently no fetal harm, but the neonatal outcomes were not described.

There are substantial – more than 900 – human pregnancy exposures in the first trimester with phenazopyridine. The exposures were not related to an increased risk of embryo-fetal harm and so use of the drug in pregnancy can be classified as compatible. However, the low molecular weight (about 214 for the free base) suggests that the drug will cross to the embryo and fetus.
 

Antispasmodics

The eight antispasmodics are darifenacin (Enablex), fesoterodine (Toviaz), flavoxate, mirabegron (Myrbetriq), oxybutynin (Ditropan XL), solifenacin (Vesicare), tolterodine (Detrol LA), and trospium.

These agents are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The molecular weights range between 342 and 508, suggesting that all will cross the human placenta. There are no human pregnancy data for six of these agents and very limited data for flavoxate and oxybutynin. There is no evidence of embryo-fetal harm from these two drugs, but only one case involved exposure in the first trimester.

In seven of these drugs, the animal data suggested low risk. There was no embryo harm from doses that were equal to or less than 10 times the human dose based on body surface area (BSA) or area under the concentration curve (AUC). Solifenacin did cause embryo toxicity in pregnant mice. There was no embryo toxicity in pregnant rats and rabbits, but the maximum doses used were very low. Overall, the available data suggest that exposure to an antispasmodic in pregnancy is low risk for embryo, fetal, and newborn harm.
 

Urinary acidifiers

Ammonium chloride is a urinary acidifier as well as a respiratory expectorant. There is a large amount of data related to when the drug was used as an expectorant. There was no evidence that this use was associated with large categories of major or minor malformations. However, there were possible associations with three individual defects: inguinal hernia, cataract, and any benign tumor. No reports describing its use as a urinary acidifier have been located. When large amounts are consumed near term, the drug may cause acidosis in the mother and fetus. The molecular weight (about 53) suggests that it will cross the placenta.

Urinary alkalinizers

Potassium citrate (Urocit-K) is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate with nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. The molecular weight (about 307) suggests it will cross the placenta. Only one case of its use in pregnancy has been located. The newborn had an unspecified defect but no other information was provided. The animal data in four species suggest low risk.

Urinary germicides

There are three urinary germicides: methenamine, methylene blue, and nitrofurantoin. Methenamine is available as methenamine mandelate (molecular weight abut 292) and methenamine hippurate (molecular weight about 319). Both are metabolized to formaldehyde (molecular weight about 30), the active agent. The molecular weights suggest that all will cross the placenta. The use of methenamine during pregnancy has been reported in more than 750 pregnancies. There have been no embryo or fetal adverse effects attributed to the drug.

The human data involving oral methylene blue, a weak urinary germicide, is limited to 55 exposures. There were three infants with birth defects (type not specified). Several reports have described the use of intra-amniotic injections to assist in the diagnosis of suspected membrane rupture. This use has resulted in newborns with hemolytic anemia, hyperbilirubinemia with or without Heinz body formation, blue staining of the skin, and methemoglobinemia. Fetal deaths have also been described. Recommendations to avoid the intra-amniotic use of methylene blue were issued more than 10 years ago. Moreover, the use of oral methylene blue as a urinary germicide is no longer recommended.

The low molecular weight (about 238) of nitrofurantoin suggests that it will cross the placenta. It is commonly used in pregnancy for the treatment or prophylaxis of urinary tract infections. The large amount of human data indicates that the risk of drug-induced birth defects is low. Several cohort studies have found no increased risk for birth defects. However, some case-control studies have found increased risks for hypoplastic left heart syndrome and oral clefts. A 2015 review concluded that this difference was due to the increased sensitivity of case-control studies to detect adverse effects (J Obstet Gynaecol Can. 2015 Feb;37[2]:150-6).

Use of the drug close to term may cause hemolytic anemia in newborns who are glucose-6-phosphate dehydrogenase (G6PD) deficient. Although rare, this may also occur in newborns who are not G6PD deficient. The best course is to avoid use of the drug close to delivery. As for use of the drug in the first trimester, ACOG’s Committee on Obstetric Practice stated in Committee Opinion No. 717 that nitrofurantoin was still thought to be appropriate when no other suitable alternative antibiotics were available (Obstet Gynecol. 2017 Sept;130[3]:666-7).
 

Breastfeeding

Except for methenamine and nitrofurantoin, there are no data related to the use of the urinary tract drugs during breastfeeding. Peak levels of methenamine occur at 1 hour, but no reports of adverse effects on nursing infants have been located. Several reports have described the use of nitrofurantoin during breastfeeding. Minor diarrhea was noted in two infants. However, breastfeeding an infant with G6PD deficiency could lead to hemolytic anemia.

Phenazopyridine should be used with caution especially for an infant younger than 1 month or with G6PD deficiency because of the risk for methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia.

Although there have been no reports of the use of mirabegron during lactation, the characteristics of the drug – low molecular weight (about 397), long elimination half life (50 hours), and moderate plasma protein binding (about 71%) – suggest that the drug will be excreted into milk, potentially in clinically significant amounts. There is also concern with use of tolterodine (molecular weight about 476) because both the primary drug and its equipotent metabolite may be excreted into milk.
 

Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.

 

There are currently 15 drugs indicated for adverse conditions of the urinary tract. The reported frequency of use in pregnancy and during breastfeeding for most of these agents is very low or completely absent.

The five subclasses of urinary tract agents are analgesics, antispasmodics, urinary acidifiers, urinary alkalinizers, and urinary germicides. With the exception of the three urinary germicides, anti-infectives are not covered in this column.

 

Analgesics

The analgesic subclass includes pentosan and phenazopyridine. Pentosan (Elmiron), a heparinlike compound, is an oral drug that is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. Systemic absorption is low, at about 6%. Because of the high molecular weight (4,000-6,000), it does not appear to cross the placenta, at least in the first half of pregnancy. A 1975 reference described its use in five women with preeclampsia. Each patient received 100 mg intramuscularly every 8 hours for about 5 days in the last weeks of pregnancy. No maternal benefit from the therapy was observed. There was apparently no fetal harm, but the neonatal outcomes were not described.

There are substantial – more than 900 – human pregnancy exposures in the first trimester with phenazopyridine. The exposures were not related to an increased risk of embryo-fetal harm and so use of the drug in pregnancy can be classified as compatible. However, the low molecular weight (about 214 for the free base) suggests that the drug will cross to the embryo and fetus.
 

Antispasmodics

The eight antispasmodics are darifenacin (Enablex), fesoterodine (Toviaz), flavoxate, mirabegron (Myrbetriq), oxybutynin (Ditropan XL), solifenacin (Vesicare), tolterodine (Detrol LA), and trospium.

These agents are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The molecular weights range between 342 and 508, suggesting that all will cross the human placenta. There are no human pregnancy data for six of these agents and very limited data for flavoxate and oxybutynin. There is no evidence of embryo-fetal harm from these two drugs, but only one case involved exposure in the first trimester.

In seven of these drugs, the animal data suggested low risk. There was no embryo harm from doses that were equal to or less than 10 times the human dose based on body surface area (BSA) or area under the concentration curve (AUC). Solifenacin did cause embryo toxicity in pregnant mice. There was no embryo toxicity in pregnant rats and rabbits, but the maximum doses used were very low. Overall, the available data suggest that exposure to an antispasmodic in pregnancy is low risk for embryo, fetal, and newborn harm.
 

Urinary acidifiers

Ammonium chloride is a urinary acidifier as well as a respiratory expectorant. There is a large amount of data related to when the drug was used as an expectorant. There was no evidence that this use was associated with large categories of major or minor malformations. However, there were possible associations with three individual defects: inguinal hernia, cataract, and any benign tumor. No reports describing its use as a urinary acidifier have been located. When large amounts are consumed near term, the drug may cause acidosis in the mother and fetus. The molecular weight (about 53) suggests that it will cross the placenta.

Urinary alkalinizers

Potassium citrate (Urocit-K) is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate with nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. The molecular weight (about 307) suggests it will cross the placenta. Only one case of its use in pregnancy has been located. The newborn had an unspecified defect but no other information was provided. The animal data in four species suggest low risk.

Urinary germicides

There are three urinary germicides: methenamine, methylene blue, and nitrofurantoin. Methenamine is available as methenamine mandelate (molecular weight abut 292) and methenamine hippurate (molecular weight about 319). Both are metabolized to formaldehyde (molecular weight about 30), the active agent. The molecular weights suggest that all will cross the placenta. The use of methenamine during pregnancy has been reported in more than 750 pregnancies. There have been no embryo or fetal adverse effects attributed to the drug.

The human data involving oral methylene blue, a weak urinary germicide, is limited to 55 exposures. There were three infants with birth defects (type not specified). Several reports have described the use of intra-amniotic injections to assist in the diagnosis of suspected membrane rupture. This use has resulted in newborns with hemolytic anemia, hyperbilirubinemia with or without Heinz body formation, blue staining of the skin, and methemoglobinemia. Fetal deaths have also been described. Recommendations to avoid the intra-amniotic use of methylene blue were issued more than 10 years ago. Moreover, the use of oral methylene blue as a urinary germicide is no longer recommended.

The low molecular weight (about 238) of nitrofurantoin suggests that it will cross the placenta. It is commonly used in pregnancy for the treatment or prophylaxis of urinary tract infections. The large amount of human data indicates that the risk of drug-induced birth defects is low. Several cohort studies have found no increased risk for birth defects. However, some case-control studies have found increased risks for hypoplastic left heart syndrome and oral clefts. A 2015 review concluded that this difference was due to the increased sensitivity of case-control studies to detect adverse effects (J Obstet Gynaecol Can. 2015 Feb;37[2]:150-6).

Use of the drug close to term may cause hemolytic anemia in newborns who are glucose-6-phosphate dehydrogenase (G6PD) deficient. Although rare, this may also occur in newborns who are not G6PD deficient. The best course is to avoid use of the drug close to delivery. As for use of the drug in the first trimester, ACOG’s Committee on Obstetric Practice stated in Committee Opinion No. 717 that nitrofurantoin was still thought to be appropriate when no other suitable alternative antibiotics were available (Obstet Gynecol. 2017 Sept;130[3]:666-7).
 

Breastfeeding

Except for methenamine and nitrofurantoin, there are no data related to the use of the urinary tract drugs during breastfeeding. Peak levels of methenamine occur at 1 hour, but no reports of adverse effects on nursing infants have been located. Several reports have described the use of nitrofurantoin during breastfeeding. Minor diarrhea was noted in two infants. However, breastfeeding an infant with G6PD deficiency could lead to hemolytic anemia.

Phenazopyridine should be used with caution especially for an infant younger than 1 month or with G6PD deficiency because of the risk for methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia.

Although there have been no reports of the use of mirabegron during lactation, the characteristics of the drug – low molecular weight (about 397), long elimination half life (50 hours), and moderate plasma protein binding (about 71%) – suggest that the drug will be excreted into milk, potentially in clinically significant amounts. There is also concern with use of tolterodine (molecular weight about 476) because both the primary drug and its equipotent metabolite may be excreted into milk.
 

Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.

 

On May 5, 2017, the Food and Drug Administration approved edaravone (Radicava) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Developed by Mitsubishi Tanabe Pharma Corporation, edaravone is the first FDA-approved treatment for ALS since the approval of riluzole (Rilutek) in 1995. Edaravone was originally developed as an acute stroke treatment and then later studied in two separate trials in Japan to assess its efficacy in treating ALS.

The first trial was a 24-week double-blind, placebo-controlled trial of edaravone in 206 ALS patients. Eligibility requirements for this study included a forced vital capacity of at least 70% of the predicted value and onset of illness within 3 years of study entry. Patients were randomized to receive either edaravone or placebo, and the ALS functional rating scale (ALSFRS-R) was used as the primary endpoint measurement. This study failed to show a benefit of using edaravone. However, subsequent analysis revealed that a subgroup of patients with shorter duration of illness had slower progression than did those in the placebo group. This subgroup analysis prompted a second study.

The second study, also conducted in Japan, was a 24-week, randomized, double-blind, placebo-controlled trial of edaravone in 137 ALS patients. The eligibility requirements for this study included a forced vital capacity of at least 80% predicted and onset of illness within 2 years of study entry. The primary endpoint measurement was the ALSFRS-R. Both groups of ALS patients began the trial with a mean ALSFRS-R score of 42 points out of the maximal 48 points. The trial showed that patients receiving placebo worsened by 7.5 points on the ALSFRS-R, while the patients receiving edaravone worsened by 5.0 points. The conclusion was that progression of ALS was about 33% less in the edaravone-treated group than in the placebo group. Edaravone was generally well tolerated with side effects of rash, injection site bruising, and gait difficulty being more common in the edaravone group.

Edaravone is administered intravenously and the standard dose of 60 mg takes about 1 hour to complete. The initial treatment cycle consists of once-daily dosing for 2 weeks, followed by a 2-week drug-free period. After the initial cycle, subsequent cycles consist of once-daily dosing for 10 days out of the next 2 weeks, followed by a 2-week drug-free period. The question of how long patients should take edaravone has not been resolved. The FDA did not define a limit to the duration of treatment. Some insurance companies have limited authorization to 6 months as that was the duration of treatment that showed benefit in the study. However, an open-label, 24-week extension of the second study showed that the change in ALSFRS-R was linear throughout the study. This suggests that the treatment benefit in patients with short duration of illness may continue for an additional 24 weeks. Thus, patients who have duration of illness of less than 2 years at presentation may benefit from 12 months of treatment.

The rigorous treatment schedule and IV administration of edaravone create additional concerns for ALS patients. Many patients will need to have a port placed. Patients with impaired mobility will need assistance with transportation to an infusion center. The time involved with taking all of these IV infusions will be considerable. Our experience at the Mayo Clinic reflects differing patient opinions. Some ALS patients with short duration of illness who clearly meet the criteria are not willing to commit to this form of therapy even if insurance will cover it. In contrast, some patients with advanced disease who do not meet the eligibility criteria have expressed the wish to try it.

To have access to edaravone in the United States, ALS patients must first complete an enrollment form and register with a Mitsubishi Tanabe subsidiary called Searchlight. Searchlight creates a Searchlight patient ID and conducts a benefit investigation to determine if the patient’s insurance will cover edaravone treatment. If the patient’s insurance approves edaravone, arrangements are made to ship the drug to the site or company that will perform the infusions. Insurance companies have taken different approaches to the approval of edaravone for ALS patients. Some insurers require that the patient meets the eligibility requirements of the Japanese study that showed benefit (duration of illness less than 2 years from symptom onset and forced vital capacity of at least 80% predicted). These strict criteria will exclude many patients. Other insurers have required only the diagnosis of ALS and the physician’s order. The cost of edaravone is estimated to be around $145,500 per year. The actual out-of-pocket cost to patients will vary depending on their specific insurance plans. In-home infusion of edaravone is another option patients can consider. Patients can pay the separate charges for in-home infusion if their insurance plans do not cover this.

The costs of edaravone are substantial. Beyond the expenses for the medication and infusion services, the patient faces the burden of committing time to frequent IV infusions and potential complications associated with having a port placed. Many ALS patients have decided against pursuing edaravone, suggesting that the perceived costs exceed the perceived benefits. Many ALS patients have started edaravone treatment with the belief that slowing of progression is worth the costs. It is too soon to know if those who have started edaravone will remain committed to the treatment for 6-12 months. Despite the differing approaches to edaravone treatment, it can be agreed upon that it is good to have a new treatment for ALS and that we must continue working to find therapies effective in substantially slowing or stopping the progression of ALS.
 

Ms. Chang is a research intern, and Dr. Ross is a professor of neurology and director of the ALS Clinic, at Mayo Clinic Arizona in Scottsdale. Dr. Ross reported serving as the Mayo Clinic Arizona site primary investigator for the ALS investigational drug NP001.

 

On May 5, 2017, the Food and Drug Administration approved edaravone (Radicava) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Developed by Mitsubishi Tanabe Pharma Corporation, edaravone is the first FDA-approved treatment for ALS since the approval of riluzole (Rilutek) in 1995. Edaravone was originally developed as an acute stroke treatment and then later studied in two separate trials in Japan to assess its efficacy in treating ALS.

The first trial was a 24-week double-blind, placebo-controlled trial of edaravone in 206 ALS patients. Eligibility requirements for this study included a forced vital capacity of at least 70% of the predicted value and onset of illness within 3 years of study entry. Patients were randomized to receive either edaravone or placebo, and the ALS functional rating scale (ALSFRS-R) was used as the primary endpoint measurement. This study failed to show a benefit of using edaravone. However, subsequent analysis revealed that a subgroup of patients with shorter duration of illness had slower progression than did those in the placebo group. This subgroup analysis prompted a second study.

The second study, also conducted in Japan, was a 24-week, randomized, double-blind, placebo-controlled trial of edaravone in 137 ALS patients. The eligibility requirements for this study included a forced vital capacity of at least 80% predicted and onset of illness within 2 years of study entry. The primary endpoint measurement was the ALSFRS-R. Both groups of ALS patients began the trial with a mean ALSFRS-R score of 42 points out of the maximal 48 points. The trial showed that patients receiving placebo worsened by 7.5 points on the ALSFRS-R, while the patients receiving edaravone worsened by 5.0 points. The conclusion was that progression of ALS was about 33% less in the edaravone-treated group than in the placebo group. Edaravone was generally well tolerated with side effects of rash, injection site bruising, and gait difficulty being more common in the edaravone group.

Edaravone is administered intravenously and the standard dose of 60 mg takes about 1 hour to complete. The initial treatment cycle consists of once-daily dosing for 2 weeks, followed by a 2-week drug-free period. After the initial cycle, subsequent cycles consist of once-daily dosing for 10 days out of the next 2 weeks, followed by a 2-week drug-free period. The question of how long patients should take edaravone has not been resolved. The FDA did not define a limit to the duration of treatment. Some insurance companies have limited authorization to 6 months as that was the duration of treatment that showed benefit in the study. However, an open-label, 24-week extension of the second study showed that the change in ALSFRS-R was linear throughout the study. This suggests that the treatment benefit in patients with short duration of illness may continue for an additional 24 weeks. Thus, patients who have duration of illness of less than 2 years at presentation may benefit from 12 months of treatment.

The rigorous treatment schedule and IV administration of edaravone create additional concerns for ALS patients. Many patients will need to have a port placed. Patients with impaired mobility will need assistance with transportation to an infusion center. The time involved with taking all of these IV infusions will be considerable. Our experience at the Mayo Clinic reflects differing patient opinions. Some ALS patients with short duration of illness who clearly meet the criteria are not willing to commit to this form of therapy even if insurance will cover it. In contrast, some patients with advanced disease who do not meet the eligibility criteria have expressed the wish to try it.

To have access to edaravone in the United States, ALS patients must first complete an enrollment form and register with a Mitsubishi Tanabe subsidiary called Searchlight. Searchlight creates a Searchlight patient ID and conducts a benefit investigation to determine if the patient’s insurance will cover edaravone treatment. If the patient’s insurance approves edaravone, arrangements are made to ship the drug to the site or company that will perform the infusions. Insurance companies have taken different approaches to the approval of edaravone for ALS patients. Some insurers require that the patient meets the eligibility requirements of the Japanese study that showed benefit (duration of illness less than 2 years from symptom onset and forced vital capacity of at least 80% predicted). These strict criteria will exclude many patients. Other insurers have required only the diagnosis of ALS and the physician’s order. The cost of edaravone is estimated to be around $145,500 per year. The actual out-of-pocket cost to patients will vary depending on their specific insurance plans. In-home infusion of edaravone is another option patients can consider. Patients can pay the separate charges for in-home infusion if their insurance plans do not cover this.

The costs of edaravone are substantial. Beyond the expenses for the medication and infusion services, the patient faces the burden of committing time to frequent IV infusions and potential complications associated with having a port placed. Many ALS patients have decided against pursuing edaravone, suggesting that the perceived costs exceed the perceived benefits. Many ALS patients have started edaravone treatment with the belief that slowing of progression is worth the costs. It is too soon to know if those who have started edaravone will remain committed to the treatment for 6-12 months. Despite the differing approaches to edaravone treatment, it can be agreed upon that it is good to have a new treatment for ALS and that we must continue working to find therapies effective in substantially slowing or stopping the progression of ALS.
 

Ms. Chang is a research intern, and Dr. Ross is a professor of neurology and director of the ALS Clinic, at Mayo Clinic Arizona in Scottsdale. Dr. Ross reported serving as the Mayo Clinic Arizona site primary investigator for the ALS investigational drug NP001.

 

On May 5, 2017, the Food and Drug Administration approved edaravone (Radicava) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Developed by Mitsubishi Tanabe Pharma Corporation, edaravone is the first FDA-approved treatment for ALS since the approval of riluzole (Rilutek) in 1995. Edaravone was originally developed as an acute stroke treatment and then later studied in two separate trials in Japan to assess its efficacy in treating ALS.

The first trial was a 24-week double-blind, placebo-controlled trial of edaravone in 206 ALS patients. Eligibility requirements for this study included a forced vital capacity of at least 70% of the predicted value and onset of illness within 3 years of study entry. Patients were randomized to receive either edaravone or placebo, and the ALS functional rating scale (ALSFRS-R) was used as the primary endpoint measurement. This study failed to show a benefit of using edaravone. However, subsequent analysis revealed that a subgroup of patients with shorter duration of illness had slower progression than did those in the placebo group. This subgroup analysis prompted a second study.

The second study, also conducted in Japan, was a 24-week, randomized, double-blind, placebo-controlled trial of edaravone in 137 ALS patients. The eligibility requirements for this study included a forced vital capacity of at least 80% predicted and onset of illness within 2 years of study entry. The primary endpoint measurement was the ALSFRS-R. Both groups of ALS patients began the trial with a mean ALSFRS-R score of 42 points out of the maximal 48 points. The trial showed that patients receiving placebo worsened by 7.5 points on the ALSFRS-R, while the patients receiving edaravone worsened by 5.0 points. The conclusion was that progression of ALS was about 33% less in the edaravone-treated group than in the placebo group. Edaravone was generally well tolerated with side effects of rash, injection site bruising, and gait difficulty being more common in the edaravone group.

Edaravone is administered intravenously and the standard dose of 60 mg takes about 1 hour to complete. The initial treatment cycle consists of once-daily dosing for 2 weeks, followed by a 2-week drug-free period. After the initial cycle, subsequent cycles consist of once-daily dosing for 10 days out of the next 2 weeks, followed by a 2-week drug-free period. The question of how long patients should take edaravone has not been resolved. The FDA did not define a limit to the duration of treatment. Some insurance companies have limited authorization to 6 months as that was the duration of treatment that showed benefit in the study. However, an open-label, 24-week extension of the second study showed that the change in ALSFRS-R was linear throughout the study. This suggests that the treatment benefit in patients with short duration of illness may continue for an additional 24 weeks. Thus, patients who have duration of illness of less than 2 years at presentation may benefit from 12 months of treatment.

The rigorous treatment schedule and IV administration of edaravone create additional concerns for ALS patients. Many patients will need to have a port placed. Patients with impaired mobility will need assistance with transportation to an infusion center. The time involved with taking all of these IV infusions will be considerable. Our experience at the Mayo Clinic reflects differing patient opinions. Some ALS patients with short duration of illness who clearly meet the criteria are not willing to commit to this form of therapy even if insurance will cover it. In contrast, some patients with advanced disease who do not meet the eligibility criteria have expressed the wish to try it.

To have access to edaravone in the United States, ALS patients must first complete an enrollment form and register with a Mitsubishi Tanabe subsidiary called Searchlight. Searchlight creates a Searchlight patient ID and conducts a benefit investigation to determine if the patient’s insurance will cover edaravone treatment. If the patient’s insurance approves edaravone, arrangements are made to ship the drug to the site or company that will perform the infusions. Insurance companies have taken different approaches to the approval of edaravone for ALS patients. Some insurers require that the patient meets the eligibility requirements of the Japanese study that showed benefit (duration of illness less than 2 years from symptom onset and forced vital capacity of at least 80% predicted). These strict criteria will exclude many patients. Other insurers have required only the diagnosis of ALS and the physician’s order. The cost of edaravone is estimated to be around $145,500 per year. The actual out-of-pocket cost to patients will vary depending on their specific insurance plans. In-home infusion of edaravone is another option patients can consider. Patients can pay the separate charges for in-home infusion if their insurance plans do not cover this.

The costs of edaravone are substantial. Beyond the expenses for the medication and infusion services, the patient faces the burden of committing time to frequent IV infusions and potential complications associated with having a port placed. Many ALS patients have decided against pursuing edaravone, suggesting that the perceived costs exceed the perceived benefits. Many ALS patients have started edaravone treatment with the belief that slowing of progression is worth the costs. It is too soon to know if those who have started edaravone will remain committed to the treatment for 6-12 months. Despite the differing approaches to edaravone treatment, it can be agreed upon that it is good to have a new treatment for ALS and that we must continue working to find therapies effective in substantially slowing or stopping the progression of ALS.
 

Ms. Chang is a research intern, and Dr. Ross is a professor of neurology and director of the ALS Clinic, at Mayo Clinic Arizona in Scottsdale. Dr. Ross reported serving as the Mayo Clinic Arizona site primary investigator for the ALS investigational drug NP001.

 

As medicine struggles with rising rates of physician burnout, dissatisfaction, depression, and suicide, one solution comes in the form of Physician Health Programs, or PHPs. These organizations were originally started by volunteer physicians, often doctors in recovery, and funded by medical societies, as a way of providing help while maintaining confidentiality. Now, they are run by independent corporations, by medical societies in some states, and sometimes by hospitals or health systems. The services they offer vary by PHP, and they may have relationships with state licensing boards. While they can provide a gateway to help for a troubled doctor, there has also been concern about the services that are being provided.

ThinkStock

Physicians find their way to PHPs in a number of ways. A doctor whose behavior suggests impairment can be referred to the PHP by his employer, or by a licensing board, following a complaint. In these instances, participation often is a condition of employment or of continued licensure, and the PHP serves as an agent of the hospital or the state. Doctors may also be referred to PHPs for monitoring if they ascribed to having a diagnosis of psychiatric illness or substance abuse, either now or in the past, and are with or without obvious impairment. Finally, PHPs serve as a portal to treatment for physicians who self-identify and self-refer in an effort to get help. Their use is encouraged in an effort to prevent bad outcomes from mental health conditions, stress, and substance abuse, in those who are suffering in ways that would not otherwise call attention to their plights. In these situations, the PHP may serve as the agent of the patient or client, but there may remain dual-agency issues if the physician says something that leads the PHP to be concerned about the doctor’s fitness. Compliance with PHP recommendations, including drug screening, might be mandated, and physicians may resent these requirements.

Louise Andrew, MD, JD, served as the liaison from the American College of Emergency Physicians (ACEP) to the the Federation of State Medical Boards from 2006 to 2014. In an online forum called Collective Wisdom, Andrew talked about the benefits of Physician Health Programs as entities that are helpful to stuggling doctors and urged her colleagues to use them as a safe alternative to suffering in silence.

More recently, Dr. Andrew has become concerned that PHPs may have taken on the role of what is more akin to “diagnosing for dollars.” In her May, 2016 column in Emergency Physician’s Monthly, Andrew noted, “A decade later, and my convictions have changed dramatically. Horror stories that colleagues related to me while I chaired ACEP’s Personal and Professional WellBeing Committee cannot all be isolated events. For example, physicians who self-referred to the PHP for management of stress and depression were reportedly railroaded into incredibly expensive and inconvenient out-of-state drug and alcohol treatment programs, even when there was no coexisting drug or alcohol problem.”

Dr. Andrew is not the only one voicing concerns about PHPs. In “Physician Health Programs: More harm than good?” (Medscape, Aug. 19, 2015), Pauline Anderson wrote about a several problems that have surfaced. In North Carolina, the state audited the PHPs after complaints that they were mandating physicians to lengthy and expensive inpatient programs. The complaints asserted that the physicians had no recourse and were not able to see their records. “The state auditor’s report found no abuse by North Carolina’s PHP. However, there was a caveat – the report determined that abuse could occur and potentially go undetected.

“It also found that the North Carolina PHP created the appearance of conflicts of interest by allowing the centers to provide both patient evaluation and treatments and that procedures did not ensure that physicians receive quality evaluations and treatment because the PHP had no documented criteria for selecting treatment centers and did not adequately monitor them.”

Finally, in a Florida Fox4News story, “Are FL doctors and nurses being sent to rehab unnecessarily? Accusations: Overdiagnosing; overcharging” (Nov. 16, 2017), reporters Katie Lagrone and Matthew Apthorp wrote about financial incentives for evaluators to refer doctors to inpatient substance abuse facilities.

“Medical professionals who enter the programs must pay for all treatment out-of-pocket, which could add up to thousands of dollars each year. There are also no standards on how much treatment can cost.”

The American Psychiatric Association has made it a priority to address physician burnout and mental health. Richard F. Summers, MD, APA Trustee-at-Large noted: “State PHPs are an essential resource for physicians, but there is a tremendous diversity in quality and approach. It is critical that these programs include attention to mental health problems as well as addiction, and that they support individual physicians’ treatment and journey toward well-being. They need to be accessible, private, and high quality, and they should be staffed by excellent psychiatrists and other mental health professionals.”

PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

 

As medicine struggles with rising rates of physician burnout, dissatisfaction, depression, and suicide, one solution comes in the form of Physician Health Programs, or PHPs. These organizations were originally started by volunteer physicians, often doctors in recovery, and funded by medical societies, as a way of providing help while maintaining confidentiality. Now, they are run by independent corporations, by medical societies in some states, and sometimes by hospitals or health systems. The services they offer vary by PHP, and they may have relationships with state licensing boards. While they can provide a gateway to help for a troubled doctor, there has also been concern about the services that are being provided.

ThinkStock

Physicians find their way to PHPs in a number of ways. A doctor whose behavior suggests impairment can be referred to the PHP by his employer, or by a licensing board, following a complaint. In these instances, participation often is a condition of employment or of continued licensure, and the PHP serves as an agent of the hospital or the state. Doctors may also be referred to PHPs for monitoring if they ascribed to having a diagnosis of psychiatric illness or substance abuse, either now or in the past, and are with or without obvious impairment. Finally, PHPs serve as a portal to treatment for physicians who self-identify and self-refer in an effort to get help. Their use is encouraged in an effort to prevent bad outcomes from mental health conditions, stress, and substance abuse, in those who are suffering in ways that would not otherwise call attention to their plights. In these situations, the PHP may serve as the agent of the patient or client, but there may remain dual-agency issues if the physician says something that leads the PHP to be concerned about the doctor’s fitness. Compliance with PHP recommendations, including drug screening, might be mandated, and physicians may resent these requirements.

Louise Andrew, MD, JD, served as the liaison from the American College of Emergency Physicians (ACEP) to the the Federation of State Medical Boards from 2006 to 2014. In an online forum called Collective Wisdom, Andrew talked about the benefits of Physician Health Programs as entities that are helpful to stuggling doctors and urged her colleagues to use them as a safe alternative to suffering in silence.

More recently, Dr. Andrew has become concerned that PHPs may have taken on the role of what is more akin to “diagnosing for dollars.” In her May, 2016 column in Emergency Physician’s Monthly, Andrew noted, “A decade later, and my convictions have changed dramatically. Horror stories that colleagues related to me while I chaired ACEP’s Personal and Professional WellBeing Committee cannot all be isolated events. For example, physicians who self-referred to the PHP for management of stress and depression were reportedly railroaded into incredibly expensive and inconvenient out-of-state drug and alcohol treatment programs, even when there was no coexisting drug or alcohol problem.”

Dr. Andrew is not the only one voicing concerns about PHPs. In “Physician Health Programs: More harm than good?” (Medscape, Aug. 19, 2015), Pauline Anderson wrote about a several problems that have surfaced. In North Carolina, the state audited the PHPs after complaints that they were mandating physicians to lengthy and expensive inpatient programs. The complaints asserted that the physicians had no recourse and were not able to see their records. “The state auditor’s report found no abuse by North Carolina’s PHP. However, there was a caveat – the report determined that abuse could occur and potentially go undetected.

“It also found that the North Carolina PHP created the appearance of conflicts of interest by allowing the centers to provide both patient evaluation and treatments and that procedures did not ensure that physicians receive quality evaluations and treatment because the PHP had no documented criteria for selecting treatment centers and did not adequately monitor them.”

Finally, in a Florida Fox4News story, “Are FL doctors and nurses being sent to rehab unnecessarily? Accusations: Overdiagnosing; overcharging” (Nov. 16, 2017), reporters Katie Lagrone and Matthew Apthorp wrote about financial incentives for evaluators to refer doctors to inpatient substance abuse facilities.

“Medical professionals who enter the programs must pay for all treatment out-of-pocket, which could add up to thousands of dollars each year. There are also no standards on how much treatment can cost.”

The American Psychiatric Association has made it a priority to address physician burnout and mental health. Richard F. Summers, MD, APA Trustee-at-Large noted: “State PHPs are an essential resource for physicians, but there is a tremendous diversity in quality and approach. It is critical that these programs include attention to mental health problems as well as addiction, and that they support individual physicians’ treatment and journey toward well-being. They need to be accessible, private, and high quality, and they should be staffed by excellent psychiatrists and other mental health professionals.”

PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

 

As medicine struggles with rising rates of physician burnout, dissatisfaction, depression, and suicide, one solution comes in the form of Physician Health Programs, or PHPs. These organizations were originally started by volunteer physicians, often doctors in recovery, and funded by medical societies, as a way of providing help while maintaining confidentiality. Now, they are run by independent corporations, by medical societies in some states, and sometimes by hospitals or health systems. The services they offer vary by PHP, and they may have relationships with state licensing boards. While they can provide a gateway to help for a troubled doctor, there has also been concern about the services that are being provided.

ThinkStock

Physicians find their way to PHPs in a number of ways. A doctor whose behavior suggests impairment can be referred to the PHP by his employer, or by a licensing board, following a complaint. In these instances, participation often is a condition of employment or of continued licensure, and the PHP serves as an agent of the hospital or the state. Doctors may also be referred to PHPs for monitoring if they ascribed to having a diagnosis of psychiatric illness or substance abuse, either now or in the past, and are with or without obvious impairment. Finally, PHPs serve as a portal to treatment for physicians who self-identify and self-refer in an effort to get help. Their use is encouraged in an effort to prevent bad outcomes from mental health conditions, stress, and substance abuse, in those who are suffering in ways that would not otherwise call attention to their plights. In these situations, the PHP may serve as the agent of the patient or client, but there may remain dual-agency issues if the physician says something that leads the PHP to be concerned about the doctor’s fitness. Compliance with PHP recommendations, including drug screening, might be mandated, and physicians may resent these requirements.

Louise Andrew, MD, JD, served as the liaison from the American College of Emergency Physicians (ACEP) to the the Federation of State Medical Boards from 2006 to 2014. In an online forum called Collective Wisdom, Andrew talked about the benefits of Physician Health Programs as entities that are helpful to stuggling doctors and urged her colleagues to use them as a safe alternative to suffering in silence.

More recently, Dr. Andrew has become concerned that PHPs may have taken on the role of what is more akin to “diagnosing for dollars.” In her May, 2016 column in Emergency Physician’s Monthly, Andrew noted, “A decade later, and my convictions have changed dramatically. Horror stories that colleagues related to me while I chaired ACEP’s Personal and Professional WellBeing Committee cannot all be isolated events. For example, physicians who self-referred to the PHP for management of stress and depression were reportedly railroaded into incredibly expensive and inconvenient out-of-state drug and alcohol treatment programs, even when there was no coexisting drug or alcohol problem.”

Dr. Andrew is not the only one voicing concerns about PHPs. In “Physician Health Programs: More harm than good?” (Medscape, Aug. 19, 2015), Pauline Anderson wrote about a several problems that have surfaced. In North Carolina, the state audited the PHPs after complaints that they were mandating physicians to lengthy and expensive inpatient programs. The complaints asserted that the physicians had no recourse and were not able to see their records. “The state auditor’s report found no abuse by North Carolina’s PHP. However, there was a caveat – the report determined that abuse could occur and potentially go undetected.

“It also found that the North Carolina PHP created the appearance of conflicts of interest by allowing the centers to provide both patient evaluation and treatments and that procedures did not ensure that physicians receive quality evaluations and treatment because the PHP had no documented criteria for selecting treatment centers and did not adequately monitor them.”

Finally, in a Florida Fox4News story, “Are FL doctors and nurses being sent to rehab unnecessarily? Accusations: Overdiagnosing; overcharging” (Nov. 16, 2017), reporters Katie Lagrone and Matthew Apthorp wrote about financial incentives for evaluators to refer doctors to inpatient substance abuse facilities.

“Medical professionals who enter the programs must pay for all treatment out-of-pocket, which could add up to thousands of dollars each year. There are also no standards on how much treatment can cost.”

The American Psychiatric Association has made it a priority to address physician burnout and mental health. Richard F. Summers, MD, APA Trustee-at-Large noted: “State PHPs are an essential resource for physicians, but there is a tremendous diversity in quality and approach. It is critical that these programs include attention to mental health problems as well as addiction, and that they support individual physicians’ treatment and journey toward well-being. They need to be accessible, private, and high quality, and they should be staffed by excellent psychiatrists and other mental health professionals.”

PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

 

A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.

Which of these treatments do you recommend?

A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).

B. Oxygen, morphine, ASA.

C. ASA.

Greta Tubbesing, MD

For many years, a standard treatment of providing morphine, oxygen, nitroglycerin, and aspirin (MONA) was the standard initial treatment approach for all patients presenting with chest pain due to suspected myocardial ischemia.

In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.

There is controversy over the safety of routine morphine use for patients with chest pain.

Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.¹ Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.² Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.³

Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).⁴ They found no increase in in-hospital complications or 1-year mortality.

The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.^5,6

It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.⁷

The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.

In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).⁸ They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.

Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.⁹

This year, a large randomized trial of 6,629 patients across 35 Swedish hospitals was published by Robin Hofmann, MD, and colleagues.¹⁰ The DETO2X-AMI study compared 6 L/min of oxygen delivered for an average of 11.6 hours to ambient air in normoxemic patients with suspected MI (76% with ultimately confirmed MI). They found no difference in death at 30 days or 1 year. While this finding reinforced the lack of benefit of supplemental oxygen shown in the AVOID trial, the findings by Dr. Stub and colleagues of increased tissue damage were not borne out: Both groups showed similar troponin levels.

Where does all this leave us in the treatment of suspected MI?

Morphine should only be used when the patient has pain, and is probably best reserved for severe pain, as the safety of its use is not clear. While hypoxemia is a common consequence of MI – and may correlate with worse outcomes – treatment with supplemental oxygen in the absence of hypoxemia is not supported by current evidence, and may carry risk of harm. Nitroglycerin should be avoided in patients with right ventricular infarcts, and in patients who present with hypotension.
 

 

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

References

1. Am Heart J. 2005 Jun;149(6):1043-9.

2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.

3. Clin Res Cardiol. 2015 Sep;104(9):727-34.

4. Eur Heart J. 2016 Apr 1;37(13):1063-71.

5. BMJ. 1900 Dec 1;2(2083):1568.

6. JAMA. 1930 May 3;94(18):1363-5.

7. Br Med J. 1976 May 8;1(6018):1121-3.

8. Circulation. 2015 Jun 16;131(24):2143-50.

9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.

10. N Engl J Med. 2017 Sep 28;377(13):1240-9.

 

A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.

Which of these treatments do you recommend?

A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).

B. Oxygen, morphine, ASA.

C. ASA.

Greta Tubbesing, MD

For many years, a standard treatment of providing morphine, oxygen, nitroglycerin, and aspirin (MONA) was the standard initial treatment approach for all patients presenting with chest pain due to suspected myocardial ischemia.

In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.

There is controversy over the safety of routine morphine use for patients with chest pain.

Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.¹ Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.² Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.³

Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).⁴ They found no increase in in-hospital complications or 1-year mortality.

The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.^5,6

It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.⁷

The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.

In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).⁸ They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.

Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.⁹

This year, a large randomized trial of 6,629 patients across 35 Swedish hospitals was published by Robin Hofmann, MD, and colleagues.¹⁰ The DETO2X-AMI study compared 6 L/min of oxygen delivered for an average of 11.6 hours to ambient air in normoxemic patients with suspected MI (76% with ultimately confirmed MI). They found no difference in death at 30 days or 1 year. While this finding reinforced the lack of benefit of supplemental oxygen shown in the AVOID trial, the findings by Dr. Stub and colleagues of increased tissue damage were not borne out: Both groups showed similar troponin levels.

Where does all this leave us in the treatment of suspected MI?

Morphine should only be used when the patient has pain, and is probably best reserved for severe pain, as the safety of its use is not clear. While hypoxemia is a common consequence of MI – and may correlate with worse outcomes – treatment with supplemental oxygen in the absence of hypoxemia is not supported by current evidence, and may carry risk of harm. Nitroglycerin should be avoided in patients with right ventricular infarcts, and in patients who present with hypotension.
 

 

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

References

1. Am Heart J. 2005 Jun;149(6):1043-9.

2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.

3. Clin Res Cardiol. 2015 Sep;104(9):727-34.

4. Eur Heart J. 2016 Apr 1;37(13):1063-71.

5. BMJ. 1900 Dec 1;2(2083):1568.

6. JAMA. 1930 May 3;94(18):1363-5.

7. Br Med J. 1976 May 8;1(6018):1121-3.

8. Circulation. 2015 Jun 16;131(24):2143-50.

9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.

10. N Engl J Med. 2017 Sep 28;377(13):1240-9.

 

A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.

Which of these treatments do you recommend?

A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).

B. Oxygen, morphine, ASA.

C. ASA.

Greta Tubbesing, MD

For many years, a standard treatment of providing morphine, oxygen, nitroglycerin, and aspirin (MONA) was the standard initial treatment approach for all patients presenting with chest pain due to suspected myocardial ischemia.

In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.

There is controversy over the safety of routine morphine use for patients with chest pain.

Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.¹ Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.² Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.³

Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).⁴ They found no increase in in-hospital complications or 1-year mortality.

The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.^5,6

It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.⁷

The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.

In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).⁸ They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.

Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.⁹

This year, a large randomized trial of 6,629 patients across 35 Swedish hospitals was published by Robin Hofmann, MD, and colleagues.¹⁰ The DETO2X-AMI study compared 6 L/min of oxygen delivered for an average of 11.6 hours to ambient air in normoxemic patients with suspected MI (76% with ultimately confirmed MI). They found no difference in death at 30 days or 1 year. While this finding reinforced the lack of benefit of supplemental oxygen shown in the AVOID trial, the findings by Dr. Stub and colleagues of increased tissue damage were not borne out: Both groups showed similar troponin levels.

Where does all this leave us in the treatment of suspected MI?

Morphine should only be used when the patient has pain, and is probably best reserved for severe pain, as the safety of its use is not clear. While hypoxemia is a common consequence of MI – and may correlate with worse outcomes – treatment with supplemental oxygen in the absence of hypoxemia is not supported by current evidence, and may carry risk of harm. Nitroglycerin should be avoided in patients with right ventricular infarcts, and in patients who present with hypotension.
 

 

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

References

1. Am Heart J. 2005 Jun;149(6):1043-9.

2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.

3. Clin Res Cardiol. 2015 Sep;104(9):727-34.

4. Eur Heart J. 2016 Apr 1;37(13):1063-71.

5. BMJ. 1900 Dec 1;2(2083):1568.

6. JAMA. 1930 May 3;94(18):1363-5.

7. Br Med J. 1976 May 8;1(6018):1121-3.

8. Circulation. 2015 Jun 16;131(24):2143-50.

9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.

10. N Engl J Med. 2017 Sep 28;377(13):1240-9.

 

Years ago, after the revelation of sexual predations of male members of the U.S. Navy upon their female underlings, the Navy announced a “zero tolerance” policy. I, then the chair of the American Psychiatric Association Committee on Women, was invited to address a meeting of top Naval officers. They seemed dismayed when I told them that zero tolerance was just the beginning. Declarations that certain behaviors are unacceptable are facile, flimsy, and ultimately disingenuous substitutes for the infinitely more difficult task of monitoring and policing forbidden behaviors and protecting potential and actual victims.

The United States, I pointed out, has a zero tolerance policy on murder but still has to maintain a large force of police officers, detectives, judges, and prison guards to enforce that policy. The Navy had to have a similar approach to sexual assaults. Judging from the recent reports of female members of the military, that hasn’t happened.

However, as we know all too well, sexual harassment is a phenomenon plaguing many segments of society, from the film industry to the news media to politics – and beyond. Men also are victims of sexual harassment and assault, and the negative reactions they endure are as least as severe as are those of women. As these reports surface, several key questions arise for those of us who treat patients: What accounts for the guilt and embarrassment that women feel after they have been victimized, and what can psychiatrists say to patients to help them process these breaches? Also, how can we differentiate between clear harassment and uncomfortable sexual transgressions that are grayer in nature?

Clarity in the law

Unwanted physical intrusion by one adult on another is against the law in the United States. Then why do we need laws specifically banning rape? In addition to the fact that rape, unlike any other assault, can result in conception, sexual assault is recognized as a particularly and uniquely evil and damaging invasion and degradation.

Although there are cultural differences about responsibility for rape, and whether marriage obviates a woman’s right to refuse sexual contact, there is little or no dispute about the need to recognize rape as a distinct, degrading, and particularly heinous attack. It is, therefore, no surprise that people who are raped feel soiled, shamed, and degraded. Those feelings are exacerbated by centuries of shifting responsibility for sexual assault, whether forced intercourse or other unwanted sexual behavior, from the perpetrator onto the victim.

The shifting of blame has been rejected in theory, but it very much persists in actuality. Who among us does not wonder how the victim was dressed or why (s)he was on that street, at that party, in that man’s room? Other forms of harassment echo the motivations of rape – to demonstrate the unanswerable power to degrade – and result in similar psychological responses.

The recent media revelations have lumped physical assault together with unwanted touching, sexual acts undergone as a result of psychological coercion, unwanted exposure to perpetrators’ genitalia and masturbation, and offensive sexual requests and comments. All of those acts are wrong, but they are not equivalent. An elderly man in a wheelchair grabbing an adult woman’s buttocks is not in the same category as an adult man sexually assaulting an underage girl.

What is the genesis of all this misbehavior? It’s not just about sex; it’s about sex and power. For many men, bragging about sexual conquests and making derogatory remarks about women’s physical appearance demonstrate machismo – define maleness.

It is not surprising that such comments are called “locker room talk”; sports are macho displays as well. Physically violating sexual boundaries is just the talk put into action. And macho works. Last November, more than 40% of female voters in the United States voted for the candidate who reportedly cheated on at least one of his three wives, bragged about unwanted sexual assault, and has been credibly accused of many other illegal and/or inappropriate behaviors.

Where does it end?

What is going to be the result of all this hullabaloo? The list of convincingly accused perpetrators grows by the day. Sexism and sexual misbehavior are endemic in every sphere of human endeavor, up to and including, of course, the clergy, who are meant to be models and protectors of virtue. The scope of recent revelations may be unusual, but revelations about one sector or another have happened every few years: the military, clergy, Wall Street, Silicon Valley, academia. What would happen if all the sexual misbehavior were to be revealed, and the perpetrators removed from their leadership and management positions? Would we have a film industry, a financial industry, a legislature? I saw a headline somewhere: “He’s always indispensable; you never are.” The argument, or myth, of indispensability is a powerful protection for powerful individuals. The powerful are too powerful to tolerate mass expulsions. Already, Congress has resorted to the time-honored and demonstrably useless response: training. Others among the accused report that they are undergoing treatment of sex addiction, a diagnosis our profession has wisely discarded, and for which there was no effective treatment.

Sex, while not addictive, does have a role in sexual misbehavior. Through the ages, women’s reproductive hormones have been a focus of social and medical attention, as the source of unpleasant behaviors, and, in fact, psychopathology: premenstrual dysphoric disorder, postpartum depression. Little or no attention has been paid to the problematic psychosocial effects of male reproductive hormones. In addition to the offensive behaviors currently in the headlines, there is the behavior of adolescent males. Isn’t reckless driving related to the pubertal influx of testosterone (Neurosci Biobehav Rev. 2006;30[3]:319-45)? This gender discrepancy deserves scientific and social attention.

What can psychiatrists do to help women (and men) who are affected by sexual misbehavior? This is a difficult problem. What would help most victims, of any injustice, most would be to confront those responsible, and see them removed from positions of power and otherwise punished. However, the recent reports of seemingly swift and severe responses are misleading. The responsible journalists who have reported these cases have, in most cases, devoted months to finding victimized women, persuading them to go public, and corroborating their accounts. The perpetrators, even when complaints have been made, have gone unpunished, and often been promoted, for years or even decades. Women who complain often are subject to employer retaliation.

So a treating psychiatrist is left with less-than-satisfactory recommendations and responses. The most important intervention is to identify and counter the patient’s inaccurate and damaging assumptions: that she was responsible, that she should and could have refused to tolerate the misbehavior, that she has been left tainted, impure. Some social groups and families will have reinforced the latter feeling. The remainder of the psychiatric intervention will be focused on the patient’s particular symptoms – of posttraumatic stress, anxiety, or depression – and the relationship between her symptoms, history, and psychodynamics. Group therapy or other support by women who have faced similar abuse may be helpful. I’m afraid that we will continue to have many such patients to treat.

Dr. Stotland, past president of the American Psychiatric Association, is professor of psychiatry, and obstetrics and gynecology, at Rush Medical College, Chicago. She has written numerous articles and books, including “Cutting Edge Medicine: What Psychiatrists Need to Know” (American Psychiatric Association Publishing, 2002).

 

Years ago, after the revelation of sexual predations of male members of the U.S. Navy upon their female underlings, the Navy announced a “zero tolerance” policy. I, then the chair of the American Psychiatric Association Committee on Women, was invited to address a meeting of top Naval officers. They seemed dismayed when I told them that zero tolerance was just the beginning. Declarations that certain behaviors are unacceptable are facile, flimsy, and ultimately disingenuous substitutes for the infinitely more difficult task of monitoring and policing forbidden behaviors and protecting potential and actual victims.

The United States, I pointed out, has a zero tolerance policy on murder but still has to maintain a large force of police officers, detectives, judges, and prison guards to enforce that policy. The Navy had to have a similar approach to sexual assaults. Judging from the recent reports of female members of the military, that hasn’t happened.

However, as we know all too well, sexual harassment is a phenomenon plaguing many segments of society, from the film industry to the news media to politics – and beyond. Men also are victims of sexual harassment and assault, and the negative reactions they endure are as least as severe as are those of women. As these reports surface, several key questions arise for those of us who treat patients: What accounts for the guilt and embarrassment that women feel after they have been victimized, and what can psychiatrists say to patients to help them process these breaches? Also, how can we differentiate between clear harassment and uncomfortable sexual transgressions that are grayer in nature?

Clarity in the law

Unwanted physical intrusion by one adult on another is against the law in the United States. Then why do we need laws specifically banning rape? In addition to the fact that rape, unlike any other assault, can result in conception, sexual assault is recognized as a particularly and uniquely evil and damaging invasion and degradation.

Although there are cultural differences about responsibility for rape, and whether marriage obviates a woman’s right to refuse sexual contact, there is little or no dispute about the need to recognize rape as a distinct, degrading, and particularly heinous attack. It is, therefore, no surprise that people who are raped feel soiled, shamed, and degraded. Those feelings are exacerbated by centuries of shifting responsibility for sexual assault, whether forced intercourse or other unwanted sexual behavior, from the perpetrator onto the victim.

The shifting of blame has been rejected in theory, but it very much persists in actuality. Who among us does not wonder how the victim was dressed or why (s)he was on that street, at that party, in that man’s room? Other forms of harassment echo the motivations of rape – to demonstrate the unanswerable power to degrade – and result in similar psychological responses.

The recent media revelations have lumped physical assault together with unwanted touching, sexual acts undergone as a result of psychological coercion, unwanted exposure to perpetrators’ genitalia and masturbation, and offensive sexual requests and comments. All of those acts are wrong, but they are not equivalent. An elderly man in a wheelchair grabbing an adult woman’s buttocks is not in the same category as an adult man sexually assaulting an underage girl.

What is the genesis of all this misbehavior? It’s not just about sex; it’s about sex and power. For many men, bragging about sexual conquests and making derogatory remarks about women’s physical appearance demonstrate machismo – define maleness.

It is not surprising that such comments are called “locker room talk”; sports are macho displays as well. Physically violating sexual boundaries is just the talk put into action. And macho works. Last November, more than 40% of female voters in the United States voted for the candidate who reportedly cheated on at least one of his three wives, bragged about unwanted sexual assault, and has been credibly accused of many other illegal and/or inappropriate behaviors.

Where does it end?

What is going to be the result of all this hullabaloo? The list of convincingly accused perpetrators grows by the day. Sexism and sexual misbehavior are endemic in every sphere of human endeavor, up to and including, of course, the clergy, who are meant to be models and protectors of virtue. The scope of recent revelations may be unusual, but revelations about one sector or another have happened every few years: the military, clergy, Wall Street, Silicon Valley, academia. What would happen if all the sexual misbehavior were to be revealed, and the perpetrators removed from their leadership and management positions? Would we have a film industry, a financial industry, a legislature? I saw a headline somewhere: “He’s always indispensable; you never are.” The argument, or myth, of indispensability is a powerful protection for powerful individuals. The powerful are too powerful to tolerate mass expulsions. Already, Congress has resorted to the time-honored and demonstrably useless response: training. Others among the accused report that they are undergoing treatment of sex addiction, a diagnosis our profession has wisely discarded, and for which there was no effective treatment.

Sex, while not addictive, does have a role in sexual misbehavior. Through the ages, women’s reproductive hormones have been a focus of social and medical attention, as the source of unpleasant behaviors, and, in fact, psychopathology: premenstrual dysphoric disorder, postpartum depression. Little or no attention has been paid to the problematic psychosocial effects of male reproductive hormones. In addition to the offensive behaviors currently in the headlines, there is the behavior of adolescent males. Isn’t reckless driving related to the pubertal influx of testosterone (Neurosci Biobehav Rev. 2006;30[3]:319-45)? This gender discrepancy deserves scientific and social attention.

What can psychiatrists do to help women (and men) who are affected by sexual misbehavior? This is a difficult problem. What would help most victims, of any injustice, most would be to confront those responsible, and see them removed from positions of power and otherwise punished. However, the recent reports of seemingly swift and severe responses are misleading. The responsible journalists who have reported these cases have, in most cases, devoted months to finding victimized women, persuading them to go public, and corroborating their accounts. The perpetrators, even when complaints have been made, have gone unpunished, and often been promoted, for years or even decades. Women who complain often are subject to employer retaliation.

So a treating psychiatrist is left with less-than-satisfactory recommendations and responses. The most important intervention is to identify and counter the patient’s inaccurate and damaging assumptions: that she was responsible, that she should and could have refused to tolerate the misbehavior, that she has been left tainted, impure. Some social groups and families will have reinforced the latter feeling. The remainder of the psychiatric intervention will be focused on the patient’s particular symptoms – of posttraumatic stress, anxiety, or depression – and the relationship between her symptoms, history, and psychodynamics. Group therapy or other support by women who have faced similar abuse may be helpful. I’m afraid that we will continue to have many such patients to treat.

Dr. Stotland, past president of the American Psychiatric Association, is professor of psychiatry, and obstetrics and gynecology, at Rush Medical College, Chicago. She has written numerous articles and books, including “Cutting Edge Medicine: What Psychiatrists Need to Know” (American Psychiatric Association Publishing, 2002).

 

Years ago, after the revelation of sexual predations of male members of the U.S. Navy upon their female underlings, the Navy announced a “zero tolerance” policy. I, then the chair of the American Psychiatric Association Committee on Women, was invited to address a meeting of top Naval officers. They seemed dismayed when I told them that zero tolerance was just the beginning. Declarations that certain behaviors are unacceptable are facile, flimsy, and ultimately disingenuous substitutes for the infinitely more difficult task of monitoring and policing forbidden behaviors and protecting potential and actual victims.

The United States, I pointed out, has a zero tolerance policy on murder but still has to maintain a large force of police officers, detectives, judges, and prison guards to enforce that policy. The Navy had to have a similar approach to sexual assaults. Judging from the recent reports of female members of the military, that hasn’t happened.

However, as we know all too well, sexual harassment is a phenomenon plaguing many segments of society, from the film industry to the news media to politics – and beyond. Men also are victims of sexual harassment and assault, and the negative reactions they endure are as least as severe as are those of women. As these reports surface, several key questions arise for those of us who treat patients: What accounts for the guilt and embarrassment that women feel after they have been victimized, and what can psychiatrists say to patients to help them process these breaches? Also, how can we differentiate between clear harassment and uncomfortable sexual transgressions that are grayer in nature?

Clarity in the law

Unwanted physical intrusion by one adult on another is against the law in the United States. Then why do we need laws specifically banning rape? In addition to the fact that rape, unlike any other assault, can result in conception, sexual assault is recognized as a particularly and uniquely evil and damaging invasion and degradation.

Although there are cultural differences about responsibility for rape, and whether marriage obviates a woman’s right to refuse sexual contact, there is little or no dispute about the need to recognize rape as a distinct, degrading, and particularly heinous attack. It is, therefore, no surprise that people who are raped feel soiled, shamed, and degraded. Those feelings are exacerbated by centuries of shifting responsibility for sexual assault, whether forced intercourse or other unwanted sexual behavior, from the perpetrator onto the victim.

The shifting of blame has been rejected in theory, but it very much persists in actuality. Who among us does not wonder how the victim was dressed or why (s)he was on that street, at that party, in that man’s room? Other forms of harassment echo the motivations of rape – to demonstrate the unanswerable power to degrade – and result in similar psychological responses.

The recent media revelations have lumped physical assault together with unwanted touching, sexual acts undergone as a result of psychological coercion, unwanted exposure to perpetrators’ genitalia and masturbation, and offensive sexual requests and comments. All of those acts are wrong, but they are not equivalent. An elderly man in a wheelchair grabbing an adult woman’s buttocks is not in the same category as an adult man sexually assaulting an underage girl.

What is the genesis of all this misbehavior? It’s not just about sex; it’s about sex and power. For many men, bragging about sexual conquests and making derogatory remarks about women’s physical appearance demonstrate machismo – define maleness.

It is not surprising that such comments are called “locker room talk”; sports are macho displays as well. Physically violating sexual boundaries is just the talk put into action. And macho works. Last November, more than 40% of female voters in the United States voted for the candidate who reportedly cheated on at least one of his three wives, bragged about unwanted sexual assault, and has been credibly accused of many other illegal and/or inappropriate behaviors.

Where does it end?

What is going to be the result of all this hullabaloo? The list of convincingly accused perpetrators grows by the day. Sexism and sexual misbehavior are endemic in every sphere of human endeavor, up to and including, of course, the clergy, who are meant to be models and protectors of virtue. The scope of recent revelations may be unusual, but revelations about one sector or another have happened every few years: the military, clergy, Wall Street, Silicon Valley, academia. What would happen if all the sexual misbehavior were to be revealed, and the perpetrators removed from their leadership and management positions? Would we have a film industry, a financial industry, a legislature? I saw a headline somewhere: “He’s always indispensable; you never are.” The argument, or myth, of indispensability is a powerful protection for powerful individuals. The powerful are too powerful to tolerate mass expulsions. Already, Congress has resorted to the time-honored and demonstrably useless response: training. Others among the accused report that they are undergoing treatment of sex addiction, a diagnosis our profession has wisely discarded, and for which there was no effective treatment.

Sex, while not addictive, does have a role in sexual misbehavior. Through the ages, women’s reproductive hormones have been a focus of social and medical attention, as the source of unpleasant behaviors, and, in fact, psychopathology: premenstrual dysphoric disorder, postpartum depression. Little or no attention has been paid to the problematic psychosocial effects of male reproductive hormones. In addition to the offensive behaviors currently in the headlines, there is the behavior of adolescent males. Isn’t reckless driving related to the pubertal influx of testosterone (Neurosci Biobehav Rev. 2006;30[3]:319-45)? This gender discrepancy deserves scientific and social attention.

What can psychiatrists do to help women (and men) who are affected by sexual misbehavior? This is a difficult problem. What would help most victims, of any injustice, most would be to confront those responsible, and see them removed from positions of power and otherwise punished. However, the recent reports of seemingly swift and severe responses are misleading. The responsible journalists who have reported these cases have, in most cases, devoted months to finding victimized women, persuading them to go public, and corroborating their accounts. The perpetrators, even when complaints have been made, have gone unpunished, and often been promoted, for years or even decades. Women who complain often are subject to employer retaliation.

So a treating psychiatrist is left with less-than-satisfactory recommendations and responses. The most important intervention is to identify and counter the patient’s inaccurate and damaging assumptions: that she was responsible, that she should and could have refused to tolerate the misbehavior, that she has been left tainted, impure. Some social groups and families will have reinforced the latter feeling. The remainder of the psychiatric intervention will be focused on the patient’s particular symptoms – of posttraumatic stress, anxiety, or depression – and the relationship between her symptoms, history, and psychodynamics. Group therapy or other support by women who have faced similar abuse may be helpful. I’m afraid that we will continue to have many such patients to treat.

Dr. Stotland, past president of the American Psychiatric Association, is professor of psychiatry, and obstetrics and gynecology, at Rush Medical College, Chicago. She has written numerous articles and books, including “Cutting Edge Medicine: What Psychiatrists Need to Know” (American Psychiatric Association Publishing, 2002).

 

This past Thanksgiving weekend I left a message on my office machine that we were closed because my staff and I were camping in a tent outside a store to save $3 on socks on Black Friday.

Of course, I had the usual legal disclaimers about calling 911 for emergencies and how to reach the doctor on call, but the message was just silly.

This isn’t anything new for my practice. My patients are used to the occasional humor. Most of them probably expect it by now.

Does it put some people off? Probably. But hey, it’s my dinky little practice. Medicine is a serious business, and sometimes a sense of humor is all that keeps us sane.

It’s been 17 years since I left a large group and opened up my solo operation, and I’m still here. I have no regrets. My little practice may be eclectic. I wear shorts to work. My secretary’s 2 year old is at work everyday, keeping us laughing. I get to leave goofy messages on office voice mail. But it suits me.

This doesn’t change my focus of trying to practice competent neurology. I don’t claim to be the world’s best doctor, but I hope I know what I’m doing. I may be trying to have some fun here, but that doesn’t mean I take this job any less seriously.
 

Although things may change, right now I just can’t see myself as part of a large institution. I know my patients. I see each of them myself. I try to understand their concerns and backgrounds so I can treat them appropriately. I don’t try to cram them through in 10 minutes while checking off electronic medical record boxes to document “meaningful use” requirements.

Of course, the flip side is that I don’t make as much money as I could. But as long as I can stay open and support my family, I don’t care. I came here to help in a way that’s meaningful to both my patients and myself, and I’ve found it.

In the November 2017 issue of Medscape Business of Medicine was an article about physicians choosing private practice. Dr. Richard May, a nephrologist in Ohio, said: “We’ve opted to stay with this model because we control our lives. We know the cost of doing that is that we are probably not making as much as we could if we were with a system, but we get up every morning feeling good about how we practice medicine. We’re happy answering to no one but ourselves and not feeling any pressure to meet patient-load quotas and hit monetary goals.”

And all I can say to that is: “Amen, brother.”
 

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

 

This past Thanksgiving weekend I left a message on my office machine that we were closed because my staff and I were camping in a tent outside a store to save $3 on socks on Black Friday.

Of course, I had the usual legal disclaimers about calling 911 for emergencies and how to reach the doctor on call, but the message was just silly.

This isn’t anything new for my practice. My patients are used to the occasional humor. Most of them probably expect it by now.

Does it put some people off? Probably. But hey, it’s my dinky little practice. Medicine is a serious business, and sometimes a sense of humor is all that keeps us sane.

It’s been 17 years since I left a large group and opened up my solo operation, and I’m still here. I have no regrets. My little practice may be eclectic. I wear shorts to work. My secretary’s 2 year old is at work everyday, keeping us laughing. I get to leave goofy messages on office voice mail. But it suits me.

This doesn’t change my focus of trying to practice competent neurology. I don’t claim to be the world’s best doctor, but I hope I know what I’m doing. I may be trying to have some fun here, but that doesn’t mean I take this job any less seriously.
 

Although things may change, right now I just can’t see myself as part of a large institution. I know my patients. I see each of them myself. I try to understand their concerns and backgrounds so I can treat them appropriately. I don’t try to cram them through in 10 minutes while checking off electronic medical record boxes to document “meaningful use” requirements.

Of course, the flip side is that I don’t make as much money as I could. But as long as I can stay open and support my family, I don’t care. I came here to help in a way that’s meaningful to both my patients and myself, and I’ve found it.

In the November 2017 issue of Medscape Business of Medicine was an article about physicians choosing private practice. Dr. Richard May, a nephrologist in Ohio, said: “We’ve opted to stay with this model because we control our lives. We know the cost of doing that is that we are probably not making as much as we could if we were with a system, but we get up every morning feeling good about how we practice medicine. We’re happy answering to no one but ourselves and not feeling any pressure to meet patient-load quotas and hit monetary goals.”

And all I can say to that is: “Amen, brother.”
 

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

 

This past Thanksgiving weekend I left a message on my office machine that we were closed because my staff and I were camping in a tent outside a store to save $3 on socks on Black Friday.

Of course, I had the usual legal disclaimers about calling 911 for emergencies and how to reach the doctor on call, but the message was just silly.

This isn’t anything new for my practice. My patients are used to the occasional humor. Most of them probably expect it by now.

Does it put some people off? Probably. But hey, it’s my dinky little practice. Medicine is a serious business, and sometimes a sense of humor is all that keeps us sane.

It’s been 17 years since I left a large group and opened up my solo operation, and I’m still here. I have no regrets. My little practice may be eclectic. I wear shorts to work. My secretary’s 2 year old is at work everyday, keeping us laughing. I get to leave goofy messages on office voice mail. But it suits me.

This doesn’t change my focus of trying to practice competent neurology. I don’t claim to be the world’s best doctor, but I hope I know what I’m doing. I may be trying to have some fun here, but that doesn’t mean I take this job any less seriously.
 

Although things may change, right now I just can’t see myself as part of a large institution. I know my patients. I see each of them myself. I try to understand their concerns and backgrounds so I can treat them appropriately. I don’t try to cram them through in 10 minutes while checking off electronic medical record boxes to document “meaningful use” requirements.

Of course, the flip side is that I don’t make as much money as I could. But as long as I can stay open and support my family, I don’t care. I came here to help in a way that’s meaningful to both my patients and myself, and I’ve found it.

In the November 2017 issue of Medscape Business of Medicine was an article about physicians choosing private practice. Dr. Richard May, a nephrologist in Ohio, said: “We’ve opted to stay with this model because we control our lives. We know the cost of doing that is that we are probably not making as much as we could if we were with a system, but we get up every morning feeling good about how we practice medicine. We’re happy answering to no one but ourselves and not feeling any pressure to meet patient-load quotas and hit monetary goals.”

And all I can say to that is: “Amen, brother.”
 

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

 

Editor’s note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their first, second and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.

Piloting of data collection is finally underway! My mentor, Dr. Ian Jenkins, an attending in the Division of Hospital Medicine at the University of California, San Diego, and I are currently collaborating with the Surgical Intensive Care Unit at UC San Diego to conduct a daily review of urinary catheter (UC) necessity for patients on the unit, and subsequently coordinating with nursing staff on the unit to look for opportunities to implement UC alternatives.

Specifically, we are collecting data about the percentage of appropriate UC as well as data regarding the response to intervention for inappropriate UC identified. We decided to pilot the data in the ICU because of its excellent safety culture. A potential downside to piloting data on this hospital unit is that fewer catheters are typically removable in this setting, but we are hopeful that we will still obtain a rich data set, with a better understanding of how to expand data collection to other hospital units.

As far as timeline, we are past the halfway point. One thing that has surprised me is how long it has taken to get piloting phase underway. To that end, I think that our initial project timeline was ambitious, especially because we were unclear on how well initial project enthusiasm would translate into subsequent project participation. Up until this point, our research approach has largely been to fine tune each process prospectively. For instance, we decided a pilot run of data collection prior to final project data collection would allow us to ensure a smoother data collection process. While this has slowed things initially, we are optimistic that this will allow us to progress more quickly and smoothly in the latter stages of the project. We are not currently planning to change this research approach for the time being, but we are open to the idea depending on how well the data piloting phase progresses.

Outside of data collection, the project has provided an excellent opportunity to learn and improve clinical skills. Specifically, the project has improved my understanding of the indications for urinary catheter use, as well as helped me to develop a more critical mindset regarding medical indications in general. The project has made me more aware of the importance of really asking and thinking about why a patient is on a specific medication or using a specific medical device, which is something that is very helpful for anticipating and avoiding errors in the clinical setting.

Overall, I have enjoyed my participation in the project to date and it has increased my enthusiasm for participating in a quality improvement project.

Victor Ekuta is a third-year medical student at UC San Diego.

 

Editor’s note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their first, second and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.

Piloting of data collection is finally underway! My mentor, Dr. Ian Jenkins, an attending in the Division of Hospital Medicine at the University of California, San Diego, and I are currently collaborating with the Surgical Intensive Care Unit at UC San Diego to conduct a daily review of urinary catheter (UC) necessity for patients on the unit, and subsequently coordinating with nursing staff on the unit to look for opportunities to implement UC alternatives.

Specifically, we are collecting data about the percentage of appropriate UC as well as data regarding the response to intervention for inappropriate UC identified. We decided to pilot the data in the ICU because of its excellent safety culture. A potential downside to piloting data on this hospital unit is that fewer catheters are typically removable in this setting, but we are hopeful that we will still obtain a rich data set, with a better understanding of how to expand data collection to other hospital units.

As far as timeline, we are past the halfway point. One thing that has surprised me is how long it has taken to get piloting phase underway. To that end, I think that our initial project timeline was ambitious, especially because we were unclear on how well initial project enthusiasm would translate into subsequent project participation. Up until this point, our research approach has largely been to fine tune each process prospectively. For instance, we decided a pilot run of data collection prior to final project data collection would allow us to ensure a smoother data collection process. While this has slowed things initially, we are optimistic that this will allow us to progress more quickly and smoothly in the latter stages of the project. We are not currently planning to change this research approach for the time being, but we are open to the idea depending on how well the data piloting phase progresses.

Outside of data collection, the project has provided an excellent opportunity to learn and improve clinical skills. Specifically, the project has improved my understanding of the indications for urinary catheter use, as well as helped me to develop a more critical mindset regarding medical indications in general. The project has made me more aware of the importance of really asking and thinking about why a patient is on a specific medication or using a specific medical device, which is something that is very helpful for anticipating and avoiding errors in the clinical setting.

Overall, I have enjoyed my participation in the project to date and it has increased my enthusiasm for participating in a quality improvement project.

Victor Ekuta is a third-year medical student at UC San Diego.

 

Editor’s note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their first, second and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.

Piloting of data collection is finally underway! My mentor, Dr. Ian Jenkins, an attending in the Division of Hospital Medicine at the University of California, San Diego, and I are currently collaborating with the Surgical Intensive Care Unit at UC San Diego to conduct a daily review of urinary catheter (UC) necessity for patients on the unit, and subsequently coordinating with nursing staff on the unit to look for opportunities to implement UC alternatives.

Specifically, we are collecting data about the percentage of appropriate UC as well as data regarding the response to intervention for inappropriate UC identified. We decided to pilot the data in the ICU because of its excellent safety culture. A potential downside to piloting data on this hospital unit is that fewer catheters are typically removable in this setting, but we are hopeful that we will still obtain a rich data set, with a better understanding of how to expand data collection to other hospital units.

As far as timeline, we are past the halfway point. One thing that has surprised me is how long it has taken to get piloting phase underway. To that end, I think that our initial project timeline was ambitious, especially because we were unclear on how well initial project enthusiasm would translate into subsequent project participation. Up until this point, our research approach has largely been to fine tune each process prospectively. For instance, we decided a pilot run of data collection prior to final project data collection would allow us to ensure a smoother data collection process. While this has slowed things initially, we are optimistic that this will allow us to progress more quickly and smoothly in the latter stages of the project. We are not currently planning to change this research approach for the time being, but we are open to the idea depending on how well the data piloting phase progresses.

Outside of data collection, the project has provided an excellent opportunity to learn and improve clinical skills. Specifically, the project has improved my understanding of the indications for urinary catheter use, as well as helped me to develop a more critical mindset regarding medical indications in general. The project has made me more aware of the importance of really asking and thinking about why a patient is on a specific medication or using a specific medical device, which is something that is very helpful for anticipating and avoiding errors in the clinical setting.

Overall, I have enjoyed my participation in the project to date and it has increased my enthusiasm for participating in a quality improvement project.

Victor Ekuta is a third-year medical student at UC San Diego.

 

This month we learned of the passing of Dr. Marv Sleisenger. There are few physicians who have had a greater impact on our field than Dr. Sleisenger. He was a consummate gentleman, enthusiastic teacher, great mentor, authored hundreds of research papers, and edited the most famous textbook of gastroenterology. Our thoughts and hearts are with his family and friends.

Articles in this month’s issue cover some of the most difficult and vexing problems in gastroenterology. One article is a reminder to use colonoscopy resources wisely and back off surveillance intensity for some nonadvanced adenomas. Another highlights an issue that frustrates many of us – anesthesia’s requirement to intubate UGI bleeds – and may not be the best practice. The third brings up the ongoing issue of biosimilars. Deeper in the issue we cover interesting findings about nonmedicine therapy for abdominal distention. Project ECHO is a tremendous demonstration of how changing our care delivery process can enhance patient care and maintain safe therapies. We cover an article on ERCP outcomes – linked to high volume (important for individual physicians and for centers where procedures are performed).

I would like to highlight our liver coverage. AASLD had their annual meeting in Washington in November. My colleague at University of Michigan (Anna Lok, MD) is the current president and helped spearhead a meeting that was packed with research and clinical information. We will be covering AASLD in greater depth in the months to come.

And while initial efforts to repeal the ACA have stalled, several key parts of the ACA continue to be modified or repealed either by Executive Orders or as part of the current tax reform efforts. We continue to view these efforts through the lens of our patients’ access to care.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

 

This month we learned of the passing of Dr. Marv Sleisenger. There are few physicians who have had a greater impact on our field than Dr. Sleisenger. He was a consummate gentleman, enthusiastic teacher, great mentor, authored hundreds of research papers, and edited the most famous textbook of gastroenterology. Our thoughts and hearts are with his family and friends.

Articles in this month’s issue cover some of the most difficult and vexing problems in gastroenterology. One article is a reminder to use colonoscopy resources wisely and back off surveillance intensity for some nonadvanced adenomas. Another highlights an issue that frustrates many of us – anesthesia’s requirement to intubate UGI bleeds – and may not be the best practice. The third brings up the ongoing issue of biosimilars. Deeper in the issue we cover interesting findings about nonmedicine therapy for abdominal distention. Project ECHO is a tremendous demonstration of how changing our care delivery process can enhance patient care and maintain safe therapies. We cover an article on ERCP outcomes – linked to high volume (important for individual physicians and for centers where procedures are performed).

I would like to highlight our liver coverage. AASLD had their annual meeting in Washington in November. My colleague at University of Michigan (Anna Lok, MD) is the current president and helped spearhead a meeting that was packed with research and clinical information. We will be covering AASLD in greater depth in the months to come.

And while initial efforts to repeal the ACA have stalled, several key parts of the ACA continue to be modified or repealed either by Executive Orders or as part of the current tax reform efforts. We continue to view these efforts through the lens of our patients’ access to care.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

 

This month we learned of the passing of Dr. Marv Sleisenger. There are few physicians who have had a greater impact on our field than Dr. Sleisenger. He was a consummate gentleman, enthusiastic teacher, great mentor, authored hundreds of research papers, and edited the most famous textbook of gastroenterology. Our thoughts and hearts are with his family and friends.

Articles in this month’s issue cover some of the most difficult and vexing problems in gastroenterology. One article is a reminder to use colonoscopy resources wisely and back off surveillance intensity for some nonadvanced adenomas. Another highlights an issue that frustrates many of us – anesthesia’s requirement to intubate UGI bleeds – and may not be the best practice. The third brings up the ongoing issue of biosimilars. Deeper in the issue we cover interesting findings about nonmedicine therapy for abdominal distention. Project ECHO is a tremendous demonstration of how changing our care delivery process can enhance patient care and maintain safe therapies. We cover an article on ERCP outcomes – linked to high volume (important for individual physicians and for centers where procedures are performed).

I would like to highlight our liver coverage. AASLD had their annual meeting in Washington in November. My colleague at University of Michigan (Anna Lok, MD) is the current president and helped spearhead a meeting that was packed with research and clinical information. We will be covering AASLD in greater depth in the months to come.

And while initial efforts to repeal the ACA have stalled, several key parts of the ACA continue to be modified or repealed either by Executive Orders or as part of the current tax reform efforts. We continue to view these efforts through the lens of our patients’ access to care.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

 

At a time when the Department of Veterans Affairs is criticized for the care it delivers, and when some also see it threatened by privatization, it was refreshing to hear the VA praised for the quality of its hypertension care, a model for success in a new era of reduced blood pressure treatment targets and revised hypertension guidelines that classify millions more Americans as having hypertension.

“In systems of care, like the VA and Kaiser Permanente Northern California, we are doing much better with hypertension control, reaching control rates greater than 90%,” Paul Whelton, MD, said in November during a talk at the American Heart Association scientific sessions in Anaheim, Calif. In a separate report at the same meeting, Dr. Whelton, a professor of public health at Tulane University in New Orleans, first presented the new hypertension diagnosis and management guidelines, produced by the American College of Cardiology/American Heart Association panel that he chaired (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.006).

Mitchel L. Zoler/Frontline Medical News

Earlier, I asked Dr. Whelton specifically about the prospects for successful hypertension control as the number of targeted patients grows. He acknowledged that, overall, about half of all U.S. patients with hypertension currently have their blood pressure at goal, even when measured against the old target of less than 140/90 mm Hg rather than against the new target of less than 130/80 mm Hg. He also noted that even this very modest level of control allowed the United States, along with Canada, to “lead the world in blood pressure control.”

He again stressed that the VA and Kaiser are doing “remarkably well” when it came to controlling hypertension in the vast majority of their patients.

That assessment seems especially appropriate for Kaiser Permanente Northern California, Oakland, Calif. Data from an audit of Kaiser’s hypertension registry showed that during 2000-2013 the percentage of patients with hypertension at their goal blood pressure rose from 44% in 2000 to 90% in 2013 (J Clin Hypertension. 2016 April;18[4]:260-1). The two Kaiser researchers who reported these findings attributed the rise in control rates to a hypertension treatment program that Kaiser Permanente Northern California put into practice starting in 2000.

Current success in the VA Health System is harder to pin down and put in the Kaiser ballpark. The most up-to-date audit I could find was a 2012 report from a team of VA researchers who reviewed control rates of more than half a million hypertensive veterans at 15 VA medical centers during 2000-2010. They found that, during that 11-year period, the percentage of hypertensive patients with their blood pressure controlled to their target level had risen from 46% in 2000 to 76% in 2010 (Circulation. 2012 May 22;125[20]:2462-68).

While this 76% rate of control in 2010 is short of the 90% rate in Kaiser in 2013, it’s still not shabby. To put the 76% control rate in perspective, consider data reported at the AHA meeting from TargetBP, a national program begun in late 2015 to aid all U.S. health care programs in improving their hypertension control rates: This data showed that, among 310 participating programs that filed 2016 control-rate data with TargetBP, the average control rate was 66%. Specifically, of those 310 reporting programs, 191 (62%) had control rates that exceeded 70%, with an average control rate among these more successful programs of 76%.

But this 76% average was for 2016 versus the 76% success rate among VA patients during 2010. Given the trajectory of improving control among VA patients during 2000-2010, when the rate rose from 46% to 76%, it seems reasonable to suspect that this steady improvement continued such that by 2016 the control rate at these 15 centers may well have been higher than the 76% tallied in 2010.

As-yet-unpublished data collected by the VA show that other centers in the system beyond those 15 included in the study discussed above have also recently reached a similar control level of about 75%, said Vasilios Papademetriou, MD, a professor of medicine at Georgetown University and the director of the Interventional Hypertension and Vascular Medicine Program at the VA Medical Center in Washington. Plus, certain VA centers are now up to an 85% control rate, he added in an interview. “Blood pressure control rates have been exceptionally good in the VA medical system,” he declared. Dr. Papademetriou attributed the rising control rates to a concerted hypertension program the VA instituted starting in the early 2000s.

“The VA has had some physicians who have championed this issue, and they have built computer-based systems to identify patients with uncontrolled hypertension, and then they plug these patients into their care algorithms,” commented Donald M. Lloyd-Jones, MD, a professor and chairman of preventive medicine at Northwestern University in Chicago. “Often, when there are champions, things change,” he noted.

William C. Cushman, MD, a hypertension specialist who is chief of preventive medicine for the VA Medical Center in Memphis and professor of preventive medicine at the University of Tennessee, also in Memphis, highlighted several steps the VA took that have helped fuel the program’s success in controlling blood pressure.

“We began using electronic medical records earlier than most systems, and the medical staff receives feedback on which patients are not at their blood pressure goal,” he said in an interview. Also, patients receive their antihypertensive medications at little or no out-of-pocket cost, and once a patient is in the VA system, they receive long-term, comprehensive care.

Dr. Cushman couldn’t resist adding that this successful approach to hypertension management is now threatened by potential changes to the VA system that could take some patients out of the existing program and move them to privatized medical care. “If that happens, patients will not get the same comprehensive care” that until now has produced such high rates of hypertension control, he warned.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

 

At a time when the Department of Veterans Affairs is criticized for the care it delivers, and when some also see it threatened by privatization, it was refreshing to hear the VA praised for the quality of its hypertension care, a model for success in a new era of reduced blood pressure treatment targets and revised hypertension guidelines that classify millions more Americans as having hypertension.

“In systems of care, like the VA and Kaiser Permanente Northern California, we are doing much better with hypertension control, reaching control rates greater than 90%,” Paul Whelton, MD, said in November during a talk at the American Heart Association scientific sessions in Anaheim, Calif. In a separate report at the same meeting, Dr. Whelton, a professor of public health at Tulane University in New Orleans, first presented the new hypertension diagnosis and management guidelines, produced by the American College of Cardiology/American Heart Association panel that he chaired (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.006).

Mitchel L. Zoler/Frontline Medical News

Earlier, I asked Dr. Whelton specifically about the prospects for successful hypertension control as the number of targeted patients grows. He acknowledged that, overall, about half of all U.S. patients with hypertension currently have their blood pressure at goal, even when measured against the old target of less than 140/90 mm Hg rather than against the new target of less than 130/80 mm Hg. He also noted that even this very modest level of control allowed the United States, along with Canada, to “lead the world in blood pressure control.”

He again stressed that the VA and Kaiser are doing “remarkably well” when it came to controlling hypertension in the vast majority of their patients.

That assessment seems especially appropriate for Kaiser Permanente Northern California, Oakland, Calif. Data from an audit of Kaiser’s hypertension registry showed that during 2000-2013 the percentage of patients with hypertension at their goal blood pressure rose from 44% in 2000 to 90% in 2013 (J Clin Hypertension. 2016 April;18[4]:260-1). The two Kaiser researchers who reported these findings attributed the rise in control rates to a hypertension treatment program that Kaiser Permanente Northern California put into practice starting in 2000.

Current success in the VA Health System is harder to pin down and put in the Kaiser ballpark. The most up-to-date audit I could find was a 2012 report from a team of VA researchers who reviewed control rates of more than half a million hypertensive veterans at 15 VA medical centers during 2000-2010. They found that, during that 11-year period, the percentage of hypertensive patients with their blood pressure controlled to their target level had risen from 46% in 2000 to 76% in 2010 (Circulation. 2012 May 22;125[20]:2462-68).

While this 76% rate of control in 2010 is short of the 90% rate in Kaiser in 2013, it’s still not shabby. To put the 76% control rate in perspective, consider data reported at the AHA meeting from TargetBP, a national program begun in late 2015 to aid all U.S. health care programs in improving their hypertension control rates: This data showed that, among 310 participating programs that filed 2016 control-rate data with TargetBP, the average control rate was 66%. Specifically, of those 310 reporting programs, 191 (62%) had control rates that exceeded 70%, with an average control rate among these more successful programs of 76%.

But this 76% average was for 2016 versus the 76% success rate among VA patients during 2010. Given the trajectory of improving control among VA patients during 2000-2010, when the rate rose from 46% to 76%, it seems reasonable to suspect that this steady improvement continued such that by 2016 the control rate at these 15 centers may well have been higher than the 76% tallied in 2010.

As-yet-unpublished data collected by the VA show that other centers in the system beyond those 15 included in the study discussed above have also recently reached a similar control level of about 75%, said Vasilios Papademetriou, MD, a professor of medicine at Georgetown University and the director of the Interventional Hypertension and Vascular Medicine Program at the VA Medical Center in Washington. Plus, certain VA centers are now up to an 85% control rate, he added in an interview. “Blood pressure control rates have been exceptionally good in the VA medical system,” he declared. Dr. Papademetriou attributed the rising control rates to a concerted hypertension program the VA instituted starting in the early 2000s.

“The VA has had some physicians who have championed this issue, and they have built computer-based systems to identify patients with uncontrolled hypertension, and then they plug these patients into their care algorithms,” commented Donald M. Lloyd-Jones, MD, a professor and chairman of preventive medicine at Northwestern University in Chicago. “Often, when there are champions, things change,” he noted.

William C. Cushman, MD, a hypertension specialist who is chief of preventive medicine for the VA Medical Center in Memphis and professor of preventive medicine at the University of Tennessee, also in Memphis, highlighted several steps the VA took that have helped fuel the program’s success in controlling blood pressure.

“We began using electronic medical records earlier than most systems, and the medical staff receives feedback on which patients are not at their blood pressure goal,” he said in an interview. Also, patients receive their antihypertensive medications at little or no out-of-pocket cost, and once a patient is in the VA system, they receive long-term, comprehensive care.

Dr. Cushman couldn’t resist adding that this successful approach to hypertension management is now threatened by potential changes to the VA system that could take some patients out of the existing program and move them to privatized medical care. “If that happens, patients will not get the same comprehensive care” that until now has produced such high rates of hypertension control, he warned.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

 

At a time when the Department of Veterans Affairs is criticized for the care it delivers, and when some also see it threatened by privatization, it was refreshing to hear the VA praised for the quality of its hypertension care, a model for success in a new era of reduced blood pressure treatment targets and revised hypertension guidelines that classify millions more Americans as having hypertension.

“In systems of care, like the VA and Kaiser Permanente Northern California, we are doing much better with hypertension control, reaching control rates greater than 90%,” Paul Whelton, MD, said in November during a talk at the American Heart Association scientific sessions in Anaheim, Calif. In a separate report at the same meeting, Dr. Whelton, a professor of public health at Tulane University in New Orleans, first presented the new hypertension diagnosis and management guidelines, produced by the American College of Cardiology/American Heart Association panel that he chaired (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.006).

Mitchel L. Zoler/Frontline Medical News

Earlier, I asked Dr. Whelton specifically about the prospects for successful hypertension control as the number of targeted patients grows. He acknowledged that, overall, about half of all U.S. patients with hypertension currently have their blood pressure at goal, even when measured against the old target of less than 140/90 mm Hg rather than against the new target of less than 130/80 mm Hg. He also noted that even this very modest level of control allowed the United States, along with Canada, to “lead the world in blood pressure control.”

He again stressed that the VA and Kaiser are doing “remarkably well” when it came to controlling hypertension in the vast majority of their patients.

That assessment seems especially appropriate for Kaiser Permanente Northern California, Oakland, Calif. Data from an audit of Kaiser’s hypertension registry showed that during 2000-2013 the percentage of patients with hypertension at their goal blood pressure rose from 44% in 2000 to 90% in 2013 (J Clin Hypertension. 2016 April;18[4]:260-1). The two Kaiser researchers who reported these findings attributed the rise in control rates to a hypertension treatment program that Kaiser Permanente Northern California put into practice starting in 2000.

Current success in the VA Health System is harder to pin down and put in the Kaiser ballpark. The most up-to-date audit I could find was a 2012 report from a team of VA researchers who reviewed control rates of more than half a million hypertensive veterans at 15 VA medical centers during 2000-2010. They found that, during that 11-year period, the percentage of hypertensive patients with their blood pressure controlled to their target level had risen from 46% in 2000 to 76% in 2010 (Circulation. 2012 May 22;125[20]:2462-68).

While this 76% rate of control in 2010 is short of the 90% rate in Kaiser in 2013, it’s still not shabby. To put the 76% control rate in perspective, consider data reported at the AHA meeting from TargetBP, a national program begun in late 2015 to aid all U.S. health care programs in improving their hypertension control rates: This data showed that, among 310 participating programs that filed 2016 control-rate data with TargetBP, the average control rate was 66%. Specifically, of those 310 reporting programs, 191 (62%) had control rates that exceeded 70%, with an average control rate among these more successful programs of 76%.

But this 76% average was for 2016 versus the 76% success rate among VA patients during 2010. Given the trajectory of improving control among VA patients during 2000-2010, when the rate rose from 46% to 76%, it seems reasonable to suspect that this steady improvement continued such that by 2016 the control rate at these 15 centers may well have been higher than the 76% tallied in 2010.

As-yet-unpublished data collected by the VA show that other centers in the system beyond those 15 included in the study discussed above have also recently reached a similar control level of about 75%, said Vasilios Papademetriou, MD, a professor of medicine at Georgetown University and the director of the Interventional Hypertension and Vascular Medicine Program at the VA Medical Center in Washington. Plus, certain VA centers are now up to an 85% control rate, he added in an interview. “Blood pressure control rates have been exceptionally good in the VA medical system,” he declared. Dr. Papademetriou attributed the rising control rates to a concerted hypertension program the VA instituted starting in the early 2000s.

“The VA has had some physicians who have championed this issue, and they have built computer-based systems to identify patients with uncontrolled hypertension, and then they plug these patients into their care algorithms,” commented Donald M. Lloyd-Jones, MD, a professor and chairman of preventive medicine at Northwestern University in Chicago. “Often, when there are champions, things change,” he noted.

William C. Cushman, MD, a hypertension specialist who is chief of preventive medicine for the VA Medical Center in Memphis and professor of preventive medicine at the University of Tennessee, also in Memphis, highlighted several steps the VA took that have helped fuel the program’s success in controlling blood pressure.

“We began using electronic medical records earlier than most systems, and the medical staff receives feedback on which patients are not at their blood pressure goal,” he said in an interview. Also, patients receive their antihypertensive medications at little or no out-of-pocket cost, and once a patient is in the VA system, they receive long-term, comprehensive care.

Dr. Cushman couldn’t resist adding that this successful approach to hypertension management is now threatened by potential changes to the VA system that could take some patients out of the existing program and move them to privatized medical care. “If that happens, patients will not get the same comprehensive care” that until now has produced such high rates of hypertension control, he warned.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

 

For many, the holiday season is a time to celebrate, relax, and enjoy the company of family. Much of this celebrating centers on eating and food. For youth struggling with eating disorders, holidays can be a particularly challenging time. Historically, eating disorders were associated with young, straight, cisgender, white females. Data collected over the past 15 years suggest that eating disorders can affect youth of all ethnicities and genders.

Ingram Publishing/ThinkStock

Studies suggest that many adolescents engage in disordered eating behaviors. A national study in 2000 of high school students found that 25% of girls and 11% of boys reported disordered eating and weight control symptoms severe enough to warrant clinical evaluation.¹ Studies indicate that anorexia nervosa affects 0.3%-1% of adolescents, and bulimia nervosa affects approximately 0.9%-3% of adolescents.^2,3,4 Data in sexual and gender minority youth are sparse but suggest that these youth may be at increased risk of disordered eating behaviors. A 2015 study of 289,000 U.S. college students reported an approximately four times increased risk of eating disorder diagnosis and an approximately 2 times increased risk of disordered eating behaviors (diet pill use, vomiting, or laxative use).⁵ Two national studies of LGB-identified youth demonstrated higher rates of binge eating, purging, and diet pill use, compared with their heterosexual identified peers.^6,7

Below are some tips from the National Eating Disorder Association that may be helpful for youth struggling with an eating disorder over the holiday season:

• Eat regularly and in a consistent pattern. Avoid skipping meals or restricting intake in preparation for a holiday meal.

• Discuss any anticipated struggles around food or family with your parents, therapist, health care provider, dietitian, or other members of your support group. This can allow you to plan ahead for any challenges that may arise, and could prevent potential negative or harmful coping behaviors

• Think of someone to call if you are struggling with negative behaviors, thoughts, or emotions. Alert them ahead of time so they are aware of the possibility of you needing them for support.

• Consider choosing a loved one to be your “reality check” with food, to either help fix a plate for you or to give you sound feedback on the food portion sizes you make for yourself.

• Have a game plan before you go to a holiday event. Know who your support people are and how you’ll recognize when it may be time to make a quick exit and get connected with needed support.

• Avoid overextending yourself. A lower stress level can decrease the need to turn to eating-disordered behaviors or other unhelpful coping strategies.

• Work on being flexible in your thoughts. Learn to be flexible when setting guidelines for yourself and expectations of yourself and others. Strive to be flexible in what you can eat during the holidays. Take a holiday from self-imposed criticism, rigidity, and perfectionism.
 

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

Resources

National Eating Disorders Association: www.nationaleatingdisorders.org

“Body image and eating disorders among lesbian, gay, bisexual, and transgender youth” (Pediatr Clin North Am. 2016 Dec;63[6]:1079-90.

References

1. Prev Chronic Dis. 2008 Oct;5(4):A114.

2. Arch Gen Psychiatry. 2011 Jul;68(7):714-23.

3. Pediatr Clin North Am. 2016 Dec;63(6):1079-90.

4. Curr Psychiatry Rep. 2012 Aug;14(4):391-7.

5. J Adolesc Health. 2015 Aug;57(2):144-9.

6. Am J Public Health. 2013 Feb;103(2):e16-22.

7. J Adolesc Health. 2009 Sep;45(3):238-45.
 

 

For many, the holiday season is a time to celebrate, relax, and enjoy the company of family. Much of this celebrating centers on eating and food. For youth struggling with eating disorders, holidays can be a particularly challenging time. Historically, eating disorders were associated with young, straight, cisgender, white females. Data collected over the past 15 years suggest that eating disorders can affect youth of all ethnicities and genders.

Ingram Publishing/ThinkStock

Studies suggest that many adolescents engage in disordered eating behaviors. A national study in 2000 of high school students found that 25% of girls and 11% of boys reported disordered eating and weight control symptoms severe enough to warrant clinical evaluation.¹ Studies indicate that anorexia nervosa affects 0.3%-1% of adolescents, and bulimia nervosa affects approximately 0.9%-3% of adolescents.^2,3,4 Data in sexual and gender minority youth are sparse but suggest that these youth may be at increased risk of disordered eating behaviors. A 2015 study of 289,000 U.S. college students reported an approximately four times increased risk of eating disorder diagnosis and an approximately 2 times increased risk of disordered eating behaviors (diet pill use, vomiting, or laxative use).⁵ Two national studies of LGB-identified youth demonstrated higher rates of binge eating, purging, and diet pill use, compared with their heterosexual identified peers.^6,7

Below are some tips from the National Eating Disorder Association that may be helpful for youth struggling with an eating disorder over the holiday season:

• Eat regularly and in a consistent pattern. Avoid skipping meals or restricting intake in preparation for a holiday meal.

• Discuss any anticipated struggles around food or family with your parents, therapist, health care provider, dietitian, or other members of your support group. This can allow you to plan ahead for any challenges that may arise, and could prevent potential negative or harmful coping behaviors

• Think of someone to call if you are struggling with negative behaviors, thoughts, or emotions. Alert them ahead of time so they are aware of the possibility of you needing them for support.

• Consider choosing a loved one to be your “reality check” with food, to either help fix a plate for you or to give you sound feedback on the food portion sizes you make for yourself.

• Have a game plan before you go to a holiday event. Know who your support people are and how you’ll recognize when it may be time to make a quick exit and get connected with needed support.

• Avoid overextending yourself. A lower stress level can decrease the need to turn to eating-disordered behaviors or other unhelpful coping strategies.

• Work on being flexible in your thoughts. Learn to be flexible when setting guidelines for yourself and expectations of yourself and others. Strive to be flexible in what you can eat during the holidays. Take a holiday from self-imposed criticism, rigidity, and perfectionism.
 

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

Resources

National Eating Disorders Association: www.nationaleatingdisorders.org

“Body image and eating disorders among lesbian, gay, bisexual, and transgender youth” (Pediatr Clin North Am. 2016 Dec;63[6]:1079-90.

References

1. Prev Chronic Dis. 2008 Oct;5(4):A114.

2. Arch Gen Psychiatry. 2011 Jul;68(7):714-23.

3. Pediatr Clin North Am. 2016 Dec;63(6):1079-90.

4. Curr Psychiatry Rep. 2012 Aug;14(4):391-7.

5. J Adolesc Health. 2015 Aug;57(2):144-9.

6. Am J Public Health. 2013 Feb;103(2):e16-22.

7. J Adolesc Health. 2009 Sep;45(3):238-45.
 

 

For many, the holiday season is a time to celebrate, relax, and enjoy the company of family. Much of this celebrating centers on eating and food. For youth struggling with eating disorders, holidays can be a particularly challenging time. Historically, eating disorders were associated with young, straight, cisgender, white females. Data collected over the past 15 years suggest that eating disorders can affect youth of all ethnicities and genders.

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Studies suggest that many adolescents engage in disordered eating behaviors. A national study in 2000 of high school students found that 25% of girls and 11% of boys reported disordered eating and weight control symptoms severe enough to warrant clinical evaluation.¹ Studies indicate that anorexia nervosa affects 0.3%-1% of adolescents, and bulimia nervosa affects approximately 0.9%-3% of adolescents.^2,3,4 Data in sexual and gender minority youth are sparse but suggest that these youth may be at increased risk of disordered eating behaviors. A 2015 study of 289,000 U.S. college students reported an approximately four times increased risk of eating disorder diagnosis and an approximately 2 times increased risk of disordered eating behaviors (diet pill use, vomiting, or laxative use).⁵ Two national studies of LGB-identified youth demonstrated higher rates of binge eating, purging, and diet pill use, compared with their heterosexual identified peers.^6,7

Below are some tips from the National Eating Disorder Association that may be helpful for youth struggling with an eating disorder over the holiday season:

• Eat regularly and in a consistent pattern. Avoid skipping meals or restricting intake in preparation for a holiday meal.

• Discuss any anticipated struggles around food or family with your parents, therapist, health care provider, dietitian, or other members of your support group. This can allow you to plan ahead for any challenges that may arise, and could prevent potential negative or harmful coping behaviors

• Think of someone to call if you are struggling with negative behaviors, thoughts, or emotions. Alert them ahead of time so they are aware of the possibility of you needing them for support.

• Consider choosing a loved one to be your “reality check” with food, to either help fix a plate for you or to give you sound feedback on the food portion sizes you make for yourself.

• Have a game plan before you go to a holiday event. Know who your support people are and how you’ll recognize when it may be time to make a quick exit and get connected with needed support.

• Avoid overextending yourself. A lower stress level can decrease the need to turn to eating-disordered behaviors or other unhelpful coping strategies.

• Work on being flexible in your thoughts. Learn to be flexible when setting guidelines for yourself and expectations of yourself and others. Strive to be flexible in what you can eat during the holidays. Take a holiday from self-imposed criticism, rigidity, and perfectionism.
 

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

Resources

National Eating Disorders Association: www.nationaleatingdisorders.org

“Body image and eating disorders among lesbian, gay, bisexual, and transgender youth” (Pediatr Clin North Am. 2016 Dec;63[6]:1079-90.

References

1. Prev Chronic Dis. 2008 Oct;5(4):A114.

2. Arch Gen Psychiatry. 2011 Jul;68(7):714-23.

3. Pediatr Clin North Am. 2016 Dec;63(6):1079-90.

4. Curr Psychiatry Rep. 2012 Aug;14(4):391-7.

5. J Adolesc Health. 2015 Aug;57(2):144-9.

6. Am J Public Health. 2013 Feb;103(2):e16-22.

7. J Adolesc Health. 2009 Sep;45(3):238-45.